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EP-3503845-B1 - A CATHETER FOR DELIVERING A RIGID INTRAVASCULAR DEVICE

EP3503845B1EP 3503845 B1EP3503845 B1EP 3503845B1EP-3503845-B1

Inventors

  • VALENCIA, Francisco
  • MCNIVEN, SEAN A.
  • VON OEPEN, RANDOLF

Dates

Publication Date
20260506
Application Date
20170728

Claims (5)

  1. A catheter (302) for delivering a rigid intravascular device (308) to a target location (306) within a human heart (334) through the inferior vena cava, the catheter (302) comprising: an outer sleeve (324); and an inner steerable catheter (326) having a proximal end, a distal end, and a deflection portion (338) located at a distal tip of the inner steerable catheter (326) such that longitudinal movement of the inner steerable catheter (326) moves the deflection portion (338) relative to the outer sleeve (324), steering of the catheter (302) being reliant upon the inner steerable catheter (326), the inner steerable catheter (326) being longitudinally moveable relative to the outer sleeve (324) by greater than 0.5mm, a first plurality of cuts (356, 358) being formed in a first section of the outer sleeve (324) in a first cut pattern for causing the catheter (302) to selectively form a first bend (350) in a first direction, and a second plurality of cuts (356, 358) being formed in a second section in the outer sleeve (324) in a second cut pattern for causing the catheter (302) to selectively form a second bend (352) in a second direction.
  2. The catheter of claim 1, wherein the first cut pattern comprises one or more slits (356) in a first side of the outer sleeve (324).
  3. The catheter of claim 2, wherein the first cut pattern further comprises one or more island cuts (358) in the first side of the outer sleeve (324).
  4. The catheter of claim 3, wherein the second cut pattern comprises one or more slits (356) in a second side of the outer sleeve (324), the second side being opposite the first side.
  5. The catheter of claim 4, wherein the second cut pattern further comprises one or more island cuts (358) in the second side of the outer sleeve (324).

Description

BACKGROUND OF THE DISCLOSURE Intravascular medical procedures allow the performance of therapeutic treatments in a variety of locations within a patient's body while requiring only relatively small access incisions. An intravascular procedure may, for example, eliminate the need for open-heart surgery, reducing risks, costs, and time associated with an open-heart procedure. The intravascular procedure also enables faster recovery times with lower associated costs and risks of complication. An example of an intravascular procedure that significantly reduces procedure and recovery time and cost over conventional open surgery is a heart valve replacement or repair procedure. An artificial valve is guided to the heart through the patient's vasculature. For example, a catheter is inserted into the patient's vasculature and directed to the inferior vena cava. The catheter is then urged through the inferior vena cava toward the heart by applying force longitudinally to the catheter. Upon entering the heart from the inferior vena cava, the catheter enters the right atrium. The distal end of the catheter may be deflected by one or more wires positioned inside the catheter. Precise control of the distal end of the catheter allows for more reliable and faster positioning of a medical device and/or implant and other improvements in the procedure. The devices can also be directed through the valve chordae or papillary muscles, for example, for interventional therapy to the mitral valve. When such procedures require the use of more than one instrument, each instrument would be dependent upon proper positioning in relation to the valve. Therefore, positioning or steering mechanisms need to be built into each instrument. This adds further cost, complexity, and time to the procedures. Other procedures may include tracking a catheter and/or access sheath from a puncture in the femoral vein through the intra-atrial septum to the left atrium. This pathway may be used to access the left atrium for ablation of the atrium wall or ablation around the pulmonary veins. Such interventional therapies would require precise alignment with target areas for proper ablation placement. Additionally, alternative access routes and/or access routes to other cavities may be desired. The scope of intravascular procedures has increased in recent years with more intravascular devices delivered to the heart through the patient's vasculature. Intravascular device delivery utilizes comparatively small radius turns through torturous anatomy that limits the capacity of the intravascular device delivery system to deliver intravascular devices of different dimensions. InUS 2010/0217261 there is described a steerable catheter sheath for use in directing a catheter into a desired position. The sheath includes an elongated member configured to receive the catheter therein. The distal end of the elongated member is steerable in two directions, each direction having a different bent configuration, e.g., a sharp curve in one direction and an open arching curve in the other direction. A resilient structure having different bending properties in each of its lateral sides is carried in the distal portion of the elongated member and causes the asymmetric bending. In one arrangement, the resilient structure includes a hypotube with a plurality of notches and slits in the sides. In another arrangement, the resilient structure is covered in an outer coating having different durometer portions. The sheath is said to be particularly useful for accessing left and right pulmonary veins when a transeptal entry approach is used into the left atrium. BRIEF SUMMARY OF THE DISCLOSURE According to the present invention there is provided a catheter having the features of claim 1 for delivering a rigid intravascular device to a target location within a human heart through the inferior vena cava. There is also described a method of delivering an intravascular device which includes positioning a distal tip of an elongated member of the intravascular device delivery system in a right atrium of a heart; moving the distal tip of the elongated member into a left atrium of the heart; advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance; deflecting at least a portion of the inner steerable catheter a first deflection amount; advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance; and deflecting at least a portion of the inner steerable catheter a second deflection amount. This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to be used in limiting the scope of the claimed subject matter. Additional features will be set forth in the description that follows. These a