# US 10,765,842 B2 · Expandable medical devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,842 B2 - Document ID: US10765842B2 - Status: Granted - Kind: B2 - Application number: 15/146,047 - Filed: 2016-05-04 - Published: 2016-08-25 - Granted: 2020-09-08 - Earliest claimed: 2011-07-14 - Assignees: W. L. Gore & Associates, Inc. - Applicants: W.L. Gore & Associates, Inc. - Inventors: Carey V. Campbell; Cody L. Hartman - Web page: https://patentgrep.com/patent/US10765842B2 ## CPC - A61M 25/104: {used for angioplasty} - A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for - A61L 29/041: {obtained by reactions only involving carbon-to-carbon unsaturated bonds} - A61L 29/146: {Porous materials, e.g. foams or sponges} - A61B 2017/22001: {Angioplasty, e.g. PCTA} - A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)} - A61B 2017/22081: {Treatment of vulnerable plaque} - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - 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 2025/1084: {having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands} - 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) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract A medical device with an expandable element and expandable tubular sleeve surrounding at least a portion of the expandable element which influences the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided. ## Claims ### Claim 1 A medical device, comprising: an elongated tubular body having proximal and distal ends; an expandable element at the distal end of the elongated tubular body, the expandable element being configured to be actuated to exert a first expansion pressure and a second expansion pressure that is greater than the first expansion pressure; and an expandable tubular sleeve including a first end portion, a second end portion, and a middle portion between the first and second end portions, the expandable tubular sleeve disposed about the expandable element such that the expandable tubular sleeve can be fully expanded and retracted in association with the expandable element, the first end portion of the expandable tubular sleeve having a first radial strength and the middle portion of the expandable tubular sleeve having a second radial strength that is less than the first radial strength, wherein the expandable element has a sequence of expansion dictated only by the first and second radial strengths of the expandable tubular sleeve such that the middle portion of the expandable tubular sleeve expands first in response to applying the first expansion pressure to the expandable tubular sleeve and the first end portion of the expandable tubular sleeve expands subsequently in response to applying the second expansion pressure to the expandable tubular sleeve that is greater than the first expansion pressure, and wherein the first radial strength of the first end portion is defined by an amount of longitudinal compression of the first end portion such that the first end portion is characterized by a first compression ratio and the second radial strength of the middle portion is defined by an amount of longitudinal compression of the middle portion such that the middle portion is characterized by a second compression ratio that is lower than the first compression ratio. ### Claim 2 (depends on 1) The medical device of claim 1, wherein the expandable tubular sleeve is positioned internally to the expandable element. ### Claim 3 (depends on 1) The medical device of claim 1, wherein the expandable tubular sleeve is positioned externally to the expandable element. ### Claim 4 (depends on 1) The medical device of claim 1, wherein the expandable element is mechanically expanded. ### Claim 5 (depends on 1) The medical device of claim 1, wherein the expandable tubular sleeve has a uniform wall thickness prior to expansion. ### Claim 6 (depends on 1) The medical device of claim 1, wherein the expandable tubular sleeve has a uniform wall thickness after expansion. ### Claim 7 (depends on 1) The medical device of claim 1, wherein the first end portion of the expandable tubular sleeve comprises a distal end portion and the second end portion comprises a proximal end portion. ### Claim 8 (depends on 1) A method of treating a site on a body lumen using the medical device of claim 1, comprising: positioning within a body lumen the medical device of claim 1 so that the expandable element in folded form is adjacent to a treatment site; expanding the expandable element at a pressure sufficient to expand the expandable element at the middle portion of the expandable tubular sleeve; and expanding the expandable element at an increased pressure to expand the expandable element at the first end portion of expandable tubular sleeve. ### Claim 9 (depends on 8) The method of claim 8, wherein the middle portion of the expandable tubular sleeve corresponds to a central portion of the expandable tubular sleeve and the first end portion of the expandable tubular sleeve corresponds to at least one of a distal end portion and a proximal end portion of the expandable tubular sleeve. ### Claim 10 (depends on 1) The medical device of claim 1, wherein the expandable tubular sleeve comprises expanded polytetrafluoroethylene. ### Claim 11 A medical device comprising: an elongated tubular body having proximal and distal ends; an expandable element at the distal end of the elongated tubular body, the expandable element being configured to exert a first expansion pressure and a second expansion pressure that is greater than the first expansion pressure; and an expandable tubular sleeve including a first end region, a second end region, and a middle region disposed between the first and second end regions, the expandable tubular sleeve disposed about the expandable element such that the expandable tubular sleeve can be fully expanded and retracted in association with the expandable element, the first end region having an amount of longitudinal compression that defines a first compression ratio and the middle region having an amount of longitudinal compression that defines a second compression ratio that is less than the first compression ratio such that first and second compression ratios of the expandable tubular sleeve alone are sufficient to dictate a sequence of expansion of the expandable element that includes the middle region expanding first in response to applying the first expansion pressure and the first end region expanding subsequently in response to applying the second expansion pressure greater than the first expansion pressure. ### Claim 12 (depends on 11) The medical device of claim 11, wherein the expandable tubular sleeve is positioned internally to the expandable element. ### Claim 13 (depends on 11) The medical device of claim 11, wherein the expandable tubular sleeve is positioned externally to the expandable element. ### Claim 14 (depends on 11) The medical device of claim 11, wherein the expandable element is mechanically expanded. ### Claim 15 (depends on 11) The medical device of claim 11, wherein the expandable sleeve has a uniform wall thickness prior to expansion. ### Claim 16 (depends on 11) The medical device of claim 11, wherein the expandable tubular sleeve has a uniform wall thickness after expansion. ### Claim 17 (depends on 11) The medical device of claim 11, wherein the expandable tubular sleeve comprises one or more materials having a porous microstructure. ### Claim 18 (depends on 17) The medical device of claim 17, wherein the one or more materials includes expanded polytetrafluoroethylene. ### Claim 19 (depends on 17) The medical device of claim 17, wherein the one or more materials includes ultra high molecular weight polyethylene. ### Claim 20 (depends on 17) The medical device of claim 17, wherein the one or more materials includes a fibrillated material. ### Claim 21 (depends on 11) The medical device of claim 11, wherein the first end region of the expandable tubular sleeve comprises a distal end portion and a second end region comprises a proximal end portion. ### Claim 22 (depends on 11) A method of treating a site on a body lumen using the medical device of claim 11, comprising: positioning within a body lumen the medical device so that the expandable element in folded form is adjacent to a treatment site; expanding the expandable element at a pressure sufficient to expand the expandable element at the middle region of the expandable tubular sleeve; and expanding the expandable element at an increased pressure to expand the expandable element at the first end region of expandable tubular sleeve. ### Claim 23 (depends on 22) The method of claim 22, wherein the middle region of the expandable tubular sleeve corresponds to a central or middle portion of the expandable tubular sleeve and the first end region of the expandable tubular sleeve corresponds to at least one of a distal end portion and a proximal end portion of the expandable tubular sleeve. ### Claim 24 A medical device, comprising: an elongated tubular body having proximal and distal ends; an expandable element at the distal end of the elongated tubular body, the expandable element being configured to be activated to outwardly exert expansion pressure; and an expandable tubular sleeve disposed about the expandable element such that the expandable tubular sleeve can be fully expanded and retracted in association with the expandable element, the expandable tubular sleeve comprising at least a first end portion, a second end portion, and a middle portion between the first and second end portions, the middle portion having a radial strength less than a radial strength of the first end portion and less than a radial strength of the second end portion, the radial strength of the first end portion being defined by a compression ratio of the first end portion, the radial strength of the second end portion being defined by a compression ratio of the second end portion, and the radial strength of the middle portion being defined by a compression ratio of the middle portion of the expandable element, the middle element having a lower compression ratio than the first and second end portions such that first and second compression ratios of the expandable tubular sleeve alone are sufficient to dictate a sequence of expansion of the expandable tubular sleeve according to which the middle portion expands first in response to applying a lower expansion pressure and the first or second end portion expands subsequently to the middle portion in response to applying a higher expansion pressure. ### Claim 25 (depends on 24) The medical device of claim 24, wherein the expandable element is inflated within the body lumen at a force sufficient to inflate the at least two portions of the expandable tubular sleeve. ### Claim 26 (depends on 24) The medical device of claim 24, wherein the expandable element is evacuated prior to being withdrawn from the body lumen. ### Claim 27 (depends on 24) The medical device of claim 24, wherein the expandable tubular sleeve is positioned internally to the expandable element. ### Claim 28 (depends on 24) The medical device of claim 24, wherein the expandable tubular sleeve is positioned externally to the expandable element.