Modified fixed flat wire bifurcated catheter and its application in lower extremity interventions

Information

  • Patent Grant
  • 10857014
  • Patent Number
    10,857,014
  • Date Filed
    Wednesday, November 7, 2018
    6 years ago
  • Date Issued
    Tuesday, December 8, 2020
    3 years ago
Abstract
A bifurcated catheter and methods of use are disclosed herein. The bifurcated catheter can include a fixed flat wire that is configurable as a stabilization wire. The bifurcated catheter can be configured to improve the initial access and directability by application of a pull force to the stabilization wire, in addition to a push force from the proximal end of the bifurcated catheter. The stabilization wire is anchored once the bifurcated catheter is positioned. The anchored, bifurcated catheter provides stability and pushability to assist the procedural catheter in traversing the tortuous peripheral vasculature.
Description
TECHNICAL FIELD

The present disclosure relates to improved methods and apparatuses for traversing a tortuous vasculature. Specifically, the present disclosure relates to providing support to procedural catheters during lower extremity intervention procedures to traverse the procedural site through the tortuous access vessels.


BACKGROUND

Technology associated with interventional procedures is ever developing, particularly in the areas of stenting and balloon angioplasty of Interventional procedures are typically challenging, as accessing various regions of the artery can be dependent on the anatomical disposition of the access location. Specifically, accessing regions of a tortuous peripheral arteries and performing interventional procedures in a hostile anatomy can be very difficult. Furthermore, the subsequent removal of blockages and placement of a stent delivery system into aorto femoral arteries becomes more difficult, or in some instances impossible. The interventional procedure may also be difficult for the popliteal and tibial arteries. The stenting procedure is meant to re-establish a more normalized blood flow through these tortuous arteries by opening up regions constricted by plaque or embolic deposits, which inhibit blood flow.


Although the stent delivery systems are designed to accommodate very acute bends, they are reliant upon guide catheters, guide wires and/or embolic protection devices during deployment. When long delivery systems in tortuous arteries the pushability of catheters and guide wires become critical. As a result, the rigid or stiff catheters and guide wires are needed to manipulate the tortuous entry. With these type of rigid devices, injuries to the tortuous arteries and access vessels often occur during the insertion, manipulation and stabilization of the stent delivery mechanism. Injuries to the tortuous arteries and access vessels often occur during removal of the guide wires, secondary equipment and wires as well. Specifically, the injuries can be caused by puncturing or cutting into the arterial walls resulting in dissections and trauma to the vessels involved. These traumas can be dangerous to the patient as they can ultimately affect blood flow by leakage at the dissections. In some instances, the traumas can create accumulation of thrombus. Dissections and the accumulation of thrombus can require additional procedures to repair and heal the damaged artery walls.


In view of the foregoing, there exists a need to provide a simplified procedure that reduces the injuries caused to the arterial walls during lower extremity interventions. Furthermore, there exists a need for a usable sheath and catheter stabilization system that enable the use of softer catheters and less stiff guide wires for the treatment of lower extremities.





BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited disclosure and its advantages and features can be obtained, a more particular description of the principles described above will be rendered by reference to specific examples illustrated in the appended drawings. These drawings depict only example aspects of the disclosure, and are therefore not to be considered as limiting of its scope. These principles are described and explained with additional specificity and detail through the use of the following drawings.



FIG. 1 illustrates tortuous arteries of the lower extremities, in accordance with one embodiment of the disclosure.



FIG. 2 illustrates the difficulty of access by pushing a sheath from a contralateral percutaneous access at point “X” to the location of a procedure at point Y.



FIG. 3 illustrates the distal end of a fixed flat wire bifurcated catheter in accordance with an embodiment of the disclosure.



FIG. 4 illustrates the process of establishing a contralateral percutaneous femoral access for the main access sheath and an ipsilateral percutaneous femoral access for the snare access sheath while in accordance with an embodiment of the disclosure.



FIG. 5 illustrates the process of inserting a snare catheter and extending a snare wire having a snare at its distal end to the aortic bifurcation through the ipsilateral access, in accordance with an embodiment of the disclosure.



FIG. 6 illustrates the process of inserting the fixed flat stabilization wire bifurcated catheter through the main access sheath from the contralateral access to the aortic bifurcation where the stabilization wire extension is captured by the snare, in accordance with an embodiment of the disclosure.



FIG. 7 illustrates the process of pulling the bifurcated catheter down the ipsilateral iliac artery while providing a push force on the proximal end of the bifurcated catheter from the contralateral access, in accordance with an embodiment of the disclosure.



FIG. 8 illustrates the process of pulling the bifurcated catheter into the ipsilateral femoral artery with the stabilization wire externalized and anchored to provide end to end stabilization for the procedural lumen, in accordance with an embodiment of the disclosure.



FIG. 9 illustrates a process for providing stability, tension and pushability of the bifurcated catheter, in accordance with an embodiment of the disclosure.





DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The present disclosure is described with reference to the attached figures, where like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not drawn to scale, and they are provided merely to illustrate the instant disclosure. Several aspects of the disclosure are described below with reference to example applications for illustration. It should be understood that numerous specific details, relationships, and methods are set forth to provide a full understanding of the disclosure. One having ordinary skill in the relevant art, however, will readily recognize that the disclosure can be practiced without one or more of the specific details, or with other methods. In other instances, well-known structures or operations are not shown in detail to avoid obscuring the disclosure. The present disclosure is not limited by the illustrated ordering of acts or events, as some acts may occur in different orders and/or concurrently with other acts or events. Furthermore, not all illustrated acts or events are required to implement a methodology in accordance with the present disclosure.


The present disclosure provides a system and method for providing access to tortuous arteries to perform lower extremity interventions. The present disclosure is directed towards employing a flat fixed wire bifurcated catheter. The flat fixed wire bifurcated catheter can include a flat wire fixed along the length of the bifurcated catheter from its proximal end to the bifurcation. The flat wire can convert to a normal round stabilization wire as it emerges from a side hole at the bifurcation end of the bifurcated catheter to extend for an additional length beyond the bifurcation. The distal end of the bifurcated catheter can be configured to have a dual lumen (e.g., a large procedural lumen and a small stabilization lumen) from which the flat wire emerges. Alternatively, the distal end of the bifurcated catheter can be configured to have a procedural lumen and a side hole for the stabilization wire.


A small sheath can be provided to enable percutaneous access for the distal end of the support wire. A push and pull force can be applied to the bifurcated catheter using the stabilization wire to enable the bifurcated catheter to traverse the tortuous vessels. This process allows the bifurcated catheter to be positioned in either the common femoral artery or the proximal superficial femoral artery. Furthermore, the stabilization wire can be locked at the accesses to apply tension and stabilization to the procedural lumen.


It should be understood by one of ordinary skill in the art, that the disclosed apparatus can be implemented in any type of lower extremity peripheral arterial intervention. In addition, the apparatus can also be implemented for intervention within the internal iliac artery vascular distribution (e.g., uterine artery embolization, prostate artery embolization, proximal internal iliac artery embolization prior to endovascular common iliac artery aneurysm repair, etc.). As disclosure herein, the disclosed system and method can reduce injury to the vessels within the arteries, reduce trauma caused during the intervention procedure, and improve the procedural success rate. The disclosed system and method can also improve navigation speed through difficult anatomy and enhance stability.



FIG. 1 illustrates an exemplary tortuous vessel artery 100, in accordance with an embodiment of the disclosure. The tortuous vessel artery 100 can include an abdominal aortic bifurcation with tortuous branch arteries. The tortuous branch arteries can include a right renal artery 101b and a left renal artery 101a extending from an abdominal aorta 102. The abdominal aorta 102 can be parted at an aortic bifurcation 115, and connected to arteries of the lower limbs. The arteries of the lower limbs can include a right common iliac 103 and a left common iliac 104. The left common iliac 104 can be split into a left external iliac 106 and a left internal iliac 112a. The left external iliac 106 can be connected to a left common femoral 108, and further split into a left deep femoral 113a, and a left superficial femoral 110.


The right common iliac 103 can be split into a right external iliac 105 and a right internal iliac 112b. The right external iliac 105 can be connected to a right common femoral 107, which splits into a right deep femoral 113b and a right superficial femoral 109. FIG. 1 illustrates the tortuous nature of the peripheral arteries.


When performing interventions within the tortuous vessel artery 100, it is common to encounter difficulties associated with pushability and torque. As the catheters and wires are guided over a highly angulated aortic bifurcation 115 or through the extremely tortuous common iliac arteries 103 and 104, it can be extremely difficult to apply torque. Furthermore, these arteries can contain calcific plaques or other obstructions which can add anatomic and technical challenges with traversing the tortuous vessel artery 100.



FIG. 2 illustrates a tortuous anatomical pathway 200 from the percutaneous access within the common femoral artery to a potential procedure location on the ipsilateral side, in accordance with an embodiment of the disclosure. In some embodiments, interventional devices such as wires and catheters are pushed from the contralateral access at point ‘X’ to the treatment site ‘Y’. The devices would need to travel through the general pathways 1 through 9. Due to the multi directional twists and turns along the pathways 1 through 9, the devices can suffer from a significant loss of performance such as torque and pushability. While FIG. 2 illustrates the tortuous anatomical pathway 200 in a two-dimensional format, the tortuousity of the anatomical pathway 200 is often significantly more severe, as illustrated in FIG. 1.



FIG. 3 illustrates a bifurcated catheter 300, in accordance with an embodiment of the disclosure. The bifurcated catheter 300 includes a bifurcated sheath 301 and a fixed flat-wire 302. The fixed flat wire 302 can be configured to bifurcate from a bifurcated sheath 301 of the bifurcated catheter 300. The fixed flat wire 302 can bifurcate close to a distal end of the bifurcated catheter 300. In some embodiments, the fixed flat wire 302 can be attached to, or integrated within, the main lumen 303 of the bifurcated catheter 300. This is discussed in greater detail below.


The bifurcated catheter has a proximal end (not shown) and a distal end. In some embodiments, as shown in FIG. 3, the distal end includes a side hole 305 for a stabilization wire 306. The stabilization wire 306 can be an extension of the fixed flat wire 302. Furthermore, the stabilization wire 306 can be attached to or embedded within a wall of the bifurcated sheath 301 of the bifurcated catheter 300. The stabilization wire 306, can extend from the proximal end (not shown) to the side hole 305 at the distal end of the bifurcated catheter 300.


For the purpose of this embodiment, the procedural lumen is illustrated as the main lumen 303 at the distal end of the bifurcated catheter 300. A stabilization wire 306 is also illustrated. In some embodiments, the stabilization wire 306 can be round. In alternative embodiments, the stabilization wire can take on various shapes, including, for example square, oval, hollow, etc., as required for the application of the bifurcated catheter 300. For the purpose of this disclosure, the shape of the stabilization wire 306 exiting from the side hole 305 should not be considered limiting. In some embodiments of the disclosure, the bifurcated catheter 300 includes two lumens (not shown): the procedural lumen 303 and a smaller stabilization lumen (not shown) which has the fixed flat wire 302.


In some embodiments, both lumens span almost the entire length of the bifurcated catheter 300 and bifurcate at the distal end into two independent lumens. In an alternative embodiment, the fixed flat wire 302 can be attached to or embedded into an inner side wall of the stabilization lumen. In some embodiments, the bifurcated catheter 300 bifurcate into two catheters (not shown) close to the distal end of the bifurcated catheter 300. In some embodiments, the two catheters formed at the bifurcation can be configured as a larger, procedural catheter and a smaller, stabilization catheter. In such embodiments, the larger, procedural catheter can include a large lumen, which is a continuation of the procedural lumen 303. The second smaller catheter can include a smaller stabilization lumen configured to carry the stabilization wire.


In some embodiments the bifurcated catheter 300 can include a radio opaque band 304 at its distal end. The radio opaque band 304 can be implemented to track the distal end of the bifurcated catheter 300 as it is advanced through the arteries of FIG. 1. The procedural lumen 303 can extend from its proximal end to its distal end within the bifurcated sheath 301. The stabilization wire 306 can be configured to protrude from the bifurcated catheter 300 at the side hole 305 as an extension of the fixed flat wire 302. In some embodiments, the stabilization wire 306 can extend beyond the end of the bifurcated catheter 300. Typically, such extension can be as much as 6 to 10 cm or more.


As indicated above, the stabilization wire 306 can be a flat wire, a round wire or a wire of any suitable cross-sectional shape. Additionally, the stabilization wire 306 may be sold or hollow. The fixed flat wire 302 and the stabilization wire 306 can be fabricated using commonly known materials in the art including, for example, stainless steel, nickel titanium, composites, metal reinforced polymer, polymer, a combination thereof, or the like.



FIGS. 4 to 8 illustrate an exemplary process for lower extremity intervention implemented using the bifurcated catheter 300 of FIG. 3. While the reference numbers are not always repeated on all the figures to make the figures more readable, the reference numbers are used consistently across all these figures and their descriptions.


The lower extremity intervention can include, for example, an aorto-bifemoral bypass or a tortuous aortoiliac artery treatment. Furthermore, FIGS. 4 to 8 illustrate the process of providing end-to-end stability and improved accessibility to any additional procedural catheter and instruments introduced through the procedural lumen 303 of the bifurcated catheter 300.



FIG. 4 illustrates a diagram 400 where a percutaneous contralateral femoral access 402 is introduced into the right common femoral artery 107. The percutaneous contralateral femoral access 402 can be implemented to introduce a main access sheath 401 into the right common femoral artery 107. The main access sheath 401 can be configured as a 7 Fr. vascular sheath. The main access sheath 401 can be advanced through the right external 105 and right common iliac 103 to the aortic bifurcation 115. The main access sheath 401 can be tracked using a radio opaque band 304 as the main access sheath 401 is advanced to the aortic bifurcation 115. FIG. 4 also illustrates the introduction of a percutaneous ipsilateral femoral access 404 into the left common femoral artery 108. The percutaneous ipsilateral femoral access 404 is introduced for a snare access sheath 403 of a 4 Fr. internal lumen.



FIG. 5 illustrates a process for introducing a snare catheter and extending a snare wire to an aortic bifurcation, in accordance with an embodiment of the disclosure. Once the main access sheaths 401 and 403 are in place, a 4 Fr snare sheath 504 and snare wire 506 are introduced through the retrograde snare access sheath 403. In some embodiments, the snare wire 506 includes a snare 505 at its distal end extending to the aortic bifurcation 115. The snare 505 can be 20 to 30 mm (or smaller) in diameter. In some embodiments, the fixed flat wire bifurcated catheter 300 includes a dilator 503 in the main sheath. The fixed flat wire bifurcated catheter 300 and the stabilization wire 306 are introduced through the main access sheath 401. The main access sheath 401 includes the distal end, the tip of the main access sheath aligned to the aortic bifurcation 115. FIG. 5 further illustrates the fixed flat wire bifurcated catheter 300 having a bifurcated sheath 301 and the stabilization wire 306 being pushed through the distal end of the main access sheath 401. The stabilization wire 306 is extended out of the distal end of the main sheath 401 to enable it to be captured by the snare 505 at the distal end of the snare wire 506.



FIG. 6 illustrates an exemplary process of capturing the stabilization wire 302 by the snare 505 at the end of the snare wire 506, where the stabilization wire 302 extends from the sheath 504 inserted through the access sheath 403 and inserted via the ipsilateral percutaneous access 404. The stabilization wire 306 can be tightened to a snare knot 601. This allows a pull force 703 to be applied to the distal end of the bifurcated catheter 300 from the ipsilateral femoral access 404. The pull force 703 can be applied through the snare catheter 504 and the snare wire 506, which has snared the stabilization wire 306. A push force 701 can also be applied on the proximal end of the bifurcated catheter 300 from the contralateral femoral access 402. The push force 701 and the pull force 703 can be applied simultaneously. The push force 701 and the pull force 703 are used to guide the distal end of the bifurcated catheter 300 with the dilator tip 503 over the aortic bifurcation and down the ipsilateral left iliac arteries 104 and 106.



FIG. 7 illustrates a process for advancing the bifurcated catheter 300 into the ipsilateral iliac artery, in accordance with one embodiment of the disclosure. Once guided over the aortic bifurcation and down the ipsilateral left iliac arteries 104 and 106, the bifurcated catheter 300 can be guided to the left common femoral artery 108. The snare wire 506, encompassing the snared stabilization wire 306, can be pulled out of the ipsilateral snare access sheath 403 and anchored outside ipsilateral access 404, and outside the body of the patient.



FIG. 8 illustrates an exemplary process for advancing the bifurcated catheter into the ipsilateral femoral artery while externalizing the stabilization wire 306 and subsequently anchoring it, using a wire lock 801. The bifurcated catheter 300 can be pulled by the snare wire 506, using the snared stabilization wire 306, from the ipsilateral access 404. Simultaneously, the bifurcated catheter can be pushed from the contralateral femoral access 402 to guide the bifurcated sheath down the left common femoral artery 108. The side hole 305 with the stabilization wire 306 of the bifurcated catheter 300 can be positioned at the ipsilateral access 404 by applying the push force 701 to the proximal end of the bifurcated catheter and the pull force to the distal end of the bifurcated catheter 300. The pull force can be applied through the snared stabilization wire 306, snared by the snare wire 506 from the ipsilateral femoral access 404. This push-pull capability can also be used to guide the bifurcated sheath 301 and any procedural catheters within the main procedural lumen 303 of the bifurcated catheter 300 down the narrow and tortuous branches of the femoral artery. For example, the bifurcated sheath 301 can be guided through the superficial femoral artery 110, where the procedure is performed. The snare wire 306 can be externalized and locked external to the snare access sheath 403. At this point it is possible to lock the bifurcated catheter 300 at its proximal end outside the main access sheath 401. The stabilization wire 306 can also be locked at or outside the snare access sheath 403 using a wire lock 801. By locking the stabilization wire 306 outside the snare access sheath 403, locking the bifurcated sheath with the fixed flat wire outside the main access sheath 401 and providing a pull force on the distal end of the bifurcated catheter, a tension can be applied via the bifurcated catheter 300 to any procedural catheter or instruments introduced through the main procedural lumen 303 of the bifurcated catheter 300. This tension can provide stabilization to the main procedural lumen 303 of the bifurcated catheter 300. Any procedural catheters and instruments within the main procedural lumen 303 can also be stabilized using this system and method. Anchoring and locking the stabilization wire can cause bifurcation of the bifurcated catheter at the snare access sheath. This bifurcation can provide an anchor point for procedural catheters and instruments introduced via the procedural lumen 303 of the bifurcated catheter improved pushability and improved accessibility to the procedural sites.


By externalizing the stabilization wire outside the ipsilateral femoral access and fixing the flat wire to the bifurcated catheter 300 outside the contralateral femoral access allow a push/pull force to be applied on the bifurcated catheter 300 and any procedural catheters or instruments inserted through the bifurcated catheter. This push/pull force provides a see-saw motion of the bifurcated catheter 300. This motion can make enable safe and efficient access into tortuous lower extremities of the vasculature, particularly access below the knees of a patient.



FIG. 9 illustrates an exemplary process 900 for providing stability, tension and pushability of the bifurcated catheter of FIG. 3, for procedures within the left superficial femoral artery.


At step 901, a small lumen snare access sheath is inserted into the left common femoral artery to provide an ipsilateral retrograde access. A snare catheter is inserted through the snare access sheath with a snare wire. The snare catheter can be 4 Fr or smaller. The snare wire can have a 20-30 mm snare at its distal end. In some embodiments, the snare wire can have a snare less than 20 mm at its distal end. The snare wire can be guided to the aortic bifurcation.


At step 902, a main access sheath is used to establish a contralateral retrograde access at the right common femoral artery location. The main access sheath can be a 7 Fr. lumen or larger. A large sheath catheter is advanced up the right femoral artery and the iliac arteries towards the aortic bifurcation. The large sheath catheter can be guided using radiographic imaging. The large sheath catheter can be 7 Fr.


At step 903, a modified bifurcated catheter can be inserted into the main sheath and guided to the aortic bifurcation. The modified bifurcated catheter has a fixed flat wire secured within the main lumen of the bifurcated catheter, from its proximal end to the bifurcation. An extension of the flat wire emerges through a side exit hole at the bifurcation. The extension is the stabilization wire. The side exit hole at the bifurcation can be between 2-4 cm prior to the distal end of the bifurcated catheter. In some embodiments, the stabilization wire can have a length of 6 to 13 cm beyond the side exit hole. In alternative embodiments, the stabilization wire can be extended beyond 13 cm from the side exit hole.


At step 904 the stabilization wire, extending from the side exit hole, is captured by the snare at the distal end of the snare wire. The snare typically captures the stabilization wire at the aortic bifurcation. The snare is tightened to secure the stabilization wire and apply a pull pressure on it.


At step 905 a reverse curve catheter can be inserted through the main lumen of the bifurcated catheter to access the left common iliac artery. The reverse curve catheter can assist in transitioning the bifurcated catheter from the contralateral right common iliac artery to the ipsilateral left common iliac artery over the aortic bifurcation.


At step 906, an external pull force can be applied on the snare wire with the stabilization wire snared, while a push force is applied to the proximal end of the bifurcated catheter 300. The procedural lumen 300 and the bifurcated catheter 300 are able to be pulled and pushed over the reverse curve catheter into the contralateral common left iliac artery.


At step 907 a push force is applied on the bifurcated catheter at its proximal end to assist advance the bifurcated catheter past sharp corners and reduce tension on the catheter as it is pulled by the stabilization wire. The combination of the push and pull force enable the bifurcated catheter to easily overcome obstructions as it traverses down the tortuous curves of the left femoral vessels. The combination of push and pull forces also help to reduce the tension on the bifurcated catheter and increase access while reducing the trauma to the vessels.


At step 908 the bifurcated sheath is simultaneously pulled and pushed down the ipsilateral left side vasculature, until the side exit hole of the stabilization wire is at the ipsilateral snare access sheath location. The stabilization wire is externalized by pulling the snare wire out of the access sheath through the ipsilateral access.


At step 909 the externalized stabilization wire is anchored by locking it in place at the ipsilateral access by a wire lock. The modified bifurcated catheter is anchored at the distal end of the bifurcation.


At step 910, a tension is applied to the fixed Flat wire at the proximal end of the bifurcated catheter. The tension is applied at the contralateral access with the stabilization wire. The stabilization wire can be locked in place at the distal end. An end-to-end application of tension can be applied to provide stability to the bifurcated catheter. This stability increases pushability of any procedural catheters within its main procedural lumen.


At step 911 any optional reverse curve catheter can be removed. Furthermore, any dilator used to reduce trauma to vessels can also be removed from the bifurcated catheter.


At step 912 the bifurcated catheter is configured to accept the procedural catheters and instruments for procedure, through its main lumen. Stabilization and tension can be provided by the locked stabilization wire at the distal end of the bifurcation and the fixed flat wire. The bifurcated catheter is configured for interventional procedures (stents, atherectomy, etc.) within the left peripheral vasculature. The process 900 is terminated after step 912.


The examples provided herein are directed towards specific examples. One of ordinary skill in the art would understand the provided examples are not intended to be exhaustive. There exists other exemplary access and stabilization of a procedural catheter or sheath. As is well understood, the preferred method will vary based on the location of the procedure and the physical condition of the patient.


As is well understood by those familiar with the art, the disclosure may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Likewise, the naming and division of the members, features, attributes, and other aspects are not mandatory or significant, and the mechanisms that implement the disclosure or its features may have different structural construct, names, and divisions. Accordingly, the disclosure of the disclosure is intended to be illustrative, but not limiting, of the scope of the disclosure.


The embodiments disclosed herein can be implemented as hardware, firmware, software, or any combination thereof. Moreover, the software is preferably implemented as an application program tangibly embodied on a program storage unit or computer readable medium. The application program may be uploaded to, and executed by, a machine comprising any suitable architecture.

Claims
  • 1. A system for performing a lower extremity intervention procedure, the system comprising: a bifurcated catheter configured to be inserted through a first percutaneous access in a lower extremity vasculature, the bifurcated catheter comprising a proximal end and a distal end, wherein the distal end of the bifurcated catheter comprises a bifurcation, and wherein the bifurcated catheter further comprises at least one lumen that extends from the proximal end to the distal end of the bifurcated catheter, and wherein the bifurcated catheter further comprises a side hole; anda flat wire attached within the at least one lumen of the bifurcated catheter, wherein the flat wire is attached to an inner wall of the at least one lumen of the bifurcated catheter from the proximal end to the bifurcation at the distal end;wherein the flat wire is configured to emerge from the side hole and exit a second percutaneous access in a lower extremity vasculature and configured to function as a stabilization wire by the application of an end to end tension to the flat wire.
  • 2. The system of claim 1, wherein the bifurcation is at least 2 cm from the distal end of the bifurcated catheter.
  • 3. The system of claim 1, wherein the flat wire is configured to extend for a length up to 10 cm beyond the bifurcation.
  • 4. The system of claim 1, wherein the bifurcated catheter further comprises a procedural lumen and a stabilization lumen, wherein the stabilization lumen is smaller than the procedural lumen.
  • 5. The system of claim 4, wherein the side hole is in the stabilization lumen.
  • 6. The system of claim 4, wherein the side hole is in the procedural lumen.
  • 7. The system of claim 4, wherein the flat wire is configured to apply tension and stabilization to the procedural lumen for access to a location of the lower extremity intervention procedure.
  • 8. The system of claim 1, further comprising an access sheath configured to provide a percutaneous ipsilateral femoral artery access for a distal end of the flat wire to exit a patient.
  • 9. The system of claim 8, wherein the second percutaneous access is an ipsilateral percutaneous femoral artery access and wherein the first percutaneous access is a contralateral percutaneous femoral artery access, wherein a proximal end of the bifurcated catheter is configured to receive a push force to advance the bifurcated catheter through a tortuous peripheral vasculature to the location of the lower extremity intervention procedure.
  • 10. The system of claim 1, wherein the bifurcated catheter is configured to receive a pull force to its distal end from the flat wire and a push force from its proximal end at a contralateral access to advance the bifurcated catheter through tortuous vessels to a site of the lower extremity intervention procedure.
  • 11. A method for performing a lower extremity intervention procedure in a femoral artery of a patient, the method comprising: establishing a first percutaneous ipsilateral femoral artery access for a snare access sheath into an ipsilateral femoral artery of a patient to enable an ipsilateral retrograde access for a snare catheter;inserting the snare catheter through the snare access sheath, the snare catheter comprising a snare wire having a proximal end and a distal end, the distal end of the snare wire comprising a snare, wherein the proximal end of the snare wire extends out of the percutaneous ipsilateral femoral artery access, and wherein the snare at the distal end of the snare wire is guided to an aortic bifurcation, using radiographic imaging;establishing a percutaneous contralateral femoral artery access for a main access sheath into a contralateral femoral artery to enable a contralateral retrograde access;advancing the main access sheath through the contralateral retrograde femoral access into the contralateral femoral artery and guiding the main access sheath to the aortic bifurcation, using the radiographic imaging;inserting a bifurcated catheter into the main access sheath and guiding a distal end of the bifurcated catheter to the aortic bifurcation; wherein the bifurcated catheter comprises a proximal end and a distal end, wherein the distal end comprises a bifurcation and a side hole at the bifurcation, wherein the bifurcated catheter further comprises a flat wire attached to a lumen of the bifurcated catheter, wherein the flat wire is affixed to the lumen of the bifurcated catheter from the proximal end to the bifurcation at the distal end, wherein the flat wire exits the side hole of the bifurcated catheter;capturing a distal end of the flat wire by the snare at the distal end of the snare wire;applying a pull force on the proximal end of the snare catheter and the snare wire external to the percutaneous ipsilateral femoral artery access, which applies a pull force on the bifurcated catheter via the flat wire;applying a push force, while applying the pull force, to the proximal end of the bifurcated catheter external to the contralateral femoral access, thereby moving the bifurcated catheter over the aortic bifurcation;further applying the pull force and the push force simultaneously on the bifurcated catheter to enable the bifurcated catheter to move to the ipsilateral femoral artery over sharp corners, bends and partial blockages while reducing tension on the bifurcated catheter;simultaneously pulling and pushing the bifurcated catheter until the side hole of the bifurcated catheter is at the ipsilateral snare access sheath;pulling the snare catheter and the snare wire such that the flat wire extends out of the percutaneous ipsilateral femoral artery access through the snare access sheath;anchoring the flat wire by locking the flat wire in place external to the ipsilateral snare access sheath using a wire lock, thereby anchoring the bifurcated catheter at the snare access sheath; andapplying tension to the fixed wire at the proximal end of the bifurcated catheter, at the percutaneous contralateral femoral artery access, wherein the applied tension allows an end-to-end application of tension and stability to the bifurcated catheter, wherein the stability of the bifurcated catheter increases a stability and a pushability of a procedural catheters or instruments within the procedural lumen of the bifurcated catheter for access to a location of a lower extremity intervention procedure.
  • 12. The method of claim 11, further comprising using a dilator during the access of the procedural catheter to the location and removing the dilator prior to the lower extremity intervention procedure.
  • 13. The method of claim 11, wherein the bifurcated catheter is configured to accept procedural catheters and instruments for procedure, through its procedural lumen, with stabilization and tension.
  • 14. The method of claim 11, wherein the bifurcated catheter is configured for interventional procedures within an ipsilateral vasculature.
  • 15. The method of claim 11, wherein flat wire enables a sea-saw movement of the bifurcated catheter, enabling access to a location of the procedure below the bifurcation of the bifurcated catheter through tortuous vasculature.
  • 16. The method of claim 11, wherein using a combination of push and pull forces that are applied on the bifurcated catheter via the flat wire reduce tension on the bifurcated catheter and increased ease of access while reducing the trauma to vessels within the femoral artery of a patient during access to the location of the lower extremity intervention procedure.
CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 62/631,904, entitled “MODIFIED FIXED FLAT WIRE BIFURCATED CATHETER AND ITS APPLICATION IN AORTO BIFEMORAL BYPASS,” and filed on Feb. 18, 2018. The contents of that application are hereby incorporated by reference in their entirety.

US Referenced Citations (204)
Number Name Date Kind
3896815 Fettel Jul 1975 A
4243040 Beecher Jan 1981 A
4790331 Okada et al. Dec 1988 A
5098707 Baldwin et al. Mar 1992 A
5293772 Carr, Jr. Mar 1994 A
5344426 Lau et al. Sep 1994 A
5419777 Hofling May 1995 A
5433705 Giebel et al. Jul 1995 A
5571135 Fraser et al. Nov 1996 A
5651366 Liang et al. Jul 1997 A
5662703 Yurek et al. Sep 1997 A
5669924 Shaknovich Sep 1997 A
5690644 Yurek et al. Nov 1997 A
5718702 Edwards Feb 1998 A
5720735 Dorros Feb 1998 A
5766192 Zacca Jun 1998 A
5807330 Teitelbaum Sep 1998 A
5813976 Filipi et al. Sep 1998 A
5824055 Spiridigliozzi Oct 1998 A
5957901 Mottola et al. Sep 1999 A
5997563 Kretzers Dec 1999 A
6027462 Greene et al. Feb 2000 A
6059813 Vrba et al. May 2000 A
6070589 Keith et al. Jun 2000 A
6152141 Stevens et al. Nov 2000 A
6238410 Vrba et al. May 2001 B1
6245017 Hashimoto Jun 2001 B1
6245573 Spillert Jun 2001 B1
6428567 Wilson et al. Aug 2002 B2
6450964 Webler Sep 2002 B1
6464665 Heuser Oct 2002 B1
6494875 Mauch Dec 2002 B1
6544278 Vrba et al. Apr 2003 B1
6663613 Lewis et al. Dec 2003 B1
6764505 Hossainy et al. Jul 2004 B1
6780174 Mauch Aug 2004 B2
6808520 Fouirkas et al. Oct 2004 B1
6837881 Barbut Jan 2005 B1
6929633 Evans et al. Aug 2005 B2
6932829 Majercak Aug 2005 B2
6942682 Vrba et al. Sep 2005 B2
7235083 Perez et al. Jun 2007 B1
7393358 Malewicz Jul 2008 B2
7651520 Fischell et al. Jan 2010 B2
7674493 Hossainy et al. Mar 2010 B2
7740791 Kleine et al. Jun 2010 B2
7758624 Dorn et al. Jul 2010 B2
7763010 Evans et al. Jul 2010 B2
7766961 Patel et al. Aug 2010 B2
7828832 Belluche et al. Nov 2010 B2
7842026 Cahill et al. Nov 2010 B2
7955370 Gunderson Jun 2011 B2
8092509 Dorn et al. Jan 2012 B2
8119184 Hossainy et al. Feb 2012 B2
8202309 Styrc Jun 2012 B2
8241241 Evans et al. Aug 2012 B2
8343181 Duffy et al. Jan 2013 B2
8419767 Al-Qbandi et al. Apr 2013 B2
8535290 Evans et al. Sep 2013 B2
8721714 Kelley May 2014 B2
8727988 Flaherty et al. May 2014 B2
8728144 Fearnot May 2014 B2
8740971 Iannelli Jun 2014 B2
8986241 Evans et al. Mar 2015 B2
8998894 Mauch et al. Apr 2015 B2
9301830 Heuser et al. Apr 2016 B2
9314499 Wang et al. Apr 2016 B2
9636244 Syed May 2017 B2
9855705 Wang et al. Jan 2018 B2
9980838 Syed May 2018 B2
20010003985 Lafontaine et al. Jun 2001 A1
20010049534 Lachat Dec 2001 A1
20020077691 Nachtigall Jun 2002 A1
20020123698 Garibotto et al. Sep 2002 A1
20020156518 Tehrani Oct 2002 A1
20020165535 Lesh Nov 2002 A1
20030088187 Saadat et al. May 2003 A1
20030204171 Kucharczyk Oct 2003 A1
20030216721 Diederich Nov 2003 A1
20030229282 Burdette Dec 2003 A1
20040002714 Weiss Jan 2004 A1
20040073190 Deem et al. Apr 2004 A1
20040087995 Copa et al. May 2004 A1
20040138734 Chobotov et al. Jul 2004 A1
20040147837 MacAulay et al. Jul 2004 A1
20040167463 Zawacki Aug 2004 A1
20040089249 Cook Oct 2004 A1
20050043779 Wilson Feb 2005 A1
20050085841 Eversull et al. Apr 2005 A1
20050101968 Dadourian May 2005 A1
20050113798 Slater May 2005 A1
20050113862 Besselink et al. May 2005 A1
20050222488 Chang et al. Oct 2005 A1
20050234499 Olson et al. Oct 2005 A1
20050251160 Saadat et al. Nov 2005 A1
20050267010 Goodson Dec 2005 A1
20060025752 Broaddus et al. Feb 2006 A1
20060025844 Majercak et al. Feb 2006 A1
20060030923 Gunderson Feb 2006 A1
20060036218 Goodson et al. Feb 2006 A1
20060155363 Laduca et al. Jul 2006 A1
20060200221 Malewicz Sep 2006 A1
20060257389 Binford Nov 2006 A1
20060259063 Bates et al. Nov 2006 A1
20060270900 Chin et al. Nov 2006 A1
20070016019 Salgo Jan 2007 A1
20070016062 Park Jan 2007 A1
20070038061 Huennekens et al. Feb 2007 A1
20070038293 St. Goar et al. Feb 2007 A1
20070049867 Shindelman Mar 2007 A1
20070083215 Hamer et al. Apr 2007 A1
20070118151 Davidson et al. May 2007 A1
20070129719 Kendale et al. Jun 2007 A1
20070219614 Hartley et al. Sep 2007 A1
20070288082 Williams Dec 2007 A1
20080039746 Hissong et al. Feb 2008 A1
20080114239 Randall et al. May 2008 A1
20080194993 McLaren et al. Aug 2008 A1
20080208309 Saeed Aug 2008 A1
20080281398 Koss Nov 2008 A1
20080306467 Reydel Dec 2008 A1
20090005679 Dala-Krishna Jan 2009 A1
20090018526 Power et al. Jan 2009 A1
20090036780 Abraham Feb 2009 A1
20090093791 Heuser Apr 2009 A1
20090132019 Duffy et al. May 2009 A1
20090171293 Yang et al. Jul 2009 A1
20090177035 Chin Jul 2009 A1
20090240253 Murray Sep 2009 A1
20090254116 Rosenschein et al. Oct 2009 A1
20090270975 Giofford, III et al. Oct 2009 A1
20090319017 Berez et al. Dec 2009 A1
20100016943 Chobotov Jan 2010 A1
20100024818 Stenzler et al. Feb 2010 A1
20100030165 Takagi et al. Feb 2010 A1
20100030256 Dubrul et al. Feb 2010 A1
20100069852 Kelley Mar 2010 A1
20100168583 Dausch et al. Jul 2010 A1
20100185161 Pellegrino et al. Jul 2010 A1
20100185231 Lashinski Jul 2010 A1
20100204708 Sharma Aug 2010 A1
20100211095 Carpenter Aug 2010 A1
20100268067 Razzaque et al. Oct 2010 A1
20100272740 Vertegel et al. Oct 2010 A1
20100298922 Thornton et al. Nov 2010 A1
20110009943 Paul et al. Jan 2011 A1
20110034987 Kennedy Feb 2011 A1
20110071394 Fedinec Mar 2011 A1
20110082533 Vardi et al. Apr 2011 A1
20110213459 Garrison Sep 2011 A1
20110224773 Gifford et al. Sep 2011 A1
20110230830 Gifford, III et al. Sep 2011 A1
20110270375 Hartley et al. Nov 2011 A1
20120016343 Gill Jan 2012 A1
20120020942 Hall et al. Jan 2012 A1
20120022636 Chobotov Jan 2012 A1
20120029478 Kurosawa Feb 2012 A1
20120034205 Alkon Feb 2012 A1
20120035590 Whiting et al. Feb 2012 A1
20120169712 Hill et al. Jul 2012 A1
20120209375 Madrid et al. Aug 2012 A1
20120221094 Cunningham Aug 2012 A1
20120289945 Segermark Nov 2012 A1
20130053792 Fischell et al. Feb 2013 A1
20130131777 Hartley et al. May 2013 A1
20130296773 Feng et al. Nov 2013 A1
20130310823 Gelfand et al. Nov 2013 A1
20130331819 Rosenman et al. Dec 2013 A1
20130331921 Roubin Dec 2013 A1
20140031925 Garrison et al. Jan 2014 A1
20140142427 Petroff May 2014 A1
20140214002 Thermopeutix Jul 2014 A1
20140228808 Webster et al. Aug 2014 A1
20140276602 Bonnette Sep 2014 A1
20140358123 Ueda et al. Dec 2014 A1
20150018942 Hung et al. Jan 2015 A1
20150174377 Syed Jun 2015 A1
20150190576 Lee et al. Jul 2015 A1
20150201900 Syed Jul 2015 A1
20150245933 Syed Sep 2015 A1
20150250991 Silvestro Sep 2015 A1
20150352331 Helm, Jr. Dec 2015 A1
20150366536 Courtney et al. Dec 2015 A1
20150374261 Grunwald Dec 2015 A1
20160008058 Hu et al. Jan 2016 A1
20160038724 Madsen et al. Feb 2016 A1
20160120509 Syed May 2016 A1
20160120673 Siegel et al. May 2016 A1
20160296355 Syed Oct 2016 A1
20160338835 Bioventrix Nov 2016 A1
20170119562 Syed May 2017 A1
20170119563 Syed May 2017 A1
20170135833 Syed May 2017 A1
20170181876 Syed Jun 2017 A1
20170304095 Syed Oct 2017 A1
20170361062 Syed Dec 2017 A1
20180042743 Syed Feb 2018 A1
20180059124 Syed Mar 2018 A1
20180116780 Laine May 2018 A1
20180250147 Syed Sep 2018 A1
20190091441 Syed Mar 2019 A1
20190254675 Syed Aug 2019 A1
20190336114 Syed Nov 2019 A1
20200038210 Syed Feb 2020 A1
Foreign Referenced Citations (32)
Number Date Country
108472124 Aug 2018 CN
108472472 Aug 2018 CN
108882975 Nov 2018 CN
109475722 Mar 2019 CN
111629696 Sep 2020 CN
3280355 Feb 2018 EP
3367969 Sep 2018 EP
3368123 Sep 2018 EP
3399944 Nov 2018 EP
3405261 Nov 2018 EP
3471815 Apr 2019 EP
201827018555 Oct 2018 IN
201827018768 Oct 2018 IN
WO 1996036269 Nov 1996 WO
2004089249 Oct 2004 WO
WO 2010129193 Nov 2010 WO
WO 2011011539 Jan 2011 WO
WO 2011106502 Sep 2011 WO
WO 2011137336 Nov 2011 WO
WO 2012030101 Aug 2012 WO
WO 2014081947 May 2014 WO
WO 2014197839 Dec 2014 WO
WO 2016164215 Oct 2016 WO
WO 2017074492 May 2017 WO
WO 2017074536 May 2017 WO
WO 2017127127 Jul 2017 WO
WO 2017222571 Dec 2017 WO
WO 2017222612 Dec 2017 WO
WO 2018164766 Sep 2018 WO
2019070349 Apr 2019 WO
2019160625 Aug 2019 WO
2019160626 Aug 2019 WO
Non-Patent Literature Citations (29)
Entry
International Search Report and Written Opinion for International Application No. PCT/US2013/071271 dated Feb. 10, 2014, 7 pages.
International Preliminary Report on Patentability issued in International Application No. PCT/US2013/071271 dated May 26, 2015, 6 pages.
International Search Report and Written Opinion issued for International Application No. PCT/US2016/024794 dated Jul. 1, 2016, 10 pages.
International Search Report and Written Opinion for International Application No. PCT/US2016/024795 dated Aug. 30, 2016, 14 pages.
International Search Report and Written Opinion issued for International Application No. PCT/US2016/047163 dated Oct. 28, 2016, 9 pages.
International Search Report and Written Opinion issued for International Application No. PCT/US2016/047165 dated Jan. 5, 2017, 13 pages.
International Search Report and Written Opinion issued for International Application No. PCT/US2017/021188 dated May 10, 2017, 11 pages.
International Search Report and Written Opinion issued for International Application No. PCT/US2018/012834 dated Mar. 15, 2018,13 pages.
International Preliminary Report on Patentability issued in International Application No. PCT/US2016/024795 dated May 1, 2018, 10 pages.
International Preliminary Report on Patentability issued in International Application No. PCT/US2016/047165 dated May 1, 2018, 5 pages.
Beckman et al., Venous Thromboembolism: A Public Health Concern, Am J Prev Med., 2010, vol. 38(4), pp. S495-S501.
Godwin, J., The Circulatory and Respiratory Systems, Z0250 Lab III, 2002, retrieved from: https://projects.ncsu.edu/cals/course/zo250/lab-3.html.
Meunier et al., Individual Lytic Efficacy of Recombinant Tissue Plasminogen Activator in an in-vitro Human Clot Model: Rate of Nonresponse Acad Emerg Med., 2013, vol. 20(5), pp. 449-455.
Schwartz et al., Intracardiac Echocardiography in Humans using a Small-Sized (6F), Low Frequency (12.5 MHz) Ultrasound Catheter Methods, Imaging Planes and Clinical Experience, Journal of the American College of Cardiology, 1993, vol. 21(1), pp. 189-198.
Tripathi et al., Use of Tissue Plasminogen Activator for Rapoid Dissolution of Fibrin and Blood Clots in the Eye After Surgery for Claucomoa and Cataract in Humans, Drug Development Research, 1992, vol. 27(2), pp. 147-159.
Stroke Treatments, American Heart Association, Retrieved from: http://www.strokeassociation.org/STROKEORG/AboutStroke/Treatment/Stroke-Treatments_UCM_310892_Article.jsp#V9Hrg2WfV_1 on Sep. 8, 2016.
Blaney et al., Alteplase for the Treatment of Central Venous Catheter Occlusion in Children: Results of a Prospective, Open-Label, Single-Arm Study (The Cathflo Activase Pediatric Study).
Shah, T., Radiopaque Polymer Formulations for Medical Devices, MDDI Medical Diagnostic and Device Industry: Materials, 2001, retrieved from: https://www.mddionline.com/radiopaque-polymer-formulations-medical-devices.
International Preliminary Report on Patentability issued for PCT/US2016/047163 dated Dec. 25, 2018, 7 pages.
International Preliminary Report on Patentability issued for PCT/US2017/021188 dated Dec. 25, 2018, 9 pages.
International Search Report and Written Opinion for PCT/US2018/047372 dated Jan. 2, 2019, 8 pages.
International Search Report and Written Opinion for PCT/US2019/012727 dated Mar. 21, 2019, 12 pages.
International Search Report and Written Opinion for PCT/US2019/12745 dated Apr. 1, 2019, 10 pages.
EP 16777055.1 Extended Search Report dated Feb. 12, 2019, 7 pages.
EP 18725097.2 Extended Search Report dated Apr. 24, 2019, 9 pages.
EP 16860437.9 Extended Search Report dated May 17, 2019.
EP 16860409.8 Extended Search Report dated Jun. 27, 2019.
EP 16906475.5 Extended Search Report dated Jan. 24, 2020.
EP 17815838.2 Extended Search Report dated Jan. 20, 2020.
Related Publications (1)
Number Date Country
20190255286 A1 Aug 2019 US
Provisional Applications (1)
Number Date Country
62631904 Feb 2018 US