JP2006523515A - Medical devices and methods - Google Patents

Abstract

Catheter / dilator assembly (94), rapid exchange dilator assembly (116), funnel catheter (190,290), anastomosis medical device (348,380,386-392,410,418-422,434), etc. Medical devices and their associated methods.

Description

  The present invention relates to improved medical devices and methods.

  Obstructive vascular disease is a common illness in people and brings significant costs to the insurance system. The increase in blood clots and their associated plaques is the most common type of obstruction. Removing this disease from the body has been studied for many years and many techniques (devices and methods) have been studied and implemented. Sometimes the vascular disease / stenosis area can be removed using embolectomy, atherectomy, thrombolysis, etc., or the diseased blood vessels are repaired by angioplasty and / or stenting It is possible, but not all of these are effective. Accumulation of wavy plaque (arteriosclerosis) on the inner wall of the artery usually precedes clot formation. Several expensive devices (dilatation balloons, stents, mechanical cutters, etc.) have been introduced to combat this vaso-occlusive disease, all of which are “magic” to treat this common disease It has been found that it is not a bullet. Even if effective, these techniques are often effective only in a short time. Because all of the techniques and approaches for solving this medical condition have various problems, no particular method or device is considered as the most accepted treatment.

  Unfortunately, cancer is a common disease that causes more than 1,500 deaths every day in the United States (550,000 annually, the second leading cause of death in the United States after vascular disease). There are many cancer treatment methods, and they are continually being studied. Nevertheless, the preferred treatment remains the physical removal of cancer. If applicable, surgical removal is desirable (milk, colon, brain, lung, kidney, etc.). In many cases, these cancers occur in passages in the body that do not actually resemble blockages in blood vessels.

  In techniques for removing obstructions in the tubular passages in the body and / or bypassing them by self or artificial means (both surgical and percutaneous and minimally invasive techniques) Numerous techniques and devices are known, as with other pathological tissue removal, but once the diseased tissue has been removed, it is necessary to recombine healthy pieces of tissue. is there. This removed tissue may be removed for a number of reasons. Some of the reasons include (but are not limited to) cancerous or potentially carcinogenic substances, vascular diseases (or potential vascular diseases), tissue damage, tissue It is a congenital disease.

  The first problem is cost reduction. This has become particularly important in recent years, apparently for safety and hygiene reasons, as these are disposable devices. The device will not be widely used if it is much more expensive than other available alternatives, even if it is improved in some function.

  The second problem is to provide a device that is simple to use and easy to understand in the true sense. This will promote its application and use by medical personnel. This will also tend to keep costs low.

  A third challenge is to provide a device that requires procedures that allow medical professionals to become familiar with it and thereby continue to utilize the skills learned from past experience.

  The fourth problem relates to the effectiveness and thoroughness of the device, such as the removal of obstructions and the placement of complex devices. For example, it is recognized that any device is unlikely to provide 100 percent removal, but it is important that the maximum amount of obstruction be removed. With regard to bypass and recombination, it is important that the optimal amount of tissue be removed and thereby replaced, while recognizing that no device is likely to provide 100 percent optimization.

  The fifth issue relates to safety, i.e., matters that are often more important than other considerations. It is important to avoid tissue damage. In many situations, for example, it is important to avoid disrupting the obstruction so that the flushing element of the obstruction is scattered throughout the object. When using an anastomosis device within a tubular passage in the body, it is very important that the anastomosis is joined while avoiding tissue damage. Often, this damage is not immediately apparent after surgery. Furthermore, the leakage must be maintained near zero.

  There are trades in design considerations to achieve the five interrelated issues described above. Extreme simplicity and very simple procedures may overly sacrifice safety. Addressing all these considerations requires some trade between issues.

  An improved medical device and method are provided to address some or all of the above problems.

SUMMARY OF THE INVENTION A first aspect of the invention relates to a catheter / dilator assembly comprising a catheter assembly, a dilator, and a compression member. The catheter assembly is movable between a catheter having a proximal catheter end, a distal catheter end, a lumen, and an outer catheter surface, and between a radially expanded state and a radially contracted state. A substance guide member fixed to the distal end of the distal catheter and extending beyond the end, and the substance guide member has an axial length in the radially contracted state. The dilator comprises a hollow shaft within the lumen of the catheter, the hollow shaft being at the outer shaft surface, the proximal shaft end, the distal shaft end, and the distal shaft end. And a recessed region formed on the outer shaft surface. The recessed region and the substance guiding member are aligned substantially in line with each other. A compression member covers the substance guide member and temporarily holds the substance guide member in a radially contracted state. The recessed area is dimensioned to receive at least substantially the entire axial length of the material guide member so as to reduce a radial cross-sectional area of the assembly in the material guide member.

  A second aspect of the invention relates to a method for assembling a catheter / dilator assembly. A catheter assembly is selected. The catheter assembly is movable between a catheter having a proximal catheter end, a distal catheter end, a lumen, an outer catheter surface, and a radially expanded state and a radially contracted state. And a substance guide member which is fixed to the distal end of the distal catheter and extends beyond the distal end. The substance guide member has an axial length in the radially contracted state. A hollow shaft of a dilator is inserted through the proximal catheter end into the lumen of the catheter. A recess formed in the distal shaft end of the hollow shaft is positioned below the substance guide member. The substance guide member is disposed in the radially contracted state. A first sleeve in a proximal direction to a first position covering the distal shaft end of the dilator and beyond the material guide member to maintain the material guide member in the radially contracted state Slide.

  A third aspect of the invention relates to a dilator assembly. The longitudinal dilator comprises a proximal and distal portion, a dilator tip at the distal portion, and a dilator lumen extending along the dilator from the dilator tip to at least a first position. Prepare. The dilator further comprises a guidewire passage that extends from a second position to the first position in the proximal portion of the dilator. The dilator has an opening connecting the guidewire passage and the dilator lumen in the first position. A variable guidewire extends along the guidewire path, through the opening, the dilator lumen, and out of the dilator tip.

  A fourth aspect of the invention relates to a rapid exchange dilator assembly. The catheter has a catheter lumen extending between the distal catheter end and the proximal catheter end. A longitudinal dilator removably housed within the catheter lumen includes a proximal portion extending to a proximal dilator end, a distal portion extending to a dilator tip, and the dilator A dilator lumen extending along the dilator from the tip to at least a first position. The dilator includes a guidewire passage that extends from the proximal portion of the dilator to the first position. The dilator has an opening provided in the first position for connecting the guidewire passage and the dilator lumen. A variable guidewire comprising a guidewire proximal end and a guidewire distal end is disposed along the guidewire passage, through the opening, through the dilator lumen, and into the dilator. Extends from the tip. The guidewire proximal end and the proximal dilator end are positioned proximal to the proximal catheter end, and the guidewire distal end and the distal dilator end are Positioned distal to the distal catheter end. Thus, when the assembly is in a desired position in the body, the dilator can be removed while leaving the catheter and guidewire in place.

  A fifth aspect of the invention relates to a method for providing access to a target site within a patient's tubular structure. The distal catheter end of the first guide catheter is positioned at a first position within the patient's tubular structure. A rapid exchange dilator assembly is passed through the first catheter. The rapid exchange dilator assembly includes a second catheter, the second catheter includes a removable dilator, a guide wire, and a second catheter lumen, the second catheter lumen being the dilator. The container and the guide wire are accommodated. The dilator is removed from the patient while leaving the second catheter and the guidewire in the patient. A surgical device is passed through the second catheter to perform the treatment of the target site.

  According to a sixth aspect of the present invention, there is provided an outer tube, an inner tube that is slidably positioned in the outer tube, a first and second end portion, a radially expanded use state, and a diameter The present invention relates to a funnel catheter including a tubular sleeve movable between a contracted deployed state in a direction. The first end of the sleeve is secured to the distal end of the outer tube. The second end of the sleeve is fixed to the distal end of the inner tube. The sleeve is configured such that the position of the direction reversal region moves relative to the distal ends of the inner and outer tubes when the first and second ends move relative to each other. A movable, generally U-shaped direction reversal region, the direction reversal region constituting the distal funnel catheter end.

  A seventh aspect of the invention relates to a method for deploying a material guide member within a tubular structure within a patient. A funnel catheter having a distal funnel catheter end is selected. The funnel catheter has an outer tube, an inner tube slidably positioned in the outer tube, and first and second ends, and is between a radially expanded use state and a radially contracted and deployed state. The sleeve has a tubular sleeve movable, the first end of the sleeve being fixed to the distal end of the outer tube, and the second end of the sleeve being fixed to the distal end of the inner tube. Has been. The sleeve has a moveable and generally U-shaped direction reversal region that constitutes the distal funnel catheter end. The funnel catheter is deployed in a state where the sleeve is in a reduced diameter state and the sleeve is substantially parallel to the outer and inner tubes. The direction reversal region is positioned at a selected location within the tubular structure within the patient. The distal ends of the inner and outer tubes are moved relative to each other, thereby moving the position of the direction reversal region relative to the first and second ends and the sleeve to the distal funnel portion. And a distal funnel portion comprising a proximal funnel portion and contacting the inner wall of the tubular structure.

  An eighth aspect of the present invention relates to a method for manufacturing a funnel catheter. The material is wrapped over a mandrel to form a tubular braided sleeve comprising a proximal portion, a distal portion, a proximal end and a distal end. The proximal end is fixed in a first position on the outer tube and the distal end is fixed in a second position on the inner tube to form a funnel catheter.

  According to a ninth aspect of the present invention, there is provided a shaft including an end portion, a main lumen, and an expansion lumen, and is attached to the end portion of the shaft and is fluidly connected to the expansion lumen and is not radially contracted. The present invention relates to a balloon funnel catheter comprising an annular balloon that moves between an inflated state and a radially expanded, inflated state. The balloon forms an opening region that opens into the main lumen in the inflated state. The balloon extends distally beyond the end of the shaft in the inflated state.

  A tenth aspect of the present invention relates to a method of securing a tubular braid to a tube. The first end of the tubular braid is engaged with the end portion of the tube. The end portion comprises a tube material that can be temporarily softened. Thereafter, the temporary softening tube material is softened. The end portion of the tube and the first end of the tubular braid are fused together to form a tube material / tubular braid matrix.

  An eleventh aspect of the present invention relates to a method for controlling the shape of a radially braided tubular braiding device. The braided device has a radially expanded shape such that when the braided device is in a radially expanded state, the radially expanded shape has a length and a different cross-sectional area at selected positions along the length. Select. A material is selectively applied to at least a portion of the selected position along the braiding device. The stretch resistance of the material is adjusted according to the selected position. Accordingly, due to the different stretch resistances at these selected positions, the braiding device assumes the selected radially expanded shape when the braided device is in the radially expanded state.

  A twelfth aspect of the present invention relates to a method for imparting a shape to a thermoplastic film. At least a portion of the radially expandable device is surrounded by a thermoplastic membrane. The radially expandable device is radially expanded to a selected expanded shape, thereby shaping the thermoplastic film into an expanded state corresponding to the selected expanded shape. While in the expanded state, the thermoplastic membrane is set.

  According to a thirteenth aspect of the present invention, there is provided a tube having a first end portion, a second end portion, and a lumen extending therebetween, and the first end portion provided at the first end portion. An anastomosis medical device comprising an anchor member fixed to a first tubular structure of a patient, wherein the first tubular structure has a first opening inner surface, and the first opening inner surface opens into the lumen. is doing.

  A fourteenth aspect of the present invention relates to an anastomotic medical assembly comprising first and second anastomotic medical devices. The first anastomosis medical device is provided at a first tube having first and second ends and a first lumen extending therebetween, and at the first end of the first tube, A first anchor member for securing the first end of the first tube to a first tubular structure of the patient. The first tubular structure includes a first opening inner surface having a first opening inner surface that opens into the first lumen. The second anastomosis medical device is provided at the first end of the second tube, the second tube having first and second ends and a first lumen extending therebetween, A second anchor member for securing the first end of the second tube to a second tubular structure of the patient. The second tubular structure has a second opening inner surface having a second opening inner surface that opens into the second lumen. The second ends of the first and second tubes are connected to each other to form a fluid path between the first and second anchor members. Thus, the inner surfaces of the first and second openings of the first and second tubular structures of the patient can be fluidly connected.

  Various features and advantages of the present invention will become apparent from the following description, in which the preferred embodiment is set forth with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1 and 2 illustrate an expandable member guidewire in a radially contracted and radially expanded state.

  FIG. 3 illustrates another embodiment of the expandable member guidewire of FIG.

  FIG. 4 illustrates the needle inserted into the graft near the occlusion.

  5-7 illustrate the insertion of the expandable member guidewire through the needle of FIG. 4, expansion of the expandable member, and subsequent removal of the needle, leaving the guidewire in place.

  FIG. 8 illustrates a recessed dilator.

  FIG. 9 illustrates a funnel catheter assembly.

  9A is a cross-sectional view taken along line 9A-9A in FIG.

  FIG. 10 is an isometric view of the split stopper sleeve of FIG.

  FIG. 11 illustrates inserting the recessed dilator of FIG. 8 into the funnel catheter assembly of FIG. 9 to form a funnel catheter / dilator subassembly.

  12 and 13 illustrate the movement of the compression sleeve on the funnel-shaped member of FIG.

  FIG. 14 is an enlarged view of the peelable sleeve.

  14A is a cross-sectional view taken along line 14A-14A in FIG.

  FIG. 15 illustrates sliding the peelable sleeve of FIG. 14 over the subassembly of FIG. 11 to form a catheter / dilator assembly.

  16 illustrates the result of sliding the assembly of FIG. 15 over the expandable member guidewire of FIG.

  FIG. 17 illustrates the assembly of FIG. 16 after the peelable sleeve has been pulled proximally to allow the funnel to expand.

  FIG. 18 illustrates operating the device of FIG. 17 to move the closure into the funnel.

  18A is an enlarged sectional view taken along line 18A-18A in FIG.

  FIG. 19 is an enlarged side view of the proximal and distal portions of the rapid exchange dilator assembly.

  20 is a partial cross-sectional view of the distal end of the assembly of FIG.

  21 and 22 are cross-sectional views taken along lines 21-21 and 22-22 in FIGS. 19 and 20, respectively.

  FIG. 23 illustrates a heart having a bypass graft connecting the ascending aorta and the coronary artery.

  FIGS. 24-28 illustrate the use of the rapid exchange dilator assembly of FIG. 19 to access a position along the bypass graft of FIG.

  29 and 30 are cross-sectional views of the distal end of two examples of funnel catheters.

  FIG. 31 illustrates the funnel catheter of FIG. 30 in a radially expanded state.

  FIG. 32 illustrates another embodiment of the funnel catheter of FIG. 31 with an elastic film on its outer surface.

  FIGS. 33 and 34 illustrate placement and use of the funnel catheter of FIG. 30 within a vessel.

  FIG. 35 illustrates a mandrel having tapered proximal and distal portions that are wound in a braided fashion to form a braided structure.

  FIGS. 36-39 illustrate the braided structure of FIG. 35 used to manufacture the funnel catheter, wherein the braided structure is in an expanded diameter state within the large and small diameter vessels.

  FIG. 40 illustrates another embodiment of the embodiment of FIG.

  41 and 42 illustrate two different embodiments of the embodiment of FIG.

  43 and 44 illustrate two additional embodiments of the braided structure of FIG.

  45 and 46 illustrate another winding manner to form a more closely spaced turn at the proximal portion than at the distal portion.

  47 and 48 are similar to FIGS. 36 and 37 but illustrate the use of the winding style of FIG.

  FIG. 49 illustrates another winding modality for forming more closely spaced turns at the distal portion than at the proximal portion.

  50 and 51 are similar to FIGS. 47 and 48 but illustrate the use of the winding style of FIG.

  52 and 53 illustrate a balloon funnel catheter in a vessel near an obstruction, in a radially expanded and contracted state.

  FIG. 54 is an enlarged partial cross-sectional view of the balloon of FIG.

  55-58 illustrate the use of a heated tool and mandrel to secure the end of the tubular braid within the end portion of the tube.

  FIGS. 59 and 60 illustrate two embodiments of radially expandable and retractable braiding devices in which expansion is controlled by applying material over a portion of their length.

  61 and 62 illustrate the use of a radially expandable device to impart shape to the membrane.

  FIG. 63 illustrates a first end of an anastomotic medical device disposed within a tubular structure.

  FIGS. 64 and 65 illustrate the second end of the tube of the device of FIG. 63 and illustrate the actuator pulled proximally in FIG. 65 to expand the tubular braided anchor member of FIG.

  FIG. 66 illustrates the device of FIG. 63 with the tubular braided anchor member in the radially expanded state and the dilator and the guidewire removed.

  FIG. 67 is similar to FIG. 66 but illustrates the use of hooks to assist in securing the tubular braided anchor member to the tubular structure.

  68 and 69 illustrate the tubular mesh braid in the axially compressed and axially expanded state.

  FIG. 70 is similar to FIG. 68 but illustrates the use of hooks to help secure the tubular mesh braid to the vessel wall.

  FIG. 71 illustrates a tubular braided anastomosis medical device that covers both ends of a cut tubular structure.

  FIG. 72 illustrates an internally applied tubular braided anastomosis medical device used to secure the end of a cut tubular structure.

  73 and 74 illustrate the use of hooks to help secure the anastomotic medical device to the tubular structure, similar to FIGS. 71 and 72.

  75 and 76 illustrate two different types of variable porosity anastomosis medical devices.

  77 to 80 illustrate a Marcot anastomosis medical device in a radially expanded state and a radially contracted state.

  81 and 82 illustrate a variable porosity expandable device in a radially contracted and radially expanded state.

  83 and 84 illustrate a spiral ribbon type radially expandable and retractable device in a radially contracted and radially expanded state.

  FIG. 85 illustrates a coiled cylindrical radial expandable and retractable device.

  86-91 illustrate different embodiments of Marcot anastomosis medical devices in a radially expanded state and a radially contracted state.

  92 and 93 illustrate a self-expanding braided anastomosis medical device in a radially contracted state in the outer tube.

  FIG. 94 illustrates another configuration of the tubular braided anchor member of FIG. 63 in which one or two radially expandable mechanisms are used to engage the perimeter of the opening in the tubular structure.

  95-97 illustrate the tubular mesh braid at the distal end of the internal device, in different states within the tubular structure.

DETAILED DESCRIPTION OF THE INVENTION There continues to be a need for improved medical devices and methods to address some or all of the following issues.

  The first problem is cost reduction. This has become particularly important in recent years, apparently for safety and hygiene reasons, as these are disposable devices. The device will not be widely used if it is much more expensive than other available alternatives, even if it is improved in some function.

  The second problem is to provide a device that is simple to use and easy to understand in the true sense. This will promote its application and use by medical personnel. This will also tend to keep costs low.

  A third challenge is to provide a device that requires procedures that allow medical professionals to become familiar with it and thereby continue to utilize the skills learned from past experience.

  The fourth problem relates to the effectiveness and thoroughness of the device, such as the removal of obstructions and the placement of complex devices. For example, it is recognized that any device is unlikely to provide 100 percent removal, but it is important that the maximum amount of obstruction be removed. With regard to bypass and recombination, it is important that the optimal amount of tissue be removed and thereby replaced, while recognizing that no device is likely to provide 100 percent optimization.

  The fifth issue relates to safety, i.e., matters that are often more important than other considerations. It is important to avoid tissue damage. In many situations, for example, it is important to avoid destroying the obstruction so that the flushing pieces of the obstruction are scattered throughout the object. When using an anastomosis device within a tubular passage in the body, it is very important that the anastomosis is joined while avoiding tissue damage. Often, this damage is not immediately apparent after surgery. Furthermore, the leakage must be maintained near zero.

  There are trades in design considerations to achieve the five interrelated issues described above. Extreme simplicity and very simple procedures may overly sacrifice safety. Addressing all these considerations requires some trade between issues.

Clot dragger lock
One aspect of the invention relates to a locking mechanism for a blocking or engaging member. In particular, the present invention relates to a locking mechanism for an engaging member. One such preferred embodiment includes an interference fit when inner and outer slidable longitudinal members are used. Once deployed, the force required to maintain the engagement member is usually small compared to the force required to deploy (in the case of a non-automatic expansion mechanism). In this case, a light interference fit between the inner and outer slidable longitudinal members can be easily overcome by an interventionist (interventionalist), but the engagement or blocking member is deployed. When done (partially or completely), the interference fit creates sufficient force to keep the system in a deployed state. This same invention can be used when the engaging member or the blocking member is of the self-expanding type, but in this case, the tight fitting is to maintain any member in the unexpanded and non-expanded state. Become.

  This aspect is particularly useful for engaging members. This is because such an interference fit can be made particularly small. When the substance removal system of the present invention is used percutaneously (through the skin) and a needle is used for the initial introduction of the engagement member, it is the small needle (usually such an intervention (intervention: can be inserted through a 19, 18 or 21 gauge needle typically used for intervention) and then deployed. In this case, it is necessary to remove the needle and remove it on the longitudinal axis of the engaging member (wire guide). In order to facilitate its removal, the locking mechanism must be small or negligible relative to the axis of the longitudinal engagement member. A preferred embodiment of this locking mechanism when the engagement member comprises an inner longitudinal member is to set a slight bend or kink in the inner member that interferes / abuts the outer tubular longitudinal member. In particular, the outer tubular longitudinal member can be provided with three components in order to facilitate locking of the engaging member. The first component is the main longest part of the axis of the longitudinal member. This material can be tuned to the required properties required for the shaft, such as torqueability, maneuverability, flexural modulus, softness, stiffness, etc. This first component can be attached to the proximal side of the engagement member mechanism, but not to the inner tubular or wire longitudinal member therein. The second component can be disposed in the vicinity of the main shaft. This embodiment is a handle-type tubular member sized to fit a physician's finger approximately 0.5-2.0 inches in length. It is not glued or otherwise attached to the inner member. If the properties of the first and second components are different, it is manufactured from a different material than the main shaft. The outer surface of the handle is roughened or formed with a high friction coating to assist the physician grasping the handle. This second component may need to have some “rigidity” when the inner tubular or wire longitudinal member is twisted or bent. This second component can be made stronger or more rigid so that twisting of the inner member that prevents axial movement prevents the material from bending or deforming. The rigidity of the second material is such that the torsion or bending of the inner member sufficiently interferes, and once deployed (or unexpanded if the expansion mechanism is in a small unexpanded state) It is important to have sufficient power. Furthermore, the inner diameter of this second component can be made smaller than the inner tubular or wire longitudinal member to create the proper interference. The inner diameter of this second component is greater in diameter than the inner longitudinal member. 0001-. It can be 002 inches small. This interference fit is sufficient to hold the expansion mechanism in an expanded or unexpanded state, while this interference fit makes it easy for the physician to overcome the force to deploy or undeploy the mechanism. It's not too big to do. Further, this second component combination with an inner diameter that is smaller than, equal to or larger than the diameter of the inner longitudinal member may be combined with the kink / bend / ferrule or short It can also be used to lock any expandable mechanism in combination with a drop of glue or epoxy to form a tight fit.

  The third component can be approximately the same as the outer diameter of the first and second components, but glue, other adhesives, heat staking (or the polymer handle is dissolved in the inner member). Or, alternatively, a “press” interference fit may be attached or otherwise attached to the inner tubular member such that the third component is configured to move with the inner longitudinal member.

  Therefore, in such a configuration, the doctor uses the both hands (two fingers of each hand) to expand and release the expansion and contraction mechanism, and to lock and unlock, respectively. This is because the physician grasps the third component with one hand and the second component with the other hand, with a varying distance from the deployment / undeployment distal member between the two components. This is accomplished by pulling these two components apart from each other so that an approximately equal space is created.

  To facilitate ease of use, the physician may recognize the difference between these two handles and color-code the two handles for training when using them to use the locking mechanism. it can.

  1 and 2 illustrate an expandable member guidewire 10 that includes outer and inner guidewires 12, 14. The braidable expandable member 16 has a proximal end 18 secured to the distal end 20 of the outer guidewire 12 and a distal end 22 secured to the distal end 24 of the inner guidewire 14. Have. A deployment grip 26 is secured to the proximal end 24 of the inner guidewire 14. The proximal end 28 of the outer guidewire 12 is spaced from the deployment grip 26 to form a lock region 30. Relative movement between the outer and inner guide wires 12, 14 can be regulated by a guide wire lock 31. The guide wire lock 31 includes a twisted portion (kink) 32 provided on the inner guide wire 14 along the region 30, and a twisted portion engaging sleeve 34 slidably mounted on the region 30 of the inner guide wire 14. Have The twist portion engaging sleeve 34 may be fixed to the outer guide wire 12 or may not be fixed. As suggested in FIG. 2, the inner guidewire deployment grip to separate the proximal ends 24, 28 while maintaining the twist engagement sleeve 34 in the vicinity of the proximal end 28 of the outer guidewire 12. By pulling 26, the twisted portion 32 moves within the deformable twisted portion engaging sleeve 34. Due to the resistance to movement of the twisted portion 32 within the twisted portion engaging sleeve 34, the expandable member 16 is in the radially contracted state of FIG. 1 or a range of radial directions as illustrated in FIG. Maintained in one of the expanded states. The expandable member 16 may be another type of expandable member, such as a Marcot expandable member (ie, a tube with multiple longitudinally extending slits), or a wire basket / expansion as illustrated in FIG. A possible braided expandable member 16A is also possible. It is also possible to replace the twisted portion 32 with other types of engagement sleeve-deformation structures, such as balls or ring-like materials disposed along the lock region 30.

Catheter / Dilator Assembly and Method Another aspect of the present invention is specifically configured for the removal of obstructions or particulates (substances) in hollow tissue. This aspect combines a catheter with a blocking configuration that blocks the annulus between the catheter and the vessel or other hollow tissue. The catheter can also include an inner support wire with a closure engagement member.

  The support wire extends through the catheter, through or around the obstruction, and has an annular braid attached to its distal end or two or more tubes. A Marcot type member having a slit is provided. The support wire is a dual member support wire comprising a core and an annular shell that slides on the core. The distal end of the core is attached to the distal end of the annular braid member (or slit-tube / markot) and the distal end of the shell is attached to the annular braid member (or slit-tube / markot). ) Attached to the proximal end. Thus, when the core and shell are moved relative to each other, the braided member moves it away from the radially retracted position, useful for insertion through the catheter into the radially expanded position. Move to its radially expanded position to expand to. When the annular engagement member is in its radially compressed state, it extends with or through the obstruction with the rest of the wire and is positioned on the distal end of the obstruction. it can. When the engagement member is expanded and moved proximally (ie, retrogradely), it engages the occlusion and pushes the occlusion into the catheter. Alternatively, if suction is used, the engagement member need not be moved. Further, the suction and proximal movement of the engagement member may be combined in a synergistic manner to remove the occlusion.

  The distal end of the catheter is proximal to the occlusion and includes a blocking mechanism that extends radially from the distal end of the catheter to the graft wall or body passage. The catheter blocking member further has a radially retracted insertion state and a radially expanded blocking state. The blocking member is a multi-wing Marcot device and can be covered with a thin elastomer film or membrane. Another configuration of the blocking member is a tubular mesh braid mechanism, which can also be covered.

  This marcot (or tubular mesh braiding mechanism) is connected to the distal end of the catheter or is an integral part of the catheter. The blocking member (or the engaging member) is developed by a plurality of methods. That is, 1. The distal tip of the dilator on which the catheter is inserted has a slightly enlarged diameter. This tip portion has the nature of a metal leaf. When the dilator is removed in the opposite direction or pulled out (from the body), the brace abuts the distal end of the multi-wing marcot (or tubular mesh braid) and compresses the blocking member in its radial compression. Push from state to its radially expanded state. 2. Alternatively, the tip of the dilator is bonded to the catheter by a peel bond so that when the dilator is removed, the blocking member is similarly expanded. In this radially expanded state, the annulus around the catheter is blocked and removed by the marcot (or tubular mesh braid) and its film cover (if necessary), and removed occluded blood, embolus, plaque or other The obstruction is pushed into the catheter where it is aspirated, removed, or otherwise removed. 3. It is also possible for the blocking member or engaging member to be formed from a material that has a memory and thus automatically expands. These materials vary from polymers to metals. Specific examples include, but are not limited to, pebax, nylon, polyurethane, polyethylene (hdpe, uhwpe, ldpe, or the above-mentioned polyethylenes). (Mixture), Pet, niTi, MYLAR (nickel titanium alloy, TWSM (bidirectional shape memory or superplastic properties)) with or without. It can be regulated by an outer tube that maintains an unexpanded shape, or an inner support member can be used to maintain the member in a small unexpanded shape. And the engagement member can be deployed by moving the two slidable longitudinal members relative to each other. This movement of the two slidable members causes the blocking or engaging member to be expanded and / or unexpanded.

Dilator Recess Another aspect of the invention relates to an expansion mechanism on the blocking or engaging member, and more particularly to an expansion mechanism on a blocking member on a catheter or tubular device. This aspect relates to reducing the space required for arranging the blocking member in an unexpanded and unexpanded state. When transcutaneous introduction into a hollow organ takes place, the most common approach to introduction is “dilation”, more specifically the “Seldinger method” for expansion (in the name of Dr. Seldinger in the mid-1900s). ). This is a method in which an interventionalian uses a needle for introduction into the body, then inserts a guide wire through the needle and removes the needle as described above. Thereafter, an assembly known as a dilator / sheath assembly is placed over the guidewire and into the body. The dilator / sheath assembly typically consists of an inner dilator with a hole through which a guide wire is inserted therethrough in the middle of a somewhat solid cylindrical dilator. The dilator is usually tapered conically with a small taper angle of about 4-20 degrees. The sheath typically consists of a thin-walled tube made of ptfe, fep, polyurethane, pebax, or similar materials and fits snugly on the inner dilator. Traditionally, once a physician has expanded into the body, the inner dilator is removed, thereby gaining access to the body through the thin wall dilator (0.004-.018 inch thick). How this relates to the present invention, the inner dilator usually tends to be “solid” to some extent in its cylindrical shape, which is usually the distal end of the device. Interesting in that a portion of the dilator located in the vicinity of can have a recess or groove in the cylindrical portion of the dilator. This recess or groove is a convenient place to place the blocking (or engaging) member there while the device is placed in the body. This arrangement of blocking or engaging members makes the overall device diameter particularly important so that the physician does not need to make access sites / perforations / holes in the body larger than absolutely necessary. Allows more material to be placed in the device without increasing the. The dilator can have a lumen with a side port that enables the monorail structure described below in the Rapid Exchange section. A long dilator structure can be used to support a device across a vessel that spans the length of the human body. By providing the monorail structure, the dilator can be removed from the device and a guidewire that is slightly longer than the dilator shaft.

  4-18A illustrate a novel method and apparatus associated with an example thromboectomy. FIG. 4 illustrates a needle 36 inserted into a graft 38 or other tubular structure, such as a blood vessel, having an occlusion 40 within a lumen 42. In FIG. 5, the expandable member guidewire 10 is inserted through the lumen 42 with the aid of the needle 36 with the expandable member 16 in a radially contracted state distal to the occlusion 40. Is shown. FIG. 6 illustrates the expandable member 16 rendered radially expanded by pulling on the deployment grip 26. FIG. 7 illustrates removal of the needle 36 while leaving the guidewire 10 in place.

  FIG. 8 illustrates a recessed dilator 46 for use with the funnel catheter assembly of FIG. The dilator 46 has a hollow shaft 50 with a fitting 52 at the proximal shaft end 54 and a recess 56 at the distal shaft end 58. The shaft 50 ends at the tip 59.

  9, 9A, and 10 illustrate a funnel catheter assembly 48 that includes a catheter 60 that extends from a proximal catheter end 62 to a distal catheter end 64. FIG. A radially contractible funnel member 66 extends from the distal catheter end 64. The funnel-shaped member 66 is preferably a braided funnel-shaped member having a normal radially expanded state illustrated by a solid line in FIG. 9 and a radially contracted state illustrated by a broken line in FIG. The funnel-shaped member 66 has an axial length 68 in its radially contracted state. The funnel catheter assembly 48 further includes a compression sleeve 70 and a split stopper sleeve 72 that are both slidably mounted on the catheter 60. A split stop 72 is also illustrated in FIG. 10, which has a notched proximal sleeve portion 74 and a weakened portion 76, the purpose of which will be described below. The catheter 60 has a lumen 78, see FIG. 9A, for receiving the hollow shaft 50. The proximal catheter end 62 has a port 80 connected to a tube 82 with a fitting 84 at its end. This allows fluid or other flowable material to flow through lumen 78.

  FIG. 11 illustrates the insertion of the distal end 60 of the shaft 50 of the user's concave dilator 46 into the proximal catheter end 62 of the funnel catheter assembly 48. Tube clamp 86 is shown mounted along tube 82. FIG. 12 illustrates a recessed dilator 46 that is fully inserted into the funnel catheter assembly 48 to form a funnel catheter / dilator subassembly 88. The funnel-shaped member 66 is shown in a state in which the user is prepared to slide the compression sleeve 70 in the direction of the arrow 90 and is placed in line with the recess 56. ing. FIG. 13 illustrates the compression sleeve 70 completely covering the funnel-shaped member 66, leaving a portion of the catheter 60 between the compression sleeve and the exposed split stop sleeve 72. Providing a recess 56 and aligning the funnel top member 66 relative to the recess 56 helps to minimize the outer diameter of the subassembly 88 and thus minimizes patient damage. Useful.

  FIG. 14 illustrates a tearaway sleeve 92 used with subassembly 88 to form the catheter / dilator assembly 94 of FIG. The sleeve 92 includes a small diameter distal portion 95 and a large diameter proximal portion 96. The inner diameter 98 of the distal portion 95 is sized to fit snugly over the distal shaft end 58 of the shaft 50 in the recess 56 and the funnel member 66. The inner diameter 100 of the proximal portion 96 is sized to fit snugly on the catheter 60. Thus, when the sleeve is slid in the proximal direction, ie, in the direction of arrow 102 illustrated in FIG. 15, the proximal portion 96 contacts the compression sleeve 70, first the compression sleeve 70 and Next, both compression sleeve 70 and split stopper sleeve 72 are connected in the proximal direction between the distal and proximal portions 95, 96 of sleeve 92, see FIG. Drive until approximately 60 distal catheter ends 64 abut. The proximal movement of the split stopper sleeve 72 is adjusted by the proximal sleeve portion 74 being deformed and / or bent as shown in FIG. The outer diameter of the distal portion 95 is approximately equal to the inner diameter 100 of the proximal portion 96.

  FIG. 16 illustrates the expandable member guidewire 10, see FIG. 7, with the catheter / dilator assembly 94 mounted thereon, with the tip 59 located proximal to the occlusion 40. FIG. In order to minimize the size of the access opening formed in the graft through which the tip 59 passes, it is preferred that the connection 104 remain outside the graft 38. To allow the funnel member 66 to expand, the peelable sleeve 92 is pulled proximally as indicated by arrow 106. Since the inner diameter 98 is smaller than the outer diameter of the catheter 60, this movement is coordinated by the splitting open of the weakened region 108 of the distal portion 95 of the sleeve 92, see FIG. The tip 110 of the distal portion 95 is preferably not split open to accommodate any further manipulation of the assembly. This movement also causes the split stopper sleeve 72 to tear along the weakened region 76, thereby allowing the sleeve 72 to be completely removed from the device. To remove the obstruction 40, the user pulls the guidewire 10 and drives the obstruction 40 toward the funnel member 66 by the expandable member 38. Typically, a vacuum syringe attached to the fitting 84 is used to create a vacuum space in the tube 82 and thus between the distal catheter end 64 and the shaft 50 as illustrated in FIG. 18A. A suction force may be generated at 112. Depending on the composition of the occlusion 40, the occlusion can be completely drawn into the tube 82. The tube 82 can be sufficiently transparent or translucent so that the residue of the occlusion 40 can be visually observed by the user in the tube.

Rapid Exchange
Another aspect of the invention relates to a configuration that provides the manufacture and function of the substance removal system. One such aspect is often referred to as a “rapid exchange” or “Mono Rail” structure. This common structure is used for longitudinal catheters when used with guidewires (also known as wire guides). Typically, an interventionalist inserts a guidewire into the body through an existing opening or often a percutaneous opening formed by a needle. The guide wire is easier to maneuver into place than a catheter or other longitudinal device because it is a small wire. Once set in place, the interventionalist typically inserts a longitudinal catheter or other device into the appropriate position over the guidewire. Therefore, this is why it is called a guide wire. Prior to the development of rapid exchange or monorail technology, interventional practitioners can insert a longitudinal catheter or device so that the device can be inserted over the wire outside the body with the guidewire in place in the body. It was necessary to use a guide wire that was at least twice as long. This “double length feature” allows the interventionist to safely insert the device over the guide wire while holding the guide wire in place so that it does not move away from the desired position in the body. Was provided. This technique has been cumbersome due to the double length of the guidewire. The rapid exchange or monorail technology provides a small hole in the distal end of the catheter or device, which is typically about 3-12 (7.6-30 cm) from the distal end of the device. ) Exit the catheter or device at a short distance of inches.

  This aspect of the invention is a variation of the rapid exchange feature. A dilator is used in the tubular catheter or device of the present invention so that the dilator exits at or near the distal end and about 3-12 inches from the distal end. However, instead of sliding the catheter or device of the present invention “on” the guidewire, the guidewire is positioned within the dilator longitudinal lumen, which is within the tubular longitudinal lumen of the present invention. Is loaded. As the assembly approaches the problem area in the body to be intervened, the interventionalist can manipulate the wire from within the dilator, but outside the body. This allows features similar to the rapid exchange or monorail technology described above. When the interventionist is near the area to be treated, the interventionist can remove the inner dilator while leaving the inner guidewire in place, thereby providing a double length guide. The need for wires can be eliminated.

  19-22 illustrate a rapid exchange dilator assembly 116 that includes a catheter 118 with a distal catheter end 120 and a proximal catheter end 122. Catheter 118 includes an outer catheter 124 and an inner catheter 126 slidably housed within the outer catheter. The outer catheter 124 has an outer catheter coupling 130 that includes a conventional sealing member 132 for forming a fluid seal between the outer catheter 124 and the proximal portion 134 of the inner catheter 26. I have. The outer and inner catheters 124, 126 are preferably variable along most of their length, while the proximal portion 134 of the inner catheter 126 and the proximal portion 136 of the outer catheter 124 are both Preferably, it is formed from a metal tube. The inner catheter 126 further has an inner catheter coupling 138 that includes a fluid port 140 that opens into the catheter lumen 142 of the catheter 118.

  The assembly 116 further includes a dilator 144 that includes a distal portion 146 and a proximal portion 148 and a guidewire 150 that extends generally parallel to the dilator 144. In the assembled configuration of FIGS. 19-22, a guidewire 150 extends through and through a tip 152 that extends beyond the dilator tip 154 and an inner catheter fitting 138. A proximal end 156. The proximal portion 148 of the dilator 144 has a relatively small diameter to provide sufficient margin for passage of the guidewire 150 through the catheter lumen 142, as illustrated in FIG. However, it is desirable to minimize the diameter of the catheter 118 and pass the guidewire 150 through the dilator lumen 158 at the dilator tip 154. Accordingly, a guide wire passage as groove 160 is formed along dilator 144 to accommodate guide wire 150. Toward the dilator tip 154, for example, about 15 cm from the tip 154, an opening 162 is formed in the dilator 144 to connect the groove 160 and the dilator lumen 158, and the guide wire 150 is Along the groove 160, through the opening 162, along the lumen 158, and through the dilator tip 154, it is possible to exit therefrom. See FIG. The guidewire passage can also be formed by a lumen formed in the dilator 144 or a separate tubular member attached to the dilator.

  The catheter 118 further has an expandable braid 164 connected to the distal ends of the outer and inner catheters 124, 126. Pulling the inner catheter joint 138 relative to the outer catheter joint 130 expands the braid 164. The braid 164 can be expanded similarly to that shown in FIGS. 1 and 2, but it can also be as described above with reference to FIGS. 9 and 12, or as described below with reference to FIGS. As illustrated at 54, it can also be expanded to form a funnel material guide. The inner catheter coupling 138 further includes a dilator / guidewire sealing member 166 that allows a seal between the proximal portion 134 of the inner catheter 126 and the proximal portion 148 of the dilator 144. To.

  An example of use of the rapid exchange dilator assembly 116 will be described with reference to FIGS. FIG. 23 illustrates a heart 170 that includes a bypass graft 172 that connects the ascending aorta 174 with the coronary artery 176. FIG. 24 shows a state in which the first guide wire 178 enters the bypass graft 172 through the ascending aorta 174 and the distal end portion 180 of the first guide wire 178 is located in the vicinity of the lesion 182 in this example. Is illustrated. Guidewire 178 is typically a large, eg, diameter, used to help the physician reach near the treatment site. A 038 inch guidewire. Thereafter, as illustrated in FIG. 25, a conventional guide catheter, typically 7 French or 8 French in size, is positioned using a first guide wire 178. Next, the first guide wire 178 is removed while leaving the guide wire 184 in place. This allows the distal portion of the rapid exchange dilator assembly 116 to be extended until the expandable braid 184 extends beyond the distal end 186 of the guidewire 184, as illustrated in FIG. It can be passed through the guide catheter 184. Next, as illustrated in FIG. 27, the guidewire 150 is expanded to a selected position relative to the lesion 182.

  The dilator 144 is then removed by pulling on the proximal portion 148 of the dilator while holding the inner catheter fitting 138 and the proximal end 156 of the guidewire 150. This leaves the catheter 118 and guide wire 156 in place. This is possible because of the rapid exchange feature of the assembly 116 provided by the passage of the outer guidewire 150 for most of the length of the dilator 144. Next, the expandable braid 164 is expanded to a working material guiding state, such as the funnel shape of FIG. 28, to block the blood flow to stop the embolus from flowing downstream. Thereafter, appropriate medical treatment such as placement of a stent or angiogenesis can be performed.

RF Coupling Another aspect of the present invention relates to an apparatus and method for producing a thermoplastic material. As the name thermoplastic suggests, in the manufacture of components or other products, the temperature of the polymer (or metal to polymer) is used for molding, manufacturing bending, casting, bonding, and tipping. be able to. There are a number of techniques well known to those skilled in the art of “plastic work” that use heat to change the physical shape or properties of a plastic material. There are injection molding, plug, insert molding, as well as blow molding, heated tubes, hot water or other liquids, flames, heat guns, heat-shrinkable tube formation, and other techniques that cannot be too much.

  This aspect of the invention utilizes a constant temperature that can be quickly brought to a specific Curie temperature. The present invention uses automatic temperature controlled heaters and high density materials such as ferromagnetic materials or temperature control is achieved by using ferromagnetic materials or the like having a Curie temperature at the desired maximum working temperature. Is done. The Curie point, also known as the Curie temperature, is the point / temperature at which a ferromagnetic material exhibits paramagnetism. Once this point is achieved, no additional energy is required to be input to the system and its temperature (Curie temperature) is maintained. This preselected temperature can be set to various temperatures depending on the chemical structure of the ferromagnetic material, and this selection can be harmonized near or close to the melting temperature of a particular plasticizer. .

  It is desirable for several reasons to be able to control a heating member for the production / creation of a thermoplastic material that does not require a temperature feedback loop to control the temperature of a particular member / die or other mechanism. This aspect of the invention uses a low conductivity ferromagnetic metal that can be excited by high frequency alternating current. By selecting the dimensions and material parameters for the heating element, a narrow range centered on the Curie temperature of the ferromagnetic material, regardless of its thermal load (i.e., near the melting or dissolved state of the plastic material) Can produce temperature control.

  This therefore does not require a conventional feedback loop (and no necessary controller and necessary calibration) to control the temperature of the heating element. A specific ferromagnetic material that reaches a specific Curie temperature can be selected, and for a specific application, a specific ferromagnetic material having a specific Curie temperature is selected for a heating element having a specific Curie temperature By doing so, the temperature can be selected. This makes it possible to achieve a narrow range of temperatures. Since the mechanism of use for excitation of the ferromagnetic member is immediate to the AC power source, the ferromagnetic material / member will reach its predefined Curie temperature very quickly. This fast-acting heat source is essential for a low-cost manufacturing environment because it quickly forms a thermoplastic under efficient manufacturing conditions.

  Briefly described, one embodiment of the present invention is particularly directed to manipulating thermoplastic materials with molds / members, castings (“heaters”) to produce components or other products in a manufacturing environment. Especially adapted. By purchasing an off-the-shelf RF generator / alternating current source, the ferromagnetic heater is excited to its Curie temperature and then selected for the production of a specific thermoplastic material by selecting a specific ferromagnetic alloy. It is possible to use different temperatures for the heater in the process.

  A specific example of a ferromagnetic material that exhibits different Curie temperatures when excited by an alternating radio frequency source is Invar, an alloy of approximately 36% nickel and balanced iron, often Depending on the nickel content, there is an alloy 36. When alloy 36 is excited to its Curie temperature, the temperature is controlled to a temperature in the vicinity of ~ 230 degrees Fahrenheit (~ 230 ° F or 110 ° C). If alloy 42 is selected (meaning ~ 42% nickel and the balance iron), the Curie temperature achieved is ~ 380 ° F or 193 ° C. For alloy 49, the temperature is ˜475 ° F. or 246 ° C. For alloy 32, approximately 130 ° F. or 54 ° C. For alloy 34, 165 ° F or 74 ° C and for alloy 42-6, 290 ° F or 143 ° C. Therefore, by selecting a specific ferromagnetic alloy, a specific melting temperature of a specific thermoplastic material or a temperature close thereto can be selected. Such ferromagnetic materials are readily available from a wide range of vendors including SCIENTIFIC ALLOY, Westerly, RI (401 596-4947).

  By trial and error connecting a power supply to the alloy, the alloy was excited and measured to its specific Curie temperature. These temperatures have been described above. By processing different structures on the heating element, the inventors have successfully combined thermoplastic materials with various other materials (metals, thermoplastics, thermosetting polymers, fibers, etc.). Furthermore, the present inventor has also succeeded in forming and programming a thermoplastic material in a shape and use conditions that seem to be infinite variety.

  Another aspect of the present invention relates to the engaging or blocking member. If any member is bonded to the tubular longitudinal member in any way, this bond should be strong but its overall dimensions should be minimal. If a tubular mesh braid is used to attach the mechanism to the tube, additional connecting tubes can often be used to overlap both the tubular longitudinal member and the tubular mesh braid. However, this aspect of the invention makes it possible to achieve this “coupling” by joining the two components together without the addition of this tubing, which is This is because any additional space required for “joints” in the intervention is detrimental to the overall functionality of the device. If a tube or other assembly mechanism is used outside the two materials or inside these materials, the body will have larger holes / perforations with high mortality / morbidity Or the inner diameter of the tubular longitudinal member is reduced, so that the interventionalist has less space to deliver other instruments and removes material from the body The space is reduced and the annular space is reduced and sacrificed. Thus, this aspect of the present invention allows the tubular mesh braid to be “connected” to the tubular portion of the catheter or device while at the same time minimizing the increase in wall thickness due to the connecting tube and other assembly components. About that. This can be achieved in several ways.

  In most cases, the wall of the tubular longitudinal member is. 002. In the range of 015 inches (.051-.38 mm), but more generally,. 004. The thickness is in the range of 006 (.10-.15 mm). Due to its manufacturing method (by the Maypole type braiding machine below), the mesh yarn used to manufacture tubular mesh braids usually has a diameter of. 0001-. 005 inches (.0025-.13 mm), but more generally,. 0015-. Manufactured from monofilaments with diameters in the range of 003 inches. Since these individual mesh yarns overlap each other, the wall thickness of the tubular mesh braid is usually twice the thickness of the mesh yarn used for its manufacture. The invention relates to the fact that the tubular mesh braid can be melted into the wall of the tubular longitudinal member using heat. This is especially true when a thermoplastic polymer is used for one or both of the tubular mesh braid and the tubular longitudinal member. A mold that matches the outer diameter of the tubular longitudinal member is used to apply heat and at the same time place the inner mandrel in an assembly that is equal to the inner diameter of the tubular longitudinal member to force both materials into the mold. it can. Next, using heat and force, the two components (tubular mesh braid and tubular longitudinal member) are melted into one unit, thereby the two components thus joined together The wall thickness of the part can be minimized. This heated mold is usually accomplished by using a glass or metal mold. The heat is a number of well known to those skilled in the art including, but not limited to, convective heating, electrical resistance heating, RF excitation of the metal to create heat, simply blowing hot air over the mold, etc. Given in the way.

  One preferred embodiment of the present invention utilizes an RF heater comprising an RF power supply and a nickel iron alloy. By combining radio frequency (RF) energy with a suitable nickel-iron alloy, the metal alloy mold is excited by the high frequency energy, which generates heat up to the Curie temperature of the alloy. Nickel-iron alloy blends can be adjusted to reach different Curie temperatures. This RF excitation is extremely rapid, which is crucial for the effective manufacture of the device. The molds can be made very small, i.e. with a very small amount of alloy, so that they can not only be heated quickly, but can also be cooled rapidly. Therefore, the fewer the alloys in the mold, the faster the throughput during the manufacturing process. This technique is extremely repeatable due to the repeatability of the interaction between RF and the alloy. These different temperatures are important because different temperatures are required for different thermal bonding processes (which depend on the thermal bonding geometry and also the materials used for the thermal bonding). is there. This configuration was used to manufacture the expansion mechanism described above. Here, in a preferred embodiment of the present invention,. NiTi (nickel titanium) tubular mesh braids having individual mesh yarns of 003 "(.076 mm) are fused to give 0.005 to .006" (.13 to .15 mm without compromising their inner and outer diameters. ) Wall thickness of PEBAX and polyurethane (and .002 "(.051 mm) diameter mesh yarn fused to both polyethylene and FEP). No additional material for this bond This is to allow more material to be removed through the inner diameter (not optimized, reduced or compromised) because no additional area is needed to form this bond. The initial perforation into the body is minimized by the minimized / optimized outer diameter of the assembly, as will be described further below.

Braided shape by heat treatment and elastomer (variable tube diameter)
Another aspect of the invention relates to a funnel section manufactured using a tubular mesh braid. In one preferred embodiment, the funnel member is made from the tubular mesh braid described above. In particular, the mesh yarn in the braid is made of metal, more specifically nickel titanium alloy (NiTi). The preferred embodiment of this aspect of the invention is such that the tubular mesh braid is attached to the inner longitudinal member at the distal end and the outer longitudinal tubular member where the braid is attached to the proximal end. Configured. Pulling the inner member in the reverse / proximal direction pulls the braid inward, causing it to buckle and wind as “rolling a sock”. In this preferred embodiment, the braid has a funnel shape. In some cases, the braid is covered by an inelastic or elastic membrane. The membrane can be applied by immersion, pouring and spraying with a dispersion, including but not limited to silicone or polyurethane. Alternatively, the membrane is a tubular extrudate, which is then bonded by heat or adhesive onto the two (proximal and distal) ends of the braid to which it is attached to the inner and outer longitudinal members. . When using the extrudate, this material includes, but is not limited to, silicone, polyurethane, chronoprene, polyethylene, C-Flex, and the like.

  Of particular importance to the construction of the tubular mesh braid is the method of forming the tubular mesh braid. In a preferred embodiment of the present invention, a tubular mesh braid is formed on a Maypole braiding machine, described below, using a 48 carrier braid made from NiTi on a 48 carrier or 96 carrier Maypole braiding machine. However, in some cases it may be advantageous to use a machine with more or fewer braid carriers to adjust braiding machine performance. The NiTi yarn used has a diameter of. 001-. 005 inches (0.025-.13 mm), more specifically 0.0015-. It is as small as 0025 inches (0.038-0.064 mm). They can be formed on a cylindrical mandrel on a braiding machine with a diameter of typically 5-6 mm, but more preferably to facilitate the deployment of funnel-shaped members in various sized lumens. A conical mandrel is used to create a mesh braid with variable wire density and variable maximum expansion diameter. In fact, the mandrel shape can be set to any line-symmetric shape (eg, a rotating parabolic arc) to further optimize the performance of the expansion member. In some cases, non-axisymmetric shapes such as elliptical cones and pyramids can also be used. Furthermore, the tubular mesh braid can be self-expanding when the mesh is programmed to have its expanded funnel shape. In this embodiment, the system can be constrained with an oversheath to maintain its small contracted state. Conversely, the inner and outer longitudinal members can be held in an expanded state relative to each other such that the braid is in an unexpanded shape. Upon removal of the stretch on the inner and outer longitudinal members, the braid typically expands to a funnel type shape with a diameter of 1.5-7 mm, in particular 2.5-5.5 mm. Furthermore, any combination of active or passive expansion and automatic expansion can be used to optimize the design.

  An additional aspect of the present invention relating to how the braid is opened into a funnel shape is the “programming” method of the tubular mesh braid. When the braid is pulled so that it automatically expands into a funnel shape, it forms a funnel shape and when it impacts the vessel wall, it is at least It may also be important that there is a shape memory for the braid so that it collides with less damage to the intima. The NiTi wire is preferably adjusted to behave as a superplastic or pseudoelastic material. When attempting to block the blood by expanding the funnel shape, the funnel shape exerts an outward radial force on the vessel, thereby actually closing the vessel and stopping the blood flow. It is important to do so. This is important when the present invention is used for “proximal occlusion”.

  Proximal occlusion, as the name suggests, is a place where a blood vessel is occluded proximally (upstream) where an intervention is performed (ie, balloon angioplasty or stenting, etc.). That's it. If flow is stopped or reduced upstream from where the intervention is taking place, this prevents movable brittle embolic material from moving downstream during the intervention. This migrated embolism can be very dangerous, resulting in a stroke or even worse death.

  Different characteristics can be imparted to the tubular mesh braid by shaping the braid by braiding / wrapping it on a tapered mandrel or various shaped mandrels. By braiding on mandrel tools of different diameters at a constant braiding machine speed, the pitch of the braid and the number of intersections in the braid of a given length are changed. Changing these parameters of a braid component helps determine where the braid first buckles and then acts as a “wound sock”. Furthermore, heat treatment for changing the material or the braided shape also has an effective action. The material properties of the braid may be changed only in certain portions so that a stiffness gradient exists along the length of the braid. These changes in stiffness can be very rapid to promote buckling (funnel formation) at a specific location or actuating force, or prevent buckling and possibly reduce radial forces. It can be gradual to maintain. This allows the funnel to be formed in a specific way while the braid is held and unfolded. Furthermore, the braid is heat-treated to obtain a geometric change so that it is properly occluded by the deployed braid / funnel member with the desired amount of radial force and at the same time the desired diameter and shape. The braid tends to unfold / rotate in the desired manner, such as expanding to a traumatic fashion. For example, by forming a shape step on the braided wire, the distal shape of the braid expands radially outward during operation and contacts the vessel wall, leading to a buckled shape of the braid. To form. The geometry of this step dimension can be adjusted for a particular application. Any kind of geometrical change can be formed by secondary mechanical or thermal means during the actual braiding process or at any time during the manufacturing process.

  Another secondary task that can be used to improve the performance of the extended braid is a braid turn. By turning the mesh braid to the “right side out”, it will exhibit different characteristics than the “front and back” braid. These differences are greatest when the braided wire material is Nitinol, which is turned after the heat treatment. However, some desirable performance characteristics may also be obtained when other braided wire materials such as stainless steel are used or when the braid is turned without heat treatment.

  As noted above, in order to allow the physician to use the minimum incision required while ensuring the largest sized lumen available for other treatment devices, the entire device Properties are very important. With this in mind, another preferred embodiment uses a braided shaft with an integral extended braid at its distal end. The braided shaft can be configured as having a desired wall thickness (specifically, .002 "to .015" (.051-.38 mm)) and rigid characteristics, It can be formed simply by continuing the braid beyond the polymer component of the shaft. This method eliminates secondary coupling between the expansion braid and the shaft, while at the same time creating a more powerful and robust device. One of many possible manufacturing methods is to place a braided shaft polymer inner liner on a mandrel and load the mandrel and liner assembly into a Maypole braiding machine. The mandrel can include a distal shaped portion that can be used to form a desired expanded braided shape. The braiding is continued over the extended braid portion of the mandrel and heat treated if necessary. Thereafter, the outer polymer component (s) are laminated onto the braided shaft.

  Using different covers on the tubular mesh braid can also change all of these properties. For example, one embodiment of the present invention is a thermoplastic extrudate having a variable wall thickness. The wall thickness of the membrane can be varied along the length of the braid to form zones with greater or lesser resistance to manipulation or more durable zones. These variable wall thicknesses also allow the thinnest part of the tubular mesh braid to expand first or to a larger full diameter for zones with a greater thickness of film thickness. Adjusting the sequence or degree of actuation of the various parts along the length of the expanded braid allows the device to achieve an optimal balance of actuation reliability, operating force, and radial force on the vessel wall To. Generally, about. Tubes up to a wall thickness of 003 "(.76 mm) can be extruded. In the manufacturing process, the technician can" pre-expand "(all or part of) the extrudate, and then In addition, for pre-expanded membranes, the expansion characteristics and wall thickness can be controllably varied to achieve better device performance. The simplest way to achieve this “pre-expansion” is to apply air pressure to the extrudate when it is sealed at one end. Most thermoplastic polymers used for this application have elastic modulus properties of 300-1500%, more specifically 600-1000%. Examples such as chloroprene, polyurethane, C-Flex, latex, polyisoprene, and silicon show these properties.

  FIG. 29 includes an outer tube 192 with a distal tip 194, an inner tube 196 with a distal end 198, and first and second ends secured to the distal ends 194,196. The distal end of a funnel catheter 190 having a tubular sleeve 200 is illustrated. The tubular sleeve 200 is shown in its radially contracted and expanded state. Importantly, the tubular sleeve 200 includes a generally U-shaped direction reversal region 206 so that when the first and second ends 202, 204 move toward each other from their positions in FIG. 200 is moving to a distal opening, radially expanded use, as illustrated in FIG. FIG. 30 illustrates another embodiment of the funnel catheter 190, where the deployed region 206 has a sharper U-shape than the embodiment of FIG. FIG. 31 illustrates the funnel catheter 190 in a radially expanded use state. The funnel catheter 190 is typically used to seal the interior of a graft, blood vessel or other hollow body structure so that the material from which the funnel catheter 200 is formed is typically substantially free of liquid flow. Impervious to. The tubular sleeve 200 is preferably a braided tubular sleeve impregnated with a variable polymer material, whereas the sleeve 200 can be configured in other ways. FIG. 32 illustrates a tubular sleeve 200 where a liquid flow barrier is provided as a variable elastic film 208 on the outside of the tubular sleeve 200. 33 and 34 illustrate the placement and use of funnel catheter 180 within vessel 210. FIG. By pulling the inner tube 196 with respect to the outer tube 198, the tubular sleeve 200 forms a funnel-type material guide member in which the large portion 212 contacts the inner wall 214 of the vessel 210. Funnel catheter 190 may be configured to provide a sufficiently high level of force against inner wall 214 over a relatively large contact area to provide a good seal while minimizing the risk of tissue damage. it can.

  Another method of achieving a funnel catheter that reliably forms a distally directed open funnel member end is described below with reference to FIGS. In general, these different techniques include adjusting the taper angle at the distal and proximal portions of the mandrel, selectively applying material to one or both of the distal and proximal portions of the braid, Changing the pic count between the distal and proximal portions. In practice, it is possible to construct an actuator using one or more of these techniques, but these different techniques are described below with respect to a particular embodiment that includes one technique.

  FIG. 35 illustrates a mandrel 218 comprising a proximal tapered portion 220 and a distal tapered portion 222 connected by a central, usually constant diameter, portion 224. The mandrel 218 is wound in a braided shape, and a braided structure 228 is formed by the braided winding portion 226. The proximal taper portion 220 has a gentler taper shape than the distal taper portion 222, that is, θ1> θ2. In the embodiment of FIG. 35, the pick count value, ie the number of crossings of the braided turns 226 per unit length, is constant along the entire length of the mandrel 218. A membrane (not shown) can be used with the braided structure 228. This membrane can be incorporated into, placed on, or provided within the braided structure 228. The membrane is selected to stop all liquid flow through it or to prevent the passage of the smallest size particles. Next, the braided structure 228 is removed from the mandrel 218 and attached to the outer and inner tubes 230, 232 to form a funnel catheter 234 with a tubular braided sleeve 236. See Figures 36-39.

  The proximal end 238 of the sleeve 236 is secured to a first position 240 on the outer tube 230 and the distal end 242 of the sleeve 236 is secured to a second location 244 on the inner tube 232. The large taper shape in the distal tapered braid 22 helps to ensure that θ1> θ2 and the distal portion 246 of the sleeve 236 buckles before the proximal portion 248 of the sleeve. See Figures 38 and 39. Although the inner tube 232 is illustrated with an intermediate distance extension distally, it can also be terminated, for example, at or near the second location 244 on the inner tube 232. is there.

  FIG. 36 illustrates a tubular braided sleeve 236 within a large diameter vessel 250. As the pipe diameter increases, the contact length of the braid decreases. This makes distal / proximal competition more important because the friction between the device and the vessel wall does not help much to form a distal funnel shape (the distal portion 246 of the sleeve 236 is less important). You must buckle first). For smaller diameter vessels 254 (see FIGS. 37 and 39), outer tube 230 is typically held stationary while inner tube 232 is pulled proximally. While the friction between the braided sleeve 236 and the vessel 254 causes the distal portion 246 of the sleeve 236 to deflate by movement of the sleeve 236 to the distal end 242, the proximal outer tube 230 remains stationary. Help hold. In the case of large vessels (see FIGS. 36 and 38), the friction is less than in the case of small diameter vessels, which causes the entire tubular braided sleeve 236 to shift (slid), thereby causing the braided sleeve. The possibility of buckling the proximal portion 248 of 236 increases. If the pick count value is constant or nearly constant as in the embodiment of FIGS. 35-39, the difference in taper angle will always cause the distal portion 246 to fall first (ie, more than the proximal portion 248). Before, it is very important to provide the necessary bias to deflate to the funnel shape as illustrated in FIG.

  37 and 39 illustrate a tubular braided sleeve 236 having a constant pick count value within a smaller diameter vessel 254. In this situation, many portions of the braided sleeve 236 contact the vessel wall. By providing an appropriate difference in taper angle with θ1> θ2, it is ensured that the distal portion 246 buckles before the proximal portion 248.

  FIG. 40 illustrates another example of a constant pick count tubular braided sleeve 236 configured such that the distal portion 246 buckles before the proximal portion 248. The braided winding portion 226, which is usually made of NiTi, at the distal end 242 of the sleeve 236 is heat-treated so that its diameter changes rapidly after braiding. This weakens the geometry of the shape at this location and causes the sleeve 236 to buckle in the region of the distal end 242 by applying a small compressive force. This effect is made more effective by increasing the taper angle θ1 of the distal end and decreasing the diameter at this position. Other methods of forming a steep step shape in the braid after knitting can also be used.

  FIG. 41 illustrates another embodiment of a constant pick count tubular braided sleeve 236 configured such that the distal portion 246 buckles before the proximal portion 248. A portion of the proximal portion 248 is coated with a polymer 256 that is typically somewhat elastic to limit the expansion of the proximal portion 248 so that it can fully expand and buckle. I can't. To promote buckling of the distal portion 246, the remaining portion of the sleeve 236 is uncoated.

  FIG. 42 is similar to FIG. 41 and uses a relatively stiff and relatively stretch resistant polymer coating 256 for the proximal portion 248 and a relatively soft and relatively easily stretchable distal portion 246. The polymer coating 258 is used. The polymer coating 256 prevents the proximal braid from fully expanding and buckling. The soft distal coating provided by the polymer coating 258 allows for full expansion, buckling and good water sealing to ensure suction through the center of the device. If desired, the central portion 260 of the sleeve 236 can also be coated with the same soft, easily stretchable polymer 258 for another polymer that is more easily stretchable than the polymer 258.

  43 and 44 illustrate another configuration of the braided structure 228 of FIG. FIG. 43 illustrates a double wire braid structure 262 having a constant pick count value. This double wire can be a circle or ribbon from one or two spools. More wires, such as 2, 3, 4 or 5, can be twisted together to allow low bending forces with high hoop forces. This allows the braid to have a large combined strength with the ability to shift to a low profile and become variable within the catheter. FIG. 44 illustrates a ribbon band braid structure 264 with a constant pick count value. This structure 264 is typically. 0003-. With a thickness of 0005 inches,. 001-. Formed from NiTi, stainless steel, titanium, polymer or tungsten with a width of 030 inches (.0076 to .13 mm thickness, 0.025 to .76 mm width). As an example,. With a width of 0005 inches. 003 inches wide (.13 mm thick and 0.076 mm wide).

  FIG. 45 illustrates another configuration of the constant pick count value embodiment of FIG. Braided structure 266 has a variable pick count value with a high pick count value along proximal tapered portion 268 and a small pick count value along distal tapered portion 270. The braid structure 266 can be created by gradually speeding up the “take up” reel on the braid while operating the wire spool at a constant speed. This configuration adjusts the distal tapered portion 270 to be weaker with a larger opening (distance between wire intersections) so that it buckles into a tunnel shape before the proximal tapered portion 268. It is configured. This configuration can accommodate a relatively large radial expansion to cover a wide range of vessel sizes. By removing a portion of the wire strand to form a braided structure 272 as illustrated in FIG. 46, a similar effect is achieved, ie, distal buckling before proximal buckling. Can force the action, can be created. The wire is braided a fixed distance on the mandrel 218 and every other wire is cut (as an example), thereby reducing the pick count value, reducing the number of wires, and continuing the braiding.

  A variable pick count value funnel catheter 274 is illustrated in FIG. 47, which has a tubular braided sleeve 276 formed from the braided structure of FIG. The variable pick funnel catheter 274 is shown partially expanded within the large diameter vessel 250. The proximal tapered portion 268 of the braided structure 266 is fully expandable, but because the taper is so gradual, it behaves more like a coil. The distal braided portion 270 must have a sufficiently low pick count value to be weak enough to initially collapse. The state in which the funnel catheter 247 is in the small diameter vessel 254 is illustrated in FIG. In this case, it is advantageous to have a low pick count value on the distal side so that the distal tapered portion 270 is weaker than the proximal tapered portion 268 and buckles under compressive loading. This is effective as long as the proximal end cannot fully expand at the vessel diameter. At high pick count values that cannot be fully expanded, there is a tendency to lock if the number of supports (closer support intersections) is large.

  The variable pickcount value braided structure 278 of FIG. 49 reverses the winding pattern of the braided structure 266 of FIG. 45 to provide a higher pickcount value at the distal tapered portion 280 than at the proximal tapered portion 282. Yes. This is adjusted to allow the smallest portion of the distal tapered portion 280 to fully expand before impacting the vessel wall or even the smallest expected vessel size Can do. When fully expanded, the winding 226 (see FIGS. 50 and 51) of the variable pick count funnel catheter 284 of the distal portion 242 is easily buckled away before the proximal end is buckled. It is pushed almost into the coil coupling hoop path that can form the displacement funnel. After the initial buckling, as the distal and proximal ends 242, 230 move toward each other to enlarge the funnel opening, the distal funnel end can become curly sock-like. . FIG. 48 illustrates a funnel catheter 284 within a small diameter vessel 252. A high pick count value at the distal portion of the braided structure 286 causes the distal portion to buckle first as long as it can be fully expanded within the vessel. The higher the pick count value of a portion of the tubular braided structure 278 on the mandrel, the less the portion will expand due to axial compression. The portion of the structure 278 that has a very high pick count value remains almost fully expanded within the low profile catheter. After the operation, the portion having a very high pick count value becomes a hoop and buckles.

The balloon which is a funnel part Another aspect of this invention is related with the funnel-shaped balloon. This is easily accomplished by forming the balloon to expand into a funnel shape when it is expanded by a gas or liquid. This can be achieved in several ways. When balloons are made from thermoplastic materials, including but not limited to chloroprene, polyurethane, C-Flex, latex, rubber, etc., these are immersed, cast, sprayed, etc. on a funnel shaped mandrel Or they can be extrudates that are then placed on a funnel-shaped mandrel and then heat is applied to cause the polymer to form its mandrel. Become. Furthermore, when the extrudate is placed inside a funnel mold, heat is applied, and then air pressure is applied to the extrudate, the polymer expands to the internal shape of the mold cavity. Removing heat from any of the processes described above and allowing the system to cool results in a funnel shaped balloon.

  Alternatively, the polymer can be formed from an inelastic material including, but not limited to, polyethylene, PET, HDPE, and the like. These shapes can be achieved in a manner similar to that described above. Furthermore, since their properties are inelastic, they can be plastically deformed to create a funnel shape.

  A balloon funnel catheter 290 is illustrated in FIGS. Catheter 290 has a shaft 292 with a distal end 294 to which an annular balloon 296 is secured. Balloon 296 extends beyond distal end 294. Balloon 296 forms a central open region 298 that is aligned with the main lumen 300 of shaft 292. The shaft 290 also has an inflation lumen 302 that opens into the interior 304 of the balloon 296. The balloon 296 moves between the unexpanded and radially contracted state of FIG. 52 and the expanded and radially expanded state of FIGS. 53 and 54. When the balloon 296 is in the inflated and radially expanded state, the opening region 298 has a funnel shape.

Expansion of the elastomer by braiding and heat application The interaction between the braiding and the membrane is of course important, but it can be optimized to provide a variety of funnel shapes and properties. Further, the elastomer has no attachment to the braid that extends over one or more portions, yet it is coupled to the outer member and the inner member, respectively, at the proximal and distal sides. Can be. This structure has the advantage that no protrusions are formed by the joint or braid geometry. Specifically, it is preferred to use this technique at the distal end of the expanded braided portion to create a smooth, uninterrupted funnel shape. This smooth shape improves hydrodynamics and possibly enables more complete suction of the embolus, possibly by eliminating swirl.

  It is preferable to form a membrane that is securely attached in one part to the braid and not in another part. With this configuration, the braid can be held in a desired shape (which can be the final deployed shape or any other intermediate position) and the membrane is placed on the braid. The assembly can then be placed in a heated mold or other device to heat the membrane and flow it to fuse with the braided wire. An insulator may be placed in the mold to prevent heating of certain portions of the membrane, thereby keeping the membrane free from the braid.

  Another aspect of the invention relates to a configuration in which the polymer is formed using heat with an expanding braid. For example, a thermoplastic elastomer (including but not limited to polyurethane, C-Flex, chloroprene, etc.) can be applied to a tubular mesh braid (this application can be sprayed, cast dipped on the braid) Can be extruded, and then manipulate the tubular mesh braid to make it into the desired shape (including but not limited to funnel, disc, egg, sphere, cone, etc.) Expand. In this case, the addition of heat is advantageous because the polymer can be formed into the desired shape. This can be achieved during and / or after expansion of the tubular mesh braid. Furthermore, since the interaction between the braid and the membrane is of course important, it is necessary to control this interaction by joining the braid to the membrane along its entire length or along several separate parts. might exist. The elastomer has no attachment to a braid that extends over one or more parts, yet is connected to the outer member and the inner member on the proximal and distal sides, respectively. can do. This structure has the advantage that there are no protrusions formed by the joints or braid geometry. More specifically, the preferred embodiment is to use this technique at the distal end of the expanded braided section to create a smooth and uninterrupted funnel shape. This smooth shape improves hydrodynamics and possibly enables more complete suction of the embolus, possibly by eliminating swirl.

  In some situations it is desirable to form a membrane that is securely attached in one part to the braid and not in another part. The braid can be held in a desired shape (which can be the final deployed shape or any other undeployed intermediate position) and the membrane is placed on the braid. The assembly can then be placed in a heated mold or other device to heat the membrane and flow it to fuse with the braided wire. An insulator (eg, PTFE tube) may be placed in the mold to prevent heating of certain portions of the membrane, thereby keeping the membrane free from the braid. This forming method is effective for use with all thermoplastic braids (elastic or inelastic).

  Furthermore, in the case of inelastic polymers, tubular mesh braids can be used to actually plastically deform the inelastic polymer. In this case, it may be advantageous to use a tubular mesh braid with a greater outer radial force so that plastic deformation is achieved. This large radial force of the tubular mesh braid can be achieved by using larger and / or stronger netting yarns during the braiding. In both cases of using a tubular mesh braid as a “tool” to create an elastomeric shape, air pressure and heat can be used to aid the process. In the case of the embodiment described above, this braid can also be used as a tool when making a balloon in the shape of a funnel, disk, egg, or cone.

  A method of securing the end 306 of the tubular braid 308 to the softenable end portion 310 of the tube 312 is illustrated in FIGS. 55-58. The end portion 310 is inserted into a heated tool 314 and the end 306 of the tubular braid 308 is placed within the open end portion 310 as shown in FIG. The heating tool 314 sufficiently softens the end portion 310 so that when the mandrel 316 is inserted through the tubular braid 308 and into the heating tool 314 as shown in FIGS. The first end 306 is pushed into the softenable end portion 310 to form a tube / braid matrix 316. The resulting bond forms a strong and tight bond even if there is a slight change in either the outer or inner diameter of the tube 312.

  The heating tool 314 can be heated by a variety of conventional or non-conventional methods, including electrical resistance heating and RF heating. Sensors or feedback loops can be used to maintain the heating tool 314 at the desired temperature, but the heating tool 314 has a Curie temperature at the desired operating temperature to maintain the tool at the desired operating temperature. It can form from the material which has.

  The shape of the radially expandable and retractable tubular device can be controlled as shown in FIGS. FIG. 59 illustrates a funnel-shaped, radially expandable and retractable tubular braiding device 320. The device 320 has different cross-sectional areas at different locations along its length, such as locations 322, 323, 324, etc., when in the radially expanded state. The device 320 can be expanded or contracted in a radial direction naturally or by an external force or stimulus such as heating or physical manipulation. By varying the thickness of the impregnating material 326, the resistance to radial expansion can be adjusted to achieve the desired shape. For example, the device 320 is made of a material 326 that is thickest at location 322, gradually decreasing at locations 323 and 324, and no material at locations beyond location 324. FIG. 60 illustrates a tubular braiding device 330 that has an elastomeric material 332 along the proximal and distal portions 334 and 335 of the device to form an expanded diameter bowling pin-like shape for the device 330. . Application of material 326, 332 results in a material having a thickness that varies over at least a portion of its length, which application results in a material having a constant thickness or a finite number of thicknesses. For example, multiple hands of material with the same or different thickness and the same or different axial spacing can be applied to the braid. It is also possible to use other materials with the same or different stretch resistance characteristics. The material can be generally elastic or generally inelastic or a combination thereof. In general, it is preferable to use an impregnating material 326, but a suitable radial expansion inhibitor can be applied to the outer surface of the braid or, if properly attached, to the inner surface of the braid.

  In some cases, a shape is imparted to the thermoplastic membrane, which is then used in conjunction with a radial expansion member such as a tubular braided member or a Marcot member so that the radially expandable member has the desired radially expanded shape. It may be desirable to configure to assist in achieving. 61 and 62 illustrate the use of a radially expandable device 336 comprising inner and outer tubes 338, 340 and a tubular braid member 342 at the distal end of these tubes 338, 340. The device 336 is a tool that can be replaced by other tools, such as a Marcot device, that perform the same function. A thermoplastic membrane 344 is disposed on the tubular braided member 342, and the member 342 is radially expanded as illustrated in FIG. Typically, heating and cooling cycles provide a bend to the thermoplastic film 344, but the method of providing this bend is generally determined by the material from which the thermoplastic film 344 is formed. It is done. The membrane 344 can be an elastic material or an inelastic material. The thermoplastic membrane 344 is coated with a thermoplastic liquid material, for example, by sliding the tubular membrane over the member 342, or the tubular braided member 342 (or other such tools can be used). In particular, it can be applied by: In the latter case, it may be desirable or necessary to use one or more separation layers between the tubular braid 342 and the thermoplastic membrane 344.

Anastomosis Medical Device This aspect of the invention relates to a device / implant that is particularly useful for bypassing, joining or rejoining tissue pieces in the body. Furthermore, this aspect of the invention relates to means for bypassing or recombining the tubular structure within the body. The system can be used to perform an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly port-access CABG surgery. Alternatively, it can be used to bypass any diseased vessel (blood vessel or other vessel / lumen) in the body. The first configuration has two parts: an anchor member for forming an attachment to the target vessel wall and a coupling member for forming an attachment to the bypass graft. With the graft attached, the anastomosis is completed by inserting the coupling member into the tube. A second aspect of the invention includes an anastomotic joint with an expandable flange to which the vessel is attached and contacts the outer surface of the target vessel. A regulated amount of pressure is applied by the expandable mechanism, which in turn grips the target vessel and forms a leak-free seal between the anastomosis mechanism and the target vessel. A third aspect of the invention has a flange to which the vessel is attached by attaching a hook incorporated into the expandable anastomosis device to attach to the wall of the target vessel to form the anastomosis. A method is provided for sealing or bonding a graft at an anastomosis site to a target vessel having an opening. The method includes positioning a clasp made of a deformable material in the radial vicinity of the free end portion of the graft. The material is deformable between a small dimension state and a large dimension state when energy is applied to the material. The method further comprises inserting at least the free end portion of the device into the target vessel through the opening of the target vessel. The free end portion of the device is radially expanded to closely contact the inner wall of the target vessel. The method and apparatus described above are shown at least schematically in the attached drawings for the present invention.

  Another aspect of the invention is particularly configured for the repair of an anastomosis of a hollow conduit in the body. For example, if the tubular conduit in the body is partially, general, relative, or completely blocked, lesioned, restricted, etc., the preferred solution is the removal of the lesioned conduit followed by An anastomotic repair, or perhaps an anastomotic repair by bypass where the present invention can be used to connect, rejoin, or bypass a suspected portion of the conduit.

  If the lesion conduit is removed and it is preferred that the conduit be replaced by a recombination or other anastomosis or synthetic conduit (or combination thereof), these examples allow the physician to use the remaining end of the conduit in the body. A radially expandable tubular structure can be inserted into (or above) the part. Presumably, the radially expanded tubular structure is not fully expanded or partially radially contracted (or at least somewhat radially contracted, although this is for the purposes of the present invention). Will be placed in the vessel). However, in this case, the device is at least equal to or smaller than the inner diameter of the vessel, but possibly more or less slightly contracted, at both ends of the vessel (possibly those Of the blood vessels). The ends of the device can be provided with hooks or other fasteners, or can be provided with other connection areas that the device can attach (or not attach) to organ conduits. In addition, tissue adhesives available today are probably used and may actually be incorporated into the procedures taught herein. This can be assisted by physical, chemical, or other means, or no connection may be required at all. Where any connection mechanism is used / necessary, these mechanisms include, but are not limited to, hooks, stitches, staples, adhesives, physical interlocks, friction, compression, and the like.

  The present invention can be enhanced by the use of a tubular mesh weave knitted from individual mesh yarns, or a braid. The use of such braids is common in both industry and medical devices / implants. See, for example, U.S. Patent Nos. 6,179,860, 6,221,006, 6,635,068, 6,258,115 and 6,450,989.

  One particular advantage of the tubular mesh braid described in the above paragraph is that it can shrink and expand into a tube. In this disclosure, a description of a tubular braided member and its coating is included below. (The coating described in the previous paragraph and further described below may be necessary or unnecessary). Further, instead of or in addition to the “coating”, the braid is composed of a plurality (18-144 or more or less) of “mesh yarns”, and a part of these mesh yarns acts as a coating. Thus, it can be configured to be part of the actual braided mesh, not a coating at all.

  This contraction / expansion phenomenon of the tubular braided member may be useful in this embodiment. For example, a braid of a specific length can be formed with a specific diameter. The braid can be stretched or extended by pulling it somewhat stretched. This shrinks the diameter of the braid and can therefore easily fit within the tubular conduit (s) in the body. The braid can then be relaxed and its diameter expanded radially to a predetermined diameter or the inner diameter of the organ conduit. Conversely, the braid is constructed with a specific diameter smaller than the organ conduit, and then compressed to expand it radially to the appropriate diameter to join and recombine the conduit. It is also possible to do. This compression or tension can be permanently controlled, if desired, by maintaining the braid in an expanded state for an appropriate time. Of course, this can also be controlled using the “memory” of the braid, as described below in the description of the tubular braid member, or elsewhere. Alternatively, the braid can be maintained in an extended / small diameter or shortened / large diameter state by physical attachment that maintains a suitable state.

  The tubular mesh braid includes, but is not limited to, polymers such as PET, silicon, nylon, polyester, mylar, stainless steel, Elgiloys, NiTi (nickel titanium alloy, TWSM (two-way shape memory: Two Way Shaped Memory) A wide variety of materials currently used in the medical device industry or newer to be announced or discovered, including metals or alloys, such as both)) and Super Elastic NiTi) It can be formed from a material.

  In addition, these radial expansion devices and methods employ a “slit tube” structure, commonly referred to as a Marcot structure, that can be easily expanded and contracted by placing the tube in a compressed or expanded state, respectively. Can be achieved.

  Furthermore, these radial expansion mechanisms are such that in the small / contracted state, the walls of the material contract and contact each other (like cinnamon rolls), and in the large diameter state, the walls do not contact each other. It can also be achieved by winding a material such as a “roll”. This cinnamon roll “rolls” the sheet material (with porosity, holes, cover, film, membrane, drug, compound) into a small diameter tube / cylindrical state and then rolled at the desired location. This can be accomplished by allowing the sheet to “roll back” at least partially into the desired tubular structure.

  Furthermore, the present invention and method can also be achieved with a sheet material (eg, a ribbon) that is longer than its width. The long dimension is then programmed to become a tubular shape by "wrapping" it around a small cylindrical mandrel (or other means) and processed to maintain that small tubular shape. . Thereafter, in the desired state, the small diameter tube can be manipulated to have a larger diameter tubular shape. One way to achieve this is to use the above-described TWSM NiTi, which is disclosed as “porous stent” in US Pat. No. 6,258,115.

  In all cases, these mechanisms can be covered by a film of elastic or inelastic material. Further, the film can be incorporated into these mechanisms instead of coating the mechanisms. Such films, covers, and other built-in materials include, but are not limited to: Silicone, nylon, polyethylene, wovens, hybrid, PET, woven metal, PTFEs, expandable PTFE, FEP, Teflon, hydromers, collagen, polymers, bichryl Bioabsorbable materials such as autogenous substances (animals, humans or plants).

  At its distal and proximal ends (or near them), support wire (s) can be provided that can extend through or along the expandable passage device. These wires can be used to assist in the deployment or undeployment of the radially expandable member. In addition, these wires can be used to help maintain their preferred state when in a preferred position within the host. The number of the support wire (s) can be one, two, three, four or more and can be placed inside or outside the tubular structure. They can be used to put the mechanism in an expanded or compressed state that allows it to be in a small or large diameter state. These wires can be configured to be permanently attachable to maintain their desired shape by permanently attaching them to maintain the mechanism in the desired shape. The distal end of the core is attached to the distal end of an annular braid member (or other mechanism disclosed herein), and the distal end of the shell is attached to the proximal end of the annular braid member. It is attached. Thus, when the core and shell are moved relative to each other, the braided member expands from a radially contracted position, useful for insertion into the body in a small state, to the side wall of the body passage. Move to the direction extension position.

  A device made according to this aspect of the present invention may be a bodily tubular passage (arteries, veins, biliary tract, urinary tract, gastrointestinal tract, stent, graft, sinuses, nasopharynx, heart, ear, etc.) or Used for interventions in hollow cavities (stomach, gallbladder, bladder, peritoneum, etc.). Furthermore, the present invention is useful in solid or semi-solid tissues including, but not limited to, breast, liver, brain, pancreas, lung, etc. It is convenient for use in environments such as operating rooms, surgical wards, interventional wards, emergency rooms, patient bedsides, etc. One preferred embodiment of this device is to insert the variable shaft, usually through a percutaneous approach or surgical incision, into a tissue, tubular passage or hollow cavity in the body. In the case of lumens that naturally enter and exit the body, the devices can be introduced through either their inlet or outlet passages (ie, rectal mouth, mouth, ear, etc.).

  In addition, the use of lytic agents, laser energy, dissolving agents, hydrodynamic assistance, mechanical agitation, vibration, ultrasonic energy, etc., or other aids for removal assistance Other techniques can be used, such as any variety of assistance. Image enhancement (ultrasound, fluoroscopy, MRI, etc.) can also be used to help the technique / removal work well. Furthermore, direct fluoroscopy using a camera or an endoscope can also be used.

  Further, the materials disclosed herein can be any hybrid elastic / inelastic or compliant material. In addition, the balloon can be assisted by some other mechanical substructure that assists in the outer radial force caused by the balloon. In addition, if a balloon is used, a single fiber such as a mylar, pet, polymer flakes such as polyethylene can be used to create the desired action (shape, etc.) when the balloon is inflated. All of these configurations may or may not have a rough texture on the outer surface to assist in the removal of obstructions or deposits on the tissue. Alternatively, all of the above-described arrangements may have a separate or additional material applied to the expandable mechanism that is a membrane, roughened or not. The roughened surface on the expandable mechanism is easily achieved in a manufacturing environment. One such method is to create bubbles in the polymer liquid slurry prior to its curing. Another method is to add soluble crystals to the surface of the liquid polymer before curing. These dissolvable crystals can then be removed (washed out) after curing of the polymer.

  Another configuration that can be used for the expandable mechanism is the mechanism (s) known as Marcot. This Marcot is a common configuration used in catheters to hold them in place (when feeding a tube to the intestine or stomach). It is a polymer tube with one or more, usually two or more symmetrically opposed slits. When the distal tip of the Marcot is compressed (usually by pulling the inner wire or mandrel or tube), the polymer side is pushed outward creating a large diameter at the distal end. This large diameter is larger than the body / axis of the device. In the case of a Marcot-type structure (as in the case of the inflatable mechanism described above), the surface of the Marcot is roughened, or a separate film (attached or not attached) is placed on or below the Marcot. To roughen or strengthen it. Furthermore, a membrane connecting the Marcot ribs or wings can be easily made to increase the surface area of the Marcot ribs or wings.

  Furthermore, yet another configuration of the expandable mechanism is similar to the Marcot but uses a multi-strand braid at the distal end. As the braid is compressed, the braids are pulled together and spread, creating a large diameter at the distal end. The braid is easily modified by changing the hole size along the braid so that the holes in the braid change from zero to large holes / holes. This braids the braid with metal and polymer, dissolves and removes the polymer, or simply creates different pore sizes during the braiding, also known as pics per inch in the braiding industry. This can be achieved by braiding at different speeds. This is easily accomplished on-the-fly by braiding by using a programmable braiding machine. The pics per inch varies with the time the tubular mesh braid is being braided. This varying pore size may have a number of advantages for the present invention. It can stop porosity when needed and help to allow porosity when it is needed. For example, in some cases ingrowth in contact with the tubular body structure is desired and there is no porosity when trying to achieve a leak-free environment (possibly between two attached tubular structures or when bypassed). Is possible.

  Alternatively, the braid or marcot may incorporate a permanent set so that it normally opens with a large diameter. In this case, when it is stretched (usually from some inner (or outer) core wire or mandrel), it will deflate to the diameter of the device shaft.

  Alternatively, if the abrasive action on the surface of the mechanism (s) is too great, it may be harmful to the patient. In the case of a braided configuration, some smoother may be required so that a reasonable amount of friction is achieved for its effective fault removal. Furthermore, whatever type (s) of mechanism must be optimized for this removal in a particular application.

  The radially contractible tubular passage can be made from a plurality of materials and structures. One suitable structure is a multi-chain braiding device. The chain is made of any material useful for a specific application (polymers such as polyester, nylon, mylar, etc.) or metal (stainless steel, nickel titanium alloy (Nitinol), platinum, etc.) Can do. Of course, potentially useful materials are not limited to the materials listed here. The mechanism passage is coated or wrapped with an elastic or other cover member. Furthermore, the mechanism passage can be made of a material that expands with a force different from that of the braid described above. An example of such a force derivation mechanism may be a material that expands / expands when placed in a humid environment. Another example of such a force derivation mechanism is a material that expands / expands when heat is applied, such as a two-way shape memory alloy (TWSMA), such as a nickel-titanium alloy. Further, it may be derived from electrical, magnetic, or other physical configuration / design / force.

Tubular Braided Member The mechanism described above includes a longitudinal tube, a longitudinal mandrel within the tube, and an expandable tubular braid. The longitudinal mandrel extends from the proximal end of the device to the distal end. The longitudinal tube typically extends from near the proximal end of the device to near the distal end. The distal end of the tubular braid is coupled to the distal end of the inner longitudinal mandrel. The mandrel can extend beyond the tubular braid. The proximal end of the tubular braid is coupled to the distal end of the longitudinal tube.

  The braid may be open, but elastic, such as silicone rubber, latex, polyethylene, thermoplastic elastomer (such as C-Flex available from Consolidated Polyer Technology), polyurethane, etc. It can also be laminated or covered by a coating of elastic, plastic or plastically deformable material. The tube, mandrel and braid assembly is introduced percutaneously in its radially compressed state. In this state, the outer diameter of the braid is close to the outer diameter of the longitudinal tube. This diameter is in the range of 10-500 mils, typically 25-250 mils (i.e., 1/1000 inch) (0.25-12.7 mm, typically .64-6.4 mm). After insertion, moving the mandrel proximally relative to the tube expands the tubular braid.

  The tubular braid is preferably formed as a mesh of individual inelastic monofilaments (called “net yarn” in the braiding industry). However, it is possible to weave some elastic monofilament into it to create certain properties. The inelastic mesh yarn is polyester, PET, polypropylene, polyamide fiber (DuPont's Kevlar), multi-layer single fiber wound polymer, extruded polymer tube (Nylon II commercially available from General Electric). ), Ultem), stainless steel, nickel titanium (Nitinol), etc., it is possible to cause radial expansion of the braid by contraction in the axial direction. These materials are sufficiently strong so that the tubular braid member is maintained in its expanded state within the body lumen while the material is removed therefrom. Furthermore, all the expandable mechanisms described so far are manufactured using shape memory materials so that they automatically expand or expand when a certain temperature or thermal energy is applied to them. can do. Such material properties can be achieved by a variety of programming methods including, but not limited to, Two Way Shape Memory (TWSM) alloys.

  The braid may have a conventional structure such as a circular single fiber, a flat or ribbon single fiber, a square single fiber, or the like. Non-circular monofilaments may be advantageous to reduce the axial force required for expansion to create a suitable surface area configuration, or to reduce the wall thickness of the tubular braid. The width or diameter of the monofilament is in the range of about 0.5-50 mils (0.013-1.3 mm), typically about 5-20 mils (0.13-.51 mm). Suitable braids are commercially available from various commercial suppliers.

  The tubular braid is usually formed by a “maypole” dance of a mesh carrier. The braid consists of two systems of yarns that alternately pass above and below to form a zigzag pattern on the surface. One mesh yarn system moves spirally clockwise with respect to the fabric axis, while the other mesh yarn system moves spirally counterclockwise. The resulting fabric becomes a tubular braid. Typical uses for tubular braids are lace fabrics, electrical cable covers (ie for insulation and sheathing), “Chinese hand-cuffs”, and composite reinforcement. In order to form a balanced, torque-free fabric (tubular braid), the structure must contain the same number of braids in each spiral direction. It is also possible to press the tubular braid flat to form a double-thick fabric piece. The braid used in the tubular braid of the present invention preferably has a 1/1 crossing pattern of mesh yarn called “intersection repeat”, “two-dimensional, tubular, diamond braid” Is of the structure known as Alternatively, standard braids with 2/2 cross repeats and Hercules braids with 3/3 cross repeats can be used. In any case, when the braid is expanded, its twist angle (angle between the axis of the tubular braid and the net yarn) increases. In addition, a longitudinal “(Lay-In)” yarn can be added parallel to the axis within the braided mesh yarn to aid in fabric stability and improve stretch and compression properties and modulus. it can. If the properties of these longitudinal “(Lay-In)” yarns are elastic, the tubular braid is known as an elastic braid. When these longitudinal mesh yarns are hard, the fabric becomes a rigid braid. Biaxially knitted fabrics such as those of the present invention are not dimensionally stable. This is why it is possible to place the braid from a relaxed state (when it is compressed) to an expanded state. Alternatively, it can be in a reduced / reduced (reduced braid diameter) state when placed from a relaxed state to an extended state. When in the stretched state (or compressed state), the braid eventually reaches a state where its diameter does not decrease any further. This is called the “Jammed State”. On the stress-strain curve, this corresponds to an increase modulus. Many of the engineering analyzes for braids are calculated using the “jammed state” of the structure / braid. These calculations help one skilled in the art to design a braid having certain desired characteristics. Further material properties are tensile strength, stiffness and Young's modulus. In most cases, changing the material properties changes the force that the expanded state of the tube can exert in the radial direction. Furthermore, the friction between the individual braids affects the force required to compress and decompress the tubular braid. In the present invention, the friction should be relatively low for the selected screen yarn so that the user can deploy the engagement member with little difficulty. This is particularly important when the engagement member is located far away from the user. Such a case is when the percutaneous introduction is in the groin (femoral artery for vascular intervention) and the point of engagement with the engagement member is some distance away (ie the carotid artery of the neck). It is a case. Similarly, this is also true for long distances that are not vascular or transdermal applications.

Tubular Braid Coating Throughout this disclosure, it is described that a tubular braid can be coated with a material so as not to have porosity or variable porosity within the individual filaments of the braid. This is an important feature of the present invention and may be essential in certain cases (i.e. when the gun is removed from a small perforation, the gun may be seeded along the tube) So it must be ensured that the cancer tissue cannot leak through the wall of the tubular braid, which is equally important in the case of laparoscopic surgery, in fact, in many cases the cancer is obvious It is important if not.) One simple way to coat the tubular braid is to attach tube material to it. When this was done for the exemplary type of the present invention, it worked very well. Elastomers and inelastic covers were used. In some cases, a thermoplastic cover was used, after which heat and compressive force was applied along the tubular braid to dissolve it into the braided monofilament. This goes well. The braid was expanded from its original small diameter state by sliding the mandrel into the tubular braid. When the braid is expanded, liquid thermosetting elastomers including, but not limited to, silicone rubber, latex rubber, or, but not limited to, thermoplastic materials including polyurethane can be sprayed, dip, brushed. Coated by other methods. When the material is cured, the mandrel can be removed and the tubular braid can be pulled (compressed) at its ends, which then returns to its original diameter. This is important for several reasons. That is, the method described herein allows the material to be applied from within a single fiber rather than from above the single fiber. This greatly reduces the overall diameter of the tubular braid while placing the cover thereon. Furthermore, the material integrity between the single fibers increases over the single fibers. This is because when the expandable passage is pushed forward, the material is hidden in the braid and thus the tissue forces acting on it are not visible. When a cover is used on the braid, the force during the pushing operation is directly transmitted to the cover on the braid. In addition, reliability and manufacturing costs are greatly improved. Furthermore, and most importantly, it is possible to change the porosity along the tubular braid by using a liquid that hardens or a thermoplastic cover that dissolves into a braid rather than a cover. It is a fact. This is extremely important when variable porosity is desired.

Device Testing An exemplary type of the mechanism was created from materials of the dimensions disclosed so far and suitable for this disclosure.

  In addition, several different types of tubular braids were coated / covered with the polymer elastomers and inelastomers (inelastic materials) described above. In one case, the braid was expanded to a state somewhat larger than its relaxed small diameter state. This was achieved using a Teflon mandrel. With the tubular braid in this somewhat expanded state, the assembly was coated with liquid silicone rubber. When it was dried, the assembly could be stretched by stretching the system so that the original small diameter condition was again achieved. The braid was then covered so that there was no hole between the single fibers of the braid, as it expanded, as it was in a compressed state, and thus in a shortened state. Furthermore, the overall diameter of the tubular braid is probably. No increase other than 0001 "(.0025 mm). In addition, a capture device was created, whereby the silicone rubber was sprayed or painted onto the tubular braid when the tubular braid was in the expanded / expanded state. The assembly could easily be undeployed and redeployed without holes between the single fibers, and finally the tubular braid as described above to create a variable porosity along the braid. Coated only by partial coating, and the multi-chain braided tube was braided using 100 individual mesh yarns made of thermoplastic and metallic materials. Removed to change porosity, or when a combination of metal mesh and thermoplastic mesh is used, the thermoplastic mesh is heated and dissolved and removed from the tubular braid to a higher melting temperature. High Genera or polymer (or, in the case of thermosetting polymers, materials with higher temperature resistance) left, by leaving intact a material having higher metal or the temperature resistance, alter the pore size.

  An example device has the following characteristics:

  Action length

  10-500cm

Working diameter The expandable mechanism comprises: It has an outer diameter in the range of 006 "-. 450" (.15mm-1.14cm), but can extend to smaller or larger dimensions depending on the needs of the technique and procedure. In the undeployed state, the expandable mechanism of the present invention is. 020-. Although it is as small as 090 inches (0.51 mm-2.3 mm), it can be expanded to a diameter that is ten times or more.

Physical Configuration The device of the present invention may be provided with a conventional lubricious coating such as, for example, a coating of hyaluronic acid or its equivalent to facilitate introduction into the target body lumen. In addition, the technician can apply a lubricious coating prior to surgical treatment. Also, various devices can be used with the device, as well as the devices described above, for various reasons such as reduced infection and / or rejection, and depending on some vascular conditions, drug elution mechanisms may be used. It is added to help prevent stenosis or restenosis. Such agents or compounds include, but are not limited to, sirolimus, which is an immunosuppressant that is commonly used to prevent organ transplant rejection and can cause scar tissue to grow Elutes from the stent into the vessel wall over a period of time. Paclitaxel, a chemotherapeutic agent, can also be used. This paclitaxel is gradually released directly into the coronary artery to prevent the restenosis process, but this can be achieved by embedding the material in the polymer rather than coating the device. This is also true for Siolimus.

  As an advantage of the present invention, the device is easy to deliver to a desired location within the body due to its reduced size. Another advantage of the present invention is that it allows a bypass or anastomosis procedure to be easily achieved. It can also be done percutaneously rather than opening, surgical procedures. Over the past few decades, percutaneous interventional procedures have proven to show a significant reduction in morbidity and mortality, unlike open surgical interventions. This reduced difficulty will reduce operating room time costs (operating room costs are estimated to be over $ 90 per minute in the United States).

  FIG. 63 illustrates the distal end of an anastomosis medical device 348 having a tube 350 with a tubular braided anchor member 352 secured to its first end 354. The apparatus 348 further extends through the tube 350 beyond the second end 356 of the tube 350, see FIGS. 64 and 65, and is connected to the distal end 358 of the anchor member 352. 355. The dilator 360 passes through the tube 350, which helps guide the medical device 348 through the relatively small opening 362 of the patient's tubular structure 364. FIG. 63 illustrates the device 348 in the state of penetrating the blood vessel and proximate to the disease blocker 366. Finally, the device 348 has a guide wire 368 that passes through the center of the dilator 360. After being properly positioned, the dilator 360 and guidewire 368 are removed and the actuator 355 is pulled as shown in FIG. 65 to cause the anchor member 352 to expand as shown in FIG. If desired, the anchor member 352 can be automatically expanded or expandable, for example, by application of heat or the like. FIG. 67 illustrates an anchor member 352 that includes a hook 370 that is deployed to assist in locking the anchor member 352. These hooks 370 can be used by first pushing them distally and then pulling them proximally to lock / hook the tubular structure 364, or by pushing the anchor member 352 to expose the hooks. Deployment can be achieved by contraction in the axial direction. It should be noted that although the tubular structure 364 is illustrated as being radially expanded when the anchor member 352 is locked in position, such expansion of the tubular structure may not be necessary.

  An example of a tubular mesh braid 372 is illustrated in FIGS. The braid 372 can easily change in diameter by 1000% due to compression / extension forces as indicated by arrows 374 and 376 or due to the permanent set of the braid 372 being manufactured. it can. Alternatively, if desired, temperature changes or electrical, mechanical or magnetic forces can be used to create this change in diameter. FIG. 70 illustrates a tubular mesh braid 372 with hooks 378. The hook 378 can be deployed by shortening the braid 372. This shortening can be caused by the other expandable mechanisms described above so that this hook deployment can be accomplished using such other expandable mechanisms.

  The anastomosis medical device 348 can include a second end 356 located outside the patient's body to provide access to a single tubular structure. However, it is also possible to use two anastomosis medical devices 340 on the patient's body and connect them to two different tubular structures within the patient's body or to bypass parts of the same tubular structure It is. In either case, the second ends 256 of the two anastomotic medical devices 348 are secured together in a suitable manner. FIGS. 71-74 below illustrate various structures for joining the ends of the patient's tubular structure, which structures can also be used to join the second end 356 where appropriate. can do.

  FIG. 71 illustrates a tubular braided anastomosis medical device 380 that covers the ends 382, 384 of the cut tubular structure 364. FIG. Although the ends 382 and 384 are shown in contact with each other, they can also be separated from each other. The relaxed state of the medical device 380 is a small diameter state, which causes the device 380 to compress the tubular structure 364 and hold the ends 382, 384 in position. If desired, the central portion of the device can be liquid impervious, or the entire device can be liquid impervious. FIG. 72 illustrates the use of a radially outward dilating anastomosis medical device 386 inside the tubular structure 364 to join the ends 382, 384. FIG. The ends 382, 384 may be separated from each other or abut each other as indicated by the dashed lines in FIG. Appropriate portions of the device 386 are typically liquid impervious to prevent leakage. If desired, a radially inward expander 380 can be used outside the tubular structure 364 and a radially outward expander 386 can be used inside the tubular structure 364 at the same connection. 73 and 74 illustrate anastomotic medical devices 380, 386, where they are added with hooks 378 to help position the anastomotic medical devices. Various membranes, films, fabrics or coatings can be used to assist the function of the mechanism described above. Multiple porosities may also be advantageous for different applications. It is also possible to use drugs and other therapeutic agents with the devices described above.

  FIG. 75 illustrates a linear tube shaped variable porosity anastomosis device 388. FIG. 76 illustrates a tapered tube-shaped variable porosity anastomosis device 390. When such a structure is placed in a body passage, it may be desirable to have a small hole at the central portion and a large hole at the outer end. The materials used in the various anastomosis devices described above can be total non-absorbable / degradable, total absorbable / degradable, or a combination of the two, depending on the particular anastomosis application.

  77 and 78 illustrate a Marcot anastomosis device 392 in a radially contracted and radially expanded state. Device 392 is shown with four slits 393, but two or more may be sufficient for radial expansion. 79 and 80 illustrate the application of an extension force indicated by arrow 376 and a compression force indicated by arrow 374 to device 392 to place the device in a radially contracted state and a radially expanded state, respectively. ing.

  81 and 80 are placed in the radially contracted and radially expanded states of FIGS. 81 and 82 by sliding the inner tube 398 within the outer tube 400 as indicated by the arrows in the figure. A variable porosity expandable device 394 is shown comprising a variable porosity braid 396 capable of.

  83 and 84 illustrate the variable diameter device 402 in a radially contracted state in FIG. 83 and in a radially expanded state in FIG. The device 402 is a helical ribbon made of a material configured such that the lateral edges 406 of the helical ribbon 404 are close to or overlap each other to provide a substantially continuous cylindrical surface to approximate a solid cylinder. 404. FIG. 85 is an end view of the coiled cylinder 408.

  86-87 illustrate a self-expanding, expandable passage anastomosis device 410 having two slits 412 formed in the outer tube 414. The expandable end 416 of this device 410 can be maintained in its radially contracted state of FIG. 86 by pushing the inner tube 417 or by allowing the inner tube 417 to move in the direction of the arrow. 87 can be in the radially expanded state. FIG. 88 illustrates an anastomosis device 418 that naturally enters the radially expanded state of FIG. 88 but is initially maintained in a radially contracted state by an outer tube not shown. When it is desired to expand, the outer tube is pulled or otherwise removed to allow expansion of the expandable end 416. The anastomosis device 420 of FIGS. 89-91 is similar to the device of FIGS. 86 and 87, but is naturally in the radially contracted state of FIG. To place the device in the radially expanded state, the inner tube 417 is pulled as shown in FIG. Although not shown, various membranes, films, etc. can be used to fill all or part of the space formed by the slits 412 in the expandable end 416 of these devices.

  An anastomosis device 422 comprising an outer tube 424 and an inner self-expanding braided member 426 is illustrated in FIGS. The braided member 426 is initially restricted by an outer tube 424 that can be variable and / or lubricated. The braid 426 can be expanded by sliding the outer tube 424 in the opposite direction in the direction of arrow 428, or by pushing the braid member 426 in the direction of arrow 430, or both. Other types of structures are also possible, such as a marcot such as that illustrated in FIGS. 86 and 87, a coiled tubular device such as that illustrated in FIGS. 83 and 84, and a coiled cylindrical device such as that illustrated in FIG. In this way, it can be mechanized.

  FIG. 94 illustrates another configuration of the tubular braided anchor member 352 of FIGS. 63 and 66. The anastomosis device 434 is a tube comprising an inner expandable mechanism 438 or both an inner expandable mechanism 438 and an outer expandable mechanism 440 used to engage the perimeter of the opening 362 of the tubular structure 364. 436. The expandable mechanisms 438, 440 may be tubular mesh braids as shown, or other types of expandable devices such as inflatable balloons, marcots, coiled tubular devices or coiled cylindrical devices. Can do.

  FIG. 95 illustrates a tubular mesh braid 444 attached to the exterior, such as an endoscope or other longitudinal device within a tubular structure 364, such as a bowel or intestine. FIG. 96 illustrates the braid 444 in an expanded state by pushing on the braid as indicated by the arrows. By advancing the endo device, the tubular braid 444 is contracted again onto the internal device as illustrated in FIG.

  Other modifications and alterations may be made to the disclosed embodiments without departing from the scope of the present invention as defined in the following claims.

  All the patents, patent applications and printed publications mentioned above are hereby incorporated by reference.

Diagram illustrating an expandable member guidewire in a radially contracted and radially expanded state Diagram illustrating an expandable member guidewire in a radially contracted and radially expanded state 2 illustrates another embodiment of the expandable member guidewire of FIG. Figure illustrating the needle inserted into the graft near the occlusion FIG. 5 illustrates insertion of an expandable member guidewire through the needle of FIG. 4, expansion of the expandable member, and subsequent removal of the needle leaving the guidewire in place. FIG. 5 illustrates insertion of an expandable member guidewire through the needle of FIG. 4, expansion of the expandable member, and subsequent removal of the needle leaving the guidewire in place. FIG. 5 illustrates insertion of an expandable member guidewire through the needle of FIG. 4, expansion of the expandable member, and subsequent removal of the needle leaving the guidewire in place. Figure illustrating a recessed dilator Diagram illustrating funnel catheter assembly Sectional drawing along the 9A-9A line of FIG. Isometric view of the split stopper sleeve of FIG. 8 illustrates inserting the recessed dilator of FIG. 8 into the funnel catheter assembly of FIG. 9 to form a funnel catheter / dilator subassembly. Diagram illustrating the movement of the compression sleeve on the funnel-shaped member of FIG. Diagram illustrating the movement of the compression sleeve on the funnel-shaped member of FIG. Enlarged view of peelable sleeve Sectional drawing along the 14A-14A line of FIG. 14 illustrates sliding the peelable sleeve of FIG. 14 over the subassembly of FIG. 11 to form a catheter / dilator assembly. 15 illustrates the result of sliding the assembly of FIG. 15 over the expandable member guidewire of FIG. 16 illustrates the assembly of FIG. 16 after the peelable sleeve has been pulled proximally to allow the funnel to expand. The figure which illustrates moving the obstruction | occlusion part into a funnel part by operating the apparatus of FIG. 18 is an enlarged sectional view taken along line 18A-18A in FIG. Expanded side view of the proximal and distal portions of the rapid exchange dilator assembly 19 is a partial cross-sectional view of the distal end of the assembly of FIG. Sectional drawing along line 21-21 in FIG. Sectional view along line 22-22 in FIG. Diagram illustrating a heart having a bypass graft connecting the ascending aorta and coronary artery FIG. 19 illustrates the use of the rapid exchange dilator assembly of FIG. 19 to access a position along the bypass graft of FIG. FIG. 19 illustrates the use of the rapid exchange dilator assembly of FIG. 19 to access a position along the bypass graft of FIG. FIG. 19 illustrates the use of the rapid exchange dilator assembly of FIG. 19 to access a position along the bypass graft of FIG. FIG. 19 illustrates the use of the rapid exchange dilator assembly of FIG. 19 to access a position along the bypass graft of FIG. FIG. 19 illustrates the use of the rapid exchange dilator assembly of FIG. 19 to access a position along the bypass graft of FIG. Sectional view of the distal end of two examples of funnel catheters Sectional view of the distal end of two examples of funnel catheters Figure illustrating the funnel catheter of Figure 30 in a radially expanded state. Figure illustrating another embodiment of the funnel catheter of Figure 31 with an elastic film on its outer surface. Diagram illustrating placement and use of the funnel catheter of FIG. Diagram illustrating placement and use of the funnel catheter of FIG. FIG. 6 illustrates a mandrel having tapered proximal and distal portions that are wound in a braided form to form a braided structure. FIG. 35 illustrates the braided structure of FIG. 35 used to manufacture a funnel catheter, wherein the braided structure is in an expanded diameter state in the large and small diameter vessels. FIG. 35 illustrates the braided structure of FIG. 35 used to manufacture a funnel catheter, wherein the braided structure is in an expanded diameter state in the large and small diameter vessels. FIG. 35 illustrates the braided structure of FIG. 35 used to manufacture a funnel catheter, wherein the braided structure is in an expanded diameter state in the large and small diameter vessels. FIG. 35 illustrates the braided structure of FIG. 35 used to manufacture a funnel catheter, wherein the braided structure is in an expanded diameter state in the large and small diameter vessels. The figure which illustrates another Example of the Example of FIG. FIG. 36 illustrates two different embodiments of the embodiment of FIG. FIG. 36 illustrates two different embodiments of the embodiment of FIG. Diagram illustrating two additional embodiments of the braided structure of FIG. Diagram illustrating two additional embodiments of the braided structure of FIG. FIG. 6 illustrates another winding pattern for forming a more closely spaced turn at the proximal portion than at the distal portion. FIG. 6 illustrates another winding pattern for forming a more closely spaced turn at the proximal portion than at the distal portion. Diagram illustrating the use of the winding style of FIG. 45, similar to FIGS. 36 and 37 FIG. 6 illustrates another winding pattern for forming more closely spaced turns at the distal portion than at the proximal portion. Figure illustrating the use of the winding style of Figure 49, similar to Figures 47 and 48 Figure illustrating the use of the winding style of Figure 49, similar to Figures 47 and 48 Diagram illustrating a balloon funnel catheter in a vessel near an obstruction, in a radially expanded and contracted state Figure illustrating a balloon funnel catheter in the vessel near the obstruction, in a radially expanded and contracted state 53 is an enlarged partial cross-sectional view of the balloon of FIG. Figure illustrating the use of a heated tool and mandrel to secure the end of a tubular braid within the end portion of the tube Figure illustrating the use of a heated tool and mandrel to secure the end of a tubular braid within the end portion of the tube Figure illustrating the use of a heated tool and mandrel to secure the end of a tubular braid within the end portion of the tube Figure illustrating the use of a heated tool and mandrel to secure the end of a tubular braid within the end portion of the tube Figure 2 illustrates two embodiments of radially expandable and retractable braiding devices in which expansion is controlled by applying material over a portion of their length. Figure 2 illustrates two embodiments of radially expandable and retractable braiding devices in which expansion is controlled by applying material over a portion of their length. Diagram illustrating the use of a radially expandable device to impart shape to a membrane Diagram illustrating the use of a radially expandable device to impart shape to a membrane The figure illustrating the first end of the anastomosis medical device disposed within the tubular structure 63 illustrates the second end of the tube of the apparatus of FIG. 63 and illustrates the actuator pulled proximally in FIG. 65 to expand the tubular braided anchor member of FIG. 63 illustrates the second end of the tube of the apparatus of FIG. 63 and illustrates the actuator pulled proximally in FIG. 65 to expand the tubular braided anchor member of FIG. 63 illustrates the apparatus of FIG. 63 with the tubular braided anchor member in a radially expanded state, with the dilator and the guidewire removed. 66 is a view similar to FIG. 66 illustrating the use of hooks to help secure the tubular braided anchor member to the tubular structure. Figure illustrating a tubular mesh braid in an axially compressed and axially expanded state Figure illustrating a tubular mesh braid in an axially compressed and axially expanded state 68 is a view similar to FIG. 68 illustrating the use of hooks to assist in securing the tubular mesh braid to the vessel wall. Figure illustrating a tubular braided anastomosis medical device covering both ends of a cut tubular structure Figure 2 illustrates an internally applied tubular braided anastomosis medical device used to secure the end of a cut tubular structure 71, similar to FIGS. 71 and 72, illustrating the use of hooks to assist in securing an anastomotic medical device to a tubular structure. 71, similar to FIGS. 71 and 72, illustrating the use of hooks to assist in securing an anastomotic medical device to a tubular structure. Diagram illustrating two different types of variable porosity anastomosis medical devices Diagram illustrating two different types of variable porosity anastomosis medical devices Diagram illustrating a Marcot anastomosis medical device in a radially expanded state and a radially contracted state Diagram illustrating a Marcot anastomosis medical device in a radially expanded state and a radially contracted state Diagram illustrating a Marcot anastomosis medical device in a radially expanded state and a radially contracted state Diagram illustrating a Marcot anastomosis medical device in a radially expanded state and a radially contracted state Diagram illustrating a variable porosity expandable device in a radially contracted and radially expanded state Diagram illustrating an expandable device with variable porosity in a radially contracted and radially expanded state Diagram illustrating a spiral ribbon type radially expandable and retractable device in a radially contracted and radially expanded state Diagram illustrating a spiral ribbon type radially expandable and retractable device in a radially contracted and radially expanded state Figure illustrating a coiled cylindrical radial expandable and retractable device The figures illustrating different embodiments of a Marcot-type anastomosis medical device in a radially expanded state and a radially contracted state The figures illustrating different embodiments of a Marcot-type anastomosis medical device in a radially expanded state and a radially contracted state The figures illustrating different embodiments of a Marcot-type anastomosis medical device in a radially expanded state and a radially contracted state The figures illustrating different embodiments of a Marcot-type anastomosis medical device in a radially expanded state and a radially contracted state The figures illustrating different embodiments of a Marcot-type anastomosis medical device in a radially expanded state and a radially contracted state The figures illustrating different embodiments of a Marcot-type anastomosis medical device in a radially expanded state and a radially contracted state Figure illustrating a self-expanding braided anastomosis medical device in a radially contracted state in the outer tube 93 illustrates a self-expanding braided anastomosis medical device in a radially expanded state after extending from the outer tube of FIG. 63 illustrates another configuration of the tubular braided anchor member of FIG. 63 in which one or two radially expandable mechanisms are used to engage the perimeter of the opening of the tubular structure. Figure illustrating a tubular mesh braid at the distal end of the internal device, at different conditions within the tubular structure. Figure illustrating a tubular mesh braid at the distal end of the internal device, at different conditions within the tubular structure. Figure illustrating a tubular mesh braid at the distal end of the internal device, at different conditions within the tubular structure.

Claims (122)

A catheter / dilator assembly comprising:
A catheter having a proximal catheter end, a distal catheter end, a lumen, and an outer catheter surface; and
A substance guide member that is movable between a radially expanded and a radially contracted state and is fixed to the distal catheter end and extends beyond the distal catheter end, the substance guide member being in the radial direction A catheter assembly comprising an axial length in a deflated state,
A dilator comprising a hollow shaft provided in the lumen of the catheter, the hollow shaft formed on the outer shaft surface at an outer shaft surface, a proximal shaft end, a distal shaft end, and the distal shaft end Having a recessed area formed,
The recessed area and the substance guiding member are aligned substantially in line with each other;
A compression member that covers the substance guide member to temporarily hold the substance guide member in a radially contracted state; and
The catheter / expansion comprising: the recessed region is sized to receive at least substantially all of the axial length of the substance guide member to reduce a radial cross-sectional area of the assembly in the substance guide member. Assembly.   The compression member comprises a sleeve slidable between a position covering the substance guide member and a position along the catheter between the proximal catheter end and the distal catheter end. Item 4. The assembly according to Item 1.   The assembly of claim 1, wherein the material guide member comprises a funnel member.   The assembly of claim 3, wherein the funnel member comprises a braided funnel member.   The assembly of claim 3, wherein the funnel-shaped member comprises an inflatable funnel-shaped member.   The assembly of claim 3, wherein the funnel member comprises a Marcot funnel member.   The compression member comprises a sleeve, the sleeve comprising a distal portion and a proximal portion, the distal portion covering the substance guide member, and the proximal portion being the distal The assembly of claim 1 covering the catheter end.   When at least a portion of the distal portion of the sleeve is pulled proximally to expose the substance guide member, at least a portion of the distal portion of the sleeve is The assembly of claim 7, wherein the assembly is configured to be weak enough to substantially expand as it passes over the ends.   The assembly of claim 7, wherein the distal portion has an outer diameter and the proximal portion has an inner diameter.   The assembly of claim 9, wherein the outer diameter and the inner diameter are substantially equal to each other.   The assembly of claim 9, wherein the catheter has an outer catheter diameter substantially equal to the outer diameter of the distal portion of the sleeve.   The assembly of claim 9, wherein the outer diameter of the distal portion is within 25% of the outer diameter of the catheter.   The assembly of claim 9, wherein the outer diameter of the distal portion is within 15% of the outer diameter of the catheter.   The assembly of claim 9, wherein the outer diameter of the distal portion is within 10% of the outer diameter of the catheter. The outer diameter and the inner diameter are substantially equal to each other,
The catheter has an outer catheter diameter substantially equal to the outer diameter of the distal portion of the sleeve and the inner diameter of the proximal portion of the sleeve; and
When at least a portion of the distal portion of the sleeve is pulled proximally to expose the material guide member, at least a portion of the distal portion of the sleeve is at the distal catheter end. 10. The assembly of claim 9, wherein the assembly is configured to be weak enough to substantially expand when passing over a section.   The assembly of claim 15, wherein the portion of the distal portion comprises a weakened region.   The assembly of claim 16, wherein the weakened region comprises a material separation region within the distal portion of the sleeve.   The assembly of claim 16, wherein the weakened region comprises a reduced thickness region at the distal portion of the sleeve.   A spacer sleeve is slidably mounted on the outer catheter surface between the sleeve and the proximal catheter end, the spacer sleeve overlying the distal portion of the sleeve on the substance guide member. 9. The assembly of claim 8, further sized to assist in properly positioning the proximal portion of the sleeve over the distal catheter end.   The spacer sleeve is configured to allow the sleeve to be pulled proximally to a material guide member deployment position, thereby allowing the sleeve to no longer cover the material guide member. Item 20. The assembly according to Item 19.   20. The assembly of claim 19, wherein the spacer sleeve comprises a bendable sleeve portion that bends when the sleeve is pulled proximally to the material guide member deployment position.   The assembly of claim 7, wherein the material guide member comprises a funnel-shaped member. A method of assembling a catheter / dilator assembly comprising:
A proximal catheter end, a distal catheter end, a lumen, a catheter having an outer catheter surface, and
A substance guide member that is movable between a radially expanded state and a radially contracted state, is fixed to the distal catheter end, and extends beyond the distal catheter end, the substance guide member comprises: Selecting a catheter assembly having an axial length when in the radially contracted state,
Inserting a dilator hollow shaft through the proximal catheter end into the lumen of the catheter;
Positioning a recess formed in a distal shaft of the hollow shaft under the substance guiding member;
Installing the substance guide member in the radially contracted state; and
To maintain the substance guide member in the radially contracted state, a first sleeve is disposed proximally in a first position covering the end of the distal shaft of the dilator and the substance guide member. Sliding the top of the catheter / dilator assembly.   A sliding step is such that when the first sleeve is in the first position, the distal portion of the sleeve covers the funnel member and the proximal portion of the sleeve covers the distal catheter end. 24. The method of claim 23, wherein the method is performed as follows.   24. The method of claim 23, wherein the placing step includes moving a second sleeve slidably mounted on the outer catheter surface in a distal direction to cover the funnel-shaped member.   26. The method of claim 25, wherein a sliding step moves the second sleeve in a proximal direction to a third position on the outer catheter surface. A method of removing material from a tubular structure in the body,
A catheter having a proximal catheter end, a distal catheter end, a lumen, and an outer catheter surface; and
A substance that is movable between a radially expanded and radially contracted state, is fixed to the distal catheter end, extends beyond the distal catheter end, and has an axial length in the radially contracted state A catheter assembly comprising: a guide member;
A dilator comprising a hollow shaft disposed in the lumen of the catheter, wherein the hollow shaft is an outer shaft surface, a proximal shaft end, a distal shaft end, the distal shaft end or near the outer shaft surface Having a recessed region formed in the
The recessed area and the substance guiding member are aligned substantially in line with each other;
A sleeve comprising a distal portion and a proximal portion, the distal portion covering the substance guide member to temporarily hold the substance guide member in a radially contracted state, the proximal portion being the distal Covering the catheter end, and wherein the recessed region is dimensioned to reduce a radial cross-sectional area of the assembly at the substance guide member to receive at least substantially all of the axial length of the substance guide member. Selecting a catheter / dilator assembly comprising:
Locating the substance guiding member at a first target position within the lumen of the tubular structure;
Uncovering the substance guide member for disposing the substance guide member in a radially expanded state where the substance guide member contacts an inner surface of the tubular structure;
Transferring the material within the lumen into the catheter / dilator assembly; and
Removing the catheter / dilator assembly from the body, and removing the material from the tubular structure within the body. Positioning process is
Positioning a distal end of a guide wire at a second target location within the lumen of the tubular structure, the guide wire having a proximal end; and
Passing the proximal end of the guidewire into the distal shaft end of the dilator and at least partially through the dilator;
28. The method of claim 27, comprising removing the guidewire from the body. The guide wire positioning process
Drilling the tubular structure to access the lumen with a hollow needle;
Passing the guide wire through the hollow needle until the distal end of the guide wire reaches the second target position; and
29. The method of claim 28, comprising removing the needle until the guidewire is left in place. Selecting a guidewire having a radially expandable and retractable member at the distal end; and when the distal end of the guidewire is in the second target position, the radially expandable and retractable member is in a radially expanded state 29. The method of claim 28, comprising installing in. The member movement process
Creating a suction force between the catheter and the hollow shaft of the dilator; and
31. The method of claim 30, comprising moving the material guide member and the radially expandable and retractable member toward each other. Prior to the catheter / dilator assembly removal step, sliding the sleeve distally to cover the substance guide member to place the substance guide member in a radially contracted state; and
32. The method of claim 31, comprising placing the radially expandable and retractable member in a radially contracted state prior to the guidewire removal step.   28. The method of claim 27, wherein the member moving step includes creating a suction force between the catheter and the hollow shaft of the dilator.   28. The method of claim 27 including the step of sliding the sleeve distally to cover the substance guide member to place the substance guide member in a radially contracted state prior to the catheter / dilator assembly removal step. The method described.   28. The method of claim 27, wherein a location step is performed on the tubular structure comprising a blood vessel.   28. The method of claim 27, wherein a location step is performed on the tubular structure comprising an implant. A method of removing material from a tubular structure in the body,
Selecting a catheter / dilator assembly assembled according to the method of claim 23;
Locating the substance guiding member at a first target position within the lumen of the tubular structure;
Uncovering the substance guide member to place the substance guide member in a radially expanded state where the substance guide member contacts the inner surface of the tubular structure;
Moving material within the lumen into the catheter / dilator assembly; and
Removing the catheter / dilator assembly from the body, and removing the material from the tubular structure within the body. A dilator assembly,
A longitudinal dilator comprising a proximal portion and a distal portion, a dilator tip at the distal portion, and a dilator lumen extending along the dilator from the dilator tip to at least a first position. ,
The dilator comprises a guidewire passage extending from a second position of the proximal portion of the dilator to the first position;
An opening provided in the first position of the dilator for connecting the guidewire passage and the dilator lumen; and
An assembly comprising a variable guidewire extending along the guidewire passage, through the opening, through the dilator lumen, and out of the dilator tip.   40. The assembly of claim 38, wherein the guidewire passage comprises a groove formed in the dilator. A rapid exchange dilator assembly,
A catheter with a catheter lumen extending between the distal catheter end and the proximal catheter end;
A longitudinal dilator removably housed within the catheter lumen, the dilator having a proximal portion extending to a proximal dilator end, a distal portion extending to a dilator tip; A dilator lumen extending along the dilator from the dilator tip to at least a first position;
The dilator comprises a guidewire passage extending from the proximal portion of the dilator to the first position.
An opening provided in the first position of the dilator for connecting the guidewire passage and the dilator lumen;
A variable guidewire comprising a guidewire proximal end and a guidewire distal end, along the guidewire passage, through the opening, through the dilator lumen, from the dilator tip Variable guide wire extending out and
The guidewire proximal end and the proximal dilator end are positioned proximal to the proximal catheter end, and the guidewire distal end and distal dilator end are the distal end. Positioned distal to the distal catheter end,
Thereby, when the assembly is in a desired position in the body, the dilator can be removed while leaving the catheter and the guidewire in place.   41. The assembly of claim 40, wherein the catheter comprises a material guide member that is movable between a radially expanded state and a radially contracted state and secured to the distal catheter end.   42. The assembly of claim 41, wherein the material guide member comprises an expandable braid member.   42. The assembly of claim 41, wherein the material guide member comprises an expandable braided funnel member.   42. The assembly of claim 41, wherein the material guide member comprises an inflatable member.   42. The assembly of claim 41, wherein the material guide member comprises an inflatable funnel member.   42. The assembly of claim 41, wherein the material guide member comprises an expandable Marcot member.   42. The assembly of claim 41, wherein the material guide member comprises an expandable Marcot funnel member. The catheter is
An outer catheter and an inner catheter, wherein the inner catheter is slidably mounted within the outer catheter, the outer catheter and the inner catheter comprising a distal outer catheter end and a distal inner catheter end; And
41. The assembly of claim 40, comprising a material guide member movable between a radially expanded state and a radially contracted state and secured to the distal outer catheter end and the distal inner catheter end.   49. The assembly of claim 48, wherein the material guide member comprises an expandable braided funnel member. A method for providing access to a target site in a patient's tubular structure comprising:
Positioning the distal catheter end of the first guide catheter in a first position within the patient's tubular structure;
Passing a rapid exchange dilator assembly through the first catheter, wherein the rapid exchange dilator assembly comprises a second catheter, the second catheter being a removable dilator An instrument, a guidewire and a second catheter lumen, wherein the second catheter lumen houses the dilator and the guidewire;
Removing the dilator from the patient while leaving the second catheter and the guidewire in the patient; and
Passing a surgical device through the second catheter to perform a procedure at the target site, and providing access to the target site within the patient's tubular structure. The positioning step includes
Disposing a distal end of a second guidewire at a second position in the tubular structure;
Passing the first catheter over the second guidewire; and
51. The method of claim 50, performed by removing the second guidewire from the patient while leaving the first catheter in the patient.   51. The method of claim 50 including the step of radially expanding a material guide member attached to the second catheter to a radially expanded state.   51. The method of claim 50, comprising radially expanding a material guiding funnel member attached to the second catheter to a radially expanded state that contacts an inner wall of the tubular structure.   51. The method of claim 50, wherein a surgical device passing step includes passing a stent through the second catheter and placing the stent at the target site.   51. The method of claim 50, wherein a surgical device passing step includes passing a balloon catheter comprising a balloon through the second catheter and expanding the balloon at the target site. A method for providing access to a target site in a patient's tubular structure comprising:
A catheter lumen extending between the distal catheter end and the proximal catheter end, movable between a radially expanded state and a radially contracted state, and secured to the distal catheter end A catheter comprising a substance guide member,
A longitudinal dilator removably housed within the catheter lumen, a proximal portion extending to the proximal dilator end, a distal portion extending to the dilator tip, and A dilator lumen comprising a dilator lumen extending along the dilator from the dilator tip to at least a first position;
The dilator comprises a guidewire passage extending from the proximal portion of the dilator to the first position;
An opening provided in the first position of the dilator for connecting the guidewire passage and the dilator lumen;
A guidewire comprising a guidewire proximal end and a guidewire distal end, along the guidewire passage, through the opening, through the dilator lumen, and the dilator tip A variable guidewire extending out of and
The guidewire proximal end and the proximal dilator end are positioned proximal to the proximal catheter end, and the guidewire distal end and distal dilator end are the distal end. Selecting a rapid exchange dilator assembly comprising: positioned distal to the distal catheter end;
Positioning the distal end of the guide catheter in a second position within the patient's tubular structure;
Passing the rapid exchange dilator assembly through the guide catheter;
Removing the dilator from the patient while leaving the catheter and guidewire of the rapid exchange dilator assembly in the patient; and
Passing a surgical device through the catheter of the rapid exchange dilator assembly to perform a treatment at the target site, and providing access to the target site in the patient's tubular structure. The positioning process
Disposing a distal end of a second guidewire at a second position in the tubular structure;
Passing the guide catheter over the second guidewire; and
57. The method of claim 56, performed by removing the second guidewire from the patient while leaving the guide catheter in the patient. A funnel catheter comprising a distal funnel catheter end,
Outer tube,
An inner tube slidably positioned within the outer tube;
A tubular sleeve having a first end and a second end and movable between a radially expanded use state and a radially contracted and expanded state;
The first end of the sleeve is secured to the distal end of the outer tube;
The second end of the sleeve is secured to the distal end of the inner tube; and
The sleeve has a moveable, generally U-shaped direction reversal region, and when the first end and the second end move relative to each other, the position of the direction reversal region is the inner tube and the A funnel catheter comprising: moving relative to the distal end of the outer tube, wherein the direction reversal region constitutes the distal funnel catheter end.   59. A funnel catheter according to claim 58, wherein the tubular sleeve comprises a braided material.   60. A funnel catheter according to claim 59, wherein the tubular sleeve comprises a fluid passage blocking film in contact with the braided material.   The funnel catheter according to claim 60, wherein the film is impregnated in the braided material.   61. A funnel catheter according to claim 60, wherein the film covers the braided material.   61. A funnel catheter according to claim 60, wherein the film is an elastic material.   59. The funnel catheter of claim 58, wherein the sleeve forms a distal open funnel when the first distal end and the second distal end are substantially aligned.   65. The funnel catheter of claim 64, wherein the funnel portion has a generally cylindrical distal portion and a generally conical proximal portion.   59. The funnel catheter according to claim 58, wherein the tubular sleeve is an elastic tubular sleeve, and the radial expansion and use state is a relaxed state. A funnel catheter,
An outer tube having a first distal end and an inner surface, the inner surface forming an outer lumen;
An inner tube slidably disposed within the outer lumen and having a second distal end and an outer surface positioned opposite the inner surface;
A tubular sleeve having a first end and a second end and movable between a radially expanded use state and a radially contracted and expanded state;
The first end of the sleeve is secured to the first distal end;
The second end of the sleeve is secured to the second distal end and extends from other than the outer surface, and the sleeve has a moveable, generally U-shaped reversal region. And the position of the direction reversal region moves relative to the first distal end and the second distal end when the first distal end and the second distal end move relative to each other. A funnel catheter comprising: A method for deploying a material guide member within a tubular structure of a patient, comprising:
Selecting a funnel catheter having a distal funnel catheter end, the funnel catheter comprising:
Outer tube,
An inner tube slidably positioned within the outer tube;
A tubular sleeve having a first end and a second end and movable between a radially expanded use state and a radially contracted and expanded state;
The first end of the sleeve is secured to the distal end of the outer tube;
The second end of the sleeve is secured to the distal end of the inner tube; and
The sleeve has a moveable, generally U-shaped reversal region, the reversal region comprising the distal funnel catheter end;
Deploying the funnel catheter in the sleeve in a reduced diameter deployed state and in a state where the sleeve is substantially parallel to the outer tube and the inner tube;
Positioning the direction reversal region at a selected location within a tubular structure within a patient; and
Moving the distal ends of the inner tube and the outer tube relative to each other, comprising:
Moving the position of the direction reversal region relative to the first end and the second end;
Forming a distal opening material guide funnel in the sleeve, the funnel having a distal funnel portion and a proximal funnel portion; and
Contacting the distal funnel portion with an inner wall of the tubular structure;
A method of deploying a material guide member within a tubular structure of a patient comprising:   69. The method of claim 68, wherein the distal end moving step causes the sleeve to form a funnel having a generally cylindrical distal portion and a generally conical proximal portion. A method of manufacturing a funnel catheter, comprising:
Winding a material on a mandrel to form a tubular braided sleeve having a proximal portion, a distal portion, a proximal end, and a distal end;
Removing the tubular braided sleeve from the mandrel, and securing the proximal end in a first position on the outer tube and forming the distal end in a second position on the inner tube to form a funnel catheter. A method of manufacturing a funnel catheter.   71. selecting a mandrel comprising a radially expanded proximal taper region connected to a radially contracted distal taper region, wherein the distal taper region has a steeper taper than the proximal taper region. The device described in 1.   72. The apparatus of claim 71, wherein the selecting step is performed to select a mandrel having a constant diameter central region connecting the proximal tapered region and the distal tapered region.   71. The apparatus of claim 70, wherein the winding step is performed such that the pick count value, i.e., the material cross count value per unit length, is substantially constant along the proximal and distal portions.   The inner tube and the outer tube are in a first orientation in which the sleeve is substantially tubular and the first position and the second position are separated by a first distance from the first orientation. 71. Assisting the formation of a distal opening funnel as the position and the second position move to a second orientation separated by a second distance that is shorter than the first distance. Equipment.   75. The apparatus of claim 74, wherein the assisting step comprises applying a radial expansion restricting material to the proximal portion of the sleeve.   The assisting step includes applying a radial expansion restricting material to the proximal and distal portions of the sleeve, wherein the radial expansion restricting material of the proximal portion is the diameter of the distal portion. 75. The device of claim 74, wherein the device is more resistant to stretching than directional expansion restricting materials.   75. The apparatus of claim 74, wherein the assisting step includes changing a pick count value, i.e., a material crossing count value per unit length, along the sleeve.   78. The apparatus of claim 77, wherein pick count value changing comprises forming a pick count value at the distal portion of the sleeve that is less than the proximal portion of the sleeve.   79. The apparatus of claim 78, wherein a small pick count value forming step is performed by removing selected strands of wound material of the distal portion of the sleeve.   78. The apparatus of claim 77, wherein the pick count value changing step includes forming a pick count value at the distal portion of the sleeve that is greater than the proximal portion of the sleeve.   The apparatus of claim 74, wherein the assisting step comprises increasing resistance to radial expansion of the proximal portion of the sleeve.   71. The apparatus of claim 70, wherein the material winding step includes winding a plurality of strands of the material onto the mandrel.   71. The apparatus of claim 70, wherein the material winding step includes winding the material onto the mandrel with a ribbon-type material. A balloon funnel catheter,
A shaft comprising an end, a main lumen, and an inflation lumen;
An annular balloon attached to the end of the shaft and fluidly connected to the inflation lumen and moving between a radially contracted uninflated state and a radially expanded inflated state;
The balloon forms an open region that opens into the main lumen when in the inflated state; and
A balloon funnel catheter, wherein the balloon extends distally through the end of the shaft in the inflated state.   85. The catheter of claim 84, wherein the open area is a funnel shaped open area.   85. The catheter of claim 84, wherein the main lumen at the end of the shaft has a cross-sectional area and the open area has an average cross-sectional area that is larger than the cross-sectional area of the main lumen. . A method of fixing a tubular braid to a tube,
Engaging the first end of the tubular braid with the end portion of the tube, the end portion comprising a tube material that can be temporarily softened;
Softening the temporarily softenable tube material; and
A method of securing a tubular braid to a tube comprising fusing the end portion of the tube and the first end of the tubular braid together to form a tube material / tubular braid matrix.   88. The method of claim 87, wherein the engaging step is performed by inserting a selected one of the first end and the end portion into the other of the first end and the end portion.   90. The method of claim 88, wherein the softening step comprises heating the end portion of the tube.   90. The method of claim 89, wherein the heating step includes the step of placing the end portion in a tool.   90. The method of claim 89, wherein the heating step includes placing the end portion in a heated tool.   90. The method of claim 89, wherein the heating step comprises placing the end portion in a tool that can be heated by RF energy.   90. The heating step includes the step of placing the end portion in a tool made from a material having a Curie temperature at a desired operating temperature to facilitate maintaining the tool at the desired operating temperature. The method described in 1.   The method of claim 90, wherein a fusing step is performed with the end portion and the first end being within an open area of the tool.   The fusion step includes the step of squeezing the end portion and the first end portion between the tool and the mandrel while the mandrel is positioned within the end portion and the first end portion. 95. The method of claim 94. A method of controlling the shape of a radially braided and expandable tubular braiding device comprising:
Selecting a radially expanded shape for the braided device when the braided device is in a radially expanded state, wherein the radially expanded shape is different in length and at different selected locations along the length. Having an area,
Selectively applying material to at least a portion of the selected location along the braiding device; and
Adjusting the stretch resistance of the material according to the selected position;
Thereby, due to the different stretch resistance at the selected position, when the braiding device is in the radially expanded state, the braided device becomes the selected radially expanded shape and expands in the radial direction. A method for controlling the shape of a retractable and retractable tubular braiding device.   99. The method of claim 96, wherein the selective application step is performed using a substantially elastic material.   99. The method of claim 96, wherein the selective application step is performed using a substantially inelastic material.   99. The method of claim 96, wherein a selective application step is performed by selectively impregnating the braiding device.   99. The method of claim 96, wherein the selecting step includes selecting a funnel shape as the radially expanded shape.   101. The method of claim 100, wherein adjusting comprises reducing the stretch resistance of the material from a first end to a second end of the braiding device.   99. The method of claim 96, wherein the selective application step applies the material to the braiding device along a portion of the length of the braiding device.   99. The method of claim 96, wherein an adjusting step is performed by changing the thickness of the material depending on the desired stretch resistance at the selected location.   99. The method of claim 96, wherein the adjusting step includes selecting a material having a plurality of different stretch resistant properties.   99. The method of claim 96, wherein the adjusting step includes selecting a plurality of materials having different stretch resistance properties. A method of imparting a shape to a thermoplastic film,
Surrounding at least a portion of the radially expandable device with a thermoplastic membrane;
Radially expanding the radially expandable device to a selected expanded shape, thereby bringing the thermoplastic membrane into an expanded state corresponding to the selected expanded shape; and A method of imparting a shape to a thermoplastic film comprising the step of imparting a set to the thermoplastic film during the expanded state.   107. The method of claim 106, wherein the surrounding step is performed using a thermoplastic film that is substantially elastic.   107. The method of claim 106, wherein the surrounding step is performed using a thermoplastic film that is substantially inelastic.   107. The method of claim 106, comprising preventing at least a portion of the thermoplastic film from adhering to the radially expandable device.   107. The method of claim 106, wherein the enclosing step is performed by sliding a tubular thermoplastic membrane over the radially expandable device.   107. The method of claim 106, wherein an enclosing step is performed by coating the radially expandable device with a thermoplastic liquid material to form the thermoplastic film.   107. The method of claim 106, comprising selecting a tubular braided radially expandable device.   107. The method of claim 106, wherein the step of bending includes heating and cooling the thermoplastic film.   107. The method according to claim 106, wherein the bending step includes heating and cooling the thermoplastic film a plurality of times. An anastomosis medical device,
A tube comprising a first end and a second end and a lumen extending therebetween; and
An anchor member provided at the first end for securing the first end to a first tubular structure of a patient, the first tubular structure having an inner surface of the first opening, and the inner surface of the first opening is An anastomosis medical device comprising: opening in the lumen.   An anchor member provided at the second end for securing the second end to a second tubular structure of a patient, wherein the second tubular structure has an inner surface of a second opening; 116. The medical device of claim 115, wherein an inner surface opens into the lumen.   116. The medical device of claim 115, wherein the anchor member comprises a tubular braid member.   116. The medical device of claim 115, wherein the anchor member comprises a radially expandable tubular braided member comprising a tubular structure penetrating member.   119. The medical device of claim 118, wherein the penetrating member comprises a hook.   119. The medical device of claim 115, wherein the anchor member comprises an annular inflatable member that is sealably engageable with the opening of the first tubular structure.   116. The medical device of claim 115, wherein the anchor member comprises a Marcot device. An anastomosis medical assembly,
A first tube comprising a first end and a second end and a first lumen extending therebetween; and
A first anchor member provided at the first end of the first tube for securing the first end of the first tube to a first tubular structure of a patient; the first tubular structure being a first opening; A first anastomosis medical device comprising an inner surface, wherein the first opening inner surface opens into the first lumen;
A second tube comprising a first end and a second end and a first lumen extending therebetween; and
A second anchor member provided at the first end of the second tube for securing the first end of the second tube to a second tubular structure of the patient, the second tubular structure being a second opening; A second anastomosis medical device comprising: an inner surface, wherein the second opening inner surface opens into the second lumen; and
The second ends of the first tube and the second tube are connected to each other to form a fluid passage between the first anchor member and the second anchor member, whereby the first tubular structure of the patient. And an anastomosis medical assembly, wherein the inner surface of the first opening and the inner surface of the second opening of the second tubular structure are fluidly connectable.

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