# US 10,441,380 B2 · Body-inserted tube cleaning

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- Number: US 10,441,380 B2
- Document ID: US10441380B2
- Status: Granted
- Kind: B2
- Application number: 15/971,449
- Filed: 2018-05-04
- Published: 2018-12-13
- Granted: 2019-10-15
- Earliest claimed: 2009-02-06
- Assignees: Endoclear LLC
- Applicants: Endoclear LLC
- Inventors: Brad E. Vazales; Arthur Bertolero; Ken Watson; James M. Gracy
- Web page: https://patentgrep.com/patent/US10441380B2

## CPC

- A61B 1/06: with illuminating arrangements
- A61B 1/00082: {Balloons}
- A61B 1/00096: {Optical elements}
- A61B 1/122: {using cleaning tools, e.g. brushes}
- A61B 1/126: {provided with means for cleaning in-use}
- A61B 1/267: for the respiratory tract, e.g. laryngoscopes or bronchoscopes
- A61B 1/2676: {Bronchoscopes}
- A61B 90/70: Cleaning devices specially adapted for surgical instruments
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- A61M 16/0434: {Cuffs}
- A61M 16/0463: {combined with suction tubes, catheters or the like; Outside connections}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- B08B 9/0436: {provided with mechanical cleaning tools, e.g. scrapers, with or without additional fluid jets (B08B9/045, B08B9/047 take precedence)}
- A61B 2090/701: {for flexible tubular instruments, e.g. endoscopes}
- A61M 16/0486: {Multi-lumen tracheal tubes}
- A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement}
- A61M 2202/203: Bacteria
- A61M 2209/10: Equipment for cleaning
- 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)}
- B08B: CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL

## Abstract

Systems, devices, and methods are disclosed for the cleaning of an endotracheal tube while a patient is being supported by a ventilator connected to the endotracheal tube for the purpose of increasing the available space for airflow or to prevent the build up of materials that may constrict airflow or be a potential nidus for infection. In one embodiment, a method for cleaning endotracheal tubes comprises inserting a cleaning device within an endotracheal tube while a cleaning member is in a compressed position, radially expanding the cleaning member to an expanded position within the endotracheal tube, and withdrawing the cleaning device from the endotracheal tube with the cleaning member in the expanded position.

## Claims

### Claim 1

A method for cleaning an inside surface of an endotracheal tube without removing the endotracheal tube from a native airway of a patient, the method comprising:
coupling a distal port of an adapter to an endotracheal tube, the adapter comprising a proximal ventilation port configured to facilitate ongoing ventilation of the patient, a proximal device insertion port configured to facilitate access to the endotracheal tube by one or more aspiration or cleaning instruments without disconnecting a ventilator from the ventilation port or the adapter from the endotracheal tube, and an elastomeric diaphragm configured to provide a seal around an inserted instrument so as to prevent loss of ventilator tidal volume through the adapter;
connecting a ventilator to the ventilation port of the adapter;
aspirating an interior of the endotracheal tube using an aspiration instrument;
inserting an endotracheal tube cleaning device through the device insertion port of the adapter and into the endotracheal tube, the endotracheal tube cleaning device having a radially expandable cleaning member;
determining a deployment depth for the endotracheal tube cleaning device by aligning visible indicia on the endotracheal tube with corresponding indicia on the endotracheal tube cleaning device;
actuating the cleaning member from a radially-collapsed configuration to a radially-expanded configuration by manipulating an actuation assembly of the endotracheal tube cleaning device with a single hand;
wherein actuating the cleaning member causes at least a portion of the cleaning member to engage an interior wall of the endotracheal tube;
withdrawing the endotracheal tube cleaning device from the endotracheal tube in order to remove biofilm from the interior wall of the endotracheal tube; and
removing the adapter from the endotracheal tube after withdrawing the endotracheal tube cleaning device from the endotracheal tube.

### Claim 2 (depends on 1)

The method of claim 1, wherein the endotracheal tube cleaning device comprises a suction conduit configured to facilitate suction.

### Claim 3 (depends on 1)

The method of claim 1, wherein the step of actuating the cleaning member comprises mechanically actuating the cleaning member.

### Claim 4 (depends on 1)

The method of claim 1, wherein the step of actuating the cleaning member comprises inflating the cleaning member.

### Claim 5 (depends on 1)

The method of claim 1, wherein the step of aspirating the interior of the endotracheal tube using the aspiration instrument is performed prior to the step of inserting the endotracheal tube cleaning device through the adapter and into the endotracheal tube.

### Claim 6 (depends on 1)

The method of claim 1, wherein the step of aspirating the interior of the endotracheal tube using the aspiration instrument is performed during the step of withdrawing the endotracheal tube cleaning device from the endotracheal tube in order to remove biofilm from the interior wall of the endotracheal tube.

### Claim 7 (depends on 1)

The method of claim 1, wherein the step of aspirating the interior of the endotracheal tube using the aspiration instrument is performed after the step of withdrawing the endotracheal tube cleaning device from the endotracheal tube.

### Claim 8 (depends on 1)

The method of claim 1, wherein the elastomeric diaphragm comprises a one-way valve.

### Claim 9 (depends on 1)

The method of claim 1, further comprising sampling the biofilm removed by the endotracheal tube cleaning device to identify bacteria present in the biofilm.

### Claim 10 (depends on 1)

The method of claim 1, further comprising aspirating portions of a tracheobronchial tree of the patient using the aspiration instrument.

### Claim 11

A method for cleaning an inside surface of an endotracheal tube without removing the endotracheal tube from a native airway of a patient, the method comprising:
coupling a distal port of an adapter to the endotracheal tube, the adapter comprising a proximal ventilation port configured to facilitate ongoing ventilation of the patient a proximal device insertion port configured to facilitate access to the endotracheal tube by one or more aspiration or cleaning instruments without disconnecting a ventilator from the ventilation port or the adapter from the endotracheal tube, and an elastomeric diaphragm configured to provide a seal around an inserted instrument so as to prevent loss of ventilator tidal volume through the adapter;
connecting a ventilator to the ventilation port of the adapter;
inserting an endotracheal tube cleaning device through the device insertion port of the adapter and into the endotracheal tube without disconnecting the ventilator from the ventilation port or disconnecting the adapter from the endotracheal tube, the endotracheal tube cleaning device having a radially expandable cleaning member;
actuating the cleaning member from a radially-collapsed configuration to a radially-expanded configuration by manipulating an actuation assembly of the endotracheal tube cleaning device;
wherein actuating the cleaning member causes at least a portion of the cleaning member to engage an interior wall of the endotracheal tube;
withdrawing the endotracheal tube cleaning device from the endotracheal tube in order to remove biofilm from the interior wall of the endotracheal tube;
aspirating an interior of the endotracheal tube; and
removing the adapter from the endotracheal tube after withdrawing the endotracheal tube cleaning device from the endotracheal tube.

### Claim 12 (depends on 11)

The method of claim 11, wherein the endotracheal tube cleaning device comprises an aspiration conduit, and wherein the step of aspirating the interior of the endotracheal tube is performed by the endotracheal tube cleaning device.

### Claim 13 (depends on 12)

The method of claim 12, wherein the step of aspirating the interior of the endotracheal tube is performed during the step of withdrawing the endotracheal tube cleaning device from the endotracheal tube in order to remove biofilm from the interior wall of the endotracheal tube.

### Claim 14 (depends on 12)

The method of claim 12, further comprising aspirating portions of a tracheobronchial tree of the patient using the endotracheal tube cleaning device.

### Claim 15 (depends on 11)

The method of claim 11, wherein the step of actuating the cleaning member comprises mechanically actuating the cleaning member.

### Claim 16 (depends on 11)

The method of claim 11, wherein the step of actuating the cleaning member comprises inflating the cleaning member.

### Claim 17 (depends on 11)

The method of claim 11, wherein the step of aspirating the interior of the endotracheal tube is performed by a separate aspiration instrument prior to the step of inserting the endotracheal tube cleaning device through the adapter and into the endotracheal tube.

### Claim 18 (depends on 11)

The method of claim 11, wherein the step of aspirating the interior of the endotracheal tube is performed after the step of withdrawing the endotracheal tube cleaning device from the endotracheal tube.

### Claim 19 (depends on 11)

The method of claim 11, further comprising delivering oxygen through the endotracheal tube using the ventilator for a predetermined duration of time prior to coupling the adapter to the endotracheal tube and connecting the ventilator to the ventilation port of the adapter.

### Claim 20 (depends on 11)

The method of claim 11, further comprising aspirating portions of a tracheobronchial tree of the patient.