# US 10,307,569 B2 · Transseptal access device and method of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,569 B2 - Document ID: US10307569B2 - Status: Granted - Kind: B2 - Application number: 14/567,427 - Filed: 2014-12-11 - Published: 2018-03-08 - Granted: 2019-06-04 - Earliest claimed: 2010-04-23 - Assignees: Mark D. Wieczorek - Applicants: Mark D. Wieczorek - Inventors: Christopher Gerard Kunis - Web page: https://patentgrep.com/patent/US10307569B2 ## CPC - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61M 25/0082: {Catheter tip comprising a tool} - A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization} - A61B 2017/306: {holding by means of suction} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to “tent” the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof. ## Claims ### Claim 1 A device for transseptal access, comprising: an elongated member having a proximal end and a distal end, the elongated member having defined therein a pressure lumen; and a funnel coupled to the elongated member at the distal end of the elongated member, the funnel having a convoluted shape, the funnel having a proximal end with a first radius and a distal end with a second radius, the second radius greater than the first radius, the funnel having a retracted configuration and an expanded configuration, the expanded configuration defining an interior; such that the elongated member and the funnel are configured to be delivered to a septal location through a transseptal sheath; and such that upon removal of the funnel from the sheath, the funnel transitions from the retracted configuration to the expanded configuration; and wherein the pressure lumen is configured to transmit a negative pressure from a proximal end of the pressure lumen to the interior of the funnel to create a suction effect to hold the funnel against the septum of the heart, and further comprising a piercing element configured to pierce the septum of the heart when the suction effect is holding the funnel against the septum of the heart, wherein the piercing element is stationary. ### Claim 2 (depends on 1) The device of claim 1, wherein the piercing element is attached to a tubular element that moves within the elongated member. ### Claim 3 (depends on 2) The device of claim 2, further comprising a mechanical mechanism configured to enable steering. ### Claim 4 (depends on 2) The device of claim 2, wherein the piercing element is advanced distally or proximally by a mechanical slide located at a handle of the device, the mechanical slide attached to the tubular member. ### Claim 5 (depends on 2) The device of claim 2, wherein the piercing element is advanced distally or proximally by a knob located at a handle of the device, the knob coupled to the tubular member. ### Claim 6 (depends on 1) The device of claim 1, further comprising a governor coupled to the piercing element, to inhibit movement of the piercing element past a pre-specified point. ### Claim 7 (depends on 1) The device of claim 1, wherein the piercing element is coupled to the elongated member. ### Claim 8 (depends on 1) The device of claim 1, wherein in the retracted configuration, the funnel substantially surrounds the stationary piercing element. ### Claim 9 (depends on 1) The device of claim 1, wherein in the expanded configuration, the funnel distal end extends further in a distal direction than does the piercing element. ### Claim 10 (depends on 1) The device of claim 1, wherein the piercing element is a dilator with a sharp tip. ### Claim 11 (depends on 1) The device of claim 1, wherein the funnel is formed from multiple segments. ### Claim 12 (depends on 1) The device of claim 1, wherein the first radius is between about 3 French to 10 French and the second radius is between about 2.5 mm and 15 mm. ### Claim 13 (depends on 12) The device of claim 12, wherein the first radius is between about 5 French to 8 French and the second radius is between about 5 mm and 10 mm. ### Claim 14 (depends on 1) The device of claim 1, further comprising a fitting attached to the pressure lumen, the fitting configured to attach a negative pressure source thereto. ### Claim 15 (depends on 14) The device of claim 14, wherein the fitting is configured to attach a syringe thereto. ### Claim 16 (depends on 14) The device of claim 14, wherein the negative pressure source is configured to draw a negative pressure of between about that drawn by a 5 cc syringe and that drawn by a 100 cc syringe. ### Claim 17 (depends on 16) The device of claim 16, wherein the negative pressure source is configured to draw a negative pressure of between about that drawn by a 10 cc syringe and that drawn by a 20 cc syringe. ### Claim 18 (depends on 1) The device of claim 1, further comprising a rib or spine member attached to the funnel. ### Claim 19 (depends on 1) The device of claim 1, wherein the elongated member has further defined a guidewire lumen therein, the guidewire lumen extending from the proximal end and into the interior of the funnel.