# US 8,465,470 B2 · Patent foramen ovale catheter and method of using the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,465,470 B2 - Document ID: US8465470B2 - Status: Granted - Kind: B2 - Application number: 12/843,273 - Filed: 2010-07-26 - Published: 2011-01-27 - Granted: 2013-06-18 - Earliest claimed: 2009-07-27 - Applicants: Robert Kipperman - Inventors: Robert Kipperman - Web page: https://patentgrep.com/patent/US8465470B2 ## CPC - A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)} - A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence) - 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 A catheter for use in accessing a left atrium of a living heart within a subject's body by passing from the heart's right atrium to the heart's left atrium through a patent foramen ovale (PFO) in the heart, such as performing a percutaneous procedure for closing the PFO, includes a specialized preformed catheter with curves on the distal portion to be adapted within living anatomy to allow access from a subject's heart's right atrium through the PFO to the left atrium. The catheter facilitates access to the left atrium and the use of devices in procedures within and involving the left atrium, such as PFO closure devices. A method is also provided for using the catheter. ## Claims ### Claim 1 A catheter having a preformed shape for accessing a left atrium of a living heart within a subject's body by passing from the heart's right atrium to the heart's left atrium through a patent foramen ovale in the heart, the catheter comprising a tube of a length of about 60 cm to about 120 cm to extend out of the body containing the heart, the tube having a lumen of a diameter of about 4 French to about 8 French adapted to accommodate a wire within the lumen, the catheter having a proximal end portion terminating at a proximal opening, the catheter further having a distal end portion terminating at a distal opening, the proximal end portion being extendable from the subject's body when the distal end portion is at least partially within the subject's heart, and the catheter further comprising a primary curve and a secondary curve between the proximal end portion and the distal opening, the primary curve having a beginning curvature point and an end curvature point of the primary curve, the secondary curve having an initial curvature point and a final curvature point, and the catheter having an intermediate segment between the end curvature point of the primary curve and the initial curvature point of the secondary curve and a distal segment between the final curvature point of the secondary curve and the distal opening; wherein: the beginning curvature point of the primary curve is located about 4 cm to about 9 cm from the distal opening, the primary curve being oriented in a first direction and having a radius of curvature of about 2 cm to about 4 cm; the secondary curve is located at the distal end portion with an initial curvature point beginning about 0.25 cm to about 2 cm from the distal opening, the secondary curve being oriented in a second direction opposite the first direction of the primary curve and having a radius of curvature of about 0.1 cm to about 0.4 cm; the catheter having a projected longitudinal distance from the beginning curvature point of the primary curve to the initial curvature point of the secondary curve of about 3 cm to about 6 cm; the catheter having a projected lateral distance from the beginning curvature point of the primary curve to the initial curvature point of the secondary curve of about 2 cm to about 6 cm; and the catheter having a projected longitudinal distance from the initial curvature point of the secondary curve to the distal opening of about 0.2 cm to about 2 cm. ### Claim 2 (depends on 1) The catheter of claim 1, wherein the beginning curvature point of the primary curve is located about 4 cm to about 7 cm from the distal opening, and the initial curvature point of the secondary curve is located about 0.25 cm to about 1 cm from the distal opening. ### Claim 3 (depends on 2) The catheter of claim 2, wherein the beginning curvature point of the primary curve is located about 4.5 cm to about 6 cm from the distal opening, and the initial curvature point of the secondary curve is located about 0.4 cm to about 0.8 cm from the distal opening. ### Claim 4 (depends on 3) The catheter of claim 3, wherein the beginning curvature point of the primary curve is located about 5 cm from the distal opening, and the initial curvature point of the secondary curve is located about 0.5 cm from the distal opening. ### Claim 5 (depends on 2) The catheter of claim 2, wherein the primary curve has an arc length of about 52.1% of the distance from the beginning curvature point of the primary curve to the distal opening, the intermediate segment has a length of about 37.3% of the distance from the beginning curvature point of the primary curve to the distal opening, the secondary curve has an arc length of about 4% of the distance from the beginning curvature point of the primary curve to the distal opening, and the distal segment has a length of about 6.2% of the distance from the beginning curvature point of the primary curve to the distal opening. ### Claim 6 (depends on 2) The catheter of claim 2, wherein the primary curve has an arc length of about 2.1 cm to about 3.65 cm, the intermediate segment has a length of about 1.5 cm to about 2.6 cm, the secondary curve has an arc length of about 0.18 cm to about 0.31 cm, and the distal segment has a length of about 0.25 cm to about 0.43 cm; and wherein the projected longitudinal distance from the beginning point of curvature of the primary curve to the initial curvature point of the secondary curve is about 3 cm to about 5 cm, the projected lateral distance from the beginning point of the primary curve to the initial curvature point of the secondary curve is about 2 cm to about 5 cm, and the projected longitudinal distance from the initial curvature point of the secondary curve to the distal opening is about 0.25 cm to about 1 cm. ### Claim 7 (depends on 6) The catheter of claim 6, wherein the primary curve has an arc length of about 2.3 cm to about 3.1 cm, the intermediate segment has a length of about 1.7 cm to about 2.2 cm, the secondary curve has an arc length of about 0.2 cm to about 0.26 cm, and the distal segment has a length of about 0.28 cm to about 0.37 cm; and wherein the primary curve has a radius of curvature of about 2.5 cm to about 3.5 cm and the secondary curve has a radius of curvature of about 0.2 cm to about 0.3 cm. ### Claim 8 (depends on 7) The catheter of claim 7, wherein the primary curve has an arc length of about 2.61 cm, the intermediate segment has a length of about 1.87 cm, the secondary curve has an arc length of about 0.22 cm, and the distal segment has a length of about 0.31 cm; wherein the primary curve has a radius of curvature of about 3 cm and the secondary curve has a radius of curvature of about 0.25 cm; and wherein the projected longitudinal distance from the beginning point of curvature of the primary curve to the initial curvature point of the secondary curve is about 3.5 cm, the projected lateral distance from the beginning point of the primary curve to the initial curvature point of the secondary curve is about 2.5 cm, and the projected longitudinal distance from the initial curvature point of the secondary curve to the distal opening is about 0.5 cm. ### Claim 9 (depends on 2) The catheter of claim 2, wherein the catheter tube has a plane that includes the primary curve, and the secondary curve is angled from the plane of the primary curve at the initial curvature point of the secondary curve in a third direction at an angle of about ±30° from the plane of the primary curve. ### Claim 10 (depends on 9) The catheter of claim 9, wherein the angle of the secondary curve in the third direction is an angle of about ±15° from the plane of the primary curve. ### Claim 11 (depends on 1) The catheter of claim 1, wherein the catheter tube has a plane that includes the primary curve, and the secondary curve is angled from the plane of the primary curve at the initial curvature point of the secondary curve in a third direction, measured from the plane of the primary curve. ### Claim 12 (depends on 11) The catheter of claim 11, wherein angle of the secondary curve in the third direction is an angle of about ±60° from the plane of the primary curve. ### Claim 13 (depends on 1) A method of accessing a left atrium of a living heart within a subject's body by passing from the heart's right atrium to the heart's left atrium through a patent foramen ovale in the heart, the method comprising: a. providing a catheter according to claim 1; b. passing, with imaging guidance, from the subject's femoral vein to the subject's heart's superior vena cava, the catheter alone or the catheter over a guide wire within the catheter's lumen when the guide wire has previously been inserted from the subject's femoral vein to the subject's heart's superior vena cava; c. positioning, with imaging guidance, the catheter by manipulating the catheter until the distal opening of the catheter engages the fossa ovalis in the subject's heart's right atrium; d. locating, with imaging guidance, the distal opening of the catheter in the subject's heart's patent foramen ovale canal; and e. advancing, with imaging guidance, the catheter's distal opening by manipulating the catheter itself, or by advancing the guide wire within the lumen of the catheter, into the subject's heart's left atrium. ### Claim 14 (depends on 13) The method of claim 13, wherein the b. positioning includes rotating the catheter medially and pulling the catheter inferiorly into the right atrium. ### Claim 15 (depends on 13) The method of claim 13, wherein the beginning curvature point of the primary curve is located about 4 cm to about 7 cm from the distal opening, and the initial curvature point of the secondary curve is located about 0.25 cm to about 1 cm from the distal opening. ### Claim 16 (depends on 15) The method of claim 15, wherein the catheter tube has a plane that includes the primary curve, and the secondary curve is angled from the plane of the primary curve at the initial curvature point of the secondary curve in a third direction at an angle of about ±30° from the plane of the primary curve. ### Claim 17 (depends on 16) The catheter of claim 16, wherein the angle of the secondary curve in the third direction is an angle of about ±15° from the plane of the primary curve. ### Claim 18 (depends on 13) The method of claim 13, wherein the beginning curvature point of the primary curve is located about 4.5 cm to about 6 cm from the distal opening, and the initial curvature point of the secondary curve is located about 0.4 cm to about 0.8 cm from the distal opening. ### Claim 19 (depends on 13) The method of claim 13, wherein the beginning curvature point of the primary curve is located about 5 cm from the distal opening, and the initial curvature point of the secondary curve is located about 0.5 cm from the distal opening. ### Claim 20 (depends on 13) The method of claim 13, wherein the primary curve has an arc length of about 52.1% of the distance from the beginning curvature point of the primary curve to the distal opening, the intermediate segment has a length of about 37.3% of the distance from the beginning curvature point of the primary curve to the distal opening, the secondary curve has an arc length of about 4% of the distance from the beginning curvature point of the primary curve to the distal opening, and the distal segment has a length of about 6.2% of the distance from the beginning curvature point of the primary curve to the distal opening. ### Claim 21 (depends on 13) The method of claim 13, wherein the primary curve has an arc length of about 2.1 cm to about 3.65 cm, the intermediate segment has a length of about 1.5 cm to about 2.6 cm, the secondary curve has an arc length of about 0.18 cm to about 0.31 cm, and the distal segment has a length of about 0.25 cm to about 0.43 cm; and wherein the projected longitudinal distance from the beginning point of curvature of the primary curve to the initial curvature point of the secondary curve is about 3 cm to about 5 cm, the projected lateral distance from the beginning point of the primary curve to the initial curvature point of the secondary curve is about 2 cm to about 5 cm, and the projected longitudinal distance from the initial curvature point of the secondary curve to the distal opening is about 0.25 cm to about 1 cm. ### Claim 22 (depends on 13) The method of claim 13, wherein the primary curve has an arc length of about 2.3 cm to about 3.1 cm, the intermediate segment has a length of about 1.7 cm to about 2.2 cm, the secondary curve has an arc length of about 0.2 cm to about 0.26 cm, and the distal segment has a length of about 0.28 cm to about 0.37 cm; and wherein the primary curve has a radius of curvature of about 2.5 cm to about 3.5 cm and the secondary curve has a radius of curvature of about 0.2 cm to about 0.3 cm. ### Claim 23 (depends on 13) The method of claim 13, wherein the primary curve has an arc length of about 2.61 cm, the intermediate segment has a length of about 1.87 cm, the secondary curve has an arc length of about 0.22 cm, and the distal segment has a length of about 0.31 cm; wherein the primary curve has a radius of curvature of about 3 cm and the secondary curve has a radius of curvature of about 0.25 cm; and wherein the projected longitudinal distance from the beginning point of curvature of the primary curve to the initial curvature point of the secondary curve is about 3.5 cm, the projected lateral distance from the beginning point of the primary curve to the initial curvature point of the secondary curve is about 2.5 cm, and the projected longitudinal distance from the initial curvature point of the secondary curve to the distal opening is about 0.5 cm. ### Claim 24 (depends on 13) The method of claim 13, wherein the catheter tube has a plane that includes the primary curve, and the secondary curve is angled from the plane of the primary curve at the initial curvature point of the secondary curve in a third direction, measured from the plane of the primary curve. ### Claim 25 (depends on 24) The method of claim 24, wherein angle of the secondary curve in the third direction is an angle of about ±60° from the plane of the primary curve.