# US 11,027,099 B2 · Vascular access device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,099 B2 - Document ID: US11027099B2 - Status: Granted - Kind: B2 - Application number: 15/568,765 - Filed: 2016-04-15 - Published: 2018-10-18 - Granted: 2021-06-08 - Earliest claimed: 2015-04-30 - Assignees: Smiths Medical ASD, Inc. - Applicants: Smiths Medical ASD, Inc. - Inventors: Steven F. Bierman - Web page: https://patentgrep.com/patent/US11027099B2 ## CPC - A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters} - A61M 25/0668: {splittable, tear apart} - A61M 25/0693: {Flashback chambers} - A61M 39/02: Access sites - A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body} - A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/09041: {Mechanisms for insertion of guide wires} - 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 2039/0258: {for vascular access, e.g. blood stream access} - A61M 2039/0273: {for introducing catheters into the body} - A61M 2039/0291: {method or device for implanting it in the body} - A61M 2039/062: {used with a catheter} - 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 An access device for placing a medical article within a body space includes a syringe, a needle, and a sheath which are employed together with a guide wire. The sheath can be coaxially and slideably disposed about the needle. During insertion of the sheath over the needle, guide wire and into the body space, the syringe provides a negative pressure to ensure that any air located between the inside diameter of the sheath and the outside diameter of the needle is drawn into the needle rather than into the body space. In certain embodiments, a dilator is coaxially and slideably disposed about the needle and within the sheath. ## Claims ### Claim 1 An access device for placing a medical article within a body space, the access device comprising: a barrel and a plunger slidingly disposed in the barrel, the plunger having a channel sized and shaped to receive a guide wire therethrough, the barrel defining a fluid chamber; an interior needle portion at least partially disposed in the channel, the interior needle portion comprising an aperture extending through a side wall of the interior needle portion and into the fluid chamber; a needle hub disposed on an exterior needle portion extending from the barrel and being in flow communication with the interior needle portion and the fluid chamber, the needle hub comprising a first locking structure at a proximal part of the needle hub and a second locking structure at a distal part of the needle hub; a sheath coaxially disposed about the exterior needle portion and slideable along the exterior needle portion, a distal end of the sheath being positioned proximal to a distal end of the exterior needle portion; and a dilator disposed about the exterior needle portion and within the sheath, the dilator comprising a dilator hub and a dilator body, a distal end of the dilator body positioned distal to the distal end of the sheath, wherein the first locking structure is configured to releasably secure the needle hub to the barrel, and wherein the second locking structure is configured to releasably secure the needle hub to the dilator hub. ### Claim 2 (depends on 1) The access device of claim 1, wherein the sheath is splittable into a plurality of portions. ### Claim 3 (depends on 2) The access device of claim 2, wherein the sheath comprises a sheath body and a sheath hub, the sheath body being a tubular structure of sufficient flexibility to extend without kinking through the skin of a patient and into and along the patient's vessel, and wherein the sheath body includes a pre-determined line along which the sheath body is splittable into the plurality of portions. ### Claim 4 (depends on 3) The access device of claim 3, wherein the pre-determined line is parallel to a longitudinal axis of the sheath body. ### Claim 5 (depends on 1) The access device of claim 1, wherein the sheath comprises a valve. ### Claim 6 (depends on 5) The access device of claim 5, wherein the sheath comprises a sheath body and a sheath hub, the sheath hub defining an inner cavity, and wherein the valve is disposed in the inner cavity. ### Claim 7 (depends on 5) The access device of claim 5, wherein the valve is configured to seal against the exterior needle portion. ### Claim 8 (depends on 1) The access device of claim 1, wherein the plunger comprises a valve, the valve being configured to seal against the guide wire disposed in the channel. ### Claim 9 An access device for placing a medical article within a body space, the access device comprising: a syringe and a needle extending from the syringe, the syringe having a channel configured to receive a guide wire extending through the needle, the needle comprising a first locking structure and a second locking structure, wherein the syringe comprises a barrel and a plunger slidingly disposed in the barrel, wherein the plunger comprises a valve and a valve channel in flow communication with the valve, the valve being configured to seal against the guide wire disposed in the valve channel; a sheath coaxially disposed about the needle and slideable along the needle; and a dilator disposed about the needle and within the sheath, a distal end of the dilator positioned distal to a distal end of the sheath, wherein the first locking structure is configured to releasably secure the needle to the syringe, and wherein the second locking structure is configured to releasably secure the needle to the dilator. ### Claim 10 (depends on 9) The access device of claim 9, wherein the sheath is peelable. ### Claim 11 (depends on 9) The access device of claim 9, wherein the sheath comprises a sheath valve. ### Claim 12 (depends on 11) The access device of claim 11, wherein the sheath valve is configured to seal against the needle. ### Claim 13 A method for placing a medical article within a body space, the method comprising: penetrating a blood vessel with an access device, the access device comprising: a syringe and a needle extending from the syringe, the syringe having a channel configured to receive a guide wire extending through the needle, the needle comprising a first locking structure and a second locking structure, a sheath coaxially disposed about the needle, and a dilator disposed about the needle and within the sheath, a distal end of the dilator positioned distal to a distal end of the sheath, wherein the first locking structure is configured to releasably secure the needle to the syringe, and wherein the second locking structure is configured to releasably secure the needle to the dilator; feeding the guide wire through the channel, the needle, and into the blood vessel; sliding the sheath along the needle in a distal direction until at least a portion of the sheath is disposed in the blood vessel; and removing the syringe, the needle, and the guide wire from the blood vessel leaving the sheath. ### Claim 14 (depends on 13) The method of claim 13, wherein the syringe comprises a barrel and a plunger slidingly disposed in the barrel, and wherein penetrating the blood vessel further comprises retracting the plunger in the barrel to create a negative pressure in the syringe. ### Claim 15 (depends on 13) The method of claim 13, further comprising inserting a medical article into the blood vessel through the sheath. ### Claim 16 (depends on 15) The method of claim 15, further comprising peeling the sheath into a plurality of portions for removal from the medical article. ### Claim 17 (depends on 13) The method of claim 13, further comprising: sliding the dilator along the needle in a distal direction until at least a portion of the dilator is inserted into tissue; and removing the syringe, the needle, the dilator, and the guide wire from the body of the patient while leaving the sheath in the blood vessel. ### Claim 18 (depends on 13) The method of claim 13, wherein removing the syringe, the needle, and the guide wire from the blood vessel is performed simultaneously.