U.S. patent application number 10/315233 was filed with the patent office on 2004-05-13 for laparoscopic sealed access device.
This patent application is currently assigned to Atropos Limited. Invention is credited to Bonadio, Frank, Cushieri, Alfred, McManus, Ronan Bernard, Reid, Alan, Young, Derek William.
Application Number | 20040092795 10/315233 |
Document ID | / |
Family ID | 27547370 |
Filed Date | 2004-05-13 |
United States Patent
Application |
20040092795 |
Kind Code |
A1 |
Bonadio, Frank ; et
al. |
May 13, 2004 |
Laparoscopic sealed access device
Abstract
A hand access device for use in hand assisted laproscopic
surgery comprises a substantially tubular inflatable sleeve of
pliable gas tight material having a twisted inner sleeve section
and an outer sleeve section. The device has an inner O-ring for
insertion through a wound opening in the abdominal wall and an
outer O-ring for location outside of the wound opening. On
insertion of a surgeon's arm the sleeve everts while monitoring a
reduced lumen seal to the arm and a seal to the wound openings.
Inventors: |
Bonadio, Frank; (Wicklow,
IE) ; McManus, Ronan Bernard; (Wicklow, IE) ;
Young, Derek William; (Blackrock, IE) ; Reid,
Alan; (Clontarf, IE) ; Cushieri, Alfred;
(Fife, GB) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
1300 I STREET, NW
WASHINGTON
DC
20005
US
|
Assignee: |
Atropos Limited
|
Family ID: |
27547370 |
Appl. No.: |
10/315233 |
Filed: |
December 10, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10315233 |
Dec 10, 2002 |
|
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|
09804552 |
Mar 13, 2001 |
|
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|
6578577 |
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09804552 |
Mar 13, 2001 |
|
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PCT/IE99/00123 |
Dec 1, 1999 |
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Current U.S.
Class: |
600/207 |
Current CPC
Class: |
A61B 2017/3482 20130101;
A61M 2025/109 20130101; A61M 25/0119 20130101; A61B 17/3423
20130101; A61B 2017/22051 20130101; A61M 29/02 20130101; A61B
17/3431 20130101; A61B 2017/00557 20130101; A61B 17/0293 20130101;
A61M 2025/0062 20130101; A61B 17/3462 20130101; A61B 17/3498
20130101; A61B 2017/00477 20130101; A61B 2017/3435 20130101 |
Class at
Publication: |
600/207 |
International
Class: |
A61B 001/32 |
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 medical device comprising:--a sleeve of defining a lumen; the
sleeve having a twisted sleeve section defining a reduced lumen
section; and tensioning means to facilitate axial extension of the
twisted sleeve section.
2. A device as claimed in claim 1 wherein the sleeve is twisted to
provide the twisted sleeve section.
3. A device as claimed in claim 1 or 2 wherein the sleeve is of
pliable material.
4. A device as claimed in claim 1 wherein the means to facilitate
axial extension of the twisted sleeve section comprises a chamber
for a pressuring fluid.
5. A device as claimed in claim 4 wherein the chamber is defined by
an outer sleeve section and an inner sleeve section.
6. A device as claimed in claim 5 wherein the outer sleeve section
is a substantially cylindrical sleeve section and the inner sleeve
section is a twisted sleeve section of the same untwisted diameter
as that of the outer sleeve section.
7. A device as claimed in claim 5 or 6 wherein the sleeve is turned
axially back on itself to define the outer sleeve section and the
inner sleeve section.
8. A device as claimed in any preceding claim wherein the reduced
lumen section is of a smaller size than that of an object to be
received therein or passed therethrough.
9. A device as claimed in any of claims 5 to 8 wherein, on
engagement of an object in the reduced lumen section and axial
movement of the object relative thereto, the sleeve everts so that
the twisted inner sleeve section is rolled over outwardly to become
an untwisted outer sleeve section and the outer sleeve section is
correspondingly rolled over inwardly to become a twisted inner
sleeve section.
10. A device as claimed in any of claims 4 to 9 wherein the chamber
is fluid impermeable.
11. A device as claimed in any of claims 4 to 10 wherein the
chamber is inflatable.
12. A device as claimed in any of claims 4 to 11 wherein the
chamber has an access port for inflation of the chamber.
13. A device as claimed in any of claims 5 to 12 including eversion
limiting means to axially limit eversion of the sleeve.
14. A device as claimed in claim 13 including a first eversion
limiting means for location externally of the opening and a second
eversion limiting means for location internally of the opening.
15. A device as claimed in claim 13 or 14 wherein the or each
eversion limiting mean is an O-ring.
16. A device as claimed in claim 15 wherein the O-ring is of a
resilient material.
17. A device as claimed in any of claims 13 to 16 wherein the or
each eversion limiting means is housed in the chamber.
18. A device as claimed in claim 17 wherein the or each eversion
limiting means is movable axially in the chamber.
19. A device as claimed in claim 18 wherein there are two eversion
limiting means and both are independently movable in the
chamber.
20. A device as claimed in claim 18 wherein there are two eversion
limiting means and a linkage means is provided between them.
21. A device as claimed in claim 20 wherein the linkage means is of
pliable material.
22. A device as claimed in claim 20 or 21 wherein the linkage means
comprises a linkage sleeve.
23. A device as claimed in any of claims 13 to 22 wherein the
eversion limiting means comprises first and second eversion
limiting means attached at different locations to the sleeve.
24. A device as claimed in claim 23 wherein the first eversion
limiting means is attached to one end of the sleeve and the second
eversion limiting means is attached at another end of the
sleeve.
25. A device as claimed in claim 23 or 24 wherein the eversion
limiting means are movable relative to one another for twisting the
sleeve.
26. A device as claimed in claim 25 wherein the eversion limiting
means are rotatable relative to one another for twisting the
sleeve.
27. A device as claimed in claim 25 or 26 including handle means to
facilitate movement of the eversion limiting means relative to one
another.
28. A device as claimed in any of claims 25 to 26 including locking
means for locking the first eversion limiting means relative to the
second eversion limiting means.
29. A device as claimed in claim 1 wherein the tensioning means is
a mechanical tensioning means.
30. A device as claimed in claim 29 wherein the tensioning means
comprises a spring means.
31. A device as claimed in any preceding claim wherein the reduced
lumen section is sized to sealing engage an object passing
therethrough.
32. A device as claimed in any preceding claim for use in
surgery.
33. A device as claimed in any preceding claim wherein the device
is a forearm seal for use in carrying out hand assisted laproscopic
surgery.
34. A device as claimed in any of claims 1 to 31 wherein the device
is an endoluminal device.
35. A device as claimed in any of claims 1 to 31 wherein the device
is an introducer for introducing an instrument into a body through
an opening.
36. A device as claimed in any of claims 1 to 31 wherein the device
is an exsanguinator.
37. A device as claimed in any of claims 1 to 31 wherein the device
is an envaginator.
38. A device as claimed in any of claims 1 to 31 wherein the device
is a tissue dissector.
39. A device as claimed in any of claims 1 to 31 wherein the device
is a trocar seal.
40. A medical device substantially as hereinbefore described with
reference to the accompanying drawings.
Description
INTRODUCTION
[0001] The invention relates to a medical device particularly for
use in 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 surgery unhindered by the lack of space.
This insufflation creates a working space known as the
pneumoperitoneum. Trocars through which instruments are inserted
are constructed to prevent loss of the gas through them resulting
in collapse of the pneumoperitoneum.
[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
will be to provide a device that will seal 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 has 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 not clear how this device provides a seal however
in any event it would be 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, to enable 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. It is expected that the seal in this apparatus would
not maintain complete insufflation of the body cavity as gas can
gradually leak out through the flapvalves and seal. The valve
configuration also makes it impossible to extracorporealise an
organ, which is preferred in hand-assted surgery devices. The
device also has a complicated construction.
[0015] A surgical glove suitable for use in endoscopic surgical
procedures is described in U.S. Pat. No. 5,526,536 (Cartmill). The
glove has an inflatable wrist section, which when inflated, is said
to provide a seal between the surgeon's hand and the body wall. The
surgeon's gloved hand must remain in the body cavity to maintain
insulation 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
the other end of the sleeve is mounted to the retractor.
[0017] U.S. Pat. No. 5,545,179 (Williamson) describes an access
assembly, which provides access for surgical instruments to a body
cavity during surgery. 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. It is difficult to
retract a surgical instrument through a balloon portion and out of
the body cavity, because of frictional resistance to the movement
of the surgical instrument relative to the balloon sleeve.
[0018] 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
re-established each time the gloved hand is inserted into the body
cavity, if insufflation of the body cavity is to be maintained.
[0019] 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.
[0020] U.S. Pat. No. 5,653,705 (de la Torre et al) discloses an
envelope, which is said to provide 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.
[0021] 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 to provide 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.
[0022] 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.
[0023] 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.
[0024] 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 pneumpperitoneum.
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 is relatively large, requires a multistep
process for installation and comes in several parts.
[0025] 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.
[0026] 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.
[0027] An access port device for use during hand-assisted
laparoscopic surgery is described in JP 10-108868 (Tamai,
Shitomura). This 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 is inserted
through the device. The iris valve is then closed around the arm to
effect a seal to prevent the escape of insufflation gas.
[0028] Generally known devices are difficult to use because they
are cumbersome and/or because of their complexity. In addition,
tight seals are often not maintained and/or the movement of a
surgeons arm is restricted and/or the device may become dislodged
from a wound.
[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 OR INVENTION
[0030] According to the invention there is provided a medical
device comprising
[0031] a sleeve of defining a lumen;
[0032] the sleeve having a twisted sleeve section defining a
reduced lumen section; and
[0033] tensioning means to facilitate axial extension of the
twisted sleeve section.
[0034] In a particularly preferred embodiment the sleeve is twisted
to provide the twisted sleeve section. Most preferably the sleeve
is of pliable material.
[0035] In a preferred embodiment the means to facilitate axial
extension of the twisted sleeve section comprises a chamber for a
pressuring fluid.
[0036] In this case the chamber may be defined by an outer sleeve
section and an inner sleeve section.
[0037] Preferably the outer sleeve section is a substantially
cylindrical sleeve section and the inner sleeve section is a
twisted sleeve section of the same untwisted diameter as that of
the outer sleeve section.
[0038] In a particularly preferred embodiment the sleeve is turned
axially back on itself to define the outer sleeve section and the
inner sleeve section.
[0039] Preferably the reduced lumen section is of a smaller size
than that of an object to be received therein or passed
therethrough.
[0040] In a particularly preferred embodiment on engagement of an
object in the reduced lumen section and axial movement of the
object relative thereto, the sleeve everts so that the twisted
inner sleeve section is rolled over outwardly to become an
untwisted outer sleeve section and the outer sleeve section is
correspondingly rolled over inwardly to become a twisted inner
sleeve section.
[0041] Preferably the chamber is fluid impermeable. Ideally the
chamber is inflatable.
[0042] Preferably the chamber has an access port for inflation of
the chamber.
[0043] In one particularly preferred embodiment the device includes
eversion limiting means to axially limit eversion of the
sleeve.
[0044] The device may have a first eversion limiting means for
location externally of the opening and a second eversion limiting
means for location internally of the opening.
[0045] Preferably the or each eversion limiting mean is an O-ring,
preferably of a resilient material.
[0046] In one arrangement the or each eversion limiting means is
housed in the chamber.
[0047] The or each eversion limiting means may be movable axially
in the chamber.
[0048] In another arrangement there are two eversion limiting means
and both are independently movable in the chamber.
[0049] In a further arrangement there are two eversion limiting
means and a linkage means is provided between them. The linkage
means may be of pliable material. Typically the linkage means
comprises a linkage sleeve.
[0050] In another embodiment the eversion limiting means comprises
first and second eversion limiting means attached at different
locations to the sleeve.
[0051] Preferably the first eversion limiting means is attached to
one end of the sleeve and the second eversion limiting means is
attached at another end of the sleeve.
[0052] In a particularly preferred embodiment the eversion limiting
means are movable relative to one another for twisting the sleeve.
The eversion limiting means may be rotatable-relative to one
another for twisting the sleeve.
[0053] In one embodiment the device includes handle means to
facilitate movement of the eversion limiting means relative to one
another.
[0054] Preferably the device includes locking means for locking the
first eversion limiting means relative to the second eversion
limiting means.
[0055] In another embodiment of the invention the tensioning means
is a mechanical tensioning means.
[0056] In this case the tensioning means may comprise a spring
means.
[0057] Preferably the reduced lumen section is sized to sealing
engage an object passing therethrough.
[0058] In one aspect the device is for use in surgery.
[0059] The device may be a forearm seal for use in carrying out
hand assisted laproscopic surgery.
[0060] Alternatively the device is an endoluminal device.
[0061] The device may be an introducer for introducing an
instrument into a body through an opening.
[0062] The device may also be an exsanguinator or an
envaginator.
[0063] In another aspect the device is a tissue dissector.
[0064] Alternatively the device is a trocar seal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0065] 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:--
[0066] FIG. 1 is a perspective view of a hand access device
according to the invention;
[0067] FIG. 2 is a cross sectional view of the device of FIG.
1;
[0068] FIGS. 3 and 4 are a perspective view of the device being
inserted into an incision in the abdominal wall;
[0069] FIGS. 5 to 7 are perspective, partially cross sectional
views of a surgeons hand being inserted through the device;
[0070] FIG. 8 is a distal end view of the device with a hand in
place;
[0071] FIG. 9 is a perspective, partially cross sectional view of
the hand access device with a surgeons hand fully inserted;
[0072] FIG. 10 is a perspective view of the device in an
intermediate position on a surgeon's arm;
[0073] FIG. 11 is a perspective view of a hand access device in
position on a surgeon's arm;
[0074] FIG. 12 is a cross sectional vie of the device of FIG. 11
showing the sealing engagement to the surgeon's arm;
[0075] FIG. 13 is a cross sectional view of the device of FIGS. 1
to 10 in position ready to receive a surgeon's arm;
[0076] FIG. 14 is a cross sectional view similar to FIG. 13 fully
inserted through an incision;
[0077] FIG. 15--Not used.
[0078] FIG. 16 is a perspective view of a tube from which the
device may be formed;
[0079] FIG. 17 is a view of the sleeve of FIG. 16 partially folded
over;
[0080] FIG. 18 is a view of the sleeve of FIG. 17 in a twisted
configuration;
[0081] FIG. 19 is a side view of the twisted sleeve;
[0082] FIGS. 20 and 21 are perspective views illustrating the
insertion of an instrument through an access device of the
invention;
[0083] FIGS. 22 to 25 are side views of the device of FIG. 20
illustrating stages of instrument insertion through the device;
[0084] FIG. 26 is a cross sectional view of an access device with a
circular cross sectional instrument in place;
[0085] FIG. 27 is a cross sectional view of an access device with a
non-circular cross sectional instrument in place;
[0086] FIGS. 28 and 29 are respectively plan and elevational views
of a non-twisted sleeve;
[0087] FIGS. 30 and 31 are respectively plan and elevational views
of a twisted sleeve;
[0088] FIGS. 32 and 33 are respectively plan and elevational views
of the twisted sleeve with an object extending through the lumen of
the sleeve;
[0089] FIGS. 34 to 39 are views of the twisting of a tube similar
to FIGS. 28 to 33;
[0090] FIGS. 40 and 41 are a graphical representation of the angel
of twist plotted against lumen diameter.
[0091] FIG. 42 is a perspective view of a twisted tube with an
elongate object passing therethrough;
[0092] FIG. 43 is an end view of the tube of FIG. 42;
[0093] FIGS. 44 to 50 are various plan and elevational views
illustrating the formation and internal pressurising of a thin
walled tubed;
[0094] FIGS. 51 to 61 are various plan and elevational views
illustrating the formation and internal pressurising of a thin
walled twisted tube;
[0095] FIGS. 62 to 67 are various side cross sectional and end
views illustrating the translation of a elongate object through a
twisted tube;
[0096] FIG. 68 is a perspective view of a hand access device with
an integral glove;
[0097] FIG. 69 is a perspective view of the gloved hand access
device of FIG. 68, in place;
[0098] FIG. 70 is a perspective view of another hand access device
with adjustable twist;
[0099] FIG. 71 is a perspective view of ring's used in the access
device of FIG. 70;
[0100] FIG. 72 is a plan view of the rings of FIG. 71;
[0101] FIG. 73 is a cross sectional view of a detail of proximal
rings of the device of FIG. 71;
[0102] FIG. 74 is a perspective view of a detail of a seal between
the proximal rings of FIG. 73;
[0103] FIG. 75 is a cross sectional view of another hand access
device with adjustable twist;
[0104] FIG. 76 is an exploded sectional view of part of the
proximal rings of the device of FIG. 75;
[0105] FIG. 78 is an enlarged cross sectional view of a sealing
mechanism between the proximal rings of FIGS. 76 and 77;
[0106] FIG. 79 is a perspective view of another hand access device
of the invention;
[0107] FIG. 80 is a side, partially cross sectional view of the
device of FIG. 79, in use;
[0108] FIG. 81 is an enlarged cross sectional view of a detail of
the device of FIG. 80;
[0109] FIG. 82 is a cross sectional view of a sleeve used to form
another hand access device of the invention;
[0110] FIG. 83 is a cross sectional view of the device formed from
the sleeve of FIG. 82;
[0111] FIG. 84 is a cross sectional view of the device of FIG. 83,
inflated;
[0112] FIG. 85 is an enlarged view of a detail of the device of
FIG. 84;
[0113] FIG. 86 is a perspective view of another device of the
invention;
[0114] FIG. 87 is a perspective view of the device of FIG. 86 being
adjusted;
[0115] FIG. 88 is a side, partially cross sectional view of the
device of FIGS. 86 and 87;
[0116] FIG. 89 is a view similar to FIG. 88 of the device partially
disassembled;
[0117] FIG. 90 is a view similar to FIG. 88 with the device of FIG.
89 re-assembled;
[0118] FIGS. 91a and 91b are cross sectional views of two
devices;
[0119] FIG. 92 is a prospective, partially cut-away view of a
further hand access device of the invention;
[0120] FIG. 93 is a perspective, partially cut-away view of another
hand access device of the invention;
[0121] FIG. 94 is a view of the device of FIG. 93, in use;
[0122] FIG. 95 is a perspective, partially cut-away view of a
further hand access device of the invention;
[0123] FIG. 96 is a view of the device of FIG. 95, in use;
[0124] FIG. 97 is a perspective, partially cut-away view of a still
further hand access device of the invention; and
[0125] FIG. 98 is a view of the device of FIG. 97, in use;
[0126] FIG. 101 is a perspective, partially cut-away view of a
further kind hand access device;
[0127] FIG. 102 is a plan view of a device according to the
invention;
[0128] FIG. 103 is an elevational view of the device of FIG.
102;
[0129] FIG. 104 is a cross sectional elevational view of the device
of FIG. 102;
[0130] FIG. 105 is a perspective view of the device of FIG.
102;
[0131] FIGS. 106 to 109 are views illustrating the device of FIGS.
102 to 105 with the sleeve in an extended position;
[0132] FIG. 110 is a plan view of a device according to another
aspect of the invention;
[0133] FIG. 111 is an elevational view of the device of the device
of FIG. 110;
[0134] FIG. 112 is a cross sectional view of the device of FIG.
110;
[0135] FIG. 113 is a perspective view of the device of FIG.
110;
[0136] FIGS. 114 to 117 are views illustrating the device of FIGS.
110 to 113 in a compressed condition;
[0137] FIG. 118 is an exploded perspective view of another device
according to the invention;
[0138] FIG. 119 is an exploded perspective view of the sealing
device of FIG. 118 with the sleeve is an extended position;
[0139] FIG. 120 is a perspective view of the sealing device of FIG.
118;
[0140] FIG. 121 is a perspective view of the sealing device of FIG.
118 with the sleeve in an extended position;
[0141] FIG. 122 is a plan view of the sealing device of FIG. 118
with the sleeve in an extended position;
[0142] FIG. 123 is an elevational view of the sealing device of
FIG. 118 with the sleeve in an extended position;
[0143] FIG. 124 is a perspective cross sectional view of the
sealing device of FIG. 118 with the sleeve in an extended
position;
[0144] FIG. 125 is a perspective view of the sealing device of FIG.
118 with the sleeve in an extended position;
[0145] FIG. 126 is a cross sectional view of another device
according to the invention;
[0146] FIG. 127 is a cross sectional view of the device of FIG. 126
with the sleeve inflated;
[0147] FIG. 128 is a cross sectional view of another device
according to the invention; and
[0148] FIG. 129 is a cross sectional view of the sealing device of
FIG. 128 with the sleeve inflated and with the tubes axially
extended.
DETAILED DESCRIPTION
[0149] In a first preferred embodiment of the invention and
referring in particular to FIGS. 1 to 16, there is illustrated a
hand access device 1 according to the invention which in this case,
is 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.
[0150] Referring in particular to FIGS. 16 to 19 the sealing device
1 comprises a substantially tubular sleeve 5 of pliable gas tight
material formed from a tube 10 such as a suitable biocompatible
plastics material. The tube 10 is turned axially back on itself to
define an outer sleeve section 11 and an inner sleeve section 12.
The tube 10 is twisted so that the axially opposite datum
indicators 15, 16 are circumferentially spaced-apart as illustrated
in FIG. 18.
[0151] The inner and outer sleeve sections 11, 12, define
therebetween a seated inflatable chamber 20. The inner sleeve
section 12, defines a lumen 25 and, on inflation of the chamber 20,
the inner sleeve section 12 sealingly engages an object extending
or passing through the lumen 25.
[0152] 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.
[0153] 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 effective seal
is maintained around the surgeon's forearm 2 and the sealed
integrity of the body cavity being operated upon is maintained. To
facilitate insertion of the surgeon's arm 2 lubrication may be
used. In this case the device 1 is pre-twisted, and may be inflated
prior to or during use.
[0154] 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 33.
[0155] 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.
[0156] The invention provides a device which allows laparoscopic
surgeons insert their hand into the abdominal space during
laparoscopic surgery and 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. An
effective seal is provided to both the operator's forearm and to
the wound edges so as to prevent the escape of gases used to
maintain the pneumoperitoneum.
[0157] 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. It is a further object of the
invention to allow the operator to remove the hand from the device
and leave the device in place without compromising the
pneumoperitoneum.
[0158] The device 1 consists of a double-layer polymeric sleeve 5
through which the operator can extend a hand 2 into the abdomen.
The device 1 is held in place in the abdominal incision 3 by an
arrangement of rings 30, 31 which may be attached to the outer
layer of the sleeve 5. The rings 30, 31 provide an anchorage for
the polymeric sleeve 5 when it is in the abdominal incision 3. A
stopcock valve 26 and inflation bulb allow the device to be
inflated through an inflation tube 27 leading into the chamber 20
when it is in position in the incision.
[0159] When the device 1 is in its correct position and is inflated
the lumen 25 closes and the device seals up against the edges of
the incision 3, thus 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 5 when it is inflated, the lumen 25 will
close around the arm 2 and effect a seal such that no gas can
escape from the pneumoperitoneum. The operators hand 2 need not be
within the device 1 when it is inflated. The operator's hand may be
inserted into the abdominal cavity through the device 1 after it
has been inflated. This is possible due to the manner in which the
device is constructed.
[0160] The device is assembled in such a manner so that it
effectively seals around the arm 2 without constricting the arm 2
or preventing movement of the arm. Full rotational, angular and
transverse movement for a surgeon's arm is allowed using the
device.
[0161] The device 1 is easily inserted into the abdominal incision
prior to use. The device 1 sits in the incision 3 without
distortion. A hand is readily inserted through the lumen 25 of the
device either in its inflated or uninflated state. The device 1
inflates quickly and effects a seal around the operator's arm 2 to
facilitate creation of pneumoperitoneum.
[0162] Referring to FIGS. 20 to 27 there is illustrated another
access device 40 which is similar to that described above with
reference to FIGS. 1 to 19 and like parts are assigned the same
reference numerals. In this case the device 40 is used for
insertion of an instrument 41. The instrument 41 may be of any
suitable cross section such as circular (FIG. 26) or square (FIG.
27). The device 40 operates in exactly the same way to the device 1
as described above.
[0163] The principles which underlie this invention will be more
clear from the following description with reference to FIGS. 28 to
67.
[0164] FIG. 28 depicts a thin walled tube of pliable material. It
can be considered as a number of longitudinal elements, typical of
which is the element A-B. Clearly there is a lumen passing through
the tube, the diameter of which is the diameter of the tube.
Rotation of one end of the tube relative to the other end about the
axis of the tube causes the tube to twist into the configuration
shown in FIG. 30.
[0165] The element A-B is now inclined to the axis of the tube but
still remains a straight element. It is clear that element A-B in
FIG. 30 appears longer than element A-B in 28 (it must have
stretched). It follows therefore, that a force must be applied to
the element to cause this elongation. In the absence of such a
force elongation of the element A-B would not occur and the overall
length of the tube would reduce (not depicted) in order to
accommodate the change in geometry. At angles of twist less than
180.degree. the element will not intersect the axis of the tube,
its mid point being the point of closest proximity to the axis. It
is the summation of all the elements at their midpoints that
defines the minimum diameter of the reduced lumen formed. This
diameter can be calculated knowing the original tube diameter and
the angle of twist. The profile of the tube takes the form of a
waisted, necked or hourglass shape. This profile is not determined
by the shape of any individual element or elements but is the
effect of a section in the plane of the tube axis taken through all
the elements. Before proceeding to the effects of the introduction
of an object into the reduced lumen particular notice should be
taken of the elements as they appear in the plan view FIG. 29. All
the elements are straight.
[0166] Clearly, if an object of smaller diameter than the reduced
lumen were introduced into the reduced lumen the object could pass
through with out making contact with the wall of the reduced lumen.
It would therefore not be possible for the tube to grip or create a
seal to the object. In order to accommodate the introduction of an
object of larger size (diameter) it is necessary that each element
deform or bend outward thus forming an increased lumen. This can be
seen clearly in FIG. 32. All the elements are now deformed. As
before there is an apparent increase in the length of the elements.
Also as before, in the absence of a force to elongate the elements
the overall length of the tube will reduce to accommodate the
change in geometry (FIG. 33). So it will be understood that the
lumen has increased to accommodate the introduced object with out
stretching the material of the tube and that the tube is intimate
contact with the introduced object over at least part of its
length.
[0167] The application of an axial force to the tube will cause the
now deformed elements to try to straighten. Because the elements of
the tube do not lie in the plane of the applied axial force there
will be a corresponding radially inward force. This tendency toward
straightening of the elements will be restricted by the presence of
an object in the lumen. Therefore the radially inward component of
the applied force will act on the inserted object creating a
pressure or gripping force between the tube and the inserted
object.
[0168] Referring to FIGS. 34 to 39 consider the hollow cylindrical
tube shown in FIG. 35. The wall of the cylinder defines a lumen
through its centre. Consider a linear element A-B. If the upper
edge of the tube is rotated through some angle, point A will move
to the position shown in FIGS. 36 and 37. The element A-B will
still define a straight line. The tube will distort into a
nominally hour glass shape with a reduced lumen at mid height. The
diameter of the lumen at the neck of the tube is dependant on the
angle of twist. When the upper edge is rotated through 180.degree.
the lumen will close down to zero diameter. At any horizontal plane
through a twisted tube the material must be wrinkled and hence
under compressive hoop stress. If the height of the tube remains
unaltered then the element A-B is a twisted tube, being longer than
in a plain tube, must be under tensile axial stress. If the tube is
free of axial constraint the overall length of the tube will
reduce.
[0169] Angle of Twist Vs. Lumen Diameter
[0170] FIG. 41 shows the lumen diameter (D2) as a proportion of the
tube diameter (D1) for angles of twist (E) from 0.degree. to
180.degree.. The lumen diameter (D2) is calculated from:
D2=D1 cos(E/2).
[0171] As can be seen, the lumen diameter is independent of the
tube length.
[0172] Elongate Object Passed through Twisted Tube
[0173] As can be seen from FIGS. 41, 42 and 43 the angle of twist
necessary to collapse the lumen of a tube to the diameter of an
elongate object passed therethrough is dependant on the ratio of
the tube diameter to the diameter of the elongate object. The angle
of twist can be calculated from:
E=2{cos.sup.-1(D2/D1)}
[0174] where E is the angle of twist,
[0175] D1 is the tube diameter, and
[0176] D2 is the diameter of the elongate object.
[0177] Although depicted as of circular profile, a tube of
sufficiently compliant material will conform to many non recursive
profiles. For such a profile D2 is taken as the smallest diameter
which can be inscribed within the profile.
[0178] Twin Walled Pressure Vessel Under Internal Pressure
[0179] Referring to FIGS. 44 to 50 consider a thin walled tube as
shown in FIG. 45a. One end of the tube is folded back on itself as
shown in FIG. 47 and the free ends conjoined. What is defined is
essentially a twin walled tube (or two coaxial tubes conjoined at
their ends) with an enclosed volume between the two walls. One way
of extending the thin walled tube in an axial direction is to
introduce a pressurised fluid into the enclosed volume. This causes
the outer tube to be subject to tensile axial stress and tensile
hoop stress. The inner tube will be subject to tensile axial stress
and compressive hoop stress. As a result the diameter of the lumen
reduces and the lumen collapses into a nominally duck bill
configuration but constrained by the outer tube, FIG. 50.
[0180] Greater control of the lumen can be obtained by the
introduction of a twist into the tube. The tube shown in FIG. 52 is
twisted as shown in FIG. 54. One end of the tube is folded back on
itself, as shown in FIG. 56, and the free ends conjoined. This
configuration defines two coaxial conical vessels conjoined at
their bases and at a common apex. However the common apex is not
constrained to remain in this configuration. In reality, the inner
and outer tubes are free to behave as individual tubes each with
half of the original twist and as such the composite tube can
better be defined as two coaxial hour glass tubes as shown in FIG.
59, each containing half the original total twist. As both the
inner and outer tubes are necked they each are subject to
compressive hoop stresses.
[0181] Next a pressurised fluid is introduced into the enclosed
volume. The introduction of the pressurised fluid extends the inner
and outer tubes in an axial direction, reducing the lumen diameter.
The outer tube is a necked hour glass tube with compressive hoop
stresses. The introduction of the pressurised fluid also induces
tensile hoop stresses, negating the compressive hoop stresses
induced by the twist. Since, to remain in its twisted
configuration, the tube must have compressive hoop stresses and
since the pressurised fluid overcomes these compressive stresses
the tube untwists and takes on a nominally cylindrical
configuration, FIG. 61. Since the inner and outer tubes are
conjoined, as the outer tube untwists the inner tube twists more in
response. Since the outer tube now has no twist the inner tube must
have all the twist. If the original total twist were 180.degree.
then the lumen would close totally. Additionally, the material
defining the inner tube will be central within the diameter of the
outer tube. This configuration will for brevity be called a
Cyclops.
[0182] Translation of an Elongate Object through a Cyclops
[0183] Consider the arrangement depicted in FIG. 62. A shaft is
passed through a Cyclops with the lumen in mutual contact with the
shaft. The outer tube of the Cyclops is resting in mutual contact
with a fixed surface. Consider points of contact A, between the
Cyclops and the fixed surface, and B, between the shaft and the
lumen of the Cyclops. As the shaft is translated, as shown in FIG.
64, point A remains fixed whilst the leading end of the lumen rolls
out. Since the Cyclops does not change in overall length the
trailing end of the outer tube rolls in as depicted. It will be
apparent that the shaft translates to the right twice as far as the
Cyclops. This is exactly the motion of a caterpillar track. From
this point of view a Cyclops could be considered as a three
dimensional caterpillar track. Since points A and B on the Cyclops
do not move relative to their corresponding positions on the shaft
and the fixed surface there is no frictional resistance to the
translation of the shaft. In FIG. 66, the Cyclops has translated to
the right by approximately its own length. The material which had
originally formed the inner tube has rolled out to become the outer
tube and vice versa. In other words the Cyclops has turned inside
out. Since the inner tube of the Cyclops is in a twisted
configuration and since the point B remains in contact with the
same point, the shaft rotates about it's axis as depicted by arrow
C (in this instance approx. 120.degree.). In order to obtain this
translation the resistance required to be overcome is that
generated as the leading and trailing ends of the Cyclops deform as
they roll out and roll in respectively.
[0184] Referring to FIGS. 68 and 69 there is illustrated another
access device 50 which in this case has a glove 51 integral with or
attached thereto to receive a surgeons hand.
[0185] Referring to FIGS. 70 to 74 there is illustrated another
hand access device 55 according to the invention. The device 55 is
similar to those described above except that in this case the twist
is adjustable in situ. In this case the sleeve 5 has an inner ring
56 similar to the ring 30 and an outer ring assembly comprising two
interengagable rings 57, 58 which are rotatable relative to one
another to adjust the twist in the sleeve 5. The rings 57, 58 are
snap fitted together and a seal 60 is used to present air egress.
The seal 60 has a head part 61 which is housed in a female recess
62 in the ring 57 and a sealing part 62 which extends to sealingly
to engage a projecting part 63 of the outer ring 58.
[0186] Referring to FIGS. 75 and 78 there is illustrated another
adjustable twist device 70 which is similar to the device 55 of
FIGS. 70 to 74 and like parts are assigned the same reference
numerals. In this case snap projections 79, 80 engage on assembly
of the mounting rings 57, 58. To ensure gas tight sealing between
the rings 57, 58 an elastomeric sealing ring 81 is provided. The
sealing ring 81 is housed in a recess in the male part 82 of the
outer mounting ring 59 and projects into the space between the two
rings 57, 58, on assembly to engage against an integral projection
92 of the lower ring 58. Mounting ring seals 93, 94 are used for
mounting the sleeve 5 to the outer and inner mounting rings 57, 58,
respectively.
[0187] In each of the devices 55, 70 the mounting ring 57 includes
a side port 95 having a passageway 96 for entry of an inflation gas
into the sleeve 5. The mounting rings 57, 58 are rotatable relative
to one another to twist the sleeve 5 and so reduce the diameter of
the lumen 25 defined by the sleeve 5. The relative rotation is
effected by gripping opposed handles 97, 98 on the mounting rings
57, 58 and turning them. This causes the sleeve 5 to twist from a
configuration 28 where there is no twist to, for example, a
90.degree. twist or a 180.degree. twist in which the lumen 25 is
closed. The sleeve 5 may therefore be pre-twisted or twisted during
a surgical procedure.
[0188] In use, the sleeve 5 is untwisted and the O-ring 56 is
inserted through a wound opening 3. A surgeon then inserts his hand
through the sleeve 5. The rings 57, 58 are relatively rotated to
twist the sleeve 5 and so reduce the lumen diameter. The sleeve 5
is then inflated by introducing pressurised gas through the entry
port 95. This causes the sleeve 5 to extend in the axial direction,
and the diameter of the lumen 25 to reduce, further enhancing the
seal. The surgical procedure is then carried out. On completion of
the surgical procedure, a combination of deflation and/or
untwisting of the sleeve 5 is used to allow a surgeon to remove his
hand. In this way, if required, the gas seal may be maintained as a
surgeon removes his hand and when the hand is fully removed.
[0189] One advantage of this sealing device is that it is
adjustable on site and in situ to suit a particular patient,
surgeon and/or procedure.
[0190] The mounting rings 57, 58 slide over one another as they
rotate relative to one another. It is desirable to have a small
frictional force acting between the surfaces as they rotate
relative to one another to facilitate ease of operation of the
device 55, 70 and also to maintain the desired sealing contact
between the two rings 57, 58.
[0191] Referring to FIGS. 79 to 81 there is illustrated another
surgical device 100 according to the invention. In this case an
inner ring 101 has engagement means in the form of a radially and
axially extending lip seal 105 to engage an inner wall of a patient
at the wound opening. This facilitates positive location and
engagement of the device 100, in use.
[0192] Referring to FIGS. 82 to 85, there is illustrated another
device 109. In this case an inner liner or bladder 110, extending
between the outer and inner rings 111, 112 is provided to ensure
that the inflated sleeve 5 interior is maintained sealed while the
rings 111, 112 are rotated relative to one another.
[0193] Referring to FIGS. 86 to 88 there is illustrated another
surgical device 20 according to the invention. The device 1
comprises a first O-ring 201, a first outer mounting means in the
form of a O-ring 202 mounted in a first receiver 203, and a second
mounting means in the form of a O-ring 205 mounted in a second
receiver 206. The receivers 203, 206 are in this case
interconnectable as illustrated and a fourth O-ring 207 is provided
between the receivers 203, 206 on assembly.
[0194] A sleeve 210 of flexible pliable plastics material extends
from the second outer receiver 206 to the first outer receiver 203.
The receivers 203, 206 are de-mountable as illustrated in FIG. 87
to facilitate relative rotation therebetween in the direction of
the arrows to vary the degree of twist in the sleeve 210.
[0195] Referring to FIGS. 89 and 90 there is illustrated another
surgical device 220 which is similar to the device 200. In this
case the O-ring 205 is de-mountable from the receiver 206 to
facilitate length adjustment of the sleeve 210. On removal of the
O-ring 205 the sleeve 210 is adjusted to a desired length d. In
this way a single device 220 may be used for a variety of thickness
of abdomens. The lumen diameter defined by the twist does not need
to be changed to cater for a range of abdomen sizes. The excess
sleeve may be cut off or wound around the O-ring seal 205.
[0196] Referring to FIGS. 91a and 91b there is illustrated an
assembly of two surgical devices 250, 260. The device 250 is a
forearm seal and the device 260 is a wound protector retractor
which is assembled to an outer sealing device 250. The sealing
device 250 provides an outer sealed access port through which a
surgeon may insert his forearm or for insertion of an instrument or
the like.
[0197] Referring to FIG. 92 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.
[0198] Referring to FIGS. 93 and 94 there is illustrated another
hand access device 160 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 162 is free between the walls of the sleeve 5 when
the sleeve is fully everted into the wound as illustrated in FIG.
94. On withdrawal of a surgeons arm eversion the sleeve outwardly
is limited by engagement of the ring 162 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.
[0199] Referring to FIGS. 95 and 96 there is illustrated another
hand access device 165 which is again similar to those described
above. In this case inner and outer rings 166, 167 are not attached
to the sleeve 5, however a linking section 168 of pliable material
extends between the rings 166, 167.
[0200] Referring now to FIGS. 97 and 98 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.
[0201] Referring to FIG. 99 there is illustrated another medical
device 700 according to the invention which is similar to those
described above and like parts are assigned the same reference
numerals. The device includes a shielding device to shield the
existing connection between the rings 30, 31. The shield shields
the sleeve section 35 that engages with the incision from the axial
tensile force. This facilitates improved conformity to the incision
margins and enhanced retraction and sealing.
[0202] In this case the shield is in the form of a film 701 which
is of lighter gauge than that of the main sleeve 5. There is a hole
702 in the main sleeve 5 which allows air access to the chamber 706
between the main sleeve 5 and the film 701. The hole 702 may be
covered by a valve such as a non return flap valve 705.
[0203] The shielding film 701 is illustrated as deflated in FIG.
99a. After inflation it bulges outwardly as illustrated in FIG. 99b
and a better conformity to the incision is achieved as illustrated
in FIG. 99c.
[0204] This arrangement may then be used to allow deflation of the
inner sleeve for improved access as illustrated in FIG. 99d.
[0205] Referring to FIG. 100, in this case the shield is provided
by a compressible foam like sleeve 750. The foam may include
stiffening means 751 as illustrated in FIG. 101. It will be
appreciated that the shield may be of any suitable material.
[0206] Referring to FIGS. 102 to 109 there is illustrated a sealing
device 250 according to the invention. The sealing device 250
comprises a tubular sleeve 251 of pliable material mounted at a
first end to a first mounting means and mounted at a second end to
a second mounting means. The first mounting means is a resilient
ring 252, the second mounting means is a resilient ring 253. The
sleeve 251 defines a lumen 254. The rings 252, 253 are rotated
relative to one another to cause the sleeve 251 to twist, thereby
reducing the diameter of the lumen 254. The sleeve 251 is
illustrated in a twisted, flaccid position in FIGS. 102 to 105. The
rings 252, 253 are moved away from each other in the axial
direction, thereby extending the sleeve 251 and reducing the lumen
diameter further, FIGS. 106 to 109.
[0207] The sleeve 251 is sealed around an object passing through
the lumen 254;
[0208] (i) by rotating the rings 252, 253 relative to one another,
thereby twisting the sleeve 1 and reducing the diameter of the
lumen 254; or
[0209] (ii) by moving the rings 252, 253 away from one another in
the axial direction, thereby extending the sleeve 1 and reducing
the diameter of the lumen 254; or
[0210] (iii) by a combination of (i) and (ii).
[0211] Referring to FIGS. 110 to 117 there is illustrated a sealing
device 300 which is similar to the sealing device 250 of FIGS. 102
to 109 and like parts are assigned the same reference numerals. In
this case resilient struts 305 are connected between the first
resilient ring and the second resilient ring. As the two rings are
moved together, the struts 305 bend outwardly in a buckling manner.
This causes the twisted sleeve to take up a flaccid configuration
increasing the lumen diameter, FIGS. 114 to 117. The material
properties of the struts 305 cause them to unbuckle when released.
The struts 305 spring back to their straight positions parallel to
the sleeve axis, FIGS. 110 to 113. The unbuckling of the struts 305
moves the two rings away from each other in the axial direction and
extends the sleeve, thereby reducing the lumen diameter. In this
case the sleeve is pre-twisted and the resilient rings are
constrained by the struts 305 to remain in the twisted position.
The resilient rings cannot rotate relative to one another.
[0212] Referring to FIGS. 118 to 125 there is illustrated another
medical device 400 forming a trocar seal. In this case a coiled
spring 401 is positioned between two resilient rings 402, 403 with
a sleeve 404 therebetween. The upper end of the coiled spring 401
bears against the underside of the first ring 402 and the lower end
of the coiled spring 401 bears against the top side of the second
ring 403. The coiled spring 401 and sealing sleeve 404 are enclosed
within a housing. The housing comprises a rigid casing having an
upper part 407 and a lower part 408 which are separable from one
another and a pliable tubular elastomeric sleeve 409 extending
therebetween. The elastomeric sleeve 409 is sealed to the casing
upper part and the casing lower part so that it joins the upper
part and the lower part together. This arrangement facilitates the
movement of the coiled spring 401 from a compressed position to an
extended position, with the spring 401 remaining enclosed within
the housing.
[0213] When the coiled spring 401 is compressed, the two rings 402,
403 move together. This causes the twisted sleeve to take up a
flaccid configuration, increasing the lumen diameter. This
compresses the elastomeric sleeve so that the upper and lower parts
of the casing are adjacent to each other. When the coiled spring
401 is released, it moves to an extended position. This causes the
two rings to move away from each other, extending the twisted
sleeve and reducing the lumen diameter. The elastomeric sleeve is
extended to a position in which the upper and lower parts of the
casing are distal from each other. The device 400 is used for
sealing a cannula.
[0214] Referring to FIGS. 126 and 127 there is illustrated a
sealing device 500 according to the invention. In this case a
twisted tubular sleeve 501 is mounted at one end to one end of a
rigid tube 502 and at the other end to the other end of the rigid
tube 502, with an enclosed volume 503 between the sleeve 501 and
the rigid walls of the tube 502. The sleeve 501 is inflated by
passing air through a port 504 in the tube 502 and into the
enclosed volume 505. The inflation of the sleeve 501 extends the
sleeve 501 in the axial direction, thereby reducing the lumen
diameter.
[0215] Referring to FIGS. 127 and 128 there is illustrated a
sealing device 600 which is similar to the sealing device 500 of
FIGS. 125 and 126. One end of a twisted tubular sleeve 601 is
mounted to a first rigid tube 602, the other end of the twisted
sleeve 501 is mounted to a second rigid tube 603. The rigid tubes
602, 603 partially overlap and are movable in an axial direction
relative to one another, so that when the sleeve is inflated and
extends in the axial direction, the tubes move axially away from
one another in a "trombone-type" action, reducing the lumen
diameter. The tubes are constrained at the overlapping ends so that
they always overlap at least partially.
[0216] Reference is also made to appropriate alternatives and
modifications which are outlined in our parallel applications
referenced ATRO1/C, ATRO14/C/, ATRO15/C, ATRO16/C/, ATRO17/C, the
entire contents of which are incorporated herein by reference.
[0217] The invention is not limited to the embodiments hereinbefore
described which may be varied in construction and detail.
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