CN1204244A - Device. system and method for interstitial transvascular - Google Patents

Abstract

Methods and apparatus for using the vascular system as a conduit to reach other blood vessels within the body and extravascular sites. This includes methods for vascular reconstruction that establish extravascular access to allow blood flow between vessels. It also includes methods for performing transvascular interstitial surgery (TVIS), which establishes an extravascular access from one blood vessel to another blood vessel or non-vascular site within the body. According to the invention, apparatus for establishing extravascular access, or apparatus for modifying, regulating, maintaining, or closing such access, is also disclosed.

Description

Devices, systems and methods for interstitial transvascular access

Background of the Invention Percutaneous Transvascular Arterial Bypass

Atherosclerosis is a progressive disease caused by an obstruction, typically atherosclerotic plaque, that restricts blood flow in the lumen of an artery. Blockage of the heart and peripheral arteries can lead to pain, dysfunction, and even death. Over the past few years, a number of approaches have been used to revascularize tissues downstream of blocked arteries. These methods include bypass grafting using artificial, orthotopic veins or vein grafts, as well as angioplasty, atherectomy, and more recently, laser transmyocardial revascularization. Bypass grafting has proven to be very successful, but it requires great surgical skill. Recently, newer techniques such as transthoracic endoscopy have been adopted by Heartport, Inc. and Cardiothoracic Systems, Inc. adopted, demonstrating the need for a less invasive approach to coronary artery bypass establishment. These methods are very difficult to implement and cannot be widely applied. Transmyocardial laser revascularization, a technique in which multiple small holes are drilled in the heart wall, may seem practical, but the method has not been fully accepted, and there are still problems in the application of laser energy to create channels. The technique remains of great interest to clinicians because of its potential to be minimally invasive and eliminate the need to place the patient on cardiopulmonary bypass.

In the 1970s, several cardiovascular surgeons experimented with the use of cardiac veins for revascularization. This method is used in patients with severe diffuse stenosis of coronary vessels. This technique involves the use of the internal mammary artery or the aorta attached to the saphenous vein as a graft. Instead of being sutured to the distal end of the coronary artery, the graft is attached to the coronary artery or cardiac vein at the same location. Ligate the concentric end of the vein to prevent shunting, remove the patient's cardiopulmonary bypass device, and close the chest. In this mode, the veins are "arterialized," allowing the venules and capillaries to carry oxygenated blood in a retrograde fashion to the heart. The probability of success of this technique varies widely and has been largely abandoned. Problems include anastomotic stenosis, intracardiac hemorrhage from ruptured venules, and intragraft thrombosis.

The devices, systems and methods presented in this disclosure illustrate a new approach to percutaneous vascular reconstruction. Here, the cardiac vein can either be arterialized or simply used as a bypass graft. This point has not been shown to have been attempted in the literature. Orthotopic bypass grafts have been used peripherally, but still require incision to connect and ligate the venous ends. Another method, which has some similarities to this technique, is called the TIPS method—transjugular intrahepatic portosystemic shunt. In this method, a stent is placed in the liver tissue to connect the portal vein and the inferior vena cava. This method can be done percutaneously, does not have the purpose of reconstructing blood vessels for organs or establishing bypasses for blocked blood vessels, does not allow reverse flow of blood in any two blood vessels, is not accompanied by the formation of embolism, and requires the use of a graft stent. Furthermore, the devices and methods used in this method are too bulky to be directly applied to the small blood vessels of the heart. transvascular interstitial surgery

For many years, open surgery has been the only way to access tissue to perform surgical procedures. With the advent of the optical age, a variety of endoscopic methods have been developed. Initially, these methods utilize natural orifices such as the urethra, oral cavity, nasolacrimal duct, and anus. Recently, new techniques have been developed using transabdominal and transthoracic procedures. These thoracoscopic or laparoscopic approaches primarily employ long rod-shaped, bendable devices in open surgery. General anesthesia is required and there are still a few small wounds that need to heal.

Another problem with this method is the identification of anatomically consistent reference sites. For precision surgery, such as intracerebral surgery, a brace is usually attached to the patient's head to provide this reference. More recently, a "small rack" system has been developed which employs smaller racks equipped with several light emitting diodes (LEDs). These LEDs are interrelated with the three cameras equipped on the top. This helps establish the association between the stent and landmarks and ensures proper positioning of the device. While it may seem like a rudimentary attempt, it underscores the importance of getting exactly where you want.

Traditionally, access to the vascular system has been aimed solely at addressing vascular problems. Angioplasty, atherectomy, stents, laser angioplasty, thrombolysis, and even intracardiac biopsy devices are all designed for endovascular applications.

Summary of the invention

Provided herein is a device, system and method for using the vasculature as a conduit to place interventions in and out of the vessel wall. According to one embodiment, the device is introduced into the vasculature at a convenient entry point and then forwardly introduced to a specific target site where a surgical incision is made to allow the device or other devices to pass through or around the ostium into the tract inner space. In one embodiment, a system is used as access to a space for operable access. Such procedures may be freezing or partial removal of tissue; injection or infusion of drugs, substances or materials; removal, manipulation or repair of tissue; providing access for endoscopic inspection or diagnosis; placement of implantable or temporary devices; Vascular revascularization is aimed at the creation of an alternative conduit that allows blood to flow; or some other surgical procedure may be performed. In another embodiment, the system is used to make another incision in a blood vessel adjacent to the first incision to allow blood to flow through the conduit created by the device. This approach is useful for creating alternative vascular access to provide an alternative revascularization path, such as between the heart's coronary arteries and cardiac veins. With enhanced specificity, the system can be used to create coronary artery bypass, provide cardiac vein arterial or segmental grafting. In addition, the stability of the vessel-oriented distribution of anatomical landmarks provides an easy way to repeatedly access peripheral vasculature under imaging or other guidance. This is particularly useful for accessing the brain, kidney, lung, liver, spleen, and other tissues, and presents significant advantages over tissue marker localization, in vitro stents, or so-called "small scaffold" in vitro directional device systems. In the last embodiment, the system is used to make an incision at the concentric end of the vessel, then re-enter the vessel at the distal end of the vessel through tissue adjacent to the vessel. This is very beneficial in providing a blood flow bypass for perivascular injuries.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention utilizes the vascular system as a well-established conduit to any part of the body. The devices, systems and methods provide a new approach for surgical access to interstitial sites. The present invention provides a system for percutaneous access to any part of the body through the vascular system and provides a basic combination of instruments for several surgical and medical effects.

The invention provides a percutaneous blood vessel reconstruction method for the organ with diseased blood vessels. According to another embodiment of the present invention, establishment of all multiple coronary artery bypasses can be accomplished without thoracotomy, general anesthesia or cardiopulmonary bypass.

In order to provide a more comprehensive understanding of the present invention, the method of the present invention will be discussed with reference to the application of the device to percutaneously bypass the site of coronary artery injury in the heart. However, for those skilled in the art, it can be understood that the general method, system and device described in the present invention can also be used for surgical operations on any perivascular structure. The present invention provides a new concept in minimizing surgical trauma, that is, the vascular system is simply used as a channel to reach the desired surgical site. After reaching the surgical site with proper guidance, a device is used to pass through the perivascular region to allow the insertion of various instruments to perform the procedure. Examples of these methods may include, but are not limited to: intracranial access via blood vessels and interventional therapy or diagnosis of various perivascular tumors, hemorrhages, stroke-affected areas, and diseased areas; brain, heart, kidney, liver, lung or bone biopsy; transvascular implantation of drugs, materials, or devices such as receptors, radioactive tubules, magnetic iron particles, balloons, cells, or genetic material.

Referring to FIG. 1 , a typical coronary sinus guiding catheter 4 is shown, advanced to the vena cava 7 and into the heart 1 . Although not shown, the guiding catheter 4 has reached the coronary sinus located in the right atrium of the heart 1 . The guiding catheter is of a type well known in the art and includes a tip of sufficient compliance and size to allow atraumatic insertion into the coronary sinus, and a distal balloon to allow retrograde injection of contrast agent for imaging of the cardiac venous system. A transvascular interstitial surgery (TVIS) guide catheter 5 is inserted through the guide catheter, a cardiac vein 3 is inserted over a guide wire 28 , and a desired site adjacent to the coronary artery 2 is reached. This figure shows that the TVIS probe 27 is brought forward through the TVIS guiding catheter 5 , through the surgical incision on the cardiac vein 3 to the desired site of the coronary artery 2 .

FIG. 2 shows in more detail the various functions and components included in the TVIS guiding catheter 5 . The TVIS guiding catheter 5 is shown here advanced over a guide wire 28 to and positioned within the cardiac vein 3 . The TVIS guide catheter 5 also provides a balloon 21, the purpose of which is to block blood flow, balance the catheter in the lumen, or dilate the pathway. The TVIS guiding catheter 5 also provides either or both of an active orientation detection tool 23 and a passive orientation detection tool 22 . Those of ordinary skill in the art will appreciate that the passive directional detection tool 22 can be configured using any set of known materials that can detect the location by radiographic, fluoroscopy, magnetic or ultrasound and place the distal portion of the TVIS guiding catheter 5 in place. In vivo positioning. These materials include, but are not limited to: any radiopaque substance such as barium or steel; any magnetic ferrous substance such as ferrous substances; or any substance or composition capable of substantially interfering with sound waves, such as closed gas bubbles, scored metal or A few sheets. The active positioning detection tool 23 can perform 360° positioning on the distal end of the TVIS guiding catheter located in the blood vessel cavity. In this example, the blood vessel cavity is the cardiac vein 3 . The active orientation detection tool 23 can use any one of the following technical methods, but is not limited to this: the active orientation tool 23 can be a simple piezoelectric wire or a silicon plate, which can send and receive signals to detect the presence of blood flow in adjacent blood vessels or speed; this same device could also be a series of receivers in communication with the transmitter, the purpose of which is to provide an image of the surrounding tissue; Simple transmitter for signal sent by lead 202 - here lead 202 could be further modified to include a small receiver/transmitter 203 and harness 204 to be able to send the signal back once a signal from the active directional tool 23 is detected Surgeon; a reverse system is also applicable, i.e. a small receiver/transmitter 203 sends a signal to the active directional tool 23; the directional tool 23 can also send a signal to or receive a signal from any of a range of known signal generators, including ultrasound , electromagnetic, optical or radiative signals. The TVIS guiding catheter 5 presented here also has an additional opening allowing the selective injection of contrast media or fluids into a blood vessel, in this case the cardiac vein 3 . Once the positioning of the TVIS guiding catheter 5 is confirmed, the TVIS stylet 27 and TVIS sheath 26 can be passed through the vessel wall of the cardiac vein 3 and introduced anteriorly into the interstitial region 29 and the coronary artery 2 . The TVIS probe 27 and the TVIS sheath 26 do not necessarily have to be brought forward at the same time, and can have the following orientations: the TVIS sheath 26 can be a sharp or semi-rigid sleeve that can be inserted into the tissue alone; the TVIS probe 27 can be a relatively rigid wire , antenna, light guide or energy guide, can be inserted into the tissue alone with the support of the TVIS sheath 26; or in addition, the TVIS probe 27 and the TVIS sheath 26 can be connected together for operation, that is, both are inserted into the tissue together. The TVIS probe 27 and/or the TVIS sheath 26 provide the initial connection between the two blood vessels, the cardiac vein 3 and the coronary artery 2 . Once the TVIS sheath 26 is in place, another softer guide wire can be placed through it to allow additional devices to be introduced forward into another lumen to be accessed. Alternatively, if a different type of procedure is to be performed to access the interstitium, the guide wire may not be necessary. This maneuver can be used to create a bypass from the coronary artery 2 near the coronary artery stenosis 201 to the cardiac vein 3 and, in some cases, back to the coronary artery 2 .

Blockage of blood flow at one or more points within the cardiac veins is necessary to prevent direct shunting of blood from the coronary arteries back to the right atrium through the coronary sinus. Referring to FIG. 3 , once the tunnel is formed and confirmed to be large enough, an embolization device, such as an embolization balloon 33 , is used to block the blood flow in the cardiac vein 3 near the tissue channel 36 . This operation ensures that coronary blood flow 34 flows through tissue channel 36 against the cardiac vein in the direction indicated by arrows 35a and 35b. The embolic balloon 33 is placed and properly inflated using the embolic catheter 31 , which is detached from the catheter through the detachable portion 32 . Those skilled in the art will recognize that any of several devices and materials may be used for embolization purposes. These include detachable balloons, coils, bundles of coagulation-producing material, microfilamentous collagen, collagen sponges, cellulose gels or sponges such as Gelfoam(TM) or special stents. Figure 3 shows how these devices are used to re-arterialize the distally connected venous system. However, as shown in Figure 12, it is also feasible to simply provide a bypass by performing the same reverse operation at a suitable downstream location. It should be noted that these occlusive devices can also be used to block any undesired flow from the cardiac vein. Figures 4 and 9 will be referred to later in this text.

Figures 10A-10B and 11A-11B show two other occluding devices according to the present invention that can also be used to achieve the desired closure.

FIG. 10A shows a compressed collagen sponge 101 within an outer sheath 102 that can be delivered through a guide wire 51 . As shown in FIG. 10B , once the guide wire 51 enters the blood vessel to be embolized, the outer sheath 102 withdraws along the inner core 103 to expand the collagen sponge 101 in the blood vessel. Once delivery is complete, guide wire 51 and catheter assembly 102 and 103 are withdrawn, leaving the sponge in the desired location.

FIG. 11A shows a stent 112 for a one-way valve graft. Membrane 111 placed within stent 112 is cylindrical at flanks 116 and collapses on itself at flanks 113 to form a one-way valve. As shown in the longitudinal cross-sectional view of FIG. 11B, it allows blood flow in the direction indicated by arrow 114, and insertion of the device in that direction; but prevents blood flow in the direction indicated by arrow 115, and prevents insertion of the device in that direction. The one-way valve graft stent 112 is easily placed by catheter at the desired site and expandable at the site for positioning. Once the inner delivery catheter is removed, the membrane 111 can collapse, immediately forming a valve-like action.

As shown in Figure 4, in another embodiment, an occluding device may not be required. The graft stent 41 is placed through the tissue channel 36, and its coronary artery portion 41a and vein portion 41b are positioned as shown in the figure. The graft stent 41 can be coated with a material, dense mesh or cell matrix, so that the coronary blood flow 34 cannot easily flow through the outer wall of the graft stent 41 and flow to the stenosis 201, but through the established path, by The graft stent 41 flows into the cardiac vein 3 to generate a reverse cardiac vein blood flow 35 . In this figure, the position of the graft stent is shown: the TVIS guiding catheter is placed in the coronary artery 2, and the tissue channel 36 is established in the direction from the artery to the vein. This allows for proper positioning of the guide wire and subsequent stent, allowing for orientation of the device from the arterial to the venous direction. Obviously, a similar graft stent can also be placed downstream in the vein-to-arterial direction (for example, at the position corresponding to 1203 in FIG. bypass. The stent 41 must be dimensioned such that its proximal portion 41a and distal portion 41b , respectively, expand to a shape well suited to the wall of the vessel into which it is placed. Alternatively, as shown in FIG. 4 a , when the graft stent 410 is placed, neither the proximal portion 410 a nor the distal portion 410 b obstructs blood flow, but only serves to maintain the size of the tissue channel 36 .

Figure 5 shows how to dilate the tissue channel 36 using a standard balloon 52 placed through a guide wire 51, the purpose of which is to ensure that the tissue channel 36 has sufficient width to receive blood flow. Additionally, this step is necessary to properly dimension the tissue channel 36 prior to inserting other devices, such as stent 41 as seen in Figure 4, or stent 410 as seen in Figure 4a.

If sufficient material can be removed or resected between the coronary arteries 2 and the cardiac veins 3, a stent to maintain the size of the tissue channel 36 is not necessary. FIG. 6 shows a steam conduit 63 leading forward through the guide wire 51 . Here, energy 61 is delivered through the distal portion 62 of the steam conduit 63 to the tissue channel 36 to create a properly sized connection between the artery and vein. Those skilled in the art will recognize that the steam conduit 63 can also be used to deliver thermal energy, cutting energy, welding energy or coagulation energy, methods including but not limited to: laser, bipolar or monopolar radio frequency (RF), microwave, Ultrasound, hot wires, or radiation.

A stent as shown in Figures 4 and 4a is essential to control the size of the tissue channel 36, preventing it from expanding under pressure, or closing due to restenosis. Another method of permanently or temporarily maintaining the size of the tissue channel 36 during the healing and remodeling process is shown in FIG. 7 . A polymeric stent 71 is shown here covering the wall of the tissue channel 36 . The polymeric stent 71 can be placed by insertion and dilation using a balloon catheter, or established in situ using a variety of methods well known in the art and practiced by FOCAL(TM) Corporation of Massachusetts. The polymeric stent 71 provides temporary protection against restenosis or pseudoaneurysm formation and dissolves after a period of time, reducing the likelihood of any long-term tissue reaction effects.

Some of the created tissue channels may no longer be needed due to the high likelihood of complications such as restenosis or pseudoaneurysm. This problem can be solved using the methods shown in Figures 8, 9, 9a, 9b, 9c, 22, 22a and 23.

In FIG. 8 , the applied welding catheter system includes a welding catheter 81 at the proximal end and a welding catheter 86 at the distal end. After establishing a tissue channel in the interstitial region 29 between the cardiac vein 3 and the coronary artery 2, a guide wire 51 is inserted. Then, the distal end welding catheter 86 is advanced along the guide wire 51, and the distal proximal balloon 89 is inflated. Subsequently, the proximal welding catheter 81 is advanced along the distal welding catheter 86 . At this point, inflate the near-cardiac airbag 82 and pull the two airbags to the positions where the openings of the coronary artery 2 and the cardiac vein 3 are opposite to each other. The access balloon and weld conduit may be assembled with one or more of the following: inner weld electrode 83, opposite weld surfaces 87 and 88, return electrodes 85 and 84 and a thermocouple 801. In this case, bipolar RF energy can be applied to weld the two vessel openings together without other mechanical attachments. Energy is transferred either between opposite welding surfaces 87 and 88 or between inner welding electrode 83 and return electrodes 85 and 84 . In either case, the temperature of the local tissue in and around the two openings will be measured by thermocouple 801 and raised to the desired temperature. This temperature will be maintained for a period of time during which the tissue fuses. After fusion, the power is turned off, the bladder deflates, and the device is removed, leaving the two openings fused around it.

Figure 9 depicts the connection of two vascular openings using mechanical staple fixation. Staple fixation catheter 91 has outer sheath 96 , optional thermal coils 94 and 97 , staple 95 and micromechanical staple holder 93 . Staple fixation catheter 91 is advanced through tissue channel 36 until the device is well into coronary artery 2 . The outer diameter of the outer sheath 96 should be such that the tissue channel 36 between the two blood vessels can be slightly expanded. The outer sheath 96 is pulled back until the upper half of the staple 95 is fully exposed. This point of pullback is controlled by the proximal end of the catheter. Staple 95 is constructed either of a spring-like substance such as stainless steel, or of a highly resilient alloy so as to bend into position as seen in Figure 9a. This effect can also be accomplished by applying a shape memory material such as Nitinol and heating it through the coil 97 . Once the upper half of the staples 95 have reached their bent state, the staple fixing catheter 91 can be withdrawn, as shown in FIG. The outer sheath 96 can now be fully withdrawn (as shown in FIG. 9B ), allowing the lower half of the staple 95 to fit into the inner surface around the opening of the cardiac vein. This effect can also be accomplished by passive withdrawal of the sheath, or active application of thermal energy from the heating coil 94 . While the passive method is simpler, the active method allows the device to be reversed by applying an injection of cold saline. This point needs to be done when the insertion of the staple 95 is not completed accurately. Finally, once the staple position is confirmed, it can be released by the micromechanical staple holder 93, resulting in the staple 95 leaving the tissue channel 36 open as shown in FIG. 9C. Those skilled in the art will recognize that, besides the use of micromechanics, several methods can be used to release staples, including thermal material methods such as solder melting, thermal degradation of retained polymers or biomaterials, and mechanical methods such as retained wire removal, balloon expansion of weakly retained material, or non-locking movement of the stapled catheter 91 determined by the staples 95, the latter can only be accomplished after the staples are securely secured.

Figure 22 shows another embodiment for securing the two openings of two blood vessels together. This embodiment employs a distal guide catheter 2205 inserted through a guide wire 2206 . An upper small clip 2204 is secured to the distal guide catheter 2205 by a collapsible retention unit 2207 located adjacent thereto. This aggregate advances through the tissue channel 36 until it passes completely. In this example, since the upper clip 2204 is slightly larger than the diameter of the tissue channel 36 , the collapsible retention unit 2207 assists in expanding the tissue channel 36 . A proximal guiding catheter 2201 with a lower small clip 2202 at its top is advanced toward the tissue channel 36 through the distal guiding catheter 2201 . The two small clips 2204 and 2202 are drawn closer to each other until the prongs 2208 of the upper small clip 2204 pass through and lock into the receiving holes 2209 of the lower small clip 2202 . After successful locking, the collapsible retention unit 2207 collapses and the proximal and distal catheters are withdrawn, leaving behind a small clip as shown in Figure 22a. The collapsible retention unit can be, for example, a balloon, a compression resistant member of shape memory material, or a wire pin, and is controlled by the proximal end of the catheter.

Another welding device according to an embodiment of the present invention is shown in Figure 23 for details. A very similar technique to that of FIG. 8 is applied here, except that the energy is released from the central release core 2301 to the opposite openings of blood vessels 2 and 3 . In this example, the central delivery core is anteriorly positioned in the center of the catheter assemblies 81 and 86 to the midpoint of the tissue channel 36 after the two openings are opposed by the balloons 89 and 81 . Energy is released from the central release core, generating sufficient temperature in the local tissue surrounding the device to fuse it. Such energy and deliverers may be laser fibers emitting 360 degrees, microwave or other electromagnetic antennas, or localized device piezoelectric crystals or laser deliveries that generate ultrasound. A thermocouple 801 can be used to define and control the welding process.

Figure 12 shows the final results after completion of the coronary artery bypass procedure. The normal coronary blood flow 34 bypasses the stenosis 201 , enters the cardiac vein 3 through the tissue channel 1202 , and then returns to the coronary artery 2 through the tissue channel 1203 . A common embolization device 1201 is shown here, blocking the blood flow of the upper and lower reaches of the cardiac vein and its tributary veins 1204 . If only the cardiac vein is to be arterialized here, then only proximal embolization and accessories are required.

Figure 13 shows a typical TVIS entry port 1301 . The TVIS port has a cover 130 and an inlet 138 through which various devices can be introduced. Inlet 138 also has the function of maintaining pressure or hemostasis within the catheter or when a device is inserted through it. Conduit 133 has a proximal portion constituting shield 130 and a distal portion constituting tip 1302 . The TVIS access port 1301 may also provide a visibility marker 139 and a balancing balloon 134 at its distal location. After the TVIS guide catheter 5 shown in FIG. 5 reaches the interstitium and leaves a guide wire, the distal gun tip of the TVIS inlet 1301 is inserted percutaneously, and is led forward to the interstitium 138 through the guide wire. After confirming that the marker 139 is outside the blood vessel 132, the balloon 134 is inflated. Those skilled in the art will recognize that the method of balancing the tips may also include locking wires, expandable stents, and expandable graft fixation pattern stents. Once the TVIS access port is secured in place, a number of other devices can be inserted to perform medical or therapeutic interventions. These include endoscopes 135, surgical tools 136 such as needles, cannulas, catheter scissors, holders or biopsy devices, and energy delivery devices 137 such as laser fibers, bipolar and monopolar RF wires, microwave antennas, radiation delivery devices and heat transfer device. Once one or more TVIS access ports 1301 are in place, various surgical procedures can be performed through the vasculature in the surrounding tissue.

Figure 14 shows another embodiment of a TVIS guiding catheter 146 in accordance with the present invention. The TVIS guide catheter 146 is shown here with a distal tip 145 that is flexibly steerable. In this example, the steering of the distal tip 145 can be achieved by the shape memory material 142 embedded in the distal tip 145 of the device. When the material is heated by the heating coil 147, it can be quickly bent to the desired orientation. Working channel 143 provides a pre-route for required TVIS devices. Needle 141 is shown here injecting drug 140 into the perivascular tissue. As previously discussed, the TVIS guiding catheter 146 may also include an intravascular balancing balloon 144 , and passive visibility markers 148 .

Figure 15 shows the same TVIS catheter 146 with an additional component, active visibility device 23 as previously described. Also in Figure 16, the TVIS probe 27 and TVIS sheath 26 are shown exiting the working channel 143 where the distal tip 145 is located. Also shown is a flush channel 150 .

Figure 17 illustrates another method of creating precisely sized tissue channels 36, according to one embodiment of the present invention. A retrograde tissue cutter catheter assembly 173 is advanced through tissue channel 36 along guide wire 51 . The reverse tissue cutter catheter assembly 173 has a cylindrical blade 171 connected to the expansion gun head 170 . Tip 170 is advanced through tissue channel 36 until blade 171 is within artery 2 distal to the opening. Once this location has been found, a larger base catheter 172 is advanced into the vein 3, opposite its proximal opening. The blade 171 and gun tip 170 are then pulled back against the edge of the tissue channel 36, and when the cylindrical blade 171 is pressed against the base conduit 172, the severed tissue remains therein. After the assembly 173 is withdrawn, the size of the tissue channel 36 is exactly the size of the outer diameter of the cylindrical blade 171 .

Figure 18 shows a TVIS guiding catheter 182 with its distal balloon 181 and proximal balloon 182 isolating a section of the artery to be traversed, according to one embodiment of the present invention. This facilitates the use of TVIS guiding catheter 182 in high pressure vessels such as arteries. Such a conduit 182 can be used in a substantially similar manner to the conduit 5 of FIG. 2 .

Another method of bypassing a section of blood vessel according to one embodiment of the present invention is shown in Figures 19A and 19B. The TVIS guide catheter 146 shown in Fig. 19A is as described in Figs. 14 and 15, except that there is a distal tip 145 made of a plastic memory material 142 and capable of active control. The TVIS guiding catheter 146 shown here is passed through the surrounding tissue under the guidance of the stylet 27 and sheath 26 . Finally, catheter 146 creates a channel 190, as shown in Figure 19B, for allowing blood in artery 2 to flow from one point to another.

Figures 20, 20A and 20B illustrate the use of a transmyocardial revascularization device according to one embodiment of the present invention. FIG. 20 shows how the TVIS guiding catheter 5 is placed into the ventricle 2001 . The TVIS probe 27 is shown here creating an elongated channel 2003 through the myocardium 2000 . This channel provides a direct connection between the ventricle and the capillary bed located within the myocardium 2000 . Figure 20A shows how an alternative TVIS guiding catheter 146 of Figure 19A can be used to create these elongated channels 2003 within the heart. The TVIS guide catheter 146 in this example is further modified with a balloon tip 2002, the purpose of which is to cover the channel 2003 during the vaporization process; the balloon 2002 also helps to ensure insertion into the ventricular wall 2004, which is This is accomplished by providing suction from the catheter 146 to the opening at the distal end of the balloon 2002. Finally, Fig. 20B shows several channels 2003 created by the TVIS guiding catheter 5 through the blood vessels, allowing blood to flow directly from the blood vessels to the heart.

Figure 24A shows an edge-to-edge fistula graft stent 2400, according to one embodiment of the present invention. The graft stent 2400 is like a clover with different leaf heights. The two high lobes 2401 and 2403 and the two low lobes 2402 and 2404 are placed as shown in Figure 24B so that they are on either side of the vessel edge. An intervening portion 2405 perpendicular to the plane of the clover 2401-2404 is located within the channel created by the TVIS device. The device is deployed from within catheter 2407 positioned over guide wire 2408, as shown in Figure 24C. The inner sheath 2409 wraps the stent so that the clover leaves 2401 and 2403 are located at the distal end, while 2402 and 2404 are located at the proximal end. When the guide tube 2407 moves relative to the sheath 2409, the two distal clover leaves 2401 and 2403 are released, returning to the stent. The device is withdrawn until the clover leaves 2401 and 2403 are in contact with the inner surface of the distal vessel. Catheter 2407 is then moved further relative to sheath 2409, and proximal clover leaves 2402 and 2404 are released to the inner surface of the proximal vessel, as shown in Figure 24E.

Figure 25 shows in more detail the various types of devices that may be advanced through the TVIS catheter 146, according to one embodiment of the present invention. Dilator 2502 and sheath 2503 are shown here being advanced through vessel wall 2504 over guide wire 2501 .

Alternatively, a separate sheath as shown in Figure 13 can also be advanced. Figures 26A and 26B show the components of such a system in more detail. Initially, a locking guidewire 2602 is placed into tissue using a TVIS catheter. The guidewire has a very small locking knot 2604, the purpose of which is to anchor the guidewire within tissue during device exchange. Then, the TVIS port introduction assembly as shown in FIG. 26A is advanced over the locking guide wire 2602 . The assembly includes a dilator 2601 positioned within the catheter 133 . The catheter 133 also provides a balancing tool 134, here shown as a balloon. After the catheter 133 is in place, the balancing tool 134 is expanded and the dilator 2601 and locking guidewire 2602 are removed. Cover 1301 may or may not be fitted with a valve to prevent backflow of blood into catheter 133, as appropriate. Various devices can then be inserted into catheter 133 as previously described.

According to another embodiment of the invention, the TVIS catheter may be unit 2704 as seen in Figures 27A and 27B. Here, the TVIS catheter 2704 has a pre-formed bend, as shown in Figure 27A. When the catheter is compressed as shown in Figure 27B, it maintains a linear position. When the catheter 2704 is in a linear state (FIG. 27B), the guide wire 2701 is withdrawn from the guide wire tube 2709. When the catheter returns to its pre-formed shape (FIG. 27A), the guide wire 2701 will exit from the side hole 2702. quit. The TVIS probe 2703 is shown entering the other channel and can exit the top of the device at either location. Catheter 2704 can be used in the form of the other catheters described above, but has the advantage that the tip can be bent in a desired direction.

Figure 28 shows a TVIS catheter 2800 according to another embodiment of the invention. Here, the two openings of the blood vessel are formed using the evaporative energy beam 2805 instead of the probe. The method applies energy directing 2801, delivering energy to a deflection plate 2802, which in turn delivers energy into tissue. The operation time and energy level must be precisely set to ensure that the opposing walls of the vessel 2 are not damaged. Also shown is an optional guide wire 2804 that can be used to block or display a signal through which laser energy passes.

Figure 29 shows another mechanism for enlarging or cutting an incision, according to one embodiment of the invention. Here, the device is advanced over the guide wire 2903 through the tissue channel, moving the sheath 2904 relative to the central body 2902 and expanding the cutting wings 2901 . The cutting wings 2901 should be sharp, or apply additional energy, to widen the incision as the device is withdrawn from the tissue channel.

Figures 16 and 21 are intentionally omitted.

Claims (10)

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.

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