# US 2019/0167965 A1 · Vacuum assisted percutaneous appliance

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- Number: US 2019/0167965 A1
- Document ID: US20190167965A1
- Status: Published application
- Kind: A1
- Application number: 16/268,693
- Filed: 2019-02-06
- Published: 2019-06-06
- Earliest claimed: 2010-02-23
- Assignees: Viaderm LLC
- Applicants: Viaderm LLC
- Inventors: Allen B. Kantrowitz; Chris Mortis; Daniel C. Wadsworth, JR.
- Web page: https://patentgrep.com/patent/US20190167965A1

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- 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})
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 2025/006: {having a special surface topography or special surface properties, e.g. roughened or knurled surface}
- 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}
- A61M 2039/027: {having a particular valve, seal or septum}
- A61M 2039/0282: {with implanted tubes connected to the port}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 1

A process for stabilizing an implanted device to create an access point in subject tissue comprising:
placing the implanted device extending from outside the subject tissue and beneath the subject tissue in an insertion site of a subject to create the access point, the implanted device comprising:
a conduit having a bore and an outer conduit surface, where the bore has a percutaneous instrument therein and extending beyond the bore;
a vacuum seal or gasket between said conduit and said percutaneous instrument; and
a sleeve extending from above an epidermis layer of the subject tissue in the insertion site, and through to a subcutaneous layer of the subject tissue, said sleeve surrounding the bore and having a surface in fluid communication with the bore or the outer conduit surface of said conduit, said outer sleeve formed of collagen, thermoplastic elastomer, nylons, polypropylenes, polyurethanes, polyethylenes, polyethylene terephthalate, silicone rubber, latex, glass having a rigidity sufficient to prevent collapse through which vacuum or hydrodynamic draw is achieved, said sleeve and said conduit being cylindrical and are coaxial with said percutaneous instrument; and
drawing mechanical vacuum or hydrodynamic draw against the subject tissue at the insertion site in subject tissue through said sleeve and said conduit for a sufficient amount of time to draw fibroblasts into and onto said sleeve to stabilize the implanted device in the subject tissue at the insert site.

### Claim 2 (depends on 1)

The process of claim 1 further comprising attaching fibroblasts to the surface of said sleeve.

### Claim 3 (depends on 1)

The process of claim 1 further comprising manifolding the vacuum or hydrodynamic draw along the outer conduit surface, the outer conduit surface having at least one of: channels, texturing, or a porous covering.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 1)

The process of claim 1 wherein the drawing step retains the subject tissue defining the insertion site against the implanted device by the vacuum or hydrodynamic draw.

### Claim 7 (depends on 1)

The process of claim 1 wherein the drawing step conveys at least one of: biological fluids or bioburden from the insertion site into said conduit.

### Claim 8 (depends on 1)

The process of claim 1 wherein the drawing step creates a seal between the device and the subject tissue.

### Claim 9 (depends on 1)

The process of claim 1 further comprising placing a gas-tight bandage over the subject tissue at the insertion site.