# US 11,076,856 B2 · Anastomosis device

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- Number: US 11,076,856 B2
- Document ID: US11076856B2
- Status: Granted
- Kind: B2
- Application number: 16/303,188
- Filed: 2017-05-23
- Published: 2019-07-18
- Granted: 2021-08-03
- Earliest claimed: 2016-05-23
- Assignees: Mor Research Applications Ltd.
- Applicants: Mor Research Applications Ltd.
- Inventors: Doron Kopelman
- Web page: https://patentgrep.com/patent/US11076856B2

## CPC

- A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/12136: {Balloons}
- A61B 17/1227: {Spring clips}
- A61B 17/32: Surgical cutting instruments ({A61B18/042 takes precedence; suture cutters A61B17/0467;} implements for ligaturing and cutting {A61B17/122, A61B17/12; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133})
- A61B 17/083: {Clips, e.g. resilient}
- A61B 17/115: Staplers for performing anastomosis, e.g. in a single operation
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00084: {Temperature}
- A61B 2017/00106: {ultrasonic}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00818: {Treatment of the gastro-intestinal system}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00876: {magnetic}
- A61B 2017/081: {Tissue approximator (A61B2017/1103, A61B17/8866 take precedence)}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2017/12004: {for haemostasis, for prevention of bleeding}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

According to some embodiments there is provided an anastomosis device configured to reduce leakage, comprising: a first set of rings sized to be positioned at a first tissue wall; a second set of rings sized to be positioned at a second tissue wall adjacent the first tissue wall; and an element configured to draw the ring sets towards each other; wherein each set of rings comprises an inner ring, an outer ring, and a coupling for aligning the inner and outer rings with respect to each other; wherein the inner ring applies a first pressure onto the tissue wall which is sufficient to gradually form a passage between the first and second tissue walls; and the outer ring applies a second pressure onto the tissue wall, the second pressure applied radially outwardly relative to the first pressure, the second pressure sufficient to reduce leakage in a vicinity of the passage.

## Claims

### Claim 1

An anastomosis device configured to reduce leakage, comprising:
a first set of rings sized to be positioned at a first tissue wall;
a second set of rings sized to be positioned at a second tissue wall, the second tissue wall being adjacent the first tissue wall; and
drawing means for approximating the ring sets towards each other;
wherein each set of rings comprises:
an inner ring having a tissue-facing surface;
an outer ring having a tissue-facing surface; and
a coupling between the inner ring and the outer ring for aligning the inner and outer rings with respect to each other; the inner ring and the outer ring being co-axial, the outer ring circumferentially surrounding the inner ring;
wherein when the device is deployed in tissue and the rings sets are approximated towards each other by the drawing means:
tissue-facing surfaces of the inner rings overlap to compress tissue in-between, and tissue-facing surfaces of the outer rings overlap;
the inner rings apply a first pressure between them onto the first and second tissue walls, the first pressure sufficient to gradually form a passage between the first and second tissue walls; and
the outer rings apply a second pressure between them onto the first and second tissue walls, the second pressure applied radially outwardly relative to the first pressure, the second pressure sufficient to reduce leakage in a vicinity of the passage.

### Claim 2 (depends on 1)

The device according to claim 1, wherein one or both of the inner ring and the outer ring of each set is inflatable.

### Claim 3 (depends on 2)

The device according to claim 2, wherein pressure applied by the inner ring and the outer rings onto the tissue is controlled by inflation pressures.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the drawing means comprise an inner construction incorporated in each of the ring sets.

### Claim 5 (depends on 4)

The device according to claim 4, wherein the inner construction comprises magnetic material incorporated in or mounted on one or both of the inner ring and the outer rings of each set, the magnetic material positioned to induce magnetic attraction between the inner rings of the two sets and/or between the outer rings of the two sets.

### Claim 6 (depends on 4)

The device according to claim 4, wherein the inner construction comprises shape memory material incorporated in one or both of the inner ring and the outer rings of each set, the shape memory material shaped and positioned so that deformation of the shape memory material changes a level of pressure applied by one or both of the inner ring and the outer rings onto the tissue.

### Claim 7 (depends on 1)

The device according to claim 1, wherein the drawing means comprise an elongated element which extends between the two sets of rings, interconnecting the two sets.

### Claim 8 (depends on 7)

The device according to claim 7, wherein the elongated element is one of: a string, wire or cable.

### Claim 9 (depends on 7)

The device according to claim 7, wherein the elongated element is tensioned to set at least an initial pulling force between the—inner rings of the two sets and/or between the outer rings of the two sets.

### Claim 10 (depends on 1)

The device according to claim 1, wherein the coupling between the inner ring and the outer ring comprises one or more bridging elements extending between the inner ring and the outer ring.

### Claim 11 (depends on 1)

The device according to claim 1, wherein the coupling between the inner ring and the outer ring comprises an adhesive attaching the at least a portion of an outer lining of the inner ring to at least a portion of an inner lining of the outer ring.

### Claim 12 (depends on 1)

The device according to claim 1, wherein the device comprises a leakage indicator comprising a temperature sensor or a PH meter.

### Claim 13 (depends on 1)

The device according to claim 1, wherein the device comprises one or more pressure sensors positioned at an interface between the tissue and one or both of the inner ring and the outer ring of each set, the pressure sensors configured to detect an actual pressure applied by the inner ring and/or the outer ring onto the tissue.

### Claim 14 (depends on 1)

The device according to claim 1, wherein the device comprises one or more sensors configured for detecting a level of oxygen saturation of the compressed tissue.

### Claim 15 (depends on 1)

The device according to claim 1, wherein the inner ring of each set further comprises a cutting wire.

### Claim 16 (depends on 1)

The device according to claim 1, wherein one or both of the inner ring and the outer ring of each set comprises a toroidal shaped balloon.

### Claim 17 (depends on 1)

The device according to claim 1, wherein a contact surface area of the outer ring with the tissue is larger than a contact surface area of the inner ring with the tissue.

### Claim 18 (depends on 1)

The device according to claim 1, wherein the drawing means comprise an interconnecting element configured to be tensioned and/or shortened to approximate the ring sets towards each other.

### Claim 19 (depends on 1)

The device according to claim 1, wherein the first pressure is sufficient to cut through tissue to gradually form the passage, and the second pressure is high enough to reduce leakage in a vicinity of the passage yet low enough to avoid ischemia and tissue necrosis.

### Claim 20 (depends on 1)

The device according to claim 1, wherein the tissue facing-surface of the inner ring of each set comprises a protrusion for applying increased pressure at a localized point.

### Claim 21 (depends on 1)

The device according to claim 1, wherein the drawing means are configured to exert a pulling force sufficient to produce the first pressure and the second pressure.

### Claim 22

An anastomosis device configured to reduce leakage, comprising:
a set of two rings for positioning over adjacent first and second tissue walls, each ring comprising at least:
a first chamber configured to apply a first pressure onto a respective tissue wall out of the first and second tissue walls, the pressure sufficient to form a passage between the first and second tissue walls; and
a second chamber configured to apply a second pressure onto the respective tissue wall out of the first and second tissue walls, the pressure applied radially outwardly relative to the first pressure, the second pressure sufficient to reduce leakage in a vicinity of the passage.

### Claim 23 (depends on 22)

The device according to claim 22, wherein the chambers are inflatable.

### Claim 24 (depends on 22)

The device according to claim 22, wherein each ring out of the set of two rings further comprises a third chamber configured to apply a third pressure onto the respective tissue wall, the third pressure lower than the second pressure.

### Claim 25

An anastomosis device configured to reduce leakage, comprising:
a first set of structures shaped and sized to be positioned at a first tissue wall;
a second set of structures shaped and sized to be positioned at a second tissue wall, the second tissue wall being adjacent the first tissue wall; and
an element configured to draw the sets towards each other;
wherein each set of structures comprises an inner substantially closed shape, an outer substantially closed shape surrounding the inner shape, and a coupling element between the inner substantially closed shape and the outer substantially closed shapes, the coupling element configured to control a ratio between a first pressure applied by the inner substantially closed shape onto the tissue, and a second pressure applied by the outer substantially closed shape onto the tissue.
