# US 11,896,524 B2 · Tissue removal devices, systems and methods

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- Number: US 11,896,524 B2
- Document ID: US11896524B2
- Status: Granted
- Kind: B2
- Application number: 16/599,887
- Filed: 2019-10-11
- Published: 2020-02-20
- Granted: 2024-02-13
- Earliest claimed: 2013-04-26
- Assignees: Med-Logics, Inc.
- Applicants: Med-Logics, Inc.
- Inventors: Rodney L. Ross; James Dennewill
- Web page: https://patentgrep.com/patent/US11896524B2

## CPC

- A61F 9/00745: {using mechanical vibrations, e.g. ultrasonic}
- A61F 9/007: Methods or devices for eye surgery
- A61F 9/00736: {Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments (A61F9/008 takes precedence)}
- A61B 2017/00154: {pulsed}
- A61B 2017/00176: {Two pulses, e.g. second pulse having an effect different from the first one}
- A61B 2217/005: with suction drainage system
- A61M 1/743: {by changing the cross-section of the line, e.g. flow regulating valves (A61M1/7413 takes precedence)}
- A61M 1/75: {Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence)}
- 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)
- 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

A tissue removal device includes a hollow needle, an ultrasonic transducer for mechanically vibrating the needle, an aspiration line communicating with the needle, and a vacuum pulsing device for generating vacuum pulses in the needle. The device may be utilized for breaking up tissue by phacoemulsification, vacuum pulsing, or both.

## Claims

### Claim 1

A tissue removal device for removal of tissue from an eye during surgery, comprising:
a hollow needle comprising an open distal tip;
an aspiration line communicating with the hollow needle and configured for communicating with a vacuum source, wherein the hollow needle and the aspiration line define an aspiration path from the distal tip to the vacuum source;
a vacuum device configured for controlling a vacuum at the distal tip;
a first collection chamber connected to the aspiration line;
a second collection chamber a valve connected between the first collection chamber and the second collection chamber;
a vacuum regulator configured to control vacuum levels in the first collection chamber and the second collection chamber applied by the vacuum device, wherein the vacuum regulator applies vacuum only to the first collection chamber in a first tissue collection state for tissue collection only in the first collection chamber, and wherein the vacuum regular applies vacuum to both the first and second collection chambers in a second tissue collection states for tissue collection in both the first and second collection chambers; and
a restrictor at the distal tip of the hollow needle, the restrictor having an inner diameter smaller than an inner diameter of the hollow needle.

### Claim 2 (depends on 1)

The device of claim 1, wherein the vacuum device comprises a vacuum pulsing device configured to provide vacuum pulses at an open end of the distal tip.

### Claim 3 (depends on 2)

The device of claim 2, wherein the vacuum pulsing device comprises an actuator and a movable member, wherein the actuator is configured for moving the movable member alternately between a closed position that obstructs the aspiration path and an open position.

### Claim 4 (depends on 3)

The tissue removal device of claim 3, wherein the actuator is pneumatically driven, mechanically driven, electrically driven, electromechanically driven, magnetically driven, or electromagnetically driven, and at least one of a vacuum pulse duration, a vacuum level, and a vacuum pulse frequency is set by operator control.

### Claim 5 (depends on 3)

The tissue removal device of claim 3, wherein the actuator is configured for communicating with a valve control device such that the movable member is movable between the open position and the closed position to induce the vacuum pulses in an aspiration cannula of the vacuum pulsing device according to a controllable pulse parameter.

### Claim 6 (depends on 2)

The tissue removal device of claim 2, wherein the vacuum pulsing device comprises a valve port through which the aspiration path passes, at an open position the valve port is open such that a vacuum applied at the distal tip, and at a closed position the valve port is closed such that the vacuum is prevent from being applied at the distal tip, and the valve port is configured to be adjustable between either totally closed or partially closed.

### Claim 7 (depends on 6)

The tissue removal device of claim 6, wherein a movable member comprises an inner cannula, the vacuum pulsing device comprises an outer cannula coaxially disposed about at least a portion of the inner cannula, the valve port is formed in the outer cannula, at the open position the aspiration path passes from the valve port into the inner cannula, at the closed position the inner cannula blocks the valve port.

### Claim 8 (depends on 7)

The tissue removal device of claim 7, wherein the vacuum pulsing device comprises an aspiration inlet communicating with the aspiration line in the housing, and a transition communicating with the aspiration inlet and adjoining the outer cannula at the valve port in a fluid-sealed manner, wherein the aspiration inlet extends along a first axis to the transition and the inner cannula extends along a second axis offset from the first axis.

### Claim 9 (depends on 1)

The tissue removal device of claim 1, further comprising an ultrasonic transducer configured to provide phacoemulsification to assist in breaking up the tissue.

### Claim 10 (depends on 1)

The tissue removal device of claim 1, wherein the restrictor comprises a ring-shaped component connected to the distal tip.

### Claim 11 (depends on 10)

The tissue removal device of claim 10, further comprising a bypass of the ring-shaped component.

### Claim 12 (depends on 1)

The tissue removal device of claim 1, further comprising a bypass of the tapered end component.

### Claim 13 (depends on 1)

The tissue removal device of claim 1, wherein the restrictor comprises a thermal element for heating an obstruction occluding an opening at the distal tip.

### Claim 14 (depends on 1)

The device of claim 1, further comprising a cassette for tissue collection, wherein at an installed position of the cassette in a cassette housing, the cassette communicates with the vacuum source, and the aspiration path runs through the cassette housing.

### Claim 15 (depends on 1)

The device of claim 1, wherein the cassette comprises the first collection chamber connected to the aspiration line and the second collection chamber, and a cassette valve connected between the first collection chamber and the second collection chamber.

### Claim 16 (depends on 15)

The device of claim 15, wherein
in operation, opening the cassette valve transfers broken-up tissue from the first collection chamber to the second collection chamber.

### Claim 17 (depends on 1)

The tissue removal device of claim 1, comprising a control console configured for receiving user input to determine a flow rate in the aspiration path, and controlling the flow rate based on the user input by controlling a base vacuum provided by the vacuum source.

### Claim 18 (depends on 17)

The tissue removal device of claim 17, wherein the control console is further configured for providing a pulsed vacuum as a series of the vacuum pulses having a vacuum on period followed by a vacuum off period to form a pulse period, the vacuum pulses being generated at a frequency determined by the pulse period.
