U.S. patent application number 11/923357 was filed with the patent office on 2008-06-19 for mechanical distension systems for performing a medical procedure in a remote space.
Invention is credited to Ronald D. Adams, Douglas R. Drew, David L. Foshee, William H. Gruber, Theodore J. Mosler.
Application Number | 20080146872 11/923357 |
Document ID | / |
Family ID | 39365329 |
Filed Date | 2008-06-19 |
United States Patent
Application |
20080146872 |
Kind Code |
A1 |
Gruber; William H. ; et
al. |
June 19, 2008 |
MECHANICAL DISTENSION SYSTEMS FOR PERFORMING A MEDICAL PROCEDURE IN
A REMOTE SPACE
Abstract
Systems are disclosed, for performing therapeutic or diagnostic
procedures at a remote site. According to one embodiment, the
system includes an introducer designed for transcervical insertion
into the uterus. The introducer is constructed to include a fluid
lumen, an instrument lumen, and a visualization lumen. The system
may include a fluid source, which is coupled to the fluid lumen and
is used to deliver a fluid to the uterus either for washing the
uterus or for fluid distension of the uterus. The system
additionally includes a tissue modifying device, such as a
morcellator, and a distension device for distending the uterus
and/or for maintaining the uterus in a distended state. The tissue
modifying device and the distension device are alternately
deliverable to the uterus through the instrument lumen. The system
may further include a hysteroscope deliverable to the uterus
through the visualization lumen.
Inventors: |
Gruber; William H.;
(Southborough, MA) ; Adams; Ronald D.; (Holliston,
MA) ; Foshee; David L.; (Apex, NC) ; Mosler;
Theodore J.; (Raleigh, NC) ; Drew; Douglas R.;
(Raleigh, NC) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET, FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
39365329 |
Appl. No.: |
11/923357 |
Filed: |
October 24, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60857440 |
Nov 7, 2006 |
|
|
|
60910618 |
Apr 6, 2007 |
|
|
|
60910625 |
Apr 6, 2007 |
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Current U.S.
Class: |
600/104 ;
600/158; 606/198 |
Current CPC
Class: |
A61B 2017/22069
20130101; A61B 17/42 20130101; A61B 2017/00867 20130101; A61B
2017/4216 20130101; A61B 1/00135 20130101; A61B 1/303 20130101;
A61M 25/0097 20130101; A61B 2017/3445 20130101; A61B 2017/320775
20130101; A61B 2090/3614 20160201; A61M 25/0023 20130101; A61B
17/0218 20130101 |
Class at
Publication: |
600/104 ;
606/198; 600/158 |
International
Class: |
A61B 1/012 20060101
A61B001/012; A61M 29/00 20060101 A61M029/00 |
Claims
1. A system for use in performing a medical procedure, the system
comprising: a) an introducer for providing access to an internal
site within a body; b) a mechanical expansion structure, the
mechanical expansion structure being deliverable to the internal
site using the introducer; c) a visualization device, the
visualization device being deliverable to the internal site using
the introducer; and d) a tissue modifying device, the tissue
modifying device being deliverable to the internal site using the
introducer.
2. The system as claimed in claim 1 wherein the introducer includes
a dedicated fluid channel, the system further comprising a fluid
source adapted to be coupled to the introducer so that fluid may be
dispensed through the fluid channel.
3. The system as claimed in claim 1 wherein the introducer includes
a plurality of channels.
4. The system as claimed in claim 3 wherein the plurality of
channels includes a first channel, a second channel, and a third
channel, the first channel being the dedicated fluid channel, the
system further comprising a fluid source adapted to be coupled to
the introducer so that fluid may be dispensed through the dedicated
fluid channel.
5. The system as claimed in claim 4 wherein the second channel is
adapted to receive alternately the mechanical expansion structure
and the tissue modifying device.
6. The system as claimed in claim 4 wherein the second channel is
radially expandable.
7. The system as claimed in claim 4 wherein the third channel is
adapted to receive the visualization device.
8. The system as claimed in claim 1 wherein the mechanical
expansion structure is self-expanding.
9. The system as claimed in claim 8 further comprising a tie-line
secured at one end to the mechanical expansion structure.
10. The system as claimed in claim 1 wherein the mechanical
expansion structure is not self-expanding, the system further
comprising an actuator for expanding the mechanical expansion
structure.
11. The system as claimed in claim 1 wherein the visualization
device includes a hysteroscope.
12. The system as claimed in claim 1 wherein the tissue modifying
device includes a morcellator.
13. The system as claimed in claim 1 wherein the introducer
includes a first channel, a second channel, a third channel, and a
fourth channel, the first channel being a fluid channel, the second
channel receiving the mechanical expansion structure, the third
channel receiving the visualization device, and the fourth channel
receiving the tissue modifying device.
14. The system as claimed in claim 13 further comprising a fluid
source coupled to the introducer so that fluid may be dispensed
through the fluid channel.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 U.S.C.
119(e) of U.S. Provisional Patent Application Ser. No. 60/857,440,
filed Nov. 7, 2006, U.S. Provisional Patent Application Ser. No.
60/910,618, filed Apr. 6, 2007, and U.S. Provisional Patent
Application Ser. No. 60/910,625, filed Apr. 6, 2007, all of which
are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to methods and
systems for performing medical procedures and relates more
particularly to a new method and system for performing a medical
procedure.
[0003] There are many types of situations in which it is desirable
for a medical procedure to be performed on a patient. Such a
procedure may be diagnostic and/or therapeutic in nature. For
example, in the field of gynecology, one may wish to examine and/or
treat a uterus for various abnormal conditions including, but not
limited to, the presence of fibroids, polyps, tumors, adhesions, or
other abnormalities within a uterus; endometriosis or other
abnormal bleeding; uterine prolapse; ectopic pregnancy; and
fertility issues (both the inability to conceive and the desire to
avoid pregnancy).
[0004] The uterus is a pear-shaped organ made up two distinct
anatomical regions: the cervix and the corpus. The cervix is a
narrow cylindrical passage (about 1.5-4.0 mm in diameter) which
connects at its lower end with the vagina. The corpus, which is the
portion of the uterus that grows during pregnancy to carry a fetus,
is shaped to include two portions: the lower uterine segment and
the fundus. The cervix widens at its upper end to form the lower
uterine segment of the corpus. The lower uterine segment, in turn,
widens at its upper end into the fundus of the corpus.
Dimensionally, the length of the uterus, measured from the cervix
to the fundus, is approximately 8-10 cm, and the maximum width of
the uterus, which is near the fundus, is about 4-5 cm. Extending
from the fundus of the uterus on either side are fallopian tubes.
The fallopian tubes are continuous with the uterine cavity and
allow the passage of an egg from an ovary to the uterus where the
egg may implant if fertilized.
[0005] To facilitate the examination and/or treatment of the
uterus, there should be ample space within the uterus.
Unfortunately, however, adequate space typically does not exist
naturally in the uterus because the uterus is a flaccid organ. As
such, the walls of the uterus are typically in contact with one
another when in a relaxed state. Consequently, active steps need to
be taken to create a working space within the uterus.
[0006] The conventional technique for creating such a working space
within the uterus is to administer a fluid to the uterus,
transcervically, under sufficient pressure to cause the uterus to
become distended. Examples of the fluid used conventionally to
distend the uterus include gases like carbon dioxide and liquids
like water or certain aqueous solutions (e.g., a saline solution or
a sugar-based aqueous solution).
[0007] With the uterus thus distended, examination of the uterus is
typically performed using a hysteroscope--a visualization device
that is inserted transcervically into the uterus. If fibroids
(i.e., benign tumors), polyps or other abnormalities are detected,
such abnormalities may be removed, for example, by resection.
Certain devices include the combination of visualization means,
such as a hysteroscope, and resection means, such as a morcellator.
Examples of such devices are disclosed in U.S. Pat. No. 6,032,673,
inventor Savage et al., issued Mar. 7, 2000; U.S. Pat. No.
5,730,752, inventors Alden et al., issued Mar. 24, 1998; and PCT
International Publication Number WO 99/11184, published Mar. 11,
1999.
[0008] Although the above-described technique of fluid distension
is commonly practiced, there are certain shortcomings associated
therewith. For example, because the distending fluid is
administered under pressure (which pressure may be as great as 120
mm Hg or greater), there is a risk that such fluids may be taken up
by a blood vessel in the uterus, i.e., intravasation, which uptake
may be quite harmful to the patient. Because the risk of excess
intravasation can lead to death, it is customary to monitor the
fluid uptake on a continuous basis using a scale system. This risk
of excess intravasation is particularly great when the fluid
distension technique is followed by a procedure in which a blood
vessel is cut, such as when abnormal or undesired tissue located in
the uterus is resected.
[0009] Moreover, the above-described technique of fluid distension
suffers from additional shortcomings. For example, throughout the
entire period of time that the diagnostic and/or therapeutic
procedure is performed, the distension fluid must be continuously
administered under pressure to the patient to keep the uterus
distended. This requires the availability of an adequate supply of
the distending fluid. In addition, suitable equipment must be
available to provide the requisite continuous flow of distending
fluid to the patient. Furthermore, the above-described fluid
distension technique may become messy, particularly when a liquid
is used as the distension fluid, as some of the distension fluid
within the uterus may escape proper collection and, instead, may
leak from the patient to the surrounding environment.
[0010] For at least the above reasons, medical procedures involving
fluid distension of the uterus are typically performed in a
hospital and, as a result, bear a large cost due to the setting and
the support personnel required.
SUMMARY OF THE INVENTION
[0011] The present invention provides a method and system as
described below that may be used, for example, in the examination
and/or treatment of the uterus.
[0012] Therefore, according to one aspect of the invention, there
is provided a system for use in performing a medical procedure, the
system comprising: an introducer for providing access to an
internal site within a body; a mechanical expansion structure, the
mechanical expansion structure being deliverable to the internal
site using the introducer; a visualization device, the
visualization device being deliverable to the internal site using
the introducer; and a tissue modifying device, the tissue modifying
device being deliverable to the internal site using the
introducer.
[0013] According to another aspect of the invention, there is
provided a method of performing a medical procedure, said method
comprising the steps of using a mechanical expansion structure to
distend a uterus or to maintain a distended uterus in a distended
state; and performing at least one of examining and treating tissue
located within the distended uterus.
[0014] According to yet another aspect of the invention, there is
provided a method of performing a medical procedure, said method
comprising the steps of inserting an introducer into a body to an
internal site, the introducer including a visualization lumen and
an instrument lumen; delivering a visualization device to the
internal site through the visualization lumen; delivering a
mechanical expansion structure to the internal site; deploying the
mechanical expansion structure to distend the internal site;
observing the distended internal site using the visualization
device; delivering a tissue modifying device to the internal site
through the instrument lumen; and modifying tissue at the internal
site using the tissue modifying device.
[0015] Additional aspects, features and advantages, of the present
invention will be set forth in part in the description which
follows, and in part will be apparent from the description or may
be learned by practice of the invention. In the description,
reference is made to the accompanying drawings which form a part
thereof and in which is shown by way of illustration various
embodiments for practicing the invention. The embodiments will be
described in sufficient detail to enable those skilled in the art
to practice the invention, and it is to be understood that other
embodiments may be utilized and that structural changes may be made
without departing from the scope of the invention. The following
detailed description is, therefore, not to be taken in a limiting
sense, and the scope of the present invention is best defined by
the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The accompanying drawings, which are hereby incorporated
into and constitute a part of this specification, illustrate
various embodiments of the invention and, together with the
description, serve to explain the principles of the invention. In
the drawings wherein like reference numerals represent like
parts:
[0017] FIG. 1 is a plan view, partly in section, of a first
embodiment of a system for use in accessing and in examining and/or
treating a body cavity, the system being constructed according to
the teachings of the present invention and being shown in a
partially disassembled state;
[0018] FIG. 2 is a fragmentary, perspective view, shown partly in
section, of the introducer sheath shown in FIG. 1;
[0019] FIGS. 3(a) through 3(f) are fragmentary, schematic views,
partly in section, showing one way in which the system of FIG. 1
may be used to perform a medical procedure, such as the removal of
a fibroid in a uterus;
[0020] FIGS. 4(a) through 4(d) are fragmentary, schematic views,
partly in section, showing an alternate way in which the system of
FIG. 1 may be used to perform a medical procedure, such as the
removal of a fibroid in a uterus;
[0021] FIG. 5 is a section view of an alternate sheath to the
sheath shown in FIG. 1;
[0022] FIG. 6 is a plan view of a second embodiment of a system for
use in accessing and in examining and/or treating a body cavity,
the system being constructed according to the teachings of the
present invention, with the mechanical expansion structure shown in
a retracted and non-expanded state;
[0023] FIG. 7 is a plan view of the system shown in FIG. 6, with
the mechanical expansion structure shown in an advanced and
non-expanded state;
[0024] FIG. 8 is a plan view of the system shown in FIG. 6, with
the mechanical expansion structure shown in an advanced and
expanded state;
[0025] FIG. 9 is a longitudinal section view of the system shown in
FIG. 6, with the mechanical expansion structure shown in a
retracted and non-expanded state;
[0026] FIG. 10 is a transverse section view of the system shown in
FIG. 6, with the hysteroscope, the morcellator and the distension
mechanism being shown in simplified form;
[0027] FIG. 11 is a plan view of a mechanical expansion structure
that may be used to maintain a uterus in a distended state, the
mechanical expansion structure being constructed according to the
teachings of the present invention; and
[0028] FIGS. 12(a) and 12(b) are fragmentary schematic views,
partly in section, illustrating one way in which the mechanical
expansion structure of FIG. 11 may be used to maintain a uterus in
a distended state.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0029] Referring now to FIG. 1, there is shown a plan view, partly
in section, of one embodiment of a system that may be used in
accessing and in examining and/or treating a body cavity, the
system being constructed according to the teachings of the present
invention and being represented generally by reference numeral
11.
[0030] System 11, which is shown in a partially disassembled state,
is particularly well-suited for use in accessing and examining
and/or treating the uterus of a female patient. However, it should
be understood that system 11 is not limited to such a use and may
be used in other anatomies that may be apparent to those of
ordinary skill in the art.
[0031] System 11 may comprise an introducer 12, a visualization
device 13, a distension device 14 and a tissue modifying device 15.
Introducer 12, in turn, may include a first port 16, a second port
17, a third port 19, and a flexible sheath 21. Ports 16, 17 and 19
are typically not intended for insertion into a patient whereas the
distal end of sheath 21 is typically configured for insertion into
a patient. A distal zone on sheath 21, configured to extend through
and beyond the cervix typically has an OD of less than about 9 mm,
typically less than about 8 mm and preferably less than about 7 mm
(e.g., less than about 5.5 mm).
[0032] First port 16, which may be adapted to receive, for example,
the distal end of a fluid-containing syringe (not shown) or other
fluid source, may be shaped to include a proximal end 25, a distal
end 27 and a longitudinal lumen 29. A helical thread or luer lock
31 may be provided on the exterior of port 16 near proximal end 25
to matingly engage a complementary thread or luer lock on a syringe
or the like. Second port 17, which may be adapted to receive, for
example, mechanical distension device 14, tissue modifying device
15, or another desired tool, may be shaped to include a proximal
end 31, a distal end 33 and a longitudinal lumen 35. Third port 19,
which may be adapted to receive, for example, visualization device
13, may be shaped to include a proximal end 37, a distal end 39 and
a longitudinal lumen 41. Each of first port 16, second port 17, and
third port 19 may be made of a rigid material, such as a rigid,
medical grade plastic.
[0033] Sheath 21, which is also shown in FIG. 2, may be an
elongated member made of an elastic or compliant or substantially
noncompliant material, depending upon the desired radial expansion
characteristic. Sheath 21 may be shaped to include a trifurcated
proximal end and an unbranched distal end 43. The trifurcated
proximal end of sheath 21 may include a first arm 45, a second arm
47 and a third arm 49. First arm 45 may be secured to distal end 27
of first port 16, second arm 47 may be secured to distal end 33 of
second port 17, and third arm 49 may be secured to distal end 39 of
third port 19. Sheath 21 may include a plurality of longitudinal
lumens 51, 53 and 55, the proximal end of lumen 51 being aligned
with lumen 29 of port 15, the proximal end of lumen 53 being
aligned with lumen 35 of port 17, and the proximal end of lumen 55
being aligned with lumen 41 of port 19.
[0034] As will be discussed further below, sheath 21 is preferably
appropriately dimensioned to permit its insertion into a desired
anatomy, such as, in the present embodiment, to permit its
transcervical insertion into a uterus. For such an application,
sheath 21 is preferably about 22-25 cm in length.
[0035] In the illustrated embodiment, sheath 21 is provided with a
dedicated fluid lumen 51, placing the proximal fluid port 16 in
communication with a distal opening on fluid lumen 51. The
dedicated fluid lumen 51 permits controllable and optimized fluid
infusion rates, compared to a multi-function lumen such as in an
alternate embodiment in which fluid is infused in the annular space
surrounding another tool such as a visualization element or
distension device. The dedicated fluid lumen 51 is preferable in an
embodiment in which simultaneous tissue cutting and tissue removal
is to be accomplished. Fluid may be introduced through the lumen 51
to the working site, to facilitate aspiration of morcellated or
otherwise cut tissue through the tissue removal device and out of
the patient. The dedicated fluid lumen 51 may be omitted, in an
embodiment in which a grasper or other tool is repeatedly
introduced and withdrawn through a working channel in order to
remove the desired volume of tissue.
[0036] Visualization device 13, which may be used for direct visual
observation of a uterus, may be, for example, a rod-lens
hysteroscope or a flexible hysteroscope and is shaped to include a
proximal end 63 and a distal end 65. Device 13 may be inserted into
introducer 12 through third (visualization) port 19, preferably
with proximal end 63 of device 13 not being inserted into
introducer 12 and with distal end 65 of device 13 being positioned
at or beyond distal end 43 of sheath 21.
[0037] In the illustrated embodiment, the visualization port 19 is
in communication with a visualization lumen 55. Visualization lumen
55 extends throughout the length of the sheath 21 to the distal
end. In one embodiment (not illustrated), the distal end of the
visualization lumen 55 is provided with a transparent barrier such
as a window or lens, so that the visualization lumen 55 has a
closed distal end. This prevents the introduction of body fluids
into the visualization lumen 55, and thereby avoids contamination
of the visualization device 13. In this embodiment, the
visualization device 13 may be advanced distally through
visualization lumen 55 to a position at or about the location of
the distal window, and visualization may be accomplished through
the closed end of the visualization lumen 55 without contact
between the hysteroscope and body fluids.
[0038] Distension device 14, which may be particularly well-suited
for distending the uterus of a patient, comprises a mechanical
expansion structure. Expansion of the expansion structure can be
accomplished either actively or passively, depending upon the
desired clinical functionality. Active expansion occurs in response
to the application of force by the clinician, which may be
accomplished in of a variety of ways. For example, rotatable knobs,
slider switches, thumb wheels or other controls may be actuated to
axially proximally retract or distally advance an actuation wire,
or rotate a threaded shaft. An electrical signal can be utilized to
activate an electromechanical expansion structure, or any of a
variety of inflation media including gas or liquid can be utilized
to activate an inflatable component on an active expansion
structure. Passive expansion structures include structures which
will self expand following the removal of a restraint. When in a
constrained configuration, the passive mechanical expansion
structures typically exhibit a spring force bias in the direction
of the expanded configuration. This may be accomplished using any
of a variety of spring constructions, and also through the use of
shape memory materials such as various Nitinol or elgiloy alloys,
in some instances stainless steel, and shape memory polymeric
material which are known in the art.
[0039] In the present embodiment, said mechanical expansion
structure comprises a self-expanding scaffolding 83. Scaffolding 83
may include a resiliently-biased foldable weave of filaments 84
made of Nitinol (nickel-titanium alloy) shape-memory alloy, spring
steel or a similar shape-memory material. Scaffolding 83 may be
constructed so that, when fully expanded within a uterus, it
distends the uterus or a portion of the uterus to a desired extent.
If desired, scaffolding 83 may be constructed so that its expanded
shape mimics the shape of the uterus. Preferably, scaffolding 83 is
constructed to distend the uterus to an extent equivalent to that
which would be attained using the above-described conventional
fluid distension technique at a pressure of at least 40 mm Hg but
not greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg. If desired, scaffolding 83 may be
constructed to provide a uniform radial force in all directions or
may be constructed to provide different radial forces in different
directions, such as along the coronal and sagittal planes.
[0040] The woven filaments 84 making up scaffolding 83 may be sized
and spaced (e.g., diameter, length, width) to effectively cover a
small portion of the contacted surface area, thereby leaving one or
two or more large working "windows" between adjacent filaments 84
through which diagnostic and/or therapeutic tool may be advanced
and/or procedures may be performed, or the members may be sized and
spaced to cover a large portion of the contacted surface area, with
comparatively smaller "windows." It should be noted that, by
appropriately sizing and positioning such "windows" over a target
tissue, scaffolding 83 may cause a target tissue to avulse through
a window and into the interior of scaffolding 83, where it may then
be treated. (As seen in FIGS. 3(d) and 4(c), scaffolding 83 may
additionally be provided with an enlarged window 86, which may be
used to provide facile access to target tissue from within
scaffolding 83.)
[0041] Distension device 14 may further comprise an outer sheath
85. Sheath 85, which may be a unitary, tubular member, has a
proximal end 87 and a distal end 89. Sheath 85 may be inserted into
introducer 12 through second port 17, preferably with proximal end
87 remaining external to introducer 12 and with distal end 89 being
positioned at or beyond distal end 43 of sheath 21. As will be
discussed further below, when scaffolding 83 is positioned within
sheath 85, scaffolding 83 is maintained in a compressed state by
sheath 85. By contrast, when scaffolding 83 is positioned distally
relative to sheath 85, scaffolding 83 may self-expand.
[0042] Distension device 14 may further comprise a tie-line 91 and
an ejector rod 92. Tie-line 91 may have a proximal end 93 extending
proximally from sheath 85 and a distal end fixed to scaffolding 83.
Ejector rod 92 may be slidably and removably mounted within sheath
85 for ejecting scaffolding 83 distally from sheath 85.
[0043] Tissue modifying device 15 may comprise a morcellator and/or
another tissue modifying device including, for example, a drug
delivery device. In the present embodiment, tissue modifying device
15 is a morcellator, which may be used to remove abnormalities,
such as fibroids and polyps, from a uterus. The morcellator may be
conventional in size, shape and construction, and may have a
proximal end 97 and a distal end 99. Tissue modifying device 15 may
be inserted into introducer 12 through second port 17, preferably
with proximal end 97 not being inserted into introducer 12 and with
distal end 99 being positioned at or beyond distal end 43 of sheath
21.
[0044] Referring now to FIGS. 3(a) through 3(f), there is shown one
way in which system 11 may be used to perform a medical procedure.
For illustrative purposes, system 11 is shown in FIGS. 3(a) through
3(f) being used to remove a fibroid F from a uterus; however, it
should be understood that system 11 may be used to perform other
types of medical procedures, whether in the uterus or otherwise.
First, as seen in FIG. 3(a), with visualization device 13 loaded
into introducer 12 through third port 19, and with a fluid source,
such as a fluid-containing syringe 100, coupled to first port 16,
distal end 43 of sheath 21 is inserted transcervically into the
patient up to the os (i.e., the portion of the anatomy where the
cervix CE transitions to the corpus CO). At this time, it may be
desirable to dispense at least some of the fluid contained in
syringe 100 through lumen 51 to wash distal end 65 of visualization
device 13 (as mucus, blood and other debris may have become
deposited on distal end 65 of visualization device 13 during the
insertion of visualization device 13 into the patient), unless a
closed visualization lumen is used as discussed above, as well as
to flush the uterus. Next, distension device 14 is loaded into
introducer 12 through second port 17 so that distal end 89 of
sheath 85 is positioned at or beyond distal end 43 of sheath 21. As
seen in transverse cross-section in FIG. 3(b), the insertion of
distension device 14 into sheath 21 causes sheath 21 to expand
radially to accommodate distension device 14. To minimize
discomfort to the patient, such as by obviating the need for
administration of anesthetic to the patient, the expanded
cross-sectional diameter of sheath 21 is preferably less than about
5.5 mm, more preferably less than about 5.0 mm.
[0045] Next, ejector rod 92 is used to eject scaffolding 83
distally from sheath 85, whereby scaffolding 83 automatically
self-expands to distend corpus CO. Ejector rod 92 and sheath 85 are
then removed proximally from introducer 12. As seen in FIG. 3(c),
this leaves scaffolding 83 deployed in the uterus, with the distal
end of tie-line 91 connected to scaffolding 83 and proximal end 93
of tie-line 91 passing through introducer 12 and remaining external
to the patient. It may be noted that the removal of ejector rod 92
and sheath 85 from introducer 12 causes sheath 21 to return back to
its original transverse cross-sectional size. With the uterus thus
distended by scaffolding 83, a visual examination of the uterus may
be conducted using visualization device 13. In the event that a
fibroid or other abnormality is detected that one wishes to remove,
then, as seen in FIG. 3(d), tissue modifying device 15 is loaded
into introducer 12 through second port 17 along side of tie-line
91, tissue modifying device 15 being moved distally until
positioned in the area of the fibroid F one wishes to remove.
(Scaffolding 83 is shown in FIG. 3(d) with an enlarged window 86 to
provide facile access to target tissue through scaffolding 83.) As
seen in transverse cross-section in FIG. 3(e), the insertion of
tissue modifying device 15 into sheath 21 again causes sheath 21 to
expand radially. Once again, to minimize discomfort to the patient,
such as by obviating the need for administration of an aesthetic to
the patient, the expanded cross-sectional diameter of sheath 21 is
preferably less than about 5.5 mm, more preferably less than about
5.0 mm.
[0046] With tissue modifying device 15 thus introduced into the
patient, device 15 is used to remove fibroid F. When tissue
modifying device 15 is no longer needed, device 15 is withdrawn
proximally from introducer 12. The withdrawal of tissue modifying
device 15 from introducer 12 causes sheath 21 to return back to its
original transverse cross-sectional size. Sheath 85 is then
inserted over tie-line 91 and loaded back into introducer 12,
causing sheath 21 again to expand radially. Then, as seen in FIG.
3(f), tie-line 91 is pulled proximally until scaffolding 83 is
drawn back into sheath 85. The retraction of scaffolding 83 into
sheath 85, in turn, causes corpus CO to return to its relaxed
state. Finally, the components of system 11 that still remain in
the patient are removed proximally from the patient.
[0047] As compared to existing systems for accessing, examining
and/or treating fibroids in a uterus, system 11 possesses the
benefit of not requiring that a fluid be used to distend the
uterus. Instead, as illustrated above, system 11 uses mechanical
means to distend the uterus. Fluid may be used, however, for
irrigation and aspiration purposes, and to clear the optical field.
This may be accomplished by introduction of fluid through fluid
lumen 51, and aspiration through working lumen 53.
[0048] Referring now to FIGS. 4(a) through 4(d), there is shown
another way in which system 11 may be used to perform a medical
procedure. For illustrative purposes, system 11 is shown in FIGS.
4(a) through 4(d) being used to remove a fibroid from a uterus;
however, it should be understood that system 11 may be used to
perform other types of medical procedures, whether in the uterus or
otherwise. First, as seen in FIG. 4(a), with visualization device
13 loaded into introducer 12 through third port 19, and with a
fluid source, such as a fluid-containing syringe 100, coupled to
first port 16, distal end 43 of sheath 21 is inserted
transcervically into the patient up to the os. At this time, it may
be desirable to dispense at least some of the fluid contained in
syringe 100 through lumen 51 to wash distal end 65 of visualization
device 13, as well as to flush the uterus.
[0049] Next, distension device 14 is inserted transcervically into
the patient up to the os. However, it should be noted that, as
compared to the technique discussed above in which distension
device 14 is inserted through introducer 12, distension device 14
is inserted in the present embodiment parallel to, but outside of,
introducer 12. To minimize discomfort to the patient, such as by
obviating the need for administration of an aesthetic to the
patient, the combined cross-sectional diameter of sheath 21 and
distension device 14 is preferably less than about 5.5 mm, more
preferably less than about 5.0 mm.
[0050] Next, as seen in FIG. 4(b), ejector rod 92 is used to eject
scaffolding 83 distally from sheath 85, whereby scaffolding 83
automatically self-expands to distend corpus CO. Ejector rod 92 and
sheath 85 are then removed proximally from the patient, leaving
scaffolding 83 deployed in the uterus, with proximal end 93 of
tie-line 91 remaining external to the patient. With the uterus thus
distended by scaffolding 83, a visual examination of the uterus may
be conducted using visualization device 13. In the event that a
fibroid F or other abnormality is detected that one wishes to
remove, then, as seen in FIG. 4(c), tissue modifying device 15 is
loaded into introducer 12 through second port 17 and is inserted
into the distended uterus. (Scaffolding 83 is shown in FIG. 4(c)
with an enlarged window 86 to provide facile access to target
tissue through scaffolding 83.) The insertion of the tissue
modifying device 15 into sheath 21 causes sheath 21 to expand
radially. To minimize discomfort to the patient, such as by
obviating the need for administration of an aesthetic to the
patient, the combined cross-sectional diameter of sheath 21 and
tie-line 91 is preferably less than about 5.5 mm, more preferably
less than about 5.0 mm.
[0051] With tissue modifying device 15 thus introduced into the
uterus of the patient, device 15 may then be used to remove fibroid
F. When tissue modifying device 15 is no longer needed, device 15,
introducer 12 and visualization device 13 are withdrawn proximally
from the patient. Sheath 85 is then inserted distally over proximal
end 93 of tie-line 91 and is re-introduced transcervically into the
patient. Then, as seen in FIG. 4(d), tie-line 91 is then pulled
proximally until scaffolding 83 is retracted into sheath 85. The
retraction of scaffolding 83 into sheath 85, in turn, causes corpus
CO to return to its relaxed state. Scaffolding 83 and sheath 85 are
then removed proximally from the patient.
[0052] According to yet another embodiment (not shown), prior to
inserting introducer 12 and visualization device 13 into the
patient, distension device 14 is inserted transcervically into the
patient, scaffolding 83 is deployed in the uterus, and ejector rod
92 and sheath 85 are removed from the patient. Introducer 12 and
visualization device 13 are then inserted into the patient, with
introducer 12 being inserted along side of tie-line 91. The uterus
may then be examined and treated in the manner described above.
Alternatively, prior to inserting distension device 14 into the
patient, one could insert introducer 12 and visualization device 13
into the patient, use visualization device 13 to take a quick look
at the uterus to make sure that there is no reason why distension
device 14 should not be used, remove introducer 12 and
visualization device 13 from the patient and then, assuming no
reason was detected to preclude using distension device 14, proceed
in the fashion described above.
[0053] Referring now to FIG. 5, there is shown a section view of an
alternate sheath which may be used instead of sheath 21 as part of
introducer 12, the alternate sheath being constructed according to
the teachings of the present invention and represented generally by
reference numeral 101.
[0054] Sheath 101, which preferably is flexible, may comprise an
inner member 103 and an outer film 105. Inner member 103, which may
be made of a semi-rigid material, is shaped such as by extrusion to
include a first lumen 104 and a second lumen 106. First lumen 104
may be aligned with longitudinal lumen 29 of first port 16, and
second lumen 106 may be aligned with longitudinal lumen 41 of port
19.
[0055] Outer film 105 and inner member 103 jointly define a third
lumen 107, which may be aligned with longitudinal lumen 35 of port
17. Preferably, film 105 is an elastic material capable of radial
expansion so that third lumen 107 may expand when distension device
14 or tissue modifying device 15 is inserted into lumen 107 and may
return to a compact state when neither is inserted into lumen
107.
[0056] Referring now to FIGS. 6 through 10, there are shown various
views of a second embodiment of a system for use in accessing and
in examining and/or treating a body cavity, the system being
constructed according to the teachings of the present invention and
being represented generally by reference numeral 111.
[0057] System 111, like system 11, is particularly well-suited for
use in accessing and in examining and/or treating the uterus of a
female patient. However, it should be understood that system 111 is
not limited to such a use and may be used in other anatomies that
may be apparent to those of ordinary skill in the art.
[0058] System 111 may comprise an introducer 112, a visualization
device 113, a distension device 114 and a tissue modifying device
115. Introducer 112, in turn, may include a first member 116, a
second member 117, a third member 119, and a sheath 121. Members
116, 117 and 119 are typically not intended for insertion into a
patient whereas the distal end of sheath 121 is typically intended
for insertion into a patient. First member 116, which may be
adapted to receive, for example, the distal end of a
fluid-containing syringe (not shown) or another fluid source, may
be shaped to include a proximal end 125, a distal end (not shown)
and a longitudinal lumen (not shown). A helical thread or luer lock
131 may be provided on the exterior of member 116 near proximal end
125 to matingly engage a complementary thread or luer lock on a
syringe or the like. Second member 117, which may be adapted to
receive, for example, distension device 114 and tissue modifying
device 115, may be shaped to include a proximal end 131, a distal
end (not shown) and a pair of longitudinal lumens 135 and 136.
Third member 119, which may be adapted to receive, for example,
visualization device 113, may be shaped to include a proximal end
137, a distal end (not shown) and a longitudinal lumen (not shown).
Each of first member 116, second member 117, and third member 119
may be made of a rigid material, such as a rigid, medical grade
plastic.
[0059] Sheath 121 may be an elongated member made of an elastic
material capable of radial expansion in one or more places. Sheath
121 may be shaped to include a branched proximal end and an
unbranched distal end 143. The branched proximal end of sheath 121
may include a first arm 145, a second arm 147 and a third arm 149.
First arm 145 may be secured to the distal end of first member 116,
second arm 147 may be secured to the distal end of second member
117, and third arm 149 may be secured to the distal end of third
member 119. Sheath 121 may include a plurality of longitudinal
lumens 151, 153, 154 and 155, the proximal end of lumen 151 being
located in first arm 145 and aligned with the lumen of member 116,
the proximal end of lumen 153 being located in second arm 147 and
aligned with lumen 135 of member 117, the proximal end of lumen 154
being located in second arm 147 and aligned with lumen 136 of
member 117, and the proximal end of lumen 155 being located in
third arm 149 and aligned with the lumen of member 119.
[0060] Sheath 121 is preferably appropriately dimensioned to permit
its insertion into a desired anatomy, such as, in the present
embodiment, to permit its transcervical insertion into a
uterus.
[0061] Visualization device 113, which may be used for direct
visual observation of a uterus, may be, for example, a rod-lens
hysteroscope or a flexible hysteroscope. (For simplicity and
clarity, visualization device 113 is shown only in FIG. 10 and is
showed therein in simplified form.) Device 113 may be inserted into
introducer 112 through third member 119, preferably with the
proximal end of device 113 not being inserted into introducer 112
and with the distal end of device 113 being positioned at or beyond
distal end 143 of sheath 121.
[0062] Distension mechanism 114, which may be particularly
well-suited for distending the uterus of a patient, may comprise an
elongated structure slidably disposed in lumens 135 and 153. The
elongated structure may comprise a proximal portion 183 and a
distal portion 185. Proximal portion 183 may be an elongated member
having a handle 187 at its proximal end and a plurality of teeth
189 along its top surface. Proximal portion 183 may be made of a
rigid material, such as a rigid, medical grade plastic. Distal
portion 185 may be an elongated member preferably made of a
resilient material, such as Nitinol (nickel-titanium alloy)
shape-memory alloy, spring steel, a shape-memory plastic, or a
similar shape-memory material.
[0063] Distal portion 185 may be bent at a point 188, with one end
191 of distal portion 185 being fixed to the distal end 190 of
proximal portion 183 and the opposite end 193 of distal portion 185
being fixed to a ring 195 slidably inserted over an intermediate
portion of distal portion 185. As a result, as can be seen by
comparing FIGS. 7 and 8, when ring 195 is distally advanced to a
position proximate to point 188 (FIG. 8), distal portion 185 "bows
out" to assume an expanded shape. Alternatively, when ring 195 is
proximally retracted with respect to point 188, distal portion 185
assumes a non-expanded shape.
[0064] As can be appreciated, distal portion 185 may be constructed
so that, when fully expanded within a uterus, it distends the
uterus or a portion of the uterus to a desired extent. If desired,
distal portion 185 may be constructed so that its expanded shape
mimics the shape of the uterus. Preferably, distal portion 185 is
constructed to distend the uterus to an extent equivalent to that
which would be attained using the above-described conventional
fluid distension technique at a pressure of at least 40 mm Hg but
not greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg.
[0065] Distension mechanism 114 may additionally include a
mechanism for selectively positioning ring 195 so that distal
portion 185 may assume an expanded shape at any desired point
within a working range in between a fully expanded shape and a
non-expanded shape. Said ring-positioning mechanism may comprise a
biasing mechanism such as coiled spring 197 and a control such as
switch 199. Coiled spring 197, which may be inserted coaxially over
adjacent sections of proximal portion 183 and distal portion 185,
may have a proximal end 201 fixed to switch 199 and a distal end
203 fixed to ring 195. Switch 199, which may be inserted coaxially
over proximal portion 183, is accessible through a transverse slot
205 in second member 117 and is adapted for sliding movement back
and forth between the proximal and distal ends of slot 205. A pawl
207 may be pivotally mounted in switch 199 to engage teeth 189 in a
ratchet-like fashion. In this manner, when switch 199 is moved
distally within slot 205, undesired proximal movement of switch 199
is prevented. However, when one wishes to return switch 199 to its
proximal position, pawl 207 may be pivoted away from engagement
with teeth 189, thereby allowing spring 197 to decompress, which,
in turn, causes switch 199 to be moved back to its proximal
position.
[0066] Tissue modifying device 115 may comprise a morcellator or
other mechanical cutting tool, or a transducer or emitter for any
of a variety of energy forms such as laser, ultrasound, RF or
others known in the art. Another tissue treating device includes,
for example, a drug delivery device. In the present embodiment,
tissue modifying device 115 is a side opening or end opening
morcellator, which may be used to remove abnormalities, such as
fibroids and polyps, from a uterus. (For simplicity and clarity,
tissue modifying device 115 is shown only in FIG. 10 and is shown
therein in simplified form.) Tissue modifying device 115 may be
inserted into introducer 112 through lumen 136 of second member
117, preferably with the proximal end of device 115 not being
inserted into introducer 112 and with the distal end of device 115
being positioned at or beyond distal end 143 of sheath 121.
[0067] One way in which system 111 may be used is as follows:
First, system 111 is prepped by loading visualization device 113
into introducer 112 through third member 119 and by ensuring that
distension mechanism 114 is in its retracted and non-expanded state
(as in FIGS. 6 and 9). In addition, a fluid source, such as a
fluid-containing syringe, is preferably coupled to first member
116. Next, distal end 143 of sheath 121 is inserted transcervically
into the patient up to the os. At this time, it may be desirable to
dispense at least some of the fluid contained in the syringe
through lumen 151 to wash the distal end of visualization device
113, as well as to flush the uterus. Next, distension mechanism 114
is placed in its advanced and non-expanded state (as in FIG. 7) by
moving proximal portion 183 distally until handle 187 abuts
proximal end 131 of second member 117. (Pawl 207 will need to be
pivoted out of engagement with teeth 189 as proximal portion 183 is
moved distally.) Next, distension mechanism 114 is placed in its
advanced and expanded state (as in FIG. 8) by moving switch 199
from its proximal position within slot 205 to its distal position
within slot 205. With the uterus thus distended, a visual
examination of the uterus may be conducted using visualization
device 113. In the event that a fibroid or other abnormality is
detected that one wishes to remove, then the tissue modifying
device 115 is loaded into introducer 112 through lumen 136 of
second member 117 and into lumen 154 of sheath 121. As seen in FIG.
10, the introduction of tissue modifying device 115 into lumen 154
causes sheath 121 to be distended. Next, tissue modifying device
115 is moved distally until positioned in the area of the fibroid
or other abnormality one wishes to remove. Tissue modifying device
115 is then used to remove the fibroid. When tissue modifying
device 115 is no longer needed, device 115 is withdrawn proximally
from introducer 112. Distension mechanism 114 is then placed in its
advanced and non-expanded state by moving pawl 207 out of
engagement with teeth 189, thereby causing spring 197 to pull ring
195 away from point 188 (and causing switch 199 to be moved back to
the proximal end of slot 205). Distension mechanism 114 is then
placed in its retracted and non-expanded state by pulling handle
187 proximally until distal portion 185 is retracted into sheath
121. Finally, the components of system 111 that still remain in the
patient are removed proximally from the patient.
[0068] In the various embodiments discussed above, although fluid
may be used to flush the uterus and/or the distal end of the
visualization device, non-fluid mechanical means are used to
distend the uterus. However, according to a further aspect of the
invention, fluid means are used initially to distend the uterus,
and non-fluid mechanical means are thereafter used to maintain the
uterus in its distended state. As can be appreciated, this two-part
distension technique is not limited to the particular types of
distension devices described above.
[0069] Referring now to FIG. 11, there is shown a plan view of a
mechanical expansion device suitable for use in practicing the
aforementioned two-part distension method, the mechanical expansion
device being constructed according to the teachings of the present
invention and being represented generally by reference numeral
301.
[0070] Device 301 may comprise a pair of arms 303 and 305. A
pressure pad 307 may be mounted on the outer end of arm 303, and a
pressure pad 308 may be mounted on the outer end of arm 305. The
inner ends of arms 303 and 305 may be joined to a spring 309 that
biases arms 303 and 305 away from one another. A loop 311, whose
purpose will become apparent below, may be positioned adjacent to
spring 309.
[0071] Referring now to FIGS. 12(a) and 12(b), there is shown one
way in which device 301 may be used to maintain a uterus in a
distended state. In FIG. 12(a), a pair of devices 301 are shown
loaded into lumen 53 of introducer 13, introducer device 13 having
been inserted transcervically into a patient up to the os. The
uterus of the patient is shown distended with a distension fluid,
which preferably has previously been delivered to the uterus by
means of a fluid-containing syringe (not shown) coupled to lumen
51. Devices 301 may be ejected from lumen 53 of introducer device
13 into the distended uterus by an ejector rod 315. In FIG. 12(b),
devices 301 are shown deployed in the uterus to maintain the uterus
in its already distended state. With the uterus thus maintained in
its distended state, a morcellator or other desired tool may be
inserted through lumen 53 of introducer 13 into the uterus. When
distension of the uterus is no longer desired, devices 301 may be
removed from the uterus by inserting a hook 319 or similar
structure into the uterus through introducer 13, using hook 319 to
grasp devices 301 by their respective loops 311, and then pulling
hook 319 proximally to retract the hooked devices 301 into lumen 53
of introducer 13.
[0072] In general, the mechanical distension device is thus any of
a wide variety of structures which are capable of translumenal
introduction through the working channel in a first, reduced cross
sectional profile and transformation to a second, enlarged cross
sectional profile once in the vicinity of the treatment site. The
second, enlarged cross sectional profile creates a sufficient space
at the site to allow manipulation of diagnostic or therapeutic
tools necessary for the intended procedure. This may be, for
example, equivalent to at least the volume of the cavity created by
70 to 80 mm Hg of fluid distension.
[0073] Typically, the distension provided by a fluid or gas is
diffuse in nature. Rather than creating a discrete working space at
the desired treatment site, the media expands the associated cavity
without preference. In the case of uterine distension, a fluid
pressure of 35 to 60 mm Hg typically produces a cavity of 10 to 50
cc in total volume. But the volume of the distension media is
distributed evenly throughout the entire uterus, so that the
effective working space provided in the immediate vicinity of any
particular treatment site is relatively small compared to the total
volume of the cavity. The addition of additional pressure that can
reach 100 to 120 mm Hg does provide additional cavity volume but at
the risk of fluid intravasation and greater pain for the
patient.
[0074] One particular advantage of the mechanical distension
structures in accordance with the present invention is the ability
to create a specific working space at a desired site, while leaving
other parts of the cavity in its collapsed configuration. By
localizing the distension to the desired site, the size of the
working cavity at that site can be optimized while minimizing the
total volume of the distension and the associated pain for the
patient.
[0075] For example, it may be desirable to provide a working space
in the immediate vicinity of a treatment site having dimensions
that would approximate a 10 cc sphere. To create that same working
space by infusion of distension media, the infused volume may need
to be at least about 40 cc or 50 cc or more. Thus, in accordance
with the present invention, the working space created at the
desired site is at least about 50%, often at least about 70% and
preferably at least about 85% of the enclosed volume of the
expandable portion of the distension device. The working space may
be approximately equal to the volume of the expanded device, which
may be less than about 50%, often less than about 35% and
preferably less than about 25% of the volume of distension media
which would be necessary to achieve a similar working volume at the
treatment site.
[0076] The expansion device may be permanently attached to the
distal end of an operating shaft, permanently attached to the
distal end of a tether, or detachable at the treatment site. Any of
a wide variety of detachable expansion structures may be
subsequently removed by advancing a grasper down the working
channel and grasping the device under endoscopic visualization. The
device may be thereafter be proximally retracted into the working
channel and reduced in cross section for removal.
[0077] In general, the tissue distension structure will have at
least a first surface for contacting a first tissue zone and a
second surface for contacting a second tissue zone. Activation of
the distension structure advances the first and second surfaces
away from each other, to enlarge the distance between the first and
second tissue zones. In the embodiment illustrated in FIGS. 7 and
8, for example, the tissue distension structure opens such that it
resides substantially within a single plane which contains the
longitudinal axis of the device. In alternative embodiments, the
tissue distension structure may open in two transverse planes
having an intersection along the longitudinal axis of the device,
or such that the distension structure opens into a more complex
three dimensional configuration, including spherical, elliptical,
and other geometric forms of rotation about an axis. In each
instance, the tissue distension device preferably includes at least
one opening in a side or end wall thereof, to permit access to the
target tissue.
[0078] Thus, the embodiment of FIGS. 7 and 8 can be modified such
that two or three or four or more axially extending ribs are
advanceable from a generally axially extending configuration such
as that illustrated in FIG. 7 to a radially outwardly inclined
configuration such as that illustrated in FIG. 8.
[0079] In an alternate embodiment (not illustrated), a plurality of
axially extending ribs are connected together at a distal end to a
pull wire which extends to the proximal end of the instrument. The
proximal ends of the ribs are connected to a tubular column
strength support having a central lumen through which the pull wire
extends. Proximal retraction of the pull wire axially shortens the
distension element while simultaneously radially expanding the ribs
to the second, radially enlarged configuration to produce a cage
having a three dimensional volume.
[0080] Both the endoscope and the tissue cutting element may be
provided in a steerable configuration, such that they may be
distally advanced into the working space created by the distension
element and laterally deflected which, in combination with axial
rotation, gives access to a wide variety of treatment sites within
the distension structure. Any of a wide variety of deflection
mechanisms may be utilized, as are well understood in the art,
including axially extending pull wires and push wires mechanically
linked to a proximal control such as a rotatable knob or slider
switch.
[0081] In any of the foregoing embodiments, the expansion structure
may be utilized both to accomplish initial expansion as well as
retention of the tissue in the expanded configuration.
Alternatively, fluid pressure such as water pressure as has been
used conventionally may be utilized to achieve tissue expansion,
and the expansion structures of the present invention may be
utilized to retain the tissue in the expanded configuration. At
that point, the fluid pressure may be reduced, such that the risk
of intravasation is thereby eliminated.
[0082] The embodiments of the present invention described above are
intended to be merely exemplary and those skilled in the art shall
be able to make numerous variations and modifications to it without
departing from the spirit of the present invention. All such
variations and modifications are intended to be within the scope of
the present invention as defined in the appended claims.
* * * * *