# US 10,499,893 B2 · Apparatus and methods for sealing a vascular puncture

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- Number: US 10,499,893 B2
- Document ID: US10499893B2
- Status: Granted
- Kind: B2
- Application number: 15/662,506
- Filed: 2017-07-28
- Published: 2018-01-11
- Granted: 2019-12-10
- Earliest claimed: 2012-03-23
- Assignees: AccessClosure, Inc.
- Applicants: Accessclosure, Inc.
- Inventors: Ronald R. Hundertmark; Andy H. Uchida; David L. Fiscella; Moshe Zilversmit; Brandon R. Fell; Vincent Ku; Curt Guyer; Richard E. Repp; Mark Sponsel
- Web page: https://patentgrep.com/patent/US10499893B2

## CPC

- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/0065: {the implement being an adhesive}
- A61B 2017/00654: {entirely comprised between the two sides of the opening}
- A61B 2017/00672: {Locating means therefor, e.g. bleed back lumen}
- A61B 2017/22067: {Blocking; Occlusion (A61B2017/22054 takes precedence)}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An apparatus for sealing a puncture through a vessel wall including a positioning assembly, a sheath releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element positioned at a distal portion of the positioning assembly and a sealant disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.

## Claims

### Claim 1

A method for sealing an arteriotomy in a vessel, the method comprising:
positioning an apparatus relative to an arteriotomy, the apparatus comprising:
a positioning assembly comprising an elongate member and a positioning element at a distal portion of the elongate member;
a sealant disposed at a distal portion of the positioning assembly;
a support tube proximal to the sealant; and
a positioning assembly retraction lock provided in a first position that prevents the positioning assembly from moving proximally relative to the support tube;
exposing the sealant;
tamping the sealant by distally advancing the support tube, wherein distal advancement of the support tube moves the positioning assembly retraction lock to a second position that allows at least a portion of the positioning assembly to move proximally relative to the support tube;
retracting the positioning element from the sealant by withdrawing at least a portion of the positioning assembly proximally while the support tube maintains the position of the sealant; and
retracting the positioning assembly and the support tube from the arteriotomy, leaving the sealant to seal the arteriotomy.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of positioning the apparatus relative to the arteriotomy comprises:
inserting a distal end of the apparatus into the arteriotomy until the positioning element is within the vessel having the arteriotomy; and
withdrawing the positioning element within the vessel until the positioning element abuts the arteriotomy.

### Claim 3 (depends on 2)

The method of claim 2, further comprising:
expanding the positioning element prior to withdrawing the positioning element within the vessel; and
reducing a cross-section of the positioning element prior to retracting the positioning element from the sealant.

### Claim 4 (depends on 3)

The method of claim 3, further comprising:
locking the positioning element in an expanded state prior to withdrawing the positioning element within the vessel; and
unlocking the positioning element to allow the cross-section of the positioning element to be reduced prior to reducing the cross-section of the positioning element.

### Claim 5 (depends on 2)

The method of claim 2, wherein the sealant is exposed by retracting a sheath relative to the sealant.

### Claim 6 (depends on 1)

The method of claim 1, wherein the steps are performed in the order recited.

### Claim 7 (depends on 1)

The method of claim 1, wherein retracting the positioning element from the sealant occurs after tamping the sealant.

### Claim 8 (depends on 1)

The method of claim 1, wherein the apparatus comprises a handle and the handle is configured such that tamping the sealant can be performed using a single hand.

### Claim 9 (depends on 1)

The method of claim 1, wherein tamping the sealant is performed by actuating a support tube actuator.

### Claim 10 (depends on 9)

The method of claim 9, wherein actuating the support tube actuator moves the positioning assembly retraction lock to the second position.

### Claim 11 (depends on 1)

The method of claim 1, wherein retracting the positioning element is performed by actuating a positioning assembly retraction actuator.

### Claim 12 (depends on 11)

The method of claim 11, wherein actuating the positioning assembly retraction actuator is prevented when the positioning assembly retraction lock is in the first position.

### Claim 13

A method for sealing an arteriotomy in a vessel, the method comprising:
inserting a distal end of an apparatus into an arteriotomy, the apparatus comprising:
a positioning assembly comprising an elongate member and a positioning element at a distal portion of the elongate member;
a sealant disposed at a distal portion of the positioning assembly;
a support tube proximal to the sealant; and
a positioning assembly retraction lock provided in a first position that prevents the positioning assembly from moving proximally relative to the support tube;
wherein the positioning element is positioned within the vessel having the arteriotomy;
expanding the positioning element;
locking the positioning element in an expanded state;
withdrawing the positioning element within the vessel until the positioning element abuts the arteriotomy;
exposing the sealant;
tamping the sealant by distally advancing the support tube, wherein distal advancement of the support tube moves the positioning assembly retraction lock to a second position that allows at least a portion of the positioning assembly to move proximally relative to the support tube;
unlocking the positioning element to allow a cross-section of the positioning element to be reduced;
reducing the cross-section of the positioning element;
retracting the positioning element from the sealant by withdrawing at least a portion of the positioning assembly proximally while the support tube maintains the position of the sealant; and
retracting the positioning assembly and the support tube from the arteriotomy, leaving the sealant to seal the arteriotomy.

### Claim 14 (depends on 13)

The method of claim 13, wherein the sealant is exposed by retracting a sheath relative to the sealant.

### Claim 15 (depends on 13)

The method of claim 13, wherein the steps are performed in the order recited.

### Claim 16 (depends on 13)

The method of claim 13, wherein retracting the positioning element from the sealant occurs after tamping the sealant.

### Claim 17 (depends on 13)

The method of claim 13, wherein the apparatus comprises a handle and the handle is configured such that tamping the sealant can be performed using a single hand.

### Claim 18 (depends on 13)

The method of claim 13, wherein tamping the sealant is performed by actuating a support tube actuator.

### Claim 19 (depends on 18)

The method of claim 18, wherein actuating the support tube actuator moves the positioning assembly retraction lock to the second position.

### Claim 20 (depends on 13)

The method of claim 13, wherein retracting the positioning element is performed by actuating a positioning assembly retraction actuator.

### Claim 21 (depends on 20)

The method of claim 20, wherein actuating the positioning assembly retraction actuator is prevented when the positioning assembly retraction lock is in the first position.
