# US 11,027,097 B2 · Monorail mircocatheter and methods for use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,097 B2 - Document ID: US11027097B2 - Status: Granted - Kind: B2 - Application number: 15/870,943 - Filed: 2018-01-13 - Published: 2018-07-19 - Granted: 2021-06-08 - Earliest claimed: 2017-01-13 - Assignees: Sanford Health - Applicants: Sanford Health - Inventors: Thomas Haldis; Alexander Drofa - Web page: https://patentgrep.com/patent/US11027097B2 ## CPC - A61M 25/0169: {Exchanging a catheter while keeping the guidewire in place} - A61M 25/104: {used for angioplasty} - A61M 25/09041: {Mechanisms for insertion of guide wires} - A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system} - A61M 2025/0037: {characterized by lumina being arranged side-by-side} - A61M 2025/0063: {having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body} - A61M 2025/0183: {Rapid exchange or monorail catheters} - A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body} - A61M 2025/1093: {having particular tip characteristics} - 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 The present disclosure provides a catheter including a first tubular structure defining a first lumen, the first tubular structure having a first end and a second end. The catheter may also include a second tubular structure defining a second lumen, the second tubular structure having a first end and a second end. The catheter may also include an aperture between the first tubular structure and the second tubular structure. The aperture is located at the first end of the second tubular structure. A first portion of the first tubular structure extends beyond the aperture, and the second tubular structure is positioned adjacent to a second portion of the first tubular structure. ## Claims ### Claim 1 A catheter comprising: a first tubular structure defining a first lumen, the first tubular structure having a first end and a second end; a second tubular structure defining a second lumen, the second tubular structure having a first end and a second end; an aperture between the first tubular structure and the second tubular structure, the aperture located at the first end of the second tubular structure, wherein a first portion of the first tubular structure extends between the aperture and the first end of the first tubular structure, wherein a second portion of the first tubular structure is coupled to and along a length of the second tubular structure such that the first tubular structure and the second tubular structure share an internal wall having a first end at the aperture and a second end at the second end of the second tubular structure, and wherein a stiffness of an entirety of the first portion of the first tubular structure is less than a stiffness of the second portion of the first tubular structure and a stiffness of the second tubular structure; and a baffle coupled to the first end of the internal wall, wherein the baffle obstructs the first lumen of the first tubular structure in a first position, and wherein the baffle is rotatably coupled to the internal wall from the first position to a second position in which the baffle does not obstruct the first lumen of the first tubular structure; and a locking device positioned at the first end of the first tubular structure, wherein the locking device is configured to prevent the catheter from moving with respect to a guidewire positioned in the first tubular structure in a locked mode, wherein the locking device is configured to allow the catheter to move along the guidewire in an unlocked mode, wherein the locking device is configured to be positioned in the locked mode prior to introducing the catheter and the guidewire together into an arterial configuration, and wherein the locking device is configured to be positioned in the unlocked mode prior to advancing the catheter with respect to the guidewire in the arterial configuration. ### Claim 2 (depends on 1) The catheter of claim 1, wherein the second portion of the first tubular structure and the second tubular structure each comprise a first material, and wherein the first portion of the first tubular structure comprises a second material that is different than the first material. ### Claim 3 (depends on 1) The catheter of claim 1, wherein a thickness of the first portion of the first tubular structure is less than a thickness of the second portion of the first tubular structure and a thickness of the second tubular structure. ### Claim 4 (depends on 1) The catheter of claim 1, wherein a longitudinal axis of the first lumen is parallel to a longitudinal axis of the second lumen at a given location along the length of the first tubular structure and the second tubular structure. ### Claim 5 (depends on 1) The catheter of claim 1, wherein the first end of the second tubular structure comprises a first opening, wherein the second end of the first tubular structure comprises a second opening, and wherein the second end of the second tubular structure comprises a third opening. ### Claim 6 (depends on 1) The catheter of claim 1, wherein the first end of the second tubular structure comprises an angled surface arranged to provide an angled transition from the second lumen to the first lumen through the aperture. ### Claim 7 (depends on 1) The catheter of claim 1, wherein the first end of the second tubular structure comprises a rounded surface arranged to provide a rounded transition from the second lumen to the first lumen through the aperture. ### Claim 8 (depends on 1) The catheter of claim 1, wherein the first portion the first tubular structure is tapered. ### Claim 9 (depends on 1) The catheter of claim 1, wherein the first portion of the first tubular structure includes a variable diameter. ### Claim 10 (depends on 1) The catheter of claim 1, wherein the catheter includes a plurality of metal strands arranged longitudinally or helically along at least a portion of a length of one or both of the first tubular structure and the second tubular structure. ### Claim 11 (depends on 10) The catheter of claim 10, wherein the plurality of metal strands comprises stainless steel, cobalt chromium, nitinol, or a combination thereof. ### Claim 12 (depends on 10) The catheter of claim 10, wherein the plurality of metal strands are braided. ### Claim 13 (depends on 10) The catheter of claim 10, wherein the plurality of metal strands comprise strips. ### Claim 14 (depends on 10) The catheter of claim 10, wherein a portion of the plurality of metal strands arranged along the second portion of the first tubular structure and the second tubular structure are wider than a portion of the plurality of metal strands arranged along the first portion of the first tubular structure. ### Claim 15 (depends on 10) The catheter of claim 10, wherein a portion of the plurality of metal strands arranged along the second portion of the first tubular structure and the second tubular structure are thicker than a portion of the plurality of metal strands arranged along the first portion of the first tubular structure. ### Claim 16 (depends on 1) The catheter of claim 1, wherein the first lumen has a length ranging from about 30 cm to about 170 cm. ### Claim 17 (depends on 1) The catheter of claim 1, wherein a diameter of the second portion of the first tubular structure has a range from about 0.35 mm to about 6 mm. ### Claim 18 (depends on 1) The catheter of claim 1, wherein the second tubular structure has a length ranging from about 5 cm to about 160 cm. ### Claim 19 (depends on 1) The catheter of claim 1, wherein a diameter of the second tubular structure has a range from about 0.25 mm to about 1.2 mm. ### Claim 20 (depends on 1) The catheter of claim 1, wherein the first portion of the first tubular structure has a length ranging from about 3 cm to about 25 cm. ### Claim 21 (depends on 1) The catheter of claim 1, wherein a diameter of the first portion of the first tubular structure has a range from about 0.35 mm to about 6 mm. ### Claim 22 (depends on 1) The catheter of claim 1, wherein the first portion of the first tubular structure has a radius of curvature ranging from about 0 mm to about 170 mm. ### Claim 23 (depends on 1) A method comprising: introducing the catheter according to claim 1 and the guidewire together into the arterial configuration, wherein a distal end of the guidewire extends distal to the first end of the first tubular structure; advancing the catheter and the guidewire together through the arterial configuration until the distal end of the guidewire is advanced across an occlusion in the arterial configuration; advancing the catheter with respect to the guidewire in the arterial configuration such that the first end of the first tubular structure is advanced across the occlusion; retracting the distal end of the guidewire into the first tubular structure through the aperture and into the second tubular structure; advancing a revascularization device through the second end of the first tubular structure to the first end of the first tubular structure; and retracting the catheter relative to the revascularization device such that the revascularization device is deployed into the arterial configuration with a first end of the revascularization device located distal to the occlusion and a second end of the revascularization device located proximal to the occlusion. ### Claim 24 (depends on 23) The method of claim 23, further comprising: removing the revascularization device from the arterial configuration after a predetermined period of time; and determining whether the occlusion has been removed from the arterial configuration. ### Claim 25 (depends on 24) The method of claim 24, further comprising: in response to a determination that the occlusion has been removed from the arterial configuration, removing the guidewire from the arterial configuration; and removing the catheter from the arterial configuration. ### Claim 26 (depends on 24) The method of claim 24, further comprising: in response to a determination that the occlusion has not been removed from the arterial configuration, re-advancing the distal end of the guidewire through the aperture and into the first lumen of the first tubular structure and exiting the catheter at the first end of the first tubular structure; re-advancing the first end of the first tubular structure across the occlusion over the guidewire such that the first end of the first tubular structure is located distal to the occlusion; advancing a second revascularization device through the catheter, such that the second revascularization device enters the catheter at the second end of the first tubular structure and exits the catheter at the first end of the first tubular structure; introducing the second revascularization device into the arterial configuration such that a first end of the second revascularization device is located distal to the occlusion and a second end of the second revascularization device is located proximal to the occlusion; and removing the second revascularization device from the arterial configuration after a predetermined period of time. ### Claim 27 (depends on 24) The method of claim 24, further comprising: in response to a determination that the occlusion has not been removed from the arterial configuration, re-advancing the distal end of the guidewire through the aperture and into the first lumen of the first tubular structure and exiting the catheter at the first end of the first tubular structure; re-advancing the first end of the first tubular structure across the occlusion over the guidewire such that the first end of the first tubular structure is located distal to the occlusion; re-advancing the revascularization device through the catheter, such that the revascularization device enters the catheter at the second end of the first tubular structure and exits the catheter at the first end of the first tubular structure; introducing the revascularization device into the arterial configuration such that a first end of the revascularization device is located distal to the occlusion and a second end of the revascularization device is located proximal to the occlusion; and removing the revascularization device from the arterial configuration after a predetermined period of time. ### Claim 28 (depends on 23) The method of claim 23, further comprising, after retracting the distal end of the guidewire into the first tubular structure through the aperture and into the second tubular structure, retracting the guidewire along with the catheter. ### Claim 29 (depends on 23) The method of claim 23, wherein the distal end of the guidewire is retracted into the second tubular structure at least a distance corresponding to a length of the occlusion. ### Claim 30 (depends on 23) The method of claim 23, wherein retracting the distal end of the guidewire into the first tubular structure through the aperture and into the second tubular structure further comprises retracting the distal end of the guidewire out of the second end of the second tubular structure and into the arterial configuration. ### Claim 31 (depends on 30) The method of claim 30, further comprising: re-advancing the distal end of the guidewire into the second end of the second tubular structure. ### Claim 32 (depends on 1) A method comprising: introducing a guidewire into an arterial configuration and through an occlusion via arterial access; loading the catheter according to claim 1 onto the guidewire, such that a proximal end of the guidewire enters the catheter at the first end of the first tubular structure, advances past the aperture and into the second portion of the first tubular structure and exits at the second end of the first tubular structure; advancing the catheter along the guidewire and introducing the catheter into the arterial configuration such that the first end of the first tubular structure is advanced across the occlusion; advancing a revascularization device through the second end of the second tubular structure, through the aperture, and into the first end of the first tubular structure; and retracting the catheter relative to the revascularization device such that the revascularization device is deployed into the arterial configuration with a first end of the revascularization device located distal to the occlusion and a second end of the revascularization device located proximal to the occlusion. ### Claim 33 (depends on 1) A method comprising: introducing a guidewire into an arterial configuration and through an occlusion via arterial access; loading the catheter according to claim 1 onto the guidewire, such that a proximal end of the guidewire enters the catheter at the first end of the first tubular structure, advances through the aperture and into the second lumen of the second tubular structure and exits at the second end of the second tubular structure; moving the catheter along the guidewire and introducing the catheter into the arterial configuration such that the first end of the first tubular structure is advanced across the occlusion; advancing a revascularization device through the second end of the first tubular structure to the first end of the first tubular structure; and retracting the catheter relative to the revascularization device such that the revascularization device is deployed into the arterial configuration with a first end of the revascularization device located distal to the occlusion and a second end of the revascularization device located proximal to the occlusion.