# US 10,864,354 B2 · Hydraulic auto crossing balloon/catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,354 B2 - Document ID: US10864354B2 - Status: Granted - Kind: B2 - Application number: 15/814,851 - Filed: 2017-11-16 - Published: 2018-05-17 - Granted: 2020-12-15 - Earliest claimed: 2016-11-17 - Assignees: Boston Scientific Scimed, Inc.; Mayo Foundation for Medical Education and Research - Applicants: Boston Scientific Scimed Inc.; Mayo Foundation for Medical Education and Research - Inventors: Joseph E. Adriaens; Douglas D. Pagoria; Joel T. Eggert; James P. Rohl; Roger W. McGowan; Katherine L. Baldwin; Todd College; James K. Cawthra, Jr.; Eric M. Petersen; James A. Klos; Douglas Pennington - Web page: https://patentgrep.com/patent/US10864354B2 ## CPC - A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61M 25/0108: {using radio-opaque or ultrasound markers} - A61M 25/06: Body-piercing guide needles or the like - A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters} - A61M 25/1018: {Balloon inflating or inflation-control devices} - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization} - A61B 2017/3486: {Balloon} - A61B 2017/3488: {Fixation to inner organ or inner body tissue} - A61M 25/0133: {Tip steering devices} - A61M 25/104: {used for angioplasty} - 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 2025/09008: {having a balloon} - 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 Apparatuses, systems, and methods for crossing a tissue region may include a catheter and a tip section arranged therewith. The tip section may be configured to puncture the tissue region and create an opening therein, dilate the opening in the tissue region, and pass through the opening. ## Claims ### Claim 1 An apparatus for crossing a tissue region, the apparatus comprising: a catheter sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal end; and a tip section arranged at the distal end of the elongate body, the tip section including: a needle portion arranged at a distal end of the tip section and configured to puncture the tissue region to create an opening therein and retract within the elongate body, and a balloon arranged proximally of the needle portion having a first section and a second section with at least a portion of the second section being coupled to the tip section, and the balloon is configured to dilate the opening in the tissue region and pass the tip section through the opening with the first section being configured to inflate prior to the second section; and a hydraulic actuator coupled to a proximal end of the catheter and configured to drive the needle portion through the tissue region and assist in the balloon passing the tip section through the opening. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein at least a portion of the first section of the balloon comprises a first diameter and the second section of the balloon comprises a second diameter, the first diameter is less than the second diameter. ### Claim 3 (depends on 2) The apparatus of claim 2, wherein the first section tapers from the second diameter to the first diameter. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the balloon is configured to inflate to a substantially spherical shape to dilate the opening in the tissue region. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the balloon is configured to asymmetrically inflate. ### Claim 6 (depends on 5) The apparatus of claim 5, wherein a distal portion of the balloon is configured to inflate at a greater rate than a proximal section of the balloon thereby asymmetrically inflating the balloon. ### Claim 7 (depends on 1) The apparatus of claim 1, wherein the tip section comprises a first tip section having a first tip section diameter and a second tip section having a second tip section diameter, and the first tip section diameter is less than the second tip section diameter. ### Claim 8 (depends on 7) The apparatus of claim 7, further comprising a visualization element arranged at a distal end of the second tip section. ### Claim 9 (depends on 7) The apparatus of claim 7, further comprising a radiopaque marker arranged approximately at a transition between the first tip section and the second tip section. ### Claim 10 (depends on 1) The apparatus of claim 1, further comprising a hydraulic actuator configured to assist in passing the tip section through the opening in the tissue region. ### Claim 11 (depends on 1) The apparatus of claim 1, wherein the balloon is configured to concurrently dilate the opening in the tissue region and pass the tip section through the opening. ### Claim 12 An apparatus for crossing a tissue region, the apparatus comprising: a catheter sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal end; a tip section arranged at the distal end of the elongate body, the tip section including: a needle portion arranged at a distal end of the tip section and configured to puncture the tissue region in a first configuration to create an opening therein and retract within the tip section in a second configuration, and a balloon arranged proximally of the needle portion and configured to dilate the opening in the tissue region and pass a portion of the tip section through the opening while in a partially inflated configuration; and a hydraulic actuator coupled to a proximal end of the catheter and configured to drive the needle portion through the tissue region and assist in the balloon passing the tip section through the opening. ### Claim 13 (depends on 12) The apparatus of claim 12, wherein the balloon is configured to concurrently dilate the opening in the tissue region and pass the portion of the tip section through the opening in the partially inflated configuration and transition to a fully inflated configuration after passing through the opening in the tissue. ### Claim 14 (depends on 12) The apparatus of claim 12, wherein the tip section comprises a first tip section having a first tip section diameter and a second tip section having a second tip section diameter, and the first tip section diameter is less than the second tip section diameter, and a first section of the balloon is arranged to surround the first tip section and a second section of the balloon is attached to the second tip section. ### Claim 15 (depends on 14) The apparatus of claim 14, wherein the first section of the balloon comprises a tapered diameter decreasing toward the distal end of the tip section. ### Claim 16 A method for crossing a tissue region, the method comprising: arranging a tip section of a catheter on the tissue region, the catheter being sized and shaped for vascular access and including an elongate body extending between a proximal end and a distal, the tip section including a needle portion and a balloon having a first section and a second section with at least a portion of the second section being coupled to the tip section; puncturing the tissue region using the needle portion to create an opening using a hydraulic actuator coupled to a proximal end of the catheter to drive the needle portion through the tissue region; retracting the needle portion within the tip section; advancing the balloon within the opening in the tissue region; dilating the opening in the tissue region by inflating the balloon with the first section being configured to inflate prior to the second section; and passing at least a portion of the tip section through the opening in the tissue region using the hydraulic actuator. ### Claim 17 (depends on 16) The method of claim 16, wherein dilating the opening and passing the at least a portion of the tip section through the opening occurs concurrently with inflation of the balloon. ### Claim 18 (depends on 16) The method of claim 16, wherein retracting the needle portion within the tip section occurs prior to advancing a first section of the balloon within the tissue region. ### Claim 19 (depends on 16) The method of claim 16, wherein dilating the opening in the tissue region by inflating the balloon comprises asymmetrically inflating the balloon section. ### Claim 20 (depends on 19) The method of claim 19, wherein asymmetrically inflating the balloon comprises inflating a distal portion of the balloon at a greater rate than a proximal section of the balloon.