U.S. patent application number 14/042516 was filed with the patent office on 2014-05-01 for insufflation system.
This patent application is currently assigned to AeroSurgical Limited. The applicant listed for this patent is AeroSurgical Limited. Invention is credited to Conor Paul Duffy, Patrick Joseph Power.
Application Number | 20140121589 14/042516 |
Document ID | / |
Family ID | 46637434 |
Filed Date | 2014-05-01 |
United States Patent
Application |
20140121589 |
Kind Code |
A1 |
Power; Patrick Joseph ; et
al. |
May 1, 2014 |
INSUFFLATION SYSTEM
Abstract
An aerosol generator is positioned adjacent to a patient as an
attachment to a trocar. The trocar has an entry port for
insufflation gas. Aerosol generated by a vibrating element is
entrained in the insufflation gas and the mixture is delivered
through the trocar. The aerosol may contain a medicament. The
trocar may be a conventional trocar. Such trocars are typically
used for a camera. The delivery of the aerosolized 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 aerosolized medicament to the pneumoperitoneum regions.
The surgeon can temporarily remove the camera from the trocar port
to facilitate insertion and positioning of the aerosolizing
unit.
Inventors: |
Power; Patrick Joseph;
(Moycullen, IE) ; Duffy; Conor Paul; (Roscahill,
IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AeroSurgical Limited |
Galway |
|
IE |
|
|
Assignee: |
AeroSurgical Limited
Galway
IE
|
Family ID: |
46637434 |
Appl. No.: |
14/042516 |
Filed: |
September 30, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13370003 |
Feb 9, 2012 |
8551036 |
|
|
14042516 |
|
|
|
|
12853538 |
Aug 10, 2010 |
|
|
|
13370003 |
|
|
|
|
61232512 |
Aug 10, 2009 |
|
|
|
61440946 |
Feb 9, 2011 |
|
|
|
Current U.S.
Class: |
604/26 |
Current CPC
Class: |
A61M 2205/50 20130101;
A61M 11/005 20130101; A61M 2205/8206 20130101; A61M 2205/3327
20130101; A61M 2202/0241 20130101; A61M 2205/3334 20130101; B05B
17/0646 20130101; A61M 13/003 20130101; A61M 11/00 20130101; B05B
12/081 20130101; A61B 17/3474 20130101; B05B 17/0669 20130101 |
Class at
Publication: |
604/26 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61M 13/00 20060101 A61M013/00 |
Claims
1. Apparatus for use in procedures involving insufflation,
comprising: an aerosol generator for aerosolizing a fluid; a trocar
for delivery of the aerosol, the trocar comprising a housing to
which the aerosol generator is mounted, the trocar having a
proximal entry part for insufflation gas and a distal end through
which aerosol is delivered; and an aerosol delivery tube extending
from the aerosol generator into the trocar housing, the aerosol
delivery tube having an aerosol outlet located distally with
respect to the insufflation gas entry port of the trocar.
2. The apparatus of claim 1, wherein a proximal end of the aerosol
delivery tube is located adjacent to the aerosol generator.
3. The apparatus of claim 2, wherein the apparatus is adapted to
direct insufflation gas from the trocar insufflation gas entry port
to the proximal end of the aerosol delivery tube for entraining the
aerosol in the insufflation gas and delivery of the insufflation
gas and entrained aerosol through the trocar.
4. The apparatus of claim 3, wherein a gap is provided between the
aerosol delivery tube and the aerosol generator for delivery of
insufflation gas into the aerosol delivery tube at the proximal end
of the aerosol delivery tube.
5. The apparatus of claim 4, wherein the gap is defined by an
angled cut at the proximal end of the aerosol delivery tube.
6. The apparatus of claim 5, wherein the angled cut is less than
20.degree..
7. The apparatus of claim 5, wherein the angled cut is less than
15.degree..
8. The apparatus of claim 5, wherein the angled cut is less than
10.degree..
9. The apparatus of claim 5, wherein the angle cut is approximately
5.degree..
10. The apparatus of claim 3, comprising a proximal seal between
the trocar and the aerosol delivery tube.
11. The apparatus of claim 3, wherein the aerosol delivery tube
comprises an inner tube radially spaced apart from an outer tube to
define an insufflation gas flow path between the inner tube and the
outer tube.
12. The apparatus of claim 11, further comprising a distal seal
between the outer tube and the trocar.
13. The apparatus of claim 1, further comprising a controller
configured to control the operation of the aerosol generator.
14. The apparatus of claim 13, wherein the controller is remote
from the trocar.
15. The apparatus of claim 13, wherein the controller is mounted to
the trocar.
16. The apparatus of claim 13, wherein the controller is mountable
to the trocar.
17. The apparatus of claim 13, wherein the controller is releasably
mounted to the trocar.
18. The apparatus of claim 1, further comprising a control system
including configured to control the operation of the aerosol
generator, the control system comprising a first controller local
to the trocar and a second controller remote from the trocar.
19. The apparatus of claim 13, wherein the controller is configured
to control the flow rate of the fluid to be aerosolized.
20. The apparatus of claim 13, wherein the controller is configured
to deliver different flow rates of aerosol at different stages of a
surgical procedure.
21. The apparatus of claim 13, wherein the controller is set to
deliver a pre-set amount of aerosol into insufflation gas.
22. The apparatus of claim 13, wherein the controller is configured
to control operation of the aerosol generator responsive to the
insufflation gas.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 13/370,003, filed Feb. 9, 2012, which claims
the benefit of U.S. Provisional Application Ser. No. 61/440,946
filed Feb. 9, 2011 and is a continuation-in-part of U.S. patent
application Ser. No. 12/853,538 filed Aug. 10, 2010, which claims
the benefit of U.S. Provisional Application Ser. No. 61/232,512
filed Aug. 10, 2009. The disclosure of each of these applications
is incorporated herein in its entirety by reference thereto.
BACKGROUND
[0002] Laparoscopic surgery, also called minimally or less invasive
surgery (MIS or LIS) or keyhole surgery is a modern surgical
technique in which operations in the body are performed through
small incisions as compared to the larger incisions needed in
traditional surgical procedures. Gas such as carbon dioxide is
delivered, via an insufflator, into a body cavity such as the
abdomen leading to the formation of a pneumoperitoneum, thereby
providing sufficient space for the surgeon to operate. The
insufflator maintains the pneumoperitoneum and acts to renew the
gas when leaks occur.
[0003] Gas, such as, for example, carbon dioxide, that is used for
insufflation is both cold and dry and it is not surprising
therefore those patients undergoing laparoscopic procedures often
suffer a significant drop in core body temperature, which can
result in considerable post-surgical pain and significant
complications, such as cardiac stress, immunological and clotting
problems, for the patient. By using standard thermo physical
principles it has been shown that the major cause of patient heat
loss is due to evaporation from the body acting to humidify the
large volumes of dry insufflated gas at ATPD (Ambient Temperature
Pressure Dry) passing into the body which is at BTPS (Body
Temperature Pressure Saturated). If such heat loss could be
minimized, post-operative pain and the significant side effects
suffered by the patient could be considerably alleviated.
[0004] Various attempts have been made to condition insufflation
gas by heating, humidifying, and/or filtering the gas. However, in
general, known insufflation gas-conditioning systems suffer from
one or more disadvantages including complexity of construction
involving expensive monitoring devices, inaccurate control, and/or
difficulties in using them in a controlled working environment.
[0005] Some systems employ heat moisture exchangers (HME). These
operate directly in the flow path of the insufflation gas and are
therefore inherently susceptible to affecting pressure or flow,
dependent upon their level of saturation and condition. Other
systems require manual intervention to respond to patients' needs
by the adding of moisture. Other devices require the cumbersome
procedure of passing gas over and through non-heated or heated
liquid containers. Such devices present the major drawback of
impeding pressure measurement in the insufflation cavity.
[0006] Systems using conventional jet nebulizers or nebulization
catheters exhibit one or more of the following disadvantages:
impaction of larger particles; fogging in the body cavity thus
reducing the surgeon's visibility; and interference with
insufflator settings increasing flow/pressure in the system.
[0007] The present invention is directed towards providing an
insufflation method and apparatus.
[0008] Flow of aerosol through long lengths of tubing may lead to
increased rainout and loss of suspended aerosol delivered to the
pneumoperitoneum. This impacts both effectiveness of the treatment
and the time required to deliver any given medication volume.
[0009] Standard connections for inflow gas at a Trocar housing tend
to be small diameter with sharp 90.degree. changes in flow
direction. This may lead to increased rainout and loss of suspended
aerosol delivered to the pneumoperitoneum.
[0010] Access to the control mechanism for the aerosol generator is
generally remote from the patient. This may inconvenience the
surgeon where immediate changes in aerosol delivery are required
during the course of a procedure.
[0011] Delivery of aerosol into the pneumoperitoneum is generally
completely dependent on the flow at insufflator. Where the
insufflator is providing low flow, aerosol may not be carried into
the pneumoperitoneum.
[0012] Positioning the aerosol generating element on the tubing
circuit between the insufflator and the Trocar presents challenges
such are location, need for supporting brackets, and potential to
obscure displays on important equipment.
SUMMARY
[0013] In accordance with exemplary embodiments of the present
invention an apparatus for use in procedures involving insufflation
comprises: [0014] an aerosol generator for aerosolizing a fluid;
and [0015] delivery means such as a delivery tube and/or a trocar
for delivery of the aerosol.
[0016] In some exemplary embodiments, the aerosol generator is
mounted to the trocar. The aerosol generator may be mountable to
the trocar. The aerosol generator may be releasably mounted to the
trocar.
[0017] In some exemplary embodiments, the aerosol generator is
integral with the trocar.
[0018] The trocar may comprise an entry port for insufflation gas.
The apparatus may comprise means for entraining aerosol with an
insufflation gas for delivery of the insufflation gas with
entrained aerosol.
[0019] In some exemplary embodiments, 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 tub 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.
[0020] The aerosol outlet of the aerosol delivery tube may extend
into the trocar for a length which is at least 10%, at least 15%,
or at least 20% of the length of the trocar.
[0021] Preferably there is a proximal seal between the trocar and
the aerosol delivery tube.
[0022] In some exemplary embodiments, the aerosol delivery tube
comprises an entry port for receiving a flow of insufflation gas.
The insufflation gas entry port of the aerosol delivery tube may be
located proximally of the proximal end of the trocar.
[0023] The apparatus in accordance with some exemplary embodiments
comprises 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.
[0024] In some other exemplary embodiments 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.
[0025] Preferably there is a distal seal between the outer tube and
the trocar.
[0026] In some exemplary embodiments, 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.
[0027] The distal end of the outer tube may be located proximally
with respect to the distal end of the inner tube to define an entry
port for insufflation gas.
[0028] In some exemplary embodiments, the aerosol generator is
located at a proximal end of the trocar.
[0029] In some other exemplary embodiments, the aerosol generator
is located at a distal end of the trocar. In this case the
apparatus may comprise a first delivery means for delivering
insufflation gas to a location adjacent to the aerosol
generator.
[0030] The apparatus may comprise second delivery means for
delivery of liquid to be aerosolized to the aerosol generator. The
delivery means may comprise a delivery tube extending from a liquid
housing to the aerosol generator.
[0031] In some exemplary embodiments, the aerosol generator is
mounted to an outer tube which extends through the trocar from the
liquid housing. A distal end of the outer tube may be located
adjacent to a distal end of the trocar.
[0032] The aerosol generator may be located adjacent to a distal
end of the trocar.
[0033] In some exemplary embodiments, the apparatus comprises
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.
[0034] In some exemplary embodiments, the apparatus comprises an
insufflator for generating an insufflation gas.
[0035] The apparatus may comprise a controller to control the
operation of the aerosol generator. The controller may be remote
from the trocar. The controller may be mounted to the trocar. The
controller may be mountable to the trocar. The controller may be
releasably mounted to the trocar.
[0036] In some exemplary embodiments, the controller comprises a
first controller local to the trocar and a second controller remote
from the trocar.
[0037] The controller may be configured to control the flow rate of
the fluid to be aerosolized.
[0038] In some exemplary embodiments, the controller is configured
to deliver different flow rates of aerosol at different stages of a
surgical procedure.
[0039] In some exemplary embodiments, the controller is configured
to deliver full flow at the start and/or end of a procedure.
[0040] The controller may be configured to deliver reduced flow
during a procedure.
[0041] In some exemplary embodiments, the controller is set to
deliver a pre-set amount of aerosol into insufflation gas. The
apparatus may comprise means for varying the pre-set amount of
aerosol. The means for varying the pre-set amount of aerosol may
comprise a user interface such as a keypad or switch.
[0042] In some other exemplary embodiments, the controller is
configured to control operation of the aerosol generator responsive
to the insufflation gas. The controller may be configured to
control operation of the aerosol generator responsive to the flow
rate of the insufflation gas.
[0043] In some exemplary embodiments, the aerosol generator
comprises a vibratable member having a plurality of apertures
extending between a first surface and a second surface. The first
surface may be adapted to receive the fluid to be aerosolized. The
aerosol generator may be configured to generate an aerosol at the
second surface.
[0044] In some exemplary embodiments, the vibratable member is
dome-shaped in geometry. Alternatively, the vibratable member may
comprise a stretched flat shape.
[0045] In some exemplary embodiments, the vibratable member
comprises a piezoelectric element.
[0046] In some exemplary embodiments, the apertures in the
vibratable member are sized to aerosolize 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.
[0047] The apertures in the vibratable member may be sized to
aerosolize 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.
[0048] The apertures in the vibratable member may be sized to
aerosolize 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.
[0049] The apertures in the vibratable member may be sized to
aerosolize 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. In some exemplary embodiments, a size range
band is from 3 to 15 micrometers.
[0050] In some exemplary embodiments, the controller is configured
to control the pulse rate at a set frequency of vibration of the
vibratable member.
[0051] The controller may be impedance matched to the aerosol
generator.
[0052] In some exemplary embodiments, the apparatus comprises means
to determine whether the fluid is in contact with the aerosol
generator. The determining means may be configured to determine at
least one electrical characteristic of the aerosol generator. The
determining means may be configured to determine at least one
electrical characteristic of the aerosol generator over a range of
vibration frequencies.
[0053] In some exemplary embodiments, the determining means is
configured to compare the at least one electrical characteristic
against a pre-defined set of data.
[0054] In accordance with exemplary embodiments of the present
invention, a method for carrying out a procedure involving
insufflation comprises the steps of: [0055] providing an aerosol
generator; [0056] providing a trocar; [0057] aerosolizing a fluid
using the aerosol generator; and [0058] delivering the aerosol from
the trocar.
[0059] In accordance with exemplary embodiments of the present
invention, a method of introducing aerosol to a body cavity
independent of the flow of insufflation gas is provided.
[0060] In some exemplary embodiments, the method comprises: [0061]
generating an insufflation gas; and [0062] entraining the aerosol
with the insufflation gas.
[0063] The method may comprise the step of controlling the
aerosolization of the fluid.
[0064] The method may comprise delivering different flow rates of
aerosol at different stages of a surgical procedure. The method may
comprise delivering full flow at the start and/or end of a
procedure. The method may comprise delivering reduced flow during a
procedure. The method comprise delivering a pre-set amount of
aerosol into insufflation gas.
[0065] In some exemplary embodiments, the method comprises the step
of delivering the entrained fluid and insufflation gas into the
body to insufflate at least part of the body.
[0066] In some exemplary embodiments, the fluid is an aqueous
solution.
[0067] In some exemplary embodiments, the aqueous solution is
saline having a salt concentration of greater than 1 .mu.M.
[0068] In some exemplary embodiments, the fluid contains a
therapeutic and/or prophylactic agent.
[0069] The agent may be 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.
[0070] In some exemplary embodiments, the procedure is a
laparascopic procedure.
[0071] In accordance with exemplary embodiments of the present
invention, an apparatus for use in procedures involving
insufflation comprises: [0072] an aerosol generator for
aerosolizing a fluid, [0073] a trocar for delivery of the aerosol,
the trocar comprising a housing to which the aerosol generator is
mounted, the trocar having a proximal entry part for insufflation
gas and a distal end through which aerosol is delivered, [0074] the
apparatus comprising an aerosol delivery tube 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.
[0075] In some exemplary embodiments, a proximal end of the aerosol
delivery tube is located adjacent to the aerosol generator.
[0076] In some exemplary embodiments, the apparatus is adapted to
direct insufflation gas from the trocar insufflation gas entry port
to a proximal end of the aerosol delivery tube for entraining the
aerosol in the insufflation gas and delivery of the insufflation
gas and entrained aerosol through the trocar.
[0077] A gap may be provided between the aerosol delivery tube and
the aerosol generator for delivery of insufflation gas into the
aerosol delivery tube at the proximal end thereof.
[0078] In an exemplary case the gap is defined by an angled cut at
the proximal end of the aerosol delivery tube. The angle cut may be
less than 20.degree., less than 15.degree., less than 10.degree..
In one embodiment the angle cut is approximately 5.degree..
[0079] There may be a proximal seal between the trocar and the
aerosol delivery tube.
[0080] The aerosol delivery tube means may comprise an inner tube
and an outer tube which are spaced-apart to define an insufflation
gas flow path therebetween. There may be a distal seal between the
outer tube and the trocar.
[0081] The trocar systems of the present invention may be adapted
to accommodate two or more aerosol generators. Such systems with
more than one aerosol generator increases nebulizer output and
reduces the time required to deliver a required amount of
aerosol.
[0082] In some exemplary embodiments, there is a seal between the
distal end of a trocar insert the trocar to prevent insufflation
gas from passing between the outer wall of the insert and the inner
wall of the trocar. The seal may comprise a bulbous region at the
distal end of the insert which is an interference fit in the shaft
of the trocar. This arrangement facilitates ease of insertion and
removal of the trocar insert whilst maintaining a seal when the
insert is in place in the trocar.
[0083] There may be any desired number of aerosol generators.
[0084] In some exemplary embodiments, a trocar insert has a
shortened length L which is sufficient to create a seal between the
trocar insert and the inner surface of the trocar. Typically the
length L is between 30 mm and 65 mm. By reducing the distance the
distance to be travelled by the aerosol within the narrow trocar
insert the quantity of aerosol exiting the trocar is increased.
[0085] In some exemplary embodiments, an inner tube of a trocar
insert is extended to a position close to the underside of an
aerosol generator. This has the benefit of channelling the flow of
generated aerosol for delivery to a patient. This feature may be
used with any length of trocar insert. Many different arrangements
are possible. There may be a small gap, a tapered interface, an
interface with castellations, a single gas inlet slit, and/or dual
offset slits to promote vortex formation.
[0086] In some exemplary embodiments, an aerosol insert has a
modified interface between a proximal end of an inner tube of the
insert and an aerosol generator. In some exemplary embodiments, the
inner tube comes into contact with the aerosol generator. The inner
tube may have an inlet for insufflation gas which is spaced below
the proximal end of the inner tube. This modifies the aerosol flow
dynamics for improved aerosol delivery efficiency.
[0087] A liquid reservoir for the aerosol generator may be modified
to facilitate efficient nebulization through a wide range of angles
of orientation such as would be encountered in use during
laparoscopic surgery. In some exemplary embodiments, a reservoir is
tapered. The reservoir may be fitted with a removable plug. The
plug may, for example, be of silicon.
[0088] In accordance with exemplary embodiments of the present
invention, a trocar having an aerosol generator includes a valve
such as a flap valve to facilitate the insertion of an instrument
such as a trocar blade or obdurator. As the instrument is inserted,
the flap valve moves to protect the aerosol generator. When the
instrument is not present the flap returns to a rest position and
assists in directing the flow of aerosol generated by the aerosol
generator down the shaft of the trocar.
[0089] Further features and aspects of example embodiments of the
present invention are described in more detail below with reference
to the appended Figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0090] FIG. 1 is a perspective view of an apparatus in accordance
with the present invention for use in a procedure involving
insufflation of a body cavity, such as laparoscopic surgery.
[0091] FIG. 2 is a perspective view of another apparatus in
accordance with the present invention.
[0092] FIG. 3 is a perspective view of another apparatus in
accordance with the present invention.
[0093] FIG. 4 is a perspective view of another apparatus in
accordance with the present invention.
[0094] FIG. 5 is a perspective view of the apparatus of FIG. 4 with
a lead connected.
[0095] FIG. 6 is an exploded view of another apparatus in
accordance with the present invention.
[0096] FIG. 7 is a perspective view of the apparatus of FIG. 6
assembled.
[0097] FIG. 8 is a perspective view of the apparatus of FIGS. 6 and
7 mounted to a trocar.
[0098] FIG. 9 is a cross sectional view of the apparatus of FIG.
8.
[0099] FIG. 10 is a cross sectional view of another aerosol
generator system mounted to a trocar.
[0100] FIG. 11 is an enlarged view of part of the apparatus of FIG.
10.
[0101] FIG. 12 is a cross sectional view of a further aerosol
generator system mounted to a trocar.
[0102] FIG. 13 is an enlarged view of part of the apparatus of FIG.
12.
[0103] FIG. 14 is a cross sectional view of another aerosol
generator system mounted to a trocar.
[0104] FIG. 15 is an enlarged view of one part of the apparatus of
FIG. 14.
[0105] FIG. 16 is an enlarged view of another part of the apparatus
of FIG. 14.
[0106] FIG. 17 is a cross sectional view of an alternative
seal.
[0107] FIG. 18 is a cross sectional view of a further aerosol
generator system mounted to a trocar.
[0108] FIG. 19 is an enlarged view of one part of the apparatus of
FIG. 18.
[0109] FIG. 20 is an enlarged view of another part of the apparatus
of FIG. 18.
[0110] FIG. 21 is a schematic illustration of a part of an
apparatus in accordance with the present invention.
[0111] FIG. 22 is a schematic illustration of a part of the
apparatus of FIG. 21.
[0112] FIG. 23 is an exploded isometric view of an aerosol
generator used in the present invention.
[0113] FIG. 24 is a cross-sectional view of the assembled aerosol
generator of FIG. 23.
[0114] FIG. 25 is a perspective view of a controller housing used
in the apparatus of the present invention.
[0115] FIGS. 26 and 27 are graphs of DC voltage versus time and AC
voltage versus time respectively to achieve a 100% aerosol
output.
[0116] FIGS. 28 and 29 are graphs of DC voltage versus time and AC
voltage versus time respectively to achieve a 50% aerosol
output--FIG. 28 illustrates the waveform output from a
microprocessor to a drive circuit and FIG. 29 illustrates the
waveform output from a drive circuit to a nebulizer.
[0117] FIGS. 30 and 31 are graphs of DC voltage versus time and AC
voltage versus time respectively to achieve a 25% aerosol
output--FIG. 30 illustrates the waveform output from a
microprocessor to a drive circuit and FIG. 31 illustrates the
waveform output from a drive circuit to a nebulizer.
[0118] FIG. 32 is a graph of AC voltage versus time; and
illustrates an output waveform from a drive circuit to a
nebulizer.
[0119] FIG. 33 is a graph of frequency versus current for another
apparatus in accordance with the present invention.
[0120] FIG. 34 is a perspective view of another apparatus in
accordance with the present invention.
[0121] FIG. 35 is an elevational view of portion of another
apparatus in accordance with the present invention for use in a
procedure involving insufflation of a body cavity, such as
laparoscopic surgery.
[0122] FIG. 36 is a top plan view of the apparatus of FIG. 35.
[0123] FIG. 37 is a plan view of another apparatus in accordance
with the present invention.
[0124] FIG. 38 is an elevational view of another apparatus in
accordance with the present invention.
[0125] FIG. 39 is an elevational view of another apparatus in
accordance with the present invention.
[0126] FIG. 39(a) is an enlarged view of a detail of FIG. 39.
[0127] FIG. 40 is an enlarged view of detail A of the apparatus of
FIG. 39.
[0128] FIG. 41 is an elevational view of another apparatus in
accordance with the present invention.
[0129] FIG. 42 is an elevational view of a further apparatus in
accordance with the present invention.
[0130] FIG. 42(a) is an enlarged plan view of a detail of FIG.
42.
[0131] FIG. 43 is an elevational view of another apparatus in
accordance with the present invention.
[0132] FIG. 43(a) is an enlarged plan view of a detail of FIG.
43.
[0133] FIG. 44 is an elevational view of a further apparatus in
accordance with the present invention.
[0134] FIG. 45 is a plan view of a detail of FIG. 44 illustrating a
gas flow path.
[0135] FIG. 46 is an elevational view of another apparatus in
accordance with the present invention.
[0136] FIG. 47 is an elevational view of an apparatus in accordance
with the present invention.
[0137] FIG. 48 is an elevational view of a further apparatus in
accordance with the present invention.
DETAILED DESCRIPTION
[0138] Referring to FIG. 1 there is illustrated an apparatus in
accordance with the present invention for use in insufflation of a
body cavity. One such application is laparoscopic surgery. The
device is also suitable for use in any situation involving
insufflation of a body cavity such as in arthroscopies, pleural
cavity insufflation (for example during thoracoscopy),
retroperitoneal insufflations (for example retroperitoneoscopy),
during hernia repair, during mediastinoscopy and any other such
procedure involving insufflation.
[0139] The apparatus comprises a reservoir 1 for storing an aqueous
solution, an aerosol generator 2 for aerosolizing the solution, and
a controller 3 for controlling operation of the aerosol generator
2. In the present invention aerosolized aqueous solution is
entrained with insufflation gas. The gas is any suitable
insufflation gas such as carbon dioxide. Other examples of suitable
insufflation gases are nitrogen, helium, and xenon.
[0140] The insufflation gas is delivered into an insufflation gas
tubing 15 by an insufflator 12. The insufflator 12 may be of any
suitable type such as those available from Karl Storz, Olympus, and
Stryker. The insufflator 12 has an outlet 20 through which
insufflation gas is delivered. A bacterial filter 21 may be
provided within the insufflator or, as illustrated, downstream of
the insufflator outlet 20.
[0141] Sterile water may be used. In the case of an aqueous
solution, any suitable solution may be used. Solutions with a salt
concentration in the range 1 .mu.M (micro molar) to 154 mM (milli
molar) (0.9% saline) are optimum as they cover the majority of
medical applications. In addition, such saline concentrations can
be readily nebulized using the aerosolization technology used in
the present invention.
[0142] Liquid, saline or water for humidifying purposes only and/or
medicament, can be delivered into the nebulizer reservoir through
the opening in the top of the nebulizer that is appropriately sized
to receive standard nebules or alternatively may be applied by
syringe or other delivery means. In another exemplary embodiment it
would be possible to supply the nebulizer pre-loaded with
medicament avoiding the requirement to separately add medicament to
the system.
[0143] Aqueous solution may be stored in the reservoir 1 container
of the nebulizer.
[0144] The apparatus comprises an aerosol supply conduit 34 for
delivering the aerosol from the aerosol generator 2 into the
insufflation gas conduit 15 to entrain the aerosol with the
insufflation gas, passing through the gas insufflation conduit 15.
The entrained aerosol/insufflation gas mixture passes out of the
connector 30 through the outlet 32 and is delivered to the body
cavity along a line 60 to a trocar 9.
[0145] The aerosol supply conduit 34 and the insufflation gas
conduit meet at a junction. Referring particularly to FIGS. 23 and
24, in the assembled apparatus the aerosol supply conduit 34 may be
releasably mounted to a neck 36 of the aerosol generator housing by
means of a push-fit arrangement. This enables the conduit 34 to be
easily dismounted from the aerosol generator housing 36, for
example for cleaning. The neck 36 at least partially lines the
interior of the aerosol supply conduit 34.
[0146] The nebulizer (or aerosol generator), has a vibratable
member which is vibrated at ultrasonic frequencies to produce
liquid droplets. Some specific, non-limiting examples of
technologies for producing fine liquid droplets is by supplying
liquid to an aperture plate having a plurality of tapered apertures
extending between a first surface and a second surface thereof and
vibrating the aperture plate to eject liquid droplets through the
apertures. Such technologies are described generally in U.S. Pat.
No. 5,164,740, U.S. Pat. No. 5,938,117, U.S. Pat. No. 5,586,550,
U.S. Pat. No. 5,758,637, U.S. Pat. No. 6,014,970, U.S. Pat. No.
6,085,740, and U.S. Pat. Application Publication No. 2005/021766A,
the complete disclosures of which are incorporated herein by
reference. However, it should be appreciated that the present
invention is not limited for use only with such devices.
[0147] Various methods of controlling the operation of such
nebulizers or aerosol generators are described in U.S. Pat. No.
6,540,154, U.S. Pat. No. 6,845,770, U.S. Pat. No. 5,938,117, and
U.S. Pat. No. 6,546,927, the complete disclosures of which are
incorporated herein by reference.
[0148] In use, the liquid to be aerosolized is received at the
first surface, and the aerosol generator 2 generates the
aerosolized first fluid at the second surface by ejecting droplets
of the first fluid upon vibration of the vibratable member. The
apertures in the vibratable member are sized to aerosolize the
liquid by ejecting droplets of the liquid such that the majority of
the droplets by mass have a size of less than 5 micrometers. The
vibratable member 40 could be non-planar, and may be dome-shaped in
geometry.
[0149] Referring particularly to FIGS. 23 and 24, in an exemplary
case the aerosol generator 2 comprises a vibratable member 40, a
piezoelectric element 41 and a washer 42, which are sealed within a
silicone overmold 43 and secured in place within the housing 36
using a retaining ring 44. The vibratable member 40 has a plurality
of tapered apertures extending between a first surface and a second
surface thereof.
[0150] The first surface of the vibratable member 40, which in use
faces upwardly, receives the liquid medicament from the reservoir 1
and the aerosolized medicament, is generated at the second surface
of the vibratable member 40 by ejecting droplets of medicament upon
vibration of the member 40. In use, the second surface faces
downwardly. In an exemplary case, the apertures in the vibratable
member 40 may be sized to produce an aerosol in which the majority
of the droplets by weight have a size of less than 5
micrometers.
[0151] The complete nebulizer may be supplied in sterile form,
which is a significant advantage for a surgical device.
[0152] Referring particularly to FIG. 22, the controller 3 controls
operation of and provides a power supply to the aerosol generator
2. The aerosol generator has a housing which defines the reservoir
1. The housing has a signal interface port 38 fixed to the lower
portion of the reservoir 1 to receive a control signal from the
controller 3. The controller 3 may be connected to the signal
interface port 38 by means of a control lead 39 which has a docking
member 50 for mating with the port 38. A control signal and power
may be passed from the controller 3 through the lead 39 and the
port 38 to the aerosol generator 2 to control the operation of the
aerosol generator 2 and to supply power to the aerosol generator 2
respectively.
[0153] The power source for the controller 3 may be an on-board
power source, such as a rechargeable battery, or a remote power
source, such as a mains power source, or an insufflator power
source. When the remote power source is an AC mains power source,
an AC-DC converter may be connected between the AC power source and
the controller 3. A power connection lead may be provided to
connect a power socket of the controller 3 with the remote power
source.
[0154] Referring particularly to FIG. 25, the controller 3 has a
housing and a user interface to selectively control operation of
the aerosol generator 2. Preferably the user interface is provided
on the housing which, in use, is located remote from the aerosol
generator housing. The user interface may be in the form of, for
example, an on-off button. In some embodiments a button may be used
to select pre-set values for simplicity of use. In some embodiments
a dial mechanism may be used to select from a range of values from
0-100%.
[0155] Status indication means are also provided on the housing to
indicate the operational state of the aerosol generator 2. For
example, the status indication means may be in the form of two
visible LEDs, with one LED being used to indicate power and the
other LED being used to indicate aerosol delivery. Alternatively,
one LED may be used to indicate an operational state of the aerosol
generator 2, and the other LED may be used to indicate a rest state
of the aerosol generator. 2.
[0156] A fault indicator may also be provided in the form of an LED
on the housing. A battery charge indicator in the form of an LED
may be provided at the side of the housing.
[0157] The controller 3 may be activated to supply power and a
control signal to the aerosol generator 2, which causes the
piezoelectric element 41 to vibrate the non-planar member 40. This
vibration of the non-planar member 40, causes the aqueous solution
at the top surface of the member 40 to pass through the apertures
to the lower surface where the aqueous solution is aerosolized by
the ejection of small droplets of solution.
[0158] Referring particularly to FIGS. 23 and 24, the aerosol
passes from the aerosol generator 2 into the neck 36 of the aerosol
generator housing, which is mounted within the aerosol supply
conduit 34. The aerosol is entrained in the insufflation gas
conduit with gas. The entrained mixture of the aerosol and the
insufflation gas then passes via an insufflator line 60 to a trocar
9, for example into the abdomen of the patient.
[0159] In use during laparoscopic surgery, the flow of the
insufflation gas into the abdomen of a patient is commenced to
insufflate the abdomen. The controller 3 commences operation of the
aerosol generator 2 to aerosolize the aqueous solution. The
aerosolized aqueous solution is entrained with the insufflation
gas, and delivered through the trocar 9 into the abdomen of the
patient to insufflate at least part of the abdomen.
[0160] In the event of alteration of the fluid flow rate of the
insufflation gas a flow rate sensor/meter may determine the
alteration, and the controller 3 alters the pulse rate of the
vibratable member of the nebulizer accordingly.
[0161] The controller 3 may be configured to control operation of
the aerosol generator 2, responsive to the fluid flow rate of the
insufflation gas and/or also independent of the fluid flow rate of
the insufflation gas.
[0162] In an exemplary case, the controller 3 is configured to
control operation of the aerosol generator 2 by controlling the
pulse rate at a set frequency of vibration of the vibratable
member, and thus controlling the fluid flow rate of the aqueous
solutions.
[0163] The controller 3 may comprise a microprocessor 4, a boost
circuit 5, and a drive circuit 6. FIG. 21 illustrates the
microprocessor 4, the boost circuit 5, the drive circuit 6
comprising impedance matching components (inductor), the nebulizer
2, and the aerosol. The inductor impedance is matched to the
impedance of the piezoelectric element of the aerosol generator 2.
The microprocessor 4 generates a square waveform of 128 KHz which
is sent to the drive circuit 6. The boost circuit 5 generates a 12V
DC voltage required by the drive circuit 6 from an input of either
a 4.5V battery or a 9V AC/DC adapter. The circuit is matched to the
impedance of the piezo ceramic element to ensure enhanced energy
transfer. A drive frequency of 128 KHz is generated to drive the
nebulizer at close to its resonant frequency so that enough
amplitude is generated to break off droplets and produce the
aerosol. If this frequency is chopped at a lower frequency such
that aerosol is generated for a short time and then stopped for a
short time, this gives good control of the nebulizer's flow rate.
This lower frequency is called the pulse rate.
[0164] The drive frequency may be started and stopped as required
using the microprocessor 4. This allows for control of flow rate by
driving the nebulizer 2 for any required pulse rate. The
microprocessor 4 may control the on and off times to an accuracy of
milliseconds.
[0165] The nebulizer 2 may be calibrated at a certain pulse rate by
measuring how long it takes to deliver a know quantity of solution.
There is a linear relationship between the pulse rate and the
nebulizer flow rate. This allows for accurate control over the
delivery rate of the aqueous solution.
[0166] The nebulizer drive circuit includes or consists of the
electronic components designed to generate output sine waveform of
approximately 100V AC which is fed to nebulizer 2 causing aerosol
to be generated. The nebulizer drive circuit 6 uses inputs from
microprocessor 4 and boost circuit 5 to achieve its output. The
circuit is matched to the impedance of the piezo ceramic element to
ensure good energy transfer.
[0167] The aerosol generator 2 may be configured to operate in a
variety of different modes, such as continuous, and/or phasic,
and/or optimised.
[0168] For example, referring to FIG. 26, a 5V DC square waveform
output from the microprocessor 4 to the drive circuit 6. FIG. 27
shows a low power, .about.100V AC sine waveform output from drive
circuit 6 to nebulizer 2 is illustrated. Both waveforms have a
period p of 7.8 .mu.S giving them a frequency of 1/7.8 .mu.s which
is approximately 128 KHz. Both waveforms are continuous without any
pulsing. The aerosol generator may be operated in this mode to
achieve 100% aerosol output.
[0169] Referring to FIG. 28 in another example, there being
illustrated a 5V DC square waveform output from the microprocessor
4 to the drive circuit 6. FIG. 29 shows a low power, .about.100V AC
sine waveform output from the drive circuit 6 to the nebulizer 2.
Both waveforms have a period p of 7.8 .mu.S giving them a frequency
of 1/7.8 .mu.s which is approximately 128 KHz. In both cases the
wavefoms are chopped (stopped/OFF) for a period of time x. In this
case the off time x is equal to the on time x. The aerosol
generator may be operated in this mode to achieve 50% aerosol
output.
[0170] In another exemplary case, referring to FIG. 30 there is
illustrated a 5V DC square waveform output from microprocessor 4 to
drive circuit 6. FIG. 31 shows a low power, .about.100V AC sine
waveform output from the drive circuit 6 to the nebulizer 2. Both
waveforms have a period p of 7.8 .mu.S giving them a frequency of
1/7.8 .mu.s which is approximately 128 KHz. In both cases the
wavefoms are chopped (stopped/OFF) for a period of time x. In this
case the off time is 3x while the on time is x. The aerosol
generator may be operated in this mode to achieve 25% aerosol
output.
[0171] Referring to FIG. 32, in an exemplary application pulsing is
achieved by specifying an on-time and off-time for the vibration of
the aperture plate. If the on-time is set to 200 vibrations and
off-time is set to 200 vibrations, the pulse rate is 50% (1/2 on
1/2 off). This means that the flow rate is half of that of a fully
driven aperture plate. Any number of vibrations can be specified
but to achieve a linear relationship between flow rate and pulse
rate a minimum number of on-time vibrations is specified since it
takes a finite amount of time for the aperture plate to reach its
maximum amplitude of vibrations.
[0172] The drive frequency can be started and stopped as required
by the microprocessor; this allows control of flow rate by driving
the nebulizer for any required pulse rate. The microprocessor can
control the on and off times with an accuracy of microseconds.
[0173] A nebulizer can be calibrated at a certain pulse rate by
measuring how long it takes to deliver a known quantity of
solution. There is a linear relationship between the pulse rate and
that nebulizer's flow rate. This allows accurate control of the
rate of delivery of the aerosolized aqueous solution. The ability
to calibrate each nebulizer ensures that any inherent variation in
output rate between each nebulizer can be eliminated. The output
from each nebulizer when in-line in the insufflator circuit will be
equivalent to a second nebulizer although the inherent flow rates
of the two nebulizers are different. For example, to achieve a
standard output of 0.044 ml/min at 1 L/min from two nebulizers, one
with an inherent output of 0.088 ml/min and a second with an
inherent output of 0.176 ml/min, the first nebulizer is controlled
with a 50:50 on:off pulse rate, with the second set to a 25:75
on-off pulse rate so that both nebulizers give a 0.044 ml/min
output. This feature ensures that the nebulizers when located in
the insufflation circuit have the potential to provide exactly the
same rate of aerosol output as each other. This is possible because
the amount of humidity a gas can hold is a known constant dependent
on controllable factors.
[0174] The pulse rate may be lowered so that the velocity of the
emerging aerosol is much reduced so that impaction rain-out is
reduced.
[0175] Detection of when the aperture plate is dry can be achieved
by using the fact that a dry aperture plate has a well defined
resonant frequency. If the drive frequency is swept from 120 kHz to
145 kHz and the current is measured then if a minimum current is
detected less than a set value, the aperture plate must have gone
dry. A wet aperture plate has no resonant frequency. The apparatus
of the present invention may be configured to determine whether
there is any of the first fluid in contact with the aerosol
generator 2. By determining an electrical characteristic of the
aerosol generator 2, for example the current flowing through the
aerosol generator 2, over a range of vibration frequencies, and
comparing this electrical characteristic against a pre-defined set
of data, it is possible to determine whether the aerosol generator
2 has any solution in contact with the aerosol generator 2. FIG. 33
illustrates a curve 80 of frequency versus current when there is
some of the solution in contact with the aerosol generator 2, and
illustrates a curve 90 of frequency versus current when there is
none of the solution in contact with the aerosol generator 2. FIG.
33 illustrates the wet aperture plate curve 80 and the dry aperture
plate curve 90.
[0176] Humidity may be generated via the aerosolization of any
aqueous solution. Relative humidity in the 50-100% range would be
optimum. The control module can generate a nebulizer output of any
defined relative humidity percentage based on the insufflator flow.
These solutions include any aqueous drug solution. Solutions with
salt concentrations in the range 1 .mu.M-154 mM would be
optimum.
[0177] The use of the nebulizer to humidify the insufflation gas
prior to entering the body will eliminate the need for the body to
humidify the gas once it is inside the body, thereby minimizing
body heat loss by internal evaporation.
[0178] The control in nebulizer output allows proportional delivery
of the required amount of humidity according to the amount of
insufflation gas entering the body. In addition, this control of
aerosolization rate will prevent overloading of the insufflation
gas with aerosol, which would obscure the surgeons view.
[0179] Exemplary embodiments of the present invention provide a
system that can deliver different flow rates at different stages of
the surgical procedure. Examples of such different flow rates
include: [0180] (i) delivering at 100% at the start of the
procedure (Bolus); [0181] (ii) delivering at a much lower rate say
5% during the procedure itself (Lower flow rate avoid fogging);
[0182] (iii) delivering at 100% at the end of the procedure
(Bolus); [0183] (iv) any combination of the above sequencing with
variable % values.
[0184] In an exemplary case, the controller which controls the
operation of the aerosol generator is pre-set to deliver a set
amount of aerosol into the insufflation gas. For example, the
controller may be set to deliver an amount of 5% into a flow of 1
liter per minute of insufflation gas to avoid fogging. The
controller may be pre-set in the factory to operate in this manner.
Alternatively, there may be a user interface such as a switch, or
keypad which may be used to change the setting. In these
arrangements, control responsive to an insufflation gas flow sensor
is not essential.
[0185] In addition to acting as a humidifying agent, the nebulizer
may also act to deliver any agent presented in an aqueous drug
solution. The system may facilitate delivery of, for example,
pain-relief medications, anti-infectives, anti-inflammatory, and/or
chemotherapy agents in aerosol form to the body cavity. These
therapeutic agents may also act as humidifying substances in their
own right.
[0186] The nebulized liquid entrained in the insufflation gas may
contain any desired therapeutic and/or prophylactic agent. Such an
agent may for example be one or more of an analgesic, an
anti-inflammatory, an anaesthetic, an anti-infective such as an
antibiotic, an anti-cancer chemotherapy agent, and/or any agent
which interferes with processes that result in the adhesion
function.
[0187] Typical local anaesthetics are, for example, Ropivacaine,
Bupivacaine, and Lidocaine.
[0188] Typical anti-infectives include: antibiotics such as an
aminoglycoside, a tetracycline, a fluroquinolone; and
anti-microbials such as a cephalosporin; and anti-fungals.
[0189] Anti-inflammatories may be of the steroidal or non-steroidal
type.
[0190] Anti-cancer chemotherapy agents may be alkylating agents,
antimetabolites anthracyclines, plant alkaloids, topoisomerase
inhibitors, nitrosoureas, mitotic inhibitors, monoclonal
antibodies, tyrosine kinase inhibitors, hormone therapies including
corticosteroids, cancer vaccines, anti-estrogens, aromatase
inhibitors, anti-androgens, anti-angiogenic agents, and other
antitumour agents.
[0191] The agent which interferes with the adhesion function may be
any of those outlined in PCT Application Publication No.
W02005/092264A, the entire contents of which are incorporated
herein by reference. In particular, the agent may be a crystalloid,
hyaluronic acid, polyethyleneglycol, Tranilast
(N-(3.sup.1,4.sup.1-dimethoxycinnamoyl) anthranilic acid) or a
Neurokinin 1 receptor (NK-1R) agonist, such as Aprepitant.
[0192] Typical analgesics include aspirin, acetaminophen,
ibuprofen, naproxen, a Cox-2 inhibitor such as celecoxib, morphine,
oxycodone, and hydrocodone.
[0193] To aid drug delivery at least some of the surfaces which
come into contact with the drug may be coated. Any suitable coating
may be used such as those with hydrophobic properties will cause
the drug to repel from the surface and assist in maintaining the
aerosol in motion through to the patient. PTFE based coatings such
as Teflon are examples of appropriate coatings.
[0194] Alternatively or additionally, an appropriate electrostatic
charge may be used to assist in maintaining the aerosol in motion.
If a drug has a particular charge, adding a similar charge to a
surface with which they come into contact will cause the
aerosolized drug to repel from the surface, thus keeping the drug
in the aerosol path to the patient.
[0195] These approaches may be applied to any aerosolized drug
delivery system including but not limited to insufflation systems
of the type described herein. It may be applied to
nebulization/aerosolization systems in general for home and/or
hospital use.
[0196] Exemplary systems of the present invention may be used for
precise controlled delivery of drug and/or humidity during
insufflation. No heating is required. Consequently there is no risk
of damage to drugs due to heating. The system may be used to
provide precise control over aerosol output, where such control may
be exercised, for example, by utilizing pulse rate control. The
system may be used for targeted delivery of a range of drugs,
thereby reducing systemic side effects. In addition the system
provides alleviation of post-surgical pain experienced by the
patient.
[0197] Referring to FIGS. 2 and 3 an aerosol generating element 2
is positioned adjacent to the patient as an attachment to the
trocar tool/instrument 9 with a remote located drive controller 3,
connected via a lead 16 to the aerosol generating element 2.
[0198] Referring to FIGS. 4 and 5, in another arrangement the
aerosol generating element is integrated into a trocar
tool/instrument 100 and the controller for the aerosol generator is
also fully integrated into the trocar.
[0199] Referring to FIGS. 6 to 9, the aerosol generating device 2
may be inserted into an entry port 110 of a surgery trocar 111. The
trocar 111 may be a conventional trocar with an entry port having a
diameter of circa 10 mm. Such trocars are typically one used for a
camera. A size of about 10 mm facilitates maximum inflow of
aerosol.
[0200] The delivery of the aerosolized 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
aerosolized medicament to the pneumoperitoneum regions. The surgeon
can temporarily remove the camera from the trocar port to
facilitate insertion and positioning of the aerosolizing unit.
[0201] The medicament can also be aerosolized when the peritoneum
is inflated, by assisting the flow of aerosol by generating a
larger pressure drop across the peritoneum cavity. This can be
accomplished by creating an artificial leak or vent of CO2 from the
cavity. This could be designed into the spigot of the aerosolising
device that fits into the trocar port 110.
[0202] The aerosol may be generated directly above the trocar entry
point into the pneumoperitoneum and in one embodiment can be
powered via a cable 16 attached to the separate controller unit 3.
In an exemplary case illustrated in FIG. 2, the insufflator gas
from the insufflator 12 enters the trocar 9 from the line 15 via a
separate port 17 and generated aerosol is carried into the
pneumoperitoneum by entrainment in the gas flow and through the
effects of gravity and diffusion. The controller 3 may be located
near to the trocar location or at some remote location as allowed
by the cable length 16 and the surgeon's desired ergonomical
preferences.
[0203] In another exemplary case illustrated in FIG. 3, the trocar
9 may provide a port 13 for the aerosol generator 2 only with no
provision for insufflator gas inflow. In this embodiment, the
generated aerosol is carried into the pneumoperitoneum through the
effects of gravity, diffusion, and the residual velocity of aerosol
after exiting the aerosol generator. The controller 3 may be
located near to the trocar location or at some remote location as
allowed by the cable length 16.
[0204] In the device illustrated in FIGS. 4 and 5, both the aerosol
generator 2 and control 3 functionality are integrated into one
self contained unit and placed in the trocar housing 100. The
aerosol is generated directly above the trocar entry point into the
pneumoperitoneum. The insufflator gas enters the trocar via a
separate port 17 and generated aerosol is carried into the
pneumoperitoneum by entrainment in the gas flow and through the
effects of gravity and diffusion. Control functionality is
available directly at the trocar body via buttons, indicator
lights, displays, or other user interfaces 120. The integrated
device may be operated via internal battery power or from an
external power source via a power supply cable. The device may also
have a charger port 122 for charging of an internal battery via an
external power supply cable 121. Therefore it is possible that
there are no attached or trailing cable leads on the aerosol
generating device during the surgical procedure greatly aiding the
surgeon's ease of use of the equipment and contributing to the
whole aesthetics of the equipment set up.
[0205] The integrated trocar may have no provision for insufflator
gas inflow. The control functionality may be driven by a battery
built into the trocar nebulizer body. In this embodiment, the
generated aerosol is carried into the pneumoperitoneum through the
effects of gravity, diffusion and the residual velocity of aerosol
after exiting the aerosol generator.
[0206] The nebulizer on the trocar may be provided with a
particular geometrical configuration to receive mating nebule
geometry. This will facilitate the aerosolization of this drug only
within the predesigned nebule and no other drug. This would allow
for targeted delivery of small volumes of high concentration drug
to the aperture plate, thus minimizing residual drug wastage.
[0207] Referring to FIGS. 6 to 9 an aerosol generator trocar insert
130 delivers aerosol through the trocar with no provision for
insufflator gas inflow. The trocar insert 130 is of a length that
will allow aerosol generated to be delivered beyond any trocar
valve. In this embodiment, the generated aerosol is carried into
the pneumoperitoneum through the effects of gravity, diffusion and
the residual velocity of aerosol after exiting the aerosol
generator. The controller 3 may be located near to the trocar
location or at some remote location as allowed by the cable
length.
[0208] The aerosol generator and control functionality may be
integrated into the aerosol generator trocar insert. The trocar
insert will be of a length that will allow aerosol generated to be
delivered beyond any trocar valve. In this case the aerosol is
generated directly above the trocar entry point into the
pneumoperitoneum. The insufflator gas enters the trocar via a
separate port 17 and generated aerosol is carried into the
pneumoperitoneum by entrainment in the gas flow and through the
effects of gravity and diffusion. Control functionality may be
available directly at the trocar body via buttons, indicator
lights, displays or other user interfaces. The integrated device
may be operated via internal battery power or from an external
power source via a power supply cable. The device may also have
provision for charging of the internal battery via the external
power supply cable.
[0209] Alternatively, the aerosol generator trocar insert may have
no provision for insufflator gas inflow. In a further embodiment,
the control functionality may be driven by a battery built into the
trocar insert aerosol generator body. In this embodiment, the
generated aerosol is carried into the pneumoperitoneum through the
effects of gravity, diffusion and the residual velocity of aerosol
after exiting the aerosol generator.
[0210] Referring to FIGS. 10 and 11 there is illustrated another
aerosol generator system 200 mounted to a trocar 201 having a
proximal trocar seal 202. In this case the trocar 201 has an inlet
203 for insufflation gas. The aerosol generator system 200
comprises a vibrating mesh/plate 205 and a reservoir 204 for fluid
to be aerosolized. Aerosol 207 passes down through a delivery tube
206 and is entrained with insufflation gas 208. The mixture 209 is
then delivered through the trocar 201 into a patient's abdomen. 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 has a proximal entry port 203 for
insufflation gas. The apparatus comprises an aerosol delivery tube
means extending from the aerosol generator 200 into the trocar
housing. The aerosol delivery tube has an aerosol outlet 300 which
is located distally with respect to the insufflation gas entry port
203 of the trocar. In this case the aerosol outlet 300 of the
aerosol delivery tube 206 extends into the trocar for a length
which is at least 10%, at least 15%, or at least 20% of the length
of the trocar. There is a proximal seal 202 between the trocar and
the aerosol delivery tube 206.
[0211] The embodiment of FIGS. 10 and 11 has the advantage of ease
of manufacture and use. It does not require auxiliary seals and
does not require elaborate fluid pathways.
[0212] Referring to FIGS. 12 and 13, there is illustrated another
aerosol generator system and trocar which is similar to that
described with reference to FIGS. 10 and 11 and like parts are
assigned the same reference numerals. In this case an inlet supply
line 250 for insufflation gas is split into a first leg 251 for
delivery to an inlet 252 below the vibrating plate/mesh 205 and a
second leg 253 for delivery to the trocar inlet 203. There is a
valve 254 on the aerosol generator supply line 251 and valves 255,
256 on the trocar supply line 253. In use, the valve 255 is closed
and the valve 254 is opened when it is desired to deliver
insufflation gas to the aerosol generator. The generated aerosol
207 is entrained in the insufflation gas, and the mixture 209 is
delivered through the trocar 201. The system may comprise various
quick release couplings to facilitate removal of the aerosol
generator 200 after completion of the aerosol delivery. For
decoupling, the valve 254 is closed and the valves 255, 256 are
opened to facilitate direct flow of insufflation gas to the trocar
inlet port 203. On release of the coupling, the aerosol generator
200 can be removed, allowing the continuing function of the trocar
201, for example for vision/camera systems. In this version the
aerosol delivery tube comprises an entry port for receiving a flow
of insufflation gas. In this case the apparatus comprises flow
diverting means for delivery of insufflation gas to the
insufflation gas entry port of the trocar 203 and/or to the
insufflation gas entry port 252 of the aerosol delivery tube 206.
This system conveys the CO2 gas and thus entrains the aerosol with
improved flow rate to the distal end of the trocar.
[0213] As illustrated in FIGS. 14 to 17, another exemplary
embodiment again comprises an aerosol generator 200 and a trocar
201. Parts similar to those described in other embodiments are
assigned the same reference numerals. In this case insufflation gas
is directed along a pathway comprising a first upwardly directed
leg 270 to the aerosol generator 205 at which the generated aerosol
is entrained in the insufflation gas and the mixture 209 is
delivered along a downwardly directed leg 271 to the trocar 201.
There is a seal 275 to the trocar body to ensure that the
insufflation gas passes up through the leg 271. The seal 275 may be
a tapered seal as illustrated in FIGS. 14 and 15. Alternatively, a
seal 276 (FIG. 16) of an elastometric material may be used. The
seal 276 is compliant and may be used to achieve sealing with a
range of tubes with different diameters. The leg 271 may have
additional parts, to aid balanced flow. In this case 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. In this case there is a distal seal 275 between the
outer tube and the trocar. 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. In this case
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 301 for
insufflation gas.
[0214] This embodiment has an auxiliary seal and has
bi-directional, co-axial fluid paths which has the advantage of
eliminating the need for the additional CO2 feed line of the
embodiment of FIG. 12. This eliminates additional operational steps
for clinicians. It also has the advantages that it works with
existing set up and devices. It entrains the aerosol closer to the
delivery at the aperture plate and this improves aerosol delivery
and efficiency to the patient. The aerosol delivery is more
controllable using this system.
[0215] Referring now to FIGS. 18 to 20 there is illustrated another
aerosol generator system 200 and associated trocar 201. Parts
similar to those described in other embodiments are assigned the
same reference numerals. In this case an aerosol generator
vibrating plate/mesh 280 is located at the distal end of the trocar
for localized generation of aerosol in or adjacent to a patient
such as the abdomen 281. There is a proximal reservoir 282 for
fluid to be aerosolized which is delivered to the generator 280
along a feed tube 283. The aerosol generator 280 is
operated/controlled by delivering signals along a lead 284 which
extends from a proximal connection part 285 to the aerosol
generator 280. In use, insufflation gas passes through the trocar
as illustrated and aerosol is entranced in the insufflation gas at
the distal end of the trocar 201. In this case the aerosol
generator is located at a distal end of the trocar. The apparatus
comprises first delivery means for delivering insufflation gas to a
location adjacent to the aerosol generator 280. The apparatus also
comprises second delivery means for delivery of liquid to be
aerosolized to the aerosol generator 280. The second delivery means
in this case comprises a delivery tube extending from a housing 282
for a liquid to the aerosol generator. In this embodiment the
aerosol generator is mounted to an outer tube which extends through
the trocar from the liquid housing. A distal end of the outer tube
is located adjacent to a distal end of the trocar. This system
minimizes rain out and thus there is little or no medication loss
between the aerosol generator and the patient.
[0216] The aerosol generator trocar insert may incorporate a closed
cup configuration containing medication. This will facilitate the
aerosolization of this drug only within the closed cup
configuration and no other drug. Therefore the aerosolizing device
can be used to target a particular medical condition as dictated by
the drug nebule that will match the aerosolising device. By
positioning the aerosolizing device at the trocar the amount of the
drug deposited in the pneumoperitoneum, is greatly increased by as
much as two or three fold. This has the distinct advantage of
aerosolizing a reduced drug volume for the equivalent therapeutic
value. In addition, less aerosolizing time will be required thus
shortening surgical procedures.
[0217] In one arrangement a higher concentration variant of the
drug may be aerosolized. This would allow for targeted delivery of
small volumes of high concentration drug to the aperture plate.
[0218] This has the distinct advantage of aerosolizing a smaller
quantity of a higher drug concentration which would have the
equivalent therapeutic value of a larger quantity of standard drug
concentration. In this way, the delivery time is substantially
shortened. Therefore the aerosolizing device occupies less time in
the trocar position, leading to shorter surgical procedures.
[0219] Larger particle size in the range of 5-10 microns may be
aerosolized. This will further shorten delivery time and require
the aerosolising device to occupy less time in the trocar
position
[0220] These approaches enable the delivery of a complete dose and
all fogging cleared during the insufflation phase in preparation
for the start of the actual laparoscopic procedure.
[0221] Aerosol is generated directly at the trocar entry point to
the pneumoperitoneum. This reduces rainout and loss of suspended
aerosol delivered to the pneumoperitoneum due to long tubing flow
lengths, constrictions and changes in flow direction. The volume of
medication that is delivered as suspended aerosol to the
pneumoperitoneum is increased for any given time.
[0222] Aerosol can be generated and delivered to the
pneumoperitoneum completely independently of insufflator flow
allowing more flexibility in the timing of aerosol delivery during
the procedure.
[0223] Access to the control mechanism for the aerosol generator is
nearer to the patient and accessible to the surgeon during the
procedure. This reduces inconvenience and patient risk where the
surgeon needs to make immediate changes in aerosol delivery during
the course of a procedure.
[0224] Integration of the controller functionality into a single
device removes the cable link, as the product could be battery
powered. Such cables cause inconvenience to the surgeon.
[0225] Designing the trocar nebulizer to receive a prefilled nebule
of a particular engagement geometry, ensures that no other drugs
can be used in an `off label` manner.
[0226] The insertion of the nebule activates the vibration mesh
thus creating aerosolization, consequently pouring in a drug will
not activate the vibration system to cause aerosolization.
[0227] In accordance with exemplary embodiments of the present
invention, there is increased treatment effectiveness and reduced
treatment time through increased proportion of medication delivered
as suspended aerosol. Aerosol delivery can be activated
independently of insufflator gas flow. There is increased control
and accessibility to the aerosol generator for surgeon at the
patient site.
[0228] There is also reduced complexity of the device and risk of
inconvenience or obstruction for fully integrated aerosol
generating device.
[0229] The aerosol generator trocar insert is compatible with a
standard 10 mm trocar by utilizing the camera or any other suitable
port.
[0230] The aerosol generator trocar insert may be removed post
delivery allowing the surgeon to use to port as standard.
[0231] The aerosol generator trocar insert may be fully disposable,
intended for single patient use.
[0232] The aerosol generator trocar insert may be a closed cup
configuration containing appropriate medication quantity preventing
excess medication delivery. There is a reduced risk of misuse of
system through the use of unapproved drugs.
[0233] Using a trocar to deliver an aerosol into a cavity during
procedures involving insufflation allows the concentrated local
delivery of aerosol into the cavity. The aerosol can be delivered
quickly with optimised flow rate, particle size and drug
concentration. The dose delivered can be maximized. The aerosol
generator is only required to be in situ in the trocar for a short
time which means that the trocar can be used for other tools such
as a camera during the procedure. By using an aerosol the entire
body cavity can be coated rather than a local area by instillation.
Because the aerosol generator is located at the trocar optimum
delivery of aerosol during insufflation pneumoperitoneum phase can
be achieved.
[0234] Referring to FIG. 34, there is illustrated another exemplary
insufflation system in accordance with the present invention which
is similar to that described with reference to FIG. 1. In this case
an aerosol jet nebulizer 300 is located in the insufflation
line.
[0235] All of the trocar systems described above may be adapted to
accommodate two or more aerosol generators. Such systems with more
than one aerosol generator increase nebulizer output and reduce the
time required to deliver a required amount of aerosol. One such
system is illustrated in FIGS. 35 and 36. In this case an
insufflation insert 500 for a trocar 501 has two separate aerosol
generators 502, 503. The gas flowpath in this case is similar to
that described above with reference to FIGS. 14 to 16. There may be
any desired number of aerosol generators. For example, FIG. 37
illustrates a modified version in which there are four aerosol
generators 510, 511, 512, 513.
[0236] There may be a seal 505 between the distal end of the trocar
insert 500 and the wall of the trocar to prevent insufflation gas
from passing between the outer wall of the insert and the inner
wall of the trocar. In an exemplary case the seal comprises a
bulbous region 505 at the distal end of the insert which is an
interference fit in the shaft of the trocar. Such an arrangement
facilitates ease of insertion and removal of the trocar insert
whilst maintaining a seal when the insert is in place in the
trocar.
[0237] Referring to FIG. 38 a trocar insert 520 may have a length
which is sufficient to create a seal between the trocar insert 520
and the inner surface of the trocar 501. Typically the length is
between 30 mm and 65 mm. By reducing the distance the distance to
be traveled by the aerosol within the narrow trocar insert the
quantity of aerosol exiting the trocar is increased.
[0238] Referring also to FIGS. 39 and 39(a) an inner tube 526 of a
trocar insert may be extended to a position close to the underside
of an aerosol generator 527. In this case there is a cut angle
across the top of the inner tube which may, for example, be at
about 5.degree. so as to maximize entrainment of the aerosol with
the gas so as to minimize losses in the inner tube from rainout due
to wall contact. Thus, losses of aerosol in the insert is reduced.
This system has the benefit of channeling the flow of generated
aerosol for delivery to a patient. Some or all of these features
may be used with any length of trocar insert. For example, it may
be used in association with a short insert. Many different
arrangements are possible such as those illustrated in FIGS. 40 to
45. There may be a small gap 530 which may be tapered (FIG. 40), a
tapered interface 531 (FIG. 41), an interface with castellations
532 (FIG. 42), a single gas slit 533 (FIG. 43), or dual offset
slits 534 (FIG. 44) to promote vortex formation as illustrated in
FIG. 45.
[0239] Referring to FIG. 46 there is illustrated an example of an
aerosol insert 540 with a modified interface between a proximal end
of an inner tube 541 of the insert and an aerosol generator 542. In
this case the inner tube 541 comes into contact with the aerosol
generator 542 and the inner tube has an inlet 543 for insufflation
gas which is spaced below the proximal end of the inner tube 541.
This modifies the aerosol flow dynamics for improved aerosol
delivery efficiency.
[0240] A liquid reservoir for the aerosol generator may be modified
to facilitate efficient nebulization through a wide range of angles
of orientation such as would be encountered in use during
laparoscopic surgery. One example is illustrated in FIG. 47 in
which a reservoir 550 is tapered. The reservoir 550 may be fitted
with a removable plug 552. The plug may, for example, be of
silicon.
[0241] Referring to FIG. 48 a trocar insert 560 of the present
invention having an aerosol generator 561 may include a valve 562
such as a flap valve to facilitate the insertion of an instrument
such as a trocar blade or obdurator. As the instrument is inserted,
the flap valve 562 moves over in the direction of the arrow X to
protect the aerosol generator 561. When the instrument is not
present the flap 562 returns to a rest position and assists in
directing the flow of aerosol generated by the aerosol generator
down the shaft of the trocar.
[0242] Modifications and additions can be made to the embodiments
of the present invention described herein without deporting from
the scope of the present invention. For example, while the
embodiments described herein refer to particular features, the
present invention includes embodiments having different
combinations of features. The present invention also includes
embodiments that do not include all of the specific features
described. Moreover, the features of the particular examples and
embodiments may be used in any combination.
[0243] The present invention is not limited to the embodiments
hereinbefore described, with reference to the accompanying
drawings, which may be varied in construction and detail.
* * * * *