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KR-102963006-B1 - catheter with a conforming balloon

KR102963006B1KR 102963006 B1KR102963006 B1KR 102963006B1KR-102963006-B1

Abstract

A catheter (102) is provided, comprising a catheter shaft (212) having a fluid channel (420), an ultrasonic transducer (214), and a conforming balloon (108) mounted on the catheter shaft (212) and having an interior (504) that is in fluid communication with the fluid channel (420) and accommodates the ultrasonic transducer (214). The conforming balloon (108) comprises a working section (1600) that radially surrounds the ultrasonic transducer (214), a proximal shoulder (510B) that is proximal to the working section (1600), and a distal shoulder (510A) that is distal to the working section (1600). The balloon wall (502) is thicker in the proximal shoulder (510B) and the distal shoulder (510A) than in the working section (1600).

Inventors

  • 마쪼네, 제임스
  • 데일리, 에릭
  • 도노반, 라이언 알.
  • 메리노, 제이미
  • 티루말라이, 시루티

Assignees

  • 오츠카 메디칼 디바이시스 가부시키가이샤

Dates

Publication Date
20260511
Application Date
20220716
Priority Date
20220715

Claims (20)

  1. As a catheter (102): A catheter shaft (212) having a fluid channel (420); Ultrasonic transducer (214) mounted on the above catheter shaft (212); and The invention comprises a conforming balloon (108) mounted on a catheter shaft (212) and having an interior (504) that is fluidly in communication with a fluid channel (420) and accommodates an ultrasonic transducer (214), wherein the conforming balloon (108) comprises a balloon wall (502), wherein the balloon wall (502) has a working section (1600), a proximal shoulder (510B), and a distal shoulder (510A), wherein the working section (1600) radially surrounds the ultrasonic transducer (214), the proximal shoulder (510B) is proximal to the working section (1600), and the distal shoulder (510A) is distal to the working section (1600), wherein the balloon wall (502) is thicker in the proximal shoulder (510B) and the distal shoulder (510A) than in the working section (1600). The work section (1600) has a straightness when the work section (1600) has a first diameter and when the work section (1600) has a second diameter that is at least 2 mm larger than the first diameter, A catheter, wherein the straightness includes the cylindricality of the working section (1600) being less than 1 mm, and the cylindricality is defined as the difference between the maximum diameter and the minimum diameter of the working section (1600) over the length of the working section (1600).
  2. delete
  3. In paragraph 1, A catheter having a first diameter in the range of 3.5 to 6 mm and a second diameter in the range of 8 to 9 mm.
  4. delete
  5. In paragraph 1, The above straightness includes a catheter in which the ratio of the radius of curvature of the working section (1600) to the length of the conforming balloon (108) is greater than 1.
  6. In paragraph 1, The above straightness includes a catheter in which the first radius of curvature of the working section (1600) when the working section (1600) has a first diameter is within 20% of the second radius of curvature of the working section (1600) when the working section (1600) has a second diameter.
  7. In paragraph 1, The above conforming balloon (108) is formed of a polyether-based thermoplastic polyurethane having a Shore D hardness in the range of 50 to 60, and The above-mentioned conforming balloon (108) has a first inflation pressure of 2 psi (13.79 kPa) to 10 psi (68.95 kPa) when the working section (1600) has a first diameter, and the conforming balloon (108) has a second inflation pressure of 30 psi (206.84 kPa) when the working section (1600) has a second diameter, a catheter.
  8. delete
  9. In Paragraph 7, When the conforming balloon (108) has a second expansion pressure, the balloon wall (502) contacts the blood vessel wall (303) and the catheter shaft (212) is maintained in the center within the target blood vessel (302), thereby the ultrasonic transducer (214) is positioned radially in the center within the conforming balloon (108), the catheter.
  10. In Paragraph 7, The above fluid channel includes an inlet fluid channel (403) and an outlet fluid channel (405), and the inlet fluid channel (403) and the outlet fluid channel (405) are fluidly connected to the interior (504). The above-mentioned conforming balloon (108) is configured to be expanded to a first expansion pressure by a fluid (306) circulating through the interior (504) at a flow rate of 15 to 35 mL/min, and to be expanded to a second expansion pressure by a fluid (306) circulating through the interior (504) at a flow rate of 35 to 50 mL/min, a catheter.
  11. In paragraph 1, The proximal shoulder (510B) and distal shoulder (510A) are rounded catheters.
  12. In paragraph 1, A catheter in which the proximal shoulder (510B) and the distal shoulder (510A) include a plurality of longitudinal ribs (1202).
  13. In any one of paragraphs 1, 3, 5 through 7, and 9 through 12, The above conforming balloon (108) is formed of polyether-based thermoplastic polyurethane, and the polyether-based thermoplastic polyurethane has a Shore D hardness in the range of 50 to 60, a catheter.
  14. In paragraph 1, The balloon wall (502) is a catheter that does not contain foreign matter or bubbles greater than 0.2 mm² .
  15. In paragraph 1, A catheter having a working section (1600) of balloon wall (502) having a double wall thickness of 0.0004 inches (10.16 μm) to 0.0014 inches (35.56 μm).
  16. In paragraph 1, The catheter shaft (212) extends longitudinally from a proximal end to a distal end and includes an inlet fluid channel (403), an outlet fluid channel (405), electrical wiring, and a guide wire inner diameter (213) extending through the catheter shaft (212), and the catheter (102) is: A proximal hub (240) coupled to a proximal end, wherein the proximal hub (240) comprises an inlet port (208) coupled to an inlet fluid channel (403) and an outlet port (210) coupled to an outlet fluid channel (405), and electrical wiring extends through the proximal hub (240) to a proximal wiring end; and It further includes an electric coupling (206) mounted on a proximal wiring end and configured to receive power from an electric generator, wherein The ultrasonic transducer (214) is mounted on the catheter shaft (212) and electrically connected to the electric coupling (206) via electrical wiring; and A conforming balloon (108) is a catheter having an interior (504) that is fluidly communicating with an inlet fluid channel (403) and an outlet fluid channel (405).
  17. As a catheter (102): A catheter shaft (212) having a fluid channel (420); Ultrasonic transducer (214) mounted on the above catheter shaft (212); and A conforming balloon (108) is mounted on a catheter shaft (212) and has an interior (504) that is in fluid communication with a fluid channel (420) and accommodates an ultrasonic transducer (214), wherein the conforming balloon (108) comprises a balloon wall (502) having a working section (1600) that radially surrounds the ultrasonic transducer (214), and wherein the working section (1600) has a straightness when the working section (1600) has a first diameter and when the working section (1600) has a second diameter that is at least 2 mm larger than the first diameter, A catheter, wherein the straightness includes the cylindricality of the working section (1600) being less than 1 mm, and the cylindricality is defined as the difference between the maximum diameter and the minimum diameter of the working section (1600) over the length of the working section (1600).
  18. In Paragraph 17, A catheter having a first diameter in the range of 3.5 to 6 mm and a second diameter in the range of 8 to 9 mm.
  19. delete
  20. In Paragraph 17, The above straightness includes a catheter in which the ratio of the radius of curvature of the working section (1600) to the length of the conforming balloon (108) is greater than 1.

Description

catheter with a conforming balloon The present application generally relates to a minimally invasive device, system, and method for delivering energy to a targeted anatomical location of an object, and more specifically to a catheter-based, intraluminal device and system configured to deliver ultrasonic energy to treat tissues such as nerve tissue. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately one in three adults suffers from high blood pressure, also known as hypertension. If left untreated, high blood pressure can lead to kidney disease, arrhythmias, and heart failure. Recently, the treatment of hypertension has focused on interventional approaches that inactivate the renal nerves surrounding the renal arteries. Autonomic nerves tend to follow blood vessels toward the organs they innervate. Catheters can reach specific structures, such as renal nerves, located near the lumen through which the catheter travels. Accordingly, catheter-based systems can deliver energy from within the lumen to inactivate the renal nerves. One approach to renal nerve inactivation involves connecting a catheter equipped with multiple electrodes positioned against the intima of the renal artery and using a radio frequency (RF) generator to produce an electric field in the vessel wall and surrounding tissues, thereby generating resistive (ohmic) heating of the tissue to a temperature sufficient to ablate the tissues and renal nerves passing through them. To treat all renal nerves surrounding the renal artery, the RF electrodes are repositioned multiple times around the inside of the renal artery. However, the relatively limited electric field generated by the RF electrodes may miss some of the renal nerves, leading to incomplete treatment. Additionally, to heat the renal nerves, the RF electrodes must come into contact with the intima, posing a risk of damage or necrosis to the intima, which in turn can lead to thrombus formation, fibrosis of the vessel wall, mechanical weakening of the vessel, and possible vascular dissection. Another approach to renal nerve inactivation is the use of high-intensity focused ultrasound (HIFU). HIFU relies on vibrational energy to cause frictional heating and destruction of tissue, which in turn raises the tissue temperature sufficiently to cause resection or remodeling. Warnking’s U.S. Patents No. 9,943,666, 9,981,108, and 10,039,901; Schaer’s U.S. Patents No. 9,700,372, 9,707,034, and 10,368,944; and Taylor’s U.S. Patents No. 10,350,440 and 10,456,605 address many of the disadvantages of RF and HIFU systems. An exemplary embodiment of the system includes an ultrasonic transducer positioned along the distal end of a catheter designed to be inserted into a blood vessel, e.g., a renal artery. Electrical wiring housed within the wiring lumen of the catheter may be used to power the ultrasonic transducer. The ultrasonic transducer emits one or more therapeutic doses of non-focused ultrasonic energy, which heats the tissue adjacent to the body lumen where the transducer is placed. This non-focused ultrasound energy can, for example, ablate target nerves surrounding a body lumen, but may not damage non-target tissues such as the inner wall of the body lumen or unintended organs outside the body lumen. The system may include a balloon mounted at the distal end of a catheter designed to cool the blood vessel when cooling fluid is delivered to the balloon. This design enables the creation of one or more ablation zones sufficient to achieve organ nerve inactivation at different locations around the circumference of the blood vessel. The present invention is defined in the independent claim. Further embodiments of the present invention are defined in the dependent claims. A catheter is provided herein. The catheter comprises a catheter shaft having a fluid channel, an ultrasonic transducer, and a conforming balloon mounted on the catheter shaft, having an interior that is in fluid communication with the fluid channel and accommodates the ultrasonic transducer. The conforming balloon comprises a balloon wall having a working section that radially surrounds the ultrasonic transducer. The working section has a predetermined straightness when the working section has a first diameter and when the working section has a second diameter that is at least 2 mm larger than the first diameter. A kit is provided herein. The kit comprises a first catheter and a second catheter, each covering a different and overlapping expansion diameter range. The first catheter may include a first conforming balloon having a first expansion diameter range when fluid is circulated through the balloon at a flow rate that generates an expansion pressure in the range of 10 to 30 psi. The second catheter may include a second conforming balloon having a second expansion diameter range when fluid is circulated through the balloon at a flow rate that generates an expansion pressure in the range of 10 to 3