# US 2018/0021548 A1 · Low profile introducer apparatus > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0021548 A1 - Document ID: US20180021548A1 - Status: Published application - Kind: A1 - Application number: 15/720,172 - Filed: 2017-09-29 - Published: 2018-01-25 - Earliest claimed: 2005-05-27 - Assignees: Cook Medical Technologies LLC - Applicants: Cook Medical Technologies LLC - Inventors: Arman H. Valaie - Web page: https://patentgrep.com/patent/US20180021548A1 ## CPC - A61M 25/065: {Guide needles} - A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)} - A61B 17/3421: {Cannulas} - A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)} - A61M 25/0662: {Guide tubes} - A61M 25/09: Guide wires - A61M 25/09041: {Mechanisms for insertion of guide wires} - A61M 25/001: {Forming the tip of a catheter, e.g. bevelling process, join or taper} - A61M 2025/09175: {having specific characteristics at the distal tip} - 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 An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch. The inner cannula includes a tapered distal end portion. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula. ## Claims ### Claim 1 An introducer apparatus, comprising: an outer sleeve having proximal and distal open ends, and having a lumen extending longitudinally therethrough, said outer sleeve having a profile such that at least a portion of said outer sleeve tapers toward said outer sleeve distal end at an angle not exceeding 2° relative to a longitudinal axis of the apparatus, said distal open end of said outer sleeve having a wall thickness not exceeding 0.003 inch; and an inner cannula having proximal and distal open ends, and having a lumen extending longitudinally therethrough, said inner cannula sized to be received within the lumen of said outer sleeve, said inner cannula having a portion that tapers toward the inner cannula distal end, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; and wherein the greatest radial extent of the inner cannula is not greater than the outer diameter of the outer sleeve. ### Claim 2 (depends on 1) The introducer apparatus of claim 1, wherein said outer sleeve has an outer diameter of between 2-10 French. ### Claim 3 (depends on 1) The introducer apparatus of claim 1, wherein said outer sleeve has an outer diameter not exceeding 6 French. ### Claim 4 (depends on 2) The introducer apparatus of claim 2, wherein said outer sleeve has an outer diameter of between 4-6 French. ### Claim 5 (depends on 4) The introducer apparatus of claim 4, wherein said outer sleeve has a diameter of 4 French. ### Claim 6 (depends on 4) The introducer apparatus of claim 4, wherein said outer sleeve has a diameter of 5 French. ### Claim 7 (depends on 1) The introducer assembly of claim 1, wherein said outer sleeve tapered portion comprises between the distal 5 and 50 mm of said outer sleeve. ### Claim 8 (depends on 7) The introducer apparatus of claim 7, wherein said outer sleeve tapered portion comprises between the distal 8 and 20 mm of said outer sleeve. ### Claim 9 (depends on 8) The introducer apparatus of claim 8, wherein said outer sleeve tapered portion comprises the distal 15 mm of said outer sleeve. ### Claim 10 (depends on 1) The introducer apparatus of claim 1, wherein said outer sleeve tapered portion is tapered at an angle of between 0.5° and 2°. ### Claim 11 (depends on 5) The introducer apparatus of claim 5, wherein said outer sleeve tapered portion is tapered at an angle between 1° and 1.5°. ### Claim 12 (depends on 1) The introducer apparatus of claim 1, wherein said distal open end of said outer sleeve has a wall thickness of between 0.0005 and 0.0015 inch. ### Claim 13 (depends on 12) The introducer apparatus of claim 12 wherein said distal open end of said outer sleeve has a wall thickness of between 0.0005 and 0.003 inches. ### Claim 14 (depends on 13) The introducer apparatus of claim 13 wherein said distal open end of said outer sleeve has a wall thickness of between 0.0005 and 0.0015 inches. ### Claim 15 (depends on 14) The introducer apparatus of claim 14 wherein said distal open end of said outer sleeve has a wall thickness of 0.001 inch. ### Claim 16 An introducer apparatus, comprising: an outer sleeve having proximal and distal open ends, and having a lumen extending longitudinally therethrough, said outer sleeve having a profile such that at least a portion of said outer sleeve tapers toward said outer sleeve distal end at an angle not exceeding 2° relative to a longitudinal axis of the apparatus, said distal open end of said outer sleeve having a wall thickness not exceeding 0.003 inch; and an inner cannula having proximal and distal open ends, and having a lumen extending longitudinally therethrough, said inner cannula sized to be received within the lumen of said outer sleeve, said inner cannula having a portion that tapers toward the inner cannula distal end, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; wherein the greatest radial extent of the inner cannula is not greater than the outer diameter of the outer sleeve; wherein said outer sleeve tapered portion comprises between the distal 5 and 50 mm of said outer sleeve, and wherein said outer sleeve has an outer diameter not exceeding 6 French. ### Claim 17 An introducer kit comprising: a hollow thinwall needle, said needle having an outer diameter that does not exceed 21 gauge (0.032 inch; 0.81 mm), and an inner diameter that does not exceed t 0.018 inch (0.46 mm); a first wire guide, said first wire guide having an outer diameter not less than 0.035 inch (0.89 mm); a second wire guide, said second wire guide receivable in a bore of said needle; an outer sleeve, said outer sleeve having proximal and distal open ends and having a lumen extending longitudinally therethrough, said outer sleeve having a profile such that a distal portion of said outer sleeve tapers toward said outer sleeve distal end at an angle not exceeding 2° relative to a longitudinal axis of the apparatus, said outer sleeve tapered portion comprising between the distal 8 and 20 mm of said outer sleeve, said outer sleeve having an outer diameter that does not exceed 6 French and having a distal open end sized such that said first wire guide is receivable therethrough, said distal end of said outer sleeve having a wall thickness between 0.0005 and 0.0015 inch; and an inner cannula, said inner cannula having proximal and distal open ends and having a lumen extending longitudinally therethrough, said inner cannula sized to be received within the lumen of said outer sleeve, said inner cannula having a portion that tapers toward the inner cannula distal end, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; and wherein the greatest radial extent of the inner cannula is not greater than the outer diameter of the outer sleeve. ### Claim 18 (depends on 17) The kit of claim 17, wherein said outer sleeve tapered portion comprises between the distal 5 and 50 mm of said outer sleeve, and wherein said outer sleeve has an outer diameter not exceeding 6 French. ### Claim 19 A method of inserting a wire guide into a body vessel of a patient for use in introducing a medical interventional device, comprising: providing an introducer system, said system comprising an introducer needle having an outer diameter that does not exceed 21 gauge (0.032 inch; 0.81 mm) and an inner diameter that does not exceed 0.018 inch (0.46 mm); a first wire guide having an outer diameter not less than 0.035 inch (0.89 mm); a second wire guide having an outer diameter not greater than 0.018 inch (0.46 mm) and being receivable in a bore of said introducer needle; and an introducer apparatus comprising an outer sleeve and an inner cannula, said inner cannula removably received in a lumen of said outer sleeve, said outer sleeve having proximal and distal open ends and a profile such that a distal portion of said outer sleeve tapers toward said sleeve distal end at an angle not exceeding 2° with a longitudinal axis of the sleeve, said outer sleeve distal open end sized such that said first wire guide is receivable therethrough, said inner cannula having proximal and distal open ends and a lumen extending therethrough, and having a portion that tapers toward the inner cannula distal end, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; and wherein the greatest radial extent of the inner cannula is not greater than the outer diameter of the outer sleeve; injecting said needle into said body vessel; guiding said second wire guide through said needle bore such that a distal end of said wire guide extends beyond said needle in said body vessel; withdrawing said needle from said body vessel over said second wire guide; introducing said introducer apparatus over said second wire guide such that the respective distal ends of said outer sleeve and inner cannula are in said body vessel; wherein said introducing step comprises inserting said distal end of said inner cannula into said body vessel at a first insertion force, and inserting said introducer apparatus at a juncture of said outer sleeve distal open end and said inner cannula at a second insertion force, such that said second insertion force does not exceed said first insertion force; withdrawing said second wire guide from said introducer apparatus while maintaining the introducer apparatus in the body vessel; separating the inner cannula from the outer sleeve, and removing the inner cannula while maintaining the outer sleeve in the body vessel; and guiding said first wire guide through said outer catheter such that a distal end of said first wire guide extends beyond said outer sleeve in said body vessel. ### Claim 20 (depends on 16) The method of claim 16, wherein said angle is between 1° and 1.5°.