U.S. patent application number 12/432647 was filed with the patent office on 2009-10-29 for access device with enhanced working channel.
This patent application is currently assigned to Interlace Medical , Inc.. Invention is credited to Ronald David Adams, Albert Chun-Chi Chin, William Harwick Gruber, Eric Karl Litscher, Danny Macari.
Application Number | 20090270812 12/432647 |
Document ID | / |
Family ID | 55968834 |
Filed Date | 2009-10-29 |
United States Patent
Application |
20090270812 |
Kind Code |
A1 |
Litscher; Eric Karl ; et
al. |
October 29, 2009 |
ACCESS DEVICE WITH ENHANCED WORKING CHANNEL
Abstract
Disclosed is a surgical access device for providing at least one
auxiliary lumen for the insertion of a surgical instrument or other
therapeutic device into a patient's body. The device comprises a
first working channel, a second working channel and at least one
additional lumen for infusion of a distension media. The surgical
access device comprises an outer diameter, and the ratio of the
outer diameter to the inside diameter of the working channel is
preferably less than about 2.25.
Inventors: |
Litscher; Eric Karl;
(Hopkinton, MA) ; Macari; Danny; (Natick, MA)
; Chin; Albert Chun-Chi; (Newton, MA) ; Adams;
Ronald David; (Holliston, MA) ; Gruber; William
Harwick; (Southborough, MA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET, FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
Interlace Medical , Inc.
Framingham
MA
|
Family ID: |
55968834 |
Appl. No.: |
12/432647 |
Filed: |
April 29, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12098250 |
Apr 4, 2008 |
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12432647 |
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12098318 |
Apr 4, 2008 |
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12098250 |
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60910618 |
Apr 6, 2007 |
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60910625 |
Apr 6, 2007 |
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60986912 |
Nov 9, 2007 |
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Current U.S.
Class: |
604/164.01 |
Current CPC
Class: |
A61B 2017/2905 20130101;
A61B 17/320783 20130101; A61B 17/3498 20130101; A61B 17/32056
20130101; A61B 2017/3447 20130101; A61M 1/0082 20140204; A61B 8/12
20130101; A61B 90/30 20160201; A61B 2017/320064 20130101; A61B
17/32002 20130101; A61B 2017/00331 20130101; A61B 17/3462 20130101;
A61B 2017/00685 20130101; A61B 17/32053 20130101; A61B 2010/0208
20130101; A61B 2017/320004 20130101; A61B 17/29 20130101; A61B
2017/4216 20130101; A61B 17/3496 20130101; A61B 17/320725 20130101;
A61B 17/320758 20130101; A61B 2017/3466 20130101; A61B 2217/007
20130101; A61B 2017/320028 20130101; A61B 2017/00738 20130101; A61B
1/303 20130101; A61B 2017/320775 20130101; A61B 2017/3445 20130101;
A61B 17/3421 20130101; A61B 17/42 20130101; A61B 2017/00973
20130101; A61B 2217/005 20130101; A61B 17/3201 20130101; A61B
2018/1407 20130101 |
Class at
Publication: |
604/164.01 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. A surgical access device for providing at least one auxiliary
lumen for the insertion of a surgical instrument or other
therapeutic device into a patients body, said surgical access
device comprising: a first channel providing a first lumen for the
insertion of a surgical instrument with a rigid shaft; a second
channel providing a second lumen for the insertion of a flexible or
semi-rigid visualization device; and at least one other lumen for
the installation of a distension media; wherein the surgical access
device comprises an outer diameter, and the ratio of the outer
diameter to the inside diameter of the working channel is
preferably less than about 2.25.
2. An access device as in claim 1 wherein a distal tip comprises a
flexible bumper tip to enable easy passage through a cervical
os.
3. An access device as in claim 1 wherein the visualization device
comprises independent members for visualization and
illumination.
4. An access device as in claim 1 wherein the instrument channel is
capable of sealing on an inserted instrument when inserted or
providing an outflow channel without the instrument inserted.
5. An access device as in claim 1 wherein the ratio of the overall
outer diameter to the inside diameter of the first channel is
preferably less than about 2.0.
6. An access device as in claim 1 wherein the ratio of the overall
outer diameter to the inside diameter of the first channel is
preferably less than about 2.0.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation in part of U.S.
patent application Ser. No. 12/098,250, filed Apr. 4, 2008 (titled
"METHOD, SYSTEM AND DEVICE FOR TISSUE REMOVAL"), which claims the
benefit under 35 U.S.C. .sctn. 119(e) of U.S. Provisional
Application 60/910,618, filed Apr. 6, 2007, U.S. Provisional Patent
Application Ser. No. 60/910,625, filed Apr. 6, 2007, and U.S.
Provisional Patent Application Ser. No. 60/986,912, filed Nov. 9,
2007 all of which are incorporated herein by reference. The present
application is a continuation in part of U.S. patent application
Ser. No. 12/098,318, filed Apr. 4, 2008 (titled "SYSTEM FOR USE IN
PERFORMING A MEDICAL PROCEDURE AND INTRODUCER DEVICE SUITABLE FOR
USE IN SAID SYSTEM"), which claims the benefit under 35 U.S.C.
.sctn. 119(e) of U.S. Provisional 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, systems
and devices for the removal of tissue and relates more particularly
to methods, systems, and devices well-suited for the removal of
uterine fibroids and other abnormal gynecological tissues.
[0003] It is believed that uterine fibroids occur in a substantial
percentage of the female population, perhaps in at least 20 to 40
percent of all women. Uterine fibroids are well-defined,
non-cancerous tumors that are commonly found in the smooth muscle
layer of the uterus. In many instances, uterine fibroids can grow
to be several centimeters in diameter and may cause symptoms like
menorrhagia (prolonged or heavy menstrual bleeding), pelvic
pressure or pain, and reproductive dysfunction.
[0004] Current treatments for uterine fibroids include
pharmacological therapy, hysterectomy, uterine artery embolization,
and hysteroscopic resection. Pharmacological therapy typically
involves the administration of NSAIDS (non-steroidal
anti-inflammatory drugs), estrogen-progesterone combinations, and
GnRH (gonadotropin releasing hormone) analogues. However, current
pharmacological therapies are largely ineffective and merely
palliative. By comparison, a hysterectomy involves the surgical
removal of the uterus from a patient. For this reason, a
hysterectomy represents a highly effective way of ridding a patient
of uterine fibroids. As a result, several hundred thousand
hysterectomies are typically performed annually in the United
States to treat uterine fibroids. However, despite their widespread
use, hysterectomies also possess certain disadvantages, such as a
loss of fertility, sexual dysfunction, and the risks commonly
associated with a major surgical procedure, such as hemorrhaging,
lesions, infections, pain and prolonged recovery. Uterine artery
embolization involves inserting a catheter into a femoral artery
and then guiding the catheter to a uterine fibroid artery. Small
particles are then injected from the catheter into the fibroid
artery, blocking its blood supply and causing it to eventually
shrink and die. Although this procedure is less invasive than a
hysterectomy, it often results in pain-related, post-surgical
complications. Moreover, the physicians that are trained to perform
uterine artery embolization are typically interventional
radiologists, as opposed to physicians trained specifically to take
care of gynecological problems, whereas the physicians trained
specifically to take care of gynecological problems typically do
not possess the skill to perform catheter-based uterine artery
embolization.
[0005] Hysteroscopic resection typically involves inserting a
hysteroscope (i.e., an imaging scope) into the uterus through the
vagina, i.e., transcervically, and then cutting away the fibroid
from the uterus using a device delivered to the fibroid by the
hysteroscope. Hysteroscopic resections typically fall into one of
two varieties. In one variety, an electrocautery device in the form
of a loop-shaped cutting wire is fixedly mounted on the distal end
of the hysteroscope--the combination of the hysteroscope and the
electrocautery device typically referred to as a resectoscope. The
transmission of electrical current to the uterus with a
resectoscope is typically monopolar, and the circuit is completed
by a conductive path to the power unit for the device through a
conductive pad applied to the patient's skin. In this manner,
tissue is removed by contacting the loop with the part of the
uterus wall of interest. Examples of such devices are disclosed,
for example, in U.S. Pat. No. 5,906,615, inventor Thompson, issued
May 25, 1999.
[0006] In the other variety of hysteroscopic resection, an
electromechanical cutter is inserted through a working channel in
the hysteroscope. Tissue is then removed by contacting the cutter,
which typically has a rotating cutting instrument, with the part of
the uterus wall of interest. Examples of the electromechanical
cutter variety of hysteroscopic resection are disclosed in, for
example, U.S. Pat. No. 7,226,459, inventors Cesarini et al., issued
Jun. 5, 2007; U.S. Pat. No. 6,032,673, inventors Savage et al.,
issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, inventors Alden et
al., issued Mar. 24, 1998; U.S. Patent Application Publication No.
US 2006/0047185 A1, inventors Shener et al., published Mar. 2,
2006; and PCT International Publication No. WO 99/11184, published
Mar. 11, 1999, all of which are incorporated herein by
reference.
[0007] In both of the above-described varieties of hysteroscopic
resection, prior to fibroid removal, the uterus is typically
distended to create a working space within the uterus. (Such a
working 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.) The conventional technique for creating such a working
space within the uterus is to administer a fluid to the uterus
through the hysteroscope 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 or, more commonly, liquids like water or certain aqueous
solutions (e.g., a saline solution or a sugar-based aqueous
solution). Where resection is effected using a resectoscope, it is
typically necessary that the distending fluid not be
current-conducting so that electricity is not conducted to
undesired locations. However, because the distending fluid is
administered under pressure (which pressure may be as great as 100
mm Hg or greater), there is a risk, especially when tissue is cut,
that the distending fluid may be taken up by a blood vessel in the
uterus, i.e., intravasation, which uptake may be quite harmful to
the patient. Because excess intravasation can lead to death, it is
customary to monitor the fluid uptake on a continuous basis using a
scale system.
[0008] Nevertheless, despite the aforementioned risks of
intravasation, with proper monitoring of fluid uptake,
hysteroscopic resection is a highly effective and safe technique
for removing uterine fibroids. However, one shortcoming with
hysteroscopic resection is that it typically requires that
anesthesia be administered to the patient. This is because
conventional resectoscopes typically have a diameter in excess of 7
mm and because conventional hysteroscopes of the type through which
mechanical cutter-type devices are inserted typically have a
diameter of about 9 mm. By contrast, the cervix typically cannot be
dilated to a diameter greater than about 5.5 mm without causing
considerable discomfort to the patient. As a result, due to the
need for anesthesia, hysteroscopic resection is typically performed
in a hospital operating room and, as a result, bears a large cost
due to the setting and the support personnel required.
SUMMARY OF THE INVENTION
[0009] The present invention provides a novel method, system and
device for tissue removal. The method, system and device as
described above may be used, for example, to remove uterine
fibroids and other abnormal gynecological tissues.
[0010] According to one aspect of the invention, there is provided
a tissue removal device, the tissue removal device comprising (a) a
housing; (b) an outer tube, the outer tube being fixed to the
housing and extending distally therefrom, the outer tube including
a resection window; (c) an inner tube disposed within the outer
tube, the inner tube being slidable and rotatable relative to the
outer tube, the inner tube comprising a distal end; and (d) a drive
mechanism for rotating the inner tube relative to the outer tube
and, at the same time, for translationally oscillating the inner
tube relative to the outer tube so that the distal end of the inner
tube rotates while moving back and forth across the resection
window, wherein said drive mechanism comprises a drive shaft shaped
to include a double helical groove, said drive shaft being
translationally stationary.
[0011] There is provided in accordance with one aspect of the
present invention, a surgical access device for providing at least
one auxiliary lumen for the insertion of a surgical instrument or
other therapeutic device into a patient's body. The surgical access
device comprises a first channel providing a first lumen for the
insertion of a surgical instrument with a rigid shaft. A second
channel is provided, providing a second lumen for the insertion of
a flexible or semi-rigid visualization device. At least one other
lumen is provided for the installation of a distension media. The
surgical access device comprises an outer diameter, and the ratio
of the outer diameter to the inside diameter of the working channel
is preferable less than about 2.25. The ratio may be less than
about 2.10, and, in some embodiments, less than about 2.00. In one
reusable embodiment, the outer diameter to working channel ratio is
6.25 mm to 3.0 mm. In another, disposable embodiment, the outer
diameter to working channel ratio is 5.5 mm to 3.0 mm, or 1.83.
[0012] The distal tip comprises a flexible bumper tip to enable
easy passage through a cervical os. The visualization device may
comprise first and second independent members for visualization and
illumination. The instrument channel may be capable of sealing on
an inserted instrument when inserted, or providing an outflow
channel without the instrument inserted. The ratio of the overall
outer diameter to the inside diameter of the first channel is
preferably less than about 2.10, and, more preferably, less than
about 2.0.
[0013] Additional aspects, features and advantages of the present
invention will be set forth in part in the description which
follows. 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 or process 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
[0014] 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:
[0015] FIG. 1 is a partially exploded perspective view of a first
embodiment of a tissue removal system constructed according to the
teachings of the present invention;
[0016] FIGS. 2(a) through 2(d) are various views of the tissue
removal device shown in FIG. 1, the tissue removal device being
shown in FIGS. 2(a) through 2(c) together with the distal ends of
the vacuum tube and the external drive shaft;
[0017] FIG. 3 is a perspective view of the introducer device shown
in FIG. 1;
[0018] FIGS. 4(a) and 4(b) are exploded perspective views of the
introducer device shown in FIG. 1;
[0019] FIG. 5 is a right perspective view of the introducer device
shown in FIG. 1, with the right half of the housing removed;
[0020] FIG. 6 is a longitudinal section view of the introducer
device shown in FIG. 1;
[0021] FIG. 7 is an enlarged fragmentary perspective view, shown in
section, of the introducer device shown in FIG. 1, with only the
manifold, strain relief and sheath being shown;
[0022] FIG. 8 is an enlarged distal end view of the multi-lumen
sheath of the introducer device shown in FIG. 1;
[0023] FIG. 9 is an enlarged fragmentary view of the instrument
guide assembly of the introducer device shown in FIG. 1;
[0024] FIGS. 10(a) and 10(b) are fragmentary longitudinal section
views of alternate inner tubular members that may be used in the
tissue removal device shown in FIG. 1;
[0025] FIG. 11 is a side view of an alternate indicator sleeve that
may be used in the tissue removal device shown in FIG. 1;
[0026] FIG. 12 is a fragmentary side view, partly in section, of an
alternate combination of a tissue removal device and an introducer
that may be used in the tissue removal system shown in FIG. 1;
[0027] FIGS. 13(a) and 13(b) are fragmentary side views, partly in
section, of a further alternate combination of a tissue removal
device and an introducer that may be used in the tissue removal
system shown in FIG. 1;
[0028] FIG. 14 is a fragmentary side view, partly in section, of an
alternate tissue removal device that may be used in the tissue
removal system of FIG. 1;
[0029] FIGS. 15(a) and 15(b) are fragmentary perspective and
fragmentary partially exploded perspective views, respectively, of
another alternate tissue removal device that may be used in the
tissue removal system of FIG. 1;
[0030] FIG. 16 is a fragmentary side view of another alternate
tissue removal device that may be used in the tissue removal system
of FIG. 1;
[0031] FIG. 17 is a fragmentary side view of another alternate
tissue removal device that may be used in the tissue removal system
of FIG. 1;
[0032] FIG. 18 is a fragmentary perspective view of another
alternate tissue removal device that may be used in the tissue
removal system of FIG. 1;
[0033] FIG. 19 is a fragmentary perspective view of another
alternate tissue removal device that may be used in the tissue
removal system of FIG. 1;
[0034] FIG. 20 is a fragmentary perspective view of another
alternate tissue removal device that may be used in the tissue
removal system of FIG. 1;
[0035] FIG. 21 is a fragmentary perspective view of another
alternate tissue removal device that may be used in the tissue
removal system of FIG. 1;
[0036] FIGS. 22(a) through 22(e) are various views of another
alternate tissue removal device that may be used in the tissue
removal system of FIG. 1 (the vacuum housing not being shown in
FIGS. 22(c) through 22(e) to reveal components positioned
therewithin);
[0037] FIG. 23 is a fragmentary section view of an obturator of the
present invention inserted into the introducer shown in FIG. 1;
[0038] FIG. 24 is a side view of an alternate combination of an
obturator and an introducer constructed according to the present
invention;
[0039] FIGS. 25(a) and 25(b) are unassembled side and assembled
section views, respectively, of another combination of an obturator
and an introducer constructed according to the present
invention;
[0040] FIGS. 26(a) through 26(c) are fragmentary perspective views
of another alternate introducer device to the introducer device
shown in FIG. 1, with the alternate introducer device being shown
in partially exploded states in FIGS. 26(b) and 26(c);
[0041] FIG. 27 is a perspective view of a second embodiment of a
tissue removal system constructed according to the teachings of the
present invention;
[0042] FIGS. 28(a) through 28(d) are bottom exploded perspective,
top exploded perspective, bottom partially exploded, and
fragmentary, partly in section, side views, respectively, of the
morcellator assembly shown in FIG. 27;
[0043] FIGS. 29(a) and 29(b) are partially exploded top perspective
and partially exploded bottom perspective views, respectively, of
the drive assembly shown in FIG. 27;
[0044] FIG. 30 is a fragmentary, partially exploded, perspective
view of an alternate tissue removal device that may be used in the
tissue removal system of FIG. 27;
[0045] FIGS. 31(a) and 31(b) are fragmentary, partially exploded,
perspective views of another alternate tissue removal device that
may be used in the tissue removal system of FIG. 27;
[0046] FIG. 32 is a fragmentary, partially exploded, perspective
view of another alternate tissue removal device that may be used in
the tissue removal system of FIG. 27;
[0047] FIG. 33 is a fragmentary, partially exploded, perspective
view of another alternate tissue removal device that may be used in
the tissue removal system of FIG. 27;
[0048] FIG. 34 is a fragmentary section view of another alternate
tissue removal device that may be used in the tissue removal system
of FIG. 27; and
[0049] FIG. 35 is a fragmentary section view of another alternate
tissue removal device that may be used in the tissue removal system
of FIG. 27.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0050] The present invention is described below primarily in the
context of devices and procedures optimized for performing one or
more therapeutic or diagnostic gynecological or urological
procedures such as the removal of uterine fibroids or other
abnormal uterine tissue. However, the devices and related
procedures of the present invention may be used in a wide variety
of applications throughout the body, through a variety of access
pathways.
[0051] For example, the devices of the present invention can be
optimized for use via open surgery, less invasive access such as
laparoscopic access, or minimally invasive procedures such as via
percutaneous access. In addition, the devices of the present
invention can be configured for access to a therapeutic or
diagnostic site via any of the body's natural openings to
accomplish access via the ears, nose, mouth, and via trans-rectal,
urethral and vaginal approach.
[0052] In addition to the performance of one or more gynecological
and urologic procedures described in detail herein, the systems,
methods, apparatus and devices of the present invention may be used
to perform one or more additional procedures, including but not
limited to access and tissue manipulation or removal from any of a
variety of organs and tissues such as the bladder, breast, lung,
stomach, bowel, esophagus, oral cavity, rectum, nasal sinus,
Eustachian tubes, heart, gall bladder, spine, shoulder, knee, hip,
brain, arteries, veins, and various ducts. Routes of access include
but are not limited to trans-cervical; trans-vaginal-wall;
trans-uteral; trans-vesicle; trans-urethral; and other routes.
[0053] Referring now to FIG. 1, there is shown a partially exploded
perspective view of one embodiment of a tissue removal system, the
tissue removal system being constructed according to the teachings
of the present invention and being represented generally by
reference numeral 5.
[0054] System 5 is particularly well-suited for removing uterine
fibroids and other abnormal gynecological tissues. However, it
should be understood that system 5 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.
[0055] System 5 may comprise a tissue removal device (or
morcellator) 6, an introducer device 7, a flexible hysteroscope 8,
a fluid supply 9, a vacuum assembly 10, and a motor drive assembly
11.
[0056] Referring now to FIGS. 2(a) through 2(d), tissue removal
device 6 may be seen in greater detail. Device 6 may comprise
complementary left and right housing halves 13-1 and 13-2,
respectively, each of which may be made of a rigid polymer or other
suitable material. Halves 13-1 and 13-2 may be joined together, for
example, with screws 15 to form an elongated hollow housing 13
comprising a rounded side wall 16, an open proximal end 17, and an
open distal end 19. Housing 13 may be bent or otherwise
ergonomically shaped to fit comfortably in the hand of a user. A
proximal cap 18 may be mounted in proximal end 17, cap 18 being
shaped to include a pair of lumens 18-1 and 18-2. Lumen 18-1 may be
used to receive, for example, an external drive shaft, and lumen
18-2 may be used to receive, for example, a vacuum tube. A distal
cap 20 may be mounted in distal end 19, cap 20 being shaped to
include a lumen, which may be used to receive, for example, a pair
of coaxial cutting tubes.
[0057] A plurality of ribs 14 may be integrally formed and
appropriately positioned along the respective interior surfaces of
halves 13-1 and 13-2, ribs 14 providing structural reinforcement to
housing 13 and being used to align certain of the mechanical
components that are positioned within housing 13.
[0058] Device 6 may further comprise an internal drive shaft 21
adapted for rotation about its longitudinal axis. Shaft 21, which
may be an elongated unitary structure made of a suitably rigid
metal or polymer, may be shaped to include a proximal end 23 and a
distal end 25. Proximal end 23 of shaft 21 may be coaxially mounted
over and fixed to the distal end 27 of an external drive shaft 29,
external drive shaft 29 being inserted through a retainer 28
mounted in housing 13. In this manner, the rotation of shaft 21 may
be mechanically coupled to the rotation of shaft 29. Distal end 25
of shaft 21 may be inserted through an opening 30 in an annular
bushing 31, which bushing 31 may be matingly mounted on a rib 14-1
via a circumferential slot 32 provided in bushing 31.
[0059] Device 6 may further comprise a translation drive shaft 35
adapted for rotation about its longitudinal axis. Shaft 35, which
may be an elongated unitary structure made of a suitably rigid
metal or polymer, may be shaped to include a proximal end 37, an
intermediate portion 39, and a distal end 41. Proximal end 37 of
shaft 35 may be coaxially mounted over and fixed to the distal end
25 of internal drive shaft 21. In this manner, the rotation of
shaft 35 may be mechanically coupled to the rotation of shaft 21.
Intermediate portion 39 may be shaped to include a double helical
portion comprising a right-handed threaded helical channel 42 and a
left-handed threaded helical channel 43. Helical channels 42 and 43
may have identical or different pitches but preferably have
identical pitches. Helical channels 42 and 43 may be smoothly
blended together at their respective ends to form a continuous
groove so that there may be a smooth transition from one helical
channel to the other. Distal end 41 of shaft 35 may be
appropriately dimensioned to be received within an opening 44 in an
annular bushing 45, which bushing 45 may be matingly mounted on a
rib 14-2 via a circumferential slot 46 provided in bushing 45. It
should be noted that, although shaft 35 is adapted for rotation,
shaft 35 is translationally stationary.
[0060] Device 6 may further comprise a gear assembly 50 adapted for
rotation about its longitudinal axis. Gear assembly 50, which may
be an elongated unitary structure made of a suitably rigid metal or
polymer, may be shaped to include a proximal spur gear 51 and a
distal tube portion 52. Gear assembly 50 may be coaxially mounted
over intermediate portion 39 of shaft 35 in an area between the
double helical portion and distal end 41, and gear assembly 50 may
be fixed to shaft 35 using a pin inserted radially through tube
portion 52 and into an opening provided in shaft 35. In this
manner, the rotation of spur gear 51 may be mechanically coupled to
the rotation of shaft 35.
[0061] Device 6 may further comprise an oscillating translation
assembly 61. Translation assembly 61, in turn, may comprise a
carriage 62 and a channel engagement member 63. Carriage 62, which
may be a unitary structure made of a suitably rigid metal or
polymer, may be shaped to include a proximal portion 64, an
intermediate portion 65, and a distal portion 66. The tops of
proximal portion 64 and distal portion 66 may extend beyond the top
of intermediate portion 65 and may be shaped to include loops 67-1
and 67-2, respectively, loops 67-1 and 67-2 being aligned with one
another. A longitudinal bore 68-1 may be provided near the bottom
of carriage 62, bore 68-1 being appropriately dimensioned to
coaxially receive intermediate portion 39 of shaft 35 while
permitting intermediate portion 39 to rotate freely therewithin.
Channel engagement member 63, which may be a unitary structure made
of a suitably rigid metal or polymer, may be shaped to include a
base 69 and a pawl 70. Base 69 may be disposed in an opening 68-2
that may extend downwardly from the top of intermediate portion 65
into communication with bore 68-1, with pawl 70 traveling within
the double helical portion of shaft 35. In this manner, as shaft 35
rotates, pawl 70 may continuously travel back and forth through the
double helical portion of shaft 35, thereby causing carriage 62 to
oscillate translationally. As can be appreciated, the speed at
which carriage 62 oscillates translationally may be varied, for
example, by varying the translational length of the double helical
portion of shaft 35, the angles of channels 42 and 43, the
rotational speed of shaft 29, etc. As will be discussed further
below, it may be desirable to operate device 6 so that carriage 62
oscillates translationally at about 2.8 cycles/second.
[0062] Device 6 may further comprise a shaft 72 adapted for
rotation about its longitudinal axis. Shaft 72, which may be an
elongated, unitary, tubular structure made of a suitably rigid
metal or polymer, may be shaped to include a proximal portion 72-1
and a distal portion 72-2. Proximal portion 72-1 may be inserted
through loops 67-1 and 67-2 of carriage 62 and may freely rotate
relative to loops 67-1 and 67-2. Distal portion 72-2 may be in the
form of an elongated spur gear. Distal portion 72-2 may be engaged
with spur gear 51 of gear assembly 50 so that the rotation of spur
gear 51 causes the rotation of shaft 72. Distal portion 72-2 may be
elongated so that it may maintain engagement with spur gear 51 even
as distal portion 72-2 moves translationally relative to spur gear
51. The speed at which distal portion 72-2 rotates (and, therefore,
the speed at which shaft 72 rotates) may be the same as or
different than the speed at which spur gear 51 rotates, depending,
for example, on the relative diameters of the two gears (the ratio
of the rotational speeds of the two gears being inversely
proportional to the ratio of the diameters of the two gears).
Consequently, by appropriately dimensioning spur gear 51 and distal
portion 72-2, one can achieve a desired rotational speed, even
where the rotational speed of the external drive shaft is fixed.
For example, in the embodiment shown, distal portion 72-2 has a
diameter that is one-fourth the diameter of spur gear 51 and,
therefore, rotates four times as fast as gear 51. Therefore, if the
external drive shaft has a speed of rotation of about 1500 rpm,
gear 51 would rotate at 1500 rpm and distal portion 72-2 would
rotate at 6000 rpm. As can be appreciated, the rotational speed of
distal portion 72-2 does not depend on the interaction of
translation assembly 61 with the double helical portion of shaft
35; consequently, distal portion 72-2 may attain higher or lower
rotational speeds than would be possible based on the requirements
of a desired translational speed. Notwithstanding the above, shaft
72 is translationally coupled to carriage 62. Consequently, as
carriage 62 oscillates translationally, so does shaft 72.
[0063] Device 6 may further comprise a strain relief member 74,
which may be a unitary tubular structure made of a rigid polymer or
metal. The proximal end of strain relief member 74 may be fixedly
mounted in a retainer 75, which may be mounted at the distal end of
housing 13, with the distal end of strain relief 74 extending
distally from housing 13 for a short distance, such as, for
example, approximately 2 inches.
[0064] Device 6 may further comprise a cutting mechanism. In the
present embodiment, the cutting mechanism may comprise an outer
tubular member 76 and an inner tubular member 77, inner tubular
member 77 moving rotationally and, at the same time, oscillating
translationally relative to outer tubular member 76 in the manner
to be described further below. Outer tubular member 76, which may
be a unitary structure made of stainless steel or another similarly
suitable material, may be shaped to include an open proximal end, a
closed distal end 81, and a lumen 82 extending from open proximal
end 79 to a point just prior to closed distal end 81. Member 76 may
be coaxially mounted within strain relief member 74, with the
proximal end of member 76 disposed within the proximal end of
strain relief member 74 and with distal end 81 of member 76
extending distally beyond the distal end of strain relief member 74
for an extended distance, such as, for example, five inches. The
proximal end of member 76 may be fixed within retainer 75.
[0065] Outer tubular member 76 may be further shaped to include a
resection window 89 into which tissue may be captured and drawn,
window 89 being located proximate to distal end 81, such as, for
example, 0.25 inch from distal end 81. Window 89 may be shaped to
include a proximal end 89-1 and a distal end 89-2. Proximal end
89-1 may slope gradually proximally, and distal end 89-2 may slope
gradually distally. More specifically, window 89 may have a length
of approximately 0.55 inch, proximal end 89-1 may be a radial end
having a radius of curvature of, for example, 0.085 inch, and
distal end 89-2 may be a radial end having a radius of curvature
of, for example, 0.150 inch. Window 89 may extend over a
substantial portion of the circumference of tubular member 76, such
as, for example, about 60% of the circumference.
[0066] Outer tubular member 76 may have an outer diameter less than
about 5.5 mm. However, in order to reduce the risk of injury to the
patient and in order to obviate the need for anesthesia to be
administered to the patient, outer tubular member 76 preferably has
an outer diameter less than about 5 mm, more preferably less than 4
mm, even more preferably less than 3 mm, and still even more
preferably less than 2 mm. However, should device 6 be used in an
operating room setting where general anesthesia is available, the
diameter of the outer tubular member 76 could be increased to
maximize tissue removal. In such a case, outer tubular member 76
could have a diameter generally less than about 12 mm, preferably
less than about 11 mm, and for certain applications less than 10
mm. Depending on the particular clinical application, outer tubular
member 76 could be constructed having an outer diameter of no more
than about 9 mm, in some applications less than about 8 mm,
preferably less than 7 mm, and more preferably less than 6 mm where
OD is desirably minimized.
[0067] Inner tubular member 77, which may be an elongated unitary
structure made of stainless steel or another similarly suitable
material, may be shaped to include a proximal end 91, a distal end
92, and a longitudinal lumen 93. Distal end 92 may be shaped to
include an external bevel, such as, for example, an external bevel
of approximately 20 degrees. An intermediate length of tubular
member 77 may be coaxially received within shaft 72 and may be
fixedly coupled to shaft 72 for translational and rotational
movement therewith. Proximal end 91 of tubular member 77 may be
slideably mounted within a vacuum tube connector 95, which may, in
turn, be coupled to a vacuum tube 393 inserted through lumen 18-2
of cap 18. An O-ring 96 may be mounted within connector 95 to
maintain a good seal with tubular member 77. An annular bushing 98
mounted within housing 13 may be used to receive tubular member 77
and to maintain its alignment.
[0068] Tubular members 76 and 77 may be arranged so that, when
tubular member 77 is in a fully retracted (i.e., proximal)
position, distal end 92 of tubular member 77 may be withdrawn
sufficiently to permit tissue to enter window 89 (preferably with
distal end 92 of tubular member positioned proximal to window 89),
and so that, when tubular member 77 is in a fully advanced (i.e.,
distal) position, distal end 92 of tubular member 77 may be
positioned distally of distal end 89-2 of window 89. In this
manner, as tubular member 77 is moved translationally and
rotationally past window 89, tissue within window 89 may be
sheared. To promote such a shearing of tissue, the outer diameter
of inner tubular member 77 may be just slightly less (e.g., about
0.002 inch) than the inner diameter of outer tubular member 76.
[0069] It has been shown that the thermal energy created by the
contact of the rotating inner tube 77 and outer tube 76 can lead to
galling where the two tubular members fuse together. To mitigate
that galling risk, the outer surface of inner tube 77 has been
covered with a low friction, low abrasion coating (i.e., Titanium
Nitride). Alternatively, the coating can be carried by the inner
surface of the outer tube 76. The coating may have a Rockwell C
hardness of at least about 50, preferably at least about 60 and in
some devices at least about 70.
[0070] Device 6 may further comprise an indicator sleeve 98. Sleeve
98, which may be an elongated tubular member made of a material
that is easily distinguishable visually from strain relief member
74, may be coaxially mounted over strain relief member 74 and
fixedly mounted thereto, with a proximal end 98-1 of sleeve 98
lying flush against the distal end of housing 13. An example of a
material suitable for use as sleeve 98 may be a white or colored
length of shrink-wrap material. Sleeve 98 may be dimensioned so
that, when device 6 is inserted into introducer device 7, distal
end 98-2 of sleeve 98 is visible to a user until distal end 81 of
device 6 is advanced beyond the distal end of introducer 7. In
other words, distal end 98-2 may be used to indicate when distal
end 81 of device 6 lies flush with the distal end of introducer 7.
In this manner, a user may safely control the position of the
distal end of device 6 and, therefore, keep it within introducer 7
when inserting device 6 into a patient, thereby reducing the risks
for lacerations and perforations during introduction of device
6.
[0071] Referring now to FIGS. 3 through 7, introducer 7 may
comprise a housing 121. Housing 121, in turn, may comprise a left
handle half 123 and a right handle half 125. Left handle half 123
and right handle half 125, which may be molded or otherwise
fabricated from a rigid polymer or other suitable material, may be
joined by a plurality of screws 127. Instead of being joined by
screws 127, left handle half 123 and right handle half 125 may be
joined using a suitable adhesive, crush pins, or may be welded
together ultrasonically or otherwise. Left handle half 123 and
right handle half 125 jointly define a hollow, gun-shaped structure
comprising a handle portion 129 and a barrel portion 131. Handle
portion 129 may be shaped to include an opening 133 provided at its
bottom end 134 and an opening 135 provided along its distal face
136 near bottom end 134. A slot 133-1 may be provided in right
handle half 125, slot 133-1 extending from opening 133 towards
barrel portion 131 for a short distance. Barrel portion 131 may be
shaped to include an opening 137 provided at its proximal end 138
and an opening 139 provided at its distal end 140. In addition,
barrel portion 131 may be shaped to include a transverse opening
141 provided in right handle half 125 at a location intermediate to
proximal end 138 and distal end 140.
[0072] The interior surfaces of left handle half 123 and right
handle half 125 may shaped to include complementary sets of ribs
(not shown). Such ribs may provide structural reinforcement to left
handle half 123 and right handle half 125 and may help to maintain
the correct positioning and alignment of the components positioned
within housing 121.
[0073] Introducer 7 may further comprise a manifold 145. Manifold
145, which may be molded or otherwise fabricated from a rigid
polymer or other suitable material, may be a unitary, branched
structure shaped to include a main tubular member 147 and a side
tubular member 149. Main member 147 may comprise a proximal end
151, an open distal end 153, a side wall 155, and a longitudinal
lumen 157. Proximal end 151 of main member 147 may be shaped to
include a top opening 159 of comparatively greater diameter and a
bottom opening 161 of comparatively smaller diameter. Side member
149 may comprise an open proximal end 163, an open distal end 165,
a side wall 167, and a longitudinal lumen 169. Lumen 169 of side
member 149 may be in fluid communication with lumen 157 of main
member 147 through open distal end 165.
[0074] Manifold 145 may be coupled to housing 121 using a pair of
pins 171 and 173 that may extend from side wall 155 and that may be
received within hollow embossments 175 and 177, respectively,
provided on the interior faces of left handle half 123 and right
handle half 125, respectively. With manifold 145 thus coupled to
housing 121, proximal end 151 of manifold 145 may be positioned in
barrel portion 131, with side wall 155 tightly fitting within
opening 139 and with distal end 153 of manifold 145 extending
distally a short distance beyond distal end 140.
[0075] Introducer 7 may further comprise a strain relief member
181. Strain relief member 181, which may be molded or otherwise
fabricated from a rigid polymer or other suitable material, may be
a unitary tubular structure shaped to include an open proximal end
183, an open distal end 185, a side wall 187, and a longitudinal
lumen 189. Strain relief member 181 may be partially inserted into
lumen 157 of manifold 145 and may be tightly fitted within lumen
157 and fixedly secured thereto using a suitable adhesive or the
like, with proximal end 183 of strain relief member 181 being
positioned just distal to open distal end 165 of side member 149
and with distal end 185 of strain relief member 181 extending
distally a short distance beyond distal end 153 of main member
147.
[0076] Introducer 7 may further comprise a sheath 191, which is
also shown separately in FIG. 8. Sheath 191, which may be extruded
or otherwise fabricated from a suitable polymer, such as nylon 12,
may be a rigid, unitary structure shaped to include a proximal end
192, a distal end 193, and a side wall 194. Sheath 191 may be
further shaped to include a plurality of longitudinal lumens of
fixed shape and size, such lumens including a top lumen 196, a
bottom lumen 197, and a pair of side lumens 198-1 and 198-2. As
will be discussed further below, top lumen 196 may be used as an
instrument lumen, bottom lumen 197 may be used as a visualization
lumen, and side lumens 198-1 and 198-2 may be used as inflow fluid
supply lumens. (Openings (not shown) may be provided in side wall
194 proximate to distal end 193, such side openings fluidly
communicating with side lumens 198-1 and 198-2, for example, to
dispense some of the inflow fluid supply conducted distally through
side lumens 198-1 and 198-2.) Proximal end 192 of sheath 191 may be
partially inserted into lumen 189 of strain relief member 181 and
may be tightly fitted within lumen 189 and fixedly secured thereto
using a suitable adhesive or the like, with proximal end 192 of
sheath 191 flush with proximal end 183 of strain relief member 181
and with distal end 193 of sheath 191 extending distally beyond
distal end 185 of strain relief member 181 for several inches.
[0077] Sheath 191, which is preferably the only component of
introducer 7 that is to be inserted into a patient, may be
dimensioned to have an outer diameter of about 5.5 mm, with lumen
196 having a diameter of about 3 mm, lumen 197 having a diameter of
about 2 mm, and lumens 198-1 and 198-2 each having a diameter of
about 1.33 mm. It can be further stated the ratio of the outer
diameter to the working channel is an exemplary metric of
introducer efficiency. It can be seen that the optimal ratio would
be about 1.0, preferably no more than about 2.1 and more preferably
no more than about 1.9. In the case provided herein, the ratio of
these diameters is about 1.83 while predicate systems have ratios
of 2.25. By thus dimensioning sheath 191, if sheath 191 is inserted
through the cervix of a patient, the risk of injury to the patient
and the need for anesthesia to be administered to the patient may
be minimized. However, it should be understood that the above
dimensions for sheath 191 are merely exemplary and may be varied
depending upon how introducer 7 is to be used.
[0078] Introducer 7 may further comprise an instrument guide
assembly mounted within housing 121 for providing a continuous
channel aligned with lumen 196 into which tissue removal device 6
may be inserted. The instrument guide assembly may comprise a guide
body 201. Body 201, which may be molded or otherwise fabricated
from a rigid polymer or other suitable material, may be a unitary
tubular structure shaped to include a proximal portion 203, a
distal portion 205 and an intermediate portion 207. Intermediate
portion 207 may be reduced in inner diameter and in outer diameter
relative to proximal portion 203 and distal portion 205 so that an
annular seat 208 is formed within body 201 at the juncture of
intermediate portion 207 and distal portion 205. The interior
surface of body 201 may taper inwardly from proximal portion 203 to
intermediate portion 207 to facilitate insertion of device 6 into
intermediate portion 207 and to delimit the extent to which device
6 may be inserted into body 201.
[0079] Body 201 may be tightly fitted within opening 137 of housing
121 and fixedly secured thereto using a suitable adhesive or the
like, with distal portion 205 and intermediate portion 207 of body
201 being positioned within barrel portion 131 of housing 121 and
with proximal portion 203 of body 201 extending through opening 137
and continuing proximally for a short distance beyond proximal end
138 of housing 121.
[0080] The instrument guide assembly may further comprise a sleeve
211. Sleeve 211, which may be molded or otherwise fabricated from a
rigid polymer or other suitable material, may be a unitary,
branched structure shaped to include a main tubular member 213 and
a side tubular member 215. Main member 213 may comprise an open
proximal end 216, an open distal end 217, and a longitudinal lumen
219. Proximal end 216 of main member 213 may be shaped to be
tightly fitted within distal portion 205 of body 201 and may be
bonded thereto using a suitable adhesive. Side member 215 may
comprise an open proximal end 220, an open distal end 221 and a
longitudinal lumen 223. Lumen 223 of side member 215 may be in
fluid communication with lumen 219 of main member 213 through open
proximal end 220. Distal end 221 of side member 215 may extend
through opening 141 provided in right handle half 125 of housing
121 and may be coupled to a valve 228. Valve 228 may be an
actively-controlled valve, such as a stopcock valve, or a
passively-controlled valve, such as a spring-activated ball valve.
Valve 228 may be connected at its output end to a length of tubing
(not shown), as well as to a fluid receptacle (not shown), for
conducting, as well as collecting, for example, outflow fluid
passing through valve 228, for example, when device 6 is not
present within introducer 7.
[0081] The instrument guide assembly may further comprise the
combination of a seal 231 and a valve 233. Seal 231 and valve 233
may be elastomeric members securely positioned between seat 208 of
body 201 and proximal end 216 of sleeve 211 (see FIG. 9). Seal 231,
which may be located proximally relative to valve 233, may include
a central opening 235. Opening 235 may be appropriately dimensioned
so that, when device 6 is inserted therethrough, fluid may not
readily pass proximally through seal 231 around the outside of
device 6. Valve 233, which may be shaped to include a dome having a
cross-slit at its top, may be designed so that, in the absence of
device 6 being inserted therethrough, fluid may not readily pass
proximally therethrough.
[0082] The instrument guide assembly may further comprise a tube
241. Tube 241, which may be a rigid hypotube made of stainless
steel or the like, may comprise a proximal end 243 and a distal end
245. Proximal end 243 may be fixedly mounted within lumen 219 of
sleeve 211 using a suitable adhesive or the like. Distal end 245 of
tube 241 may be tightly fitted within lumen 196 of sheath 191 and
may be secured therewithin using a suitable adhesive or the
like.
[0083] Introducer 7 may further comprise a visualization guide
assembly mounted within housing 121 for providing a continuous
channel aligned with lumen 197 into which hysteroscope 8 may be
inserted. The visualization guide assembly may comprise a guide
body 251. Body 251, which may be molded or otherwise fabricated
from a rigid polymer or other suitable material, may be a unitary
tubular structure shaped to include a proximal portion 253 of
comparatively greater diameter, a distal portion 255 of
comparatively smaller diameter, and an intermediate portion 257
tapering in diameter from proximal portion 253 to distal portion
255. Body 251 may be disposed within handle portion 129 of housing
121, with proximal portion 253 spaced inwardly a short distance
from opening 133 and with distal portion 255 facing towards barrel
portion 131. Proximal portion 253 may be tightly fitted between and
fixedly secured to left handle half 123 and right handle half 125
of housing 121 using adhesive or other suitable means. As will be
discussed further below, proximal portion 253 may be appropriately
dimensioned to receive the proximal portion of hysteroscope 8, with
intermediate portion 257 of body 251 being appropriately
dimensioned to serve as a stop to limit the extent to which
hysteroscope 8 may be inserted into body 251. An annular seat 258
may be provided within distal portion 255 and may be spaced
proximally relative to distal end 259 of distal portion 255.
[0084] The visualization guide assembly may further comprise a
guide connector 261. Guide connector 261, which may be molded or
otherwise fabricated from a rigid polymer or other suitable
material, may be a unitary tubular structure shaped to include a
proximal portion 263 of comparatively greater diameter, a distal
portion 265 of comparatively smaller diameter, and an intermediate
portion 267 tapering in diameter from proximal portion 263 to
distal portion 265. Proximal portion 263 may be shaped to be
tightly fitted within distal portion 255 of body 251 and may be
bonded thereto using a suitable adhesive.
[0085] The visualization guide assembly may further comprise the
combination of a seal 271 and a valve 273. Seal 271 and valve 273
may be elastomeric members securely positioned between seat 258 of
body 251 and proximal portion 263 of connector 261. Seal 271, which
may be located proximally relative to valve 273, may include a
central opening appropriately dimensioned so that, when
hysteroscope 8 is inserted therethrough, fluid may not readily pass
proximally through seal 271 around the outside of hysteroscope 8.
Valve 273, which may be shaped to include a dome having a
cross-slit at its top, may be designed so that, in the absence of
hysteroscope 8 being inserted therethrough, fluid may not readily
pass proximally therethrough.
[0086] The visualization guide assembly may further comprise a tube
281. Tube 281, which may be a flexible unitary member fabricated
from a suitable polymer or other material, may comprise a proximal
end 283, a distal end 285, and a lumen 286. Proximal end 283 may be
fixedly mounted within distal portion 265 of connector 261 using a
suitable adhesive or the like. Distal end 285 of tube 281 may be
tightly fitted within lumen 197 of sheath 191 and may be secured
therewithin using a suitable adhesive or the like. Lumen 286 may be
appropriately dimensioned so that the distal portion of
hysteroscope 8 may be inserted thereinto and, in this manner,
guided by tube 281 to lumen 197.
[0087] Introducer 7 may further comprise a mechanism for reversibly
coupling hysteroscope 8 to the visualization guide assembly. This
mechanism may comprise a cam lock 291. Lock 291, which may be
fabricated from a rigid polymer or other suitable material, may be
a unitary structure shaped to comprise a lever 292 and a fulcrum
293. The fulcrum 293 may be pivotally mounted on housing 121 using
a pivot pin 294 inserted through a transverse opening 295 in
fulcrum 293 and securely received at its opposite ends in openings
296 and 297 provided in left handle half 123 and right handle half
125, respectively. Fulcrum 293 may comprise a face 298 adapted to
frictionally engage the proximal portion of hysteroscope 8 when
lever 292 is pivoted towards handle portion 129.
[0088] Introducer 7 may further comprise a tube 301. Tube 301,
which may be fabricated from a suitable polymer or other material,
may be a flexible unitary structure shaped to include a proximal
end 303 and a distal end 305. Proximal end 303 may be secured to
the distal end of a luer fitting 307 securely mounted within
opening 135 of housing 121. Distal end 305 may be positioned within
lumen 169 of manifold 145 and may be secured in place using an
adhesive or other suitable means. As will be discussed further
below, luer fitting 307 may be connected to the output of fluid
supply 9. In this manner, fluid dispensed through fitting 307 and
into tube 301 may be conducted by tube 301 to manifold 145.
Thereafter, the fluid in manifold 145 may flow distally through
lumens 198-1 and 198-2 of sheath 191.
[0089] Referring back now to FIG. 1, hysteroscope 8, which may be,
for example, a conventional flexible hysteroscope, may comprise a
proximal portion 311 and a distal portion 313. Proximal portion
311, which may be comparatively rigid, compact in length, and wide
in diameter, may comprise an input port 315, an output port 317,
and a distal end 318. Distal portion 313, which may be
comparatively flexible, elongated in length, and narrow in
diameter, may comprise a distal end 319. Hysteroscope 8 may be
appropriately dimensioned so that distal end 318 of proximal
portion 311 may be received in body 251, with distal portion 313
extending distally through seal 271, valve 273, connector 261, tube
281 and lumen 197 and with distal end 319 positioned at or a short
distance beyond distal end 193 of sheath 191. Although not present
in the embodiment shown, proximal portion 311 of hysteroscope 8 may
be provided with notches or other physical features that may be
used to mate with or otherwise engage cam lock 291. Distal end 319
of hysteroscope 8 may be constructed to permit the viewing of
objects, such as at 0, 15 or 30 degree angles, relative to the
longitudinal axis of distal portion 313. In this manner, by placing
hysteroscope 8 in a particular angular orientation, hysteroscope 8
may be used to view the operation of the distal end of device 6.
Such an angular orientation may be ensured by orienting
hysteroscope 8 so that input port 315 is aligned with and extends
through slot 133-1.
[0090] Fluid supply 9 may comprise a fluid-containing syringe, a
peristaltic pump or another suitable fluid-dispensing device having
an output end 321 that may be coupled to luer fitting 307. Fluid
supply 9 may comprise automated means (not shown) for dispensing
inflow fluid therefrom at a desired rate.
[0091] Vacuum assembly 10 may include a specimen collection
container 391 and a vacuum source 392. The distal end of an
evacuation tube 393 may be connected to the proximal end of vacuum
tube connector 95, and the proximal end of evacuation tube 393 may
be coupled to a first port 394 of container 391. The distal end of
a tube 395 may be coupled to a second port 396 of container 391,
and the proximal end of tube 395 may be coupled to vacuum source
392. In this manner, vacuum source 392 may be used to apply suction
to device 6, and any withdrawn tissue, liquids or similar matter
suctioned through device 6 may be collected in container 391.
[0092] Motor drive assembly 11, which may be coupled to a source of
electricity, such as an AC wall outlet, using a power cord (not
shown), may include a housing 397, in which there may be disposed
electronics (not shown) and a motor (not shown). A foot pedal 398
may be coupled to the motor drive assembly by a cable 398-1 and may
be used as a power switch to selectively activate or de-activate
the motor. The proximal end of shaft 29 may be mechanically coupled
for rotation to the motor, and the distal end of shaft 29 may be
inserted through opening 18-1 in mounting block 18 and coupled to
internal shaft 21 in the manner discussed above. A protective
sheath 399 may cover much of the length of shaft 29. Motor drive
assembly 11 may further include a vacuum sensor 400, which may be
coupled to container 391 by a tube 401, so that the pressure within
container 391 may be monitored. In this manner, a sudden increase
in vacuum pressure may indicate that a clog has occurred. The
presence of a clog may be indicated via an alarm (not shown)
located on housing 397. The detection of a clog is often a clear
indication that the further operation of device 6 may only
aggravate the clogging situation and that a cessation of tissue
removal may be necessary. Motor drive assembly 11 may be configured
to synchronize actuation of the motor with actuation of vacuum
source 392. In this manner, turning on the motor will turn on
vacuum source 392 at the same time. Correspondingly, vacuum source
392 may be deactivated whenever the motor is turned off.
[0093] In use, distal end 319 of hysteroscope 8 may be inserted
first through the visualization guide channel of introducer 7, next
through manifold 145, and then through lumen 197 of sheath 191.
With hysteroscope 8 thus inserted into introducer 7, cam lock 291
may be used to secure proximal portion 311 of hysteroscope 8 to
introducer 7. Input end 315 and output end 317 of hysteroscope 8
may then be coupled to a light source and to a camera,
respectively. Alternatively, the camera may be omitted, and output
end 317 may be observed directly with the unaided eye. Fluid supply
9 may then be coupled to luer fitting 307 of introducer 7. Distal
end 193 of sheath 191 may then be inserted transcervically, i.e.,
through the vagina and the cervix, into the uterus of the patient.
Prior to introducing distal end 193 of sheath 191 into the patient,
the cervix may be gradually dilated in the conventional manner
using obturators of increasing diameter. The uterus may then be
washed of blood and other debris that may be present by dispensing
fluid from fluid supply 9 into introducer 7, which fluid may then
exit introducer 7 distally through lumens 198-1 and 198-2. Valve
228 may be opened during this washing procedure so that fluid and
any debris present in the uterus may exit the uterus proximally
through lumen 196 of sheath 191 and, thereafter, may exit
introducer 7 by passing proximally through tube 241, into main
member 213 of sleeve 211, through side member 215 of sleeve 211,
and through valve 228. When the washing procedure is complete,
valve 228 may be closed while fluid may continue to be dispensed
into the uterus through lumens 198-1 and 198-2, thereby causing the
uterus to become distended by the fluid. When the uterus becomes
sufficiently distended by such fluid, valve 228 may be opened while
fluid may continue to be dispensed into the uterus. In this manner,
the uterus may be maintained at a desired degree of distension
while fluid is continuously circulated through the uterus. With the
uterus thus distended with fluid, hysteroscope 8 may be used to
examine the interior of the uterus.
[0094] If abnormalities are detected that one wishes to remove,
tissue removal device 6 may be loaded into introducer 7, i.e., by
inserting the distal ends of outer tubular member 76 and inner
tubular member 77 distally through the instrument channel guide of
introducer 7 and then through channel 196 of sheath 191, with
housing 13 remaining external to the patient. Device 6 may then be
manipulated so that window 89 of outer tubular member 76 may be
positioned in proximity to the fibroid or other targeted tissue.
Next, vacuum source 392 may be operated so as to cause suction to
be applied to inner tubular member 77, thereby drawing tissue into
outer tubular member 76 through window 89. In addition, the motor
of motor drive assembly 11 may be actuated, thereby causing inner
tubular member 77 simultaneously to rotate and to oscillate back
and forth translationally within outer tubular member 76, resulting
in the tissue drawn through window 89 to be cut. The cut tissue may
then be suctioned from the patient through inner tubular member 77
by means of the aforementioned suction and, thereafter, collected
in container 391. Once the fibroids or other targeted tissues have
thus been removed from the patient, vacuum source 392 and the motor
may be turned off, device 6 may be withdrawn from introducer 7, and
introducer 7 may be withdrawn from the patient. Device 6 may be
designed to be a single use device. If so, device 6 may then be
disconnected from evacuation tube 393 and flexible motor shaft
398-2 and disposed of properly.
[0095] It should be noted that, although the above-discussion
contemplates using introducer 7 to introduce device 6 into the
uterus, one may insert device 6 transcervically into the uterus
without the use of introducer 7. In such a situation, fluid may be
administered transcervically to the uterus by a fluid dispensing
device in order to distend the uterus, and, thereafter, observation
of the uterus may be accomplished, for example, by ultrasonic
imaging using an ultrasonic probe inserted transcervically into the
uterus. Such an ultrasonic probe may be separate from device 6 or
may be integrated into device 6. Alternatively, imaging of the
uterus may be performed by MRI imaging.
[0096] Although one may vary one or more of the speed of rotational
movement of inner tubular member 77, the frequency of oscillating
translational movement of inner tubular member 77, the advance
ratio of inner tubular member 77 (i.e., the ratio of the speed at
which tubular member 77 oscillates translationally to the speed at
which tubular member 77 rotates), and the magnitude of suction
provided by vacuum source 392, particularly good results have been
achieved under the following conditions: speed of rotation of
tubular member 77--at least 1100 rpm, more preferably at least 5000
rpm, even more preferably approximately 6000 rpm; frequency of
oscillating translational movement of tubular member 77--at least
1.5 cycles/second, more preferably about 2.5 to 4 cycles/second,
even more preferably about 2.8 cycles/second; advance ratio of
preferably less than 0.25, more preferably less than 0.15; and
vacuum pressures in the range of 200 to 650 mmHg. Preferably, the
above parameters are selected to achieve a rate of tissue removal
of at least 1.5 gm/min while outer tubular member 76 has an outer
diameter of no greater than about 3.0 mm.
[0097] As can be appreciated, as suction is applied to inner
tubular member 77, some of the distension fluid located in the
uterus may incidentally be withdrawn from the uterus through inner
tubular member 77. This loss of distension fluid from the uterus
may be undesirable if it interferes with maintenance of the uterus
in an adequately distended state. Preferably, system 5 is
constructed and operated so that, with a vacuum in excess of 300
mmHg, a volume of no more than about 300 cc/min of fluid is
removed. This may involve, for example, applying suction only at
specific times, for example, only when the motor for moving inner
tubular member 77 is actuated or by closing resection window 89
with inner tubular member 77 each time the motor control is
stopped.
[0098] In general, morcellators may be built in accordance with the
present invention to have a lower outside diameter or crossing
profile than current commercial products such as the Smith &
Nephew Hysteroscopic Morcellator, but at the same time accomplish a
higher tissue resection rate. In addition, morcellators in
accordance with the present invention may be operated at a
significantly higher vacuum while managing total fluid flow within
acceptable limits.
[0099] For example, the cross sectional area of the aspiration
lumen in morcellators in accordance with the present invention will
typically be no more than about 12.0 square millimeters, and often
no more than about 10.0 square millimeters. In certain embodiments,
a cross sectional area of the aspiration lumen will be no more than
about 8.0 millimeters squared, and, for certain applications, the
area will be no more than about 7.5 square millimeters.
[0100] The tissue resection rate is generally at least about 1.5
gm/min, and often at least about 1.8 gm/min. In certain
embodiments, the tissue resection rate is at least about 2.0
gm/min, and, in one embodiment, 2.2 or more gm/min.
[0101] Morcellators in accordance with the present invention may be
constructed to have a fluid usage of no more than about 350 ml/min.
In certain embodiments, fluid usage of no more than about 300
ml/min or no more than about 275 ml/min may be constructed.
[0102] Applied vacuum to the morcellators of the present invention
will generally be in the range of from about 200 to about 650 mm
Hg. The morcellator will typically be run at a vacuum of at least
about 350 mm Hg, and, often at least about 500 mm Hg.
[0103] In one embodiment of the present invention, the cross
sectional area of the aspiration lumen was about 7.1 mm.sup.2, and
yielded a tissue resection rate of about 1.4 gm/min, under vacuum
of approximately 600 mm Hg.
[0104] In general, procedures accomplished in accordance with the
present invention will require no more than about 10 minutes, and
preferably, no more than about 8 or 9 minutes of active
morcellation. During that time, total fluid (e.g. saline)
introduced into the uterus will generally be no greater than about
12 liters, and, preferably no greater than about 10 liters or 8
liters. Distension fluid will preferably be maintained at a low
enough pressure and short enough time to keep the total saline
intravasation below 2.5 liters.
[0105] In a typical procedure in accordance with the present
invention, utilizing a morcellator having an outside diameter of 3
mm, the fluid flow rate for aspiration of saline through the
morcellator is approximately 260 ml/min (e.g. within the range of
from about 240 to about 280 ml/min). Thus, in a ten minute
procedure, approximately 2.6 liters of saline is aspirated through
the morcellator. In that same procedure, the tissue resection rate
is typically in excess of about 2 gm/min.
[0106] In a comparative experiment, a device manufactured in
accordance with the present invention was compared to the
performance of a reciprocating hysteroscopic morcellator from Smith
and Nephew. Over a series of experiments with the predicate device,
the vacuum was maintained on average in the 200 to 270 mm Hg range,
morcellator speed was approximately 1100 rpm, tissue resection rate
was approximately 1.4 gm/min, the fluid flow rate through the
morcellator was approximately 247 ml/min, and the outside diameter
of the morcellator was 4.0 mm.
[0107] The device constructed in accordance with the present
invention was operated at a vacuum of 600 mm Hg, a speed of about
6000 rpm, to produce a resection rate of approximately 2.2 gm/min
and an aspiration flow rate of about 266 ml/min through the
morcellator. The outside diameter of the device was 3 mm.
[0108] The morcellator in accordance with the present invention
thus produced a significantly higher resection rate, through a
smaller outside diameter morcellator, at a roughly comparable flow
rate of aspirated saline. In order to increase the resection rate
of the predicate device, the vacuum must be significantly
increased. For example, when the vacuum pressure in the predicate
system was increased to about 670 mm Hg, the tissue cutting
improved to 3.5 gm/min but fluid flow rate jumped to 540
ml/min.
[0109] One challenge with increased fluid flow rate which is
responsive to increased vacuum is that the replacement fluid must
be infused into the procedure site at an equal rate. In order to
infuse fluid at a sufficient rate to allow the predicate device to
function at a higher vacuum, the diameter of the already larger
predicate morcellator must be increased. Applicants have determined
that the use of the morcellator disclosed herein, with an outside
diameter of no more than about 3 mm, in combination with the optic
system, allows the dilatation of the cervix be limited to no more
than about 5.5 mm. Increasing the diameter of the morcellator to
accommodate the higher infusion rate as well as the already larger
outside diameter of the predicate system is believed to cross the
pain threshold and appears to impose the need or desirability for
conducting the procedure under a general anesthetic. Applicants
believe it to be a significant benefit for many patients to be able
to avoid general anesthesia.
[0110] Referring now to FIGS. 10(a) and 10(b), there are shown
fragmentary longitudinal section views of certain alternate inner
tubular members that may be used in tissue removal device 6. A
first such alternate inner tubular member is shown in FIG. 10(a)
and is represented generally by reference numeral 411. Inner
tubular member 411 may be similar in certain respects to inner
tubular member 77; however, one notable difference between the two
tubular members is that, whereas inner tubular member 77 may be a
unitary structure made from a single piece of material, inner
tubular member 411 may be formed by joining together two separate
pieces of material. More specifically, inner tubular member 411 may
comprise a first piece in the form of a proximal stem 413 and a
second piece in the form of a distal tip 415, with distal tip 415
preferably having a length greater than the length of resection
window 89 and more preferably having a length of less than about 2
inches and in one construction, about 1 inch. Proximal stem 413 and
distal tip 415 may be made of the same material or may be made of
different materials. Comparatively hard stainless steel materials,
such as 400-series stainless steels (e.g., 440C stainless steel)
where hardness exceeds Rockwell C values of about 50, are preferred
for distal tip 415 as these materials enable a much sharper edge to
distal tip 415 to be created. On the other hand, less hard
stainless steel materials, such as 300-series stainless steels
(e.g., 304 stainless steel), may be preferred for proximal stem 413
as these materials may be comparatively inexpensively formed into
long tubular structures, for example, by extrusion whereas harder
stainless steel materials must be machined to form tubular
structures. The Rockwell C hardness of these proximal tube
materials is less than about 40. Proximal stem 413 and distal tip
415 may be joined together by welding or other suitable techniques.
Any of a variety of cutter edge and window configurations may be
used, depending upon the desired performance, including any of
those disclosed in U.S. patent application Ser. No. 12/098,250,
filed Apr. 4, 2008 to Gruber, et al., the disclosure of which is
hereby incorporated by reference in its entirety herein.
[0111] Another notable difference between tubular member 411 and
tubular member 77 is that, whereas tubular member 77 may have a
uniform inner diameter over its length, the inner diameter of
distal tip 415 may be reduced as compared to the inner diameter of
proximal stem 413 (e.g., 0.082 inch vs. 0.085 inch). Applicants
believe that this increase in inner diameter from distal tip 415 to
proximal stem 413 may result in a reduction in the incidence of
clogging in tubular member 411 as the cut specimen, which has an
outer diameter similar to distal tip 415, moves from distal tip 415
into proximal stem 413, which has a greater diameter than the cut
specimen. This clearance within proximal stem 413 facilitates the
proximal movement of the specimen through tubular member 411.
[0112] A second alternate inner tubular member is shown in FIG.
10(b) and is represented generally by reference numeral 421.
Tubular member 421 may be similar in certain respects to tubular
member 411, the principal difference between the two tubular
members being that tubular member 421 may be a unitary structure
made from a single piece of material, which may be, for example, a
17-7-series stainless steel. To form tubular member 421 from a
tubular structure having a uniform inner diameter, one may first
swage or roll the distal end of the tubular structure to reduce the
inner diameter of the distal end and then may increase the inner
diameter of the remainder of the structure by mechanically honing,
expanding, or chemically etching.
[0113] Referring now to FIG. 11, there is shown a side view of an
alternate indicator sleeve 431 that may be used in tissue removal
device 6. Indicator sleeve 431 may be similar in most respects to
indicator sleeve 98, the principal difference between the two
indicator sleeves being that sleeve 431 may be provided with
labeled or unlabeled gradations 433 along its length to indicate
the distance between each gradation and a distal end 431-1 of
sleeve 431. Because sleeve 431 is preferably dimensioned and
positioned so that distal end 431-1 of sleeve 431 indicates when
distal end 92 of device 6 is aligned with the distal end of
introducer 7, gradations 433 indicate the relative distance between
distal end 92 of device 6 and the distal end of introducer 7.
Gradations 433 may comprise, for example, numerical markings,
symbols, hash marks, rings, or the like.
[0114] Referring now to FIG. 12, there is shown a fragmentary side
view, partly in section, of an alternate combination of a tissue
removal device and an introducer that may be used in tissue removal
system 5, the subject tissue removal device being represented
generally by reference numeral 441 and the subject introducer being
represented generally by reference numeral 443.
[0115] Device 441 and introducer 443 may be similar in most
respects to device 6 and introducer 7, respectively, the principal
differences being that device 441 may include, instead of sleeve
98, a position indicator ring 445 fixedly mounted on strain relief
member 74, and introducer 443 may include, instead of proximal
portion 203 of body 201, a proximal portion 447 appropriately
shaped to provide just enough interference with bumps 445-1 and
445-2 on ring 445 so that a user may be given a tactile indication
that ring 445 is being inserted into proximal portion 447.
[0116] Referring now to FIGS. 13(a) and 13(b), there are shown
fragmentary side views, partly in section, of another alternate
combination of a tissue removal device and an introducer that may
be used in tissue removal system 5, the subject tissue removal
device being represented generally by reference numeral 451 and the
subject introducer being represented generally by reference numeral
453.
[0117] Device 451 may be identical to device 441. Introducer 453
may be similar in most respects to introducer 7, the principal
difference between the two introducers being that introducer 453
may be shaped to include a sound chamber 455 and may additionally
include a spring clip or band 457. Clip 457 may have a fixed end
457-1 that is mounted within sound chamber 455 and a free end 457-2
that is constructed so as to be deflected by ring 445 when ring 445
is moved distally past clip 457. The deflection of clip 457 by ring
445 causes clip 457 to oscillate and to generate an audible
signal.
[0118] Referring now to FIG. 14, there is shown a fragmentary side
view, partly in section, of an alternate tissue removal device that
may be used in tissue removal system 5, said tissue removal device
being represented generally by reference numeral 470. Certain
aspects of device 470 not important to an understanding of the
invention are neither shown nor described herein.
[0119] Device 470 may be similar in most respects to device 6, the
principal differences between the two devices being that, whereas
device 6 may comprise a rotational mechanism comprising a spur gear
51 engaged with a gear-shaped distal portion 72-2 of a shaft 72,
device 470 instead may comprise a rotational mechanism comprising a
shaft 472 comprising a tubular elastomeric distal portion 472-2
engaged for rotation with an elastomeric O-ring 474 fixedly mounted
within a groove 476 of a cylindrical member 478 fixedly coupled to
translation drive shaft 35.
[0120] Referring now to FIGS. 15(a) and 15(b), there are shown
fragmentary perspective and exploded perspective views,
respectively, of another alternate tissue removal device that may
be used in tissue removal system 5, said tissue removal device
being represented generally by reference numeral 500. Certain
aspects of device 500 not important to an understanding of the
invention are neither shown nor described herein.
[0121] Device 500 may be similar in many respects to device 6, one
difference between the respective tissue removal devices being that
device 500 may comprise a mounting bracket 501. Bracket 501, which
may be a unitary structure made of a rigid metal or polymer, may be
shaped to include a base portion 503, a proximal block 505
extending upwardly from the proximal end of base portion 503, a
distal block 507 extending upwardly from the distal end of base
portion 503, and an intermediate block 509 extending upwardly from
an intermediate portion of base portion 503.
[0122] Another difference between device 500 and device 6 is that,
whereas device 6 may comprise an internal drive shaft 21, a
translation drive shaft 35, and a gear assembly 50, device 500 may
instead comprise an internal drive shaft 510, a translation drive
shaft 511, and a gear assembly 512. Internal drive shaft 510, which
may be an elongated unitary structure made of a suitably rigid
metal or polymer, may be shaped to include a proximal end 513 and a
distal end 515. Proximal end 513 of shaft 510 may be coaxially
mounted over and fixed to the distal end of external drive shaft
29. In this manner, the rotation of shaft 510 may be mechanically
coupled to the rotation of shaft 29. An intermediate portion of
shaft 510 may be received within a longitudinal bore 520 provided
in block 505 of bracket 501. Gear assembly 512 may be fixedly
mounted on distal end 515 of shaft 510 so as to rotate with shaft
510. Gear assembly 512 may include a larger diameter proximal spur
gear 523 and a smaller diameter distal spur gear 525. Translation
drive shaft 511, which may be an elongated unitary structure made
of a suitably rigid metal or polymer, may be shaped to include a
proximal end 537, an intermediate portion 539, and a distal end
541. Proximal end 537 of shaft 511 may be in the shape of a spur
gear, which may be engaged with distal gear 525. In this manner,
the rotation of shaft 511 may be mechanically coupled to the
rotation of shaft 510, with the speed of rotation of shaft 511
being dependent on the speed of rotation of shaft 510 and the
relative sizes of gear 525 and proximal end 537. Intermediate
portion 539 may extend through a longitudinal bore 509-1 provided
in block 509 of bracket 501. Intermediate portion 539 may be shaped
to include a double helical portion 540 similar to the double
helical portion of shaft 35. Distal end 541 of shaft 511 may be
appropriately dimensioned to be received within an opening 544
provided in block 507 of bracket 501. It should be noted that,
although shaft 511 is adapted for rotation, shaft 511 is
translationally stationary.
[0123] Another difference between device 500 and device 6 is that,
whereas device 6 may comprise a shaft 72 mechanically coupled to
inner tubular member 77 so as to rotate and to oscillate
translationally therewith, device 500 may instead comprise an
elongated shaft 551 mechanically coupled to inner tubular member 77
so as to rotate and to oscillate translationally therewith. Shaft
551, which may be a unitary tubular structure made of a rigid metal
or polymer, may be shaped to include a spur gear engaged with
proximal gear 523. The gear may be elongated so that it may
maintain engagement with proximal gear 523 even as the gear moves
translationally relative to proximal gear 523. The speed at which
shaft 551 rotates may be the same as or different than the speed at
which gear 523 rotates, depending, for example, on the relative
diameters of the two gears (the ratio of the rotational speeds of
the two gears being inversely proportional to the ratio of the
diameters of the two gears). Consequently, by appropriately
dimensioning the gears, one can achieve a desired rotational speed,
even where the rotational speed of the external drive shaft is
fixed. For example, in the embodiment shown, the gear of shaft 551
may have a diameter that is one-third the diameter of gear 523 and,
therefore, rotates three times as fast as gear 523. At the same
time, proximal end 537 of shaft 511 may have a diameter that is
four-thirds the diameter of gear 525 and, therefore, rotates
three-quarters as fast as gear 525. Therefore, if the external
drive shaft has a speed of rotation of about 2000 rpm, shaft 551
(and inner tubular member 77) would rotate at about 6000 rpm and
shaft 511 would rotate at about 1500 rpm, which, with an
appropriate shaping of the double helix portion of shaft 511, could
be used to achieve an oscillating translational speed for inner
tubular member 77 of about 2.8 cycles/second.
[0124] Referring now to FIG. 16, there is shown a fragmentary side
view of an alternate tissue removal device that may be used in
tissue removal system 5, said tissue removal device being
represented generally by reference numeral 570. Certain aspects of
device 570 not important to an understanding of the invention are
neither shown nor described herein.
[0125] Device 570 may be similar in many respects to device 6. One
difference between the two devices may be that, whereas device 6
may fix inner drive shaft 21 to external drive shaft 29 for
rotation therewith and may couple the rotation of inner tubular
member 77 to inner drive shaft 21 through the engagement of shaft
72 and gear 51, device 570 may instead fix inner tubular member 77
to external drive shaft 29 for rotation therewith and may couple
the rotation of inner drive shaft 21 to inner tubular member 77
through the engagement of a pair of spur gears 572 and 574. Gear
572 may be coaxially inserted over and fixed to inner tubular
member 77, and gear 574 may be coaxially inserted over and fixed to
inner drive shaft 21. Gears 572 and 574 may be sized to be, for
example, in a 1:4 ratio, respectively, so that, if external drive
shaft 29 rotates at about 6000 rpm, inner tubular member 77 also
rotates at about 6000 rpm whereas inner drive shaft 21 rotates at
about 1500 rpm.
[0126] Referring now to FIG. 17, there is shown a fragmentary side
view of an alternate tissue removal device that may be used in
tissue removal system 5, said tissue removal device being
represented generally by reference numeral 580. Certain aspects of
device 580 not important to an understanding of the invention are
neither shown nor described herein.
[0127] Device 580 may be similar in many respects to device 6. One
difference between the two devices may be that, whereas device 6
may fix inner drive shaft 21 to external drive shaft 29 for
rotation therewith and may couple the rotation of inner tubular
member 77 to inner drive shaft 21 through the engagement of shaft
72 and gear 51, device 580 instead may couple the rotation of inner
drive shaft 21 to external drive shaft 29 through the engagement of
a pair of spur gears 582 and 584 and may couple the rotation of
inner tubular member 77 to external drive shaft 29 through the
engagement of a spur gear 586 with gear 582. Gear 582 may be
coaxially inserted over and fixed to external drive shaft 29, gear
584 may be coaxially inserted over and fixed to inner drive shaft
21, and gear 586 may be coaxially inserted over and fixed to inner
tubular member 77. Gears 582 and 584 may be sized to be, for
example, in a 1:2 ratio, respectively, and gears 582 and 586 may be
sized to be, for example, in a 2:1 ratio, respectively. In this
manner, if external drive shaft 29 rotates at about 3000 rpm, inner
tubular member 77 rotates at about 6000 rpm and inner drive shaft
21 rotates at about 1500 rpm.
[0128] Referring now to FIG. 18, there is shown a fragmentary
perspective view of an alternate tissue removal device that may be
used in tissue removal system 5, said tissue removal device being
represented generally by reference numeral 600. Certain aspects of
device 600 not important to an understanding of the invention are
neither shown nor described herein.
[0129] Device 600 may be similar in many respects to device 6. One
difference between the two devices may be their respective
mechanisms for rotating and translationally reciprocating inner
tubular member 77. More specifically, device 600 may comprise an
internal drive shaft 603 fixed to an external drive shaft (not
shown) so as to rotate therewith. Internal drive shaft 603 may
comprise a proximal portion 605 and a distal portion 607. A spur
gear 609 and a bevel gear 611 may be coaxially mounted over distal
portion 607 and fixed thereto for rotation therewith, with bevel
gear 611 being positioned distally relative to spur gear 609. A
spur gear 613 may be coaxially mounted over inner tubular member 77
and fixed thereto for rotation therewith, gear 613 being engaged
with gear 609 so that the rotation of internal drive shaft 603
causes the rotation of inner tubular member 77. (The speed of
rotation of inner tubular member 77, as compared to that of drive
shaft 603, may be controlled by the relative diameters of gears 609
and 613). A bevel gear 615, positioned distally relative to
internal drive shaft 603, may be engaged with bevel gear 611. A
saddle 619 may be coaxially mounted over inner tubular member 77,
saddle 619 being fixed to inner tubular member 77 for translational
movement therewith but permitting tubular member 77 to freely
rotate therewithin. Saddle 619 and bevel gear 615 may be coupled to
one another by a pin (not shown) extending upwardly from the top
surface 621 of gear 615 and a slot (not shown) provided on the
bottom surface of saddle 619, the slot in saddle 619 receiving the
pin on bevel gear 615. The slot in saddle 619 may be oriented
perpendicularly to the longitudinal axis of inner tubular member 77
and may be appropriately dimensioned so that the pin on bevel gear
615 travels back and forth within the slot in saddle 619 as bevel
gear 615 rotates. In this manner, the rotation of bevel gear 615
may cause the translational oscillation of inner tubular member
77.
[0130] Referring now to FIG. 19, there is shown a fragmentary
perspective view of an alternate tissue removal device that may be
used in tissue removal system 5, said tissue removal device being
represented generally by reference numeral 700. Certain aspects of
device 700 not important to an understanding of the invention are
neither shown nor described herein.
[0131] Device 700 may be similar in many respects to device 6. One
difference between the two devices may be their respective
mechanisms for rotating and translationally reciprocating inner
tubular member 77. More specifically, device 700 may comprise an
internal drive shaft 703 fixed to an external drive shaft (not
shown) so as to rotate therewith. A spur gear 705 and a translation
cam 707 may be coaxially mounted over drive shaft 703 and fixed
thereto for rotation therewith, with translation cam 707 being
positioned distally relative to spur gear 705. A spur gear 711 may
be coaxially mounted over inner tubular member 77 and fixed thereto
for rotation therewith, gear 711 being engaged with gear 705 so
that the rotation of internal drive shaft 703 causes the rotation
of inner tubular member 77. (The speed of rotation of inner tubular
member 77, as compared to that of drive shaft 703, may be
controlled by the relative diameters of gears 705 and 711). A
saddle 713 may be coaxially mounted over inner tubular member 77,
saddle 713 being fixed to inner tubular member 77 for translational
movement therewith but permitting tubular member 77 to freely
rotate therewithin. Saddle 713 and translation cam 707 may be
coupled to one another by a pin (not shown) extending downwardly
from saddle 713 and a looped groove 717 provided in cam 707, groove
717 receiving the pin on saddle 713. Groove 717 in cam 707 may be
shaped to extend from about the proximal end 707-1 of cam 707 to
about the distal end 707-2 of cam 707 and back to about the
proximal end 707-1 of cam 707 over the course of one rotation of
cam 707. In this manner, as cam 707 rotates and the pin travels
back and forth within groove 717, inner tubular member 77 may be
translationally oscillated correspondingly.
[0132] Referring now to FIG. 20, there is shown a fragmentary
perspective view of an alternate tissue removal device that may be
used in tissue removal system 5, said tissue removal device being
represented generally by reference numeral 800. Certain aspects of
device 800 not important to an understanding of the invention are
neither shown nor described herein.
[0133] Device 800 may be similar in many respects to device 6. One
difference between the two devices may be their respective
mechanisms for rotating and translationally reciprocating inner
tubular member 77. More specifically, device 800 may comprise an
internal drive shaft 801 fixed to an external drive shaft (not
shown) so as to rotate therewith. A spur gear 803 may be coaxially
mounted over drive shaft 801 and fixed thereto for rotation
therewith. In addition, a translation cam 805 may be coaxially
mounted over drive shaft 801 and fixed thereto for rotation
therewith. Translation cam 805 may comprise a tubular portion 805-1
and a disc portion 805-2, disc portion 805-2 being fixedly mounted
on tubular portion 805-1 at a non-perpendicular angle relative to
the longitudinal axis of tubular portion 805-2. A spur gear 813 may
be coaxially mounted over inner tubular member 77 and fixed thereto
for rotation therewith, gear 813 being engaged with gear 803 so
that the rotation of internal drive shaft 801 causes the rotation
of inner tubular member 77. (The speed of rotation of inner tubular
member 77, as compared to that of drive shaft 801, may be
controlled by the relative diameters of gears 803 and 813). A
saddle 819 may be coaxially mounted over inner tubular member 77,
saddle 819 being fixed to inner tubular member 77 for translational
movement therewith but permitting tubular member 77 to freely
rotate therewithin. Saddle 819 may be shaped to include a recess
821, which may receive the top of disc portion 805-2. In this
manner, as drive shaft 801 rotates, causing disc portion 805-2 to
"wobble" back and forth, saddle 819, and thus inner tubular member
77, may be translationally oscillated correspondingly.
[0134] Referring now to FIG. 21, there is shown a fragmentary
perspective view of an alternate tissue removal device that may be
used in tissue removal system 5, said tissue removal device being
represented generally by reference numeral 900. Certain aspects of
device 900 not important to an understanding of the invention are
neither shown nor described herein.
[0135] Device 900 may be similar in many respects to device 6. One
difference between the two devices may be their respective
mechanisms for rotating and translationally reciprocating inner
tubular member 77. More specifically, device 900 may comprise an
internal drive shaft 901 fixed to an external drive shaft (not
shown) so as to rotate therewith. A spur gear 903 and a worm gear
905 may be coaxially mounted over drive shaft 901 and fixed thereto
for rotation therewith. A spur gear 907 may be coaxially mounted
over inner tubular member 77 and fixed thereto for rotation
therewith, gear 907 being engaged with gear 903 so that the
rotation of internal drive shaft 901 causes the rotation of inner
tubular member 77. (The speed of rotation of inner tubular member
77, as compared to that of drive shaft 901, may be controlled by
the relative diameters of gears 903 and 907). A worm gear 911 may
be engaged with worm gear 905 so that worm gear 911 rotates as worm
gear 905 rotates. A pin 913 may be mounted near the periphery of a
front face 911-1 of worm gear 911. A reciprocation arm 915 may have
a first end secured to pin 913 and a second end secured to a block
917 translationally coupled to inner tubular member 77. In this
manner, as worm gear 911 rotates and the position of pin 913 on
worm gear 911 changes, arm 915 moves block 917 and inner tubular
member 77 back and forth translationally.
[0136] As can be appreciated, one would like to minimize the amount
of distension fluid that flows from the uterus of the patient
through the tissue removal device when the tissue removal device is
left in the patient but the cutting motor for the tissue removal
device has temporarily been turned off, e.g., during those periods
when the operator of the tissue removal device stops cutting to
examine the patient. Such a loss of distension fluid is undesirable
for at least the reason that the lost distension fluid will need to
be replenished in order to keep the uterus distended. In device 6,
this problem may be addressed through electronics by sensing when
the motor for device 6 is about to be turned off and, in those
instances, by positioning inner tubular member 77 translationally
relative to outer tubular member 76 so that resection window 89 is
closed. An alternate approach to this problem is exemplified by
tissue removal device 940, which is shown in FIGS. 22(a) through
22(e). Certain aspects of device 940 not important to an
understanding of the invention are neither shown nor described
herein.
[0137] Device 940 is similar in certain respects to device 6.
However, one difference between the respective devices is that
device 940 may comprise an inner tubular member 943 having a closed
proximal end 945 and a side window 947. A spring mount 949 may be
coaxially mounted over inner tubular member 943 and fixed thereto
for rotation therewith. The proximal end of a spring 951 may be
fixed to spring mount 949, and the distal end of spring 951 may be
fixed to a valve member 953 coaxially mounted over inner tubular
member 943, valve member 953 being capable of rotating relative to
inner tubular member 943. Valve member 953 may include a side
window 955. Side window 955 may be alignable with side window 943
depending on the respective rotational positions of inner tubular
member 943 and valve member 953. A stop 957 may be formed on inner
tubular member 943, stop 957 being detachably engageable with valve
member 953 to couple the rotation of valve member 953 with inner
tubular member 943. A vacuum housing 959 may be coaxially mounted
over valve member 953, valve member 953 being freely rotatable
within vacuum housing 959. Outer tubular member 76 may be fixedly
mounted on vacuum housing 959. A pair of O-rings 961-1 and 961-2
may be provided to function as seals.
[0138] Prior to the cutting motor of device 940 being actuated,
side window 955 of valve member 953 and side window 947 of inner
tubular member 943 are 90 degrees out of register with one another.
However, once the cutting motor of device 940 is actuated, inner
tubular member 943 begins to rotate. This causes spring 951 to try
to unwind, thereby causing valve member 953 to rotate so that side
window 955 of valve member 953 is aligned with side window 947 of
inner tubular member 943. With valve member 953 thus rotationally
aligned with inner tubular member 943, stop 957 prevents further
rotation of valve member 953 relative to inner tubular member 943.
When the cutting motor of device 940 is then turned off, spring 951
causes valve member 953 to be rotated back to its original
orientation relative to inner tubular member 943.
[0139] As noted above, introducer 7 preferably comprises valve 233,
which is designed to keep fluid from escaping from the patient when
device 6 is not inserted into introducer 7. However, there may be
situations in which it is desirable to simultaneously have fluid
flowing into and out of the patient without having device 6
inserted into introducer 7. Therefore, referring now to FIG. 23,
there is shown a fragmentary section view of an obturator 965
positioned within a channel of introducer 7. Obturator 965 may be
shaped to include a blunt distal end 967 and a plurality of
openings 969 leading to a longitudinally-extending channel 971.
Obturator 965 may be positioned in instrument channel 196, as
shown, or may be positioned in fluid input channel 198-1 or fluid
input channel 198-2 to provide bidirectional fluid flow (for
example, with fluid inflow exiting channels 198-1 or 198-2 in the
space between channels 198-1 or 198-2 and obturator 965 and with
fluid outflow entering obturator 965 through openings 969). The
fluid outflow entering channel 971 through openings 969 may exit
obturator 965 through the proximal end (not shown) of obturator
965.
[0140] An alternate obturator 972 is shown in FIG. 24, obturator
972 having a side opening 973 at an intermediate location along its
length, side opening 973 being aligned with an outflow fluid
channel 975 provided in an alternate introducer 977. If desired,
obturator 972 may be made of a resilient member having a bend and
introducer 977 may be provided with a sheath 978 made of a flexible
material. In this manner, obturator 972 may be used to provide a
bend to sheath 978, which, by rotating the proximal end 979 of
obturator 972, may be used to steer the distal end of sheath
978.
[0141] Referring now to FIGS. 25(a) and 25(b), there is shown an
alternate combination of an obturator and an introducer according
to the present invention, the obturator being represented generally
by reference numeral 980 and the introducer being represented
generally by reference numeral 981.
[0142] Obturator 980, which may be similar in many respects to
obturator 965, may comprise a distal member 982 and a proximal
member 983. Distal member 982 may be tubular and may comprise an
open distal end 984, a closed proximal end 985, and a side opening
986, with proximal member 983 being mounted over proximal end 985
of distal member 982.
[0143] Introducer 981 may be similar in many respects to introducer
7, one difference between the respective introducers being that
introducer 981 may additionally comprise a fluid outflow channel
987. Channel 987 may comprise a distal end 987-1 that may be
aligned with side opening 986 of obturator 980 when obturator 980
is installed in introducer 981. In this manner, outflow fluid may
flow from obturator 980 to channel 987 and may exit introducer 981
through a proximal end 987-2 of channel 987. Introducer 981 may
additionally comprise a valve 988-1 and a valve 989-2. Valve 988-1,
which may be a stopcock valve, may be used to control the flow of
fluid through channel 987. Valve 988-2, which may be a stopcock
valve, may be used to control the flow of fluid through inflow
channel 989.
[0144] Referring now to FIGS. 26(a) through 26(c), there are shown
various views of an alternate introducer device to introducer
device 7, the alternate introducer device being represented
generally by reference numeral 990.
[0145] Introducer device 990 may be similar in many respects to
introducer device 7. One difference between introducer device 990
and introducer device 7 may be that, whereas introducer device 7
may comprise a sheath 191 having a top lumen 196, a bottom lumen
197 and a pair of side lumens 198-1 and 198-2, introducer device
990 may comprise a top tubular member 991, a bottom tubular member
992, a sleeve 993, and a distal cap 994. Top tubular member 991 may
be used, for example, as an instrument channel to receive, for
example, tissue removal device 6 or obturator 965. Bottom tubular
member 992 may be used, as is shown, for example, to receive distal
end 319 of hysteroscope 8. Sleeve 993, which may be made of
stainless steel or the like, may be appropriately dimensioned to
coaxially receive top tubular member 991 and bottom tubular member
992 and may be shaped to define a pair of fluid channels 995 on
opposite sides of tubular members 991 and 992 in the spaces between
the inner surface of sleeve 993 and the outer surfaces of tubular
members 991 and 992. A plurality of transverse openings 996 may be
provided in sleeve 993 near the distal end 997 thereof, openings
996 providing side access to fluid channels 995. In this manner,
fluid inflow to the patient may be provided by having the fluid
pass distally through channels 995 and then exit radially through
openings 996. Fluid outflow from the patient may travel proximally
through cap 994 and then proximally through top tubular member 991
(for example, by passing through an instrument positioned in top
tubular member 991). It is believed that the fluid flow pattern
provided by introducer device 990 may be particularly effective in
removing blood and other undesired fluids from a patient. Cap 994
may include a retainer 998, which may receive the distal ends of
tubular members 991 and 992 and which may be inserted into and
fixed to the distal end 997 of sleeve 993.
[0146] Referring now to FIG. 27, there is shown a partially
exploded perspective view of a second embodiment of a tissue
removal system, the tissue removal system being constructed
according to the teachings of the present invention and being
represented generally by reference numeral 1007.
[0147] System 1007 may comprise a tissue removal device 1008, a
vacuum assembly 1009, and a motor drive assembly 1010. Although not
shown in the present embodiment, system 1007 may also include an
introducer device, a flexible hysteroscope, and a fluid supply
similar to those of system 5 described above.
[0148] Tissue removal device 1008 may comprise a morcellator
assembly 1013 and a drive assembly 1015, morcellator assembly 1013
being removably mounted on drive assembly 1015 in the manner
described further below.
[0149] Referring now to FIGS. 28(a) through 28(d), morcellator
assembly 1013 may be seen in greater detail. Morcellator assembly
1013 may comprise a housing 1021. Housing 1021, which may be an
elongated unitary structure made of a rigid polymer or metal, may
be a generally tubular member shaped to include a proximal end
1023, a distal end 1025, and a side wall 1027. Side wall 1027 may
be generally cylindrical, with a portion 1028 of its bottom surface
being beveled. A longitudinal lumen 1029 may extend from proximal
end 1023 to distal end 1025. An intermediate portion 1031 of lumen
1029 may be expanded in diameter and may be accessible through an
opening 1033 in side wall 1027. A proximal portion 1035 of lumen
1029 extending distally from proximal end 1023 to a point spaced
proximally from intermediate portion 1031 may be expanded in
diameter and may be internally threaded.
[0150] Morcellator assembly 1013 may additionally comprise a pair
of tubular bushings 1041 and 1043. Bushing 1041, which may be a
unitary structure made of a rigid polymer or metal, may be seated
within intermediate portion 1031 of lumen 1029, near its proximal
end, and may be fixedly secured to housing 1021 with screws 1042.
Bushing 1043, which may be a unitary structure made of a rigid
polymer or metal, may be seated within intermediate portion 1031 of
lumen 1029, near its distal end, and may be fixedly secured to
housing 1021 with screws 1044. Bushing 1041 may be shaped to
include a bore 1045, and bushing 1043 may be shaped to include a
bore 1047, bores 1045 and 1047 being coaxially aligned with lumen
1029 of housing 1021.
[0151] Morcellator assembly 1013 may further comprise an elongated
shaft 1051. Shaft 1051, which may be a unitary structure made of
brass or another suitable rigid metal or polymer, may be shaped to
include a proximal portion 1053, a distal portion 1055, an
intermediate portion 1057, and a longitudinal bore 1059. Proximal
portion 1053 of shaft 1051 may be slidably mounted in bore 1045 of
bushing 1041 and may be sized to freely rotate therewithin. Distal
portion 1055 of shaft 1051 may be slidably mounted in bore 1047 of
bushing 1043 and may be sized to freely rotate therewithin.
Intermediate portion 1057 of shaft 1051 may be positioned between
bushings 1041 and 1043 and may be in the shape of a gear having an
enlarged external diameter relative to proximal portion 1053 and
distal portion 1055.
[0152] Morcellator assembly 1013 may further comprise a
translational coupling block 1061. Block 1061, which may be a
unitary structure made of a rigid polymer or metal, may be a
tubular member shaped to include a proximal end 1063, a distal end
1064, a side wall 1065, and a longitudinal bore 1066. Block 1061
may be coaxially mounted over proximal portion 1053 of shaft 1051,
with bore 1066 being sized relative to proximal portion 1053 so
that proximal portion 1053 may freely rotate within bore 1066. Side
wall 1065 of block 1061 may be shaped to correspond generally to
the shape of intermediate portion 1031 of lumen 1029. In this
manner, block 1061 may be kept rotationally stationary within
housing 1021. Block 1061 may be translationally fixed relative to
shaft 1051 with a retaining ring 1067 inserted coaxially over
proximal portion 1053 and secured to proximal portion 1053 with a
set screw 1068. A washer 1069 may be inserted coaxially over
proximal end 1053 of shaft 1051 between distal end 1063 of block
1061 and intermediate portion 1057 of shaft 1051 to prevent any
wear caused by contact between intermediate portion 1057 against
distal end 1063 of block 1061 as intermediate portion 1057 rotates.
Side wall 1065 of block 1061 may further be shaped to include a
waist 1070 of reduced external diameter. In this manner, with block
1061 coaxially mounted over proximal portion 1053 of shaft 1051, a
pair of slots 1071-1 and 1071-2 may be formed between block 1061
and housing 1021.
[0153] Morcellator assembly 1013 may further comprise a strain
relief member 1072. Strain relief member 1072, which may be a
unitary structure made of a rigid polymer or metal, may be a
tubular member shaped to include a proximal portion 1073 and a
distal portion 1074. Proximal portion 1073 may be slightly greater
in diameter than distal portion 1074 and may include a bifurcating
slot 1075. Proximal portion 1073 of strain relief member 1072 may
be disposed within the distal portion of lumen 1029, with distal
portion 1074 of strain relief member 1072 extending distally from
distal end 1025 of housing 1021 for a short distance, such as, for
example, approximately 2 inches.
[0154] Morcellator assembly 1013 may further comprise a cutting
mechanism. In the present embodiment, the cutting mechanism may
comprise an outer tubular member 1076 and an inner tubular member
1077, inner tubular member 1077 moving rotationally and, at the
same time, oscillating translationally relative to outer tubular
member 1076 in the manner to be described further below. Outer
tubular member 1076, which may be a unitary structure made of
stainless steel or another similarly suitable material, may be
shaped to include an open proximal end 1079, a closed distal end
1081, and a lumen 1083 extending from open proximal end 1079 to a
point just prior to closed distal end 1081. Member 1076 may be
coaxially mounted within strain relief member 1072, with proximal
end 1079 of member 1076 disposed within proximal portion 1073 of
strain relief member 1072 and with distal end 1081 of member 1076
extending distally beyond distal portion 1074 of strain relief
member 1072 for an extended distance, such as, for example, five
inches. The combination of proximal end 1079 of member 1076 and
proximal portion 1073 of strain relief member 1072 may be securely
retained in housing 1021 using a screw 1085 inserted through an
opening 1087 in housing 1021, screw 1085 pressing proximal portion
1073 of strain relief member 1072 tightly against proximal end 1079
of member 1076.
[0155] Outer tubular member 1076 may be further shaped to include a
resection window 1089 into which tissue may be captured and drawn,
window 1089 being located proximate to distal end 1081, such as,
for example, 0.25 inch from distal end 1081. Window 1089 may be
shaped to include a proximal end 1089-1 and a distal end 1089-2.
Proximal end 1089-1 may slope gradually proximally, and distal end
1089-2 may slope gradually distally. More specifically, window 1089
may have a length of approximately 0.55 inch, proximal end 1089-1
may be a radial end having a radius of curvature of, for example,
0.085 inch, and distal end 1089-2 may be a radial end having a
radius of curvature of, for example, 0.150 inch. Window 1089 may
extend over a substantial portion of the circumference of tubular
member 1076, such as, for example, about 60% of the
circumference.
[0156] Outer tubular member 1076 may have an outer diameter less
than about 5.5 mm. However, in order to reduce the risk of injury
to the patient and in order to obviate the need for anesthesia to
be administered to the patient, outer tubular member 1076
preferably has an outer diameter less than about 5 mm, more
preferably less than 4 mm, even more preferably less than 3 mm, and
still even more preferably less than 2 mm.
[0157] Inner tubular member 1077, which may be an elongated unitary
structure made of stainless steel or another similarly suitable
material, may be shaped to include a proximal end 1091, a distal
end 1092, and a longitudinal lumen 1093. Distal end 1092 may be
shaped to include an external bevel, such as, for example, an
external bevel of approximately 20 degrees. An intermediate portion
of tubular member 1077 may be received within bore 1059 of shaft
1051 and may be fixedly coupled to shaft 1051 for translational and
rotational movement therewith using a retaining ring 1094-1, a
slotted sleeve 1094-2 and a pair of set screws 1095. The proximal
portion of ring 1094-1 may be screwed onto the distal end of shaft
1051, with the distal portion of ring 1094-1 extending over member
1077. Sleeve 1094-2 may be inserted coaxially between member 1077
and ring 1094-1, and set screws 1095 may be inserted through a
transverse opening 1096 in retaining ring 1094-1 to couple ring
1094-1 and sleeve 1094-2 to member 1077. Tubular member 1077 may
have a suitable length so that, when tubular member 1077 is in a
fully retracted (i.e., proximal) position, proximal end 1091 of
tubular member 1077 may extend proximally a short distance from
proximal end 1023 of housing 1021 and distal end 1092 of tubular
member 1077 may be withdrawn sufficiently to permit tissue to enter
window 1089. At the same time, tubular member 1077 may have a
length so that, when tubular member 1077 is in a fully advanced
(i.e., distal) position, distal end 1092 of tubular member 1077 may
be positioned distally of distal end 1089-2 of window 1089.
[0158] Morcellator assembly 1013 may further comprise a fitting
1097. Fitting 1097, which may be a unitary structure made of a
rigid polymer or metal, may be a tubular member shaped to include a
proximal portion 1098, a distal portion 1099 and a longitudinal
lumen 1100. Proximal portion 1098, which may be barbed, may be
coupled through a length of tubing to vacuum assembly 1009. Distal
portion 1099 of fitting 1097 may be externally threaded for mating
engagement with proximal portion 1035 of housing 1021. Lumen 1100
of fitting 1097 may be dimensioned to slidably receive proximal end
1091 of tubular member 1077. An O-ring 1101 may be disposed within
lumen 1100 to provide a seal around tubular member 1077.
[0159] Referring now to FIGS. 29(a) and 29(b), drive assembly 1015
may be seen in greater detail. Drive assembly 1015 may include a
main body 1105. Main body 1105, which may be a unitary structure
made of a rigid polymer or metal, may be a generally trough-shaped
member shaped to include a distal end 1107, a proximal end 1109,
and a side wall 1111. Distal end 1107 may be generally circular and
may include a distal surface that includes a central portion 1115
and a peripheral portion 1117. Central portion 1115 may be recessed
relative to peripheral portion 1117. A central transverse opening
1119 may be provided in central portion 1115, and a pair of smaller
transverse openings 1120 may be provided in central portion 1115 on
opposite sides of central opening 1119. Proximal end 1109 may be
generally circular and may include a proximal surface that includes
a central portion 1123 and a peripheral portion 1125. Central
portion 1123 may be recessed relative to peripheral portion 1125. A
central transverse opening 1127 may be provided in central portion
1123, and a pair of smaller transverse openings 1129 may be
provided in central portion 1123 on opposite sides of central
opening 1127. Side wall 1111 may extend from distal end 1107 to
proximal end 1109 but only over about the top half of their
respective circumferences. A longitudinal groove 1131 may be
provided along the outer surface of side wall 1111 to receive a
corresponding portion of housing 1021 of morcellator assembly 1013.
Groove 1131 may include a first transverse slot 1133 extending
though side wall 1111 and a second transverse slot 1135 extending
through side wall 1111. First transverse slot 1133 may be spaced a
short distance from distal end 1107 and may be oriented generally
circumferentially relative to side wall 1111. Second transverse
slot 1135 may be spaced a short distance from proximal end 1109 and
from first transverse slot 1133 and may be oriented generally
longitudinally relative to side wall 1111. The inner surface of
side wall 1111 may additionally be shaped to include a block 1141
located between first transverse slot 1133 and second transverse
slot 1135. Block 1141 may be shaped to include an exterior groove
1143 on its bottom surface, groove 1143 extending parallel to
second transverse slot 1135. A bracket 1145, which may be a unitary
structure made of a rigid polymer or metal, may be secured to the
bottom surface of block 1141 with a pair of screws 1146. Bracket
1145 may be shaped to include a groove 1147 on its top surface that
is complementarily shaped to groove 1143, with grooves 1143 and
1147 jointly defining a channel of generally cylindrical shape.
[0160] Drive assembly 1015 may additionally comprise a mechanism
for driving rotational movement of inner tubular member 1077. Such
a mechanism may comprise a first motor 1151. Motor 1151, in turn,
may comprise a first end 1152 having a shaft 1153 extending
therefrom. First end 1152 may be received within central portion
1115 of distal end 1107 of body 1105 and may be secured thereto
with screws 1156 inserted through openings 1120 and into
complementary openings 1157 in first end 1152 of motor 1151. With
motor 1151 thus secured to distal end 1107, shaft 1153 may extend
through central transverse opening 1119 and may freely rotate
therewithin. Cables 1159 may be used to connect motor 1151 to
control unit 1010.
[0161] In addition, the aforementioned mechanism for driving
rotational movement of inner tubular member 1077 may further
comprise a coupling block 1161 and a gear 1162. Coupling block
1161, which may be a unitary structure made of a rigid polymer or
metal, may be shaped to include a distal base 1163 and a proximal
post, the proximal post extending proximally from base 1163. Base
1163 may be shaped to include a cavity 1164 accessible from its
distal end into which shaft 1153 of motor 1151 may be received and
secured with a screw 1165, thereby mechanically coupling shaft 1153
to block 1161. The proximal post may be shaped to include a distal
portion 1166 of increased diameter and a proximal portion 1167 of
decreased diameter. Gear 1162, which may be a unitary member made
of a rigid polymer or metal, may be shaped to include a distal tube
1168 and a proximal toothed wheel 1169. Tube 1168 may be coaxially
mounted on portion 1166 of block 1161 and mechanically coupled
thereto with a screw 1170. Wheel 1169 may be positioned so that a
portion of wheel 1169 extends through slot 1133 for engagement with
intermediate portion 1057 of shaft 1051. In this manner, rotation
of wheel 1169 causes the rotation of shaft 1051. Proximal portion
1167 of post 1165, which may extend proximally a short distance
beyond wheel 1169, may be seated within a bearing 1173, bearing
1173 being seated within the distal end of the channel jointly
defined by block 1141 and bracket 1145.
[0162] Drive assembly 1015 may further comprise a mechanism for
driving oscillating translational movement of inner tubular member
1077. Such a mechanism may comprise a second motor 1181. Motor
1181, in turn, may comprise a first end 1182 having a shaft 1183
extending therefrom. First end 1182 may be received within central
portion 1123 of proximal end 1109 of body 1105 and may be secured
thereto with screws 1186 inserted through openings 1129 and into
complementary openings 1187 in first end 1182 of motor 1181. With
motor 1181 thus secured to proximal end 1109, shaft 1183 may extend
through central transverse opening 1127 and may freely rotate
therewithin. A cable 1189 may be used to connect motor 1181 to
control unit 1010.
[0163] In addition, the aforementioned mechanism for driving
oscillating translational movement of inner tubular member 1077 may
further comprise a coupling block 1191, a threaded bolt 1192, and a
carriage 1193. Coupling block 1191, which may be a unitary
structure made of a rigid polymer or metal, may be shaped to
include a proximal opening 1194 and a distal opening 1195. Proximal
opening 1194 may be dimensioned to securely receive shaft 1183 of
motor 1181, thereby mechanically coupling shaft 1183 to block 1191.
Distal opening 1195 may be dimensioned to securely receive the
proximal end of threaded bolt 1192, thereby mechanically coupling
bolt 1192 to block 1191. The distal end of bolt 1192 may be seated
within a bearing 1196, which, in turn, may be seated within the
proximal end of the channel jointly defined by block 1141 and
bracket 1145. Carriage 1193, which may be a unitary structure made
of a rigid polymer or metal, may be shaped to include a bore 1197
and a pair of upwardly extending tines 1198. A rigid collar 1199
may be fixedly mounted within bore 1197 of carriage 1193 using a
pair of screws 1200. Collar 1199 may be internally threaded to
engage bolt 1192. In this manner, as bolt 1192 rotates, carriage
1193 moves translationally along the longitudinal axis of bolt
1192, with proximal or distal translational movement of carriage
1193 effected by the clockwise or counterclockwise rotation,
respectively, of bolt 1192. Carriage 1193 may be mechanically
coupled for translational movement to shaft 1051 by tines 1198,
with tines 1198 extending through slot 1135 of body 1105 and being
received within slots 1071-1 and 1071-2 of morcellator assembly
1013.
[0164] As can be appreciated from the above description, the speed
at which inner tubular member 1077 rotates and the speed at which
inner tubular member 1077 oscillates translationally are separately
and independently controlled, with the rotation of inner tubular
member 1077 being controlled by motor 1151 and with the oscillating
translation of inner tubular member 1077 being controlled by motor
1181.
[0165] Drive assembly 1015 may further comprise a body 1201. Body
1201, which may be a unitary structure made of a rigid polymer or
metal, may be shaped to include a distal end 1203, a proximal end
1205, a side wall 1207, and a cavity 1208. Distal end 1203 may be
generally semi-circular in shape, and proximal end 1205 may be
generally semi-annular in shape. Side wall 1207 may be semi-annular
in transverse cross-section and may extend from distal end 1203 to
proximal end 1205. A longitudinal groove 1209, similar in shape to
groove 1131 of body 1105, may be provided along the top, outer
surface of side wall 1207 to receive a corresponding portion of
housing 1021 of morcellator assembly 1013. Cavity 1208 may be
dimensioned to receive motor 1151. A pair of longitudinal lumens
1213 may be provided in body 1201, lumens 1213 extending through
distal end 1203, proximal end 1205, and side wall 1207. Lumens 1213
may be aligned with corresponding threaded cavities 1215 in body
1105 so that proximal end 1205 of body 1201 and may be fixed to
distal end 1107 of body 1105 using screws 1217 inserted through
body 1201 and into cavities 1215.
[0166] Drive assembly 1015 may further comprise a locking clip
1221. Locking clip 1221, which may be a unitary structure made of a
rigid polymer or metal, may be shaped to include a base 1223, a
pair of parallel legs 1225, and a pair of parallel feet 1227. Legs
1225 may extend upwardly from base 1223, with legs 1225 being
spaced inwardly a short distance from the ends of base 1223. Feet
1227 may extend transversely from legs 1225. Base 1223 may be
received within a matingly-shaped recess 1229 provided on body 1105
and may be securely retained within recess 1229 by securing body
1201 to body 1105. With clip 1221 thus mounted on body 1105, legs
1225 extend upwardly beyond body 1105 and may be inserted into
corresponding L-shaped slots 1230 in housing 1021 of morcellator
assembly 1013. In this manner, clip 1221 may be used to reversibly
and lockably couple drive assembly 1015 to morcellator assembly
1013. More specifically, to lockably couple drive assembly 1015 to
morcellator assembly 1013, one may insert feet 1227 into the
proximal portions 1230-1 of slots 1230 and may then slide feet 1227
distally to the distal portions 1230-2 of slots 1230. To uncouple
drive assembly 1015 from morcellator 1013, feet 1227 may be slid
proximally from distal portions 1230-2 to proximal portions 1230-1
and may then be removed from slots 1230.
[0167] Drive assembly 1015 may further comprise a body 1231. Body
1231, which may be a unitary structure made of a rigid polymer or
metal, may be a generally cylindrical member shaped to include a
proximal end 1233, a distal end 1235, and a side wall 1237. A
cavity 1239 may extend proximally from distal end 1235, cavity 1239
being dimensioned to receive substantially all but first end 1182
and shaft 1183 of motor 1181. A pair of longitudinal lumens 1241
may be provided in body 1231, lumens 1241 extending through
proximal end 1233, distal end 1235, and side wall 1237. Lumens 1241
may be aligned with corresponding threaded cavities 1242 in body
1105 so that distal end 1235 of body 1231 may be fixed to proximal
end 1109 of body 1105 using screws 1243 inserted through body 1231
and into cavities 1242. A groove 1245 may extend longitudinally
from proximal end 1233 to distal end 1235 along the top surface of
side wall 1237. Groove 1245 may be aligned with groove 1131 of body
1105 in order to receive a corresponding portion of housing 1021 of
morcellator assembly 1013.
[0168] Drive assembly 1015 may further comprise an endplate 1251.
Endplate 1251, which may be a unitary structure made of a rigid
polymer or metal, may be a generally disc-shaped structure shaped
to include a retaining loop 1253 at its top. Retaining loop 1253
may be dimensioned to receive the proximal end of housing 1021 of
morcellator assembly 1013. A pair of openings 1255 may be provided
in endplate 1251. Openings 1255 may be aligned with corresponding
threaded cavities 1257 in body 1231 so that endplate 1241 may be
fixed to proximal end 1233 of body 1231 using screws 1259 inserted
through endplate 1241 and into cavities 1257.
[0169] Drive assembly 1015 may further comprise a cover 1261. Cover
1261, which may be a unitary structure made of a rigid polymer or
metal, may be in the shape of a half-pipe having a proximal end
1263 and a distal end 1265. Cover 1261 may be dimensioned to
complement side walls 1111 and 1207 of bodies 1105 and 1201,
respectively. In addition, cover 1261 may be fixed to body 1105
with a screw 1267 inserted through an opening 1269 in cover 1261
and into a corresponding cavity 1271 in proximal end 1109 of body
1105 and with a screw 1273 inserted through an opening 1275 in
cover 1261 and into a corresponding cavity 1277 in distal end 1107
of body 1105. Additionally, cover 1261 may be fixed to body 1201 by
joining cover 1261 to a block 1281 using a screw 1283 and by
joining block 1281 to distal end 1203 of body 1201 using a pair of
screws 1285.
[0170] Referring back now to FIG. 27, vacuum assembly 1009 may
include a specimen collection container 1291 and a vacuum source
1292. The distal end of an evacuation tube 1293 may be inserted
over fitting 1097 and may be secured thereto by a friction fit, and
the proximal end of evacuation tube 1293 may be coupled to a first
port 1294 of container 1291. The distal end of a tube 1295 may be
coupled to a second port 1296 of container 1291, and the proximal
end of tube 1295 may be coupled to vacuum source 1292. In this
manner, vacuum source 1292 may be used to apply suction to device
1008, and any withdrawn tissue, liquids or similar matter suctioned
through device 1008 may be collected in container 1291.
[0171] Control unit 1010, which may be coupled to a source of
electricity, such as an AC wall outlet, using a power cord (not
shown), may include electronics (not shown) for controlling the
operation of motors 1151 and 1181 using a cable 1298-1 connected to
cables 1159 and 1189. A foot pedal 1297 may be coupled to control
unit 1010 by a cable 1298-2 and may be used as a power switch to
selectively activate or de-activate motors 1151 and 1181. Control
unit 1010 may further include a vacuum sensor 1299, which may be
coupled to container 1291 by a tube 1300, so that the pressure
within container 1291 may be monitored by control unit 1010. In
this manner, a sudden increase in vacuum pressure may indicate that
a clog has occurred. The presence of a clog may be indicated via an
alarm (not shown) located on control unit 1010. The detection of a
clog is often a clear indication that the further operation of
device 1008 may only aggravate the clogging situation and that a
cessation of tissue removal may be necessary. Control unit 1010 may
be configured to synchronize actuation of drive assembly 1015 with
actuation of vacuum source 1292. In this manner, turning on drive
assembly 1015 will turn on vacuum source 1292 at the same time.
Correspondingly, vacuum source 1292 may be deactivated whenever
drive assembly 1015 is turned off.
[0172] In use, the distal end of a hysteroscope may be inserted
transcervically into a patient, and a suitable fluid may be
conducted through the inlet fluid port of the hysteroscope into the
uterus until the uterus is distended. Observation of the uterus and
detection of fibroids or other abnormal gynecological tissues may
then be performed using the visualization channel of the
hysteroscope. The distal ends of outer tubular member 1076 and
inner tubular member 1077 may be inserted through a working channel
of the hysteroscope and into the uterus, with the remainder of
system 1007 remaining proximal to the hysteroscope. Device 1008 may
then be manipulated so that window 1089 of outer tubular member
1076 may be positioned in proximity to the fibroid or other
targeted tissue. Next, vacuum source 1292 may be operated so as to
cause suction to be applied to inner tubular member 1077, thereby
drawing tissue into outer tubular member 1076 through window 1089.
In addition, motors 1151 and 1181 may be operated so as to cause
inner tubular member 1077 simultaneously to rotate and to oscillate
back and forth translationally within outer tubular member 1076,
thereby causing the tissue drawn through window 1089 to be cut. The
cut tissue may then be suctioned from the patient through inner
tubular member 1077 by means of the aforementioned suction and,
thereafter, collected in container 1291. Once the fibroids or other
targeted tissues have thus been removed from the patient, vacuum
source 1292 and motors 1151 and 1181 may be turned off, device 1008
may be withdrawn from the hysteroscope, and the hysteroscope may be
withdrawn from the patient. Morcellator assembly 1013 may then be
detached from drive assembly 1015 and disconnected from vacuum
source 1292. Morcellator assembly 1013 may be designed to be a
single use device and, if so, may be disposed of after being used
on a patient. By contrast, drive assembly 1015 may be used on a
number of different patients prior to its disposal, with a
different morcellator assembly 1013 preferably being used with each
patient.
[0173] It should be noted that, although the above-discussion
contemplates inserting device 1008 through the working channel of a
hysteroscope, one may insert device 1008 transcervically into the
uterus without the use of a hysteroscope. In such a situation,
fluid may be administered transcervically to the uterus by a fluid
dispensing device in order to distend the uterus, and, thereafter,
observation of the uterus may be accomplished, for example, by
ultrasonic imaging using an ultrasonic probe inserted
transcervically into the uterus. Such an ultrasonic probe may be
separate from device 1008 or may be integrated into device 1008.
Alternatively, imaging of the uterus may be performed by MRI
imaging.
[0174] Referring now to FIG. 30, there is shown a fragmentary
exploded perspective view of an alternate tissue removal device
adapted for use in system 1007, said tissue removal device being
represented generally by reference numeral 1450. For simplicity and
clarity, certain aspects of device 1450 not important to an
understanding of the invention are neither shown nor described
herein.
[0175] Device 1450 may be similar in most respects to device 1008,
the principal differences between the two devices being that
carriage 1193 and translational coupling block 1061 of device 1008
may be replaced with carriage 1461 and translational coupling block
1463, respectively, of device 1450. Carriage 1461 of device 1450
may be similar in many respects to carriage 1193 of device 1008,
the principal difference between the two carriages being that
carriage 1461 may include an upwardly biased spring-loaded pin
1465. Translational coupling block 1463 of device 1450 may be
similar in many respects to translation coupling block 1061 of
device 1008, the principal differences between the two blocks being
that (i) translation coupling block 1463 may be shaped to include a
cavity 1467 adapted to receive pin 1465 and (ii) translation
coupling block 1463 may be shaped to include ramped surfaces 1469-1
and 1469-2 sloping downwardly towards the open end of cavity 1467
from the proximal and distal ends, respectively, of translation
coupling block 1463. In use, the morcellator assembly, which
comprises translation coupling block 1463, may be attached to the
drive assembly, which comprises carriage 1461, and the
translational motor of device 1008 may be actuated to move carriage
1461 translationally back and forth one complete cycle. Regardless
of where carriage 1461 and translational coupling block 1463 may be
initially positioned translationally relative to one another, as
carriage 1461 is moved translationally one complete cycle, pin 1465
is automatically assured of being aligned with cavity 1467. For
example, if pin 1465 is initially positioned proximally relative to
translation coupling block 1463, as carriage 1461 is moved
distally, the top surface of pin 1465 travels across ramped surface
1469-1 and is then received in cavity 1467. One advantage of this
arrangement is that pin 1465 and cavity 1467 need not be aligned
with one another as the morcellator assembly and the drive assembly
are attached to one other. As can be appreciated, because the
morcellator assembly may be a single-use item whereas the drive
assembly may be a reusable item, pin 1465 and cavity 1467 may not
initially be aligned with one another.
[0176] Referring now to FIGS. 31(a) and 31(b), there are shown
fragmentary, partially exploded, perspective views of another
alternate tissue removal device adapted for use in system 1007,
said tissue removal device being represented generally by reference
numeral 1500. For simplicity and clarity, certain aspects of device
1500 not important to an understanding of the invention are neither
shown nor described herein.
[0177] Device 1500 may comprise a morcellator assembly 1513 and a
drive assembly 1515. Morcellator assembly 1513 and drive assembly
1515 may be similar in most respects to morcellator assembly 1013
and drive assembly 1015, respectively, the principal differences
between the respective morcellator assemblies and drive assemblies
being that morcellator assembly 1513 and drive assembly 1515 may be
detachably matingly secured to one another by means of a detent
1517 provided on morcellator assembly 1513 and a slot 1519 provided
in drive assembly 1515. Accordingly, when one wishes to use device
1500, detent 1517 of morcellator assembly 1513 is preferably
inserted into slot 1519 of drive assembly 1515, thereby physically
and operatively coupling together morcellator assembly 1513 and
drive assembly 1515. Device 1500 may then be used in the same
manner discussed above in connection with device 1008. After device
1500 has been used, morcellator assembly 1513 may be separated from
drive assembly 1515, for example, by pulling apart their respective
proximal ends until detent 1517 is removed from slot 1519. If
desired, morcellator assembly 1513 may then be disposed of whereas
drive assembly 1515 may be reused.
[0178] Referring now to FIG. 32, there is shown a fragmentary,
partially exploded, perspective view of another alternate tissue
removal device adapted for use in system 1007, said tissue removal
device being represented generally by reference numeral 1600. For
simplicity and clarity, certain aspects of device 1600 not
important to an understanding of the invention are neither shown
nor described herein.
[0179] Device 1600 may comprise a morcellator assembly 1613 and a
drive assembly 1615. Morcellator assembly 1613 and drive assembly
1615 may be similar in most respects to morcellator assembly 1013
and drive assembly 1015, respectively, the principal differences
between the respective morcellator assemblies and drive assemblies
being that morcellator assembly 1613 and drive assembly 1615 may be
detachably secured to one another by means of hooks 1617 provided
on morcellator assembly 1613 near its distal end and corresponding
slots 1619 provided in drive assembly 1615 near its distal end. In
addition, drive assembly 1615 may further comprise a spring
retention member 1621 at its proximal end for engaging the proximal
end of morcellator 1613. Accordingly, when one wishes to use device
1600, hooks 1617 of morcellator assembly 1613 are preferably
inserted into slots 1619 of drive assembly 1615 and then spring
retention member 1621 engages the proximal end of morcellator
assembly 1613, thereby physically and operatively coupling together
morcellator assembly 1613 and drive assembly 1615. Device 1600 may
then be used in the same manner discussed above in connection with
device 1008. After device 1600 has been used, morcellator assembly
1613 may be separated from drive assembly 1615, for example, by
pulling apart their respective proximal ends until hooks 1617 are
removed from slots 1619. If desired, morcellator assembly 1613 may
then be disposed of whereas drive assembly 1615 may be reused.
[0180] Referring now to FIG. 33, there is shown a fragmentary,
partially exploded, perspective view of another alternate tissue
removal device adapted for use in system 1007, said tissue removal
device being represented generally by reference numeral 1700. For
simplicity and clarity, certain aspects of device 1700 not
important to an understanding of the invention are neither shown
nor described herein.
[0181] Device 1700 may comprise a morcellator assembly 1713 and a
drive assembly 1715. Morcellator assembly 1713 and drive assembly
1715 may be similar in many respects to morcellator assembly 1013
and drive assembly 1015, respectively, the principal differences
between the respective morcellator assemblies and drive assemblies
being that (i) morcellator assembly 1713 may be shaped to include a
cavity 1717 and (ii) drive assembly 1715 may be shaped to be
removably received within cavity 1717 of morcellator assembly 1713.
(Although not shown, morcellator assembly 1713 and/or drive
assembly 1715 preferably includes a mechanism for releasably
retaining drive assembly 1715 within cavity 1717.) Accordingly,
when one wishes to use device 1700, drive assembly 1715 is
preferably inserted into cavity 1717 of morcellator assembly 1713
until morcellator assembly 1713 and drive assembly 1715 are
physically and operatively coupled to one another. Device 1700 may
then be used in the same manner discussed above in connection with
device 1008. After device 1700 has been used, drive assembly 1715
may be withdrawn from cavity 1717 of morcellator assembly 1713. If
desired, morcellator assembly 1713 may then be disposed of whereas
drive assembly 1715 may be reused.
[0182] Although the present invention has been discussed above in
the context of removing tissue from within a patient's uterus, it
should be understood that there may be situations in which it may
be desirable to remove fibroids or other tissue located on the
exterior of a patient's uterus or elsewhere within a patient. In
such situations, it may be desirable to access the targeted tissue
by laparoscopy. Unfortunately, however, one cannot simply apply
suction in this type of case to draw the tissue into the resection
window of the device because the tissue would not be bathed in a
liquid, but rather, would simply be surrounded by air. Therefore,
according to the present invention, one approach to this problem is
to deliver a suitable material to the targeted tissue, which may
then be used, with the application of suction, to create a seal to
promote the drawing of the targeted tissue into the resection
window of the device. Referring now to FIG. 34, there is shown an
embodiment of a device designed for such a purpose, the device
being represented generally by reference numeral 1800. Certain
aspects of device 1800 not important to an understanding of the
invention are neither shown nor described herein.
[0183] Device 1800 may be similar in certain respects to device 6.
One difference between the two devices is that device 1800 may
comprise an inner tubular member 1803 and an outer tubular member
1805. Inner tubular member 1803 and outer tubular member 1805 may
be similar to inner tubular member 77 and outer tubular member 76,
respectively, of device 6, except that (i) outer tubular member
1805 may comprise a port 1807 adapted to receive a suitable liquid
or gel (e.g., water, glycine, a thixotropic gel, etc.) from a
supply (not shown) and (ii) inner tubular member 1803 may have an
outer diameter that is about 0.005-0.006 inch less than the inner
diameter of outer tubular member 1805 (as opposed to the about
0.002 inch of device 6) to permit the liquid or gel delivered to
outer tubular member 1805 through port 1807 to be delivered to the
targeted tissue through a resection window 1809.
[0184] An alternate tissue removal device to device 1800 is shown
in FIG. 35, said alternate tissue removal device being represented
generally by reference numeral 1900. Certain aspects of device 1900
not important to an understanding of the invention are neither
shown nor described herein.
[0185] Device 1900 may be similar in most respects to device 6, the
principal difference between the two devices being that, whereas
device 6 may comprise outer tubular member 76, device 1900 may
comprise an outer tubular member 1903. Outer tubular member 1903
may be similar to outer tubular member 76, except that outer
tubular member 1903 may be additionally shaped to include a channel
1905 having a proximal input port 1907 and a distal output port
1909. Input port 1907 may be adapted for connection to a supply
(not shown) for receipt of a suitable liquid or gel (e.g., water,
glycine, a thixotropic gel, etc.). Distal port 1909 may be
positioned proximate to a resection window 1911.
[0186] 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.
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