# US 2014/0194909 A1 · Method and apparatus for effecting a minimally invasive distal anastomosis for an aortic valve bypass

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- Number: US 2014/0194909 A1
- Document ID: US20140194909A1
- Status: Published application
- Kind: A1
- Application number: 13/961,556
- Filed: 2013-08-07
- Published: 2014-07-10
- Earliest claimed: 2009-08-14
- Assignees: Correx, Inc.
- Applicants: Correx, Inc.
- Inventors: Richard M. Beane; Ronald Boudreau; James Alan Crunkleton; Anthony G. Liepert; Joseph L. Smith, Jr.
- Web page: https://patentgrep.com/patent/US20140194909A1

## CPC

- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61B 2017/00243: {cardiac}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1121: {adapted for performing tissue or graft eversion}
- A61B 2017/1132: {End-to-end connections}
- A61B 2017/1135: {End-to-side connections, e.g. T- or Y-connections}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A connector for joining a first hollow structure to the side wall of a second hollow structure, the connector comprising a first component comprising an inner collar; a hollow body; and a graft mounted to the inner collar and forming a conduit through the hollow body and the inner collar; and a second component comprising an outer collar and a hollow body, the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component.

## Claims

### Claim 1

A connector for joining a first hollow structure to the side wall of a second hollow structure, the connector comprising:
a first component comprising:
an inner collar for disposition within the interior of the second hollow structure, the inner collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the inner collar being flexible;
a hollow body connected to the inner collar and upstanding therefrom, the hollow body of the inner collar being aligned with the inner perimeter of the inner collar; and
a graft element mounted to the inner collar and forming a conduit extending through the hollow body and the inner perimeter of the inner collar, the graft being formed out of a fluid-retaining material; and
a second component for disposition outside the second hollow structure, the second component comprising an outer collar and a hollow body connected to the outer collar, the outer collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the hollow body of the outer collar being aligned with the inner perimeter of the outer collar;
the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft element provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component.

### Claim 2 (depends on 1)

A connector according to claim 1 wherein the hollow body of the second component is connected to the hollow body of the first component with a ratchet mechanism.

### Claim 3 (depends on 1)

A connector according to claim 1 wherein the inner collar is ovoid.

### Claim 4 (depends on 1)

A connector according to claim 1 wherein the outer collar is ovoid.

### Claim 5 (depends on 1)

A connector according to claim 1 wherein the hollow body of the first component is ovoid.

### Claim 6 (depends on 1)

A connector according to claim 1 wherein the hollow body of the second component is ovoid.

### Claim 7 (depends on 1)

A connector according to claim 1 wherein the various elements of the first component are formed separate from one another, and further wherein the various elements of the first component are assembled during manufacture so as to form a single integral assembly.

### Claim 8 (depends on 1)

A connector according to claim 1 wherein the inner collar comprises a superelastic material.

### Claim 9 (depends on 1)

A connector according to claim 1 wherein the inner collar comprises a plurality of elements disposed substantially parallel to one another.

### Claim 10 (depends on 1)

A connector according to claim 1 wherein the hollow body of the first component comprises a plurality of L-shaped support arms extending therefrom, and further wherein the inner collar is carried by the L-shaped support arms.

### Claim 11 (depends on 1)

A connector according to claim 1 wherein the hollow body of the first component is molded about the inner collar.

### Claim 12 (depends on 1)

A connector according to claim 1 wherein the inner collar is enveloped with graft material, and further wherein the graft element is secured to the graft material.

### Claim 13

A delivery instrument for delivering a connector for joining a first hollow structure to the side wall of a second hollow structure, the delivery instrument comprising:
a hollow column;
at least one traction arm pivotally mounted to the hollow column so as to selectively radially project a toe of the traction arm;
a rod movably mounted to the hollow column and having a clamp at the distal end thereof, the rod being adapted to selectively engage the at least one traction arm so as to cause the at least one traction arm to radially project the toe of the at least one traction arm; and
at least one collar actuator slidably mounted to the hollow column.

### Claim 14 (depends on 13)

A delivery instrument according to claim 13 wherein the rod is movably disposed within the hollow column.

### Claim 15 (depends on 13)

A delivery instrument according to claim 13 wherein the at least one collar actuator is movably mounted to the exterior of the hollow column.

### Claim 16 (depends on 13)

A delivery instrument according to claim 13 wherein longitudinal movement of the rod causes the rod to selectively engage the at least one traction arm.

### Claim 17 (depends on 13)

A delivery instrument according to claim 13 further comprising a spring for yieldably biasing the toe of the at least one traction arm radially inwardly.

### Claim 18 (depends on 17)

A delivery instrument according to claim 17 wherein there are two traction arms, the two traction arms are diametrically opposed to one another, and the spring comprises a garter spring for inwardly biasing the toes of the two traction arms.

### Claim 19 (depends on 13)

A delivery instrument according to claim 13 wherein the hollow column is ovoid.

### Claim 20 (depends on 19)

A delivery instrument according to claim 19 wherein the at least one collar actuator is ovoid.

### Claim 21 (depends on 13)

A delivery instrument according to claim 13 wherein a plurality of collar actuators are provided.

### Claim 22 (depends on 21)

A delivery instrument according to claim 21 wherein the plurality of collar actuators can be separately actuated.

### Claim 23

A system for joining a first hollow structure to the side wall of a second hollow structure, the system comprising:
a connector comprising:
a first component comprising:
an inner collar for disposition within the interior of the second hollow structure, the inner collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the inner collar being flexible;
a hollow body connected to the inner collar and upstanding therefrom, the hollow body of the inner collar being aligned with the inner perimeter of the inner collar; and
a graft element mounted to the inner collar and forming a conduit extending through the hollow body and the inner perimeter of the inner collar, the graft being formed out of a fluid-retaining material;
a second component for disposition outside the second hollow structure, the second component comprising an outer collar and a hollow body connected to the outer collar, the outer collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the hollow body of the outer collar being aligned with the inner perimeter of the outer collar;
the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft element provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component; and
a delivery instrument for delivering the connector to the second hollow structure, the delivery instrument comprising:
a hollow column;
at least one traction arm pivotally mounted to the distal end of the hollow column so as to selectively radially project a toe of the traction arm;
a rod movably mounted to the hollow column and having a clamp at the distal end thereof, the rod being adapted to selectively engage the at least one traction arm so as to cause the at least one traction arm to radially project the toe of the at least one traction arm; and
at least one collar actuator slidably mounted to the hollow column;
the connector being mounted to the delivery tool such that the hollow body of the first component is mounted coaxially on the hollow column of the delivery instrument, and the at least one collar actuator is aligned with the hollow body of the second component.

### Claim 24

A method for joining a first hollow structure to the side wall of a second hollow structure, the method comprising:
providing a connector having (i) a first component comprising an inner collar and a hollow graft element mounted to the inner collar and extending therefrom, and (ii) a second component comprising an outer collar;
forming an opening in the side wall of the second hollow structure;
positioning the inner collar of the first component within the interior of the second hollow structure, with the graft element extending through the side wall of the second hollow structure; and
advancing the outer collar of the second component toward the inner collar of the first component so as to clamp the side wall of the second hollow structure therebetween.

### Claim 25 (depends on 24)

A method according to claim 24 further comprising connecting the graft element to the first hollow structure.

### Claim 26 (depends on 24)

A method according to claim 24 wherein the inner collar of the first component is flexible, and further wherein positioning the inner collar of the first component within the interior of the second hollow structure comprises folding the inner collar along an axis thereof prior to inserting the inner collar into the second hollow structure, and thereafter restoring the inner collar to its initial configuration after insertion of the inner collar into the second hollow structure.

### Claim 27 (depends on 26)

A method according to claim 26 wherein the first component comprises a resilient structure, and further wherein folding the inner collar along an axis thereof includes restraining the inner collar in a folded configuration with a restraint, and wherein restoring the inner collar to its initial configuration includes releasing the restraint.

### Claim 28 (depends on 26)

A method according to claim 26 wherein the inner collar comprises an ovoid structure, and further wherein said axis comprises the long axis of the ovoid structure.

### Claim 29 (depends on 27)

A method according to claim 27 wherein the restraint comprises a clothespin clamp.

### Claim 30 (depends on 29)

A method according to claim 29 wherein the clothespin clamp is disposed within the interior of the graft element.

### Claim 31 (depends on 24)

A method according to claim 24 wherein the inner collar comprises a neck upstanding from the remainder of the inner collar.

### Claim 32 (depends on 31)

A method according to claim 31 wherein the outer collar is configured to be passed over the neck.

### Claim 33 (depends on 24)

A method according to claim 24 wherein the inner collar and the outer collar are adjustably connected to one another by a ratchet mechanism.

### Claim 34 (depends on 24)

A method according to claim 24 wherein the inner collar comprises a shape memory alloy.

### Claim 35 (depends on 24)

A method according to claim 24 wherein the inner collar conforms to the curvature of the inside wall of the second hollow body.

### Claim 36 (depends on 24)

A method according to claim 24 wherein the outer collar conforms to the curvature of the outer wall of the second hollow body.

### Claim 37 (depends on 24)

A method according to claim 24 wherein the inner collar is enveloped with graft material.

### Claim 38 (depends on 24)

A method according to claim 24 wherein fluid flow through the second hollow structure is halted prior to forming an opening in the side wall of the second hollow structure.

### Claim 39 (depends on 38)

A method according to claim 38 wherein fluid flow is halted by:
delivering a first balloon within the lumen of the second hollow structure proximal to where the opening is to be formed in the side wall of the second hollow structure;
inflating the first balloon within the lumen of the second hollow structure;
delivering a second balloon within the lumen of the second hollow structure distal to where the opening is to be formed in the side wall of the second hollow structure; and
inflating the second balloon within the lumen of the second hollow structure.
