Method and apparatus for providing access to an internal body organ

• US 20120203199A1
• Filed: 11/30/2011
• Published: 08/09/2012
• Est. Priority Date: 11/30/2010
• Status: Abandoned Application

• Current Assignee: IncuMED, LLC
• Original Assignee: IncuMED, LLC
• Inventors: Mann, Alfred E., Harbers, Gregory M., Chapman, Kelly A., Janis, Abram D.
• Application Number:
  US13/373,787
• Publication Number:
  US 20120203199A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0643 Devices having a blunt needle tip, e.g. due to an additional inner component
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Catheter systems and methods for facilitating the delivery of a therapeutic agent directly to the interior of a body organ, and/or the extraction of material from said organ. The catheter distal end is placed within the body organ to be treated. The catheter may carry a fixation device near the catheter distal end. When implanted, the fixation device retains the catheter distal end in the organ despite normal patient activity. The fixation device may include porous material to promote soft tissue ingrowth for anchoring the catheter distal end within the organ.

Claims

1. Apparatus suitable for providing access to the interior of a body organ, said apparatus including:

an elongate flexible catheter having an outer surface and an inner surface enveloping a lumen extending between a catheter proximal end and a catheter distal end; and

a sleeve of porous material mounted on at least a portion of said catheter outer surface near said catheter distal end.

2. The apparatus of claim 1 further including:

a dilator fixed to said catheter outer surface having a proximal end located adjacent to said porous material sleeve distal boundary and a distal end located near said catheter distal end, said dilator having an outer peripheral surface increasing from a diameter D1 at its distal end to a diameter D2 at its proximal end where D2 is equal to or greater than a diameter D3 of said sleeve.

3. The apparatus of claim 1 further including an elongate needle configured for insertion through said catheter lumen to position the distal end of said needle beyond said catheter distal end for insertion through the peripheral wall of a body organ.

4. The apparatus of claim 3 wherein said needle distal end has a sharp tip for cutting through said organ periphery.

5. The apparatus of claim 3 wherein said needle distal end has a blunt tip for facilitating axial movement of said needle through said catheter.

6. The apparatus of claim 1 wherein said sleeve of porous material defines a distal boundary located within about 0.5 inch of said catheter distal end.

7. The apparatus of claim 1 wherein the body organ is a solid body organ.

8. The apparatus of claim 1 wherein said porous material is characterized by a pore size within a range of 50 to 200 microns and a porosity of between 60% to 95%.

9. The apparatus of claim 1 further including a device with a chamber in fluidic communication with the catheter proximal end.

10. A method for accessing the interior of a body organ, said method comprising:

providing a flexible elongate catheter having an outer surface and an inner surface enveloping a lumen extending between a catheter proximal end and a catheter distal end;

providing a layer of porous material on at least a portion of said catheter outer surface near said catheter distal end;

providing an elongate needle having a proximal end and a distal end and a sharp cutting edge located at said distal end;

implanting the distal end of said catheter in a patient'"'"'s body using said needle sharp distal end, so said catheter distal end projects into the interior of a body organ with said porous material located in subcutaneous tissue outside of said body organ.

11. The method of claim 10 further comprising:

withdrawing said needle proximally from said catheter while leaving said catheter distal end projecting into said body organ; and

inserting an additional needle having a blunt distal end through said catheter lumen to extend beyond said catheter distal end into said organ.

12. The method of claim 11 wherein said additional needle includes an interior lumen extending between said additional needle proximal and distal ends, and further including:

supplying material to the proximal end of said additional needle interior lumen for delivery to the interior of said body organ.

13. The method of claim 10 wherein said step of implanting said catheter includes percutaneously extending said catheter to locate the proximal end of said catheter exteriorly of the patient'"'"'s skin.

14. The method of claim 13 wherein the step of implanting the catheter includes coupling the catheter proximal end to a device with a chamber in fluidic communication with the catheter proximal end.

15. The method of claim 10 wherein said step of implanting said catheter includes coupling the proximal end of said catheter to a subcutaneous device.

16. The method of claim 15 wherein the subcutaneous device includes a self sealing septum.

17. The method of claim 10 where said porous material is characterized by a pore size within a range of 50 to 200 microns and with a porosity of between 60% to 95%

18. The method of claim 10 further comprising providing a dilator surface on said catheter outer surface distally of said porous material where said dilator surface defines a distal end located proximally of said catheter distal end;