# US 8,540,662 B2 · Medical devices having an atraumatic distal tip segment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,540,662 B2 - Document ID: US8540662B2 - Status: Granted - Kind: B2 - Application number: 12/410,431 - Filed: 2009-03-24 - Published: 2010-09-30 - Granted: 2013-09-24 - Earliest claimed: 2009-03-24 - Assignees: St. Jude Medical, Atrial Fibrillation Division, Inc. - Applicants: Richard E. Stehr; Martin M. Grasse; Allan M. Fuentes - Inventors: Richard E. Stehr; Martin M. Grasse; Allan M. Fuentes - Web page: https://patentgrep.com/patent/US8540662B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 5/053: Measuring electrical impedance or conductance of a portion of the body - A61B 5/0538: invasively, e.g. using a catheter - A61B 5/6855: {with a distal curved tip} - A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence) - A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS] - A61B 18/1815: {using microwaves} - A61B 2017/00867: {shape memory effect} - A61B 2018/1861: {with an instrument inserted into a body lumen or cavity, e.g. a catheter} - A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod} - A61N 7/022: {intracavitary} - 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)} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A kit for the diagnosis or treatment of tissue in a body cavity includes an introducer and a catheter insertable through the lumen of the introducer having a proximal segment, a working segment and a flexible distal tip segment. The flexible distal tip segment is located adjacent the distal end of the working segment and includes a proximal end, a distal end and a pre-formed bend or curve that permits the catheter to exit the introducer in a lateral direction relative to the introducer body to prevent inadvertent damage to the tissue during a medical procedure. All or part of the working segment and the flexible distal tip segment may be adhesive-filled. The catheter may also include a plurality of sensing and/or energy delivery elements on the working segment and a shape-memory wire terminating at the distal end of the working segment. Methods of use and methods of manufacturing are also described. ## Claims ### Claim 1 A kit for the diagnosis or treatment of tissue in a body cavity, comprising: an introducer having an introducer body defining a lumen therethrough; and an electrophysiology catheter insertable through the lumen of the introducer body, the electrophysiology catheter comprising an elongated catheter body defining a lumen therethrough, the elongated catheter body having a proximal segment, a working segment located distally of the proximal segment, the working segment having a distal end and a generally circular configuration in an unbiased state, and a flexible distal tip segment adjacent the distal end of the working segment, the flexible distal tip segment having a proximal end and a distal end, the proximal end and the distal end being off-set from one another by an angle of between 100 degrees to 175 degrees via one of a bend pre-formed in the catheter body via thermosetting and a curve pre-formed in the catheter body via thermosetting; at least one of a cardiac sensing element and an energy delivery element disposed along an outer surface of the working segment; and a shape-memory wire extending through the lumen of the catheter body from the proximal segment and terminating at the distal end of the working segment, wherein the flexible distal tip segment retains its pre-formed bend or pre-formed curve when inserted through the lumen of the introducer, such that the flexible distal tip segment exits a distal end of the introducer in a lateral direction relative to a longitudinal direction of the introducer body. ### Claim 2 (depends on 1) The kit of claim 1, wherein the pre-formed bend forms an angle of 115 degrees to 125 degrees. ### Claim 3 (depends on 1) The kit of claim 1, wherein the flexible distal tip segment is less than 20 mm in length. ### Claim 4 (depends on 1) The kit of claim 1, wherein the flexible distal tip segment comprises a segment having a length dimension of 5 mm to 10 mm. ### Claim 5 (depends on 1) The kit of claim 1, wherein the at least one of a cardiac sensing element and an energy delivery element comprises a plurality of radiofrequency electrodes. ### Claim 6 (depends on 1) The kit of claim 1, wherein the at least one of a cardiac sensing element and an energy delivery element comprises a plurality of sensing elements and/or energy delivery elements, and wherein said energy delivery elements comprise at least one of a plurality of radiofrequency electrodes, a plurality of acoustic transducers, a plurality of optical elements and a plurality of microwave elements. ### Claim 7 (depends on 1) The kit of claim 1, wherein the flexible distal tip segment is fabricated of materials that are free of electrically conductive properties. ### Claim 8 (depends on 1) The kit of claim 1, wherein a distal end of the shape-memory wire is secured at the distal end of the working segment. ### Claim 9 (depends on 8) The kit of claim 8, wherein the distal end of the shape-memory wire is embedded in an adhesive. ### Claim 10 (depends on 1) The kit of claim 1, wherein the distal end of the flexible distal tip segment comprises one of a plug or a seal. ### Claim 11 (depends on 10) The kit of claim 10, wherein the plug or the seal comprises an adhesive. ### Claim 12 (depends on 11) The kit of claim 11, wherein the adhesive comprises a UV-cured adhesive. ### Claim 13 (depends on 1) The kit of claim 1, wherein the flexible distal tip segment comprises an intermediate section between the proximal end and the distal end, and further comprising a flowable adhesive material filling the distal end and the proximal end, and wherein the intermediate section comprises a substantially hollow section devoid of the flowable adhesive. ### Claim 14 (depends on 1) The kit of claim 1, wherein the working segment and the flexible distal tip segment are integrally-formed as a unitary polymeric piece. ### Claim 15 (depends on 1) The kit of claim 1, wherein the flexible distal tip segment and the working segment are formed separately and bonded together. ### Claim 16 (depends on 1) The kit of claim 1, wherein the pre-formed bend and the working segment curve in the same direction. ### Claim 17 (depends on 1) The kit of claim 1, wherein the catheter is a 3 French catheter. ### Claim 18 An electrophysiology catheter having an atraumatic tip, comprising a body defining a lumen, the body comprising a generally straight proximal segment, a flexible distal tip segment having a bend pre-formed in the body via thermosetting and a working segment having a distal end and a generally circular configuration in an unbiased state, the working segment being located between the proximal segment and the flexible distal tip segment; at least one of a sensing element and an energy delivery element disposed along the working segment; and a shape-memory wire extending through the lumen and terminating at the distal end of the working segment, wherein the pre-formed bend forms an angle of between 100 degrees to 175 degrees, and wherein a length of the flexible distal tip segment comprises ⅙ the length of the working segment or less and wherein the pre-formed bend is not straightened when the electrophysiology catheter is inserted into an introducer. ### Claim 19 (depends on 18) The catheter of claim 18, wherein the pre-formed bend forms an angle of 115 degrees to 125 degrees. ### Claim 20 (depends on 18) The catheter of claim 18, wherein the length of the flexible distal tip segment is 1/10 the length of the working segment or less. ### Claim 21 (depends on 18) The catheter of claim 18, wherein a distal end of the shape-memory wire is secured at the distal end of the working segment. ### Claim 22 (depends on 21) The catheter of claim 21, wherein the distal end of the shape-memory wire is embedded in an adhesive. ### Claim 23 (depends on 18) The catheter of claim 18, wherein the flexible distal tip segment comprises a proximal end, a distal end and an intermediate section between the proximal end and the distal end, wherein the distal end and the proximal end are adhesive-filled, and wherein the intermediate section is substantially hollow. ### Claim 24 (depends on 18) The catheter of claim 18, wherein the at least one of the sensing element and the energy delivery element comprises a plurality of radiofrequency electrodes. ### Claim 25 (depends on 18) The catheter of claim 18, wherein the at least one of the sensing element and the energy delivery element comprises a plurality of at least one of a radiofrequency electrode, an acoustic transducer, an optical element and a microwave element.