U.S. patent application number 10/927551 was filed with the patent office on 2005-01-27 for surgical access system.
Invention is credited to Hart, Charles C., Pingleton, Edward D..
Application Number | 20050020884 10/927551 |
Document ID | / |
Family ID | 34082969 |
Filed Date | 2005-01-27 |
United States Patent
Application |
20050020884 |
Kind Code |
A1 |
Hart, Charles C. ; et
al. |
January 27, 2005 |
Surgical access system
Abstract
The invention is directed to a hand access system that provides
hand access to a surgical area while maintaining pneumoperitoneum
during laparoscopic surgery. The hand access system comprises a
sheath retractor adapted to dilate a wound stretchable to a desired
diameter, the sheath retractor includes a first ring being adapted
for disposition interiorly of the wound, a second ring being
adapted for disposition exteriorly of the wound, and a sheath being
disposed in a generally cylindrical form between the first ring and
the second ring and operable to exert a radial retraction force on
the wound. The hand access system further comprises a detachable
hand seal adapted to be removable from the second ring of the
sheath retractor. The sheath retractor may be formed of an
elastomeric material, and the hand seal may be formed of a gel
material and includes a slit providing an instrument seal in the
presence of an instrument or hand and a zero seal in the absence of
the instrument or hand. In another aspect, there is disclosed a
surgical access device adapted for disposition relative to an
incision in a patient comprising a valve including a plurality of
overlapping sheets defining an access channel, and a ring having an
inner diameter for holding the valve by fixing each of the
overlapping sheets along a portion of the perimeter, the access
channel extends into communication with the incision in the
patient. Each of the overlapping sheets includes a portion of the
perimeter that is not fixed to the inner diameter of the ring,
which provide open edges defining the access channel. The open
edges slightly overlap at the center of the ring. The open edges
may have different shapes including at least one of a straight
edge, concave, convex and a cross-configuration. The hand access
device may further comprise a septum seal formed at the proximal
and distal ends of the ring.
Inventors: |
Hart, Charles C.;
(Summerville, SC) ; Pingleton, Edward D.; (San
Juan Capistrano, CA) |
Correspondence
Address: |
APPLIED MEDICAL RESOUCES CORPORATION
22872 Avenida Empresa
Rancho Santa Margarita
CA
92688
US
|
Family ID: |
34082969 |
Appl. No.: |
10/927551 |
Filed: |
August 25, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10927551 |
Aug 25, 2004 |
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PCT/US04/05484 |
Feb 25, 2004 |
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10927551 |
Aug 25, 2004 |
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PCT/US04/05487 |
Feb 25, 2004 |
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10927551 |
Aug 25, 2004 |
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PCT/US04/05361 |
Feb 24, 2004 |
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60449857 |
Feb 25, 2003 |
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Current U.S.
Class: |
600/206 |
Current CPC
Class: |
A61B 17/0293 20130101;
A61B 17/3498 20130101; A61B 2017/00265 20130101; A61B 17/3423
20130101 |
Class at
Publication: |
600/206 |
International
Class: |
A61B 001/32 |
Claims
1. A hand access system, comprising: a sheath retractor adapted to
dilate a wound stretchable to a desired diameter, the sheath
retractor comprising a first ring being adapted for disposition
interiorly of the wound; a second ring being adapted for
disposition exteriorly of the wound; and a sheath being disposed in
a generally cylindrical form between the first ring and the second
ring and operable to exert a radial retraction force on the wound;
and a detachable hand seal adapted to be attached and detached from
the second ring of the sheath retractor.
2. The hand access system of claim 1, wherein the hand seal can be
detached from the sheath retractor to convert the hand access
system from laparoscopic surgery to open surgery.
3. The hand access system of claim 1, wherein at least one of the
first ring, the second ring and the sheath is formed from an
elastomeric material.
4. The hand access system of claim 1, wherein the hand seal is
formed of a gel material and includes a slit providing an
instrument seal in the presence of an instrument or hand and a zero
seal in the absence of an instrument or hand.
5. The hand access system of claim 1, wherein the first ring has a
first diameter and the second ring has a second diameter, and the
first and second diameters are greater than the desired diameter of
the wound.
6. The hand access system of claim 1, wherein the sheath retractor
further comprises a third ring disposed circumferentially of the
sheath and moveable between a plurality of positions between the
first ring and the second ring, each of the positions being
associated with a different retraction force, the third ring being
adapted for disposition exteriorly of the wound.
7. The hand access system of claim 6, wherein the sheath retractor
further comprises means for retaining the third ring at one of the
plurality of positions in order to provide the desired radial
retraction force associated with that position.
8. The hand access system of claim 7, wherein the retaining means
comprises a fourth ring adapted to interlock with the third ring to
fix the sheath at the desired position.
9. The hand access system of claim 8, wherein the retaining means
further comprises a wedge disposed between the third ring and the
fourth ring.
10. The hand access system of claim 1, further comprising an
adapter having a first adapter cavity for releasably attaching to
the ring of the retractor sheath and a second adapter cavity for
releasably attaching to the hand seal.
11. The hand access system of claim 10, wherein the first adapter
cavity has a first diameter and the second adapter cavity has a
second diameter less than or equal to the first diameter.
12. The hand access system of claim 1, wherein the hand seal
includes a cavity to receive the second ring of the sheath
retractor after installation of the hand seal.
13. The hand access system of claim 6, wherein the hand seal
further comprises a latch on an inner diameter for latching the
third ring.
14. The hand access system of claim 13, wherein the access sheath
may be placed inside or outside of the hand seal after attachment
of the hand seal and the seal retractor.
15. The hand access system of claim 6, wherein the third ring
comprises at least one hook to latch the hand seal as the hand seal
is attached to the sheath retractor.
16. The hand access system of claim 1, further comprising a
conformable gasket to facilitate sealing of the peritoneum.
17. The hand access system of claim 16, wherein the conformable
gasket is attached to the first ring or to the sheath of the sheath
retractor.
18. The hand access system of claim 16, wherein the conformable
gasket floats unattached to the sheath and interiorly of the
wound.
19. A hand access system, comprising: a sheath retractor adapted to
dilate a wound stretchable to a desired diameter, the sheath
retractor comprising a first ring being adapted for disposition
interiorly of the wound; a second ring being adapted for
disposition exteriorly of the wound; and a sheath being disposed in
a generally cylindrical form between the first ring and the second
ring and operable to exert a radial retraction force on the wound;
and an iris seal adapted to be attached and detached from the
sheath retractor.
20. The hand access system in claim 19, wherein the iris seal
comprises: a first iris ring; a second iris ring coaxially attached
to the first iris ring; and a cylindrical elastic member connected
to the first and second iris rings and having an opening, wherein
the first and second iris rings operate to rotate relative to one
another in either direction to open or close the opening of the
cylindrical elastic member.
21. The hand access system in claim 20, wherein the first and
second iris rings are rotated in opposite directions to create an
airtight constriction in the middle of the elastic member.
22. The hand access system in claim 21, wherein at least one of the
first and second iris rings is de-rotated to loosen or enlarge the
constriction of the elastic member.
23. The hand access system in claim 21, wherein each of the iris
rings comprises a plurality of tracks to allow the iris rings to be
relatively rotated at predetermined angles.
24. The hand access system in claim 20, wherein the sheath
retractor further comprises a third ring disposed circumferentially
of the sheath and moveable between a plurality of positions between
the first ring and the second ring, each of the positions being
associated with a different retraction force, the third ring being
adapted for disposition exteriorly of the wound.
25. The hand access system in claim 24, wherein the sheath
retractor further comprises means for retaining the third ring at
one of the plurality of positions in order to provide the desired
radial retraction force associated with that position.
26. The hand access system in claim 25, wherein the retaining means
comprises a fourth ring adapted to interlock with the third ring to
fix the sheath at the desired position.
27. The hand access system in claim 26, wherein the retaining means
further comprises a wedge disposed between the third ring and the
fourth ring.
28. The hand access system in claim 24, wherein the third ring
comprises at least one hook to latch the hand seal as the hand seal
is attached to the sheath retractor.
29. The hand access system in claim 20, further comprising a spring
connecting the first and second iris rings to further facilitate a
complete opening, a partial constriction or an airtight
constriction of the opening of the elastic member.
30. The hand access system in claim 29, wherein the spring
automatically pulls and rotates the iris rings after
de-rotation.
31. The hand access system in claim 29, wherein the spring is
formed from an elastomeric material.
32. The hand access system in claim 29, wherein as an object is
withdrawn from the iris seal, the spring contracts and causes the
sheath constriction to tighten automatically.
33. The hand access system in claim 29, wherein the amount the
spring stretches and contracts is determined by the length of the
spring.
34. The hand access system in claim 29, wherein each of the iris
springs comprises a hollow frame and a plurality of interlocking
tracks.
35. The hand access system in claim 34, wherein the interlocking
tracks operate to encase the spring to prevent the spring from
crossing into an instrument or hand passage area within the iris
rings.
36. The hand access system in claim 35, wherein the interlocking
tracks operate to open and close the seal at predetermined
angles.
37. A surgical access device adapted for disposition relative to an
incision in a patient, comprising: a valve including a plurality of
overlapping sheets defining an access channel; and a ring having an
inner diameter for holding the valve by fixing each of the
overlapping sheets along a portion of the perimeter, wherein the
access channel extends into communication with the incision in the
patient.
38. The hand access device in claim 37, wherein each of the
overlapping sheets includes a portion of the perimeter that is not
fixed to the inner diameter of the ring.
39. The hand access device in claim 38, wherein the non-fixed
portions provide open edges defining the access channel.
40. The hand access device in claim 39, wherein the open edges
slightly overlap at the center of the ring.
41. The hand access device in claim 40, wherein the overlap is
about 0.25".
42. The hand access device in claim 37, further comprising a septum
seal formed at the proximal end of the ring and having a hole at
the center of the seal.
43. The hand access device in claim 42, further comprising a second
septum seal formed at the distal end of the ring and having a hole
at the center of the second septum seal.
44. The hand access device in claim 39, wherein the open edges of
the non-fixed portions may have different shapes including at least
one of a straight edge, concave, convex, and a
cross-configuration.
45. A surgical access device adapted for disposition relative to an
incision in a patient, comprising: a plurality of septum layers
each having a hole at the center of the septum layer and a first
diameter; a ball sandwiched between the septum layers and having a
second diameter greater than the first diameter; and a ring having
an inner diameter for affixing the plurality of septum layers along
the perimeter.
46. A surgical access device facilitating a sealing relationship
with an instrument or an arm of a surgeon extending through the
device and into an incision in a patient, the access device
comprising: a valve structure including a plurality of overlapping
sheets defining an access channel, the valve in a first state
forming a zero seal in the absence of the instrument or the arm of
the surgeon extending through the valve structure, the valve in a
second state forming an instrument seal in the presence of the
instrument or the arm of the surgeon extending through the valve
structure, and the access channel extends into communication with
the incision in the patient.
47. The hand access device in claim 46, further comprising a rigid
or semi-rigid ring having an inner diameter for holding the valve
structure by fixing each of the overlapping sheets along a portion
of the perimeter.
48. The hand access device in claim 46, wherein the zero seal and
the instrument seal have properties for inhibiting the escape of
liquids and gases through the valve structure.
49. The hand access device in claim 46, wherein each of the
overlapping sheets includes a portion the perimeter that is not
fixed to the inner diameter of the ring.
50. The hand access device in claim 49, wherein the non-fixed
portions provide open edges defining the access channel.
51. The hand access device in claim 50, wherein the open edges
slightly overlap at the center of the ring.
52. The hand access device in claim 47, further comprising a septum
seal formed at the proximal end of the ring and having a hole at
the center of the seal.
53. The hand access device in claim 52, further comprising a second
septum seal formed at the distal end of the ring and having a hole
at the center of the second septum seal.
54. The hand access device in claim 50, wherein the open edges of
the non-fixed portions may have different shapes including at least
one of a straight edge, concave, convex, and a
cross-configuration.
55. A surgical access system facilitating a sealing relationship
with a robotic device or an arm of surgeon extending through the
access system and into an incision in a patient, comprising: a
sheath retractor adapted to dilate a wound stretchable to a desired
diameter, the sheath retractor comprising a first ring being
adapted for disposition interiorly of the wound; a second ring
being adapted for disposition exteriorly of the wound; and a sheath
being disposed in a generally cylindrical form between the first
ring and the second ring and operable to exert a radial retraction
force on the wound; and a detachable instrument seal adapted to be
attached and detached from the second ring of the sheath
retractor.
56. The surgical access system of claim 55, wherein at least one of
the first ring, the second ring and the sheath is formed from an
elastomeric material.
57. The surgical access system of claim 55, wherein the instrument
seal is formed of a gel material and includes a slit providing an
instrument seal in the presence of the robotic device or hand and a
zero seal in the absence of the robotic device or hand.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation application claiming the priority of
(1) PCT application Serial No. PCT/US2004/005484, entitled "Sealed
Surgical Access Device," filed on Feb. 25, 2004, (2) PCT
application Serial No. PCT/US2004/0054-87, entitled "Wound
Retractor for Use in Hand-Assisted Laparoscopic Surgery," filed on
Feb. 25, 2004, and (3) PCT application Serial No.
PCT/US2004/005361, entitled "Apparatus and Method for Illuminating
a Peritoneal Cavity During Laparoscopic Surgery," filed on Feb. 24,
2004, all of which claim priority to (4) provisional application
Ser. No. 60/449,857, filed on Feb. 25, 2003, entitled
"Hand-Assisted Laparoscopy Apparatus and Method," all of which are
fully incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention generally relates to surgical access systems
that facilitate sealed access across a body wall and into a body
cavity during a laparoscopic surgical procedure.
[0004] 2. Discussion of the Relevant Art
[0005] During laparoscopic surgery, it is desirable to inflate the
abdominal cavity in order to increase the volume of the working
space. This is accomplished with an insufflation gas which must be
maintained at a pressure sufficient to inflate the abdomen.
Maintaining the pressure of the insulation gas is difficult when it
is also desirable to insert instrumentation through the abdominal
wall. If a surgeon is interested in inserting his or her hand in a
hand-assisted laparoscopic procedure, the maintenance of insulation
pressure is even more difficult. Currently, several devices exist
that accomplish this surgical need although they suffer from
drawbacks such as difficult placement and cumbersome use. For
example, these hand-assisted devices require elaborate mechanisms
such as inflatable cuffs and adhesives to seal around a surgeon's
wrist or forearm to maintain the insulation gases. As such, there
is a need for a special seal formed around the wrist or forearm of
a surgeon to prevent the escape of insulation gases. Moreover, it
is desirable that the wound be retracted, protected and fixed while
maintaining the insufflation seal.
SUMMARY OF THE INVENTION
[0006] The invention is directed to a hand access system that
provides hand access to a surgical area while maintaining
pneumoperitoneum during laparoscopic surgery. The hand access
system comprises a sheath retractor adapted to dilate a wound
stretchable to a desired diameter, the sheath retractor includes a
first ring being adapted for disposition interiorly of the wound, a
second ring being adapted for disposition exteriorly of the wound,
and a sheath being disposed in a generally cylindrical form between
the first ring and the second ring and operable to exert a radial
retraction force on the wound. The hand access system further
comprises a detachable hand seal adapted to be attached and
detached from the second ring of the sheath retractor. In
particular, the hand seal can be detached from the sheath retractor
to convert the hand access system from laparoscopic surgery to open
surgery. In one aspect, the first ring, second ring and sheath are
formed from an elastomeric material, and the hand seal is formed of
a gel material and includes a slit providing an instrument seal in
the presence of an instrument or hand and a zero seal in the
absence of the instrument or hand. The gel material includes, for
example, a thermoplastic base such as Kraton.RTM. and an oil. The
resulting elastomer has excellent tear strength, elongation greater
than 1,000 percent, a very low durometer or hardness, and
biocompatibility. It is appreciated that the first ring has a first
diameter and the second ring has a second diameter, and the first
and second diameters are greater than the desired diameter of the
wound.
[0007] In another aspect, the sheath retractor further comprises a
third ring disposed circumferentially of the sheath and moveable
between a plurality of positions between the first ring and the
second ring, each of the positions being associated with a
different retraction force, the third ring being adapted for
disposition exteriorly of the wound. The sheath retractor may
further comprise means for retaining the third ring at one of the
plurality of positions in order to provide the desired radial
retraction force associated with that position. The retaining means
may comprise a fourth ring adapted to interlock with the third ring
to fix the sheath at the desired position. The retaining means may
include a wedge disposed between the third ring and the fourth
ring.
[0008] In yet another aspect of the invention, the hand access
system may further comprise an adapter having a first adapter
cavity for releasably attaching to a ring of the retractor sheath
and a second adapter cavity for releasably attaching to the hand
seal. The first adapter cavity has a first diameter and the second
adapter cavity has a second diameter.
[0009] In other aspects of the invention, the hand seal may include
a cavity to receive the second ring of the sheath retractor, the
hand seal may further comprise a latch on an inner diameter for
latching the third ring, and the third ring may comprise at least a
hook to latch the hand seal as the hand seal is attached to the
sheath retractor. To facilitate sealing of the peritoneum, a
conformable gasket may be provided that may be attached to the
first ring or to the sheath of the sheath retractor, or the
conformable gasket may float unattached to the sheath and
interiorly of the wound.
[0010] In another aspect of the invention, the hand access system
may comprise a detachable iris seal in place of the hand seal that
is adapted to be attached and detached from the sheath retractor.
The iris seal comprises a first iris ring, a second iris ring
coaxially attached to the first iris ring, and a cylindrical
elastic member connected to the first and second iris rings and
having an opening. With this aspect, the first and second iris
rings operate to rotate relative to one another in either direction
to open or close the opening of the cylindrical elastic member.
More specifically, the first and second iris rings may be rotated
in opposite directions to create an airtight constriction in the
middle of the elastic member. After rotation, at least one of the
first and second iris rings may be de-rotated to loosen or enlarge
the constriction of the elastic member.
[0011] Each of the iris rings may comprise a plurality of tracks to
allow the iris rings to be relatively rotated at predetermined
angles. In yet another aspect, the iris seal may further comprise a
spring connecting the first and second iris rings to further
facilitate a complete opening, a partial constriction or an
airtight constriction of the opening of the elastic member. The
spring operates to automatically pull and rotate the iris rings
after de-rotation. In particular, as an object is withdrawn from
the iris seal, the spring contracts and causes the sheath
constriction to tighten automatically. The spring may be formed
from an elastomeric material. It is appreciated that the amount the
spring stretches and contracts is determined by the length of the
spring. Each of the iris springs may comprise a hollow frame and a
plurality of interlocking tracks. The interlocking tracks operate
to encase the spring to prevent the spring from crossing into an
instrument or hand passage area within the iris rings. The
interlocking tracks also operate to open and close the seal at
predetermined angles.
[0012] In another aspect of the invention, there is disclosed a
surgical access device adapted for disposition relative to an
incision in a patient comprising a valve including a plurality of
overlapping sheets defining an access channel, and a ring having an
inner diameter for holding the valve by fixing each of the
overlapping sheets along a portion of the perimeter, the access
channel extends into communication with the incision in the
patient. With this aspect, each of the overlapping sheets includes
a portion of the perimeter that is not fixed to the inner diameter
of the ring. It is appreciated that the non-fixed portions provide
open edges defining the access channel. In one aspect, the open
edges slightly overlap for about 0.25" at the center of the ring.
The hand access device may further comprise a septum seal formed at
the proximal end and at the distal end of the ring, the septum seal
having a hole formed at the center of the seal. It is further
appreciated that the open edges of the non-fixed portions may have
different shapes including at least one of a straight edge,
concave, convex and a cross-configuration.
[0013] In yet another aspect of the invention, there is disclosed a
surgical access device adapted for disposition relative to an
incision in a patient comprising a plurality of septum layers each
having a hole at the center of the septum layer and a first
diameter, a ball sandwiched between the septum layers and having a
second diameter greater than the first diameter, and a ring having
an inner diameter for affixing the plurality of septum layers along
the perimeter. In another aspect, a surgical access device
facilitating a sealing relationship with an instrument or an arm of
a surgeon extending through the device and into an incision in a
patient is disclosed, the access device comprising a valve
structure including a plurality of overlapping sheets defining an
access channel, the valve in a first state forming a zero seal in
the absence of the instrument or the arm of the surgeon extending
through the valve structure, the valve in a second state forming an
instrument seal in the presence of the instrument or the arm of the
surgeon extending through the valve structure, and the access
channel extends into communication with the incision in the
patient.
[0014] These and other features of the invention will become more
apparent with a discussion of the various embodiments in reference
to the associated drawings.
DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings, which are included in and
constitute a part of this specification, illustrate the embodiments
of the invention and, together with the description, explain the
features and principles of the invention. In the drawings:
[0016] FIG. 1 is a perspective view showing a patient prone on an
operating table with his abdomen insufflated and with instrument
access provided by trocar and the access device of the present
invention;
[0017] FIGS. 2A and 2B illustrate a perspective view and a
cross-sectional view, respectively, of a hand access system in
accordance with a first embodiment of the invention;
[0018] FIGS. 3A-3E illustrate axial perspective views and
cross-sectional views of a hand access system in accordance with
another embodiment of the invention including a one-way
mechanism;
[0019] FIGS. 4A and 4B illustrate cross-sectional views of a hand
access system in accordance with another embodiment of the
invention including an adapter;
[0020] FIGS. 5A-5C illustrate an axial perspective view and
cross-sectional views of a hand access system in accordance with
another embodiment of the invention including a conformable
gasket;
[0021] FIG. 6 illustrates a cross-sectional view of a hand access
system in accordance with another embodiment of the invention
including an iris seal;
[0022] FIGS. 7A-7E illustrate the rotation of the iris seal rings
of the invention to create an airtight constriction in the middle
of the sheath;
[0023] FIGS. 8A-8C illustrate side views of another embodiment of
the iris seal including a spring connecting the two rings;
[0024] FIG. 9 illustrates a top view of FIG. 8B;
[0025] FIGS. 10 and 11 illustrate perspective and top views of
rings of an iris seal having interlocking tracks in accordance with
another embodiment of the invention;
[0026] FIG. 12 illustrates a perspective view of a hand-assisted
laparoscopic seal formed by overlapping sheets of elastomeric
material in accordance with another embodiment of the
invention;
[0027] FIG. 13 illustrates a perspective view of a hand-assisted
laparoscopic seal formed by differently shaped overlapping sheets
of elastomeric material in accordance with another embodiment of
the invention;
[0028] FIGS. 14 and 15 illustrate perspective views of a
hand-assisted laparoscopic seal formed by overlapping sheets of
elastomeric material having concave and convex configurations;
[0029] FIG. 16 illustrates a perspective view of a hand-assisted
laparoscopic seal formed by overlapping sheets of elastomeric
material including a central patch supported by spokes in
accordance with another embodiment of the invention; and
[0030] FIG. 17 illustrates a perspective view of a hand-assisted
laparoscopic seal formed by two septum layers sandwiching a ball in
accordance with another embodiment of the invention.
DESCRIPTION OF THE INVENTION
[0031] Referring to FIG. 1, there is shown a typical abdominal
surgery on a patient 10 in a prone position on an operating table
12. FIG. 1 further illustrates a surgeon having an arm 16 and a
hand 17 performing the surgery. In the illustrated example, the
operative procedure is performed within an abdominal cavity 18 with
instrument access provided through an abdominal wall 21. In this
type of operation, commonly referred to as laparoscopic surgery,
trocars 23 and 25 are commonly used to provide minimally invasive
access through the abdominal wall 21 for instruments such as a
grasper 27 and an endoscope 30. In addition, it is desirable that
the surgeon be able to insert his/her hand 17 through the abdominal
wall 21 and into the abdominal cavity 18. The insertion of the hand
17 provides the surgeon with direct access to various elements of
the anatomy.
[0032] In order to accommodate the hand 17 and arm 16 of the
surgeon, a small incision 32 is typically created in the abdominal
wall 21. An access device 34 of the present invention can be
provided to further facilitate this access by the hand 17 of the
surgeon. Particularly in the case of laparoscopic surgery, it is
advantageous to insufflate the abdominal cavity 18 with a gas, such
as carbon dioxide, in order to elevate the abdominal wall 21 and
thereby increase the volume of the working space within the cavity
18. Maintenance of this insufflation pressure, commonly referred to
as pneumoperitoneum, is particularly difficult where access is
desired across the abdominal wall 21, for example, through the
trocars 23, 25, as well as the access device 34. For this reason, a
substantial effort has been directed to providing such access
devices with sealing characteristics both in the presence of
instruments and in the absence of instruments, such as the grasper
27, scope 30 and hand 17.
[0033] Were it not for the desire to maintain the pneumoperitoneum,
there would be no need for the trocars 23, 25 or the access device
34. That is, one would merely cut an incision in the abdominal wall
21 and insert the instrument directly through the incision.
However, without appropriate valves or seals, the insufflation
gases would merely escape through the incision 32. This would be
particularly detrimental in the case of the incision 32 which must
be sufficiently large to accept the hand 17 of the surgeon. Thus,
the access device 34 operates to form with the incision 32 to
provide an access or working channel, and to provide a valve or
other sealing structure across the working channel in order to
maintain the pneumoperitoneum.
[0034] Referring to FIGS. 2A and 2B, there are shown a perspective
view and a cross-sectional view, respectively, of a hand access
system 100 of the invention. The hand access system 100 provides
hand access to a surgical area such as the abdominal cavity 18
while maintaining pneumoperitoneum during laparoscopic surgery. The
hand access system 100 comprises a sheath retractor 110 including a
peritoneal ring 112, a proximal ring 114, and a sheath 116
extending along an axis 117 connecting the peritoneal ring 112 and
the proximal ring 114. The sheath 116 has a generally cylindrical
configuration that may be retracted to protect an incision within a
body cavity such as the abdominal wall 21. The peritoneal ring 112
and proximal ring 114 are disposed in respective planes which
extend radially of the axis 117. The hand access system 100 further
comprises a detachable hand seal 120 that is operably attachable
and detachable to the proximal ring 114 of the sheath retractor 110
as illustrated in FIG. 2B to permit insufflation. It is appreciated
that the hand seal 120 can be separated from the sheath retractor
110 to allow removal of large organs or to provide open access to
the abdominal cavity 18. Stated another way, the hand seal 120 can
be removed at any time to allow conversion from laparoscopic
surgery to open surgery.
[0035] It is further appreciated that wound retraction in
accordance with the present invention allows a surgeon to easily
locate the sheath retractor 110 and to provide a base for the hand
seal 120. The sheath retractor 110 operates to remove the tissue
pressure from the wrist during hand-assisted laparoscopic surgery.
The sheath retractor 110 further protects tissue at the wound site,
for example, from abrasion, bacteria or other contaminated organs,
such as donor kidneys to be removed with minimal risk or damage.
The sheath retractor 110 also opens the wound providing greater
access to the operative site for instruments, such as the hand of
the surgeon. In particular, the sheath protector 110 includes the
sheath 116 having elastomeric properties that separate the two
rings 112, 114. During surgery, the peritoneal ring 112 is placed
interiorly of the abdominal wall 21 and the proximal ring 114 is
placed exteriorly of the abdominal wall 21 and is then stretched
beyond its natural state. The diameters of the rings 112, 114 are
greater than that of the wound site so as to provide sufficient
footing and tension between the rings 112, 114. This tension is
created by the elastic material that has been stretched and
retained at a distance greater than its natural state. It will be
appreciated that in other embodiments, the sheath 116 can be formed
of a non-elastic sheathing material. In a similar manner, the rings
112, 114 may be provided with a rigid configuration or
alternatively may be formed of an elastomeric material.
[0036] Referring to FIGS. 3A and 3B, there are shown perspective
views of a hand access system 100b where elements of structure
similar to those previously described are designated by the same
reference numeral followed by the lower case letter "b" in
accordance with another embodiment of the invention. The sheath
retractor 110b comprises a peritoneal ring 112b, a proximal ring
114b, a sheath 116b extending along an axis 117b connecting the
peritoneal ring 112b and the proximal ring 114b, and a one-way
mechanism 118b (a cylindrical plug) that is placed to extend above
the incision. More specifically, the one-way mechanism 118b is
placed between the peritoneal ring 112b and the proximal ring 114b.
The hand access system 100b further comprises a "plug" hand seal
120b that is operably attached to the proximal ring 114b of the
sheath retractor 110b. The hand seal 120b can be made of a soft gel
material including a slit providing an instrument seal in the
presence of an instrument or hand and a zero seal in the absence of
an instrument or hand. The gel material includes, for example, a
thermoplastic base such as Kraton.RTM. and an oil. The resulting
elastomer has excellent tear strength, elongation greater than
1,000 percent, a very low durometer or hardness, and
biocompatibility.
[0037] Referring to FIGS. 3C-3E, there are shown axial perspective
views of an exemplary embodiment of the one-way mechanism 118b of
the invention. Specifically, the one-way mechanism 118b comprises
two complimentary interlocking rings 83 and 90. The proximal ring
114b can be disposed outwardly of the sheath 116b and the locking
ring 90 can be disposed inwardly of the sheath 116b. These two
rings 114b and 90 function to clamp the sheath 116b so that the
ring 83 is maintained in a fixed position by the locking ring 90.
The interlocking rings 83, 90 of FIG. 3C provide for simple
operation of the sheath retractor 110b. These interlocking rings
83, 90 can be pushed down so that they rest on the outer surface of
the abdominal wall 21. As the sheath 116b is drawn upwardly to
achieve the proper degree of tension, it is easily moved between
the interlocking rings 83, 90. However, any tendency of this sheath
116b to move back into the wound site will tighten the interlocking
relationship of the rings 83, 90. Thus, the desired degree of
tension is maintained on the sheath 116b until it is again pulled
to release the locking ring 90 from the ring 83.
[0038] The one-way characteristics of the interlocking rings 83, 90
are further illustrated in the progressive views of FIGS. 3D and
3E. With reference to these figures, it can be seen that retraction
is maintained by preventing the sheath 116b from pulling back into
the wound by means of the one-way operation of the interlocking
rings 83, 90. The sheath 116b slides easily through the
interlocking rings 83, 90 in the upper direction, but is prevented
from sliding through the rings 83, 90 in the downward direction. In
order to disengage or separate the interlocking rings 83, 90, one
needs only re-tension the sheath 116b by pulling it proximally
thereby unlocking the rings 83 and 90. This enables the ring 83 to
be removed from the sheath 116b in order to remove the retractor
116b from the wound site.
[0039] In another aspect of the invention, FIGS. 4A and 4B
illustrate axial perspective views of a hand access system 100c
comprising a sheath retractor 110c, an adapter 140 and a detachable
hand seal 120c. The sheath retractor 110c includes a peritoneal
ring 112c, a proximal ring 114c, and a sheath 116c extending along
an axis 117c connecting the peritoneal ring 112c and the proximal
ring 114c. The adapter 140 comprises a first or lower ring 142 for
attaching to the proximal ring 114c of the sheath retractor 110c,
and a second or upper ring 144 for attaching to the detachable hand
seal 120c. FIG. 4B illustrates the hand access system 100c with the
sheath retractor 110c, the adapter 140 and the hand seal 120c
installed. More specifically, the adapter 140 is first attached to
the proximal ring 114c of the sheath retractor 110c. In turn, the
hand seal 120c may be attached and detached from the upper ring 144
of the adapter 140 as needed.
[0040] It is appreciated that the proximal ring 114c may further
include a movable ring, which together with the proximal ring 114c,
may be used to press down on the adapter 140 against the abdomen,
for example, to secure it and form an airtight connection. It is
further appreciated that the upper ring 144 may have a diameter
that is greater than, equal to or less than the diameter of the
lower ring 142. In another aspect of the invention, the adapter 140
may further comprise grooves to snap in a self-closing iris seal to
gain pneumoperitoneum.
[0041] FIGS. 5A-5C illustrate perspective and cross-sectional views
of a hand access system 100d in accordance with yet another
embodiment of the invention where elements of structure similar to
those previously described are designated by the same reference
numeral followed by the lower case letter "d". The hand access
system 100d comprises a sheath retractor 110d and a hand seal 120d
operably attached to the sheath retractor 110d. The sheath
retractor 110d includes a peritoneal ring 112d, a proximal ring
114d, a sheath (not shown) connecting the peritoneal ring 112d and
the proximal ring 114d, and a one-way mechanism 118d comprising a
plurality of interlocking rings 83d, 90d. The hand seal 120d
operably attaches to the proximal ring 114d of the sheath retractor
110d. The hand seal 120d may be formed of a soft gel material and
includes a small slit to allow passage of a hand or a surgical
instrument during surgery. Referring to FIG. 5B, there is shown a
cross-sectional view of the hand seal 120d having a cavity 125d
inside the gel to receive the proximal ring 114d of the sheath
retractor 110d. Referring to FIG. 5C, the hand seal 120d may
further comprise a latch 121d on an inner diameter for latching the
one-way mechanism 118d. The access sheath material may be placed
inside or outside of the hand seal 120d after attachment of the
hand seal 120d and the seal retractor 110d.
[0042] In another aspect, the one-way mechanism 118d may include
hooks to latch the hand seal 120d as the seal 120d is pressed down
on the open end of the sheath. As explained above, the hand seal
120d includes a small slit in the gel that will not allow air to
pass with the absence of an instrument or hand, but the slit will
stretch and the gel will compress to allow objects to pass through
with little loss of pneumoperitoneum. Compression of the gel onto
the proximal ring 114d of the sheath retractor 110d creates an
airtight connection. The sheath retractor 110d, as illustrated in
FIG. 5A, may further include a conformable gasket 123d to
facilitate sealing of the peritoneum. The conformable gasket 123d
on the peritoneum ensures an airtight seal inside the incision as
opposed to outside the incision. The gasket 123d can be attached to
the peritoneal ring 112d or the sheath 116d, or it can float
unattached to the sheath. The floating gasket 123d is less likely
to crease or bunch (a path for air leaks) as the abdominal wall 21,
sheath 116d and peritoneal ring 112d distort as the sheath 116d is
pulled up into the incision. Without the need for sealing
externally on the skin surface, the conformable gasket 123d is not
susceptible to air leaks from irregularities on the skin, such as
scars or folds. Furthermore, the conformable gasket 123d protects
the abdominal wall 21 from potential traumatic pressure or abrasion
by the peritoneal ring 112d.
[0043] In all of the above embodiments of the invention, the
ability to attach and detach the hand seal from the sheath
retractor allows larger objects to pass unfettered through the
incision. In addition, the invention is easy to use, it provides
increased comfort for the surgeon, and is less traumatic to tissue
being passed through the incision. For example, the latching or
interlocking feature of the hand seal and the adapter with the
sheath retractor makes it fast and simple to use compared to other
methods that may involve inflatable cuffs or adhesives. Adhesives
often require time to cure and inflation with pumps also creates
delay.
[0044] In another aspect of the invention, the hand access system
may comprise a sheath retractor and an iris seal directly connected
to the sheath retractor to form a continuous, seamless sheath.
Referring to FIG. 6, there is shown a hand access system in
accordance with another embodiment of the invention including an
iris seal 200. The iris seal 200 comprises a first ring 202, a
second ring 204 coaxially attachable to the first ring 202, and a
cylindrical elastic member 206 connected to the first and second
rings 202, 204 and having an opening. The first and second rings
202, 204 operate to rotate relative to one another in either
direction to open or close the opening of the cylindrical elastic
member 206. In particular, the seal 200 operates like the iris
aperture of a camera, except that the iris seal 200 is made of a
thin film sheath or elastic member 206. A ring 202, 204 is attached
to each end of the sheath or elastic sheath 206. Referring to FIGS.
7A-7C, the rings 202, 204 are rotated in opposite directions to
create an airtight constriction in the middle of the sheath or
elastic member 206. The constriction is maintained as long as the
rotation is not undone (termed de-rotation). The sheath or elastic
member 206 can be made of an elastic material, which allows objects
small in diameter relative to the rings 202, 204 to pass easily
through the constriction without the need for de-rotation. However,
objects with large diameters may require de-rotation to loosen or
enlarge the constriction in the sheath as illustrated in FIG. 7D.
Once an object is withdrawn, the rings 202, 204 must rotate back to
create the airtight constriction as illustrated in FIG. 7E. In
another aspect, the rings 202, 204 may include a plurality of
tracks 207 such that they may be relatively rotated to open or
close the opening at predetermined angles as further discussed
below and illustrated in FIG. 10. More specifically, the sectional
area of the opening changes in response to the predetermined angle
rotation of the rings.
[0045] Referring back to FIG. 6, the iris seal 200 may be attached
to a sheath retractor 110f having a peritoneal ring 112f, a
proximal ring 114f, a sheath 116f connecting the peritoneal ring
112f and the proximal ring 114f, and a one-way mechanism 118f
(comprising a plurality of interlocking rings 83f, 90f). A feature
of the iris seal 200 is its constriction can be dilated as wide as
the retracted incision and, as such, it may not be necessary for it
to be detached from the sheath retractor 110f. In this case, the
iris seal 200 can be made a permanent part of one of the
interlocking rings of the one-way mechanism 118f. Thus, the
self-closing iris seal 200 and sheath retractor 110f combination
allows pneumoperitoneum to be regained more quickly without having
to detach and reattach a seal as with previous methods. In another
aspect, an iris seal can be easily removed when constructed as part
of a two-ring design in the form of a wedge clamp similar to that
shown in FIGS. 3C-3E. Pulling up on a sheath pushes or un-wedges
the seal out of the sheath retractor.
[0046] It is appreciated that other hand seals can be used and
interchanged as contemplated by the concept of the invention. For
example, the iris seal of the invention may further include a
spring 208 connecting the first and second rings 202, 204 to
further facilitate the opening and closing of the opening of the
cylindrical elastic member 206. More particularly, one or more
springs 208 may be used to connect the first and second rings 202,
204 to provide a complete opening, a partial constriction or an
airtight constriction of the iris seal. Referring to FIGS. 8A-8C,
there are shown perspective views of the iris seal 200c of the
invention further comprising the spring 208 connecting the first
and second rings 202c, 204c. FIG. 9 is a top view of the iris seal
200c of FIG. 8B.
[0047] As illustrated in FIGS. 8 and 9, as the rings 202c, 204c are
rotated relative to one another, the spring 208 expands and
contracts causing opening and constriction of the seal. More
specifically, the spring 208 can be used to pull and rotate the
rings 202c, 204c automatically after de-rotation, for example. The
ends of the spring 208 are connected to the rings 202c, 204c in a
manner such that de-rotation causes the spring 208 to stretch as
illustrated in FIGS. 8A and 8B. Afterwards, the spring 208
contracts and causes the sheath constriction to tighten
automatically as large objects are withdrawn (FIG. 8C). The amount
the spring 208 stretches and contracts is determined by the length
of the spring 208--typically larger objects require longer springs.
Longer springs, however, may crossover the area within the rings
202c, 204c and interfere with the passage of objects as illustrated
in FIG. 9. To limit interference and to accommodate large objects,
longer springs can be housed partially within a series of
interlocking tracks 207 of hollow frame rings 202d, 204d as
illustrated in FIGS. 10 and 11. In particular, the interlocking
tracks 207 on the rings can encase longer springs so they do not
cross into the passage area. The interlocking tracks 207 also
operate to open and close the seal at predetermined angles. FIG.
11A illustrates an axial cross-sectional view of the seal with the
springs contracted and the iris closed, and FIG. 11B illustrates an
axial cross-sectional view of the seal with the springs expanded
and the iris opened.
[0048] An advantage of rotational adjustment, versus fixed rings,
is that a wider range of object sizes can easily pass through the
iris seal. A self-closing mechanism of the invention has the
advantage of hands-free adjustment. In comparison to other
self-closing methods that involve gears and springs that are
connected to stationary components external to the iris seal, the
spring(s) of the present invention are connected to and contained
within the rings, which are integral to the iris seal. With the
self-closing mechanism built in, the iris seal is portable and can
be more easily adapted to a wide range of access ports, wound
retractors and the like.
[0049] In another aspect of the invention, a hand-assisted
laparoscopy seal 300 is formed by overlapping several sheets 302,
304, 306, 308, 310, 312 of elastomeric material as illustrated, for
example, in FIG. 12. Each of these sheets 302, 304, 306, 308, 310,
312 is fixed along a portion of its perimeter to the circumference
of a semi-rigid or rigid ring (not shown). As a result, each of the
sheets 302-312 has at least a portion 302a, 304a, 306a, 308a, 310a,
312a of its perimeter fixed to the ring and a portion 302b, 304b,
306b, 308b, 310b, 312b not fixed to the ring. These non-fixed
portions 302b-312b provide open edges within the area of the ring.
The sheets 302-312 are laid on top of one another and are rotated
so that open edges extend along different planes. These open edges
slightly overlap, such as approximately one-quarter inch, at the
center of the ring to prevent leakage of the insufflation gas.
During operation, an instrument or hand of the surgeon is
introduced through the center of the ring forcing the open edges to
part, but also causing the open edges to form a sealing structure
around the forearm or wrist.
[0050] It is appreciated that in the above aspect, the overlapping
sheets 302, 312 may comprise two septum sheets having their full
perimeters fixed to the ring and a hole formed at the center of the
septum sheets. Referring to FIG. 13, there is shown another aspect
of the invention where the open edges 404b, 406b, 408b, 410b have
different shapes, which when laid on top of one another, tend to
form overlapping sections of a circle. It is appreciated that the
concept of the invention contemplates any number of overlapping
sheets of any material and of any shape. In one simple embodiment,
for example, the invention contemplates two semi-circular sheets
having slightly straight overlapping edges.
[0051] In another aspect, FIGS. 14 and 15 show how the open edges
can be provided with concave or convex configurations. The sheets
or layers having convex open edges 506, 510, 608, 610 tend to flex
more while the sheets or layers having concave edges 504, 508, 604,
606 tend to give more support. The septum sheets or layers 502, 602
provide the most support. Other shapes can be used for the layers
as illustrated in the embodiment of FIG. 16 where one of the layers
includes a central patch 704 supported by spokes 704a, 704b, 704c,
704d which extend to the ring. The central patch 704 is large
enough to cover the hole 702a in the septum layer 702. In the
embodiment of FIG. 17, two septum layers 802, 806 sandwich a ball
804 which is movable within the confines of the ring. The ball 804
has a diameter greater than the holes 802a, 806a in the septum
layers 802, 806, respectively.
[0052] It will be understood that many other modifications can be
made to the various disclosed embodiments without departing from
the spirit and scope of the invention. For these reasons, the above
description should not be construed as limiting the invention, but
should be interpreted as merely exemplary of the disclosed
embodiments.
* * * * *