# US 10,441,262 B2 · Retrievable access valve

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- Number: US 10,441,262 B2
- Document ID: US10441262B2
- Status: Granted
- Kind: B2
- Application number: 15/927,637
- Filed: 2018-03-21
- Published: 2018-09-27
- Granted: 2019-10-15
- Earliest claimed: 2017-03-22
- Assignees: Boston Scientific Corporation
- Applicants: Boston Scientific Limited
- Inventors: Javier Palomar-Moreno; Emma J. Mooney; Michael Walsh; Martyn G. Folan; Gary Duffy
- Web page: https://patentgrep.com/patent/US10441262B2

## CPC

- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0293: {with ring member to support retractor elements}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0225: {flexible, e.g. fabrics, meshes, or membranes}
- A61B 2017/0287: {with elastic retracting members connectable to a frame, e.g. hooked elastic wires}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 5/16881: {Regulating valves}
- A61M 27/002: {Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202)}
- A61M 2039/0223: {having means for anchoring the subcutaneous access site}
- A61M 2039/0229: {having means for facilitating assembling, e.g. snap-fit housing or modular design}
- A61M 2039/0232: {having means for facilitating the insertion into the body}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an access valve that may be retrieved after implantation. The access valve may include a frame having a lumen, a self-expandable member extending through the lumen, and an elastic membrane extending through the lumen and a second end of the frame to releasably seal the lumen. The access valve may releasably attach to a wall of a patient and releasably seal an opening through the wall. The access valve may be attached to the wall by placing the frame adjacent the wall, extending the self-expandable member through the opening in the wall, and expanding the self-expandable member such that the self-expandable member applies a first force against the wall and a second force opposite the first force against the frame to sandwich the wall between the self-expandable member and the frame.

## Claims

### Claim 1

An access valve comprising:
a frame having a lumen extending along a length of the frame from a first end of the frame to a second end of the frame;
a self-expandable member extending through the lumen of the frame and having a first end proximal of the first end of the frame and a second end distal of the second end of the frame; and
an elastic membrane extending within the self-expandable member, through the lumen and through the second end of the frame to releasably seal the lumen;
wherein the frame is substantially rigid and non-expandable against radial and axial forces acting on the frame from the self-expandable member.

### Claim 2 (depends on 1)

The access valve of claim 1, wherein the elastic membrane is secured to the self-expandable member.

### Claim 3 (depends on 1)

The access valve of claim 1, wherein:
the self-expandable member has a collapsed configuration and an expanded configuration; and
when the self-expandable member is in the expanded configuration, the self-expandable member applies an axially compressive force to the frame.

### Claim 4 (depends on 1)

The access valve of claim 1, wherein the frame has an interior surface defining the lumen and the interior surface tapers from the first end to the second end of the frame.

### Claim 5 (depends on 1)

The access valve of claim 1, wherein the frame has a conical first portion and a second portion extending radially outward from the conical first portion.

### Claim 6 (depends on 5)

The access valve of claim 5, wherein:
the second portion has a first side facing the conical first portion and a second side opposite the first side; and
a sealing membrane is secured to the second side of the second portion.

### Claim 7 (depends on 5)

The access valve of claim 5, wherein the second portion of the frame is configured to articulate with respect to the conical first portion of the frame.

### Claim 8 (depends on 1)

The access valve of claim 1, wherein the elastic membrane comprises a compressible foam.

### Claim 9 (depends on 1)

The access valve of claim 1, wherein the self-expandable member is formed from a metal braid.

### Claim 10 (depends on 1)

The access valve of claim 1, further comprising:
a retrieval flange connected to the self-expandable member and extending proximal of the frame.

### Claim 11

A positioning system for positioning an access valve against a bodily wall of a patient, the positioning system comprising:
a delivery sheath;
a valve comprising:
a frame having a first end, a second end, and a lumen extending from the first end to the second end;
a self-expandable member extending through the frame and having a first end proximal of the first end of the frame and a second end distal of the second end of the frame; and
an elastic membrane extending within the self-expandable member and through the lumen to releasably seal the lumen; and
wherein the delivery sheath is configured to be inserted through the lumen of the frame while covering the self-expandable member to maintain the self-expandable member in a collapsed configuration and is retractable to allow the self-expandable member to expand to an expanded configuration to allow the elastic membrane to releasably seal the lumen.

### Claim 12 (depends on 11)

The positioning system of claim 11, further comprising:
a guide wire; and
wherein the valve and the delivery sheath extend over the guide wire.

### Claim 13 (depends on 11)

The positioning system of claim 11, wherein once the delivery sheath is retracted, the self-expandable member expands radially and axially contracts.

### Claim 14 (depends on 11)

The positioning system of claim 11, wherein the valve further comprises
a retrieval flange extending proximal of the frame.

### Claim 15

A method of using an access valve, the method comprising:
advancing a guide wire to a target area on a bodily wall of a patient;
puncturing through the bodily wall of the patient at the target area;
advancing an access valve to the target area;
positioning a frame of the access valve against the bodily wall at the target area;
extending a self-expandable member of the access valve through the frame and the puncture in the bodily wall;
retracting a delivery sheath covering the self-expandable member to allow the self-expandable member to expand to an expanded configuration; and
wherein the self-expandable member in the expanded configuration applies axial compressive forces against the bodily wall of the patient and the frame to secure the frame against the bodily wall.

### Claim 16 (depends on 15)

The method of claim 15, wherein an elastic membrane of the access valve releasably seals the access valve when the self-expandable member is in the expanded configuration and extending through the frame.

### Claim 17 (depends on 16)

The method of claim 16, further comprising:
inserting a catheter into the elastic membrane and advancing the catheter through the elastic membrane to access a distal side of the bodily wall.

### Claim 18 (depends on 15)

The method of claim 15, further comprising:
inserting an endoscope into a body cavity at least partially defined by the bodily wall of the patient; and
wherein the access valve is advanced through the inserted endoscope to the target area.

### Claim 19 (depends on 15)

The method of claim 15, further comprising:
grasping a retrieval flange connected to the self-expandable member and extending proximal of the frame; and
withdrawing the self-expandable member into a retrieval sheath to place the self-expandable member in a collapsed configuration for removing the access valve from the patient.
