Substance delivery apparatus and a method of delivering a therapeutic substance to an anatomical passageway

• US 6,494,862 B1
• Filed: 12/30/1999
• Issued: 12/17/2002
• Est. Priority Date: 07/13/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Mirzaee, Daryush, Bhat, Vinayak D., Ray, Pinaki
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US09/475,727
• Time in Patent Office: 1,083 Days
• Field of Search: 604/93.01, 604/95.03, 604/95.04, 604/96.01, 604/103.01, 604/103.03, 604/117, 604/181, 604/187, 604/188, 604/207, 604/211, 604/223, 604/240, 604/242, 604/264, 604/272, 604/523, 604/20-22, 606/7, 606/32, 606/41, 607/115, 607/120, 607/122, 600/439, 600/462, 600/466, 600/467
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• 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 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter assembly is provided having a balloon disposed at the distal end thereof. The balloon is capable of being inflated to selectively dilate from a collapsed configuration to an expanded configuration. A syringe assembly is in fluid communication with a delivery lumen of the catheter assembly for allowing a therapeutic substance to be injected into a tissue of a passageway. The syringe assembly includes a portion capable of pivoting from a first position towards a second position when the balloon is being inflated from the collapsed configuration to the expanded configuration. The portion of the syringe assembly is also capable of pivoting from the second position back towards the first position when the balloon is being deflated.

Claims

1. A substance delivery apparatus, comprising:

(a) a catheter assemnbly;

(b) a balloon disposed at an end portion of said catheter assembly, said balloon being configured to have a collapsed form and an expanded form;

(c) a needle capable of penetrating into tissues of a subject for administering a substance to said subject; and

(d) a hollow body in fluid communication with said needle, said hollow body being defined by a first section and a second section, wherein said first section is capable of pivotally rotating with respect to said second section in response to inflation of said balloon from said collapsed from to said expanded form, and wherein a longitudinal axis of said needle is generally parallel to a longitudinal axis of said balloon when said balloon is in said collapsed form.

2. The substance delivery apparatus of claim 1, wherein said balloon is made from a porous membrane.

3. The substance delivery apparatus of claim 1, additionally comprising a transport element operably integrated with said catheter assembly, said transport element having a first electrode element, a second electrode element, and a power supply electrically communicating with said first and second electrode elements, wherein said first electrode element is positioned within said balloon.

4. The substance delivery apparatus of claim 1, additionally comprising a transport element operably integrated with said catheter assembly, said transport element having an ultrasonic transducer.

5. The substance delivery apparatus of claim 1, wherein said longitudinal axis of said needle is about 45°

to about 90°

from said longitudinal axis of said balloon when said balloon is in an expanded form.

6. A therapeutic substance delivery apparatus, comprising:

(a) a catheter assembly for insertion in a bodily lumen;

(b) a balloon integrated with said catheter assembly, wherein said balloon is capable of being inflated to selectively dilate from a collapsed configuration to an expanded configuration and said balloon is capable of being deflated after inflation to retract to a deflated profile; and

(c) a needle for delivering a therapeutic substance integrated with said catheter assembly, wherein said needle is essentially parallel to the longitudinal axis of the end portion of said catheter assembly when said balloon is in said collapsed configuration and said needle is positioned at an angle with respect to the longitudinal axis of the end portion of said catheter assembly when said balloon is in an expanded configuration.

7. The apparatus of claim 6, wherein said needle is calibrated to penetrate into the tunica media layer of a blood vessel for administering said therapeutic substance to a region of the tunica media layer of said blood vessel.

8. The apparatus of claim 6, wherein said balloon is made from a membrane having a plurality of pores for allowing a therapeutic substance supplied into said balloon to be discharge out from said pores.

9. The apparatus of claim 6, wherein said angle is about 45°

to about 90°

from the longitudinal axis of the end portion of said catheter assembly.