Conduit for interventional procedures
A conduit, such as an introducer sheath, catheter, or guide catheter, incorporating two or more separate lumens to prevent the entanglement of guidewires located at least partially within the conduit. The lumens are separated by at least one disruptable barrier that allows multiple lumens to be converted into fewer lumens prior to or as a device is advanced through the introducer sheath.
1. Field of the Invention
Novel conduits, such as guide catheters and catheter introducer sheaths, for use in interventional procedures, particularly introducer sheaths adapted for use with multiple guidewires.
2. Description of Related Art
It is often desirable to use multiple guidewires in various endovascular procedures. For example when deploying stent graft aneurismal repair devices within branched vasculature, a first guidewire would be used to access the main artery while second and/or third guidewires would access the side branched arteries. Stent grafts with multiple guidewire ports would then be advanced along the respective guidewires and deployed at the desired sites. A common problem associated with the use of multiple guidewires is the “crossing” or entanglement of the guidewires in the vasculature proximal to the treatment site. Crossed and entangled guidewires prohibit or severely restrict the ability to advance a device with multiple guidewire ports to the treatment site. An introducer catheter or sheath is often employed to protect the vasculature from possible damage due to the advancement of the guidewires, catheters and subsequent devices but such use does not eliminate the occurrence of crossed guidewires. See for example U.S. Pat. No. 6,884,258 (to Vardi et al.) for a disclosure of problematic crossed guidewires.
SUMMARY OF THE INVENTIONThe invention comprises a conduit (such as an introducer sheath or a guide catheter) for use in an interventional procedure comprising: a main body having a length; at least one disruptable barrier within the main body extending along at least a portion of the length of the main body, defining at least two lumens within the main body; and wherein the barrier is adapted to be disrupted before or during the procedure to reduce the number of lumens within the main body. In an aspect of the invention the at least two lumens are adapted to receive separate elongated members (such as guide wires) and prevent the elongated members from tangling with each other.
An aspect of the invention comprises an introducer sheath that incorporates at least two separate lumens to prevent the entanglement of at least two guidewires. The lumens are separated by disruptable barrier(s) that allows multiple lumens to be converted into fewer lumens. The barrier(s) forms at least two separate lumens along at least a portion of the length of the sheath. Guidewires and guide catheters can be advanced through the separate lumens to a desired treatment site. The separated lumens prevent the guidewires from crossing and becoming entangled. In an aspect of the invention, an endovascular device having multiple guidewire lumens and ports can then be “back-loaded” onto the proximal ends of the guidewires. As the multi-lumen device is advanced through the introducer sheath, the distruptable barrier tears or separates to form fewer lumens, thus allowing the multi-lumen device to pass while maintaining guidewire separation. An operational procedure using an introducer sheath of the present invention allows the user to initially place all required guidewires into the target sites. After all required guidwires are in place, the interventional device or devices can then be advanced along the guidewires.
BRIEF DESCRIPTION OF THE DRAWINGS
A better understanding of the present invention may be had with reference to the several figures.
Shown in
A typical procedure entails gaining initial femoral artery access percutaneously or with a surgical access. A floppy guidewire is then inserted into the artery past the treatment site to ensure access is maintained. An introducer sheath consisting of the outer sheath and an inner dilator is placed over the guidewire and into the vessel to the treatment site or as far as it will go. The dilator serves to both stiffen the sheath for pushability and to create a smooth transition between the relatively sharp end of the sheath and the tissue. The floppy guidewire is switched out for the appropriate stiff guidewire using the sheath to maintain arterial access. The dilator is then removed and the treatment device is then guided over the guidewire and deployed.
As shown in
Shown in
A self expanding main body stent or stent graft (for simplicity, as used herein it should be understood that “stent” shall mean both a stent or a stent graft) 63 is shown compressed onto the central catheter shaft 61. The self expanding stent 63 is constrained in the compressed state by a flexible sheath 65. The sheath 65 can be activated by a pull line (not shown) releasing a series of “slip-knots” that allow the sheath to split open and release the self expanding stent. The two guidewire tubes 67, 69 are passed through two side-branch openings in the stent 63 and also pass through two openings within the flexible sheath 65. The openings in the flexible sheath can be configured, for example, as slits propagating to the seam line of the flexible sheath.
The three guidewires 34, 36, 38 (from
Shown in
The term “disruptable barrier” is defined as a member that creates at least two lumens within a catheter shaft and is tailored to allow conversion to a fewer number of lumens. For example a pair of disruptable barriers can create three separate lumens that are then transformed into less than three lumens. Similarly, flexible partitions or walls within a catheter can initially form several lumens (for example four) that are subsequently converted into less than four lumens. A disruptable barrier (or barriers) therefore provides a means to prevent entanglement of at least two guidewires, while also allowing the subsequent advancement of a medical device along the guidewires. In an aspect of the invention, a disruptable barrier (or barriers) provides a means to isolate and prevent entanglement of at least two guidewires, while also allowing the subsequent advancement of a medical device along the guidewires.
Shown in
Shown in
Shown in
The existing guidewire placements can be subsequently used for additional diagnostics or repairs (such as ballooning or stent placement). Additional repair or diagnostic devices can include but are not limited to bifurcated stent grafts, single lumen tube grafts, combinations of modular graft components, radiographic injection devices, embolic filters, occlusion, anchoring or seating balloons, fixation or anchoring devices and endoscopes. In a preferred example the two side-branch guidewires 34, 38 can be withdrawn and an additional device (or devices) can be advanced along the central guidewire 36. When at the desired location subsequent devices can be released and engaged to the “docking” portion 92 of the main body stent 78 forming a complete repair of the aneurysmal site.
For example, shown in
As shown in
Although depicted in a renal/aortic repair procedure, the devices and methods of the present invention can be used in other repair procedures involving branched vessels. Anchoring balloons can also be incorporated into the various guidewires to help maintain the guidewire positions during the repair procedure.
During the insertion of an introducer sheath of the present invention a “split” dilator can be used in a normal fashion. Such a split dilator has longitudinal slits or separate stiffening portions that are tailored to slip into the individual lumens of the introducer sheath of the present invention.
The disruption or tearing of the barrier or barriers of the present invention can be initiated, for example, with the use of a “slitting tool”. Such a slitting tool can be partially inserted into the introducer sheath of the present invention prior to the back loading of the first stent device. The slitting tool can initiate the disruption or separation of the barrier/s and can then be removed prior to the device insertion. Similarly, the distal tip of the first stent device can incorporate a barrier “disrupting” feature such as a sharp or fluted surface. Also, the barrier can be of a material that will tear as a relatively blunt distal tip of a catheter is advanced.
When multiple guidewires are used with an introducer sheath, an effective hemostatic seal within the proximal hub assembly (
Disruptable barriers of the present invention can have various configurations. Shown for example in
Similarly,
Other configurations of the present invention, similar to that of
Shown in
Shown in
Various cross-sectional profiles according to the present invention can be extruded, formed by wrapping or windings, or be comprised of multiple sections laminated or bonded together. The initial number of lumens can include but are not limited to two, three, four, five, six, seven, eight, nine or ten or more lumens. These multi-lumen catheters can be converted, according to the present invention, into “fewer than the initial number of lumens” which includes but is not limited to one, two, three, four, five, six, seven, eight, nine or ten or more lumens.
A catheter or introducer sheath having two disruptable barriers that are “rip able”, “slit able” or tear able can be fabricated by providing, for example, a three piece mandrel having a general cross-section or end view according to
As an alternative to the concept of “disruptable barriers” modified “dilators” used in conjunction with introducer sheaths can be used to minimize or prevent the occurrence of crossed or entangled guidewires. The dilator has a length, a proximal end, and a distal end, the dilator is sized to be locatable within the lumen of an introducer sheath. The introducer sheath has a length, a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The dilator is further defined as having an outer geometric shape that defines at least two lumens between the introducer sheath and the dilator when the dilator is inserted into the introducer sheath lumen. Moreover, the dilator can comprise at least one lumen defined by an inner surface of the dilator.
For example, a dilator can have two opposing flat surfaces extending along its length. When inserted into the mating introducer sheath, the flat surfaces form two guidewire lumens between the dilator and the inner wall of the introducer sheath. When the guidewires are positioned into the desired target site the dilator can be removed and a delivery system can then be back-loaded onto the guidewires and advanced through the introducer sheath. The proximal guidewire positions can be maintained by suitable fixation at the hub assembly. Shown in
Shown in
Shown in
The modified dilators of the present invention therefore provide a “means to isolate and prevent entanglement of at least two guidewires” while also allowing the subsequent advancement of a medical device along the guidewires.
The specific configurations used to form separate guidewire lumens in the examples above can be embodied along the entire length of the dilator. Alternatively, the guidewire lumen features can be eliminated at the distal and/or proximal ends of the dilator. The elimination of the guidewire features for example at the distal end of the dilator allows a normal tapered tip of a dilator to extend from the introducer sheath during insertion. The dilator can then be further advanced into the introducer sheath to expose the distal guidewire lumens. The specific lumens of the present invention can be dimensioned to accept a variety of guidewire sizes or other devices. In any event, once the guidewires are advanced through the lumens and located at the desired treatment sites, the dilator can be removed from the introducer sheath lumen to allow for the advancement of the desired device(s) over the guidewires. The concepts of disruptable barriers can be combined with dilators modified to incorporate guidewire lumens. In addition the distal end of an introducer sheath can have staggered and/or angulated exit ports for the guidewires or other devices.
Shown in
The guidewire positioning catheters of the present invention therefore provide a means to isolate and prevent entanglement of at least two guidewires while also allowing the subsequent advancement of a medical device along the guidewires.
A method of the present invention can include the following steps:
- A) provide an introducer sheath and a matching dilator system that provides a means to prevent entanglement of at least two guidewires;
- B) insert and locate the introducer sheath approximate to a desired target site;
- C) insert and locate at least two guidewires within the introducer sheath;
- D) back-load a medical device onto the at least two guidewires; and
- E) advance the medical device over the at least two guidewires through the introducer sheath to the desired target site.
The means to prevent entanglement of at least two guidewires can include the incorporation of at least one disruptable barrier within the introducer sheath. Additional means to prevent entanglement of at least two guidewires can include, but are not limited to, the incorporation of at least two guidewire lumens into the dilator or by the use of a guidewire positioning catheter.
While particular embodiments of the present invention have been illustrated and described above, the present invention should not be limited to such particular illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.
Claims
1. A conduit for use in an interventional procedure comprising:
- a main body having a length;
- at least one disruptable barrier within the main body extending along at least a portion of the length of the main body, defining at least two lumens within the main body;
- wherein the barrier is adapted to be disrupted before or during the procedure to reduce the number of lumens within the main body.
2. The conduit of claim 1, wherein the lumens are each adapted to receive a separate elongated member and prevent the elongated members from tangling with each other.
3. The conduit of claim 2, wherein at least one of the elongated members is used to access side vessels.
4. The conduit of claim 1, that comprises at least two disruptable barriers, defining at least three lumens within the main body.
5. The conduit of claim 1, that allows for delivery of a main treatment device through the main body following disruption of the barrier.
6. The conduit of claim 1, that includes at least one hemostatic seal having multiple openings, each corresponding with each of the lumens in the main body.
7. The conduit of claim 6, wherein the multiple openings are adapted to form into a single opening.
8. The conduit of claim 1, wherein the barrier comprises a membrane.
9. The conduit of claim 2, wherein the elongated member is a guidewire.
10. The conduit of claim 1, wherein the disruptable barrier material comprises a material selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, polyurethanes, siloxanes, polyetherester, polytetrafluoroethylene, polyimide, nylon, polyethylene terephthalate, thermoplastic elastomers, polyolefins, polyester, polyamides, polydimethylsiloxane, natural rubber, polyether block amide, ethylene vinyl acetate, and combinations thereof.
11. The conduit of claim 1, wherein the conduit is an introducer sheath.
12. The conduit of claim 1, wherein the conduit is a guide catheter.
13. The conduit of claim 1, wherein the at least one disruptable barrier extends for substantially the entire length of the conduit.
14. An introducer sheath having a length, a proximal end, and a distal end comprising:
- A hemostatic seal located at the proximal end;
- The hemostatic seal comprising at least one elastomeric sealing disk;
- The at least one elastomeric sealing disk comprising a plurality of interconnected guidewire insertion sites.
15. The introducer sheath of claim 14, wherein the hemostatic seal comprises at least three elastomeric sealing disks.
16. The introducer sheath of claim 14, wherein the at least one elastomeric sealing disk comprises at least three guidewire insertion sites.
17. The introducer sheath of claim 15, wherein the at least one elastomeric sealing disk comprises at least three guidewire insertion sites.
18. The introducer sheath of claim 14, wherein the plurality of guidewire insertion sites comprise pre-punctured holes sized to accept a guidewire therethrough.
19. A kit comprising:
- An introducer sheath having a length, a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; and
- A dilator having a length, a proximal end, and a distal end, the dilator being sized to be locatable within the lumen of the introducer sheath and having an outer geometric shape that defines at least two lumens between the introducer sheath and the dilator when the dilator is inserted into the introducer sheath lumen.
20. The kit of claim 19, wherein the dilator outer geometric shape comprises at least two longitudinally extending grooves sized to accept a guidewire.
21. The kit of claim 19, wherein the dilator outer geometric shape is cross-shaped, the cross-shape forming four lumens between the dilator and the introducer sheath when the dilator is inserted into the introducer sheath lumen.
22. The introducer sheath of claim 14, wherein the guidewire insertion sites are interconnected by at least one slit.
23. The conduit of claim 1, wherein the main body has a first outer diameter, wherein the first outer diameter is expandable to a relatively larger diameter upon insertion of at least one elongated member into the main body.
Type: Application
Filed: Oct 7, 2005
Publication Date: Apr 12, 2007
Inventors: Rochelle Hamer (Flagstaff, AZ), Eric Johnson (Flagstaff, AZ), Stanislaw Zukowski (Flagstaff, AZ)
Application Number: 11/246,592
International Classification: A61F 11/00 (20060101);