# US 2017/0281907 A1 · Two-part insertion tool and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2017/0281907 A1 - Document ID: US20170281907A1 - Status: Published application - Kind: A1 - Application number: 15/467,554 - Filed: 2017-03-23 - Published: 2017-10-05 - Earliest claimed: 2016-03-31 - Assignees: SurModics, Inc. - Applicants: Surmodics, Inc. - Inventors: Bruce M. Jelle; Joram Slager; Joseph Schmidt McGonigle; Nathan A. Lockwood - Web page: https://patentgrep.com/patent/US20170281907A1 ## CPC - A61M 25/0662: {Guide tubes} - A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter} - A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/0668: {splittable, tear apart} - A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof - A61M 2025/0024: {Expandable catheters or sheaths} - A61M 2025/0046: {Coatings for improving slidability} - A61M 2025/0047: {the inner layer having a higher lubricity} - A61M 2025/006: {having a special surface topography or special surface properties, e.g. roughened or knurled surface} - A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube} - A61M 2025/0687: {having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths} - A61M 2039/064: {Slit-valve} - A61M 2039/0666: {Flap-valve} - A61M 2207/00: Methods of manufacture, assembly or production - 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)} ## Abstract Embodiments herein include an insertion tool for inserting a medical device into another medical device, such as a hemostasis sealing valve, and related methods. In an embodiment, an insertion tool includes a guide sheath and a protection tube. The guide sheath can include a flared proximal end. The guide sheath can further include a central lumen. The guide sheath can further include a locking notch disposed on the inner surface between the proximal end and the distal end. The protection tube can include a flared proximal end. A portion of the protection tube can be situated within the central lumen of the guide sheath. The flared proximal end of the protection tube can be sized to fit within the locking notch and can have an outer diameter larger than portions of the inner surface immediately adjacent to the locking notch. Other embodiments are also included herein. ## Claims ### Claim 1 An insertion tool comprising: (i) a guide sheath comprising a proximal end and a distal end, the proximal end being flared, the guide sheath comprising an inner surface defining a central lumen, the guide sheath further comprising a locking notch disposed on the inner surface between the proximal end and the distal end; and (ii) a protection tube comprising a proximal end and a distal end, the proximal ended being flared; wherein a portion of the protection tube is situated within the central lumen of the guide sheath; and wherein the flared proximal end of the protection tube is sized to fit within the locking notch and has an outer diameter larger than portions of the inner surface immediately adjacent to the locking notch. ### Claim 2 (depends on 1) The insertion tool of claim 1, wherein the distal end of the protection tube extends beyond the distal end of the guide sheath by a distance of 3 mm to 9 mm when the flared proximal end of the protection tube is seated within the locking notch of the guide sheath. ### Claim 3 (depends on 1) The insertion tool of claim 1, the inner surface of the guide sheath comprising a plurality of ridges oriented parallel to a lengthwise axis of the guide sheath. ### Claim 4 (depends on 1) The insertion tool of claim 1, the inner surface of the guide sheath comprising a plurality of projections oriented parallel to a lengthwise axis of the guide sheath. ### Claim 5 (depends on 1) The insertion tool of claim 1, the inner surface of the protection tube comprising a plurality of ridges oriented parallel to a lengthwise axis of the protection tube. ### Claim 6 (depends on 1) The insertion tool of claim 1, the inner surface of the protection tube comprising a plurality of projections oriented parallel to a lengthwise axis of the protection tube. ### Claim 7 (depends on 1) The insertion tool of claim 1, the distal end of the protection tube comprising a tapered portion. ### Claim 8 (depends on 1) The insertion tool of claim 1, the flared proximal end of the protection tube having an outside average diameter of about 0.75 mm to about 12 mm. ### Claim 9 (depends on 1) The insertion tool of claim 1, wherein the distance between the distal end of the guide sheath and the distal end of the protection tube is about 3 mm to about 9 mm when the flared proximal end of the protection tube is situated within the locking notch. ### Claim 10 (depends on 1) The insertion tool of claim 1, the protection tube comprising an inner surface defining a central lumen. ### Claim 11 (depends on 1) The insertion tool of claim 1, the guide sheath comprising a polymer. ### Claim 12 (depends on 11) The insertion tool of claim 11, the polymer selected from the group consisting of polyamide, polyimide, polyether block amide (PEBAX), polyether ether ketone (PEEK), high density polyethylene (HDPE), polyethylene, polyurethane, or polyethylene vinyl acetate. ### Claim 13 (depends on 1) The insertion tool of claim 1, the protection tube comprising a polymer. ### Claim 14 (depends on 13) The insertion tool of claim 13, the polymer selected from the group consisting of polyamide, polyimide, polyether block amide (PEBAX), polyether ether ketone (PEEK), high density polyethylene (HDPE), polyethylene, polyurethane, or polyethylene vinyl acetate. ### Claim 15 (depends on 1) The insertion tool of claim 1, the guide sheath comprising a wall thickness that is thicker than a wall thickness of the protection tube. ### Claim 16 (depends on 1) The insertion tool of claim 1, further comprising a hydrophilic coating disposed on the inner surface of the guide sheath. ### Claim 17 (depends on 1) The insertion tool of claim 1, further comprising a hydrophilic coating disposed on the inner surface of the protection tube. ### Claim 18 (depends on 1) The insertion tool of claim 1, the guide sheath wall comprising a weakened separation line to facilitate separating the guide sheath into distinct segments. ### Claim 19 (depends on 1) The insertion tool of claim 1, the protection tube wall comprising a weakened separation line to facilitate separating the protection tube into distinct segments. ### Claim 20 An insertion tool comprising: (i) a guide sheath having an outer diameter, an inner diameter, a proximal end and a distal end, the proximal end being flared; and (ii) a protection tube having an outer diameter, an inner diameter, a flared proximal end and a tapered distal end; wherein the protection tube outer diameter is less than the guide sheath inner diameter and a portion of the protection tube is situated within the guide sheath; and the flared proximal end of the protection tube is sized to fit a locking notch located between the proximal end of the guide sheath and the distal end of the guide sheath. ### Claim 21 A method for inserting a first medical device into a second medical device comprising: aligning an insertion tool with the second medical device, the insertion tool comprising: (i) a guide sheath comprising a proximal end and a distal end, the proximal end being flared, the guide sheath comprising an inner surface defining a central lumen, the guide sheath further comprising a locking notch disposed on the inner surface between the proximal end and the distal end; and (ii) a protection tube comprising a proximal end and a distal end, the proximal ended being flared; wherein the flared proximal end of the protection tube is sized to fit within the locking notch and has an outer diameter larger than portions of the inner surface immediately adjacent to the locking notch; inserting the distal end of the protection tube into the second medical device; and inserting the first medical device through the central lumen of the guide sheath into the protection tube and through the second medical device. ### Claim 22 (depends on 21) The method of claim 21, further comprising inserting the protection tube into the guide sheath until the flared proximal end of the protection tube engages the locking notch.