# US 8,540,675 B2 · Introducer assembly and method for forming an introducer assembly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,540,675 B2 - Document ID: US8540675B2 - Status: Granted - Kind: B2 - Application number: 13/356,684 - Filed: 2012-01-24 - Published: 2012-05-31 - Granted: 2013-09-24 - Earliest claimed: 2006-10-02 - Assignees: Greatbach Ltd. - Applicants: Grant A. Mauch; Brian Anderson; Kevin Pietsch; Steve Moreland - Inventors: Grant A. Mauch; Brian Anderson; Kevin Pietsch; Steve Moreland - Web page: https://patentgrep.com/patent/US8540675B2 ## CPC - B29C 66/731: {characterised by the intensive physical properties of the material of the parts to be joined} - A61M 25/0014: {Connecting a tube to a hub} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 25/0662: {Guide tubes} - B29C 66/02245: {Abrading, e.g. grinding, sanding, sandblasting or scraping} - B29C 66/026: {Chemical pre-treatments (B29C66/028 takes precedence)} - B29C 45/14336: {Coating a portion of the article, e.g. the edge of the article (B29C45/14573 and B29C45/14598 take precedence)} - B29C 45/14598: {Coating tubular articles} - B29C 65/02: by heating, with or without pressure - B29C 65/56: using mechanical means {or mechanical connections, e.g. form-fits} - B29C 66/30325: {making use of cavities belonging to at least one of the parts to be joined} - B29C 66/5344: {said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends (B29C66/5346 takes precedence)} - B29C 66/71: {characterised by the composition of the plastics material of the parts to be joined (welding bar compositions B29C65/125)} - B29C 66/7371: {oriented or heat-shrinkable} - B29C 66/73711: {oriented} - B29C 66/7392: {characterised by the material of at least one of the parts being a thermoplastic} - B29C 2793/0018: for making a hole - B29C 2793/0081: before shaping - B29K 2023/06: {PE, i.e. polyethylene} - B29K 2023/12: {PP, i.e. polypropylene} - B29K 2027/12: containing fluorine - B29K 2027/18: PTFE, i.e. polytetrafluoroethylene {, e.g. ePTFE, i.e. expanded polytetrafluoroethylene} - B29K 2075/00: Use of {PU, i.e.} polyureas or polyurethanes {or derivatives thereof}, as moulding material - B29K 2077/00: Use of {PA, i.e.} polyamides, e.g. polyesteramides {or derivatives thereof}, as moulding material - B29K 2079/08: {PI, i.e. polyimides or derivatives thereof} - B29K 2995/005: Oriented - B29L 2023/007: {Medical tubes other than catheters (catheters B29L2031/7542)} - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - 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)} - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES ## Abstract An introducer assembly includes a sheath having a sheath proximal end and distal end, and a passage therethrough. The introducer assembly further includes a handle assembly that is mechanically and/or bonded coupled with a tubular sheath. ## Claims ### Claim 1 An introducer assembly, which comprises: a) a sheath comprising a first lubricious polymeric material extending from a sheath proximal portion to a sheath distal portion with an intermediate portion therebetween, the sheath having an axial passage extending from a proximal end to a distal end thereof, the sheath proximal portion having an outer surface; and b) a handle assembly of a second lubricious polymeric material and comprising a second passage having an inner surface, c) wherein at least one of the sheath outer surface and the inner surface of the second passage in the handle assembly is characterized as having been subjected to a first mechanical surface treatment to thereby form a handle interface, d) wherein the first polymeric material at the sheath proximal portion is directly bonded to the second polymeric material of the handle assembly in an airtight seal between the respective outer and inner surfaces at the handle interface, and e) wherein at least one of the first and second lubricious polymeric materials is PTFE. ### Claim 2 (depends on 1) The introducer assembly of claim 1 further comprising a dilator disposed through the passage. ### Claim 3 (depends on 1) The introducer assembly of claim 1 wherein the first mechanical surface treatment is characterized as having been an etching of at least one of the sheath outer surface and the inner surface of the second passage in the handle assembly. ### Claim 4 (depends on 1) The introducer assembly of claim 1 wherein the handle interface includes one or more flow holes through a thickness of a sheath sidewall forming the sheath proximal portion, the second lubricious polymeric material of the handle assembly coupled to the sheath proximal portion occupying the flow holes. ### Claim 5 (depends on 1) The introducer assembly of claim 1 wherein if the other of the first polymeric tube and the second polymeric material is not PTFE, then it is selected from the group consisting of FEP (fluorinated ethylene-propylene), nylon, polyurethane, polyethylene, polyamide, polypropylene, polyimide, and mixtures thereof. ### Claim 6 (depends on 1) The introducer assembly of claim 1 wherein the first polymeric tube and the second polymeric material are of either a same or a different polymeric material. ### Claim 7 An introducer assembly, which: a) a first lubricious polymeric tube comprising a sheath extending from a sheath proximal portion to a sheath distal portion with an intermediate portion there between, the sheath proximal portion having an outer surface of a substantially constant outer diameter and with a first passage extending there through from a proximal end to a distal end thereof; b) a handle assembly of a second lubricious polymeric material, the handle assembly comprising a second passage having an inner surface of a substantially constant inner diameter; c) a mechanical surface treatment provided on at least one of the outer surface of the sheath proximal portion and the inner surface of the second passage in the handle assembly, thereby forming an interface at the mechanical surface treatment; and d) wherein the second polymeric material of the handle assembly is bonded to the first polymeric tube comprising the sheath, thereby forming an airtight seal between the substantially constant inner diameter at the inner surface of the handle assembly and the substantially constant outer diameter of the outer surface of the sheath proximal portion at the mechanical surface treatment forming the interface with the first and second passages being in aligned communication with each other, e) wherein at least one of the first and second lubricious polymeric materials is PTFE. ### Claim 8 (depends on 7) The introducer assembly of claim 7 wherein at least one of the outer surface of the sheath proximal portion and the inner surface of the second passage in the handle assembly is characterized as having been mechanically etched as the mechanical surface treatment. ### Claim 9 (depends on 8) The introducer assembly of claim 8 wherein at least one of the outer surface of the sheath proximal portion and the inner surface of the second passage in the handle assembly is characterized as having been blasted with sodium bicarbonate as the mechanical etch. ### Claim 10 (depends on 7) The introducer assembly of claim 7 wherein at least one the outer surface of the sheath proximal portion and the inner surface of the handle assembly is characterized as having been further subjected to a chemical etching treatment. ### Claim 11 (depends on 10) The introducer assembly of claim 10 wherein the at least one of the outer surface of the sheath proximal portion and the inner surface of the handle assembly characterized as having been further subjected to the chemical etching treatment overlaps at least a portion of the first mechanical surface treatment forming the interface. ### Claim 12 (depends on 10) The introducer assembly of claim 10 wherein the chemical etching treatment is characterized as having been done with sodium naphthalene/ethylene glycol dimethyl ether solution. ### Claim 13 (depends on 7) The introducer assembly of claim 7 wherein the sheath included holes into which the second polymeric material of the handle connects. ### Claim 14 (depends on 7) The introducer assembly of claim 7 wherein the mechanical surface treatment is characterized as having been done with at least one of the group consisting of sand, glass, mica, pumice, and dry ice. ### Claim 15 (depends on 10) The introducer assembly of claim 10 wherein a contact angle at the at least one of the outer surface of the sheath proximal portion and the inner surface of the second passage in the handle assembly is about 70° at the chemical treatment. ### Claim 16 (depends on 7) The introducer assembly of claim 7 wherein if the other of the first polymeric tube and the second polymeric material in not PTFE, then it is selected from the group consisting of FEP (fluorinated ethylene-propylene), nylon, polyurethane, polyethylene, polyamide, polypropylene, polyimide, and mixtures thereof. ### Claim 17 (depends on 7) The introducer assembly of claim 7 wherein the first polymeric tube and the second polymeric material are of either a same or a different polymeric material. ### Claim 18 An introducer assembly, which: a) a first lubricious polymeric tube comprising a sheath extending from a sheath proximal portion to a sheath distal portion with an intermediate portion there between, the sheath proximal portion having an outer surface with a first passage extending there through from a sheath proximal end to a sheath distal end thereof; b) a handle assembly of a second lubricious polymeric material, the handle assembly comprising a second passage having an inner surface of a substantially constant inner diameter; c) a mechanical surface treatment provided on at least one of the outer surface of the sheath proximal portion and the inner surface of the second passage in the handle assembly, thereby forming an interface at the mechanical surface treatment; and d) wherein at least one of the outer surface of the sheath proximal portion and the inner surface of the handle assembly is characterized as having been further subjected to a chemical etching treatment, e) wherein the second polymeric material of the handle assembly is bonded to the first polymeric tube comprising the sheath, thereby forming an airtight seal between the substantially constant inner diameter at the inner surface of the handle assembly and the substantially constant outer diameter of the outer surface of the sheath proximal portion at the mechanical surface treatment forming the interface with the first and second passages being in aligned communication with each other, f) wherein a contact angle at the at least one of the outer surface of the sheath proximal portion and the inner surface of the second passage in the handle assembly is about 70° at the chemical treatment, and g) wherein at least one of the first and second lubricious polymeric materials is PTFE.