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

• US 7,150,738 B2
• Filed: 10/10/2002
• Issued: 12/19/2006
• Est. Priority Date: 07/13/1999
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Mirzaee, Daryush, Bhat, Vinayak D., Ray, Pinaki
• Primary Examiner(s): Sirmons, Kevin C.
• Assistant Examiner(s): Huh, Benjamin
• Application Number:
  US10/269,539
• Publication Number:
  US 20030040712A1
• Time in Patent Office: 1,531 Days
• Field of Search: 604/96.01, 604/95.03, 604/264, 604/117, 604/223, 604/102.03, 604/103.01, 604/103.03, 604/173, 604/240, 604/242, 604/272, 604/509, 604/523, 604 20- 22, 606/32, 606/41, 607/115, 607/120, 600/439, 600/466, 600/467
• US Class Current: 604/509
• 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 method of administering a substance, comprising:

inserting a catheter assembly into a biological passageway of a subject, said catheter assembly including

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

a needle capable of penetrating into tissues of a subject for administering a substance to said subject, and

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 form 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;

positioning said balloon at a desired area of said passageway;

expanding said balloon so as to pivotally rotate said first section for penetrating said needle into a wall of said desired area; and

supplying said substance through said hollow body of said catheter assembly to administer said substance to said desired area.

2. The method of claim 1, wherein said balloon includes a porous membrane and wherein the expanding includes supplying a second substance into said balloon to inflate said balloon from said collapsed form to said expanded form, such that said second substance is dispensed from said balloon.

3. The method of claim 2, wherein said substance includes a drug that is different than a drug included in said second substance.

4. The method 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 said expanded form.

5. The method of claim 1, wherein said needle is calibrated to penetrate into the tunica media layer of a blood vessel for administering said substance to a region of the tunica media layer of said blood vessel.

6. The method of claim 1, further comprising collapsing said balloon so as to pivotally rotate said first section to remove said needle from said wall of said desired area.

7. A method of administering a substance, comprising:

inserting a catheter assembly into a lumen of a subject, said catheter assembly comprising

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

a needle, for delivering said substance, integrated with said catheter assembly, wherein said needle is essentially parallel to the direction of movement of said catheter assembly in said lumen when said balloon is in said collapsed configuration and said needle is positioned at an angle with respect to a longitudinal axis of said balloon when said balloon is in an expanded configuration;

positioning said needle at a desired area;

expanding said balloon to cause said needle to enter said lumen; and

administering said substance to said subject.

8. The method of claim 7, wherein said balloon includes a porous membrane and wherein the expanding includes supplying a second substance into said balloon to inflate said balloon from said collapsed configuration to said expanded configuration such that said second substance is dispensed from said balloon.

9. The method of claim 8, wherein said substance includes a drug that is different than a drug included in said second substance.

10. The method of claim 7, wherein said angle is between about 45°

to about 90°

.

11. The method of claim 7, further comprising deflating said balloon to remove said needle from said lumen.

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