VACUUM ASSISTED PERCUTANEOUS APPLIANCE

• US 20130006186A1
• Filed: 03/09/2012
• Published: 01/03/2013
• Est. Priority Date: 02/23/2010
• Status: Active Grant

• Current Assignee: Viaderm, LLC
• Original Assignee: L.VAD Technology, Inc.
• Inventors: Wadsworth, Daniel C. Jr., Kantrowitz, Allen B., Mortin, Chris
• Granted Patent: US 10,258,784 B2
• Time in Patent Office: Days
• US Class Current: 604/176
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• 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 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• 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 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

A device for reducing agent penetration at an insertion site is provided that has a porous inner sleeve fluidly connected to a conduit. A vacuum or hydrodynamic source is fluidly connected to the conduit. The device is stabilized by fibroblast in-growth and inhibits bacterial colonization.

A device is also provided that has a conduit having a bore and an outer conduit surface. The outer conduit surface is optionally nanotextured to promote fibroblast adhesion and limit bacterial residency. A sleeve is provided in fluid communication with the bore of the conduit, and is formed from materials characterized by a pore matrix through which vacuum or hydrodynamic draw is achieved in a process to promote stabilization and reducing bacterial colonization by draw fluid from an area around the surrounding the site of the device. The sleeve optionally has a distal nanotextured surface.

Claims

1. A process for stabilizing an implanted device in subject tissue comprising:

providing a device comprising;

a conduit having a bore and an outer conduit surface, the outer conduit surface optionally being nanotextured; and

a sleeve in fluid communication with the bore or the outer conduit surface of said conduit, said sleeve formed of a materials characterized by a pore matrix through which vacuum or hydrodynamic draw is achieved, said sleeve optionally having a distal nanotextured surface; and

drawing vacuum against the subject tissue at the insertion site in subject tissue through said sleeve and said conduit or fluid from the insertion site through said conduit to draw fibroblasts into and onto said sleeve to stabilize the implanted device.

2. The process of claim 1 further comprising attaching fibroblasts to the nanotextured surface, the surface having nanopores.

3. The process of claim 1 further comprising manifolding the vacuum or fluid draw along the surface, the surface having channels, texturing and/or a porous covering.

4. The process of claim 1 further comprising coating the surface with a scaffold, collagen, compounds, or a combination thereof.

5. The process of claim 4 wherein the coating step creates a discrete layer or a gradient, the layers or the gradients varying in at least one of mechanical, geometrical or biological properties.

6. The process of claim 4 wherein the drawing step retains tissue defining the insertion site is held against the device by the vacuum or the fluid draw.

7. The process of claim 1 wherein the drawing step conveys biological fluids and/or bioburden from the insertion point into said conduit.

8. The process of claim 1 wherein the drawing step creates a compliant bridge between the device and the tissue.

9. A process for reducing infection at the site of percutaneous access in subject tissue comprising:

inserting a percutaneous medical appliance; and

applying a vacuum pressure or a hydrodynamic dressing surrounding an area around the site of percutaneous access.

10. A process for stabilizing an implanted device at a percutaneous insertion site in subject tissue comprising:

providing a device comprising;

a conduit having a bore and an outer conduit surface, the outer conduit surface optionally being nanotextured;

a sleeve in fluid communication with the bore or the outer conduit surface of said conduit, said sleeve formed of a materials characterized by a pore matrix through which vacuum or hydrodynamic draw is achieved, said sleeve optionally having a distal nanotextured surface, said sleeve being inhomogenous with respect to at least one property of mechanical, geometrical, cross-linking, or biological properties; and

drawing vacuum or fluid from the insertion site through conduit to draw fibroblasts into on onto said sleeve to stabilize the implanted device.

11. The process of claim 10 further comprising attaching fibroblasts to the nanotextured surface, the surface having nanopores.

12. The process of claim 10 further comprising manifolding the vacuum or fluid draw along the surface, the surface having channels, texturing and/or a porous covering.

13. The process of claim 10 further comprising coating surface with a scaffold, collagen, compounds or a combination thereof.

14. The process of claim 10 wherein the coating step creates a discrete layer or a gradient, the layers or the gradients varying in at least one of mechanical, geometrical or biological properties.

15. The process of claim 10 wherein the drawing step retains tissue defining the insertion site is held against the device by the vacuum or the fluid draw.

16. The process of claim 10 wherein the drawing step conveys biological fluids and/or bioburden from the insertion point into said conduit.

17. The process of claim 10 wherein the drawing step creates a compliant bridge between the device and the tissue.