Source: https://patents.google.com/patent/US8348892B2/en
Timestamp: 2019-09-19 07:44:38
Document Index: 571561384

Matched Legal Cases: ['application No. 05', 'application No. 05', 'application No. 05', 'application No. 05', 'application No. 05', 'application No. 05', 'Application No. 05794899', 'application No. 2007', 'application No. 05', 'application No. 05', 'application No. 2007']

US8348892B2 - Expandable transluminal sheath - Google Patents
US8348892B2
US8348892B2 US13/007,280 US201113007280A US8348892B2 US 8348892 B2 US8348892 B2 US 8348892B2 US 201113007280 A US201113007280 A US 201113007280A US 8348892 B2 US8348892 B2 US 8348892B2
US13/007,280
US20110306843A1 (en
2011-01-14 Application filed by Onset Medical Corp filed Critical Onset Medical Corp
2011-01-14 Priority to US13/007,280 priority patent/US8348892B2/en
2011-12-15 Publication of US20110306843A1 publication Critical patent/US20110306843A1/en
2013-01-08 Publication of US8348892B2 publication Critical patent/US8348892B2/en
This application is a continuation of U.S. patent application Ser. No. 11/199,566, filed on Aug. 8, 2005, which issued on Feb. 22, 2011 as U.S. Pat. No. 7,892,203, which claims priority to Provisional Application 60/660,512, filed Mar. 9, 2005 and Provisional Application 60/608,355, filed on Sep. 9, 2004, the entirety of which are hereby expressly incorporated herein by reference.
Referring to FIG. 3A, the proximal end 302 generally comprises the proximal sheath tube 306 that can be permanently affixed or otherwise coupled to the sheath hub 308. The optional sleeve 310 is tightly wrapped around the proximal sheath tube 306 and is generally able to be split lengthwise and be removed or disabled as a restraint by pulling on the optional sleeve grip 312 that is affixed to the sleeve 310. The optional sleeve 310 is preferably fabricated from transparent material, or material with a color other than that of the sheath 300, and is shown so in FIGS. 3A and 3B. The proximal end further comprises the inner catheter shaft 318, the outer catheter shaft 324, and the catheter hub 316. The catheter hub 316 is integrally molded with, welded to, bonded or otherwise coupled, to the guidewire port 332. The dilator, or catheter, hub 316 allows for gripping the dilator and it allows for expansion of the dilatation balloon 320 by pressurizing an annulus between the inner catheter shaft 318 and the outer catheter shaft 324, said annulus having openings into the interior of the balloon 320. The balloon 320 is preferably bonded, at its distal end, either adhesively or by fusion, using heat or ultrasonics, to the inner catheter shaft 318. The proximal end of the balloon 320 is preferably bonded or welded to the outer catheter shaft 324. In another embodiment, pressurization of the balloon 320 can be accomplished by injecting fluid, under pressure, into a separate lumen in the inner or outer catheter shafts 318 or 324, respectively, said lumen being operably connected to the interior of the balloon 320 by openings or scythes in the catheter tubing. Such construction can be created by extruding a multi-lumen tube, rather than by nesting multiple concentric tubes. The distal end 304 generally comprises the distal sheath tube 322 which is folded into creases 328 running along the longitudinal axis and which permit the area so folded to be smaller in diameter than the sheath tube 306. The inner catheter shaft 318 comprises a guidewire lumen 334 that may be accessed from the proximal end of the catheter hub 316 and preferably passes completely through to the distal tip of the catheter shaft 318. The guidewire lumen 334 is able to slidably receive guidewires up to and including 0.038-inch diameter devices.
In the illustrated embodiment, axial separation motion between the dilator hub 316 and the sheath hub 308 easily disengages the two hubs 308 and 316 while rotational relative motion is prevented by the sidewalls of the tabs and slots. A draft angle on the sidewalls of the tabs and the slots further promotes engagement and disengagement of the anti-rotation feature. In another embodiment, the sheath hub 308 is releaseably affixed to the dilator hub 316 so the two hubs 308 and 316 are coaxially aligned and prevented from becoming inadvertently disengaged or separated laterally. In this embodiment, the two hubs 308 and 316 are connected at a minimum of 3 points, which prevent lateral relative motion in both of two substantially orthogonal axes. In a preferred embodiment, the two hubs 308 and 316 are engaged substantially around their full 360-degree perimeter. Manual pressure is sufficient to snap or connect the two hubs 308 and 316 together as well as to separate the two hubs 308 and 316.
In another embodiment, the distal end of the sheath hub 308 is configured to taper into the sheath tubing 306 at the distal taper 344 so that the sheath hub 308 distal end 344 and the proximal end of the sheath tubing 306 can be advanced, at least partly, into the urethra or urethral meatus without causing tissue damage. The sheath hub 308 serves as the handle for the sheath 300 and is generally a cylinder of revolution with certain changes in outside diameter moving from distal to proximal end. In the illustrated embodiment, the distal facing surface 340 of the sheath hub 308 can define a cone tapering inward moving increasingly distally. The cone, in longitudinal cross-section, can be characterized by two exterior walls, symmetrically disposed about a centerline, each of said exterior walls being curvilinear and describing a concave outline. In a preferred embodiment, the exterior outline of the distal surface 340 of the sheath hub 308 can describe a linear outline, with surfaces running generally parallel to the longitudinal axis of the sheath tubing 306 and other surfaces running generally perpendicular to the longitudinal axis of the sheath tubing 306. In this preferred embodiment, there are no curvilinear axial cross-sectional outlines except at regions of fillets or other rounding to substantially eliminate any sharp edges that could cut through gloves or fingers. The proximally facing surface 342 of the sheath hub 308 can be curvilinear and flared with a longitudinal cross-section outline appearing like the internal surface of a bell, such shape acting as a funnel for instrumentation. In this embodiment, the axial cross-sectional view of the distally facing surface 342 describes two interior walls, symmetrically disposed about a centerline, each of the walls being convex when viewed from the proximal end of the sheath 300. In a preferred embodiment, the proximally facing surface 342 of the sheath hub 308 can appear substantially linear with edges that are oriented substantially perpendicular to the longitudinal axis of the sheath tubing 306. The access through the proximal surface 342 of the sheath hub 308 to the inner lumen of the sheath 300, can be curvilinear and flared, or it can be linear and describe a lumen that is generally parallel to the longitudinal axis. In another embodiment, the access port through the proximal end 342 of the sheath hub 308 can comprise a straight taper, such as a 6 percent Luer taper to allow for sealing with other devices inserted therein or to allow for ease of device insertion. The amount of end taper can vary between 1½ degrees and 20 degrees between each side and the longitudinal axis of the sheath 300. The maximum outer diameter of the sheath hub 308 can be between 0.25 and 2.0 inches, with a preferred range of between 0.5 and 1.0 inches. The sheath hub 308 can be sized so that at least half a finger diameter is cradled by each side of the flange of the hub 308. The distally facing surface 340 of the sheath hub 308 can furthermore be shaped to have substantially the same curve radius as a finger, so as to be received, or grasped, between two fingers of the hand, cigarette style, like the technique used for control of cystoscopes. In another embodiment, the sheath hub 308 can be sized and configured to be grasped between a thumb and finger, like a pencil or catheter, where there are no features or curves on the distally facing surface 340 of the sheath hub 308 to approximately match or conform to the shape or diameter of two fingers.
FIG. 5C illustrates a lateral cross-section of the distal end 504 of the sheath 500. In this embodiment, the folded sheath tube 510 covering the distal section 504 is fabricated with flutes 520 on the interior, or exterior, surface. Interior flutes 520 are the preferred embodiment in this case. The flutes 520 represent longitudinally running increases in wall thickness, or high spots, of the folded sheath tube 510 which are separated by longitudinally running regions of decreased wall thickness 522 or depressions. The flutes 520 are generally integral to the folded sheath tube 510. The flutes 520 are generally created by fabricating an extrusion die with slots that permit the polymer to extrude with ridges thereon. The flutes 520 may facilitate folding and minimize damage to optical scopes, such as ureteroscopes, angioscopes, endoscopes, and the like, when inserted therethrough, due to debris scratching the lens when the scope is advanced or retracted. When the folded sheath tube 510 is dilated, the region of decreased wall thickness 522 between the flutes 520 will preferentially unfold because of the increased strength of the flutes 520.
1. A method of instrumenting a body lumen or cavity comprising the steps of:
inserting a sheath with a pre-inserted dilator, and advancing the sheath to a treatment or diagnostic site within the body lumen or cavity, wherein the sheath comprises a distal region which is collapsed in diameter, the sheath further comprising distorted proximal and distal chevrons,
dilating the distal region of the sheath so that the distal region of the sheath is expanded, wherein the proximal and distal chevrons become undistorted such that a full-size lumen exists within the sheath and extending from the proximal end to the distal end,
5. The method of claim 1 wherein a guidewire is advanced to the treatment site prior to inserting the sheath and dilator into the body lumen or cavity.
6. The method of claim 1 wherein the sheath is advanced over a previously placed guidewire, which is routed through a lumen in the dilator.
7. The method of claim 1 wherein the sheath is advanced to a point in the body lumen or cavity which is anatomically distal to the site where therapy or diagnosis will be carried out by the instrumentation.
8. The method of claim 1 wherein the full-size lumen created by the dilator comprises a final sheath configuration where the distal sheath lumen circumference is substantially the same as the proximal lumen of the sheath.
9. The method of claim 1 wherein the full-size lumen created by the dilator comprises a final sheath configuration where the distal sheath lumen has a shape different from that of the proximal sheath lumen.
10. The method of claim 1 wherein the body lumen or cavity is the mammalian urinary tract.
11. The method of claim 1 wherein the target site for therapy or diagnosis is the mammalian ureter.
12. The method of claim 1 wherein the sheath further comprises a transition zone comprising the proximal and distal chevrons, the chevrons forming a substantially even zig-zag pattern with a substantially smooth gradual transition when undistorted.
13. The method of claim 1 wherein the sheath further comprises a non-expandable proximal region and a transition zone between the non-expandable proximal region and the expandable distal region, the regions being fused together along edges of the chevrons.
14. The method of claim 1 wherein the sheath further comprises longitudinal running flutes.
15. The method of claim 14 wherein the flutes reduce friction between an inner layer of the sheath and the instrumentation.
US13/007,280 2004-09-09 2011-01-14 Expandable transluminal sheath Active US8348892B2 (en)
US13/007,280 US8348892B2 (en) 2004-09-09 2011-01-14 Expandable transluminal sheath
US13/710,762 US8764704B2 (en) 2004-09-09 2012-12-11 Expandable transluminal sheath
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