U.S. patent application number 15/150220 was filed with the patent office on 2016-09-01 for system and method for delivering expanding trocar through a sheath.
The applicant listed for this patent is Xlumena, Inc.. Invention is credited to John Lunsford, Hoang Phan, Fiona Sander.
Application Number | 20160249902 15/150220 |
Document ID | / |
Family ID | 42981548 |
Filed Date | 2016-09-01 |
United States Patent
Application |
20160249902 |
Kind Code |
A1 |
Lunsford; John ; et
al. |
September 1, 2016 |
SYSTEM AND METHOD FOR DELIVERING EXPANDING TROCAR THROUGH A
SHEATH
Abstract
A trocar has an elongate body and a tissue-penetrating tip. One
or more radially extending blade(s) are provided near the
tissue-penetrating tip of the trocar body so that they
automatically open as the trocar is advanced through tissue. The
blades will enlarge the penetration which was formed by the tip of
the trocar.
Inventors: |
Lunsford; John; (San Carlos,
CA) ; Sander; Fiona; (Los Altos Hills, CA) ;
Phan; Hoang; (Fremont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Xlumena, Inc. |
Mountain View |
CA |
US |
|
|
Family ID: |
42981548 |
Appl. No.: |
15/150220 |
Filed: |
May 9, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12757408 |
Apr 9, 2010 |
9364259 |
|
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15150220 |
|
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|
61171228 |
Apr 21, 2009 |
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Current U.S.
Class: |
600/204 |
Current CPC
Class: |
A61B 17/0218 20130101;
A61B 17/3478 20130101; A61B 2017/00818 20130101; A61B 17/320725
20130101; A61B 2017/00278 20130101; A61B 2017/3425 20130101; A61B
17/3415 20130101; A61B 17/3209 20130101; A61B 2017/346 20130101;
A61B 17/320016 20130101 |
International
Class: |
A61B 17/02 20060101
A61B017/02; A61B 17/3209 20060101 A61B017/3209; A61B 17/34 20060101
A61B017/34; A61B 17/3207 20060101 A61B017/3207 |
Claims
1. A trocar for use with a delivery sheath having a lumen, said
trocar comprising: an elongate body which can be advanced through
the sheath lumen; and at least one blade disposed near a distal end
of the elongate body, said blade being biased to open from a
radially retracted configuration to a radially extended
configuration, wherein the blade is radially retracted when the
distal end of the elongate body is within the sheath lumen and said
blade opens radially when the distal end is advanced distally
beyond the sheath lumen.
2. A trocar as in claim 1, wherein the blade closes radially in
response to being drawn back into the sheath lumen.
3. A trocar as in claim 2, wherein the blade has a proximal surface
which engages a distal surface of the delivery sheath to collapse
the blade as the blade is drawn proximally back into the sheath
lumen.
4. A trocar as in claim 1, further comprising means for pulling the
blade back into the elongate body.
5. A trocar as in claim 1, wherein said elongate body has a
tissue-penetrating distal tip.
6. A trocar as in claim 5, wherein the tissue penetrating tip
comprises a sharpened tip.
7. A trocar as in claim 1, wherein a single blade is pivotally
mounted so that opposite ends of the blade rotate to open from
opposite sides of the elongate body.
8. A trocar as in claim 7, further comprising a tether attached to
the blade, wherein the tether can be tensioned to collapse the
blade prior to drawing the blade back into the sheath.
9. A trocar as in claim 7, wherein the blade has a proximal surface
which engages a distal surface of the delivery sheath causing the
blade to collapse as the blade is drawn proximally back into the
sheath lumen.
10. A trocar as in claim 1, comprising at least two biased blades
attached to a single pivot to open in a scissors-like pattern
wherein the blades have sharpened distal edges to cut tissue as the
elongate body is advanced.
11. A trocar as in claim 1, comprising two biased blades attached
to pivot points on opposite sides of the elongate body, wherein the
blades are parallel to each other within the elongate body.
12. A trocar as in claim 1, comprising two blades which are axially
spaced-apart on the elongate body.
13. A trocar as in claim 12, comprising three blades axially
spaced-apart on the elongate body.
14. A trocar as in claim 1, wherein the blade(s) comprise
pre-shaped wires which expand radially outwardly when released from
constraint.
15. A trocar as in claim 14, further comprising a tether attached
to the wire, wherein the tether can be tensioned to collapse the
wire prior to drawing the trocar back into the sheath.
16. A trocar as in claim 1, wherein the blade is conformed
circumferentially over the surface of the elongate body, wherein
the blade is attached with an axially aligned hinge.
17. A method for accessing an internal body organ, said method
comprising: introducing a delivery sheath to a location adjacent to
a wall of the organ; and advancing a trocar from a lumen in the
delivery sheath, wherein the trocar penetrates the wall of the
organ; wherein advancing the trocar releases a blade from
constraint within the delivery sheath lumen so that the blade opens
radially as the trocar exits the lumen such that the blade enlarges
the penetration made by the distal tip of the trocar.
18. A method as in claim 17, wherein the delivery sheath is
introduced through a natural body orifice.
19. A method as in claim 18, wherein the delivery sheath is
introduced transorally or transanally into the GI tract to access a
cyst, pseudocyst or abscess.
20. A method as in claim 18, wherein the delivery sheath is
introduced transorally or transanally into the GI tract to access a
gall bladder or a urinary bladder.
21. A method as in claim 17, wherein the delivery sheath comprises
an endoscope and the lumen comprises a working channel of the
endoscope.
22. A method as in claim 17, wherein the trocar has a
tissue-penetrating tip and forms the penetration as it is advanced
through the organ wall.
23. A method as in claim 17, wherein the blade is biased to spring
open as the constraint is removed.
24. A method as in claim 17, wherein a single blade opens.
25. A method as in claim 17, wherein a pair of laterally opposed
blades open.
26. A method as in claim 18, wherein the delivery sheath is
introduced transorally or transanally into the GI tract to access
the bile duct or pancreatic duct.
27. A method as in claim 18, wherein the delivery sheath is
introduced transorally or transanally into the GI tract to access
an organ or structure in the abdominal, pelvic or thoracic cavity
adjacent to the GI tract.
28. A method as in claim 17, wherein the delivery sheath comprises
a catheter with a length from 20 cm to 500 cm and a diameter from 1
mm to 5 mm.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority of U.S.
Provisional Patent Application No. 61/171,228 (Attorney Docket No.
026923-001200US), filed on Apr. 21, 2009, which is incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical apparatus
and methods. In particular, the present invention relates to a
penetration device, such as a trocar, having the ability to expand
the size of a tissue penetration as the tool is advanced.
[0004] A number of endoscopic and other intraluminal procedures
require penetration from one body lumen into an adjacent body
lumen. For example, a number of procedures may be performed by
entering the gastrointestinal (GI) tract, particularly the stomach,
duodenum, small intestine and large intestine, and passing tools
from the GI tract into adjacent organs, ducts, cavities and
structures, such as the bile duct, the pancreatic duct, the
gallbladder, urinary tract, a cyst or pseudocyst, abscess , and the
like. Since the endoscopes and other endoscopic access tools are
generally small with narrow working channels, typically 2 to 7
millimeters in diameter, any penetrating tools which are advanced
through such working channels will necessarily be small and provide
for only small tissue penetrations.
[0005] Depending on the procedure being performed, it is often
desirable to place a catheter, a stent, a drainage tube, a fiducial
marker implant, an electrode or a like second diagnostic or
therapeutic device, through the penetrations that have been formed.
Often, placement of such tools and implants requires a relatively
large diameter hole to allow subsequent passage of the second
device. In many cases the desired diameter of the second device is
larger than the maximum diameter of the penetrating member and the
insertion of the second device is often difficult. Commonly, the
lumen walls include muscle layers and significant force is required
to advance the catheter from one lumen to the next. Such
advancement can be more difficult and may fail if the size of the
penetrating element is increased in order to provide a larger
penetration.
[0006] For these reasons, it would be desirable to provide trocars
or other tissue-penetrating devices which can be used
intraluminally to penetrate from one body lumen into an adjacent
lumen where the size of the penetration can easily be enlarged. In
particular, it would be desirable to provide such tools and methods
where a relatively low force is needed to advance the tool through
the tissue while still achieving a relatively large penetration.
Such tools and methods should be compatible with standard
endoscopes and other sheaths which can be used to access a target
location in the gastrointestinal tract or other body lumen. At
least some of these objectives will be met by the inventions
described hereinbelow.
[0007] 2. Description of the Background Art
[0008] Trocars and other medical access devices having deployable
cutting blades are described in U.S. Pat. Nos. 5,372,588;
5,620,456; 6,402,770; 7,429,264; and US 2008/0045989. Other
disclosures of interest are found in U.S. Pat. Nos. 5,224,945;
5,697,944; 6,371,964; 7,303,531; and US 2006/0190021.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention provides improved trocars and other
tissue-penetrating devices which can be used with endoscopes and
other viewing scopes and sheaths. The trocars can be advanced from
a working channel or other lumen or passage of the sheath and
penetrated through an adjacent luminal wall and, typically, further
into and through the wall of an adjacent body structure or organ.
Thus, the trocars are particularly useful for providing
intraluminal access from one body lumen or cavity into an adjacent
body lumen or cavity. The trocars will most often be used for
forming penetrations and passages from a gastrointestinal
structure, such as the esophagus, the stomach, the duodenum, the
small intestine, and the large intestine, into an adjacent
structure or organ, such as the bile duct, the pancreatic duct, the
gallbladder, the urinary tract, a cyst or pseudocyst, an abscess,
and the like. The trocars of the present invention are useful in
any medical procedure where an elongate, flexible tool is advanced
through an access sheath to a remote location in order to penetrate
tissue.
[0010] Trocars according to the present invention are intended for
use with a catheter, endoscope, or delivery sheath having a working
channel or other lumen. Such trocars usually comprise an elongate
body which can be advanced through the sheath working channel or
lumen, typically having a flexible body with a stiffness typical
for standard endoscopic biopsy needles. At least one blade will be
disposed near a distal end of the elongate body where the blade is
biased to open from a radially retracted configuration to a
radially extended configuration. In particular, the blade will be
radially retracted when the distal end of the elongate body is
disposed within the sheath lumen, and the blade will open radially
when the distal end is advanced distally beyond the end of the
sheath lumen. Usually, the blade(s) will be adapted to close
radially in response to being drawn back into the sheath lumen. In
this way, the trocar body can have a relatively small width or
diameter, typically in the range from 0.4 mm to 5 mm, while the
extended blades can significantly increase the size of the tissue
penetration which is formed when the distal end of the trocar is
advanced through tissue. Moreover, as the blade is biased to open
as the distal end of the trocar is extended beyond the working
channel of the sheath, there is no need for the physician to
separately actuate the blade and instead the larger cutting size is
automatically provided as the penetration is being performed.
[0011] Usually, at least a portion of the forward edge or surface
of the blade will be sharpened or otherwise adapted so that it can
penetrate tissue. Typically, conventional honing or other physical
modification of the blade will be sufficient to provide the cutting
surface. Alternatively, electrodes or other electrosurgical
carriers, wires, metalized surfaces, or the like, may be provided
on the blade in order to enhance the cutting effect when connected
to a suitable electrosurgical power supply. In contrast, the
trailing or proximal side of the blade will usually be blunt or
atraumatic in order to avoid accidental cutting or tissue trauma
when the trocar is pulled back. A blunt trailing edge is further
desirable when the blade is configured to close as it is drawn
proximally to engage a leading edge of the working channel of the
endoscope or sheath.
[0012] In other embodiments, the blade can be configured to be
actively closed by the physician after the tissue penetration is
complete. For example, a tether or other structure for pulling the
blade back to close the blade against the bias may be provided.
[0013] In most embodiments, the elongate body of the trocar will
also have a fixed tissue-penetrating element at its distal tip to
permit or facilitate advancement through tissue. The
tissue-penetrating tip may comprise a sharpened tip, a chamfered
tip, an electrosurgical tip, or any other common tip or
modification which allows the body to be advanced forwardly to
penetrate tissue. In other embodiments, however, it may be possible
to provide a body having a blunt or atraumatic tip where the
deployed blade provides the entire cutting surface for the
trocar.
[0014] In some embodiments, the trocar will include only a single
blade which is pivotally mounted so that opposite ends of the blade
rotate to open from opposite sides of the elongate body. Such
embodiments may be biased using a coiled spring disposed about an
axis or pivot point of the blade. Such rotating single blades can
be used together with a tether for tensioning the blade to rotate
and collapse or otherwise close the blade back into the elongate
body. Alternatively, the blade and sheath can be configured such
that drawing the trocar proximally back into the sheath
automatically retracts the blade.
[0015] In other embodiments, the trocar may comprise at least two
biased blades attached to a single pivot point to open in a
scissors-like pattern where each of the blades has a sharpened
distal edge to cut tissue as the elongate body is advanced. In
still other embodiments, two biased blades may be attached to pivot
points on opposite sides of the elongate body where the blades are
parallel to each other when retracted within the elongate body. In
further embodiments, two blades may be attached at axially
spaced-apart locations on the elongate body and/or in rotationally
spaced apart locations. In addition to planar blades, the blades
may comprise pre-shaped wires or other shape-memory components
which radially expand outwardly when released from constraint. In
such cases, the wires are typically not pivoted in any way. In
still other embodiments, the blades may be conformed
circumferentially over the surface of the elongate body and
attached with an axial line hinge with springs to radially open or
unfold the blades.
[0016] The present invention further provides methods for accessing
internal body organs. The methods of the present invention comprise
introducing a delivery sheath through the working channel of an
endoscope to a location adjacent to a target location on a wall of
an organ or lumen. A trocar is then advanced from a lumen in the
delivery sheath so that the trocar penetrates the organ or lumen
wall at the target location. As the trocar is advanced, a blade is
released from constraint so that the blade opens radially as the
trocar exits the lumen. The released, expanded blade may thus
enlarge the penetration which was made by the distal tip of the
trocar as it was advanced. In many cases, the endoscope, viewing
scope, or other delivery sheath from which the trocar was advanced
will be introduced through a natural body orifice, such as the
mouth, anus, ureter, and/or vagina and cervix, allowing for the
performance of a natural-orifice translumenal endoscopic surgery
(NOTES) which avoids the need to form a percutaneous tissue
penetration. In addition, translumenal interventional endoscopy
procedures can be accomplished including transoral or transanal
access of a cyst, pseudocyst or abscess for drainage into the GI
tract, transoral or transanal access of the gallbladder, bile duct
and pancreatic duct for drainage into the GI tract, transoral
access of the heart from the esophagus for delivery of drugs,
placement of electrodes, and ablation of tissue , transoral access
of the pancreas, gallbladder, kidneys, liver, spleen and any other
organs or structure adjacent to the GI lumen to deliver fiducial
markers, drugs, and tissue ablation from the GI tract.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 illustrates a trocar having an extendable blade
constructed in accordance with the principles of the present
invention.
[0018] FIGS. 2 and 2A illustrates a first particular construction
of the actuable blade of the trocar of the present invention.
[0019] FIG. 3 illustrates a second particular embodiment of an
actuable blade constructed in accordance with the principles of the
present invention.
[0020] FIGS. 4A and 4B illustrate yet another embodiment of the
actuable blade mechanism of the trocars of the present invention,
where FIG. 4A is a cross-sectional view of a distal section of the
trocar and FIG. 4B is an end view of the distal section.
[0021] FIGS. 5A-5C are similar to FIGS. 4A and 4B, except that the
blade structure has been actuated by advancing the trocar out the
distal end of a constraining sheath.
[0022] FIGS. 6A and 6B illustrate a blade assembly where three
blades are axially hinged in order to open in a radial or petal
pattern.
[0023] FIGS. 7A and 7B illustrate a deformable wire blade structure
on a trocar according to the present invention.
[0024] FIGS. 8A and 8B illustrate axially and radially spaced-apart
blades on a trocar in accordance with the principles of the present
invention.
[0025] FIGS. 9A to 9C illustrate a single asymmetric blade
embodiment of the trocar of the present invention.
[0026] FIGS. 10A-10D illustrate use of the trocar of FIGS. 4A/B and
5A/B for penetrating a tissue wall in accordance with the
principles of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0027] Referring to FIG. 1, a trocar 10 constructed in accordance
with the principles of the present invention comprises an elongate
body 12 having a distal end 14 and a proximal end 16. An actuable
blade structure 18 is disposed near the distal end 14 of elongate
body 12, where the blade is shown in a radially expanded
configuration in broken line.
[0028] The length and dimensions of the elongate body 12 will
depend on the intended use of the trocar. Typically for
gastrointestinal procedures, elongate body 12 of the trocar will be
sized to be introduced through an endoscope and will have a length
in the range from 50 cm to 500 cm and a width or diameter in the
range from 0.4 mm to 5 mm. The elongate body may be a solid wire or
have a hollow structure with an axial passage or lumen. The body
may be formed from polymers, such as polytetrafluoroethylene
(PTFE), nylon, poly(ether ether ketone) (PEEK) or
polyethyleneterephthalate (PET), or metals, such as stainless
steel, elgiloy, or nitinol. In certain instances, it may be
desirable to reinforce the body with braid, helical wires, or other
conventional components. In other cases, the body may be formed
from different materials over its proximal length and its distal
length. For example, the proximal length may be formed from metal
hypotube or wire while the distal, more flexible portion is formed
from a polymer tube, optionally a reinforced polymer tube. In other
embodiments, the elongate body 12 may be straight and relatively
rigid over its entire length.
[0029] The elongate body 12 will usually have a tissue-penetrating
tip 20 at its distal end, where the tip may be conical, chamfered,
electrosurgical, or be provided in any conventional form for a
trocar. For example, the tip might have a multi-faceted face with
sharpened edges for penetrating, as is commonly employed with
tissue-penetrating trocars (as shown in FIGS. 9A and 9B).
[0030] Referring now to FIG. 2, a first embodiment of the blade
assembly 18 will be described. A single blade 24 is mounted within
the elongate body 12 on a pivot 26. A pair of opposed windows 28
allow the blade to rotate or pivot between an axially aligned
configuration, as shown in broken line, where the blade is fully
refracted within the peripheral envelope of the trocar, and a
radially extended configuration shown in full line where a leading,
cutting edge 30 of the blade is disposed toward the distal end 14.
The blade is biased by a coil spring 32 (a leaf or other spring
could also be used) which is attached at one end to the blade and
the other end to the fixed pivot so that, in the absence of
constraint, the blade will open to its extended configuration as
shown in full line. Thus, when constrained within a sheath or
working channel or other lumen of an endoscope, the blade will be
held in its retracted or constrained configuration, as shown in
broken line. When advanced from the sheath or working channel,
however, the spring 32 will automatically open the blade so that
the cutting edge 30 is exposed to the tissue as the trocar is
advanced. It is also possible for the spring to only partially open
the blade once the trocar is advanced from the sheath, the initial
tissue interference of cutting edge 30 then causing the blade to
fully open and penetrate through the tissue layers. After use, the
blade can be closed by pulling proximally on a tether 34 to close
the blade down to its retracted (broken line) configuration.
[0031] Alternately the blade and constraining sheath can be
configured such that proximal movement of the trocar into the
constraining catheter results in automatic retraction of the blade.
In this instance, as shown in FIG. 2A, the lower rear edge of the
blade 24' has a protrusion 36 that contacts the constraining
catheter as the trocar is moved proximally relative to the sheath,
thus rotating the blade against the spring force into the refracted
configuration. A relief or cut out 38 may also be formed on the
upper rear edge of blade 24' to prevent the rear edge of the blade
from interfering with the catheter as it is retracted.
Alternatively, the upper rear edge of the blade may be sharpened
(in addition to or in place of the cut out 38). Drawing the trocar
into the constraining catheter or sheath causes the protrusion 36
to contact the leading edge of the constraining catheter/sheath
rotating the blade counter-clockwise (as seen in FIG. 2). The
sharpened edge will cut any tissue that may be between it and the
trocar, allowing it to retract fully.
[0032] Referring now to FIG. 3, a further embodiment of the blade
structure 18 includes a pair of opposed blades 40 and 42. Each of
the blades 40, 42 is mounted on a pivot 44 and 46, respectively,
and includes a spring 48 and 50 which will open the blade from the
retracted or constrained configuration shown in broken line to the
extended configuration shown in full line. Each blade has a cutting
edge 52 which is exposed to tissue as the trocar 10 is advanced
distally. The blades each have a tether 34 to permit the blades to
be retracted after use. Alternately these blades can be configured
such that the tip of the retracted blade is positioned distal to
the pivot, requiring a proximal rotation of the blade into the
extended orientation. In this configuration the trocar can
automatically retract as the trocar is pulled distally into the
restraining catheter.
[0033] In the embodiments of both FIGS. 2 and 3, the blades will
not automatically retract as the trocar 10 is pulled back into a
sheath or endoscope. Thus the tethers are needed to retract the
blades prior to pulling the trocars back into the sheath. In other
embodiments, however, as described below, the blades will
automatically retract as the trocar is pulled back into a sheath.
The first such structure is illustrated in FIGS. 2A, 4A/B and
5A/B.
[0034] The trocar 10 of FIGS. 4A and 4B includes blades 60 and 62
mounted on a single common pivot 64. Each blade has a coil spring
66 attached to the blade and pivot in order to open the blade, as
shown in FIGS. 5A and 5B, in the absence of constraint. As shown in
FIGS. 4A and 4B, the blades 60 and 62 are constrained within a
sheath 70 having a passage or channel 72 through which the trocar
can be advanced or retracted. So long as the blades 60 and 62 of
the trocar 10 are within the lumen 72 of the sheath 70, the blades
remain constrained as shown in FIGS. 4A and 4B. By advancing the
distal end 14 of the trocar further from the distal opening of the
sheath 70, as shown in FIGS. 5A and 5B, the blades 60 and 62 will
automatically open under the spring bias so that leading cutting
edges 74 and 76 are exposed to tissue as the trocar is advanced
therethrough. In this embodiment, the blades will automatically
retract and close as the trocar 10 is pulled back within the sheath
70 since the distal end of the sheath will engage the back sides of
the blades to close the blades as they reenter the sheath. Leading
cutting edges 74 and 76 are shown being perpendicular to the axis
of the trocar, however it may be desirable for cutting edges to be
tapered or angled proximally to enhance the ease of the puncture.
In this case, the lateral most tip of the open blade is positioned
proximal to the inboard tip of the blade as shown in FIG. 5C
(blades 60' and 62').
[0035] A variety of other biased blade constructions may be
employed. For example, as shown in FIG. 6A and 6B, multiple blades
80 may be mounted on axially aligned pivots 82 so that the blades
open or unfold in a petal-like manner as they rotate about the
longitudinal axes of the pivots 82. Springs may be provided in
order to unfold the blades 80 and tethers may be provided to close
the blades.
[0036] In still further embodiments, the blades may comprise
deformable structures rather than pivoted structures. For example,
as shown in FIGS. 7A and 7B, a plurality of wire blades 90 will be
provided on the elongate body 12 of the trocar 10. The blades may
be formed from a resilient material, such as spring stainless
steel, Nitinol, or other shape memory materials, and may be heat
set to have the open, cutting configuration as shown in FIG. 7B.
Thus, in the absence of constraint, the blades will "spring" to
their extended cutting configuration. The blades may be retracted
by drawing them into the constraining sheath 92, shown in broken
line in FIG. 7A.
[0037] Referring to FIGS. 8A and 8B, a plurality of blades may be
provided in a variety of configurations. As seen in FIG. 8A, blades
100 and 102 may be axially spaced-apart over the elongate body 12,
while as shown in FIG. 8B, the blades may be radially spaced-apart
in configurations other than 180.degree. opposition.
[0038] A trocar 120 having a single, asymmetrically attached blade
122 is illustrated in FIGS. 9A-9C. The trocar 120 has a faceted tip
124 and a trough or recess 126 which receives the pivotally mounted
blade 122. The blade 122 will be biased, typically by a resilient
structure such as a coil or leaf spring (not shown), to open at an
angle greater than 90.degree. so that the blade is "swept back" as
it is held by engaging the rear edge of the recess 126. The blade
122 has a honed edge 128, as best seen in FIG. 9C, so that it will
cut a wide incision through tissue as the trocar is advanced. The
blade 122 may be closed by refraction back into the lumen or
passage of the deployment sheath.
[0039] Referring now to FIGS. 10A-10D, use of the trocar 10 of
FIGS. 4A/4B and 5A/5B for penetrating a tissue layer TL will be
described. Initially, trocar 10 is advanced to the tissue layer
with the blades retracted within sheath 70 and the penetrating tip
20 of the trocar engaged against the tissue layer. The blades 60
and 62 extend radially as the trocar 10 is advanced from the sheath
70, as shown in FIG. 10B. The penetrating tip 20 of the trocar will
have entered the tissue as the blades extend and the cutting edges
74 and 76 engage the tissue. The trocar continues to be advanced
through the tissue layer TL until it passes out the other side, as
shown in FIG. 10C. It can be seen that the penetration P formed has
a width which is much greater than would have been obtained using
the trocar 10 without the blades 60 and 62. Before withdrawing the
sheath 70, it can be advanced over the sheath to close the blades,
as shown in FIG. 10D, and the sheath can be pulled back through the
penetration P without exposing the blades unintentionally.
[0040] While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. Therefore, the above description
should not be taken as limiting the scope of the invention which is
defined by the appended claims.
* * * * *