Vacuum assisted percutaneous appliance

• US 10,065,030 B2
• Filed: 02/23/2011
• Issued: 09/04/2018
• Est. Priority Date: 02/23/2010
• Status: Active Grant

• Current Assignee: Viaderm, LLC
• Original Assignee: Viaderm, LLC
• Inventors: Kantrowitz, Allen B., Mortis, Chris, Wadsworth, Jr., Daniel C.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US13/394,239
• Publication Number:
  US 20120310181A1
• Time in Patent Office: 2,750 Days
• Field of Search: 604304, 604305, 604307, 604308, 604313, 604315-318, 604175, 604176, 604289, 604543, 604336, 604356
• 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 device for reducing agent penetration at an insertion site in subject tissue comprising:

a medical appliance having an outer surface, said medical appliance configured to extend from outside the subject tissue to beneath the subject tissue, and where said medical appliance is one of;

a peripherally inserted central catheter (PICC), a cannula, a catheter, a Steinman pin, or a Kirschner wire;

a conduit with an open proximal end and an open distal end, said conduit forming a seal with the outer surface of said medical appliance;

a porous inner sleeve fluidly surrounding the outer surface of said medical appliance and connected to said conduit, said porous inner sleeve configured to extend extending from above an epidermis layer of the subject tissue in the insertion site, and through the epidermis layer to a subcutaneous layer of the subject tissue;

an outer sleeve that is textured with pores, ridges, depressions, or indentations at least partially surrounding said porous inner sleeve, said porous inner sleeve and said outer sleeve being coaxial with said medical appliance;

a vacuum source of a mechanical pump fluidly connected to the open proximal end of said conduit drawing vacuum against the subject tissue at the insertion site through said outer sleeve and said porous inner sleeve through said conduit to draw fibroblasts into and onto said outer sleeve; and

an intermediate matrix having a reduced pore size compared to said porous inner sleeve, said intermediate matrix between said porous inner sleeve and said outer sleeve, said intermediate matrix experiences vacuum forces created by the vacuum source in communication with said intermediate matrix, said intermediate matrix having a rigidity sufficient to prevent collapse.

2. The device of claim 1 wherein said porous inner sleeve or said outer sleeve further comprises a coating substance.

3. The device of claim 1 wherein said porous inner sleeve or said outer sleeve further comprises a coating compound, and said coating compound is a growth factor, extracellular matrix factors, fibroblast receptors, fibronectin, laminectin, RGD factor, dexamethasone, or combinations thereof.

4. The device of claim 1 further comprising a fluid, biological, or chemical-sensing device.

5. The device of claim 1 further comprising a gas-tight bandage.

6. The device of claim 5 further comprising a diffuser configured to be positioned intermediate between an outer surface of the epidermis and said bandage.

7. The device of claim 1 wherein said outer sleeve is fluidly connected to said conduit through said porous inner sleeve, where said outer sleeve movably surrounds said porous inner sleeve, and said porous inner sleeve or said outer sleeve is treated or shaped to encourage fibroblast attachment.

8. A device for reducing agent penetration at an insertion site comprising:

a medical appliance having an outer surface, said medical appliance configured to extend from outside the insertion site to beneath a subject tissue, and where said medical appliance is one of;

a peripherally inserted central catheter (PICC), a cannula, a catheter, a Steinman pin, or a Kirschner wire;

a conduit having a bore and an outer conduit surface, said conduit with an open proximal end and an open distal end, said conduit forming a seal with the outer surface of said medical appliance;

a sleeve in fluid communication with the outer conduit surface of said conduit, said sleeve formed of a material characterized by a pore matrix through which vacuum draw is achieved, and where said sleeve and said conduit are coaxial with said medical appliance; and

an intermediate matrix between the pore matrix and the outer conduit surface, the intermediate matrix having a reduced pore size compared to the pore matrix, said intermediate matrix experiences vacuum forces created by a vacuum source a mechanical pump in communication with said intermediate matrix, said intermediate matrix having a rigidity sufficient to prevent collapse under a draw pressure, and thereby maintain vacuum forces through the intermediate matrix.

9. The device of claim 8 wherein the pore matrix is a contiguous piece joined to the intermediate matrix to form said sleeve.

10. The device of claim 8 wherein the pore matrix is integral with the intermediate matrix to form a monolithic sleeve.

11. The device of claim 8 wherein the intermediate matrix has a pore size of between 3 and 50 migratory fibroblast diameters.

12. The device of claim 8 wherein said sleeve includes a scaffold.

13. The device of claim 8 wherein said sleeve further comprises a coating compound, said coating compound is growth factor, extracellular matrix factors, fibroblast receptors, fibronectin, laminectin, RGD factor, dexamethasone, or combinations thereof.

14. The device of claim 8 wherein said sleeve surrounds said medical appliance.

15. The device claim 8 wherein the pore matrix and the intermediate matrix are inhomogeneous with respect to at least one property of mechanical, geometrical, cross-linking, or biological properties.

16. The device of claim 8 wherein the outer conduit surface is nanotextured.