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Expandable transluminal sheathRelated Patent Categories: Surgery, Instruments, Internal Pressure Applicator (e.g., Dilator)Expandable transluminal sheath description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060135981, Expandable transluminal sheath. Brief Patent Description - Full Patent Description - Patent Application Claims
PRIORITY CLAIM [0001] This application claims priority to U.S. application Ser. No. 60/608,355, filed on Sep. 9, 2004, titled Expandable Transluminal Sheath, the entirety of which is hereby incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to medical devices and, more particularly, to methods and devices for accessing the mammalian urinary tract. In one application, the present invention relates to methods and devices for providing access to the ureter and kidney. [0004] 2. Description of the Related Art [0005] A wide variety of diagnostic or therapeutic procedures involves the introduction of a device through a natural access pathway. A general objective of access systems, which have been developed for this purpose, is to minimize the cross-sectional area of the access lumen, while maximizing the available space for the diagnostic or therapeutic instrument. These procedures are especially suited for the urinary tract of the human or other mammal. The urinary tract is relatively short and substantially free from the tortuosity found in many endovascular applications. [0006] Ureteroscopy is an example of one type of therapeutic interventional procedure that relies on a natural access pathway. Ureteroscopy is a minimally invasive procedure that can be used to provide access to the upper urinary tract. Ureteroscopy is utilized for procedures such as stone extraction, stricture treatment, or stent placement. [0007] To perform a procedure in the ureter, a cystoscope is placed into the bladder through the urethra. A guidewire is next placed, through the working channel of the cystoscope and under direct visual guidance, into the target ureter. Once guidewire control is established, the cystoscope is removed and the guidewire is left in place. A ureteral sheath or catheter is next advanced through the urethra over the guidewire, through the bladder and on into the ureter. The guidewire may now be removed to permit instrumentation of the ureteral sheath or catheter. [0008] Current techniques involve advancing a flexible, 10 to 18 French, ureteral catheter with integral flexible, tapered obturator over the guidewire. Because axial pressure is required to advance and place each catheter, care must be taken to avoid kinking the tapered catheter during advancement so as not to compromise the working lumen of the catheter through which instrumentation, such as ureteroscopes and stone extractors, must now be placed. [0009] One of the issues that arise during ureteroscopy is the presence of an obstruction or stenosis in the ureter, which is sometimes called a stricture, that prohibits a catheter with a large enough working channel from being able to be advanced into the ureter. Such conditions may preclude the minimally invasive approach and require more invasive surgical procedures in order to complete the task. Urologists may be required to use catheters with sub optimal central lumen size because they are the largest catheters that can be advanced to the proximal end of the ureter. Alternatively, urologists may start with a larger catheter and then need to downsize to a smaller catheter, a technique that results in a waste of time and expenditure. Finally, a urologist may need to dilate the ureter with a dilation system before placing the current devices, again a waste of time and a need for multiple devices to perform the procedure. In most cases, it is necessary for the urologist to perform fluoroscopic evaluation of the ureter to determine the presence or absence of strictures and what size catheter would work for a given patient. [0010] Additional information regarding ureteroscopy can be found in Su, L, and Sosa, R. E., Ureteroscopy and Retrograde Ureteral Access, Campbell's Urology, 8th ed, vol. 4, pp. 3306-3319 (2002), Chapter 97. Philadelphia, Saunders, and Moran, M. E., editor, Advances in Ureteroscopy, Urologic Clinics of North America, vol. 31, No. 1 (February 2004). [0011] A need therefore remains for improved access technology, which allows a device to be transluminally passed through a relatively small diameter duct, while accommodating the introduction of relatively large diameter instruments. It would be beneficial if a urologist did not need to inventory and use a range of catheter diameters. It would be far more useful if one catheter diameter could fit the majority of patients. Ideally, the catheter would be able to enter a vessel or body lumen with a diameter of 6 to 10 French or smaller, and be able to pass instruments through a central lumen that was 12 to 18 French. These requirements appear to be contradictory but can be resolved by the invention described below. SUMMARY OF THE INVENTION [0012] Accordingly, one embodiment of the present invention comprises a device adapted for providing therapeutic or diagnostic access to a kidney through the ureter comprising a sheath having a non-expandable proximal end and a radially expandable distal end that can be expanded from an outer diameter of about 10 French or smaller to an outer diameter of greater than about 12 French. [0013] Another embodiment of the present invention comprises an apparatus adapted for instrumenting a body lumen. The device includes a sheath having a proximal end and a distal end and means for radially collapsing the distal end of a sheath and maintaining said radially collapsed configuration. Means are also provided for for introducing the sheath into the body lumen while the distal end is in its radially collapsed configuration and for dilating the radially collapsed distal end of the sheath. The sheath also includes means maintaining the dilated configuration of the distal end of the sheath, following dilation by the dilator, means for performing instrumentation, material introduction or withdrawal from the body lumen through the sheath and means for removal of the sheath from the body lumen. [0014] Another embodiment of the present invention comprises a method of instrumenting a body lumen. A dilator is inserted into a sheath that has a radially collapsible distal end. The distal end of the sheath is collapsed radially inward around the dilator such that the distal end of the sheath is smaller in diameter than the proximal end of the sheath. The sheath and dilator are inserted into the body lumen and advanced to a target treatment site. The dilator is expanded and causes the distal end of the sheath to expand to a diameter substantially the same as that of the proximal end of the sheath. The dilator is removed and the central lumen that remains is substantially the same diameter moving from the proximal end to the distal end of the sheath. Instruments or catheters are inserted through the central lumen of the sheath for a therapeutic or diagnostic procedure. [0015] Another embodiment of the present invention comprises an expandable medical access sheath for providing minimally invasive access to body lumens or cavities, length of proximal sheath tubing, said proximal sheath tubing being non-expandable. The sheath includes a length of distal sheath tubing. The distal sheath tubing is collapsed to a diameter smaller than that of the proximal sheath tubing. A transition zone exists between the distal sheath tubing and the proximal sheath tubing. The transition zone tapers between the larger diameter proximal sheath tubing and the smaller diameter distal sheath tubing. A dilator is disposed within both the proximal sheath tubing and the distal sheath tubing. Radial expansion of the dilator causes the distal sheath tubing to expand diametrically to substantially the same inner diameter as that of the proximal sheath tubing. [0016] A transluminal radially expanding access sheath is provided according to an embodiment of the invention. In one embodiment, the radially expanding access sheath is used to provide access to the ureter, kidney, or bladder. In an embodiment, the sheath would have an introduction outside diameter that ranged from 4 to 12 French with a preferred range of 5 to 10 French. The inside diameter of the sheath would be expandable to permit instruments ranging from 10 French to 60 French to pass therethrough, with a preferred range of between 12 and 20 French. The ability to pass the large instruments through a catheter or sheath introduced with a small outside diameter is derived from the ability to expand the distal end of the catheter to create a larger through lumen. The proximal end of the catheter is generally larger to provide for pushability, control, and the ability to pass large diameter instruments therethrough. [0017] Another embodiment of the invention comprises a transluminal access system for providing minimally invasive access to anatomically proximal structures. The system includes an access sheath comprising an axially elongate tubular body that defines a lumen, at least a portion of the distal end of the elongate tubular body being expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile. In an embodiment, the first, smaller cross-sectional profile is created by making axially oriented folds in the sheath material. These folds may be in only one circumferential position on the sheath, or there may be a plurality of such folds or longitudinally oriented crimps in the sheath. The folds or crimps may be made permanent or semi-permanent by heat-setting the structure, once folded. In an embodiment, a releasable jacket is carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, smaller cross-sectional profile. The elongate tubular body is sufficiently pliable to allow the passage of objects having a maximum cross-sectional diameter larger than an inner diameter of the elongate tubular body in the second, greater cross-sectional profile. The adaptability to objects of larger dimension is accomplished by re-shaping of the cross-section to the larger dimension in one direction accompanied by a reduction in dimension in a lateral direction. The adaptability may also be generated through the use of malleable or elastomerically deformable sheath material. [0018] In another embodiment of the invention, a transluminal access system for providing minimally invasive access includes an access sheath comprising an elongate tubular body having a proximal end and a distal end and defining an axial lumen. At least a portion of the distal end of the elongate tubular body is expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile. The sheath wall is axially crimped or folded to form the first smaller cross-sectional profile. The sheath wall is cut or transected laterally to form a plurality of axially aligned segments. The transaction may be generated using laser cutting, a blade, or other plastic cutting technology. The plurality of sheath segments is connected using a plurality of thin pliable connector links. Alternatively, the sheath segments may be connected by an outer or inner sheath membrane with elastomeric or axially deformable properties. The sheath segments may also be created by continuously cutting a spiral in the tube thus creating flexibility and linear attachments between sheath elements since the sheath, or a layer of the sheath is continuous from the proximal to the distal end. In this way, the axial flexibility of the access sheath is increased. The outer or inner sheath engages the plurality of sheath segments by mechanical friction or by adherence. In an embodiment, a releasable jacket is carried by the access sheath to restrain at least a portion of the elongate tubular member in the first, smaller cross-sectional profile. The sheath may also be spiral or ribbed cut only partially through the thickness of the wall, for example, only through the outer portion of the wall but not through to the inner lumen of the sheath. This configuration can be used on tubes, especially those of elastomeric nature, to provide kink resistance and bendability while retaining hoop strength. [0019] In another embodiment of the invention, a transluminal access sheath assembly for providing minimally invasive access comprises a sheath that includes an elongate tubular member having a proximal end and a distal end and defining a working inner lumen. At least a portion of the distal end of the elongate tubular member is expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile by plastic yield. Thin, plastically deformable materials such as polyethylene are suitable for this application. In another embodiment, the plastically deformable tubular member is replaced by a folded or creased sheath that is expanded by a dilatation balloon or axially translating dilator. An inner member, in an embodiment, generates the force to expand the sheath. The inner member, which can be a dilatation balloon, is removable to permit subsequent instrument passage through the sheath. Longitudinal runners may be disposed within the sheath to serve as tracks for instrumentation and minimize friction while minimizing the risk of catching the instrument on the expandable plastic. Such longitudinal runners are preferably circumferentially affixed within the sheath so as not to shift out of alignment. [0020] Another embodiment of the invention comprises a transluminal access system, for providing minimally invasive access that includes an elongate tubular body that defines a lumen, at least a portion of the distal end of the elongate tubular body being expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile. Optionally, a releasable jacket can be carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, smaller cross-sectional profile. The axially elongate tubular structure is further reinforced by a stent or stent-like support structure. The stent-like support structure is expandable and may be either elastomeric and self-expanding or malleable and require an active dilator for its expansion. The stent-like support structure may also be a coil that is unwound to increase its diameter. The stent-like support structure preferably has very little foreshortening when it is expanded radially. The stent-like support structure is affixed interior to or embedded within at least a part of the wall of the axially elongate tubular structure. An expandable dilating member is positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile. [0021] Another embodiment of the invention comprises a transluminal access assembly that includes an elongate tubular body that defines an internal lumen. At least a portion of the distal end of the elongate tubular structure is expandable from a first, axially folded smaller cross-sectional profile to a second, greater cross-sectional profile. The elongate tubular structure may be creased or it may be elastomerically or malleably expandable. A releasable jacket is optionally carried by the access sheath to restrain at least a portion of the elongate tubular body in the first, smaller cross-sectional profile. A reinforcing structure fabricated from nickel-titanium alloy such as nitinol, provides the wall support to prevent re-collapse following dilatation. The nitinol can be severely distorted or pinched to form the folds or furls, and still be restored to its initial set-shape. In the first, folded, smaller-cross-sectional profile, the elongate tubular body of one embodiment, includes two creased outer sections that generally face each other. Continue reading about Expandable transluminal sheath... Full patent description for Expandable transluminal sheath Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Expandable transluminal sheath patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. 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