U.S. patent application number 09/368824 was filed with the patent office on 2002-02-14 for laparoscopic sac holder assembly.
Invention is credited to HARRINGTON, FRANK, MCCLELLAN, WALTHER M..
Application Number | 20020019594 09/368824 |
Document ID | / |
Family ID | 23452899 |
Filed Date | 2002-02-14 |
United States Patent
Application |
20020019594 |
Kind Code |
A1 |
MCCLELLAN, WALTHER M. ; et
al. |
February 14, 2002 |
LAPAROSCOPIC SAC HOLDER ASSEMBLY
Abstract
This invention relates to a surgical device and methods for
accessing and retrieving a tissue mass from a body cavity through a
minimally invasive laparoscopic procedure. The device consists of a
handle comprising an inner rod, which is rotatably engaged within a
tubular member, and a loop adapted to hold a surgical bag. The loop
comprises first and second bowed leaf elements, wherein the first
bowed leaf element is attached to the inner rod and the second
bowed leaf element is attached to the tubular member. The device
further has a rotatable articulation, such as a hinge, joining the
first and second bowed leaf elements, wherein rotation of the inner
rod causes the first bowed leaf element to rotate about the
articulation, such that the surgical bag may be opened and closed
by rotation of the inner rod.
Inventors: |
MCCLELLAN, WALTHER M.;
(GAITHERSBERG, MD) ; HARRINGTON, FRANK;
(CATONSVILLE, MD) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
620 NEWPORT CENTER DRIVE
SIXTEENTH FLOOR
NEWPORT BEACH
CA
92660
US
|
Family ID: |
23452899 |
Appl. No.: |
09/368824 |
Filed: |
August 5, 1999 |
Current U.S.
Class: |
600/562 |
Current CPC
Class: |
A61B 2017/00287
20130101; A61B 17/00234 20130101 |
Class at
Publication: |
600/562 |
International
Class: |
A61B 010/00 |
Claims
What is claimed is:
1. A surgical device for holding a sac, the device having a
rotatable hinge joining first and second bowed leaf elements, said
bowed leaf elements forming a loop adapted to open and close the
sac by rotation of said bowed leaf elements.
2. The surgical device of claim 1, further comprising an inner rod
having proximal and distal ends, wherein said first bowed leaf
element is attached to the distal end of said inner rod.
3. The surgical device of claim 2, further comprising a tubular
member having proximal and distal ends, wherein said second bowed
leaf element is attached to the distal end of said tubular
member.
4. The surgical device of claim 3, wherein said inner rod is
rotatably engaged in said tubular member.
5. The surgical device of claim 4, wherein a user rotatable knob is
attached to the proximal end of said inner rod, such that rotation
of the knob causes the inner rod with attached first bowed leaf
element to rotate with respect to the tubular member with attached
second bowed leaf element.
6. The surgical device of claim 1, wherein the sac is attached to
said loop.
7. The surgical device of claim 6, wherein the sac further
comprises a neck region with a drawstring.
8. A device for holding a sac for laparoscopic surgery, comprising:
a handle comprising an inner rod which is rotatably engaged within
a tubular member; a loop adapted to hold the sac, the loop
comprising first and second bowed leaf elements, wherein the first
bowed leaf element is attached to the inner rod and the second
bowed leaf element is attached to the tubular member; and a
rotatable articulation joining the first and second bowed leaf
elements, wherein rotation of the inner rod causes the first bowed
leaf element to rotate about the articulation, such that the sac
may be opened and closed by rotation of the inner rod.
9. A laparoscopic sac holder assembly for inserting a surgical bag
into a body cavity, comprising: a handle comprising an inner rod, a
tubular member and an outer sheath, wherein the inner rod is
rotatably engaged within the tubular member which is slideably
engaged within the outer sheath; a loop member comprising first and
second bowed leaf elements, the first bowed leaf element being
attached to the inner rod and the second bowed leaf element being
attached to the tubular member, and said surgical bag attached to
said loop member; and a rotatable articulation joining the first
and second bowed leaf elements.
10. The laparoscopic sac holder assembly of claim 9, further
comprising a means for rotating the inner rod, wherein rotation of
the inner rod causes the first bowed leaf element to rotate about
the rotatable articulation relative to the second bowed leaf
element, such that the loop member is rotatably adjustable between
at least a first closed configuration and a second open
configuration.
11. The laparoscopic sac holder assembly of claim 9, wherein said
surgical bag has a neck region with a drawstring and wherein said
surgical bag is adapted to be removed from said loop member within
the body cavity.
12. A laparoscopic sac holder, comprising a handle, a hinged loop
member, and a means for rotatably adjusting said hinged loop member
between a first closed position and a second open position.
13. A method of performing a laparoscopic surgical procedure,
comprising: providing a laparoscopic sac holder assembly having a
surgical bag with a mouth portion attached to a hinged loop member,
said hinged loop member being rotatably adjustable between a first
closed position and a second open position, wherein said hinged
loop member is in the first closed position, such that the mouth
portion of the attached surgical bag is closed; inserting the
laparoscopic sac holder assembly into a body cavity; rotatably
adjusting said hinged loop member to the second open position, such
that the mouth portion of the attached surgical bag is opened; and
placing an excised tissue mass within the open surgical bag.
14. The method of claim 13, further comprising the steps of
inserting a tissue morcellation device into the open surgical bag
containing the tissue mass and morcellating the tissue mass.
15. The method of claim 14, wherein prior to inserting the
morcellation device into the surgical bag, the method further
comprises the step of detaching the surgical bag from the hinged
loop member.
16. The method of claim 15, wherein after the bag is detached from
the hinged loop member, but before the morcellation device is
inserted into the bag, the mouth portion of the detached surgical
bag is withdrawn to a position outside of the body cavity.
17. A method of making a laparoscopic sac holder comprising:
providing a handle having an inner rod, rotatably engaged in a
tubular member; attaching a first bowed leaf element to the inner
rod; attaching a second bowed leaf element to the tubular member;
and joining the first and second bowed leaf elements by a rotatable
articulation.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates to a surgical device and methods for
accessing and retrieving tissue from a body cavity through
minimally invasive endoscopic procedures.
[0003] 2. Description of the Related Art
[0004] In recent years, the applications for endoscopic surgery,
and in particular, laparoscopic surgery, have -expanded to include
many different procedures. A benefit of laparoscopic operations is
the relatively quick recovery period experienced by patients, due
to the small incisions that are made in the body. These incisions
reduce the trauma and the required healing compared to traditional
surgery. Laparoscopic tubes and sleeves with diameters on the order
of about 5 to 15 millimeters are inserted through the incisions to
aid in accessing the tissue in the body cavity. Various instruments
and video camera are typically directed through the laparoscopic
sleeves for performing and monitoring the surgical steps.
[0005] A particular concern in laparoscopic surgery is the
transporting of tissues and other mass that are cut away or
retrieved during the surgery. While moving, manipulating or
morcellating the mass within the body cavity, pieces of infected or
cancerous mass, blood, bile, and other liquids may escape and pose
infection problems or other complications. It is desirable to
contain these materials in a bag or similar enclosure within the
body cavity before removal to minimize the risk of infection or
other complications. Thus, while it is important that the bag
possess sufficient stability and impermeability, particularly
during mechanical morcellation, it is also desirable that
containment of the materials be accomplished as quickly as possible
with minimal disturbance to the surgical site.
[0006] Instruments with bags have been designed in an attempt to
avoid the complications associated with the removal of tissue
during laparoscopic surgery. These devices have provided a bag
supported by a loop on the end of a handle, wherein the handle
provides a means for opening the bag inside the body cavity to
receive the tissue. The opening means typically relies on the
springiness or shape memory of the loop material upon release from
a radially restrained configuration. Prior art devices also employ
a means to close the bag before withdrawing the tissue from the
body cavity. The closing means usually involve a drawstring
mechanism.
[0007] One such device is disclosed by Tovey et al. in U.S. Pat.
No. 5,647,372, wherein the specimen retrieval device consists of a
handle with a loop at the distal end for supporting the mouth of a
specimen bag. The device is introduced into the patient's body
cavity in a sheath. The loop is formed from two bowed spring strips
made of elastic metal or plastic. The proximal ends of the two
spring strips are attached to an inner "drive rod" in the handle,
the bowed regions extending in opposite directions to define a
loop. The loop with attached bag is deployed by distally advancing
the drive rod out of the sheath. The spring strips bow outward
defining a loop and opening the mouth of the bag. After the
specimen is deposited in the bag, a drawstring is pulled to close
the bag.
[0008] Similarly, Middleman et al., U.S. Pat. No. 5,720,754,
discloses a device having an elongate handle with an elastic loop
made of spring metal or memory alloy at the distal end of the
handle. The handle consists of an outer sheath and a slideably
engaged inner rod. The loop is attached to the inner rod and may be
deployed by distally advancing the inner rod within the sheath and
removed by proximally retracting the inner rod within the sheath.
In one embodiment, the loop that supports the bag includes two
curved, spring metal arms within the neck of the bag; the arms do
not join one another. Middleman, like Tovey, also employs a
drawstring mechanism for closing the bag.
[0009] Heaven et al., U.S. Pat. No. 5,337,754 describes another
isolation bag, which can be inserted into a body cavity through a
tube in its collapsed configuration and then inflated by
application of gas or liquid to its expanded configuration. In
addition, the bag wall can include wires, such as shape memory
alloy, that will assist the bag in opening and maintaining its open
configuration. Similarly, Cofone et al., U.S. Pat. No. 5,341,815,
describes a pouch having a shape memory metal loop for opening the
pouch. The devices disclosed by both Heaven and Cofone include a
drawstring for closing the bag.
[0010] There remains a need for a device adapted to easily open and
close a sac designed for receiving large tissue masses. None of the
prior art devices disclose a loop formed by two bowed leaf elements
joined by a hinge, wherein the loop can be easily opened and closed
by rotating one leaf about the hinge with respect to the other
leaf.
SUMMARY OF THE INVENTION
[0011] A surgical device for holding a sac for laparoscopic surgery
is disclosed in accordance with the present invention. The device
consists of rotatable hinge joining first and second bowed leaf
elements. The bowed leaf elements form a loop which is adapted to
open and close the sac by rotation of the bowed leaf elements.
[0012] In one embodiment, the surgical device also comprises an
inner rod. The first bowed leaf element is attached to the distal
end of the inner rod. In a further variation, the device also has a
tubular member. The second bowed leaf element is attached to a
distal end of the tubular member. In a further variation, the inner
rod is rotatably engaged in the tubular member. Preferably, a user
rotatable knob is attached to the proximal end of the inner rod,
such that rotating the knob causes the first bowed leaf element to
rotate with respect to the second bowed leaf element. In one
embodiment, the surgical device includes a surgical sac. The sac
preferably has a neck region with a drawstring.
[0013] In a variation, a laparoscopic sac holder assembly for
inserting a surgical bag into a body cavity is disclosed. The
assembly has of a handle comprising an inner rod, a tubular member
and an outer sheath, wherein the inner rod is rotatably engaged
within the tubular member, which is slideably engaged within the
outer sheath. The assembly also includes a loop member comprising
first and second bowed leaf elements, the first bowed leaf element
being attached to the inner rod and the second bowed leaf element
being attached to the tubular member, wherein the surgical bag is
attached to the loop member. The first and second bowed leaf
elements are joined by a rotatable articulation.
[0014] The assembly preferably includes a means for rotating the
inner rod, wherein rotation of the inner rod causes the first bowed
leaf element to rotate about the rotatable articulation relative to
the second bowed leaf element, such that the loop member is
rotatably adjustable between at least a first closed configuration
and a second open configuration. The surgical bag employed in the
laparoscopic sac holder assembly of the present invention may have
a neck region with a drawstring. Further, the surgical bag may be
adapted to be removed from the loop member within the body
cavity.
[0015] Also disclosed is a method of performing a laparoscopic
surgical procedure. The method comprises providing a laparoscopic
sac holder assembly having a surgical bag with a mouth portion
attached to a hinged loop member, said hinged loop member being
rotatably adjustable between a first closed position and a second
open position, wherein said hinged loop member is in the first
closed position, such that the mouth portion of the attached
surgical bag is closed. The laparoscopic sac holder assembly is
inserted into a body cavity. The hinged loop member is rotatably
adjusted to the second open position, such that the mouth portion
of the attached surgical bag is opened. An excised tissue mass is
placed within the open surgical bag.
[0016] In a variation of the method, a tissue morcellation device
is inserted into the open surgical bag containing the tissue mass
and the tissue mass is morcellated. In a further variation, prior
to inserting the morcellation device into the surgical bag, the
surgical bag is detached from the hinged loop member. The mouth
portion of the detached surgical bag may be withdrawn to a position
outside of the body cavity before morcellating the tissue mass.
[0017] A method of making a laparoscopic sac holder in accordance
with the present invention is also disclosed. The method consists
of the steps of providing a handle having an inner rod, rotatably
engaged in a tubular member, attaching a first bowed leaf element
to the inner rod, attaching a second bowed leaf element to the
tubular member, and joining the first and second bowed leaf
elements by a rotatable articulation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a perspective view of a laparoscopic sac holder in
accordance with the present invention showing a hinged loop
comprising two bowed leaf elements, one attached to a tubular
member and the other attached to a rotatable inner rod.
[0019] FIG. 2 is an exploded plan view of an embodiment of the
laparoscopic sac holder assembly of the present invention showing a
rotatable inner rod with first bowed leaf element and operating
knob, a tubular member with second bowed leaf element, and an outer
sheath with retainer ring.
[0020] FIG. 3 is an enlarged perspective view of the distal end of
a laparoscopic sac holder of the present invention with a section
of the tubular member broken away to illustrate rotation of a first
bowed leaf element attached to a rotatable inner rod in relation to
a second bowed leaf element attached to the tubular member.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0021] As defined in this application, the word "distal" is used,
conventionally, to describe that portion of the device which
extends away from the user during use, and the word "proximal" is
used, conventionally, to describe that portion of the device that
extends toward the user during use.
[0022] The term "laparoscopic sac holder" is used herein to
encompass any device used for introducing a bag or sac via
laparoscopic or other minimally invasive surgical procedures into a
body cavity for isolating and/or retrieving a tissue mass. The
mechanical disruption, or "morcellation" of the tissue mass is
frequently desirable during laparoscopic procedures in order to
facilitate withdrawal and/or aspiration of the tissue through a
relatively small port. However, it is not a required feature of the
present invention that it be used only in surgical procedures that
involve tissue morcellation. Further, the terms "sac", "bag" and
"pouch" are used interchangeably herein.
[0023] Referring to FIG. 1, a laparoscopic sac holder 10 in
accordance with one embodiment of the present invention is
illustrated. The laparoscopic sac holder 10 includes a handle 20
having a loop member 50 disposed at the distal end. The handle
further comprises a tubular member 22 with proximal 24 and distal
26 end portions. In a preferred variation of the laparoscopic sac
holder 10, the tubular member 22 has a notch 28 that runs in a
longitudinal axis along a portion of the length of the tubular
member 22. As will become apparent with reference to FIG. 2, the
notch 28 is adapted to serve as a guide for the longitudinal
sliding of the tubular member 22 in relation to an outer sheath 60
during the introduction, deployment and retraction of the
laparoscopic sac holder 10 from the body cavity. The structure and
function of the notch 28 is described in greater detail below with
reference to FIG. 2. The tubular member 22 is also shown having
proximal 30 and distal 32 O-rings, which provide a sealing means
between the tubular member 22 and the outer sheath 60 (not shown in
FIG. 1) to minimize the escape and/or entry of gases into the body
cavity during the operation.
[0024] An inner rod 40, depicted in phantom, is rotatably engaged
within the tubular member 22. The rotatable inner rod 40 has
proximal 42 and distal 44 end portions. The proximal end portion 42
extends proximally beyond the proximal end portion 24 of the
tubular member 22, whereupon a knob 46 is attached to the proximal
end portion 42 of the inner rod 40 by means of a setscrew 48. When
the setscrew 48 of the knob 46 is tightened to engage the inner rod
40, manual rotation of knob 46 causes the inner rod 40 to rotate
within the tubular member 22. Other means, both "permanent" and
"removable", for fastening the knob or equivalent user operable
structure to the inner rod will be appreciated by those of skill in
the art. Such other means may include pin, solder, epoxy, weld,
threading, etc.
[0025] Equivalent user operable structure for use in rotating the
inner rod may include, for example, a rod-shaped handle
perpendicular to the longitudinal axis of the device, a lever, a
faucet-type fitting, etc. Motorized means for rotating the inner
rod are also encompassed within the present disclosure. For
example, the inner rod may be rotated by electric, pneumatic or
fluid drive system, or any other motor used in the art to generate
rotation. The rotating drive means may be automated to allow
precise control of opening and closing operations, e.g., to produce
a 180.degree. rotation.
[0026] The distal end portion 44 of the inner rod 40 extends
distally beyond the distal end portion 26 of the tubular member 22.
The distal end portion 44 is adapted to fastenably engage the
proximal end 53 of the first bowed leaf element 52 of the loop
member 50. Suitable fastening means are well known in the art and
include screws, rivets, bolts and nuts, solder, weld, crimped
ferrule, etc., and combinations thereof. In a variation, the inner
rod 40 and first bowed leaf element 52 may be a continuous,
monolithic structure, which is constructed to have the form of a
cylinder-shaped rod inside the tubular member 22 and a
ribbon-shaped bowed leaf within the loop member 50. The proximal
end 55 of the second bowed leaf element 54 is attached by
conventional means (see above) to the distal end portion 26 of the
tubular member 22. The first 52 and second 54 bowed leaf elements
are joined at their distal ends 58,59 by a rotatable articulation
56, such as a hinge, pin, rivet, joint, screw, etc.
[0027] As a result of the rotatable articulation 56, and the
attachment of the first bowed leaf element 52 to the rotatable
inner rod 40, and the attachment of the second bowed leaf element
54 to the fixed tubular member 22, as detailed above, the loop
member may assume an open configuration, as illustrated in FIG. 1,
wherein the leaves 52,54 are bowed apart and 180.degree. opposed.
When the inner rod 40 is manually rotated by 180.degree. using the
knob 46, the loop member 50 assumes a closed configuration, wherein
the leaves 52,54 are nested together and bowed in the same
direction.
[0028] Referring to FIG. 2, there is shown an exploded view of the
laparoscopic sac holder assembly 12 of the present invention.
Construction of the assembly 12 can best be understood by reference
to this drawing. The proximal end 53 of the first bowed leaf
element 52 is attached to the distal end 44 of the rotatable inner
rod 40. Attachment means are discussed above. The inner rod 40 is
rotatably engaged within tubular member 22. Knob 46 is attached and
secured to the proximal end portion 42 of the inner rod 40, by
tightening setscrew 48, or other means as detailed above. A
receiving aperture 41, which may or may not be threaded, may be
included along the proximal end portion 42 of the inner rod 40 in
order to provide a positive transfer of rotational torque from the
knob 46 to the inner rod 40.
[0029] The proximal end 55 of the second bowed leaf element 54 is
attached to the distal end 26 of the tubular member 22. Attachment
may be made by any means known in the art as discussed above,
including screws, bolts and nuts, rivets, welds, solders, epoxy,
etc. In the embodiment illustrated in FIG. 2, attachment means 72
(e.g., screws, rivets, etc.) on the distal end 55 of the second
bowed leaf element 54 are shown aligned with receiving holes 74 in
the distal end 26 of tubular member 22. Because the tubular member
22 sealably slides within outer sheath 60 and rotatably engages
inner rod 40, it is desirable that the attachment means 72 exhibit
a low inner and outer profile. Recessed sockets for screws, nuts
and/or bolts may be employed to ensure low profile. Alternatively,
the second bowed leaf element 54 may be continuous and monolithic
with the tubular member 22, as discussed above with respect to the
first bowed leaf element 52 and the inner rod 40.
[0030] Tubular member 22 is further shown to have two O-rings 30,32
that provide a sealing means between tubular member 22 and outer
sheath 60. Other sealing means consistent with the present
invention include a coating of viscous silicon or other grease
between the tubular member and the outer sheath. Moreover, a
sufficiently gas-tight seal may be formed in part by the close
tolerance employed between the tubular member 22 and the outer
sheath 60, particularly where the tubular member is fabricated from
or coated with a lubricious polymeric material. Any combination of
known sealing means may be employed in the construction and
operation of the present invention. Sealing may be important in
laparoscopic procedures, particularly when the body cavity is
insufflated with pressurized gas to expand the operating
clearance.
[0031] When fully assembled, inner rod 40, tubular member 22 and
outer sheath 60 are coaxially arranged. Retainer ring 66 slides
over the outer sheath 60 and is aligned over aperture 70 in the
proximal end portion 62 of the outer sheath 60. The retainer ring
66 has a user operable setscrew 68, which when tightened, extends
through aperture 70 and into the underlying longitudinal notch 28
in tubular member 22. The engagement of the retainer ring set screw
68 in notch 28 limits the longitudinal travel distance of the outer
sheath 60 with respect to tubular member 22. When the outer sheath
60 is positioned as far distally as possible with respect to
tubular member 22, i.e., the retainer ring set screw 68 contacts
the distal end 29 of notch 28, the outer sheath 60 covers the bowed
leaf elements 52,54 in their closed state, for insertion into and
withdrawal from the body cavity. Conversely, when the outer sheath
60 is positioned as far proximally as possible with respect to
tubular member 22, i.e., the retainer ring set screw 68 contacts
the proximal end 27 of notch 28, the bowed leaf elements 52,54 are
exposed and may be opened and closed by rotation of knob 46. The
engagement of the retainer ring set screw 68 in notch 28 also
prevents rotational movement of the outer sheath 60 and tubular
member 22 with respect to one another.
[0032] Referring to FIG. 3, there is shown an enlarged perspective
view of the distal end of an embodiment of the laparoscopic sac
holder 10 of the present invention with a section of the distal end
portion 26 of tubular member 22 broken away. O-rings 30,32 are
shown near the distal end portion 26 of tubular member 22. The
proximal end 55 of the second bowed leaf element 54 is attached to
the distal end portion 26 of the tubular member 22, as discussed
above with any suitable low-profile fastening means. As a
consequence, the rotational orientation of the second bowed leaf
element 54 is fixed with respect to the tubular member 22.
[0033] The proximal end 53 of the first bowed leaf element 52 is
attached to the distal end portion 44 of the inner rod 40. One
attachment means 51, e.g., screw, rivet, etc., is shown. However,
any number and variety of different attachment means and
combinations thereof may be used as detailed above. Moreover, since
the rotational torque of the inner rod is transferred to the first
bowed leaf member, the attachment means preferably provides a
positive transfer of this torque. Accordingly, in the embodiment
shown in FIG. 3, the distal end 44 of the inner rod 40 is modified
to include a flattened ferrule 49 for receiving the ribbon-shaped
leaf element 52.
[0034] The first 52 and second 54 bowed leaf elements are joined at
their distal ends by a rotatable articulation 56, e.g., a hinge,
pin or rivet. The articulation allows the first bowed leaf element
52 to rotate, as indicated by the arrow, relative to the second
bowed leaf element 54, which is fixed to the tubular member 22.
Thus, the loop 50 can adopt a closed configuration, wherein the
first bowed leaf element 52 is nested within the arc of the second
bowed leaf element 54, and an open configuration, wherein the two
leaf elements are bowed in opposite directions, as shown in
phantom. The user can easily actuate the change from closed to open
configurations by rotating the knob 46 (not shown in FIG. 3)
attached to the proximal end of the inner rod 40.
[0035] Commercially available surgical bags or sacs may be used in
accordance with the present invention, including bags with a
drawstring around the mouth of the bag. The bags are preferably
attached to the loop during assembly. Indeed, in a preferred
embodiment of the present invention, the laparoscopic sac holder
assembly with the sac is provided intact as a sterile disposable
unit. In a variation, the laparoscopic sac holder assembly may be
reused by attaching a new sac to the loop and sterilizing the
assembly. In any case, attachment of a bag to the loop may be
accomplished by suturing the mouth of the bag to the bowed leaf
elements. Alternatively, the bowed leaf elements may be passed
through a channel in the neck of the bag prior to forming the
rotatable articulation between the bowed leaf elements, or prior to
fastening the proximal end(s) of the bowed leaf element(s) to the
handle. In a variation, the bag may be secured to the intact loop
by folding the upper portion of the open end of the bag over the
loop and about itself to form a flap and then sealing the
folded-over flap to the bag to create a channel. Sealing can be
accomplished by conventional means including heat sealing,
ultrasonic welding and the like.
[0036] The sac may be constructed of a wide variety of materials,
but generally a biocompatible and non-toxic material is preferred.
In addition, the material preferably exhibits sufficient
conformability to fit within the outer sheath. It is also desirable
that the bag be waterproof and exhibit a high tear or burst
resistance to prevent fluids, tissue and fragments of tissue from
escaping. Physical integrity of the bag is particularly important
in applications where the tissue mass is subjected to mechanical
morcellation prior to removal from the body cavity.
[0037] Suitable materials for construction of the bag include
polymeric materials, such as but not limited to PVC, PVC
copolymers, chlorinated polyethylene, ethylene ethyl acrylate
copolymers, butadiene styrene block copolymers, polyethylene
terephthalate, ionomers, polyisoprene, silicones, polyethylene,
polyethylene copolymers, ethylene vinyl acetate copolymers,
fluoropolymers, polyvinylidene fluoride, polypropylene,
polypropylene copolymers, nylons, polyurethanes, PEBAX.RTM. block
copolyetheramide, PLATILON.RTM., MEDIFILM.RTM., polyamid, and other
suitable polymers, blends and mixtures thereof. In some embodiments
of this device where very high strength is desired, the bag may be
constructed from a fiber or cloth reinforced polymer, such as
polyethylene polyester fabric or nylon fabric composites, natural
rubber polyester fabric or nylon fabric composites, fabrics such as
GORETEX.RTM., and composites and laminates of suitable materials,
as will be apparent to those skilled in the art.
[0038] The inner rod may be made from any material that exhibits
sufficient torsional strength to permit positive transfer of the
rotational torque imparted by the user via the knob at the proximal
end to the first bowed leaf element at the distal end. Preferably,
the inner rod is made from a metallic alloy, such as stainless
steel, or polymeric material. Likewise, the outer sheath may be
made from a metallic alloy, such as stainless steel, or polymeric
material. In any case, the material should be non-toxic and
compatible with introduction into the body cavity.
[0039] The tubular member may also be made from a metallic alloy,
such as stainless steel, or polymeric material. Preferably, the
tubular member is made from a suitable polymeric material, such as
but not limited to PVC, polypropylene, polyethylene, polyimide,
polystyrene, and the like, as well as blends and mixtures thereof,
known in the art. In one embodiment, the tubular member may be
constructed from a metallic alloy such as stainless steel, coated
with a polymer having a relatively low coefficient of friction, as
will be apparent to those skilled in the art. A polymeric surface
of the tubular member may facilitate sliding of the tubular member
with respect to the outer sheath and rotation of the inner rod
within the tubular member.
[0040] The bowed leaf elements are made from any material known in
the art, having sufficient strength, springiness and shape memory,
including metallic alloys, such as spring steel and stainless
steel, and polymeric materials. Polymer-coated metallic alloys may
also be employed. Preferably, the bowed leaf elements are made from
a material that is biocompatible and rust-resistant.
[0041] The outer diameter of the complete assembly, i.e., the
diameter of the outer sheath, is preferably in a range of about 5
to about 20 millimeters, and more preferably about 10
millimeters.
[0042] Laparoscopic and other minimally invasive surgical
procedures usually require placement of at least one trocar
assembly through a body wall to provide access to the body cavity
for the surgical instruments. The trocar assembly may include an
obturator with a sharp, tissue piercing point, a cannula having a
tube and a proximal section that usually includes valve and sealing
means. Conventional trocar assemblies may be used in accordance
with the present invention. The surgeon inserts the trocar assembly
into the body wall and then removes the obturator leaving the
cannula inserted into the body cavity and the proximal section
outside the body. The body cavity is then insufflated, usually with
CO.sub.2. Additional cannulas can be inserted and various operating
and optical viewing instruments may be inserted through the several
cannulas, as will be appreciated by those of skill in the art. The
cannula sealing means helps prevent the escape or entry of gas
between the inside of the cannula and the outside of the
instrument. The instruments, including the laparoscopic sac holder
assembly of the present invention, generally have internal sealing
means, such as the 0-rings on the tubular member, to prevent the
escape or entry of gas through the interior of the instrument.
Placement of trocar cannulas and insertion of instruments
therethrough are performed in accordance with methods and apparatus
known and commonly available to those with skill in the art.
[0043] The laparoscopic sac holder assembly of the present
invention is introduced into a body cavity through a cannulated
access port (installed as described above; not shown). The loop and
the mouth of the pre-loaded bag are in their closed configurations,
wherein the two leaf elements are nested together and restrained in
a substantially linear state within the outer sheath, which is in
its distal-most position. Once inside the body cavity, the surgeon
can deploy the leaf elements and attached bag by retracting the
outer sheath relative to the underlying tubular member. The leaf
elements, which are nested in their closed configuration, spring to
their bowed state by virtue of the springiness of the leaf
material. At the appropriate time, the surgeon may open the bag by
rotating by 180.degree. the knob attached to the proximal end of
the inner rod. Consequently, the first bowed leaf element, attached
to the inner rod rotates about the hinge relative to the second
bowed leaf element, whereupon, the mouth of the bag is held open by
the oppositely bowed leaf elements.
[0044] After the surgeon has placed the excised tissue mass in the
bag using conventional laparoscopic instruments via additional
access port(s), the bag may be closed by rotating the knob
180.degree., re-sheathed, and withdrawal from the body cavity
through the access port. It is also a feature of the present
invention, that the bag containing the excised tissue may be closed
by rotating the knob 180.degree., in order to isolate the
potentially hazardous tissue from the body cavity, and
subsequently, reopened to receive additional tissue. The ability to
repetitively open and close the bag, which is made possible by the
hinged design of the loop member, is not possible with conventional
drawstring devices.
[0045] In one preferred variation of the method of using the
present invention, where the size of the tissue mass is too large
to remove intact via the access port, the tissue may be broken into
tiny fragments and/or partially liquefied using a conventional
tissue morcellation instrument. The morcellation device may be
inserted via a second access port into the bag containing the
tissue mass and actuated from outside of the patient. After
morcellation, the dispersed tissue mass may be removed by
aspiration from the second access port, or other standard
procedure. In this case, the mouth of the bag may be left in an
open or partially open configuration during morcellation.
Alternatively, where the volume of morcellated tissue is
sufficiently small, the bag may be closed and the tissue withdrawn
together with the laparoscopic sac holder.
[0046] In a variation of the above method for using the invention
to isolate and retrieve a large tissue mass, e.g., a kidney, the
attached bag is fitted with a conventional drawstring. The excised
tissue mass is placed in the open bag as above. Then the bag is
removed from the loop while still inside the body cavity by cutting
the sutures that attach the bag to the loop or by tearing along a
pre-formed perforation. The drawstring surrounding the mouth of the
bag is then grasped by a suitable instrument from a second access
port or incision and pulled out of the body cavity, such that the
substantially closed mouth and neck of the bag emerges from the
body cavity. A morcellation device can then be inserted through the
mouth and neck of the bag, into the portion of the bag remaining
within the body cavity, which holds the excised tissue. The tissue
is then morcellated and may be removed by aspiration and/or pulled
out of the body cavity through the second access port or incision,
as will be appreciated by those of skill in the art.
[0047] While we have described a number of embodiments of this
invention, it is apparent that our description of the invention can
be altered to provide other embodiments that utilize the basic
methods and compositions of this invention. Therefore, it will be
appreciated by those of skill in the art that the scope of this
invention is to be defined by the claims appended hereto rather
than the specific embodiments that have been described in detail
above by way of example.
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