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

• US 20030040712A1
• Filed: 10/10/2002
• Published: 02/27/2003
• Est. Priority Date: 07/13/1999
• Status: Active Grant

• Current Assignee: Daryush Mirzaee, Pinaki Ray, Vinayak D. Bhat
• Original Assignee: Daryush Mirzaee, Pinaki Ray, Vinayak D. Bhat
• Inventors: Mirzaee, Daryush, Bhat, Vinayak D., Ray, Pinaki
• Granted Patent: US 7,150,738 B2
• Time in Patent Office: Days
• US Class Current: 604/173
• 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. The balloon is also capable of being deflated after inflation to return to the collapsed configuration or a deflated profile. 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. The balloon can be made from a porous membrane to allow a therapeutic substance that is supplied into the balloon to be discharged out from the porous membrane.

Claims

1. A substance delivery apparatus, comprising:

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

(b) 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.

2. The substance delivery apparatus of claim 1, additionally comprising a catheter assembly and a balloon disposed at a distal end of said catheter assembly, wherein said first section of said hollow body pivotally rotates with respect to said second section in response to inflation of said balloon.

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

4. The substance delivery apparatus of claim 2, additionally comprising a transport element operably supported by 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.

5. The substance delivery apparatus of claim 2, additionally comprising a transport element operably supported by said catheter assembly, said transport element having an ultrasonic transducer.

6. A device for delivering a substance to a desired area of treatment, comprising:

(a) a catheter assembly having a distal end and a proximal end;

(b) a balloon disposed at said distal end of 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 first syringe assembly in fluid communication with said catheter assembly for allowing a first therapeutic substance to be injected into a tissue of a lumen, wherein said first syringe assembly includes a portion capable of pivoting from a first position towards a second position in response to said balloon being inflated from said collapsed configuration to said expanded configuration, and wherein said portion of said first syringe assembly is capable of pivoting from said second position back towards said first position in response to said balloon being deflated.

7. The device of claim 6, wherein said first syringe assembly is configured to penetrate into the tunica media layer of a blood vessel for administering said first therapeutic substance to a region of the tunica media layer of said blood vessel.

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

9. The device of claim 8, wherein said second therapeutic substance is different than said first therapeutic substance.

10. The device of claim 8, wherein said second therapeutic substance is the same as said first therapeutic substance.

11. The device of claim 6, wherein when said balloon is in said collapsed configuration, a longitudinal axis of said portion of said first syringe assembly is generally parallel to a longitudinal axis of said balloon and when said balloon is in said expanded configuration, said longitudinal axis of said portion of said first syringe assembly is about 45°

to about 90°

from said longitudinal axis of said balloon.

12. The device of claim 6, additionally comprising a second syringe assembly in fluid communication with said catheter assembly for allowing a second therapeutic substance to be injected into a tissue of said lumen, said second therapeutic substance being different than said first therapeutic substance, wherein said second syringe assembly comprises a portion capable of pivoting from a first position towards a second position in response to said balloon being inflated from said collapsed configuration to said expanded configuration, and wherein said portion of said second syringe assembly is capable of pivoting from said second position back towards said first position in response to said balloon being deflated.

13. The device of claim 6, additionally comprising a transport element operably connected to 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.

14. The device of claim 6, additionally comprising a transport element operably connected to said catheter assembly, said transport element having an ultrasonic transducer.

15. A method for administering a therapeutic substance, comprising the acts of:

(a) providing a catheter device having a first syringe assembly in fluid communication with a first delivery lumen of said catheter device;

(b) inserting said catheter device in a biological passageway of a subject;

(c) position said syringe assembly at a desired area of treatment;

(d) causing a portion of said first syringe assembly to pivotally rotate for penetrating a needle of said first syringe assembly into a wall of said desired area of treatment; and

(e) supplying a first therapeutic substance through said first delivery lumen of said catheter device to administer said first therapeutic substance to said desired area of treatment.

16. The method of claim 15, wherein said catheter device additionally comprises a balloon having a section communicating with said portion of said first syringe assembly, wherein said act (d) comprises inflating said balloon from a collapsed configuration to an expanded configuration to cause said portion of said first syringe assembly to pivotally rotate from a first position to a second position.

17. The method of claim 15, wherein said catheter device additionally comprises a balloon made from a porous membrane, wherein the method additionally comprises the act of supplying a second therapeutic substance into said balloon to inflate said balloon from a collapsed configuration to an expanded configuration and to discharge said second therapeutic substance out from said porous membrane.

18. The method of claim 17, wherein said first therapeutic substance is the same as said second therapeutic substance.

19. The method of claim 17, wherein said first therapeutic substance is different than said second therapeutic substance.

20. The method of claim 15, wherein said catheter device additionally comprises a second syringe assembly in fluid communication with a second delivery lumen of said catheter device, wherein the method additionally comprises the act of:

(a) causing a portion of said second syringe assembly to pivotally rotate for penetrating a needle of said second syringe assembly into said wall of said desired area of treatment; and

(b) supplying a second therapeutic substance through said second delivery lumen of said catheter device to administer said second therapeutic substance to said desired area of treatment, wherein said second therapeutic substance is different than said first therapeutic substance.

21. A medical assembly, comprising:

(a) a catheter assembly capable of being guided through anatomical passageways of a subject, said catheter assembly having a first lumen and a second lumen;

(b) a selectively inflatable member having outer ends engaged to a distal end of said catheter assembly, said member being in fluid communication said first lumen and said member being formed from a porous membrane which defines a therapeutic substance receiving and dispensing chamber bounded by said outer ends of said member, wherein a first therapeutic substance can be supplied into said first lumen to selectively inflate said member and to discharge said first therapeutic substance out from said chamber through said porous membrane; and

(c) a first syringe in fluid communication with said second lumen of said catheter assembly and capable of penetrating into a tissue of a passageway, wherein a user can supply a second therapeutic substance into said second lumen for injection of said second therapeutic substance out from said first syringe.

22. The medical assembly of claim 21, wherein said first therapeutic substance is different than said second therapeutic substance.

23. The medical assembly of claim 21, additionally comprising:

(a) a third lumen extending along at least a portion of said catheter assembly;

(b) a second syringe in fluid communication with said third lumen of said catheter assembly and capable of penetrating into a tissue of said passageway, wherein a user can supply a third therapeutic substance into said third lumen for injection of said third therapeutic substance out from said second syringe.

24. The medical assembly of claim 23, wherein said third therapeutic substance is different than said second therapeutic substance.

25. The medical assembly of claim 23, wherein said third therapeutic substance is different than said first and second therapeutic substances.