# US 2011/0030678 A1 · Insufflation system

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- Number: US 2011/0030678 A1
- Document ID: US20110030678A1
- Status: Published application
- Kind: A1
- Application number: 12/853,538
- Filed: 2010-08-10
- Published: 2011-02-10
- Earliest claimed: 2009-08-10
- Assignees: Aerosurgical Limited
- Inventors: Patrick Joseph Power; Trevor Stephen Fahy; Laurence Cormac Ryan; Kieran Hyland
- Web page: https://patentgrep.com/patent/US20110030678A1

## CPC

- A61M 13/003: {Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing}
- A61B 17/3421: {Cannulas}
- A61B 17/3474: {Insufflating needles, e.g. Veress needles}
- A61M 11/005: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 2202/0241: Anaesthetics; Analgesics
- A61M 2205/3327: Measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/50: with microprocessors or computers
- A61M 2205/8206: battery-operated
- B05B 12/081: {responsive to the weight of a reservoir or container for liquid or other fluent material; responsive to level or volume of liquid or other fluent material in a reservoir or container}
- B05B 17/0646: {Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B05B: SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES (spray-mixers with nozzles B01F25/72; processes for applying liquids or other fluent materials to surfaces by spraying B05D)

## Abstract

An aerosol generator 200 is positioned adjacent to a patient as an attachment to a trocar 201. The trocar has an entry port 203 for insufflation gas 208. Aerosol 207 generated by a vibrating element 205 is entrained in the insufflation gas and the mixture 209 is delivered through the trocar 201. The aerosol may contain a medicament. The trocar 201 may be a conventional trocar. Such trocars are typically used for a camera. The delivery of the aerosolised medicament can occur at the start of the procedure and be delivered in bolus. At the start of the procedure, the peritoneum is being inflated by means of the flow of insufflator gas. This gas flow will help to entrain the aerosolised medicament to the pneumoperitoneum regions. The surgeon can temporarily remove a camera from the trocar port to facilitate insertion and positioning of the aerosolising unit.

## Claims

### Claim 1

Apparatus for use in procedures involving insufflation comprising:
an aerosol generator for aerosolising a fluid; and
a trocar for delivery of the aerosol.

### Claim 2 (depends on 1)

An apparatus as claimed in claim 1 wherein the aerosol generator is mounted to the trocar.

### Claim 3 (depends on 1)

An apparatus as claimed in claim 1 wherein the aerosol generator is mountable to the trocar.

### Claim 4 (depends on 1)

An apparatus as claimed in claim 1 wherein the aerosol generator is releasably mounted to the trocar.

### Claim 5 (depends on 1)

Apparatus as claimed in claim 1 wherein the trocar comprises a housing having a proximal end to which the aerosol generator is mounted and a distal end through which aerosol is delivered, the trocar having a proximal entry port for insufflation gas, the apparatus comprising an aerosol delivery tube means extending from the aerosol generator into the trocar housing, the aerosol delivery tube having an aerosol outlet which is located distally with respect to the insufflation gas entry port of the trocar.

### Claim 6 (depends on 5)

Apparatus as claimed in claim 5 wherein the aerosol outlet of the aerosol delivery tube extends into the trocar for a length which is at least 10%, at least 15%, at least 20% of the length of the trocar.

### Claim 7 (depends on 5)

Apparatus as claimed in claim 5 comprising a proximal seal between the trocar and the aerosol delivery tube.

### Claim 8 (depends on 5)

Apparatus as claimed in claim 5 wherein the aerosol delivery tube comprises an entry port for receiving a flow of insufflation gas.

### Claim 9 (depends on 8)

Apparatus as claimed in claim 8 wherein the insufflation gas entry port of the aerosol delivery tube is located proximally of the proximal end of the trocar.

### Claim 10 (depends on 8)

Apparatus as claimed in claim 8 comprising flow diverting means for delivery of insufflation gas to the insufflation gas entry port of the trocar and/or to the insufflation gas entry port of the aerosol delivery tube.

### Claim 11 (depends on 5)

Apparatus as claimed in claim 5 wherein the aerosol delivery tube means comprises an inner tube and an outer tube which are spaced-apart to define an insufflation gas flow path therebetween.

### Claim 12 (depends on 11)

Apparatus as claimed in claim 11 comprising a distal seal between the outer tube and the trocar.

### Claim 13 (depends on 11)

Apparatus as claimed in claim 11 wherein the apparatus comprises an aerosol delivery chamber and the insufflation gas flow path extends into the aerosol delivery chamber for entraining insufflation gas with the aerosol, the insufflation gas with entrained aerosol being delivered through the inner tube and extending from the inner tube into the trocar at the distal end of the tube means.

### Claim 14 (depends on 11)

Apparatus as claimed in claim 11 wherein the distal end of the outer tube is located proximally with respect to the distal end of the inner tube to define an entry port for insufflation gas.

### Claim 15 (depends on 1)

An apparatus as claimed in claim 1 wherein the aerosol generator is located at a proximal end of the trocar.

### Claim 16 (depends on 1)

An apparatus as claimed in claim 1 wherein the aerosol generator is located at a distal end of the trocar.

### Claim 17 (depends on 16)

An apparatus as claimed in claim 16 comprising first delivery means for delivering insufflation gas to a location adjacent to the aerosol generator.

### Claim 18 (depends on 16)

Apparatus as claimed in claim 16 comprising second delivery means for delivery of liquid to be aerosolised to the aerosol generator.

### Claim 19 (depends on 18)

Apparatus as claimed in claim 18 wherein the second delivery means comprises a delivery tube extending from a housing for a liquid to the aerosol generator.

### Claim 20 (depends on 18)

Apparatus as claimed in claim 18 wherein the aerosol generator is mounted to an outer tube which extends through the trocar from the liquid housing.

### Claim 21 (depends on 20)

Apparatus as claimed in claim 20 wherein a distal end of the outer tube is located adjacent to a distal end of the trocar.

### Claim 22 (depends on 20)

Apparatus as claimed in claim 20 wherein the aerosol generator is located adjacent to a distal end of the trocar.

### Claim 23 (depends on 16)

Apparatus as claimed in claim 16 comprising control means for operation of the aerosol generator, the control means extending through the inner and outer tubes from a proximal end at the liquid housing to a distal end at the aerosol generator.

### Claim 24 (depends on 1)

An apparatus as claimed in claim 1 comprising an insufflator for generating an insufflation gas.

### Claim 25 (depends on 1)

An apparatus as claimed in claim 1 comprising a controller to control the operation of the aerosol generator.

### Claim 26 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller is remote from the trocar.

### Claim 27 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller is mounted to the trocar.

### Claim 28 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller is mountable to the trocar.

### Claim 29 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller is releasably mounted to the trocar.

### Claim 30 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller comprises a first controller local to the trocar and a second controller remote from the trocar.

### Claim 31 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller is configured to control the flow rate of the fluid to be aerosolised.

### Claim 32 (depends on 25)

Apparatus as claimed in claim 25 wherein the controller is configured to deliver different flow rates of aerosol at different stages of a surgical procedure.

### Claim 33 (depends on 32)

Apparatus as claimed in claim 32 wherein the controller is configured to deliver full flow at the start and/or end of a procedure.

### Claim 34 (depends on 32)

Apparatus as claimed in claim 32 wherein the controller is configured to deliver reduced flow during a procedure.

### Claim 35 (depends on 25)

Apparatus as claimed in claim 25 wherein the controller is set to deliver a pre-set amount of aerosol into insufflation gas.

### Claim 36 (depends on 35)

Apparatus as claimed in claim 35 comprising means for varying the pre-set amount of aerosol.

### Claim 37 (depends on 36)

Apparatus as claimed in claim 36 wherein the means for varying the pre-set amount of aerosol comprises a user interface such as a keypad or switch.

### Claim 38 (depends on 25)

An apparatus as claimed in claim 25 wherein the controller is configured to control operation of the aerosol generator responsive to the insufflation gas.

### Claim 39 (depends on 38)

An apparatus as claimed in claim 38 wherein the controller is configured to control operation of the aerosol generator responsive to the flow rate of the insufflation gas.

### Claim 40 (depends on 1)

An apparatus as claimed in claim 1 wherein the aerosol generator comprises a vibratable member having a plurality of apertures extending between a first surface and a second surface.

### Claim 41 (depends on 40)

An apparatus as claimed in claim 40 wherein the first surface is adapted to receive the fluid to be aerosolised.

### Claim 42 (depends on 40)

An apparatus as claimed in claim 40 wherein the aerosol generator is configured to generate an aerosol at the second surface.

### Claim 43 (depends on 40)

An apparatus as claimed in claim 40 wherein the vibratable member is dome-shaped in geometry.

### Claim 44 (depends on 40)

An apparatus as claimed in claim 40 wherein the vibratable member comprises a stretched flat shape.

### Claim 45 (depends on 40)

An apparatus as claimed in claim 40 wherein the vibratable member comprises a piezoelectric element.

### Claim 46 (depends on 40)

An apparatus as claimed in claim 40 wherein the apertures in the vibratable member are sized to aerosolise the first fluid by ejecting droplets of the first fluid such that the majority of the droplets by mass have a size of less than 100 micrometers, less than 50 micrometers.

### Claim 47 (depends on 40)

An apparatus as claimed in claim 40 wherein the apertures in the vibratable member are sized to aerosolise the first fluid by ejecting droplets of the first fluid such that the majority of the droplets by mass have a size of less than 40 micrometers.

### Claim 48 (depends on 40)

An apparatus as claimed in claim 40 wherein the apertures in the vibratable member are sized to aerosolise the first fluid by ejecting droplets of the first fluid such that the majority of the droplets by mass have a size of less than 30 micrometers.

### Claim 49 (depends on 40)

An apparatus as claimed in claim 40 wherein the apertures in the vibratable member are sized to aerosolise the first fluid by ejecting droplets of the first fluid such that the majority of the droplets by mass have a size of less than 20 micrometers.

### Claim 50 (depends on 49)

An apparatus as claimed in claim 49 wherein a size range band is from 3 to 15 micrometers.

### Claim 51 (depends on 40)

An apparatus as claimed in claim 40 wherein the controller is configured to control the pulse rate at a set frequency of vibration of the vibratable member.

### Claim 52 (depends on 40)

An apparatus as claimed in claim 40 wherein the controller is impedance matched to the aerosol generator.

### Claim 53 (depends on 40)

An apparatus as claimed in claim 40 wherein the apparatus comprises means to determine whether the fluid is in contact with the aerosol generator.

### Claim 54 (depends on 53)

An apparatus as claimed in claim 53 wherein the determining means is configured to determine at least one electrical characteristic of the aerosol generator.

### Claim 55 (depends on 54)

An apparatus as claimed in claim 54 wherein the determining means is configured to determine at least one electrical characteristic of the aerosol generator over a range of vibration frequencies.

### Claim 56 (depends on 54)

An apparatus as claimed in claim 54 wherein the determining means is configured to compare the at least one electrical characteristic against a pre-defined set of data.

### Claim 57

A method for carrying out a procedure involving insufflation comprising the steps of:
providing an aerosol generator;
providing a trocar;
aerosolising a fluid using the aerosol generator; and
delivering the aerosol from the trocar.

### Claim 58 (depends on 57)

A method as claimed in claim 57 comprising:
generating an insufflation gas; and
entraining the aerosol with the insufflation gas.

### Claim 59 (depends on 58)

A method as claimed in claim 58 comprising the step of controlling the aerosoliation of the fluid.

### Claim 60 (depends on 59)

A method as claimed in claim 59 comprising delivering different flow rates of aerosol at different stages of a surgical procedure.

### Claim 61 (depends on 60)

A method as claimed in claim 60 comprising delivering full flow at the start and/or end of a procedure.

### Claim 62 (depends on 60)

A method as claimed in claim 60 comprising delivering reduced flow during a procedure.

### Claim 63 (depends on 60)

A method as claimed in claim 60 comprising delivering a pre-set amount of aerosol into insufflation gas.

### Claim 64 (depends on 60)

A method as claimed in claim 60 wherein the method comprises the step of delivering the entrained fluid and insufflation gas into the body to insufflate at least part of the body.

### Claim 65 (depends on 58)

A method as claimed in claim 58 wherein the fluid is an aqueous solution.

### Claim 66 (depends on 65)

A method as claimed in claim 65 wherein the aqueous solution is saline having a salt concentration of greater than 1 μM.

### Claim 67 (depends on 58)

A method as claimed in claim 58 wherein the fluid contains a therapeutic and/or prophylactic agent.

### Claim 68 (depends on 67)

A method as claimed in claim 67 wherein the agent is one or more selected from the group comprising an analgestic, an anti-inflammatory, an anti-infective, an anaesthetic, an anticancer chemotherapy agent, and an anti-adhesion agent.

### Claim 69 (depends on 58)

A method as claimed in claim 58 wherein the procedure is a laparascopic procedure.
