U.S. patent application number 12/409149 was filed with the patent office on 2009-07-16 for trocar anchor.
This patent application is currently assigned to Tyco Healthcare Group LP. Invention is credited to Richard D. Gresham, Thomas Wenchell.
Application Number | 20090182279 12/409149 |
Document ID | / |
Family ID | 37608171 |
Filed Date | 2009-07-16 |
United States Patent
Application |
20090182279 |
Kind Code |
A1 |
Wenchell; Thomas ; et
al. |
July 16, 2009 |
TROCAR ANCHOR
Abstract
Apparatus and methods for providing access to a body cavity
without substantial loss of inflation gas therein. The apparatus
includes an access assembly that has a tubular member having a
proximal end, a distal end, an elastic portion interposed the
proximal end and the distal end, and a lumen therethrough. An
anchor sleeve is disposed coaxially over the tubular member and has
a radially expandable region. The anchor sleeve is moveable between
an axially elongated configuration and an axially shortened
configuration and is biased toward the axially shortened
configuration by a force exerted by the elastic portion of the
tubular member. The axially shortened configuration corresponds to
the anchor sleeve being in the fully deployed position. Methods for
providing anchored access to a cavity within a patient are also
disclosed.
Inventors: |
Wenchell; Thomas; (Durham,
CT) ; Gresham; Richard D.; (Guilford, CT) |
Correspondence
Address: |
Tyco Healthcare Group LP
60 MIDDLETOWN AVENUE
NORTH HAVEN
CT
06473
US
|
Assignee: |
Tyco Healthcare Group LP
|
Family ID: |
37608171 |
Appl. No.: |
12/409149 |
Filed: |
March 23, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11000866 |
Dec 1, 2004 |
7529184 |
|
|
12409149 |
|
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Current U.S.
Class: |
604/164.04 |
Current CPC
Class: |
A61B 2017/3486 20130101;
A61B 17/34 20130101; A61B 2017/3419 20130101; A61B 2017/3484
20130101 |
Class at
Publication: |
604/164.04 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. A trocar access assembly comprising: an anchor sleeve; and an
obturator insertable through the anchor sleeve; wherein when the
obturator is inserted through the anchor sleeve, the obturator
causes at least a portion of the anchor sleeve to be axially
elongated and a radial cross-section of the portion of the anchor
sleeve to become smaller, and wherein when the obturator is
retracted from the anchor sleeve, the obturator causes the portion
of the anchor sleeve to be axially shortened and the radial
cross-section of the portion of the anchor sleeve to become larger
such that the portion of the anchor sleeve having the enlarged
radial cross-section engages an inner surface of an incision.
2. The trocar access assembly of claim 1, wherein the expandable
portion of the anchor sleeve is located adjacent to a distal end of
the anchor sleeve.
3. The trocar access assembly of claim 2, wherein the expandable
portion of the anchor sleeve expands sufficiently to anchor the
anchor sleeve within the incision.
4. The trocar access assembly of claim 1, wherein the anchor sleeve
is formed from an elastomeric material.
5. The trocar access assembly of claim 1, wherein the portion of
the anchor sleeve that is axially elongatable is biased to its
axially shortened configuration.
6. The trocar access assembly of claim 1, wherein at least a
portion of the anchor sleeve provides a seal with the incision.
7. A method comprising the steps of: providing a trocar anchor
assembly including an obturator and an anchor sleeve; inserting the
obturator through the anchor sleeve, the obturator causing at least
a portion of the anchor sleeve to be axially elongated and a radial
cross-section of the portion of the anchor sleeve to become
smaller; inserting the trocar anchor assembly into an incision;
retracting the obturator from the anchor sleeve, the obturator
causing the portion of the anchor sleeve to be axially shortened
and the radial cross-section of the portion of the anchor sleeve to
become larger such that the portion of the anchor sleeve having the
enlarged radial cross-section engages an inner surface of an
incision; and inserting a surgical instrument through the anchor
sleeve to perform a surgical procedure.
8. The method of claim 7, wherein the portion of the anchor sleeve
that is axially elongatable is biased to its axially shortened
configuration.
9. The method of claim 7, wherein the portion of the anchor sleeve
that is radially expandable is formed from an elastomeric material.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of, priority to,
and is a continuation of U.S. patent application Ser. No.
11/249,830, filed on Oct. 13, 2005 and entitled "TROCAR ANCHOR,"
which is herein incorporated by reference in its entirety.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates generally to apparatus and
methods for accessing the interior of the body for performing
surgery, diagnostics or other medical procedures. In particular,
the present disclosure relates to an access assembly having an
expandable anchor to secure and seal the access assembly to the
patient's body.
[0004] 2. Discussion of Related Art
[0005] Minimally invasive surgical procedures have recently been
developed as alternatives to conventional open surgery. Minimally
invasive procedures, such as laparoscopy, involve accessing the
surgical area inside a patient through a plurality of ports
introduced into the patient's body. This type of procedure is
generally less traumatic to the body than open surgery, since these
ports tend to cause less tissue damage and blood loss as compared
to long incisions made for open surgery. A working space is
typically created to provide space inside the surgical area for
instruments to operate. For example, in laparoscopic surgery, the
abdominal wall is elevated away from the organs in the body cavity.
This is usually accomplished by filling the body cavity with a gas,
such as carbon dioxide, raising the abdominal wall. This process,
known as insufflation, is typically achieved by inserting a
large-gauge needle known as a Veress needle into, for example, the
intra-abdominal cavity for the introduction of gas. To perform
surgical procedures in the intra-abdominal cavity, the insufflation
pressure must be maintained, and the abdominal wall must remain
elevated from the organs in the intra-abdominal cavity.
[0006] Once enlarged, the cavity may be accessed by inserting a
trocar and cannula assembly through the abdominal wall. The trocar
is a sharp stylet used to provide an initial penetration and access
opening in the abdominal wall for the cannula. The trocar is
removed and the cannula remains in the body to provide access to
the surgical site.
[0007] In an alternative method known as the "open laparoscopy"
method or the Hasson method, access is established to the
peritoneal cavity through a small incision on the skin of the
abdomen, typically through the umbilicus. A special open
laparoscopic cannula is inserted. The physician uses standard
laparotomy instruments and grasping forceps to laterally enlarge
the initial incision and to lift/separate the fascia. This
procedure eventually exposes the peritoneum and places it under
tension so that it can be carefully pierced. Once accessed, the
physician can pass a gloved finger into the cavity accessing the
relevant anatomy and confirming safe entry. Upon securing access,
the physician inserts the cannula through the incision and
continues with a standard laparoscopic procedure.
[0008] During the surgical procedure, the pressurized integrity of
the peritoneal cavity or pneumoperitoneum must be maintained even
though there is substantial movement of the cannula during surgery.
Unfortunately, it is often difficult to maintain a proper seal
between the cannula and body tissue at the initial incision point.
Prior art devices have typically employed a conical shaped sealing
sleeve generally constructed from a rigid material. Upon insertion
into the incision, the sleeve engages the tissue along the
thickness of the incision and the sleeve's conical geometry pushes
or displaces outward the tissue surrounding the incision. The
tissue's natural resiliency will then cause the tissue to try to
return to the tissue's original position which creates a sealing
force against the surface of the sealing sleeve. The sleeve is
usually sutured to the skin at a depth and position where the
tissue's resiliency provides sufficient compression to maintain a
seal. Another device maintains the integrity of the gas seal and
anchors the cannula to the body using an inflatable membrane at the
distal end of the cannula. A sealing member is pushed against the
exterior side of the body, capturing tissue between the sealing
member and the inflatable membrane.
[0009] It is also known to provide access for a surgeon to
introduce his or her hand into the body during laparoscopic
surgery. Such a hand access port should also be anchored to the
patient's body, while providing a seal around the incision.
[0010] Accordingly, a need exists for apparatus and methods for
anchoring a cannula or other access member to a patient with
minimum tissue trauma while still providing a positive seal.
SUMMARY
[0011] The present disclosure is directed to apparatus and methods
capable of providing a gas seal against a percutaneous opening in a
patient without the use of suturing, external adhesive devices, or
an inflatable anchor. The apparatus of the present disclosure
generally has an expandable anchor designed to prevent withdrawal
of a surgical access device such as a cannula while maintaining
pneumoperitoneum in the cavity. The anchor is integrated into the
device design, will not rupture, does not traumatize the body
tissue against which it anchors, and automatically deploys
following placement into the patient.
[0012] In one embodiment, the apparatus of the present disclosure
is an access assembly having a tubular member having a proximal
end, a distal end, an elastic portion interposed the proximal end
and the distal end, and a lumen therethrough. An anchor sleeve is
disposed coaxially over the tubular member and has a radially
expandable region. The anchor sleeve is moveable between an axially
elongated configuration and an axially shortened configuration and
is biased toward the axially shortened configuration by a force
exerted by the elastic portion of the tubular member. The axially
shortened configuration corresponds to the anchor sleeve being in
the fully deployed position. Thus, an external force must be
applied to the anchor sleeve to overcome the force exerted by the
elastic portion of the tubular member and place the anchor sleeve
in the undeployed position for entry in or exit from a percutaneous
opening.
[0013] A method of the present disclosure for providing access to a
cavity in a patient includes the method step of introducing a
tubular body through a percutaneous opening in the patient's
dermis. A radially expandable member mounted on the tubular body is
axially compressed to radially expand the member. This expansion
provides a seal against the internal surface of a patient's dermis.
The cavity is insufflated with a gas to provide space in the
abdomen for surgical instruments. The seal created by the
expandable region inhibits loss of the gas through the penetration.
A proximal flange on the tubular body may be advanced to clamp
against the exterior surface of the patient's dermis.
[0014] These and other embodiments of the present disclosure, as
well as its advantages and features, are described in more detail
in conjunction with the text below and attached figures.
Advantageously, the present disclosure provides apparatus and
methods for anchoring a cannula to a patient with minimum tissue
trauma while still providing a positive seal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the disclosure and, together with a general description of the
disclosure given above, and the detailed description of the
embodiments given below, serve to explain the principles of the
disclosure.
[0016] FIG. 1 illustrates a perspective view of the access assembly
in accordance with an embodiment of the present disclosure;
[0017] FIG. 2 illustrates a perspective view of the distal end of
the access assembly in the undeployed position, in accordance with
the embodiment of FIG. 1;
[0018] FIG. 3 illustrates a perspective view of the distal end of
the access assembly in the partially deployed position, in
accordance with the embodiment of FIGS. 1 and 2;
[0019] FIG. 4 illustrates a perspective view of the access assembly
in the fully deployed position, in accordance with the embodiment
of FIGS. 1-3;
[0020] FIG. 5A is a perspective view of an access assembly in
accordance with a further embodiment of the disclosure;
[0021] FIGS. 5B-D are cross-sectional views of an access assembly
penetrating the tissue of a patient in accordance with the
embodiment of FIG. 5A;
[0022] FIGS. 6A-B are cross-sectional views of an access assembly
penetrating tissue in accordance with another embodiment of the
present disclosure;
[0023] FIGS. 6C-D are side elevational views of the distal end of
an access assembly in accordance with the embodiment of FIGS.
6A-B;
[0024] FIG. 7 is a cross-sectional view of an access assembly
having a self adjusting sheath in accordance with a further
embodiment of the present disclosure;
[0025] FIG. 8 is a cross-sectional view of an access assembly with
an undeployed anchor having an obturator positioned within the
anchor such that the obturator stretches the elastic tubing in
accordance with the embodiment of FIG. 7; and
[0026] FIG. 9 is a cross-sectional view of an access assembly with
a deployed anchor in accordance with the embodiment of FIGS. 7 and
8.
DETAILED DESCRIPTION
[0027] Methods and apparatus of the present disclosure are directed
towards providing access to a body cavity for surgical procedures.
Specifically, methods and apparatus of the present disclosure
substantially prevent substantial loss of insufflation fluids
through an incision by providing an access assembly that can form a
peripheral seal against the incision and anchor the access assembly
to the body, while allowing surgical instruments to access the
interior of the body during minimally invasive surgical
procedures.
[0028] To reach a desired body cavity, the access assembly is
inserted through a percutaneous opening in the patient's body, such
as an incision through the abdominal wall. The access assembly must
typically pass through the abdominal wall which includes the outer
skin, a layer of fat, a layer of fascia or alternating muscle and
fascia, and the peritoneum. The layers of fat and fascia may vary
in thickness, depending upon the body location and whether the
patient is asthenic or obese. The peritoneum is a strong, elastic
membrane lining the walls of the abdominal cavity. Just below the
peritoneum, lie several vital organs, such as the liver, stomach
and intestines, and other sensitive tissues. This is typically the
area that the access assembly is positioned to reach.
[0029] To perform surgical procedures in this area, the abdominal
wall is lifted off of the organs by inflating the area with an
insufflation gas such as carbon dioxide. This provides sufficient
space for surgical instruments to maneuver. To prevent loss of this
gas and loss of working space, the access assembly must provide a
gas-tight seal against the abdominal wall while permitting a
sufficient range of motion for the instruments and minimizing
damage to the portion of the abdominal wall engaged by the
seal.
[0030] Although the present disclosure is described with reference
to a surgical procedure which includes a penetration of the
abdominal wall, such description is made for illustrative and
exemplary purposes. As those skilled in the art will appreciate,
many other surgical procedures may be performed by utilizing the
methods and materials described herein. Preferred embodiments of
the presently disclosed access assembly, anchor and methods of
using the foregoing will now be described in detail with reference
to the figures, in which like reference numerals identify
corresponding elements throughout the several views. As used
herein, the term mesh is intended to encompass a broad range of
structural configurations including, but not limited to woven and
non-woven structures, fabrics, weaves, braids, knits and/or
felts.
[0031] Referring initially to FIG. 1, a perspective view of an
access assembly in accordance with an embodiment of the present
disclosure is illustrated. The access assembly 10 of the present
disclosure generally comprises a hub member 12 having a blunt
sheath tube 14 extending distally therefrom. An obturator or a
trocar, slides removably into a lumen 16 defined by the sheath tube
14.
[0032] The hub member 12 may be fitted with a pneumostasis valve
(not shown) on a proximal end for sealably receiving a surgical
instrument therethrough. The pneumostasis valve may be housed
inside hub member 12 or otherwise attached to the hub member 12 by
means known to one having ordinary skill in the art. The valve may
be a flap valve, a duckbill valve, or a gas-restricting device of
some other design, so long as it allows entry of a surgical
instrument while reducing the loss of insufflation gas during the
surgical procedure. The pneumostasis valve prevents loss of gas by
automatically closing access to the sheath tube 14 when surgical
instruments are being switched. Desirably, a second valve for
sealing around the instrument is provided for minimizing the loss
of insufflation gas while an instrument is inserted through the
access assembly.
[0033] The sheath tube 14 has an expandable region 24. The
expandable region 24 comprises an anchor sleeve 20 disposed
coaxially over the distal portion of sheath tube 14. The anchor
sleeve 20 may be retained on sheath tube 14 by an anchor flange 22,
or the anchor sleeve 20 may be attached to a distal end of sheath
tube 14. For example, the anchor flange 22 is tightened around
anchor sleeve 20 to compress the anchor sleeve against sheath tube
14 to hold the anchor sleeve 20 in place. The anchor sleeve 20 is
illustrated in FIG. 1 in an undeployed position. As will be
discussed in further detail below, the resting position for anchor
sleeve 20 is the fully deployed position. An outside force is
required to maintain anchor sleeve 20 in the undeployed
position.
[0034] FIG. 2 illustrates an isolated perspective view of the
anchor sleeve 20 in the undeployed position, in accordance with the
present disclosure. The anchor flange 22 is positioned around a
proximal end of anchor sleeve 20 to compress the anchor sleeve
against a sheath tube 14 to hold the anchor sleeve 20 in place. The
anchor flange 22 is fitted around anchor sleeve 20 in a manner
which will allow the proximal end of anchor sleeve 20 to slide
distally along sheath tube 14. In that case, the anchor sleeve 20
is fixed around a circumference of sheath tube 14 at the distal end
thereof. Thus, anchor sleeve 20 will expand to its normally biased
deployed position, as illustrated in FIGS. 3 and 4. Alternatively,
the proximal end of the anchor sleeve 20 may be fixed to sheath
tube 14 and the distal end may be slidably held to sheath tube 14
by an anchor flange.
[0035] The prior art employs a variety of mechanisms, such as using
a pistol grip advancing system or some other translating mechanism,
to move and expand the anchor mechanism. The access assembly 10 in
accordance with the present disclosure is automatically biased
toward the expanded (deployed) position. Thus, when there is no
external force holding the access assembly in the undeployed
position, the access assembly 10 will return to the deployed
position. For example, the access assembly may include a tube
disposed around sheath tube 14 and having a distal end attached to
the anchor flange 22. A latch at a proximal end of the assembly,
holds the tube in a proximal-most position, retaining the anchor
sleeve 20 in the undeployed position. Upon release of the latch,
the anchor sleeve 20 moves to the deployed position.
[0036] In a further embodiment, the sheath tube 14 comprises a
resilient and/or elastomeric material. The anchor flange 22 is
attached to the sheath tube 14, without being slidable in the
longitudinal direction. A trocar or obturator is arranged so as to
engage the sheath tube 14, stretching the sheath tube in a
longitudinal direction, when the trocar is inserted into the sheath
tube 14. As the sheath tube 14 is stretched, the anchor sleeve 20
is elongated in the longitudinal direction, moving the anchor
sleeve 20 to the undeployed position. Using the trocar, the distal
end of the access assembly is then inserted into the body. Upon
removal of the trocar, the anchor sleeve 20 returns to the deployed
position.
[0037] The trocar, sheath tube 14, or both have structure for
engaging the trocar with the sheath tube 14, when the trocar is
inserted into the sheath tube 14. The trocar may have a flange or
protrusion that engages a similar protrusion in the sheath tube 14.
The sheath tube 14, trocar, or both may have a tapered shaped. The
trocar and sheath tube 14 are arranged so that the trocar stretches
the sheath tube 14, while permitting the cutting tip on the distal
end of the trocar to protrude from the distal end of the sheath
tube 14.
[0038] In a further embodiment, the anchor sleeve 20 is
sufficiently flexible to collapse upon insertion in an incision.
Thus, upon inserting the distal end of the access assembly into the
body, the anchor sleeve 20 collapses. After the anchor sleeve 20
reaches the body cavity, the anchor sleeve 20 expands. Upon the
removal of the access assembly from the body, the anchor sleeve 20
collapses, allowing removal with the application of a small
proximately directed force.
[0039] FIGS. 3 and 4 illustrate progressive states of deployment of
anchor sleeve 20. More specifically, FIG. 3 illustrates a
perspective view of the anchor sleeve in the partially deployed
position, in accordance with the present disclosure. FIG. 4
illustrates a perspective view of the anchor sleeve in the fully
deployed position, in accordance with the present disclosure. As
can be seen by analyzing FIGS. 2-4, as the anchor flange 22 moves
distally, the anchor expands to form a peripheral seal between the
access assembly 10 and a percutaneous opening in the abdominal
wall. The anchor sleeve 20 comprises a flexible and/or elastic
material and may comprise polymeric sheet materials, braided,
woven, knitted and non-woven materials, and combinations thereof.
The materials desirably comprise medical grade materials.
[0040] In a specific aspect of the present disclosure, the
expandable region 24 is a non-distensible imperforate cylindrical
surface preferably constructed from an elastomeric sheet covering a
plurality of polymeric strands. Exemplary materials for the mesh
material include braided polymer strands such as medical grade
metals, PET, polypropylene, polyethylene, and the like. Exemplary
materials for the elastomeric sheet include latex, silicone,
thermoplastic elastomers (such as C-Flex, commercially available
from Consolidated Polymer Technology), and the like. The braided
material is braided in the shape of a cylinder, or otherwise formed
into a cylindrical geometry, and, as mentioned, is translatably
disposed over sheath tube 14.
[0041] The sheath tube 14 can be constructed from a variety of
materials including stainless steel, composite filament wound
polymer, or extruded polymer tubing (such as Nylon 11 or Ultem,
commercially available from General Electric), and other materials
known in the art. These materials have sufficient strength so that
the sheath tube 14 will not collapse when inserted into the
abdomen. Although specific dimensions vary depending on the
surgical procedure, the sheath tube 14 typically has an outer
diameter from about 4 mm to 20 mm and a length between about 5 cm
and 15 cm.
[0042] Referring now to FIGS. 5A-5D, another embodiment of an
access assembly 50 is disclosed. Access assembly 50 includes a
sheath tube 54 and anchor sleeve 52. The sheath tube 54 is
preferably configured to be self adjusting along its length. For
example, sheath tube 54 may be of a telescoping design or it may be
formed of an elastic material which will allow the sheath tube to
stretch and contract in the longitudinal direction.
[0043] A short tip section of sheath tube 54 is illustrated in FIG.
5A. Prior to making the percutaneous opening in the patient, the
anchor sleeve 52, which is made of a flexible and/or elastic
material and may comprise the materials discussed above for anchor
sleeve 20, is disposed on the patient's body and the sheath tube 54
extends proximally from the anchor sleeve 52. Once the percutaneous
opening has been made, the sheath tube 54 is at least partially
inserted into the opening.
[0044] An expandable region 56 of anchor sleeve 52 is preferably
formed of an elastic membrane layer and a plurality of polymeric
strands, such as the braided polymer strands of anchor sleeve 20.
In a specific aspect of the present disclosure, the expandable
region 56 is a non-distensible imperforate cylindrical surface
preferably constructed from an elastomeric sheet covering the
braided material. Exemplary materials for the braided material
include polymer strands such as medical grade metals, PET,
polypropylene, polyethylene, and the like. Exemplary materials for
the elastomeric sheet include latex, silicone, thermoplastic
elastomers (such as C-Flex, commercially available from
Consolidated Polymer Technology), and the like. The braided
material is braided in the shape of a cylinder or otherwise formed
into a cylindrical shape and disposed over the sheath tube 54.
[0045] The anchor sleeve initially has the shape of a circular
sheet. An outer member 53 is desirably attached to anchor sleeve 52
and is preferably formed of a relatively rigid material, as
compared to the anchor sleeve 52, so as to hold the anchor sleeve
52 on the outer surface of the body. The outer member 53 may
comprise an annular member 60 of at least semi-rigid material to
assist in maintaining a circular configuration for anchor sleeve
52.
[0046] In use, and with continued reference to FIGS. 5A-D, the
access assembly 50 is placed on the patient's body, as illustrated
in FIG. 5B. In order to access the abdominal cavity, for example, a
trocar device 62 is inserted into a proximal end of sheath tube 54.
As discussed above, at rest, the access assembly 50 is in the fully
deployed position, as illustrated in FIGS. 5A and 5B. Trocar device
62 is arranged such that, when it is inserted into a proximal end
of the lumen defined by sheath tube 54, the trocar device engages
the distal end of the sheath tube 54, thereby stretching the sheath
tube 54 to a point where the anchor sleeve 52 collapses to a
cylindrical shape with a diameter approximating the diameter of the
trocar device 62. The trocar device 62 extends beyond the distal
end of anchor sleeve 52 to form an opening in the skin of the
patient. As illustrated in FIGS. 5C and 5D, a point or cutting edge
of trocar device 62 extends beyond the distal end of the sheath
tube 54 and anchor sleeve 52, so that the trocar device 62
penetrates the patient's skin and can advance into the underlying
tissue of the abdominal wall. Once an opening is formed in the
abdominal wall 58, trocar device 62 is removed from sheath tube 54.
When the force of the trocar device 62, the sheath tube 54, which
is holding anchor sleeve 52 in the undeployed position, retracts
and anchor sleeve 52 returns to its deployed position. The opening
in the abdominal wall holds the proximal end of the anchor sleeve
52, while allowing the anchor sleeve 52 to bulge outwardly at the
distal end of the access assembly. Accordingly, in the deployed
position, anchor sleeve 52 extends radially and exerts a force upon
an inner surface of the patient's abdominal wall 58, thereby
forming a seal which will prevent insufflation gas from escaping
around the outer circumference of sheath tube 54.
[0047] To facilitate insertion of the access assembly into a
preexisting percutaneous opening, a surgical instrument such as,
preferably, a blunt obturator (not shown), is inserted into the
sheath tube 54. A blunt obturator is preferred for the reason that
it will tend to minimize the trauma to the location of the
insertion of the access assembly through the percutaneous opening.
As discussed above, at rest, the access assembly 50 is in the fully
deployed position. Accordingly, a surgical instrument having a
suitable diameter must be inserted into a proximal end of the lumen
defined by sheath tube 54. Having a suitable diameter will permit
the obturator to engage the distal end of anchor sleeve 52, thereby
stretching the anchor sleeve to a point where the anchor sleeve 52
collapses to a cylindrical shape approximating the diameter of the
blunt obturator. At this point, the access assembly 50 may be
inserted through the percutaneous hole formed in the abdomen of the
patient. Finally, the obturator is removed from the access assembly
50 and the anchor sleeve 52 will return to the fully deployed
position, in response to the force of the sheath tube 54, thereby
forming a peripheral seal against the inner surface of dermis 58 to
prevent the loss of insufflation gas.
[0048] After the access assembly 50 is secured and peripherally
sealed around the opening in the patient, the blunt obturator is
completely removed from the sheath tube 54 so that surgical
instruments (not shown) can be inserted into the lumen of sheath
tube 54 to access the body cavity below.
[0049] In removing the access assembly 50 from the body, the anchor
sleeve may be collapsible so that a small proximally-directed force
can pull the access assembly 50 out of the incision. Alternatively
or additionally, a trocar or blunt obturator may be used to stretch
the sheath tube 54 and collapse the anchor sleeve.
[0050] FIGS. 6A-D are side views of a trocar anchor penetrating the
dermis layer of a patient in accordance with another embodiment of
the present disclosure. This embodiment utilizes a step system to
penetrate the dermis of the patient to allow the access assembly 70
to be inserted into the percutaneous opening. As the access
assembly 70 is placed adjacent the dermis 78 of a patient, as
illustrated in FIG. 6A, a tailpiece 80 of the access assembly 70 is
inserted into the dermis 78 of the patient. The insertion of the
tailpiece 80 into the dermis 78 provides stability to the remainder
of the access assembly while also providing a pilot hole for the
final percutaneous opening. Thus, the formation of the percutaneous
opening and the insertion of an access assembly is achieved by a
stepped approach.
[0051] Once the tailpiece 80 has been inserted into the dermis 78,
in order to form a percutaneous opening large enough to accommodate
a surgical instrument, a trocar device 82 is inserted into a
proximal end of sheath tube 74. As discussed above, at rest, the
access assembly 70 is in the fully deployed position. Accordingly,
trocar device 82 has a suitable diameter such that, when it is
inserted into a proximal end of the lumen defined by sheath tube
74, the trocar device engages the distal end of anchor sleeve 72,
thereby stretching the anchor sleeve 72 to a point where the anchor
sleeve 72 collapses to its smallest diameter. The trocar device 82
then continues down through the pilot hole formed by tailpiece 80
to form an opening in the dermis 78 of the patient. As best
illustrated in FIGS. 6C and 6D, once an opening is formed in the
dermis 78, trocar device 82 is removed from sheath tube 74. When
the force of the trocar device 82, which is holding anchor sleeve
72 in the undeployed position, as illustrated in FIG. 6C, is
removed, anchor sleeve 72 returns to its biased, deployed position,
as illustrated in FIG. 6D. In the deployed position, anchor sleeve
72 exerts a force upon an inner surface of dermis 78, thereby
forming a seal which will prevent insufflation gas from escaping
around the outer circumference of sheath tube 74.
[0052] Referring now to FIG. 7, a side view of a trocar access
assembly 90 having a self-adjusting sheath tube in accordance with
another embodiment of the present disclosure is illustrated. The
trocar access assembly 90 includes a anchor sleeve 92; an anchor
base 94 which extends proximally from anchor sleeve 92; and an
anchor flange 96 to prevent the access assembly from falling into
the cavity of the patient. The anchor sleeve 92 is configured and
dimensioned to form a peripheral seal around the percutaneous
opening formed in the patient's body as it presses against the
inner surface of the dermis of the patient. Similar to the
embodiments described above, anchor sleeve 92 is predisposed to the
deployed position by the self-adjusting sheath tube 98. An external
force is required to alter the dimensions of anchor sleeve 92 such
that anchor sleeve 92 is capable of being inserted into a
percutaneous opening having a diameter which is less than the
diameter of anchor sleeve 92 in the fully deployed position. Anchor
flange 96 rests on an outer surface of the dermis of the patient
around the periphery of the percutaneous opening.
[0053] A self-adjusting sheath tube 98 is disposed within trocar
access assembly 90. Self-adjusting sheath tube 98 includes a tip
portion 100, an elastic tubing portion 102, and a flange portion
104. Tip portion 100 forms the distal end of the self-adjusting
sheath tube. Tip portion 100 is preferably formed of plastic. The
elastic tubing portion 102 is connected at a distal end to the
proximal end of the tip portion 100. Elastic tubing portion 102
forms the middle portion of the self-adjusting sheath tube 98.
Flange portion 104 is connected to a proximal end of elastic tubing
portion 102.
[0054] The distal end of anchor sleeve 92 is connected to a distal
end of tip portion 100. Therefore, with reference to FIGS. 7 and 8,
to insert the anchor sleeve 92 through a percutaneous opening in
the dermis 112 of a patient, an obturator 110 or other instrument
is inserted into the lumen defined by self-adjusting sheath tube
98. The obturator 110 is dimensioned such that it engages the
distal end of tip portion 100. Upon further distal translation of
the obturator 110, elastic tubing portion 102 elongates as a result
of the force exerted by the obturator on tip portion 100. As tip
portion 100 moves in the distal direction, anchor sleeve 92 is
forced into the undeployed position, thereby forcing anchor sleeve
92 to have a smaller cross-section.
[0055] Once the trocar access assembly 90 is in position within the
percutaneous opening formed in the dermis 112 of the patient, as
illustrated in FIG. 8, obturator 110 is removed from the trocar
access assembly 90 thereby allowing the elastic tubing portion 102
to return to its normal position. FIG. 9 illustrates the trocar
access assembly 90 with the anchor sleeve 92 in the fully deployed
position. Accordingly, in the deployed position, anchor sleeve 92
exerts a force upon an inner surface of dermis 112, thereby forming
a seal which prevents insufflation gas from escaping around the
outer circumference of sheath tube 98. Anchor flange 96 rests on an
outer surface of dermis 112, to prevent the access assembly from
falling into the cavity of the patient.
[0056] It will be understood that various modifications may be made
to the embodiments disclosed herein. For example, although the
above embodiments are described with reference to a surgical
procedure implicating the abdomen, it is contemplated that the
disclosure is not limited to such an application and may be applied
to various medical instruments. Therefore, the above description
should not be construed as limiting, but merely as exemplary of
preferred embodiments. Those skilled in the art will envision other
modifications within the scope and spirit of the claims.
* * * * *