Transthoracic drug delivery device

• US 6,517,527 B2
• Filed: 06/25/2001
• Issued: 02/11/2003
• Est. Priority Date: 09/30/1998
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Forcucci, Stephen J., Gambale, Richard A., Cafferata, Robert, Choh, Richard T.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/888,750
• Publication Number:
  US 20010037086A1
• Time in Patent Office: 596 Days
• Field of Search: 600/468, 600/486, 600/487, 600/508, 607/120, 604/264, 604/181, 604/187, 604/523, 604/528
• US Class Current: 604/508
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2210/10 Trunk
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

The present invention provides a transthoracic drug delivery device that utilizes pressure to determine the precise location of the distal tip of the delivery tube of the device to insure that therapeutic substances are ejected into the myocardium and not dissipated in unintended tissue locations. In one embodiment the drug delivery device comprises a pressure sensing tube mounted in parallel to a drug delivery tube wherein the tubes are staggered so that the pressure tube extends beyond the delivery tube. When the myocardium is penetrated by the tubes, advancement into the heart and penetration into the left ventricle by the pressures sensing tube results in a pressure increase that indicates to the physician that the drug delivery tube, by its placement relative to the pressure sensing tube is still in the myocardium and, thus, prepared to deliver the drug. In another embodiment, a steerable syringe is provided so that multiple sites in the myocardium can be treated with a therapeutic substance with only one penetration into the heart. Once the delivery tube of the syringe penetrates the left ventricle, its distal tip can be deflected back toward the endocardial surface and the tube withdrawn proximally to cause penetration of the tip into the myocardium. A pressure sensor mounted to the tube indicates, by a measured drop in pressure that the myocardium has been penetrated. The therapeutic substance is ejected into the myocardium and the device is then backed out of the tissue by advancing the syringe in a distal direction. The deflectable tip can be adjusted to a different deflection angle and the delivery tube rotated to make available a circular array of points that may be accessed by the syringe.

Claims

1. A method of delivering a therapeutic substance to a plurality of sites in the myocardium with a single penetration into the heart comprising:

introducing a tube having a deflectable distal portion and distal tip into the left ventricle of the heart;

deflecting the distal tip of the tube so that the tip faces the endocardium;

moving the tube in a proximal direction so that the distal tip penetrates the endocardium;

ejecting a therapeutic substance through the tube into the myocardium;

moving the distal tip from the myocardium by advancing the tube distally;

adjusting the position of the tip by changing the deflection angle of the tip or by rotating the tube to a new myocardial location;

moving the tube in a proximal direction to insert the distal tip into the myocardium at the new location;

ejecting a therapeutic substance from the tube into the myocardium.

2. A method of delivering a therapeutic substance to a plurality of locations within a myocardium as defined in claim 1 wherein the tube is equipped with a pressure sensor and the presence of the distal tip within myocardial tissue is determined by the change in pressure between the pressure indicated when the distal tip is in the myocardium versus the pressure indicated when the distal tip was in the ventricle.

3. A method of delivering a therapeutic substance to a plurality of locations within the myocardium as defined in claim 1 wherein the tube further comprises a stiffening element slidable within the tube and

prior to introducing the tube, advancing the stiffening element at least through the deflectable distal portion of the tube to provide support while introducing the tube into the heart and then

withdrawing the stiffening element proximal to the deflectable distal portion prior to deflecting the distal tip of the tube.

4. A method of delivering a therapeutic substance to a plurality of sites in the myocardium as defined in claim 1 wherein the tube is introduced through the epicardium of the heart to reach the left ventricle.