# US 9,433,492 B2 · Method and device for facilitating surgical access to a body area

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- Number: US 9,433,492 B2
- Document ID: US9433492B2
- Status: Granted
- Kind: B2
- Application number: 11/533,512
- Filed: 2006-09-20
- Published: 2010-09-02
- Granted: 2016-09-06
- Earliest claimed: 2006-09-20
- Assignees: Boarad of Regents of the University of Nebraska
- Applicants: Jeffrey W. Delaney
- Inventors: Jeffrey W. Delaney
- Web page: https://patentgrep.com/patent/US9433492B2

## CPC

- A61F 2/06: Blood vessels
- A61B 2017/00252: {for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61F 2002/061: {provided with means for allowing access to secondary lumens}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A vascular graft that has a valve incorporated into a wall thereof is described. The graft may be used in gaining access to interior portions of the heart. The valve is normally closed and may be opened by a surgical device threaded into the vascular graft and to the valve. Surgical procedures may be performed within the heart with the access provided. Alternately, the valve may be placed in an open state to permit blood communication between the interior of the graft and the interior of the heart or in a closed state to prevent such communication. The vascular graft described has application in Fontan procedures and is useful in pediatric cardiac surgery and in further treating patients who have undergone Fontan procedures.

## Claims

### Claim 1

An implant for implanting in a body, comprising:
a vascular graft having a generally elongated tubular shape and a wall defining an interior;
a valve disposed in the wall, the valve including an elastomeric membrane barrier that is impermeable to fluids to prevent the communication of fluids though the valve, wherein the valve is configured to permit penetration of the elastomeric membrane barrier by a surgical instrument inserted through the valve from the interior of the vascular graft to enable access by the surgical instrument to an area external to the vascular graft; and
a marker configured to allow location of the valve to facilitate penetration of the surgical instrument through the elastomeric membrane barrier.

### Claim 2 (depends on 1)

The implant of claim 1, wherein the valve further comprises a support defining an opening, the elastomeric membrane barrier stretched across the opening by the support to seal the opening.

### Claim 3 (depends on 2)

The implant of claim 2, wherein the marker is disposed within the support.

### Claim 4 (depends on 1)

The implant of claim 1, wherein the marker is generally ring shaped and surrounds the elastomeric membrane barrier.

### Claim 5 (depends on 1)

The implant of claim 1, wherein the marker comprises a radio-opaque material configured to be visualized fluoroscopically.

### Claim 6

An implant configured for implantation during a Fontan procedure, comprising:
a vascular graft configured to separate cyanotic blood flow from the heart and route this blood flow directly to the lungs, the vascular graft including a first end for attachment to the inferior vena cava, a second end for attachment to a pulmonary artery and a wall defining an interior;
a valve disposed in the wall, the valve including an elastomeric membrane barrier that is impermeable to fluids to prevent the communication of fluids though the valve, wherein the valve is configured to permit penetration of the elastomeric membrane barrier by a surgical instrument inserted through the valve from the interior of the vascular graft to enable access by the surgical instrument to the heart; and
a marker configured to allow location of the valve to facilitate penetration of the surgical instrument through the elastomeric membrane barrier.

### Claim 7 (depends on 6)

The implant of claim 6, wherein the valve further comprises a support defining an opening, and wherein the elastomeric membrane barrier stretched across the opening by the support to seal the opening.

### Claim 8 (depends on 7)

The implant of claim 7, wherein the marker is disposed within the support.

### Claim 9 (depends on 6)

The implant of claim 6, wherein the marker is generally ring shaped and surrounds the elastomeric membrane barrier.

### Claim 10 (depends on 6)

The implant of claim 6, wherein the marker comprises a radio-opaque material configured to be visualized fluoroscopically.

### Claim 11

An implant for implanting in a body, comprising:
a vascular graft having a generally elongated tubular shape and a wall defining an interior;
a valve disposed in the wall and including an elastomeric membrane barrier that is impermeable to fluids to prevent the communication of fluids though the valve, the valve configured to permit penetration of the elastomeric membrane barrier by a surgical instrument inserted through the valve from the interior of the vascular graft to enable access by the surgical instrument to an area external to the vascular graft, wherein the elastomeric membrane barrier is configured to close upon withdrawal of the surgical instrument from the valve so that the elastomeric membrane barrier remains at least substantially impermeable to fluids after withdrawal of the surgical instrument to prevent the communication of fluids though the valve; and
a marker configured to allow location of the valve to facilitate penetration of the surgical instrument through the elastomeric membrane barrier.

### Claim 12 (depends on 11)

The implant of claim 11, wherein the valve further comprises a support defining an opening, the elastomeric membrane barrier stretched across the opening by the support to seal the opening.

### Claim 13 (depends on 12)

The implant of claim 12, wherein the marker is disposed within the support.

### Claim 14 (depends on 11)

The implant of claim 11, wherein the marker is generally ring shaped and surrounds the elastomeric membrane barrier.

### Claim 15 (depends on 11)

The implant of claim 11, wherein the marker comprises a radio-opaque material configured to be visualized fluoroscopically.

### Claim 16 (depends on 11)

The implant of claim 11, wherein the surgical instrument comprises a stent configured to provide a fenestration to permit fluid flow through the valve.
