U.S. patent application number 10/618848 was filed with the patent office on 2004-12-09 for laparoscopic sealed access device.
This patent application is currently assigned to Atropos Limited. Invention is credited to Bonadio, Frank, McManus, Ronan Bernard, Reid, Alan, Young, Derek William.
Application Number | 20040249248 10/618848 |
Document ID | / |
Family ID | 27547370 |
Filed Date | 2004-12-09 |
United States Patent
Application |
20040249248 |
Kind Code |
A1 |
Bonadio, Frank ; et
al. |
December 9, 2004 |
Laparoscopic sealed access device
Abstract
A hand access device (1, 50, 55, 60, 65) for use as a seal for
sealing a surgeon's forearm (2) on entry through a wound opening
(3), for example in an abdominal wall (4) comprises a substantially
tubular sleeve (5) of pliable gas tight material. The tube is
turned axially back on itself to define an outer sleeve section
(11) and an inner sleeve section (12) which define therebetween a
scaled inflatable chamber. The inner sleeve section (12) is engaged
by the forearm (2) which, on insertion, causes the sleeve to ever
The device has version limiting means in the form of inner and
outer rings (30, 31) which are of elastomeric material.
Inventors: |
Bonadio, Frank; (Wicklow,
IE) ; McManus, Ronan Bernard; (Wicklow, IE) ;
Young, Derek William; (Blackrock, IE) ; Reid,
Alan; (Clontarf, IE) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
1300 I STREET, NW
WASHINGTON
DC
20005
US
|
Assignee: |
Atropos Limited
|
Family ID: |
27547370 |
Appl. No.: |
10/618848 |
Filed: |
July 15, 2003 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10618848 |
Jul 15, 2003 |
|
|
|
09804418 |
Mar 13, 2001 |
|
|
|
6623426 |
|
|
|
|
09804418 |
Mar 13, 2001 |
|
|
|
PCT/IE99/00127 |
Dec 1, 1999 |
|
|
|
Current U.S.
Class: |
600/184 |
Current CPC
Class: |
A61B 2017/22051
20130101; A61B 17/3498 20130101; A61M 25/0119 20130101; A61B
17/3431 20130101; A61M 2025/0062 20130101; A61B 2017/00477
20130101; A61B 2017/3435 20130101; A61B 17/3462 20130101; A61B
2017/00557 20130101; A61B 17/3423 20130101; A61B 17/0293 20130101;
A61B 2017/3482 20130101; A61M 29/02 20130101; A61M 2025/109
20130101 |
Class at
Publication: |
600/184 |
International
Class: |
A61B 001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 1, 1998 |
IE |
980999 |
Feb 15, 1999 |
IE |
990107 |
Feb 15, 1999 |
IE |
990108 |
Feb 15, 1999 |
IE |
990110 |
Feb 15, 1999 |
IE |
990112 |
May 24, 1999 |
IE |
990416 |
Claims
1. A surgical access device for use in laproscopic surgery through
an opening comprising: a sleeve of pliable material, the sleeve
having an outer sleeve section and an inner sleeve section; a
chamber for pressurised fluid defined between the inner and outer
sleeve sections; the inner sleeve section defining a lumen for
receiving an object such as a surgeons arm or an instrument
therein; the sleeve being evertable on engagement of an object in
the lumen and axial movement relative thereto so that the inner
sleeve section is rolled over outwardly to become an outer sleeve
section and the outer sleeve section is correspondingly rolled over
inwardly to become an inner sleeve section; and at least one
eversion limiting means to limit the eversion of the sleeve into an
opening.
2. A device as claimed in claim 1 wherein the sleeve is axially
turned back on itself to define the outer sleeve section and the
inner sleeve section.
3. A device as claimed in claim 1, wherein the nominal diameter of
the outer sleeve section is the same as the diameter of the inner
sleeve section.
4. A device as claimed in claim 1, wherein the chamber is fluid
impermeable.
5. A device as claimed in claim 1, wherein the chamber has a port
for inflation of the chamber.
6. A device as claimed in claim 1, including a first eversion
limiting means for location externally of the opening and a second
eversion limiting means for location internally of the opening.
7. A device as claimed in claim 1, wherein the or each eversion
limiting mean is an O-ring.
8. A device as claimed in claim 7 wherein the O-ring is of a
resilient material.
9. A device as claimed in claim 1, wherein the or each eversion
limiting means is housed in the chamber.
10. A device as claimed in claim 9 wherein the or each eversion
limiting means is movable axially in the chamber.
11. A device as claimed in claim 10 wherein there are two eversion
limiting means and both are independently movable in the
chamber.
12. A device as claimed in claim 10 wherein there are two eversion
limiting means and a linkage means is provided between them.
13. A device as claimed in claim 12 wherein the linkage means is of
pliable material.
14. A device as claimed in claim 12 wherein the linkage means
comprises a linkage sleeve.
15. A device as claimed in claim 1, including a sealing means to
seal an object to be passed through the access opening.
16. A device as claimed in claim 15 wherein the sealing means
comprises a glove to receive a surgeons hand and/or forearm.
17. A device as claim 1, wherein the sealing means is attached to
the sleeve.
18. (Canceled).
Description
[0001] The invention relates to a surgical/medical device for
laparoscopic surgery to provide surgical access to the abdomen and
maintain a gas-tight seal around the arm or an instrument during
surgery. Surgery of this type is referred to as hand-assisted
laparoscopic surgery or hand-access surgery.
[0002] Conventional abdominal surgery requires the creation of an
incision in the abdominal wall to allow access to, and
visualisation of the internal organs and other anatomical
structures. These incisions must be large enough to accommodate the
surgeons hands and any instruments to be utilised by the surgeon
during the surgery. Traditionally the size of these incisions has
been dictated by the need to see, retract and palpate internal
bodily structures. While a large incision will provide access to
the interior of the abdomen they are associated with longer healing
times, are more susceptible to infection and result in unsightly
scars.
[0003] Alternatives to open surgery exist in the form of endoscopic
or laparoscopic surgery. In this method of surgery, the surgeon
operates through small incisions using remotely actuated
instruments. The instruments pass through the abdominal wall using
devices called trocars. These working channels typically have a
diameter ranging from 5 to 25 millimetres. Vision is provided using
a laparoscope which is typically 20 to 25 centimetres long and uses
fibre-optic technology or a CCD camera to provide the operator with
a picture of the interior of the abdomen. The abdomen must be
insufflated with a gas such as carbon dioxide or nitrogen to
maintain a bubble effect and provide a viable working space for the
operator to perform the surgely unhindered by the lack of space.
This insufflation creates a working space known as the
pneumopentoneum. Trocars through which instruments are inserted are
constructed to prevent loss of the gas through them resulting in
collapse of the pneumopentoneum.
[0004] The benefits of laparoscopic surgery are numerous. Recovery
times have been shown to be reduced due to the absence of a large
incision. This has benefits for the patient, the health care
organisation and society. The benefits to the patient are reduced
stay in hospital, faster mobilisation and return to normal
activity. The benefits to the health care organisation is also due
to the reduced stay in hospital which is often the most expensive
aspect of health care provision. Society benefits in faster return
to work and normal activity of the patient.
[0005] However, not all surgical procedures can be performed
laparoscopically. Surgery requiring the removal of large organ
specimens, such as surgery for removal of the colon, has
traditionally been hampered by the small incisions used for the
introduction of laparoscopic instruments in the surgery.
[0006] The other major disadvantages of laparoscopic surgery are
due to the complex nature of the technique. Surgeons who wish to
practise laparoscopic surgery must spend much time training to
master the technique. The success of laparoscopic surgery depends
on the skill of the surgeon to manipulate organs and carry out
delicate tasks using remotely actuated instruments. Unfortunately
in laparoscopic surgery the surgeon is insulated from the material
that they are working on. This deprives the surgeon of tactile
feedback and the ability to palpate delicate structures. The
surgeon's most effective instrument, the hand, is reduced to a
device that must simply actuate instruments that are inherently
lacking in dexterity and operability due to the constraints on
their design placed by the nature of the narrow channels in trocars
through which they must pass. Another disadvantage of laparoscopy
is that the image viewed by the surgeon is a two dimensional image
on a video screen. The surgeon loses three dimensional perspective
of depth and distance and awareness of the proximity of other
structures during video laparoscopy.
[0007] These disadvantages have led to long learning curves for the
practitioners of laparoscopic surgery, required highly skilled and
coordinated surgical teams and has limited the application of
laparoscopic surgery to relatively simple surgical procedures.
[0008] Recently, new surgical techniques have been developed that
combine the advantages of both open surgery and laparoscopic
surgery. In these new techniques surgery is carried out using a
laparoscopic approach with the addition of a slightly larger
incision to allow the surgeon to insert a hand into the insufflated
abdomen. This is often referred to as hand-assisted laparoscopic
surgery or HALS.
[0009] HALS allows surgeons to regain the tactile feedback and
three-dimensional perspective lost in the conversion from open to
laparoscopic procedures. It also permits rapid finger dissection,
enhanced retraction capabilities and simplified haemostasis. There
are several publications in the literature describing procedures
carried out using a hand-assisted approach. These include total and
sub-total colectomy, rectopexy, Nissen's fundoplication,
gastrectomy, splenectomy, nephrectomy, pancreatectomy and others.
Some of these procedures were previously performed using an open
technique only. Over the past few years several centres have been
investigating HALS with surgical device companies and increasing
the literature on the subject. With the advent of surgical devices
for facilitating HALS it is expected that more open surgical
procedures will be converted to HALS procedures.
[0010] The key to the success of hand-assisted laproscopic surgery
is to provide that seals to the wound edge and to a surgeons arm to
maintain the pneumoperitoneum required. The device should provide
freedom of movement including rotational, lateral and
translational; In addition it should be possible to use
laparoscopic instruments with the device.
[0011] Various hand access devices have been proposed however, to
date, no hand access device is available that adequately addresses
these key issues.
[0012] U.S. Pat. No. 5,366,478 (Brinkerhoff et al) describes a
device which is said to be for use during endoscopic surgery, the
device having two inflatable toroidal sections connected by a
transitional section. The transitional section is said to function
to allow the passage of air from one toroid to the other toroid on
inflation of the device. Each toroidal section contains a flexible
stiffening ring. The stiffening ring in the outer toroid is
illustrated in a position floating above the abdominal wall after
inflation. It is unclear how this stiffening ring maintains this
configuration. It is therefore unlikely that this device will
operate as described. Also it is difficult to pass an object such
as a surgeon's forearm through a lumen in the transitional section,
because of frictional resistance to the movement of the object
relative to the transitional section.
[0013] A medical device for forming an external extension of the
pneumoperitoneum is described in U.S. Pat. No. 5,480,410 (Cuschieri
et al). The device includes an enclosure sealed into a trocar
puncture site in an abdominal wall. Insufflation gas passes from
the body cavity into the enclosure inflating it. A number of valved
openings are provided on the device to enable access to the
enclosure interior.
[0014] In U.S. Pat. No. 5,514,133 (Golub et al) describes an
endoscopic surgical apparatus, which enables a surgeon to access a
surgical site through an opening. The apparatus includes two
plates, which engage the outer and inner surfaces of the abdominal
wall, and a sealing member, which inhibits the flow of gas through
the opening. The seal in this apparatus does not maintain complete
insufflation of the body cavity, gas can gradually leak out through
the flap valves and seal. The valve configuration also makes it
impossible to extracorporealise an organ, which is preferred in
hand-assisted surgery devices. The device also has a complicated
construction.
[0015] A surgical glove suitable for endoscopic surgical procedures
is disclosed in U.S. Pat. No. 5,526,536 (Cartmill). The glove has
an inflatable wrist section, which when inflated, provides a seal
between the surgeon's hand and the body wall. The surgeon's gloved
hand must remain in the body cavity to maintain insufflation of the
body cavity. Therefore this device also restricts the actions of
the surgeon.
[0016] U.S. Pat. No. 5,522,791 (Leyva), describes an abdominal
retractor, which retracts an abdominal incision providing access
for a hand into a body cavity. The hand is passed into a sleeve and
sealed therein, the other end of the sleeve being mounted to the
retractor.
[0017] Devices for sealing a surgical incision while providing
access for a surgeon's hand are also known. For example, a method
of performing laparoscopic surgery is described in U.S. Pat. No.
5,636,645 (Ou), which includes the steps of inserting a surgeon's
gloved hand into a body cavity and sealing the hand to body tissue
surrounding the cavity. This method restricts the actions of the
surgeon because the surgeon's gloved hand must remain in the body
cavity sealed to the surrounding tissue to maintain insufflation of
the body cavity. The seal between the surgeon's gloved hand and the
surrounding tissue must be reestablished each time the gloved hand
is inserted into the body cavity, if insufflation of the body
cavity is to be maintained.
[0018] An apparatus and a method for carrying out minimally
invasive laparoscopic surgery is also described in U.S. Pat. No.
5,640,977 (Leahy et al). A surgeon's hand is passed through a
sleeve to access a body cavity, the sleeve being sealed around the
surgeon's forearm.
[0019] U.S. Pat. No. 5,653,705 (de la Torre et al) discloses an
envelope, which provides access for an object passing into a body
tissue incision, while maintaining insufflation of the body cavity.
A first opening in the envelope is sealed around the body tissue
incision and a second opening is sealed around an object passed
into the envelope.
[0020] Devices for use during surgery which provide access to a
surgical site and effect a seal independent of a surgeon's hand are
also known. In general devices of this type are positioned
predominantly external to a body cavity, and are complex, large and
bulky. These devices prove difficult to use because they are
cumbersome and/or because of their complexity. For example, a
flexible, fluid-tight envelope which provides access for an object
passing through a body tissue incision while maintaining
insufflation pressure is described in U.S. Pat. No. 5,672,168 (de
la Torre et al). This is a complex device including a first opening
secured and sealed to the body tissue incision, and a second
opening distal from the body tissue incision and sealed to a
surgeon's forearm. The device also includes a housing containing a
valve element at the body tissue incision.
[0021] An access port device for use during a surgical procedure is
described in U.S. Pat. No. 5,803,921 (Bonadio). An object is passed
into the device sleeve, the device is sealed around the object at
the sleeve opening and the device is also sealed at the body
cavity. The seals maintain insufflation of the patient's body
cavity. However it may be difficult to pass an object through the
access port device and into the body cavity because of frictional
resistance to the movement of the object relative to the device
sleeve. An adhesive flange is required to stick to the abdominal
wall. This is not very effective and can become undone due to the
presence of moisture around the wound edge. The device provides no
retraction force and the walls of the incision are displaced only
when an object is inserted through it. The feathered valve is not
an effective means of sealing and there may be leakage insufflation
gas.
[0022] U.S. Pat. No. 5,741,298 (MacLeod) describes a method for
performing surgery using a multi-functional access port. The access
port has a sealing ring which protects the body wall incision from
contamination. A sealing cap or a surgical glove is connected to
the sealing ring to maintain insufflation of the body cavity. This
surgical method is also restrictive because the surgeon's gloved
hand must remain sealed to the sealing ring, if body cavity
insufflation is to be maintained.
[0023] A surgical apparatus for use during hand assisted minimally
invasive surgery is described in U.S. Pat. No. 5,813,409 (Leahy et
al). A sleeve is mounted at one end to a body tissue incision. The
sleeve seals to the surgeon's hand to maintain pneumoperitoneum.
Surgical instruments may then be passed into the sleeve to a
surgeon's hand within, which may then be inserted into the
incision. This device requires a multistep process for installation
and comes in several parts. The device takes up a large amount of
space on the abdomen and the application of the wound-retractor
component is cumbersome.
[0024] U.S. Pat. No. 5,906,577 (Beane et al) describes a retractor
device for retracting the edges of an incision to form an opening
to a body cavity. A flexible sleeve is mounted to the retractor,
and an object passed through the device is sealed to maintain
insufflation of the body cavity. This device also consists of many
component parts that must be assembled carefully. The device has a
very constricting and uncomfortable seal to the arm. The retraction
mechanism can pop out easily, causing complete loss of
pneumoperitoneum, making the device disadvantageous. It also has a
large abdominal footprint.
[0025] WO 98/35615 (Crook) describes a device for performing HALS
that consists of a wound-edge retractor to which is attached a
sleeve similar to others mentioned above. This device also consists
of several component parts and has a complicated installation
procedure.
[0026] Generally known devices are difficult to use because they
are cumbersome and/or because of their complexity.
[0027] U.S. Pat. No. 5,545,179 (Williamson) describes an access
assembly, which provides access for surgical instruments to a body
cavity during surgery and seals the instruments passing into the
body cavity. A sealing sleeve is inflated to form a large balloon
portion within the body cavity, the balloon portion being
constrained to remain within the body cavity. Therefore it is
difficult to retract a surgical instrument through the balloon
portion of the assembly and out of the body cavity, because of
frictional resistance to the movement of the surgical instrument
relative to the balloon sleeve.
[0028] An access port device for use during hand-assisted
laparoscopic surgery is described in JP 10-108868 (Tamai,
Shitomura). This single-piece device consists of a wound retractor
component to which is attached an iris valve. The wound retractor
component is made of two rings, an inner ring and an outer ring
joined by a silastic sleeve to provide a retractive force. The
device is inserted into an incision and the surgeon's hand may be
inserted through the device. The iris valve is then closed around
the arm to effect a seal to prevent the escape of insuffiation gas.
Due to the nature of the former ring and the silastic sleeve the
device may be easily dislodged. The iris valve is not an effective
seal, especially during lateral movement of the surgeon's arm. In
addition the device does not facilitate translation movement or
reach because of the seal of the iris valve.
[0029] There is therefore a need for a sealing device, which
provides effective sealing means to seal an object passing through
the device, and which is convenient and easy to use, compact and
neat, and may be used repetitively with minimum delay and minimum
effort.
STATEMENTS OF INVENTION
[0030] According to the invention there is provided a surgical
access device for use in laproscopic surgery through an opening
comprising:
[0031] a sleeve of pliable material, the sleeve having an outer
sleeve section and an inner sleeve section;
[0032] a chamber for pressurised fluid defined between the inner
and outer sleeve sections;
[0033] the inner sleeve section defining a lumen for receiving an
object such as a surgeons arm or an instrument therein;
[0034] the sleeve being evertable on engagement of an object in the
lumen and axial movement relative thereto so that the inner sleeve
section is rolled over outwardly to become an outer sleeve section
and the outer sleeve section is correspondingly rolled over
inwardly to become an inner sleeve section; and
[0035] at least one eversion limiting means to limit the eversion
of the sleeve into an opening.
[0036] In one embodiment of the invention the sleeve is axially
turned back on itself to define the outer sleeve section and the
inner sleeve section.
[0037] In a particularly preferred embodiment the nominal diameter
of the outer sleeve section is the same as the diameter of the
inner sleeve section.
[0038] The chamber is preferably fluid impermeable. Ideally the
chamber has a port for inflation of the chamber.
[0039] In one embodiment of the invention the device includes a
first eversion limiting means for location externally of the
opening and a second eversion limiting means for location
internally of the opening.
[0040] Preferably the or each eversion limiting mean is an
O-ring.
[0041] The O-ring is of a resilient material.
[0042] In one embodiment the or each eversion limiting means is
housed in the chamber. In this case preferably the or each eversion
limiting means is movable axially in the chamber.
[0043] In one embodiment there are two eversion limiting means and
both are independently movable in the chamber.
[0044] In another embodiment there are two eversion limiting means
and a linkage means is provided between them. The linkage means may
be of pliable material. Preferably the linkage means comprises a
linkage sleeve.
[0045] In one embodiment the device includes a sealing means to
seal an object to be passed through the access opening. The sealing
means may preferably comprise a glove to receive a surgeons hand
and/or forearm. Preferably sealing means is attached to the
sleeve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] The invention will be more clearly understood from the
following description thereof given by way of example only with
reference to the accompanying drawings, in which:
[0047] FIG. 1 is a perspective view of a hand access device
according to the invention;
[0048] FIG. 2 is a cross sectional view of the device of FIG.
1;
[0049] FIGS. 3 and 4 are a perspective views of the device being
inserted into an incision in an abdominal wall;
[0050] FIG. 5 to 7 are perspective, partially cross sectional views
of a surgeons hand being inserted through the device;
[0051] FIG. 8 is a distal end view of the device with a hand in
place;
[0052] FIG. 9 is a perspective, partially cross sectional view of
the hand access device with a surgeons hand fully inserted;
[0053] FIG. 10 is a perspective view of the device in an
intermediate position on a surgeon's arm;
[0054] FIG. 11 is a cross sectional view of the device of FIGS. 1
to 10 in position ready to receive a surgeon's arm;
[0055] FIG. 12 is a cross sectional view similar to FIG. 11 with
the device inserted through an incision;
[0056] FIG. 13 is a perspective, partially cut-away view of another
hand access device of the invention;
[0057] FIG. 14 is a perspective, partially cut-away view of a
further hand access device of the invention, in use;
[0058] FIG. 15 is a perspective, partially cut-away view of another
hand access device of the invention;
[0059] FIG. 16 is a view of the device of FIG. 15, in use;
[0060] FIG. 17 is a perspective, partially cut-away view of a
further hand access device of the invention;
[0061] FIG. 18 is a view of the device of FIG. 17, in use;
[0062] FIG. 19 is a perspective, partially cut-away view of a still
further hand access device of the invention; and
[0063] FIG. 20 is a view of the device of FIG. 19, in use.
DETAILED DESCRIPTION
[0064] Referring to the drawings and initially to FIGS. 1 to 13
there is illustrated a hand access device 1 according to the
invention for use as a seal for sealing a surgeon's forearm 2 on
entry through a wound opening 3, for example in an abdominal wall
4.
[0065] The device 1 comprises a substantially tubular sleeve 5 of
pliable gas tight material formed from a tube of a suitable
biocompatible plastics material. The tube is turned axially back on
itself to define an outer sleeve section 11 and an inner sleeve
section 12.
[0066] The inner and outer sleeve sections 11, 12, define
therebetween a sealed inflatable chamber 20. The inner sleeve
section 12, defines a lumen 25 and, on inflation of the chamber 20,
the inner sleeve section 12 engages an object extending or passing
through the lumen 25.
[0067] The hand access device includes an eversion limiting means
for the sleeve 5. The eversion limiting means is in this case
provided by a first O-ring 30, which is attached to the sleeve 5
and a second O-ring 31, which is attached to an axially
spaced-apart location on the sleeve 5. The inner O-ring 30 is of a
suitable resilient elastomeric material for bunching of the ring 30
to facilitate ease of insertion into a wound 3 as illustrated in
FIGS. 3 and 4.
[0068] As a surgeon inserts his forearm 2 through the lumen 25 of
the device 1, the inner sleeve section rolls 12 along with the arm
2 and in turn the outer sleeve section 11 everts. An seal is
maintained around the surgeon's forearm 2 and the sealed integrity
of the body cavity being operated upon is substantially maintained.
To facilitate insertion of the surgeon's arm 2 lubrication may be
used. The device 1 and may be inflated prior to or during use
through a suitable inflation line 28 fitted with a valve 29.
[0069] A wound protector section 35 of the sealing device between
the rings 30, 31 may be of a plastics sheet material that has a
greater flexibility than that of the main body of the sleeve 5. In
this way, on inflation of the sleeve 5 the protector section 35
stretches to conform closely to the irregular shape of the wound 3
and provide a tight seal to the wound opening 3. In addition, the
inner ring 30 is drawn against the inner wall surrounding the wound
3, on inflation of the sleeve 5. The arrangement also facilitates
lubricated rotation of the protector section 35 which facilitates
insertion of a surgeon's arm 2.
[0070] The inner O-ring 30 may have a larger diameter than that of
the outer O-ring 31 to create a tapering effect. This arrangement
promotes a pressure differential which assists insertion of a
surgeon's arm 2 acting against the internal abdominal pressure.
[0071] The invention provides a device which allows laparoscopic
surgeons insert their hand into the abdominal space during
laparoscopic surgery and to regain the tactile feedback, three
dimensional perspective and general use of the hand as an operative
tool as it was in open surgery. The device is easy to insert into a
small incision and easy to withdraw from the same incision. The
device facilitates ease of movement within the device so that the
device is not a hindrance to the performance of the surgery. A seal
is provided to both the operator's forearm and to the wound edges
so as to substantially prevent the escape of gases used to maintain
the pneumoperitoneum.
[0072] In addition the device allows the removal of organ specimens
from the abdominal cavity through the device for the purpose of
either removing them completely from the body or for performing a
surgical procedure on them while they are temporarily removed from
the body or extracorporealised. The invention allows an operator to
remove the hand from the device and leave the device in place while
substantially maintaining the pneumoperitoneum.
[0073] The device consists of a double-layer polymeric sleeve
through which the operator can extend his hand into the abdomen.
The device is held in place in the abdominal incision by an
arrangement of rings attached to the outer layer of the sleeve and
extending around the outer layer of the sleeve. The purpose of the
rings is to provide an anchorage for the polymeric sleeve when it
is in the abdominal incision. A stopcock valve and inflation bulb
allow the device to be inflated when it is in position in the
incision.
[0074] When the device is in its correct position and is inflated
the lumen substantially closes and the device seals up against the
edges of the incision, thus substantially preventing the escape of
gas from the pneumoperitoneum to the exterior either through the
device or between the device and the edges of the incision. If the
operator's hand is within the sleeve when it is inflated, the lumen
will dose around the arm and effect a seal. The operators hand need
not be within the device when it is inflated. The operator's hand
may be inserted into the abdominal cavity through the device after
it has been inflated.
[0075] The access device may be used for insertion of an instrument
which may be of any suitable cross section such as circular or
square.
[0076] Referring to FIG. 13 there is illustrated another hand
access device 50 which is similar to the device described above and
like parts are assigned the same reference numerals. In this case a
surgical glove 51 is attached to the sleeve 5, for example by a
heat welded seam 52. This enhances the seal to the surgeons arm as
the seam 52 prevents egress of gas. The glove 51 may be of any
suitable material which may be stretchable and/or pliable. In this
case only an outer eversion limiting ring 31 is provided.
[0077] Referring to FIG. 14 there is illustrated a modified hand
access device 55 according to the invention. In this case an inner
ring 56 is enclosed in a pocket 57 on the sleeve 5 while an outer
ring 58 is free to move between the walls of the sleeve.
[0078] Referring to FIGS. 15 and 16 there is illustrated another
hand access device 60 in which eversion limiting rings 61, 62 are
free to move axially inside the sleeve 5. The device is used as
described above, the outer ring 61 engaging the outside of the
abdominal wall on insertion to limit eversion into the incision.
The inner ring 62 is free between the walls of the sleeve 5 when
the sleeve is fully everted into the wound as illustrated in FIG.
16. On withdrawal of a surgeons arm eversion of the sleeve
outwardly is limited by engagement of the ring 62 against the
inside of the abdominal wall. One advantage of this arrangement is
that the same device may be used for a wide range of different
thicknesses of abdomen.
[0079] Referring to FIGS. 17 and 18 there is illustrated another
hand access device 65 which is again similar to those described
above. In this case inner and outer rings 66, 67 are not attached
to the sleeve 5, however a linking section 68 of pliable material
extends between the rings 66, 67.
[0080] Referring now to FIGS. 19 and 20 there is illustrated
another hand access device 70 according to the invention. In this
case an inner ring 71 is held in a desired axial position in the
sleeve 5 by adhesive tapes 73. An outer ring 72 is free to move
axially within the sleeve.
[0081] Reference is also made to appropriate alternatives and
modifications which are outlined in our parallel applications
referenced ATRO1/C, ATRO12/C, ATRO14/C/, ATRO15/C, ATRO16/C/, the
entire contents of which are incorporated herein by reference.
[0082] The invention is not limited to the embodiments hereinbefore
described which may be varied in construction and detail.
* * * * *