Angioplasty and ablative devices having onboard ultrasound components and devices and methods for utilizing ultrasound to treat or prevent vasospasm

• US 5,474,530 A
• Filed: 06/08/1994
• Issued: 12/12/1995
• Est. Priority Date: 01/11/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Baxter International Inc.
• Inventors: Passafaro, James D., Gesswein, Douglas H., Nita, Henry, Siegel, Robert J.
• Primary Examiner(s): Maglione, Corrine M.
• Application Number:
  US08/255,513
• Time in Patent Office: 552 Days
• Field of Search: 604/22, 604/93, 604/101, 601/2, 606/169-171
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61M 2025/0183 : Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61M 3/0279 : Cannula; Nozzles; Tips; their connection means

Abstract

A catheter device incorporating combined ultrasound ablation and balloon dilation components. The catheter device generally comprises an elongate catheter body having proximal and distal ends and an outer surface. Disposed on the outer surface of the catheter body is a dilation balloon. At least one balloon inflation lumen fluidly connects the proximal end of the catheter body to the dilation balloon to permit injection of inflation fluid into the dilation balloon. Extending longitudinally through the catheter body is an ultrasound transmission member having a proximal end and a distal end, with the proximal end being connectable to an ultrasound transducer such that ultrasonic energy will pass through the ultrasound transmission member to the distal end thereof. In alternative embodiments of the present invention, there are provided catheter devices incorporating combined ultrasound ablation and laser ablation components as well as combined ultrasound ablation and atherectomy ablation components.

Claims

1. A catheter device insertable into a body lumen and incorporating combined ultrasound ablation and balloon dilation apparatus, said device comprising:

an elongate catheter body having a proximal end, a distal end and an outer surface;

a dilation balloon disposed on the outer surface of said catheter body;

at least one balloon inflation lumen fluidly connecting the proximal end of said catheter body to said dilation balloon to permit injection of inflation fluid into said dilation balloon; and

an ultrasound transmission member extending longitudinally through said catheter body, said ultrasound transmission member having a proximal end and a distal end, the proximal end of said ultrasound transmission member being connectable to an ultrasound transducer such that ultrasonic energy will pass through said ultrasound transmission member to the distal end thereof

said ultrasound transmission member being connected to the distal end of said catheter body such that the distal end of the catheter body will undergo ultrasonic vibratory movement concurrently with said ultrasound member.

2. The device of claim 1 wherein the distal end of said ultrasound transmission member is affixed to the distal end of said catheter body.

3. The device of claim 1 wherein the distal end of said ultrasound transmission member comprises a distal head member and wherein said connection of said ultrasound transmission member to the distal end of said catheter body is by affixation of said distal head member to the distal end of said catheter body.

4. The device of claim 3 wherein said catheter body has a first lumen having a first lumenal diameter, said ultrasound transmission member extending longitudinally through said first lumen, and wherein at least a first portion of said distal head member has an outer diameter which is substantially the same as the lumenal diameter of said first lumen, and wherein at least said portion of said distal head member is inserted into said first lumen and affixed thereto, at the distal end of said catheter body.

5. The device of claim 4 wherein the distal head member is affixed to said catheter body by adhesive.

6. The device of claim 4 wherein said distal head member is affixed to said catheter by welding.

7. The device of claim 4 wherein said distal head member and said catheter body are formed of plastic, and wherein said distal head member is affixed to said catheter body by solvent welding.

8. The device of claim 4 wherein said distal head member is affixed to said catheter body by mechanical connection.

9. The device of claim 4 wherein said distal head member is affixed to said catheter body by frictional connection.

10. The device if claim 4 wherein said distal head member and said catheter body have corresponding surface modifications formed thereon, said surface modifications being configured and constructed to engage one another so as to hold said distal head in fixed position relative to said catheter body.

11. The device of claim 3 wherein said distal head member is radiodense to facilitate radiographic discernment of the position of said distal head.

12. The device of claim 1 wherein said dilation balloon comprises a radial dilation balloon formed fully around and affixed to the outer surface of said catheter body.

13. The device of claim 1 wherein said dilation balloon is approximately 2-5 cm in length.

14. The device of claim 1 wherein said dilation balloon is positioned such that the distal most extent of the dilation balloon is approximately 1-20 mm from the distal end of said catheter body.

15. The device of claim 1 wherein said catheter body is formed of two concentric single lumen tubes comprising:

an outer tube having proximal and distal ends, an outer surface and an inner luminal surface;

an inner tube having proximal and distal ends, an outer surface and an inner luminal surface;

said inner tube being longitudinally disposed through the lumen of said outer tube;

said ultrasound transmission member being longitudinally disposed within and extending through the lumen of said inner tube; and

said balloon inflation lumen comprising a space between the outer surface of said inner tube and the inner luminal surface of said outer tube.

16. The device of claim 15 wherein the lumen of said inner tube further comprises a pathway for passage of a guidewire therethrough.

17. The device of claim 15 wherein the lumen of said inner tube further comprises a pathway for passage of irrigation fluid therethrough.

18. The device of claim 1 wherein said catheter body comprises a tube having at least first and second lumens extending longitudinally therethrough, and wherein:

said ultrasound transmission member is disposed within said first lumen; and

said second lumen comprises said balloon inflation lumen.

19. The device of claim 1 wherein said ultrasound transmission member is at least partially formed on a metal alloy which is super elastic within the temperature range at which the ultrasound transmission member operates.

20. The device of claim 19 wherein said superelastic metal alloy is a nickel-titanium allow.

21. The device of claim 20 wherein said nickel-titanium alloy is made up of 55.8% by weight nickel.