Search

US-20260123869-A1 - Basket Style Cardiac Mapping Catheter Having a Flexible Electrode Assembly for Detection of Cardiac Rhythm Disorders

US20260123869A1US 20260123869 A1US20260123869 A1US 20260123869A1US-20260123869-A1

Abstract

A system for sensing multiple local electric voltages from endocardial surface of a heart, includes: an elongate tubular member having a lumen, a proximal end and a distal end; a plurality of flexible splines; an anchor for securably affixing the proximal portions of the splines, where the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the elongate tubular member; and a metallic tip for securably affixing the distal portions of the splines.

Inventors

  • Thomas F. Kordis
  • Ruchir Sehra
  • Eric T. Johnson
  • Darrin J. Kent
  • Robert Ryan Ragland

Assignees

  • Topera, Inc.

Dates

Publication Date
20260507
Application Date
20251231

Claims (20)

  1. 1 . A basket catheter, comprising: a catheter shaft having a proximal end, a distal end, and defining a longitudinal axis therebetween; a basket electrode assembly extending distally from the distal end of the catheter shaft, the basket electrode assembly comprising: a plurality of splines, each of the plurality of splines comprising a distal portion, a medial portion, and a proximal portion; and a distal tip coupled to the distal portions of each of the plurality of splines, the distal tip comprising: a first structure comprising a plurality of spline alignment features spaced apart such that each one of the respective distal portions of each of the plurality of splines is disposed between a pair of the plurality of spline alignment features; and a second structure, wherein the distal portions of each of the plurality of splines are secured relative to the second structure by the first structure, wherein the distal portions of each of the plurality of splines are coupled to the distal tip in a predetermined angular relationship via the plurality of the spline alignment features.
  2. 2 . The basket catheter of claim 1 , further comprising a membrane extending between the plurality of splines.
  3. 3 . The basket of claim 2 , wherein the membrane comprises a polyimide material.
  4. 4 . The basket catheter of claim 1 , wherein each of the plurality of splines comprises a rectangular cross-section.
  5. 5 . The basket catheter of claim 1 , wherein each of the plurality of splines comprises an inner facing surface and an outer facing surface.
  6. 6 . The basket catheter of claim 5 , wherein each of the plurality of splines comprises at least one electrode disposed on the outer facing surface.
  7. 7 . The basket catheter of claim 1 , wherein each of the plurality of splines comprises Nitinol.
  8. 8 . The basket catheter of claim 1 , wherein the basket electrode assembly is configured to transition between a first configuration and a second configuration.
  9. 9 . The basket catheter of claim 8 , wherein the first configuration is an expanded configuration, wherein the second configuration is a collapsed configuration.
  10. 10 . The basket catheter of claim 1 , wherein, in the predetermined angular relationship, the angular spacing between pairs of the plurality of splines is 45°.
  11. 11 . A basket catheter, comprising: a catheter shaft having a proximal end, a distal end, and defining a longitudinal axis therebetween; a basket electrode assembly extending distally from the distal end of the catheter shaft, the basket electrode assembly comprising: a plurality of splines, each of the plurality of splines comprising a distal portion, a medial portion, and a proximal portion; and a distal tip having a plurality of detents disposed along a sidewall thereof, wherein the distal portions of each of the plurality of splines is secured within a respective detent of the plurality of detents of the distal tip, wherein the distal portions of each of the plurality of splines are secured within the distal tip in a predetermined angular relationship via the plurality of detents.
  12. 12 . The basket catheter of claim 11 , further comprising a membrane extending between the plurality of splines.
  13. 13 . The basket of claim 12 , wherein the membrane comprises a polyimide material.
  14. 14 . The basket catheter of claim 11 , wherein each of the plurality of splines comprises a rectangular cross-section.
  15. 15 . The basket catheter of claim 11 , wherein each of the plurality of splines comprises an inner facing surface and an outer facing surface.
  16. 16 . The basket catheter of claim 15 , wherein each of the plurality of splines comprises at least one electrode disposed on the outer facing surface.
  17. 17 . The basket catheter of claim 11 , wherein each of the plurality of splines comprises Nitinol.
  18. 18 . The basket catheter of claim 11 , wherein the basket electrode assembly is configured to transition between a first configuration and a second configuration.
  19. 19 . The basket catheter of claim 18 , wherein the first configuration is an expanded configuration, wherein the second configuration is a collapsed configuration.
  20. 20 . A basket catheter, comprising: a catheter shaft having a proximal end, a distal end, and defining a longitudinal axis therebetween; a basket electrode assembly extending distally from the distal end of the catheter shaft, the basket electrode assembly comprising: a plurality of splines, each of the plurality of splines comprising a distal portion, a medial portion, and a proximal portion; and a distal tip coupled to the distal portions of each of the plurality of splines, the distal tip comprising: a first structure comprising an interior space for receiving distal portions of each of the plurality of splines such that the distal portions of each of the plurality of splines are coupled to the distal tip in a predetermined angular relationship; and a second structure, wherein the distal portions of each of the plurality of splines are secured relative to the second structure by the first structure.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS The present application is a Continuation of U.S. patent application Ser. No. 19/220,305 filed May 28, 2025 (Pending); which is a Continuation of U.S. patent application Ser. No. 16/270,719 filed Feb. 8, 2019 (now U.S. Pat. No. 12,336,825); which is a Continuation of U.S. patent application Ser. No. 14/595,306 filed Jan. 13, 2015 (now U.S. Pat. No. 10,244,960); which is a Continuation of U.S. patent application Ser. No. 13/929,838 filed Jun. 28, 2013 (now U.S. Pat. No. 9,504,399); which is a Continuation of U.S. patent application Ser. No. 13/687,274 filed Nov. 28, 2012 (now U.S. Pat. No. 8,504,133); which is a Continuation of U.S. patent application Ser. No. 13/409,263 filed Mar. 1, 2012 (now U.S. Pat. No. 8,346,339); which claims the benefit of U.S. Provisional Appln. Nos. 61/555,190 filed Nov. 3, 2011 and 61/478,340 filed Apr. 22, 2011; the full disclosures which are incorporated herein by reference in their entirety for all purposes. BACKGROUND The present invention is related to the detection of cardiac rhythm disorders by use of basket style cardiac mapping catheters. The present invention is further related to cardiac spline baskets having flexible spline tube assemblies with electrodes. Heart rhythm disorders are very common in the United States, and are significant causes of morbidity, lost days from work, and death. Heart rhythm disorders exist in many forms, of which the most complex and difficult to treat are atrial fibrillation (AF), ventricular tachycardia (VT) and ventricular fibrillation (VF). Other rhythms may be easier to treat, but may also be clinically significant including supraventricular tachycardia (SVT), atrial tachycardia (AT), atrial flutter (AFL), premature atrial complexes/beats (PAC, APC) and premature ventricular complexes/beats (PVC). Under certain conditions, rapid activation of the normal sinus node can even cause a heart rhythm disorder such as inappropriate sinus tachycardia or sinus node reentry. Definitive diagnosis has often been performed using electrode-bearing catheters placed within the heart chambers. Electrodes have been positioned along a catheter shaft or basket splines in an attempt to analyze or map the electrical activity within a heart chamber. Mapping typically involves the use or formation external (patches on skin) of electrograms and internal (catheters with electrodes) electrograms. A typical electrocardiogram of the cardiac cycle (heartbeat) consists of a P wave, a QRS complex and a T wave. During normal atrial depolarization, the main electrical vector is directed from the SA node, and spreads from the right atrium to the left atrium. Atrial depolarization is represented by the P wave on the electrocardiogram. The QRS complex reflects the rapid depolarization of the right and left ventricles. The T wave represents the repolarization (or recovery) of the ventricles. Devices of the prior art, however, often do not provide a complete and stable map of the electrical activity within a heart chamber (recording electrograms). In particular, electrical activity in certain portions of the right atrium and the left atrium (e.g. atrial septum, region of right pulmonary veins) are often difficult to map because of the inability of devices of the prior art to adequately conform to the irregular shape of the atria and their varying shapes during beating of the heart. Further, devices of the prior art do not provide dimensionally and/or spatially stable and complete electrograms as the prior art devices often move as the heart beats, thereby moving some or all of the electrodes away from the heart tissue and making the relative position of the electrodes variable to corresponding position of atrial tissue. Thus, there is a need in the art for a cardiac mapping catheter that is capable of providing improved and dimensionally and/or spatially stable signals for diagnosis, and more complete coverage of the heart tissue, typically in the form of electrograms. BRIEF SUMMARY The present invention provides devices, systems and methods for the detection of cardiac rhythm disorders by use of a percutaneous catheter designed to permit acquisition of numerous, simultaneous endocardial electrograms from a three dimensional array of surface electrodes, herein referred to as “a basket style cardiac mapping catheter.” In one embodiment of the present invention, a system for sensing multiple local electric voltages from endocardial surface of a heart, includes: an elongate tubular member having a lumen, a proximal end and a distal end; a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces; an anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the elongate tubular member; a t