# US 2006/0135981 A1 · Expandable transluminal sheath > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2006/0135981 A1 - Document ID: US20060135981A1 - Status: Published application - Kind: A1 - Application number: 11/223,897 - Filed: 2005-09-09 - Published: 2006-06-22 - Earliest claimed: 2004-09-09 - Inventors: Jay Lenker; Onnik Tchulluian; Edward Nance - Web page: https://patentgrep.com/patent/US20060135981A1 ## CPC - A61M 25/0662: {Guide tubes} - A61B 17/3439: {with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662)} - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)} - A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)} - A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids} - A61M 25/0052: {Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port} - A61M 25/0108: {using radio-opaque or ultrasound markers} - A61M 2025/0024: {Expandable catheters or sheaths} - A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube} - A61M 2025/1081: {having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for diagnostic or therapeutic procedures such as ureteroscopy, cardiac electrophysiology, gastroenterology, and spinal access. ## Claims ### Claim 1 An expandable medical access sheath for providing minimally invasive access to body lumens or cavities, comprising: a length of proximal sheath tubing, said proximal sheath tubing being non-expandable; a length of distal sheath tubing, said distal sheath tubing being collapsed to a diameter smaller than that of the proximal sheath tubing; a transition zone between the distal sheath tubing and the proximal sheath tubing, wherein the transition zone tapers between the larger diameter proximal sheath tubing and the smaller diameter distal sheath tubing; and a dilator disposed within both the proximal sheath tubing and the distal sheath tubing, wherein 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. ### Claim 2 (depends on 1) The sheath of claim 1 wherein, following dilation, the sheath has a full internal lumen that reaches from the proximal end to the distal end. ### Claim 3 (depends on 1) The sheath of claim 1 further comprising a hub affixed at the proximal end of the sheath, wherein said hub provides for grasping the sheath and for infusion and withdrawal of fluids from said sheath. ### Claim 4 (depends on 1) The sheath of claim 1 further comprising a hub affixed to the proximal end of the dilator, wherein said hub provides for grasping of the dilator, for the infusion and withdrawal of fluids from the dilator, and for locking the hub of the dilator to a hub affixed to the proximal end of the sheath. ### Claim 5 (depends on 1) The sheath of claim 1 wherein the distal sheath tubing is composite in structure. ### Claim 6 (depends on 1) The sheath of claim 1 wherein the proximal sheath tubing is composite in structure. ### Claim 7 (depends on 1) The sheath of claim 1 wherein the composite structure of the distal sheath tubing comprises a malleable reinforcement embedded within the outer and inner surface of the distal sheath tubing. ### Claim 8 (depends on 7) The sheath of claim 7 wherein the malleable reinforcement is a coil of wire. ### Claim 9 (depends on 7) The sheath of claim 7 wherein the malleable reinforcement is an expandable stent. ### Claim 10 (depends on 1) The sheath of claim 1 wherein the dilator is removed from the sheath prior to passing instruments through the sheath. ### Claim 11 (depends on 1) The sheath of claim 1 wherein the dilator remains within the sheath while passing instruments through the sheath. ### Claim 12 (depends on 11) The sheath of claim 11 wherein the dilator is a translational dilator and is in the form of a hollow tube. ### Claim 13 (depends on 11) The sheath of claim 11 wherein the distal end of the sheath is unreinforced and does not exert substantial radial force without the presence of the dilator. ### Claim 14 (depends on 10) The sheath of claim 10 wherein the distal end of the sheath is unreinforced and does not exert substantial radial force without the presence of the dilator. ### Claim 15 A method of instrumenting a body lumen comprising the steps of: inserting a dilator into a sheath, said sheath having a radially collapsible distal end; collapsing the distal end of the sheath radially inward around the dilator such that the distal end of the sheath is smaller in diameter than the proximal end of the sheath; inserting the sheath and dilator into the body lumen and advancing said sheath to a target treatment site; expanding the dilator, wherein the dilator expansion causes the distal end of the sheath to expand to a diameter substantially the same as that of the proximal end of the sheath; removing the dilator, wherein a central lumen remains that is substantially the same diameter moving from the proximal end to the distal end of the sheath; and introducing instruments or catheters through the central lumen of the sheath for a therapeutic or diagnostic procedure. ### Claim 16 (depends on 15) The method of claim 15 further comprising the step of removing the sheath from the body lumen, following completion of the procedure. ### Claim 17 (depends on 15) The method of claim 15 further comprising the step of introducing a guidewire into the body lumen prior to introducing the sheath into the body lumen. ### Claim 18 (depends on 17) The method of claim 17 further comprising the step of introducing the dilator and sheath over the guidewire, wherein the guidewire passes through a lumen in the dilator. ### Claim 19 (depends on 15) The method of claim 15 further comprising the step of collapsing the distal end of the sheath prior to removing the sheath from the body lumen. ### Claim 20 An apparatus adapted for instrumenting a body lumen of a patient comprising: a sheath having a proximal end and a distal end; means for radially collapsing the distal end of a sheath and maintaining said radially collapsed configuration; means for introducing the sheath into the body lumen while the distal end is in its radially collapsed configuration; means for dilating the radially collapsed distal end of the sheath; means for 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. ### Claim 21 (depends on 20) The apparatus of claim 20 further comprising means to track the sheath over a guidewire. ### Claim 22 (depends on 20) The apparatus of claim 20 further comprising lubricious coating on the exterior of the sheath. ### Claim 23 (depends on 20) The apparatus of claim 20, wherein the means for dilating the distal portion of the sheath is capable of generating a minimum of 7 atmospheres of pressure within the expandable distal portion. ### Claim 24 (depends on 20) The apparatus of claim 20 wherein the radially expandable distal portion is capable of bending through tortuosity and radii less than 2 cm without substantial distortion or kinking, prior to being radially expanded. ### Claim 25 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. ### Claim 26 (depends on 27) The device of claim 27 wherein the overall sheath length is between 25 and 150 cm. ### Claim 27 (depends on 25) The device of claim 25 wherein the length of the expandable distal end of the sheath is between 1 and 50 cm.