Cleaning devices, systems and methods

• US 10,016,575 B2
• Filed: 06/01/2015
• Issued: 07/10/2018
• Est. Priority Date: 06/03/2014
• Status: Active Grant

• Current Assignee: SunMed Group Holdings LLC
• Original Assignee: Endoclear LLC (Avanos Medical, Inc.)
• Inventors: Vazales, Brad Eugene, Chersky, David Mark
• Primary Examiner(s): Bouchelle, Laura
• Assistant Examiner(s): Ahmed, Tasnim M
• Application Number:
  US14/727,665
• Publication Number:
  US 20150343182A1
• Time in Patent Office: 1,135 Days
• CPC Class Codes: A61B 1/122 using cleaning tools, e.g. brushes
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2209/10 Equipment for cleaning
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Cleaning systems and devices are provided for cleaning body-inserted tubes (e.g., endotracheal tubes, chest cleaning tubes). In one embodiment, a closed suction system includes a suction catheter having at least one deployable (e.g., inflatable) cleaning member at a distal portion of the suction catheter and at least one suction opening distal to the cleaning member. The closed suction system module may include a control unit at its proximal end adapted to facilitate operation in one of the following three operational states: i) a first operational state in which only the cleaning member is functional, ii) a second operational state in which only suction is functional, or iii) a third operational state in which neither suction nor the cleaning member is functional.

Claims

1. A cleaning system adapted to clean a body-inserted tube, the system comprising:

a suction catheter comprising;

a cleaning portion located at or near a distal end of the suction catheter, the cleaning portion comprising an expandable cleaning member;

a proximal controller located at a proximal end of the suction catheter,

wherein the proximal controller comprises a first activation member adapted to control expansion of the cleaning member and a second activation member adapted to allow a suction force to be applied to the suction catheter by a suction source,

wherein the proximal controller is adapted to enable operation in the following three operational states;

i) a first operational state in which the first activation member is allowed to be activated by an operator and in which the second activation member is prevented from being activated by the operator,

ii) a second operational state in which the second activation member is allowed to be activated by the operator and in which the first activation member is prevented from being activated by the operator, or

iii) a third operational state in which neither the first activation member nor the second activation member is allowed to be activated by the operator;

wherein, upon expansion of the cleaning member, at least a portion of the cleaning member is adapted to contact an interior surface of the body-inserted tube such that when the suction catheter is withdrawn from the body-inserted tube, biofilm or other debris collected on the interior surface is removed by the cleaning member; and

a distal suction port disposed distal of the cleaning member along a length of the suction catheter, the suction port being in fluid communication with a lumen extending from the proximal controller to the distal suction port,

wherein the distal suction port is configured to facilitate suctioning distal to the cleaning member.

2. The system of claim 1, wherein the proximal controller is adapted to rotate between three rotational positions, each rotational position corresponding to one of the three operational states.

3. The system of claim 2, wherein the proximal controller includes visual indicia corresponding to each rotational position and corresponding operational state.

4. The system of claim 2, wherein rotation between each rotation position is adapted to be confirmed by an audible confirmation, a visual confirmation and a tactile confirmation.

5. The system of claim 1, wherein the proximal controller further comprises a locking mechanism configured to prevent inadvertent activation of the first activation member and/or the second activation member.

6. The system of claim 1, wherein the cleaning member comprises an inflatable balloon having one or more integrated rings or wipers.

7. The system of claim 6, wherein a leading edge of the one or more rings or wipers comprises a squared or substantially squared edge.

8. The system of claim 1, wherein the cleaning member and/or a portion of the length of the suction catheter comprises an integral lubricious coating.

9. The system of claim 1, wherein the cleaning member and/or a portion of the length of the suction catheter comprises an antimicrobial coating.

10. The system of claim 1, wherein the suction catheter and the cleaning member are formed of silicone.

11. The system of claim 1, further comprising a manifold adapted to removably couple to the body-inserted tube and a flexible enclosure adapted to extend from the proximal controller to a coupling member at the distal end of the suction catheter that couples to the manifold, thereby preventing exposure of the suction catheter to an external environment.

12. The system of claim 1, wherein the suction catheter comprises a braided wire coextruded with at least the portion of the suction catheter.

13. The system of claim 11, further comprising a polymeric tubular extension comprising a shaft having a length extending into the flexible enclosure from the coupling member at the distal end of the suction catheter, wherein the polymeric tubular extension is configured to receive a flexible catheter and facilitate pulling of the flexible catheter into the the manifold and the body-inserted tube by the operator.

14. A cleaning device adapted to clean a body-inserted tube, the system comprising:

a suction catheter comprising a proximal end and a distal end;

a deployable cleaning member located at or near the distal end of the suction catheter;

a proximal controller located at the proximal end of the suction catheter,

wherein the proximal controller comprises a first activation member adapted to control deployment of the cleaning member and a second activation member adapted to allow a suction force to be applied to the suction catheter by a suction source,

wherein the proximal controller is adapted to enable operation in the following three operational states;

i) a first operational state in which the first activation member is allowed to be activated by an operator and in which the second activation member is prevented from being activated by the operator,

ii) a second operational state in which the second activation member is allowed to be activated by the operator and in which the first activation member is prevented from being activated by the operator, or

iii) a third operational state in which neither the first activation member nor the second activation member is allowed to be activated by the operator;

wherein, upon deployment of the cleaning member, at least a portion of the cleaning member is adapted to contact an interior surface of the body-inserted tube such that when the cleaning device is withdrawn from the body-inserted tube, biofilm or other debris collected on the interior surface is removed by the cleaning member; and

a distal suction port disposed distal of the cleaning member along a length of the suction catheter, the suction port being in fluid communication with a lumen extending from the proximal controller to the distal suction port,

wherein the distal suction port is configured to facilitate suctioning distal to the cleaning member.

15. The device of claim 14, wherein the deployable cleaning member comprises an inflatable balloon.

16. The device of claim 14, wherein the proximal controller further comprises a locking mechanism configured to prevent inadvertent activation of the first activation member and/or the second activation member.

17. The device of claim 14, wherein the suction catheter comprises a braided wire coextruded with at least the portion of the suction catheter.