MXPA05013448A - Catheter systems and methods for crossing vascular occlusions - Google Patents

Abstract

Interventional catheter-based systems and methods are described herein for use in generating an initial pathway through vascular occlusions. The catheter systems generally include two elements. A first element is a Blunt Dissection Catheter including a manually actuated assembly located at the distal tip of the Blunt Dissection Catheter that performs blunt dissection in the vascular occlusion to produce a dissection track, or small pathway through the occlusion. The second element is a Sheath Catheter that serves as a conduit within which the Blunt Dissection Catheter is freely advanced, retracted and rotated. The first and second elements are used in some combination to cross vascular occlusions in both the coronary and peripheral vasculature.

Description

CATHETER SYSTEMS AND METHODS TO CROSS VASCULAR OCCLUSIONS Field of the Invention The systems and methods described herein relate to medical devices, and more specifically, to catheter-based systems for treating occlusions within blood vessels of the human or animal body. Background of the Invention Vascular occlusions are blockages of the cardiovascular system (including both coronary and peripheral vessels) that significantly or completely block blood flow through the vessel. The progress of the condition of the disease causing vascular occlusions, generally referred to as atherosclerosis, comprises the gradual deposition of fatty, fibrous and / or calcified deposits along the inner wall of the vessel. Progress can occur slowly, sometimes taking several years. Vascular occlusions can be categorized as "functional" or as a Total Chronic Occlusion (CTO). The occlusions are functional, for example, when the vessel has developed significant stenosis that blocks most of the blood flow, but a small limited path remains through the vessel. The occlusions are categorized as CTO. In arterial disease, frequently according to REF: 168890, the lumen of the native vessel begins to close slowly, the tissue served by this native vessel becomes ischemic and the body can respond by generating angiogenic factors that initiate the growth of new "collateral" vessels "that originates close to the site of occlusion and feeds distant tissue to occlusion. These new vessels can help stabilize the tissue requirement for blood flow and oxygen during nominal activity or rest. These collateral vessels can occur in both the peripheral and coronary vasculature. However, often these collateral vessels can not sustain an adequate distribution of blood and oxygen to the tissue under more demanding situations such as exercise. For blockages in peripheral vessels such as the legs, the patient may develop clinical symptoms such as claudication in the legs (pain while exercising), or in the case of coronary blockages the patient may develop shortness of breath or pain. chest while exercising. The physical treatment of vascular occlusions may comprise interventional methods (eg, non-surgical methods based on catheters), or surgical methods. The intention of the intervention treatment is to re-channel the occluded vessel by first generating a small initial route through the occlusion, and subsequently radially expanding the small pathway via balloon angioplasty to a diameter that is nominally equal to the original diameter of the occlusion. vessel before it occludes. The site can also be treated with atherectomy and stent catheters as well as to facilitate the long-term opening of the vessel. The intervention treatment typically comprises introducing a specialized wire, referred to as a guidewire, into the vessel that is close to the occlusion and advancing the guidewire using a fluoroscopic medium through the occlusion and into the vessel that is distant to the occlusion. the occlusion This fundamental technique can be practiced in both coronary (heart) vessels and peripheral vessels (for example, iliac, superficial femoral, sub-clavian). Once the guide wire is distributed through the occlusion and in the lumen of the vessel distant from the occlusion, a balloon catheter can be distributed over the guidewire to perform the balloon angioplasty at the site of the occlusion. However, conventional guide wires are not designed to generate routes through total occlusions. Rather, they are designed with very flexible distant terminations to allow them to navigate typically through non-occluded vessels, but narrowed, for the purpose of the subsequent distribution of a balloon catheter to perform angioplasty at the site of the narrowed artery. The design of a guide wire capable of generating a route through a total occlusion is a challenging task, while the guidewire must be strong enough to pass through the occlusive material, but must also be friendly enough not to pierce through the vessel wall, if the guide wire does not take a direct route through the occlusion . However, the divergence of the route of the wires through the occlusion is a clear possibility, since the composition of a total occlusion can be very non-homogeneous, leading to deflection of the guide wires of the hard fibrous and calcified deposits, leading to its potential advance through the vessel wall, which is clearly undesirable. The methods of intervention to treat total vascular occlusions can be challenging and problematic, and present high risk factors, as described above. As such, patients who present with total vascular occlusions frequently refer directly to the surgical method of treatment. Alternatively, patients frequently refer to surgical methods after the failure of an intervention attempt. While the surgical approach is clearly more traumatic to the patient, the actual mechanics of the procedure is more direct if the procedure is generally accepted as having fewer complications. In the surgical approach, an external duct is used to derive the occlusion, "where one end of the duct joins the vessel close to the occlusion, and the other end of the duct joins the vessel distant from the occlusion. the flow of blood around the occlusion is re-routed, the conduit may be an explanted occlusion of the artery or vein, or it may be a man-made conduit, typically manufactured from a Dacron composition. It is also free of complications, while the surgical approach generally results in favorable clinical outcomes, is very invasive compared to the intervention approach and subsequently leads to a much longer period of recovery for the patient. the review of the surgical and intervention approaches to treat total chronic occlusions, it is evident that an approach would be desirable non-surgical, and an improved intervention treatment of what would be additionally desirable that could increase the success rates and decrease the complications associated with the present intervention procedures.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a catheter system that includes a Catheter for Dissection of Double Ends and Sleeve Catheter, according to one modality. Figure 2a is a Lateral Dissection Catheter and Lens Catheter at a proximal end of a vascular occlusion in the vasculature, according to one embodiment. Figure 2b is an End Dissection Catheter Romos progressing through a vascular occlusion with the Sleeve Catheter maintained close to the vascular occlusion, according to one modality. Figure 2c is a Lateral Dissection Catheter that advances through a vascular occlusion, according to one modality. Figure 2d is a Catheter of Dissection of Double Ends and Catheter of Sheath that advances through a vascular occlusion, according to a modality. Figure 2e is a Lateral Dissection Catheter that emerges from a vascular occlusion with the Sleeve Catheter within the vascular occlusion, according to one modality. Figure 2f is an End Dissection Catheter Romos and Fundal catheter both that advance through a vascular occlusion, according to one modality.

Figure 2g is a Sleeve Catheter that maintains position through vascular occlusion after the removal of a Latex Dissection Catheter, according to one modality. Figure 2h is a guide wire advanced through the sheath catheter and to an exact vessel lumen distant to an occlusion, according to one embodiment. Figure 2i is a guidewire in place through vascular occlusion after removal of a Sleeve Catheter according to one modality. Figure 3a is a catheter system that includes a sheath catheter and a sheath introducer, according to one embodiment. Figure 3b is a longitudinal cross-section of a distant segment of a sheath catheter, according to one embodiment. Figure 3c is a longitudinal cross section of a distal end of a sheath catheter, according to an alternative embodiment. Figure 3d is a longitudinal cross section of a distal end of a sheath catheter, according to another alternative embodiment. Figure 3e is a longitudinal cross section of a distal end of a sheath catheter, according to yet another alternative embodiment.

Figure 3f is a longitudinal cross section of a proximal hub of a Sleeve Catheter, according to one embodiment. Figure 4a is a longitudinal cross section of a proximal hub of introducer catheter, according to one embodiment. Figure 4b is a longitudinal cross section of a distant segment of the Introducer Catheter, in a tapered configuration and including a fluoroscopic labeled band, according to one embodiment. Figure 4c is a longitudinal cross section of a distant segment of the Introducer Catheter, in a rounded configuration and including a fluoroscopic labeled band, according to one embodiment. Figure 5a is a working element of a Latex Dissection Catheter showing two extension members in an open configuration, according to one embodiment. Figure 5b is a working element of a Latex Dissection Catheter showing two extension members in a closed configuration, according to one embodiment. Figure 5c is a view with separation of parts of a working element of a Dissection Catheter of Extremes Romos, according to one modality.

In the figures, the same reference numbers identify identical or substantially similar elements or acts. Detailed Description of the Invention Methods and methods based on interventional catheter are described for use in generating an initial route through a total vascular occlusion. It should be noted that the system described herein does not perform a therapeutic function since the initial route generated by the catheter system through vascular occlusion is not proposed to restore functional opening or blood flow to the vessel. Rather, after the route has been generated through the occlusion, the catheter system can be removed in its entirety or in part from the vessel. The generated route is subsequently used for the passage of a conventional guide wire, with the guidewire serving a conventional function of distributing therapeutic devices such as balloon catheters or stents for performing conventional angioplasty or stent placement to the vascular site previously. occluded Thus, the generation of this initial route is only to facilitate the subsequent placement of a conventional guidewire, and without the placement of the guide wire through the occlusion, additional therapeutic procedures are not possible. The system described herein is applicable for use in any vasculature of the body. In the following description, numerous specific details are introduced to provide a complete understanding of, and permit description of, modalities of catheter systems and methods. One skilled in the art, however, will recognize that these modalities can be practiced without one or more of the specific details, or with other components, systems, etc. In other cases, well-known structures or operations are not shown, or are not described in detail, to avoid obstructing aspects of the described modalities. The catheter system described herein generally includes two elements. The first element is a Lateral Dissection Catheter that includes a manually operated, remotely mounted, located at the distal tip of the catheter that performs blunt dissection in the vascular occlusion to produce a dissection path, or small path through. of the occlusion. The second element is a Sleeve Catheter which serves as a conduit within which the Blunt-End Dissection Catheter can be retracted freely or rotated. These elements are used in conjunction with each other to cross total vascular occlusions in both the coronary and peripheral vasculature. Below are descriptions of each element.

The Lateral End Dissection Catheter of one embodiment includes a catheter shaft that is remotely terminated with a work member (also referred to as a distant drive assembly or remote mount) that includes one or more blunt-ended, extenders members. non-traumatically, longitudinally arranged, each spreader member having a free remote end configured to rotate about a proximal end that hinges to a mounting base, the base that is immovable and is attached to the distal end of the catheter shaft. The spreader members are operated remotely via the proximal handles of the catheters, and move between a normally closed position where the catheter can be advanced, retracted and properly positioned within the vessel, and an open, actuated position during which the process of blunt dissection is presented. In the closed position, the free distal end of the spreader member (s) is rotated toward the central axis of the catheter shaft, and the spreader members form a blunt, blunt, ammunition shape in the end of the catheter shaft. In the open configuration, the far end of the spreader member (s) is rotated about the hinge joint near the base and the spreader member (s) moves (n) ) through an arch and laterally away from the central axis of the catheter.

An actuating element is positioned within the catheter shaft of one embodiment, the distal end of the actuating element that is in contact with the hinged spreader members pbr hinge, and the proximal end of the actuator member engages with the operated shank mechanism of the actuator. next way. The handle mechanism can be operated by the practitioner, by way of example. The actuation of the handle imparts an axial force to the actuating element, which in turn imparts an opening force to the extending members of the work element. The work element responds where one or more extenuating members, blunt, non-traumatic, rotate around their union by hinge near the base, and the free distant end of the extending member travels through an arch and laterally away from the central axis of the catheter. When placed against a vascular occlusion, lateral movement of the distant extension member imparts a force to the occluding vascular tissue to locally destabilize the occlusion and produce a small path of dissection immediately distant to the work element. The catheter can then be advanced remotely in this small path of dissection, and the process is repeated, each time it produces another small path of dissection immediately distant to the working element of the catheter, in which the catheter moves. The process continues until the catheter has advanced through vascular occlusion, and exits in the exact lumen of the vessel that is distant from the occlusion. Blunt-ended dissection catheters useful as the first element of the catheter system are described in the related applications. The second element of the catheter system is the Sleeve Catheter, which is designed as a complementary device within which the Lateral Dissection Catheter operates. The Sleeve Catheter of a modality is a low profile conduit, and includes a thin-walled catheter shaft of individual lumen that terminates distally in the nontraumatic distant orifice and terminates proximally in an individual orifice hub. The wall thickness of the Sleeve Catheter is desired to be as thin as physically possible, and the inner diameter of the individual lumen of the Sleeve Catheters is designed to provide a high tolerance fit to the outer diameter of the Lateral Dissection Catheter. . These two attributes offer the lowest total profile to the composite catheter system, which facilitates the advancement of the catheter system through the vasculature, and is especially critical in facilitating the movement of the system through heavily diseased areas of the vessel. The outer surface of the Dissection Catheter Double Ends and the inner surface of the Sleeve catheter are slippery to each other due to the reduced annular space between the surfaces; this facilitates the free rotational and axial movement of the Lateral Dissection Catheter within the sheath catheter. That lubricity is achieved by including a slippery material such as high density polyethylene (HDPE), low density polyethylene (LDPE) or polytetrafluoroethylene (PTFE) in materials of the inner surface of the Sleeve Catheter. The outer surface of the Lateral Dissection Catheter shaft can also be designed with similar materials, or other polymers such as nylon or polyurethanes, and a hydrophilic coating can be applied to the surface of the catheter to increase lubricity. The annular space between the outer diameter of the The Lateral Dissection Catheter and the inner diameter of the Sleeve Catheter of one modality are in the order of approximately 0.00254 cm (0.001 inches), but it is not limited to this. The wall thickness of the sheath catheter of one modality varies from approximately 0.00762 to 0.0254 cm (0.003 to 0.010 inches), but it is not limited to this. The nominal wall thickness is approximately 0.0127 cm (0.005 inches). A small annular space between the Latex Dissection Catheter and the Sleeve Catheter, in combination with a wall thickness reduced to the minimum Catheter sheath, but especially at the terminal end, minimizes the exposed, total leading edge of the Sleeve Catheter as it travels over the Latex Dissection Catheter during advancement within the vascular system. By procedure, the catheter system including the Lateral Dissection Catheter and the Sleeve Catheter is advanced into a vessel until the working element of the Lateral Dissection Catheter is brought into intimate contact with the vascular occlusion. . In this process, the Lateral Dissection Catheter remains in the advanced position just beyond the distal end of the Sleeve Catheter, typically about 1 to 15 centimeters (cm). In order to perform the blunt dissection process, the working element of the Lateral Dissection Catheter is coupled with sufficient force in the vascular occlusion using axial force inlet in the Lateral Dissection Catheter by the optional via the proximal handle. . The transfer of this force from the handle to the work element is facilitated by two factors. The first factor to facilitate the transfer of axial force is the physical support offered by the Sleeve Catheter. In itself, the Latex Dissection Catheter is designed to have more flexibility to be able to navigate easily through the vascular system. However, this design consideration also tends to reduce the total amount of inherent "push" that the catheter can develop on its own. In this way, the physical support offered by the Sleeve Catheter increases the total "pushing capacity" of the system. The second factor to facilitate the transfer of the axial force is the lubricity between the inner surface of the Sleeve Catheter and the outer surface of the Lateral End Dissection Catheter. These two factors maximize the transfer of the force distributed to the working element of the Latex Dissection Catheter, and facilitate the total process of blunt dissection. The maximum increase in the transfer of axial force distributed to the working element of the Lateral Dissection Catheter is the first fundamental function provided by the Sleeve Catheter. The greater transfer of the axial force input by the practitioner allows the work element to better couple the total inclusion and facilitates the blunt dissection process. As the Lateral Dissection Catheter is advanced more and more through vascular occlusion, the Sleeve Catheter can also be advanced forward as appropriate to the procedure and the patient in order to provide appropriate support to the catheter. Latex dissection. Typically, the distal end of the Sleeve Catheter is maintained at a distance of approximately 1 to 5 centimeters proximal to the Lateral End Dissection Catheter to provide appropriate support. As the Lateral Dissection Catheter progresses further into the material of vascular occlusion, the Sleeve Catheter can also be advanced further and further forward. As this continues, the sheath catheter will reach the proximal end of the occlusion, where the dissection path begins. Up to this point, the distal end of the sheath catheter could have been advanced into a diffusely diseased portion of the vessel. However, until now reaching the proximal end of the vascular occlusion, where the dissection path begins, the lumen working diameter of the vessel will have been reduced to the size of the dissection pathway produced by the Latex Dissection Catheter. The ability to advance now the Sleeve Catheter is formed distant to follow the Lateral Dissection Catheter to the occlusion now becomes dependent on the high tolerance setting between the Sleeve Catheter and the Lateral End Dissection Catheter blunt, and the low profile of the guiding edge of the Sleeve catheter. A very low profile guidewire of the sleeve catheter of one modality allows the sheath catheter to follow the dissection catheter in the dissection path. Comply with both the End Dissection Catheter Romos such as the Sleeve catheter are advanced more and more through vascular occlusion, the dissection catheter The French ends eventually exit the vascular occlusion and enter the exact lumen of the vessel that is distant from the occlusion. At this point during the procedure, the position of the Lateral Dissection Catheter is maintained, and the Catheter Sheath can be further advanced remotely over the Lateral dissection catheter until the sheath catheter has also come out of the occlusion, and has entered the exact lumen of the vessel that is distant from the occlusion. The Latex Dissection Catheter can then be removed from the vessel and the entire body, leaving the Sleeve Catheter in place through the vascular occlusion. Placement of the Sleeve Catheter through the occlusion now serves as a convenient conduit through which a conventional guidewire can be advanced in the exact lumen of the vessel that is distant from the occlusion.

This is the second fundamental function offered by the Sheath catheter. Having now placed the guidewire through the vascular occlusion, its position is maintained and the Case Catheter can be removed from the vessel and the body. The guide wire is thus left in place to facilitate the distribution of therapeutic devices such as balloon catheters or stents for performing angioplasty or stenting to treat the previously occluded vascular site.

FIG. 1 is a catheter system that includes a Catheter 100 of Lateral Dissection and the Catheter 300 of a Sleeve, according to one embodiment. The Open End Dissection Catheter 100 and the "Sleeve Catheter 300" are shown as an integral system with the Lateral Dissection Catheter 100 placed within the Sleeve Catheter 300. The Catheter 100 of the End Dissection Catheter has a length of work longer than the total physical length of the Fundal catheter 300. The working length is generally defined as the useful length of the catheter shaft that can be advanced in another device, and in this case the Catheter 100 of End Dissection Romos is advanced in the Sleeve Catheter 300. The working length is measured from the tip of a catheter to the nearest point in the catheter shaft.In Catheter 100 of Latex Dissection, the working length extends from the working element 120 at the distal end of the reinforcing shoulder 150 which interconnects the catheter shaft 160 to the handle 110. The shaft 160 of the Lateral Dissection Catheter is can advance the Sleeve Catheter 300 until the reinforcement shoulder 150 of the Lateral End Dissection Catheter abuts against the proximal hub 310 of the Sleeve Catheters. When the Lateral Dissection Catheter 100 has been completely advanced into the Sleeve Catheter 300, a distal segment of the Lateral Dissection Catheter 170 extends from the distal tip 330 of the Sleeve Catheter 300. This length can typically vary from about 1 centimeter to 15 centimeters, but it is not limited to this. The nominal extended length is approximately 10 cm, but it is not limited to this. The working length of the Catheter 100 of Latex Dissection Catheter, and the corresponding total length of the Catheter 300 of Deck depends on the area of the room in which the system is used, the entry point into the body, and the route taken by the catheter. catheter through the body to the occlusion. The sites commonly treated in the peripheral vasculature are in the two main branches of vessels that branch off from the distant aorta, each supplying blood to the trunk area and one leg. Each iliac artery is tapering into the femoral artery through the groin and upper thigh area, and further tapers into the popliteal artery in the knee area. The point of entry of the typical catheter system into the peripheral vasculature is through the location of the femoral artery in any groin. From this entry site, the catheter system can be advanced in one of two directions. If the occlusion is in the artery distant from the site of entry, the catheter system is advanced distally and in the direction of blood flow until the occlusion is advanced. This approach is commonly referred to as "ipsa-lateral", which means that the entry site and the treatment site are located in the same vascular branch on the "same side" of the aortic bifurcation. Alternatively, if the occlusion is located at the opposite vascular branch of the entry site, the catheter may use the same entry site, but is advanced first against the blood flow to reach the terminal end of the aorta, and then it is directed to the opposite iliac artery branch.

The catheter can then be advanced remotely to achieve occlusion. This approach is commonly referred to as "contralateral" since the site of vascular occlusion and the site of entry are on opposite legs of the aortic bifurcation. The nominal length of work required for the work of the Catheter 100 of Latex Dissection in ipsa-lateral applications varies from approximately 40 cm to 100 cm, but is not limited to this. A typical working length of the Catheter 100 of Latex Dissection Catheter for ipsa-lateral applications is approximately 80 cm. Accordingly, the total length of the Sleeve Catheter 300 is nominally about 10 cm shorter than the working length of the Catheter 130 of Latex Dissection, and may vary from about 30 cm to 90 cm, but is not limited to this. . For contralateral applications, the Catheter 100 Catheter of the Latex Dissection Catheter must first reach the terminal aorta via the iliac artery near the site of entry before it is directed away from the opposite iliac artery. For a vascular occlusion in the iliac artery opposite the entrance site, a working length of only about 60 cm can be used. However, if the vascular occlusion is in the superficial femoral artery (SFA) or in the popliteal artery, the working length can reach approximately 140 cm, or possibly 160 cm. A practical range of working length of the Lateral Dissection Catheter 100 for contralateral applications is approximately 60 cm or 140 cm, but is not necessarily limited to this. Accordingly, the total length of the Sheath Catheter 300 may vary from 50 cm to 130 cm, but is not limited thereto. All the dimensions of the catheters provided above and anywhere in the present are presented as examples only and may be different according to the vascular entry site, the location of the vascular occlusion and the medical procedure. For access to the coronary vasculature, the site of entry may be the same as the peripheral vasculature, specifically through the femoral artery in the groin. The minimum working length for the Catheter 100 of Latex Dissection of one modality is approximately 110 cm. The upper limit is similar to that of the peripheral version, or approximately 140 cm. A typical total length range can be from about 110 cm to 140 cm, but it is not limited to this.

Accordingly, the total length of the Sheath Catheter 300 may vary from about 100 cm to 130 cm, but is not limited thereto. The Open End Dissection Catheter 100 is shown with the proximal handle 110, the rinsing orifice 130, the rotary hemostasis valve 140, the shoulder 150 reinforcement, the next catheter shaft 160, the tree 170 of distant catheter, and work element 120. The actuation of the handle mechanism 110 communicates an opening and closing action to the working element 120 of the catheters. Specifically, depression of the distal segment of handle "T" 110 imparts proximal axial movement of the drive element (not shown) within the shaft 160/170 of catheter, whin turn opens the extension members 122 of the work element 120. The depression of the proximal segment of the "T" handle 110 imparts axial movement remote from the actuating element (not shown) within the catheter shaft 160/170, whin turn closes the extension members 122 of the work element 120. The handle assembly 110 can be constructed of common machined plastics such as polycarbonate or Delrin, but is not limited thereto. The rinsing orifice 130 provides a route for injecting saline into the interior of the catheter 100 to displace any air prior to insertion into the body. The rotary hemostasis valve 140 maintains a fluid-tight route between the interior of the catheter shaft 160/170 and the recessed orifice 130, while allowing the catheter shaft 160/170 to be rotated as required by the practitioner during use. The Sheath Catheter 300 includes the proximal hub 310, the shaft 320, and the distal termination 330. As noted above, the total length of the Sleeve Catheter 300 is such that in the complete distal advance of the Catheter 100 of Lateral Dissection in the Sleeve Catheter 300 approximately 10 cm from the Catheter 100 of Latex Dissection extend from the distal end of the Sleeve Catheter 300, but is not limited thereto. Figures 2a to 2i generally show a clinical procedure that includes the use of the catheter system, according to one modality. Figure 2a is a catheter system that includes the Lateral Dissection Catheter and the Sleeve Catheter at a proximal end of a vascular occlusion in the vasculature, according to one embodiment. The Lateral Dissection Catheter 10 and the Sleeve Catheter 300 are advanced concurrently to reach a total vascular occlusion.Next to the vascular occlusion 200 is the proximal lumen of the vessel 180, and distant to the occlusion 200 is the exact lumen distant from the vessel 190. The working element 120 of the Catheter 100 of Latex Dissection is advanced until it is placed as opposed to occlusion 200 vascular. To provide support for Catheter 100 of Latex Dissection, the far end 330 of the Sheath 300 catheter maintained approximately a few centimeters near the far end of Catheter 100 of Latex dissection. Axial force is applied Catheter 100 of Latex Dissection by the practitioner to establish proper coupling of the working element 120 of the Dissection Catheters of Blunt Ends in Occlusion 200. Figure 2b is a Dissection Catheter Late extremities that progress through a vascular occlusion with the sheath catheter maintained close to the vascular occlusion, according to one modality. Figure 2c is a Lateral dissection catheter that advances further through a vascular occlusion, according to one modality. Figure 2d is a Lateral Dissection Catheter and the Sleeve Catheter that advances through a vascular occlusion, according to one modality. In the placement in the catheter system close to the vascular occlusion 200, the user operates the sensing members 122 of the End Dissection Catheter 100.

Romos via the handle mechanism 110, pushing the tissue in contact with the extension members 122 for fracture, thereby producing a small local dissection in the occlusion immediately away from the work element 120 (Figure 2b). The spreading members 122 are then closed producing a distant, non-traumatic ammunition-shaped tip suitable for distant advancement in the dissection path (Figure 2c). The process of coupling the working element 120 in the occlusion with the closed spreader members 122, followed by the actuation of the engaging members 122 to an open position, and the subsequent closure of the members 122 Extenders and the advance in the dissection path is repeated as the work element 120 of the Catheter 100 of Latex Dissection is advanced through the vascular occlusion 200. The Sleeve Catheter is also advanced through the occlusion vascular 200 as is appropriate to the procedure (Figure 2d). Figure 2e is a Dissection Catheter of Late ends that come out of a vascular occlusion with the sheath catheter within the vascular occlusion, according to one modality. As a dissection pathway occurs in / through the 200 occlusion, and the 100th Lateral Dissection Catheter is advanced remotely, the 300 Catheter can also be advanced in the dissection path within the Occlusion 200. Figure 2f is a Dissection Catheter for The extremities and the catheter are both advanced through a vascular occlusion, according to one modality. The distal tip 330 of the Sleeve Catheter 300 has been advanced over the Catheter 100 Dissection Blunt ends and beyond total occlusion 200. At this point, the Catheter 100 of the Double End Dissection can be completely retracted and removed from the vasculature, leaving the Sleeve Catheter 300 in place, through the vascular occlusion, with the distant tip 330 distant from the 200 occlusion. Figure 2g is a Sleeve Catheter that maintains its position through vascular occlusion after removal of the End Dissection Catheter.

Romos, according to one modality. Figure 2h is a guide wire advanced through the sheath catheter and in an exact lumen of a vessel distant from an occlusion, according to one embodiment. The guidewire 400, which can be any of several types of guidewires known in the art, is advanced through the lumen of the Sheath Catheter 300 and into the exact lumen 190 of the vessel remote from the occlusion 200. After placement of the guide wire, the Sheath Catheter 300 is removed from the vasculature, leaving the guide wire 400 in place through the occlusion 200. The guidewire is then placed to distribute therapeutic treatment modalities to the vascular site, such as angioplasty balloons, atherectomy devices, or endoprostheses. Figure 2i is a guide wire in place through vascular occlusion after removal of a catheter from Funda, according to one modality. In the previous analysis, the Lateral Dissection Catheter and the Sleeve Catheter are distributed to the site of the vascular occlusion jointly, that is, the Lateral Dissection Catheter is loaded into the Sleeve Catheter for / during, the distribution. This configuration applies when the system is used in either coronary or peripheral vessels. However, for applications in which the vasculature has a high degree of tortuosity, as is more frequently seen in certain coronary anatomies, an alternative method of gaining access to the site of vascular occlusion may be desirable. If the tortuosity of the vasculature is too extreme for the Lateral Dissection Catheter and the Sleeve Catheter to navigate as a system, it may be desirable to first distribute the Sleeve Catheter via a more flexible distribution scheme, and distribute it Subsequent the Lateral Dissection Catheter within the Catheter to the site of the vascular occlusion. The Case Introducer includes very flexible polymers and in this way the Catheter combination Holster / Case Introducer can provide a greater degree of flexibility at the distant end of the assembly to allow tracking through high degrees of vascular tortuosity while distributing the distal end of the Sleeve Catheter to the desired vascular location. In this alternative approach, the catheter Cover is first distributed directly to the site of vascular occlusion via a conventional guidewire. However, while the diameter of a typical coronary guidewire is 0.0355 cm (0.014 inches), the nominal inside diameter of the Sleeve Catheter is approximately 0. 1041 cm (0.041 inch), the Sleeve Catheter can not be followed directly securely on the guide wire since the distant edge of the catheter guidewires Funda will be exhibited for the most part. This exposed guiding edge can lead to layered cutting of the vessel wall as the vasculature is advanced. To protect the vessel wall from damage by the guiding or guiding edge of the Sleeve Catheter, the Sleeve Catheter is internally supported by a Sleeve Introducer (also referred to as a shutter). The Sleeve Introducer is an individual lumen sleeve that fits snugly inside the catheter.

It covers along a portion of the length of the Sleeve Catheter, and incorporates a guidewire lumen to accommodate normal, vascular guidewires. The distal segment of the sheath introducer may extend from about 0.5 cm to 3 cm beyond the distal end of the Sleeve Catheter, but is not limited thereto. The distal segment of the sheath introducer includes at least one tapered distal end to facilitate tracking and a rounded distal end to be less traumatic. In a first mode, the Case Introducer is designed with a uniform outside diameter that runs the full length to the next hub. This allows easy removal of the FUNCTION CATHETER Sheath Introducer once it is distributed to the site of vascular occlusion. In an alternative embodiment, the diameter of the sleeve introducer sleeve that resides within the sheath catheter is a first diameter and only the distal segment of the sheath introducer extending from the distal end of the sheath catheter can be of a second diameter. slightly increased, such that the transition from the sheath introducer to the sheath catheter forms a constant, smooth diameter. In this configuration, the distant segment of the Shell Introducer may still be terminated as described above. The proximal end of the Sleeve Introducer of a modality ends with a simple cube that includes a normal Luer connector with a central lumen communicating with the guide lumen of the individual lumen sleeve. The proximal hub of the sheath introducer can also be snapped into the proximal hub of the sheath catheters to hold the sheath catheter and sheath introducer in proper axial alignment, i.e., to maintain 1 cm to 5 cm the extension of the Sleeve Introducer beyond the distal end of the Sleeve Catheter during use. In preparing to introduce the catheter Cover in the vasculature, the distal end of the sheath introducer is loaded into the proximal hub of the sheath catheter and advanced until the hub of the sheath introducer snaps into the sheath catheter hub. In this configuration, the distant segment of the introducers of Cover extends approximately 1 cm to 5 cm beyond the distant tip of the Sleeve Catheters to facilitate tracking of the combined assembly on a guidewire, but is not limited to this. Once in the desired vascular location, the sheath introducer and guidewire can be completely retracted, leaving the sheath catheter in place at the desired vascular site. With respect to the mode in which the distant segment of the sheath introducer is equal in diameter to the outer diameter of the sheath catheter, the tip of the sheath introducer can be made of a polymer with a sufficiently low durometer value such that in retraction , the tip can be compressed slightly as the Case Catheter Sleeve Introducer is removed. The durometer as used herein is a measure of the hardness of the material, but other definitions known in the art are included as aprcpiado. Consequently, the durometer of a polymer is a measure of the hardness of the polymer. Therefore, the durometer refers to a measure of the stiffness of a device formed with the polymer. As an example, catheter shafts laminated with high durometer polymers offer a comparatively higher rigidity than catheter shafts laminated with lower durometer polymers. Additionally, the trees of the catheters laminated with the lower durometer polymers offer a comparatively greater degree of flexibility than the trees of the catheters laminated with higher durometer polymers. The sheath introducer sleeve of one embodiment is formed of an individual extrusion of one or more polymers including at least one of Teflon (PTFE), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), and any of various combinations of these materials, but the Case Introducer is not limited to these polymers. One or more of the polymers of one embodiment are slippery. These polymers can also be graded to provide lower durometer polymers at the far end of the Sheath Introducer to offer a greater degree of flexibility. The manufacture of a very flexible remote end of the sheath introducer is a desirable feature since it will follow more easily over the guidewire, and will allow the sheath introducer / sheath catheter system to follow generally easier. Alternatively, the sheath introducer can be made of a braided material (stainless steel, polymeric filaments) laminated with similar polymers. When the Sleeve Sheath / Catheter Introducer is followed to a target vascular site, the far end of the Sleeve Introducer is the driving end of the system. Therefore, the Sleeve / Sheath Catheter Introducer of a modality includes a fluoroscopic marker in / on a distant segment of the Sleeve Introducer. Fluoroscopic marker components such as thin-walled Platinum bands have a thickness of about 0.001 to 0.002 inches and a length of about 0.5 millimeters (mm) to 2 mm may be embedded within the distant polymer of the Shell Introducer, or alternatively , fix the Case Introducer with medical adhesives. The bands can also be made of stainless steel and coated with gold. Alternatively, the bands can be embedded in the inner surface or outer surface of the polymer sleeve using stamping methods. Alternatively, fluoroscopic inks can be printed on the distant surface of the Sleeve Introducer to provide a similar fluoroscopic marker. This fluoroscopic image provides the clinician with information to indicate when the Sheath / Sheath Catheter Introducer has reached the proximal end of the vascular occlusion. The Case Catheter of one modality includes a tree system and a nearby Luer cube, but it is not limited to this. The tree systems comprise components that include an inner polymer layer, an intermediate layer, an outer polymeric layer, a distant fluoroscopic marker system, and an outer slippery coating, but are not limited thereto. Each of these components is described below. With respect to the tree system of one embodiment, the inner polymer layer forms the interior surface of the Sheath catheter. To facilitate the advancement and retraction of the Catheter 100 of Dissection of Late Extremities, or others Catheters within the Sheath Catheter, this inner layer includes a slippery material, such as Teflon (ETFE), Polyimide, and Polyethylenes including High Polyethylene Density (HDPE), Low Density Polyethylene (LDPE) and / or a mixture of the two, but is not limited to these materials.

These polymers are commonly used in the field of medical devices. The inner polymer layer can be chosen to make the same material and end-to-end durometer of the length of the sheath catheter, or polymers can be chosen to customize the desired operations attributes (flexibility, torsion control) of particular regions throughout of the Sleeve catheter. The intermediate layer of the tree system of one embodiment includes braided filaments, such as stainless steel wire, Nitinol wire, Kevlar fiber or Dacron, but is not limited thereto. The braided filaments form a mesh tube that serves as a supporting structural component to provide ring strength to the shaft system. The filaments used to produce this mesh tube include at least one of flat, square and round configurations, as well as combinations of these filaments. The number of the individual filaments can vary substantially from about eight (8) to 32 (thirty-two) filaments, but they are not necessarily limited to this.

Any filament material that provides the desired rim strength can be used to maintain the tubular configuration of the catheter shaft. The number of filaments per inch (feet) can be adjusted to make consistent along the entire length of the catheter shaft, or the feet can be varied to adjust the desired operational attributes (flexibility, torsion control) of the catheter. In general, lower foot counts are associated with less torsion control, greater flexibility and less hoop resistance. Alternatively, higher foot counts are associated with greater torsion control, less flexibility and greater rim strength. In one embodiment, the number of feet may vary from about 80 to 120 feet per inch. The outer polymer layer of the tree system forms the outer surface of the Sleeve Catheter. This polymer is selected from a variety of polymers commonly used in the field of medical devices that include at least one of naylon, polyurethanes, polyethylenes, and polyimides, Pebax, Grilamides or carbotan, but the outer polymeric layer is not limited thereto. The material of the outer polymeric layer is selected to adjust the desired operational attributes (flexibility, torsion control) of the catheter. The polymer of the outer layer can be chosen to make the same material and the same end-to-end durometer of the catheter length of Sheath, or the outer layer of the polymer can be chosen to provide variable operating characteristics for the different regions or sections of the * catheter shaft. Specifically, in relation to the proximal sections of the catheter shaft, the distal section of the catheter shaft may generally require a greater degree of flexibility to facilitate tracking through vascular (especially coronary) tortuosity. Alternatively, the proximal section of the catheter shaft may require greater characteristics of increased torque and thrust control to facilitate further advancement of the catheter in the vasculature. To achieve these operating attributes, variable durometer polymers are selected for the proximal, and distant, sections of the catheter. For example, low durometer polymers form one or more sections distant from the catheter shaft to facilitate flexibility, and Higher durometer polymers form one or more proximal sections of the catheter shaft to facilitate thrust and torsion control.

Another material that more specifically serves to withstand thrust and torsion control in the proximal section of the catheter is the polyimide which typically can not be re-formed using heat, as can the thermoformable polymers mentioned above.

During manufacture of the main shaft of the sheath catheter including an inner polymer, a tubular braid and an outer polymeric laminate as described above, the outer surface of the inner polymeric liner and the inner surface of the outer polymeric laminate product are brought into contact physically or join together. This connection takes place between the crossing points of the braid wire forming the braided tubular member. The physical union of these two surfaces through the braided tubular member produces a unified construction of the sheath catheter shaft. However, there is a challenge because the materials used for the interior lining of a modality, specifically polytetrafluoroethylene (PTFE) high density polyethylene (HDPE) or low density polyethylene (LDPE) are all very resistant to binding to other polymers. In a first embodiment, this challenge is overcome when PTFE is used as the inner liner by etching the outer surface of the PTFE tube with an acid to produce microscopic interstices on the surface on which the outer polymeric laminate can be bonded. If Pebax or nylon are used for the outer laminate, the processing temperature may vary from about 204 ° C (400 degrees Fahrenheit (F)) to 232.2 ° C (450 degrees F), which is sufficient to flow these polymers, but it will not be too hot to flow the PTFE liner, nor the interstices present in the outer surface of the interior. During lamination of the outer polymer onto the shaft of the sheath catheters, the outer polymeric laminate product flows through, or between the crossing points of the braid wire and on the outer surface of the PTFE inner liner. The thickness of the outer polymeric laminate is adjusted so that the braid wire is then contained completely within the outer laminate, and the outer polymeric laminate forms an uninterrupted, smooth surface. During the process of cooling the lamination, the inner surface of the outer polymer becomes "secured" in the interstices of the inner polymeric lining, thereby connecting the two polymers between the braid wire. In an alternative embodiment in which the inner polymeric liner is composed of high density or low density polyethylene, the sheath catheter shaft can be laminated with any of the same materials.

Since these materials have common melting temperatures, the inner polymeric liner and the outer polymeric laminate will easily bond with each other, producing a unified tree construction. The tree system of one embodiment includes a distant fluoroscopic marked system to indicate the distal end of the catheter when viewed under fluoroscopy. One type of marker system includes a platinum ring (wall thickness typically of about 0.001 to 0.002 inches, typically about 0.5 mm to 2 mm in length) embedded within the polymers at the distal end of the catheter. Additionally, the ring is made of stainless steel and coated with gold. The ring is placed on either the inside or the outside of the braided tubular mesh, and is laminated with either the polymer of the inner layer or the polymer of the outer layer. An alternative marker system uses a platinum spiral. The platinum spiral is placed in a manner similar to the platinum band described above, but is not limited to this. Another alternative marker system uses adhesives or radiopaque compounds printed on the surface of either the inner polymer, the braided tubular mesh, or the outer polymer. These adhesives typically employ the use of tantalum, bismuth, gold, silver or platinum, but are not limited thereto. Still another alternative marker system includes a gold coating. The gold coating is placed on the distant section of the tubular mesh, but it can be placed differently in the alternative modalities.

Still another alternative marker system includes the use of fluoroscopic material and tree system materials (eg bismuth). In one embodiment, the fluoroscopic material is impregnated into the structural polymers that laminate the distal end of the sheath catheter. With respect to the outer slippery coating of the tree system described above, the surface of the outer polymer can be coated with a slippery material such as a silicone dispersion, alternatively, a hydrophilic coating (Surmodics). While the inner surface of the diseased vessels may contain fibrotic material, calcium and / or the inner diameter of the vessel may be mostly reduced, the coating acts to further facilitate the distribution of the catheter through the vasculature by reducing the friction between the external surface of the catheters and the inner surface of the vessel. The proximal female cube of the catheter system Case includes a standardized Luer connector. The connector Luer supports the connection to other standardized intervention devices, for example, a syringe is attached to this hub to stuff the catheter before use. The proximal hub is made of several polymers commonly used in medical devices, an example of which is polycarbonate. The sheath catheter of one modality has an outer diameter in a range of about 0.127 to 0.1178 cm (0.050 to 0.070 inches), but is not limited to this. A nominal outside diameter is approximately 0.1422 cm (0.0560 inches). The sleeve catheter of a modality has an inner diameter in a diameter of approximately 0.0889 a 0. 127 cm (0.035 to 0.050 inches), but it is not limited to this.

A nominal inside diameter is approximately 0.1016 cm (0.040 inches). The Sleeve Catheter of a modality has a working length ranging from about 80 cm to 150 cm, but is not limited to this. A nominal working length is approximately 130 cm. The catheter manufacturing process of one embodiment includes polymers of the inner and / or outer layers that flow within the spaces of the braided tubular mesh (middle layer). In this way, the inner polymer fuses with the outer polymer, forming bridges through the mesh tube. This produces an integral tree lamination that provides increased strength, torsion control and reliability to the tree construction. As described above, the polymers that form the catheter shaft of one embodiment include variable durometer polymers that allow the specific operating attributes of different sections of the catheter shaft to be adapted. In addition, the graduation of the polymers from the proximal to the distal end of the catheter can increasingly decrease. As an example, a proximal region of the catheter shaft (the next most approximately 80 cm) is laminated with Grilamide, followed by a region (length of about 8 cm) of Pebax 73D, followed by a region (length of about 8 cm) of Pebax 63D, followed by a region (length of about 5 cm) of Pebax 55D. In this way, the transition from one polymer to the next is gradual, and the flexibility of the catheter shaft is gradually increased. Figure 3a is a catheter system including a Sheath Catheter 300 and Sheath Introducer 350, according to one embodiment. The Catheter 300 of Funda and the Introducer 350 of Funda is shown as a system, but is not limited to this. In this configuration, the system is traceable over a conventional guidewire, via a central Lumen 365 of the Sheath Introducer 350, to distribute the distal end 330 of the Sheath Catheter close to the site of a vascular occlusion. The Case Introducer 350 is shown with the proximal retracted hub 360 for visual clarity of the components. However, during use, the 360 cube of Case Introducer can be press fit into the hub 310 of the Sleeve Catheters, jointly holding the Sleeve Catheter 300 and the Case Introducer 350. In this configuration, a distant segment 380 of the Sheath Introducer 300 extends from the distal end 330 of the Sheath Catheter for approximately 0.5 craw about 5 cm, but is not limited thereto. After tracking on a conventional guidewire to the target vascular site, the guidewire and the Cover introducer 350 is removed, leaving the distal end of the Sleeve Catheter 330 in place close to the vascular occlusion where it is positioned to follow as the conduit through which another catheter may be distributed such as the End Dissector Catheter 100 Romos to vascular occlusion. Although the Sleeve Catheter 300 is described as working in conjunction with a 100 End Dissector Catheter Romos, once in place in the vascular site, the catheter 300 of Funda can be used to distribute other types of catheter systems or apparatuses known in the art which are dimensionally compatible with the Catheter 300 of Funda.

As an example, conventional guide wires may be dispensed first, if desired, in an attempt to first cross the occlusion prior to use Catheter 100 Dissection Romos extremes. If the guide wire is not successful in crossing the occlusion, the guide wire can be removed, and the 100 Latex Dissection Catheter can be advanced through the Sleeve 300 Catheter for use in crossing the occlusion. Figure 3b is a longitudinal cross-section of a distal segment of a Sleeve Catheter 300, according to one embodiment; The Catheter 300 shaft includes an inner polymeric liner 303 on which the wire 302 is pressed. The shaft is then laminated with another polymer (304-309). As an operating objective of the Sheath Catheter 300 is to provide a very flexible distant segment, the outer polymeric laminate product can be graduated from relatively high durometer polymers in the section near relatively smaller durometer polymers in the distal section. As an example the tree includes six separate outer laminate products in sections 304 through 309. The outer laminate of section 304 is manufactured using Pebax 63D, followed by the outer laminate of section 308 which is made of a minor polymer. durometer, possibly Pebax 55D, followed by the outer laminated product of section 307 which is Pebax 40D, and so on, gradually decreasing the polymer durometer of the outer laminate until the distant segment 330 of catheter sheath 300 is reached. While six graduated polymers are described in this embodiment, a greater or lesser number of polymers can be used to provide the correct physical attributes for the tree.

Another material for use in catheter shafts of alternative embodiments includes polyethylene, where the polyethylene is graded or staggered as is appropriate to the proposed use of the catheter system. "In another embodiment, the types of polymer can be alternated to achieve flexibility The inner polymer layer 303 of one embodiment includes a highly slippery material since the inner lumen of the Sheath Catheter 300 is used to displace other devices The inner liner 303 can be made of polytetrafluoroethylene (PTFE) or high density polyethylene (HDPE) as examples, but is not limited to this.The inner liner durometer 303 can also be graded or staggered as described above to provide the appropriate degree of flexibility.As an example, low density polyethylene (LDPE) can be used ) in segment 330 furthest from Funda catheter 300 to provide a high degree of flexibility than HDPE. The choice of braiding materials depends on the torsion control, the flexibility, the ring strength and the wall thickness appropriate to a specific application. For example, the braid wire may be 0.00254 cm (0.001 inch) flat stainless steel wire per 0.003 inches as an example. The braid wire can also be 0.002 inch round wire.

The round braid wire offers a greater degree of overall flexibility, rim resistance and torsion control to the construction of sheath catheter shaft. However, the round wire generally results in a catheter shaft having a greater total wall thickness compared to the flat wire version. Alternative press materials such as Dacron fibers, or other suitable polymers may also be used; these alternative materials do not generally offer the same degree of torsion control or rim strength but can increase the overall flexibility of the sheath catheter shaft. The placement of the distal segment 330 of the Sleeve Catheter 300, which includes the non-traumatic tip 310 and the fluoroscopic marker band 311 is as follows. The fluoroscopic marker band 311 is fixed to the sheath catheter shaft in several ways. In one embodiment, the marker band 311 is external to the wire braid 302, but is laminated to the outer polymeric layer 309. The marker band 311 is thus encapsulated within the outer polymer lamination, which provides a smooth surface to the distant segment 330 of the Sleeve catheter. Continuing with this embodiment, the distal end of the wire braid 302 and the distal end of the marker band 311 may also end concurrently with one another. Additionally, the inner polymeric liner 303 may extend from about 1 mm to 10 mm beyond the end of the marker band 311 and the braid wire 302, but is not limited thereto. To complete the fabrication, the outer polymer 309 is continued "distant on the marker band 311 to form a non-traumatic polymeric tip 310 terminating concurrently with the distal end of the inner liner 303. In this manner, the length of the non-traumatic tip 310 is equal to the length of the inner polymeric liner 303 and the outer polymeric laminate 309 extends beyond the marker band 311. The shape of the non-traumatic tip 310 is terminated by the rounding or tapering of the distant annular edge of the polymeric laminate This process is commonly referred to as tip formation and can be performed by placing the fabricated assembly in a heated glass mold, the internal control of which has been made with the final desired shape of the tip. , the outer rolled product is heated to allow the outer rolled product to begin to soften and take the inner shape of the mold. 310 of catheter remains in the mold while the mold is cooled, hardening the non-traumatic rounded or tapered shape at the tip 310 remote from the Sleeve Catheter 300.

At the completion of the cooling, the catheter tip 310 is removed from the mold. Methods for locally heating the mold can be via conventional convection heating, or alternatively, radiofrequency energy can be used to locally heat the non-traumatic tip 310. The dimensions of the marker bands can vary in general from about 0.05 mm to 3 mm in length, and from 0.001 to 0.003 inches in thickness, but it is not limited to this. Marker bands can be manufactured from a variety of materials. One material that provides adequate formation of fluoroscopic images is platinum, or an alloy such as platinum-iridium, or platinum-tungsten. Alternatively, the marking bands are made of stainless steel and coated with gold. At the dimensions indicated, the stainless steel itself does not provide adequate formation of fluoroscopic images, and thus is coated with a more fluoroscopic material such as gold to provide an adequate fluoroscopic image. In general, a gold coating layer of approximately 0.0005 to 0.002 inches provides an adequate fluoroscopic image. Figure 3c is a longitudinal cross section of a distal end of a Catheter 300 of Funda, under an alternative environment. This embodiment includes two marker bands, an inner marker band 312 and a marker band 311. The inner marker band 312 is below the braid wire 302 and abuts against a proximal section of the inner polymeric liner 303 and a distal section of the inner liner 303. polymeric liner 304. A second marker band 311 is external to the braid wire 302. In this way, the braid wire 302 is sandwiched between the two marker bands, and this area can be welded, glued or welded further to provide a secure connection of the marker bands 311/312 to the braid wire 302.

As described above, the braid wire and the marker bands may have a common distant termination point. Similarly, the proximal ends of the marker bands 311/312 may also have a common proximal termination point. Alternatively, the distant and / or proximal ends of any marker band may be close to, or distant from, the corresponding distant and / or proximal end of the other marker band.

Further describing this alternative embodiment, the inner polymeric liner 304 and the outer polymeric liner 310 may also extend beyond the far end of any marker band to provide a non-traumatic tip as described above. Figure 3d is a longitudinal cross section of a distal end of a catheter 300 of Funda, according to another alternative modality. The inner polymeric liner 303 terminates concurrently with the distal end of any marker band, and the outer polymeric laminate 309 extends distally beyond the marker bands to form the non-traumatic tip 310. This embodiment can also be manufactured with the use of only one marker band 311, which resides on the outside of the braid wire 302, as described above.Figure 3e is a longitudinal cross-section of a distal end of a Catheter 300 of FIG. Sheath, according to still another alternative embodiment, the remote end includes an inner marker band 312 and outer marker band 311 as described above, however, the inner marker band 312 extends distally beyond the far end of the band. outer marker 311. This extension provides a circumferential descent for the attachment of a pre-formed polymeric or polymer front part A metal front part can be welded or glued to the inner marker band 312, or alternatively, a part can be glued polymeric front to an extension of the inner marker band 312. The inner liner 303 can be extended to finish concurrently with the front. Figure 3f is a longitudinal cross section of a proximal hub of a Sleeve Catheter 300, according to one embodiment. The proximal hub 310 is manufactured using at least one of polycarbonate, nylon and other injection moldable polymers, but is not limited thereto. The proximal hub 310 can be connected to the proximal shaft 320 of the sheath catheter via one of glue, insert molding and thermal bonding. The proximal hub 310 has a proximal Luer connector for connection to other devices such as syringes (for flushing the catheter with saline prior to use, by way of example). The proximal Luer also includes an entry area 318 that gradually tapers to the proximal Luer opening in the proximal lumen 375 of the Sleeve Catheter. The entry area 318 allows easy introduction of the Sleeve Introducer 350 or the Catheter 100 Dissection Catheter 100 into the Sleeve Catheter 300. The Sleeve Catheter 300 described above includes a uniform inner diameter having a high tolerance fit to the outer diameter of the Catheter 100 of Lateral End Dissection. The Sleeve Catheter of an alternative modality includes a distant segment on the side of the Sleeve Catheter having a high tolerance fit to the outer diameter of the Catheter 100 of Lateral End Dissection, and next to this segment, the inner diameter of the Sleeve catheter can be increased slightly. This configuration provides more annular space between the blunt-ended dissecting catheter and the sheath catheter to provide improved total movement of the blunt-ended dissection catheter within the sheath catheter. The lengths of the distant segment having a high tolerance fit to the outside diameter of the Lateral Dissection Catheter 100 has a wide range, wherein the inner limit includes only the most distant 1 cm of the Sleeve Catheter 300, and the limit superior approximates the full length of the 300 Catheter of Funda. A practical range for the distant segment of the Sleeve Catheter that has a high tolerance fit to the Lateral End Dissection Catheter is approximately 5 cm to 20 cm. The increase in diameter can be in the order of 0.002 to 0.015 inches, but it is not limited to this. As a practical example, the inner diameter of the distal segment of the sheath catheter has a nominal diameter of approximately 0.042 inches, and the inner diameter near the distal segment can be increased to 0.045 or 0.047 inches. This small increase in annular space can provide significant improvements in movement. However, in both described embodiments, it is desirable to maintain an intimate high-tolerance fit between the Distant segment of the Sleeve Catheter and the Double-ended Dissection Catheter to provide the lowest possible profile at the distal end of the integrated system. Figure 4a is a longitudinal cross section of a proximal sheath insertion hub, according to one embodiment. Figure 4b is a longitudinal cross-section of a distant segment of sheath introducer in a tapered configuration and including a fluoroscopic marker band, according to one embodiment. Figure 4c is a longitudinal cross-section of a distant segment of sheath introducer in a rounded configuration and including a fluoroscopic marker band, according to one embodiment. With reference to Figures 4a, 4b and 4c, the Sheath introducer includes hub 360, shaft 370 and fluoroscopic marker band 385. Sheath introducer 350 is configured to be inserted into sheath catheter 300 such that, when there is complete insertion, the distant segment of introducer tree 370 of Sheath extends beyond the distal end of the Sheath Catheter 300 by approximately 0.5 cm to 5 cm, but is not limited thereto, and the proximal hub of the Sheath Introducer 360 snaps into the proximal hub 310 of the Catheters of Funda. The outer diameter of the Sheath Introducer Tree 370 is configured to provide an intimate fit to the inner diameter of the Sleeve Catheter 300, as described above for the fit between the Catheter 100 of the Soft End Dissection and the Sleeve Catheter 300. As a mount, the Sleeve / Sheath Catheter Introducer can be tracked over a guidewire to the appropriate vascular site via the guidewire, central guidewire lumen 365. As described above, the The sheath catheter 300 can not generally be followed on itself over a guide wire, since the inside diameter of the Sleeve Catheter 300 has a nominal diameter of approximately 0.042 inches and a conventional coronary guide wire has a diameter of approximately 0.0355 cm. (0.014 inches). In this way, there will be a large annular gap, which exposes the leading edge of the Sleeve Catheter against the vessel wall. The Sleeve Introducer provides the physical interconnection between the guide wire and the Sleeve Catheter 300, which fills the annular gap between the two catheters. The introducer shaft 370 of a modality includes slippery material that improves tracking over the guidewire, and facilitates retraction of the Sleeve Introducer 350 from the Sleeve Catheter 300 once the system has been advanced to the vascular site appropriate. Suitable slippery materials include polytetrafluoroethylene (PTFE), high density polyethylene (HDPE) or low density polyethylene (LDPE). The typical dimensions of the Sheath Introducer tree include an inner diameter of approximately 0.016 to 0.022 inches, and an outer diameter of approximately 0.039 to 0.043 inches, but the mode is not limited to these dimensions. On the complete insertion of the Case Introducer 350 into the Catheter 300 of Funda, a pre-determined distant segment of the tree 370 of Sheath Introducer extends beyond the distal end of the Sleeve Catheter 300 as described above. This length allows a smooth transition from the Sleeve Introducer 350 to the Sleeve Catheter 300 and facilitates tracking over the guide wire. The proximal cube 360 is shown connected to the Shell Introducer tree 370 with reference to Figure 4a. The proximal hub 360 is formed using at least one of polycarbonate, nylon and other suitable polymers moldable by injection. The proximal hub 360 includes a proximal Luer fitting 362 used to connect to conventional devices such as a syringe used to rinse the lumen 365 with saline prior to use. The proximal hub 360 also includes a guide wire entry area 367 that provides a smooth transition from the proximal opening of the hub 360 to the proximal lumen of the shaft 370, and allows easy advancement of the guide wire in the Case Introducer 350.

The entrance area 367 of guide wire can also be formed using at least one of polycarbonate, nylon and other suitable injection moldable polymers. The next cube 360, the guide wire entry area 367 and the shaft 370 are connected using one of a combination of glue, insert molding and thermal bonding. Alternatively, the guide wire entry area 367 and the proximal hub form a one-piece component. With reference to Figures 4b and 4c, the far end of the Sheath Introducer Tree 370 includes a fluoroscopic marker band 385. The marker band is embedded in or coupled to the wall of the Sheath Introducer Tree 370 via various modalities. In a first modality, as shown in Figures 4b and 4c, the marker band 485 is stamped into the body of the Case Introducer Tree 370 such that the outer surface of the marker band 385 is flush with the outer surface of the introducer shaft 370. Sheath. This provides adequate physical securing of the marker band within sheath introducer tree 370, requiring minimum total thickness of sheath introducer shaft 370. A nominal polymer thickness covering the marker band is in the order of about 0.002 to 0.004 inches, but is not limited to this. In a second embodiment, the inner surface of the marker band 385 and the inner surface of the Case Introducer shaft 370 are flush. This mode uses an equal thickness of sheath introducer tree 370. In a third embodiment, the marker band 385 is contained entirely within the body of the Sheath Introducer Tree 370, and a thin layer of the polymer covers both the inner surface and the outer surface of the marker band 385. The thickness of this layer varies from about 0.001 to 0.003 inches, but it is not limited to this. The distal end of the Sheath Introducer can determine in a tapered shape or a rounded shape. The shape of the tip is thermally formed in a manner similar to what is descrifor the distant termination of the Sleeve Catheter 300. These shapes provide a smooth transition for the guide wire to the distal end of the Sleeve Introducer, and aid in tracking the distal end of the Sleeve Introducer over a guidewire, especially in heavily diseased hermetic vessels. The blunt-ended dissection catheter descriabove can be any of several catheters and / or work elements. As examples, there are complete descriptions of End Dissection Catheters Romos, representative in the Patents of the United States Nos. 5,968,064, 6,508,825, 6,599,304 and 6,638,247, as well as the U.S. Patent Application Publication No.

US-2004-0077999-A1 and the Patent Application of the States United No. 09 / 835,043. Figure 5a is a working element 500 of a Lateral Dissection Catheter showing two extension members 506/508 in an open configuration, according to one embodiment. The work item 500 is an example of the work item 120 described above with reference to Figure 1 and the sequence of Figures 2a-2i and the mode is not limited thereto. Figure 5b is a working element 500 of a Lateral Dissection Catheter showing two extension members 506/508 in a closed configuration, according to one embodiment. Figure 5c is a sectional view of parts of a working element 500 of a Romo End Dissection Catheter, according to one embodiment. With reference to Figure 5c, the working element 500 includes a base section 502, a drive assembly 504, a first extender member 506, and a second extender member 508. The hinge pins 510 attach the first 506 and the second 508. extending members to the drive assembly 504 and the base section 502. The hinge pins 510 support the rotation of a distal end of each of the first 506 and the second 508 spreading members about a proximal end of the spreading members 508/508 during the deployment of the 506/508 spreader members as described above. The fork pins 512 couple the drive assembly 504 to each of the extension members 506/508. Accordingly, the coupling between the drive assembly 504, the hinge pins 510, the fork pins 512, and the extension members 506/508 allows the conversion of a linear drive force 514 applied to the drive assembly 504 into the movement. of the respective spreading members around the respective spike pins 510. In the operations as described above, the working element 500 is placed in close contact or contact with a vascular occlusion and / or blood vessel wall to facilitate vascular occlusion disequilibrium A driving force 514, including one exerted linearly in a proximal direction, is applied to the assembly 504, converted to an extension or mechanical force and a movement (for example radial force outwardly and movement with respect to the extension movements 506/508 of the respective hinge pin 510) and then exerted by the extension members 506 / 508 on the vascular walls. The extension or mechanical force applied to the vascular occlusion and / or a wall of blood vessels tears, fractures or otherwise breaks, a vascular occlusion without damaging the surrounding wall of the blood vessel. As described above, the continuous linear break of the vascular occlusion generates a channel or passage of sufficient size for the passage of the working element 500 and the catheter system to cross the occlusion.

A guidewire or other catheter known in the art can then be advanced within the occlusion cut for medical procedures of choice. The systems and methods based on interventional catheters described above for use in generating an initial route through vascular occlusions include a catheter system comprising: a catheter shaft including a braided tubular member, wherein at least one inner polymeric liner couples an inner surface of the braided tubular member, wherein the member is an outer polymeric laminate product engages an outer surface of the braided tubular member, wherein polymeric materials of polymeric outer laminate product are interspersed through the braided tubular member and they connect (alternatively referred to as laminated product and / or joint) in the interstices of an outer surface of the inner polymeric liner; and at least one lumen in the catheter shaft. The outer polymeric laminate product of one embodiment includes a plurality of polymers each forming one or more sections along a length of the catheter shaft. The durometer values of the sections along a length of the catheter shaft of one embodiment decrease longitudinally towards a distal end of the catheter shaft.

The outer polymeric laminate product of one embodiment further contains a plurality of polymers. One or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymeric laminate product.Polymers with relatively smaller durometer values form discrete sections of a distant end of the polymer. polymeric outer laminate product and polymers with relatively higher durometer values form discrete regions of a proximal end of the outer polymeric laminate, where the distal regions of the catheter shaft have a relatively greater degree of flexibility than the proximal regions of the catheter shaft The plurality of polymers of one embodiment includes six polymers.A distant termination of catheter shaft lumen of one embodiment forms an annular opening at a distal end of the catheter shaft.The annular opening comprises a polymer that forms a non-traumatic tip, but in a non-limited way. Non-traumatic tip may be an individual polymer that has a distant tapered region. The non-traumatic tip may be an individual polymer that has a distant rounded region. The non-traumatic tip may be comprised of an inner polymer and an outer polymer.

The catheter shaft of one embodiment includes a fluoroscopic marker system. The fluoroscopic marker system includes a first marker region external to the braided tubular member. The fluoroscopic marker system of one embodiment includes a second marker region internal to the braided tubular member. The one mode catheter system further comprises a sheath introducer that includes the member having a proximal end in a distant member and forming a lumen. individual configured to follow over a guide wire, wherein the member is configured to be inserted into the catheter shaft, wherein a distal region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted. The sheath introducer in one embodiment further comprises at least one hub at the proximal end, the hub being configured to be secured in a hub at a proximal end of the catheter shaft when the sheath introducer is fully inserted into the catheter shaft. The sheath introducer may also include a fluoroscopic marker system in a region remote from the member. The systems and methods based on interventional catheters described above for use in generating an initial route through vascular occlusions also include a catheter system comprising: a catheter shaft including a braided tubular member, wherein at least an inner polymeric liner couples an inner surface of the braided tubular member, wherein at least one outer polymeric laminate merges an outer surface of the braided tubular member, wherein the polymeric materials of the outer polymeric laminate product are interspersed through the braided tubular member and they are connected (laminated, joined in the interstices of an outer surface of the inner polymeric lining, wherein the inner polymeric lining forms a lumen in the catheter shaft, and an introducer that includes a member having a proximal end of one end distant that forms an individual lumen configured to continue on a guide wire, wherein the member is configured to be inserted into the catheter shaft, wherein a distal region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted. The introducer in one embodiment further comprises at least one tube at the proximal end, the hub being configured to be secured in a tube at a proximal end of the catheter shaft when the introducer is fully inserted into the catheter shaft. At least one of the catheter shaft and the introducer of a modality includes a fluoroscopic marker system in a region remote from the member. The outer polymeric laminate product of one embodiment further comprises a plurality of polymers. One or more of the polymers may have different durometer values, wherein each of the plurality of the polymer forms one or more discrete regions of the outer polymeric laminate product. Polymers with relatively smaller durometer values form discrete regions of a distant end of the outer polymeric laminate and polymers with relatively higher durometer values form discrete regions of a proximal end of the outer polymeric laminate, where distant regions of the catheter shaft they have a relatively greater degree of flexibility than the proximal regions of the catheter shaft. The systems and methods based on interventional catheters described above for use in generating an initial route through vascular occlusions further include a catheter system comprising: a sheath catheter comprising a catheter shaft with at least one lumen and ending to form an annular opening at a distant end of the catheter shaft; and an intravascular tissue expansion catheter comprising, a catheter including a distal end and a longitudinal axis having at least one conduit extending along the longitudinal ee, a housing formed at the distal end of the catheter shaft in wherein the housing includes at least one deflection member defined by a proximal end coupled pivotally to the catheter shaft and a distally free tip that moves through an arch away from the longitudinal axis of the shaft to expand vascular tissue, where at least one deflection member includes an integrally formed hinge, and a drive assembly positioned along the catheter shaft to move the distal tip of the at least one biasing member away from the longitudinal axis of the catheter shaft. of one embodiment includes one or more hinges The drive assembly of one embodiment includes a traction element coupled to at least one diversion member. The deviation member of one embodiment is connected to the housing with at least one hinge pin to form at least one hinge that supports the rotation of at least one biasing member when the pulling element pulls in a relatively close reaction. The durometer values of the materials forming the catheter shaft of the sheath catheter decrease longitudinally towards the distal end, but are not limited thereto.

The catheter shaft of the sheath catheter in one embodiment further comprises a braided tubular member, wherein at least one inner polymeric liner couples an inner surface of the braided tubular member, wherein at least one outer polymeric laminate product couples an outer surface of the member tubular braid, wherein the polymeric materials of the outer polymeric laminate product are interspersed through the braided tubular member and connected (laminated, bonded) in the interstices of an outer surface of the inner polymeric liner. The outer polymeric laminate product of one embodiment includes a plurality of polymers each forming one or more sections along a length of the catheter shaft. One or more of the polymers of one embodiment have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymeric laminate. Polymers with relatively smaller durometer values form discrete regions of a distant end of the outer polymeric laminate and polymers with relatively greater durometer values form complete regions of a proximal end of the outer polymeric laminate, wherein the distant regions of the The catheter has a relatively greater degree of flexibility than the proximal regions of the catheter shaft.

The annular opening of one embodiment comprises a polymer that forms a non-traumatic tip. The non-traumatic tip may be an individual polymer that has a distant tapered region. The non-traumatic tip may be an individual polymer that has a distant rounded region. The non-traumatic tip may be comprised of an inner polymer and an outer polymer. The catheter shaft of the sheath catheter of one embodiment includes a fluoroscopic marker system. The fluoroscopic marker system includes at least one of a first marker region external to the braided tubular member and a second marker region internal to the braided tubular member. The one-mode catheter system further comprises a sheath introducer that includes a member having a proximal end and a distal end and forming an individual lumen configured to follow over a guidewire, wherein the member is configured to be inserted into the guidewire. the catheter shaft of the sheath catheter, wherein a distant region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted. The sheath introducer of one embodiment further comprises at least one hub at the proximal end, the hub being configured to secure a hub at the proximal end of the catheter shaft of the sheath catheter when the sheath introducer is fully inserted into the shaft. catheter. The sheath introducer of one embodiment further comprises a fluoroscopic marker system in a region remote from the member. The systems and methods based on interventional catheters described above for use in generating an initial route through vascular occlusions include a method for crossing an occlusion, comprising: mounting a catheter system when loading an end dissecting catheter blunt in a sheath catheter; advancing the catheter system to a vascular site and placing at least one extension means of the blunt-ended dissection catheter adjacent to the occlusion; applying a fracture force to the tissue of the blood vessel and occlusion by moving a distal end of the at least one extending member laterally away from a longitudinal center line of the blunt-ended dissecting catheter by deflecting a distal end of the extending member about a proximal end of the extending member in response to an extension force; destabilize the material of the occlusion and generate a route through the destabilized material in response to the applied fracturing force; and advancing at least one of the blunt-ended dissecting catheter and the sheath catheter through an occlusion material using the path generated so that at least one of the blunt-ended dissecting catheter and the sheath catheter crosses the Through a material of the occlusion and the material of the occlusion remains external to the catheter system. The method of one embodiment further comprises advancing the sheath catheter beyond the occlusion prior to removing the dissecting catheter from the blunt ends of the blood vessel. The method of one embodiment comprises advancing a guide wire through the displaced occlusion using the sheath catheter after the removal of the blunt-ended dissecting catheter and before removing the sheath catheter. The method of one embodiment further comprises selecting and advancing a guidewire through vascular occlusion within the blood vessel. The method of one embodiment further comprises advancing the sheath catheter beyond the occlusion before removing the blunt-ended dissecting catheter and before advancing a guidewire through the sheath catheter. The method of one embodiment further comprises advancing a guide wire through an occlusion using the sheath catheter after advancing the sheath catheter beyond the occlusion. The systems and methods based on interventional catheters described above for use in generating an initial route through vascular occlusions additionally include a method for crossing an occlusion, comprising: advancing a first guide wire into a blood vessel going to occlusion, mounting a catheter system by loading a sheath introducer into a sheath catheter, advancing the catheter system on the first guidewire so that a distal end of the system is in proximity to the occlusion; remove the first guide wire and sheath introducer from the vasculature, advance a blunt-ended dissecting catheter through the sheath catheter to place at least one extension member of the blunt-ended dissecting catheter adjacent to the occlusion; fracture force to the tissue of the blood vessel and occlusion when moving a distant end of the extending member l aterally away from a longitudinal center line of the blunt-ended dissecting catheter by deflecting a distal end of the spreader member about a proximal end of the spreader member in response to an extension force; destabilize the material of the occlusion and generate a route through the destabilized material in response to the applied fracturing force; and advancing at least one of the blunt-ended dissecting catheter and sheath catheter through the occlusion material using the path generated so that at least one of the blunt-ended dissection catheter and sheath catheter crosses through of an occlusion material and the occlusion material remains external to the catheter system. The method of one embodiment further comprises advancing the sheath catheter beyond the occlusion prior to removing the dissecting catheter from the blunt ends of the blood vessel. The method of one embodiment further comprises advancing a second guidewire through the displaced occlusion using the sheath catheter after removing the blunt-ended dissecting catheter and before removing the sheath catheter. The method of one embodiment further comprises selecting and advancing a second guidewire through the vascular occlusion within the blood vessel. The method of one embodiment further comprises advancing the sheath catheter beyond the function before removing the blunt-ended dissecting catheter and before advancing a second guidewire through the sheath catheter. The method of one embodiment further comprises advancing a second guidewire through the occlusion using the sheath catheter after advancing the sheath catheter beyond the occlusion. Unless the context clearly requires otherwise, throughout the description and claims, the words "comprises", "comprising" and the like are to be considered in the inclusive sense as opposed to the exclusive or "exhaustive" sense; that is, in a sense of "that includes enunciatively and without limitation". The words are used in individual or plural number also include the plural or singular number, respectively. Additionally, the terms "in the present", "in accordance with the present", "previously", "later", and terms of similar importance, when used in this application, refer to this application as a whole and do not as some particular portion of this request. The word "or" is used in the reference to a list of two or more points, that word covers all the following interpretations of the word: any of the points in the list, all the points in the list and any combination of the points on the list. The above description of the illustrated embodiments of the catheter system is not intended to be exhaustive or to limit the catheter system to the precise manner described. Inasmuch as specific embodiments of, and examples for, the catheter system are described herein, for illustrative purposes, several equivalent modifications within the scope of the catheter system are possible, as those skilled in the art will recognize. The teachings of the catheter system provided herein may be applied to other medical devices and systems, not only to the catheter systems described above. The elements and acts of the various embodiments described above can be combined to provide additional modalities of the catheter system. These and other changes can be made to the catheter system in view of the above detailed description. All prior references and patents of the United States and United States Patent Applications are incorporated herein by reference. If necessary, aspects of the catheter system can be modified, employing the systems, functions and concepts of the various patents and applications described above to provide even further modalities of the system. In general, in the following claims, the terms used should not be considered as limiting the catheter system to the specific modalities described in the specification and the claims, but should be considered to include all the catheter systems and medical devices that operate under the claims to cross vascular occlusions. Accordingly, the catheter system is not limited by the description, but instead the scope of the catheter system will be fully determined by the claims. While certain aspects of the catheter system are presented below in certain claim forms, the inventors contemplate the various aspects of the catheter system in any of the claim forms. Accordingly, the inventors reserve the right to add additional claims after the filing of the application to demand these additional forms of claims for other aspects of the catheter system. It is noted that in relation to this date, the best method known by the applicant to carry out the present invention is that which is clear from the present description of the invention.

Claims (54)

1. CLAIMS Having described the invention as above, the claim contained in the following claims is claimed as property: 1. Catheter system, characterized in that it comprises: a catheter shaft that includes a braided tubular member, wherein at least one inner polymeric liner couples a inner surface of the braided tubular member, wherein at least one outer polymeric laminate product couples an outer surface of the braided tubular member, wherein the polymeric materials of the outer polymeric laminate product are interspersed through the braided tubular member and connected into the interstices of an outer surface of the inner polymeric liner, and at least one lumen in the catheter shaft. System according to claim 1, characterized in that the outer polymeric laminate includes a plurality of polymers each forming one or more sections along a length of the catheter shaft. System according to claim 2, characterized in that the durometer values of the sections decrelongitudinally towards a distal end of the catheter shaft. 4. System according to claim 1, characterized in that the outer polymeric laminated product further comprises a plurality of polymers. 5. System of conformity "with claim 4, characterized in that one or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymeric laminate product. according to claim 5, characterized in that the polymers with relatively lower durometer values form discrete regions of a distant end of the outer polymeric laminate and the polymers with relatively higher durometer values form discrete regions of a proximal end of the outer polymeric laminate, wherein the distant regions of the catheter shaft have a relatively greater degree of flexibility than the proximal regions of the catheter shaft 7. System according to claim 4, characterized in that the plurality of polymers includes six polymers. with claim 1, c characterized in that a distal end of the lumen of the catheter shaft forms an annular opening at a distal end of the catheter shaft. 9. System according to claim 8, characterized in that the annular opening comprises a polymer that forms a non-traumatic tip. 10. System according to claim 9, characterized in that the non-tumourous tip is an individual polymer having a tapered distance region. System according to claim 9, characterized in that the non-traumatic tip is an individual polymer having a rounded off region. 12. System according to claim 9, characterized in that the non-traumatic tip is comprised of an inner polymer and an outer polymer. 13. System according to claim 1, characterized in that the catheter shaft includes a fluoroscopic marker system. 14. System in accordance with the claim 13, characterized in that the fluoroscopic marker system includes a first marker region external to the braided tubular member. 15. System in accordance with the claim 14, characterized in that the fluoroscopic marker system includes a second internal marker region to the braided tubular member. 16. System according to claim 1, characterized in that it further comprises a sheath introducer that includes a member having a proximal end and a distal end and forming an individual lumen configured to follow on a guide wire, wherein the member is it is configured to be inserted into the catheter shaft, wherein a distal region of the limb extends beyond a distal end of the catheter shaft when the limb is fully inserted. 17. System according to claim 16, characterized in that the sheath introducer further comprises at least one hub at the proximal end, the hub is configured to be secured in a hub at a proximal end of the catheter shaft when the sheath introducer is fully inserted into the catheter shaft. System according to claim 16, characterized in that the sheath introducer further comprises a fluoroscopic marker system in a region remote from the member. 19. A catheter system, characterized in that it comprises: a catheter shaft including a braided tubular member, wherein at least one inner polymeric liner couples an inner surface of the braided tubular member, wherein at least one outer polymeric laminate product couples one outer surface of the braided tubular member, wherein the polymeric materials of the outer polymeric laminate product are interspersed through the braided tubular member and connected in the interstices of an outer surface of the inner polymeric liner, wherein the inner polymeric liner forms a lumen in the catheter tree; and an introducer including a member having a proximal end and a distal end forming an individual lumen configured to follow on a guide wire, wherein the member is configured to be inserted into the catheter shaft, wherein a region remote from the member extends beyond a distal end of the catheter shaft when the member is fully inserted. System according to claim 19, characterized in that the introducer further comprises at least one hub at the proximal end, the hub is configured to be secured in a hub at a proximal end of the catheter shaft when the inserter is fully inserted into the hub. catheter tree. System according to claim 19, characterized in that at least one of the catheter shaft and the introducer includes a fluoroscopic marker system in a region distant from the member. 22. System according to claim 19, characterized in that the outer polymeric laminated product further comprises a plurality of polymers. 23. System according to claim 22, characterized in that one or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymeric laminate. 24. System of compliance with the claim 23, characterized in that polymers with relatively smaller durometer values form discrete regions of a distant end of the outer polymeric laminate and polymers with relatively greater durometer values form discrete regions of a proximal end of the outer polymeric laminate, wherein the regions Distances of the catheter shaft have a relatively greater degree of flexibility than the proximal regions of the catheter shaft. 25. A catheter system, characterized in that it comprises: a sheath catheter comprising a catheter shaft with at least one lumen and ending to form an annular opening at a distal end of the catheter shaft; and an intravascular tissue expansion catheter, comprising: a catheter including a distal end and a longitudinal axis having at least one conduit extending along the longitudinal axis; a housing formed at the distal end of the catheter shaft wherein the housing includes at least one deflection member defined by a proximal end coupled pivotally to the catheter shaft and a free distant tip that moves through an arch away from the longitudinal shaft of the tree for expanding the vascular tissue, wherein at least one deviation member includes an integrally formed hinge, and a drive assembly positioned along the catheter shaft to move the distal tip of the at least one deviation member away of the longitudinal axis of the catheter shaft 26. System according to claim 25, characterized in that at least one deflection member includes one or more hinges 27. System according to claim 25, characterized in that the drive assembly includes a traction element coupled to at least one deflection member 28. System according to claim on 27, characterized in that at least one biasing member is connected to the housing with at least one hinge pin to form at least one hinge that supports the rotation of at least one biasing member when the pulling element is pulled in a relatively close direction . 29. System according to claim 25, characterized in that the durometer values of the materials forming the catheter shaft of the sheath catheter decrease longitudinally towards the distal end. 30. System according to claim 25, characterized in that the catheter shaft of the sheath catheter further comprises a braided tubular member, wherein at least one inner polymeric liner couples an inner surface of the braided tubular member, wherein at least one product The outer polymer laminate couples an outer surface of the braided tubular member, wherein the polymeric materials of the outer polymeric laminate product are interspersed through the braided tubular member and connected in the interstices of an outer surface of the inner polymeric liner. 31. System of compliance with the claim 30, characterized in that the outer polymeric laminate includes a plurality of polymers each forming one or more sections along a length of the catheter shaft 32. System in accordance with the claim 31, characterized in that one or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymeric laminate. 33. System according to claim 32, characterized in that polymers with relatively lower durometer values form discrete regions of a distant end of the outer polymeric laminate and polymers with relatively greater durometer values form discrete regions of a proximal end of the polymeric laminate external, wherein the discrete regions of the catheter shaft have a relatively greater degree of flexibility than the proximal regions of the catheter shaft. 34. System according to claim 25, characterized in that the annular opening comprises a polymer that forms a non-traumatic tip. 35. System according to claim 34, characterized in that the non-traumatic tip is an individual polymer having a tapered distal region. 36. System according to claim 34, characterized in that the non-traumatic tip is an individual polymer having a rounded distant region. 37. System according to claim 34, characterized in that the non-traumatic tip is comprised of an inner polymer and an outer polymer. 38. System in accordance with the claim 25, characterized in that the catheter shaft of the sheath catheter includes a fluoroscopic marker system. 39. System according to claim 38, characterized in that the fluoroscopic marker system includes at least one of a first marker region external to the braided tubular member and a second internal marker region to the braided tubular member .. 40. System according to claim 25, characterized in that it further comprises a sheath introducer including a member having a proximal end and a distal end and forming an individual lumen configured to follow on a guidewire, wherein the member is configured to be inserted into the catheter shaft of the guidewire. sheath catheter, wherein a distal region of the limb extends beyond a distal end of the catheter shaft when the member is fully inserted. 41. System according to claim 40, characterized in that the sheath introducer further comprises at least one hub at the proximal end, the hub is configured to be secured in a hub at the proximal end of the catheter shaft of the sheath catheter when completely insert the sheath introducer into the catheter shaft. 42. System according to claim 40, characterized in that the sheath introducer further comprises a fluoroscopic marker system in a region distant from the member. 43. Method for crossing an occlusion, characterized in that it comprises: mounting a catheter system by loading a blunt-ended dissecting catheter into a sheath catheter; advancing the catheter system to a vascular site and placing at least one extension member of the blunt-ended dissection catheter adjacent to the occlusion; applying a fracture force to the tissue of the blood vessel and occlusion by moving a distal end of the at least one extending member laterally away from a longitudinal center line of the blunt-ended dissecting catheter by deflecting a distal end of the spreader member about one end proximal of the extending member in response to an expanding force, destabilizing the occlusion material and generating a route through the destabilized material in response to the applied fracturing force; and advancing at least one of the blunt-ended dissecting catheter and sheath catheter through the occlusion material using the path generated so that at least one of the blunt-ended dissection catheter and sheath catheter crosses through of the occlusion material and the occlusion material remains external to the catheter system. 44. Method of compliance with claim 43, characterized in that it further comprises advancing the sheath catheter beyond the occlusion before removing the dissecting catheter of blunt ends of the blood vessel. 45. Method according to claim 43, characterized in that it further comprises advancing the guidewire through the displaced occlusion using the sheath catheter after removing the blunt-ended dissecting catheter and before removing the sheath catheter. 46. Method according to claim 43, characterized in that it further comprises selecting and advancing a guidewire through the vascular occlusion within the blood vessel. 47. Method according to claim 43, characterized in that it further comprises advancing the sheath catheter beyond the occlusion before removing the blunt-ended dissecting catheter and before advancing a guidewire through the sheath catheter. 48. Method according to claim 43, characterized in that it further comprises advancing a guidewire through the occlusion using the sheath catheter after advancing the sheath catheter beyond the occlusion 49. Method for adjusting an occlusion, characterized in that it comprises: advancing a first guide wire within a blood vessel from the vasculature to the occlusion; mount a catheter system by loading a sheath introducer into a sheath catheter; advancing the catheter system in the first guidewire so that a distal end of the system is in proximity to the occlusion; remove the first guidewire and sheath introducer from the vasculature; advancing a blunt-ended dissecting catheter through the sheath catheter to place at least one spreading member of the blunt-ended dissecting catheter adjacent to the occlusion; applying a fracturing force to the tissue of the blood vessel and occlusion by moving a distal end of the extending member laterally away from a longitudinal center line of the blunt-ended dissecting catheter by deflecting a distal end of the extending member about a proximal end of the limb. spreader in response to an extension force; destabilize the material of the occlusion and generate a route through the destabilized material in response to the applied fracturing force; and advancing at least one of the blunt-ended dissecting catheter and sheath catheter through the occlusion material using the generated pathway so that at least one of the blunt-ended dissecting catheter and sheath catheter crosses through of the occlusion material and the occlusion material remains external to the catheter system. 50. Method according to claim 49, characterized in that it further comprises advancing the sheath catheter beyond the occlusion before removing the dissecting catheter of blunt ends of the blood vessel. 51. Method according to claim 49, characterized in that it further comprises advancing a second guidewire through the displaced occlusion using the sheath catheter after removing the blunt-ended dissecting catheter and before removing the sheath catheter. 52. Method according to claim 49, characterized in that it further comprises selecting and advancing a second guidewire through the vascular occlusion within the blood vessel. 53. Method of compliance with claim 49, characterized in that it further comprises advancing the sheath catheter beyond the occlusion before removing the blunt-ended dissecting catheter and before advancing a second guide wire through the catheter. sheath. 54. Method according to claim 49, characterized in that it further comprises advancing a second guidewire through the occlusion using the sheath catheter after advancing the sheath catheter beyond the occlusion.