U.S. patent number RE35,636 [Application Number 08/547,946] was granted by the patent office on 1997-10-21 for iud inserting apparatus.
This patent grant is currently assigned to DB Inserters, Inc.. Invention is credited to Lance J. Bronnenkant, Juan Diaz.
United States Patent |
RE35,636 |
Diaz , et al. |
October 21, 1997 |
**Please see images for:
( Certificate of Correction ) ** |
IUD inserting apparatus
Abstract
Methods and apparatus are disclosed for permitting a user to
load an IUD into an IUD inserter within the confines of a tray and
thereafter to safely insert the IUD into a patient's uterus to the
proper depth while minimizing the risk of causing trauma to the
uterine wall. An IUD inserter comprises an elongated shaft adapted
to retain the arms of an IUD adjacent the distal end of the shaft,
a slidable arm retainer mounted on the shaft adaptable to abut the
outer portion of the patient's cervix, and a stop member adjustably
mounted on the shaft so that the arm retainer is forced by the
outer portion of a patient's cervix to abut the stop member as the
IUD is advanced through the cervical canal of a patient to a
preselected depth at the uterine fundus. An associated package
permits an IUD having expandable arms thereon to be loaded into an
arm retainer within the confines of the package immediately prior
to insertion of the IUD into a patient's uterus. When it is
desirable to insert the IUS into a patient after loading same in
the arm retainer of an inserter, the steps include placing the
slidable retainer of an IUD inserter against the outer portion of a
patient's cervix, aligning the inserter and the IUD device therein
with the cervical opening, advancing the end of the inserter
through the cervical canal and into the uterus to that the arm
retainer abuts a stop member arranged on the elongate shaft of the
inserter, and withdrawing the elongate shaft from the uterus while
the IUS is left at the proper depth therein.
Inventors: |
Diaz; Juan (Sao Paulo,
BR), Bronnenkant; Lance J. (Snyder, NY) |
Assignee: |
DB Inserters, Inc. (North
Tonawanda, NY)
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Family
ID: |
25471102 |
Appl.
No.: |
08/547,946 |
Filed: |
October 24, 1995 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
Reissue of: |
938208 |
Aug 28, 1992 |
05370129 |
Dec 6, 1994 |
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Current U.S.
Class: |
128/839;
128/840 |
Current CPC
Class: |
A61F
6/18 (20130101) |
Current International
Class: |
A61F
6/18 (20060101); A61F 6/00 (20060101); A61F
006/14 (); A61F 006/06 () |
Field of
Search: |
;128/830-841 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Brown; Michael A.
Attorney, Agent or Firm: Lerner, David, Littenberg, Krumholz
& Mentlik
Claims
What is claimed is:
1. A method for loading expandable arms of an intrauterine device
in an arm retainer of an intrauterine device inserter comprising
the steps of,
advancing an elongate shaft having a distal and a proximal end and
having the intrauterine device positioned thereon with its arms
initially in an expanded position so as to advance the expandable
arms of the intrauterine device and the distal end of the elongate
shaft inside an arm retainer so that the arms of the intrauterine
device are forced from their expanded position to a substantially
folded position, said advancing step being performed while said
intrauterine device and said arm retainer remain in a package so
that loading of the expandable arms of said arm retainer is
facilitated.Iadd., and adjusting a stop member having a forward
edge and a rear edge on the elongate shaft so that the forward edge
of the stop member is aligned with measurement indicia on a tray
which corresponds to the proper uterine depth of a
patient..Iaddend.
2. The method of claim 1, wherein the step of advancing the
elongate shaft comprises the step of arresting the advancing
movement of the shaft and the intrauterine device by engaging at
least one of the shaft and the intrauterine device with an abutment
surface on the package. .[.3. The method of claim 2, further
comprising the step of adjusting a stop member having a forward
edge and a rear edge on the elongate shaft so that the forward edge
of the stop member is aligned with measurement indicia on a
tray which corresponds to the proper uterine depth of a
patient..].4. An inserter for an intrauterine device having
expandable arms thereon comprising,
elongate shaft having a proximal and a distal end, said shaft being
adapted to retain an intrauterine device adjacent said distal
end;
a leading member slidably mounted on said elongate shaft adjacent
said distal end thereof, said leading member having a leading end
and a trailing end said leading member being an arm retainer, said
arm retainer including a hollow body having a passageway extending
therethrough between said trailing end and said leading end, said
passageway having a preselected interior dimension at said leading
end of said arm retainer so that the expandable arms of the
intrauterine device will be retained in a substantially folded
position when said intrauterine device is positioned within said
passageway of said arm retainer, .Iadd.said interior dimension of
said passageway through said arm retainer being narrower at said
leading end than it is at said trailing end, .Iaddend.said arm
retainer comprising a collar formed about said leading end, said
collar being arranged to abut the outer portion of a patient's
cervix during insertion of said intrauterine device into the uterus
of a patient; and
a stop member mounted on said elongate shaft for adjustment within
a range of proximal-to-distal positions proximal to said leading
member, said stop member having a rear end and a forward end and
being disposed whereby the forward end of said stop member abuts
the trailing end of said leading member when said distal end of
said shaft is advanced through the cervical canal of a patient into
the uterus to a preselected depth while said collar of said leading
member abuts the outer portion of the cervix and prevents said
leading member from entering the patient's cervical canal.
.[.5. The inserter of claim 4, wherein said leading member is an
arm retainer, said arm retainer comprises a body, said body being
hollow so as to define a passageway therethrough from said trailing
end to said leading end, said passageway having a preselected
interior dimension at said leading end of said arm retainer so that
the expandable arms of the intrauterine device will be retained in
a substantially folded position when said intrauterine device is
positioned in said passageway of said arm retainer..]..[.6. The
inserter of claim 4, wherein said interior dimension of said
passageway through said arm retainer is narrower at said
leading
end than it is at said trailing end..].7. The inserter of claim 4,
wherein said passageway has a generally rectangular cross-sectional
shape having orthogonal major and minor dimensions, said
preselected interior dimension
being the major dimension of said rectangular cross-section shape.
8. The inserter of claim 7, wherein said minor dimension of said
generally rectangular cross-sectional shape is substantially
constant from said
trailing end to said leading end. 9. The inserter of claim 7,
wherein said passageway includes a groove section extending from
said trailing end of said arm retainer to said leading end thereof,
said minor dimension of said passageway being greater in aid groove
section than in immediately adjacent regions of said passageway,
said shaft being engageable in said
groove section. .[.10. The inserter of claim 9, wherein said arm
retainer comprises a collar formed about said leading end, said
collar being arranged to abut the outer portion of a patient's
cervix during insertion
of said intrauterine device into the uterus of a patient..].11. An
inserter for an intrauterine device having expandable arms thereon
comprising, and elongate shaft having a proximal and a distal end,
said shaft being adapted to retain the intrauterine device adjacent
said distal end; and a leading member slidably mounted on said
elongate shaft adjacent said distal end thereof, said leading
member having a leading end and a trailing end, said leading member
being an arm retainer, said arm retainer comprises a body, said
body being hollow so as to define a passageway therethrough from
said trailing end to said leading end, said passageway having a
preselected interior dimension which is greater at said trailing
end than said leading end of said arm retainer, said interior
dimension of said passageway converging from a relatively large
dimension to a relatively small dimension between said trailing end
and said leading end so that the expandable arms of the
intrauterine device will be placed into a substantially folded
position upon advancement through said passageway.
2. The inserter of claim 11 further comprising a stop member
mounted on said elongate shaft for adjustment within a range of
proximal-to-distal positions proximal to said leading member, said
stop member having a rear and forward end and being disposed
whereby the forward end of said stop member abuts the trailing end
of said leading member when said distal end of said shaft is
advanced through the cervical canal of a patient into the uterus to
a preselected depth while said leading end of said leading
member abuts the outer portion of the cervix. 13. The inserter of
claim 12, wherein said arm retainer comprises a collar formed about
said leading end, said collar being arranged to abut the outer
portion of a patient's cervix during insertion of said intrauterine
device into the uterus of a
patient. 14. An inserter for a intrauterine device having
expandable arms thereon comprising, an elongate shaft having a
proximal end and a distal end, said shaft being adapted to retain
an intrauterine device adjacent said distal end, a leading member
slidably mounted on said elongated shaft adjacent said distal end
thereof, said leading member having a leading end and a trailing
end, said leading member being an arm retainer, said arm retainer
comprises a body, said body being hollow so as to define a
passageway thereto from said trailing end to said leading end, said
passageway having a preselected sized and shaped opening
.Iadd.including means .Iaddend.at the leading end of said arm
retainer .[.arranged to prevent.]. .Iadd.for preventing
.Iaddend.misalignment such as twisting of said expandable arms of
said IUD prior to insertion through the cervical
canal of a patient. 15. The inserter of clam 14 further comprising
a stop member mounted on said elongate shaft for adjustment within
a range of proximal-to-distal positions proximal to said leading
member, said stop member having a rear end and a forward end and
being disposed whereby the forward end of said stop member abuts
the trailing end of said leading member when said distal end of
said shaft is advanced through the cervical canal of a patient into
the uterus to a preselected depth while said leading end of said
leading member abuts the outer portion of the cervix.
6. The inserter of clam 15 wherein said passageway through said
body of said arm retainer has a greater dimension at said trailing
end than at
said leading end thereof. 17. The inserter of claim 16, wherein
said arm retainer comprises a collar formed about said leading end,
said collar being arranged to abut the outer portion of a patient's
cervix during insertion of said intrauterine device into the uterus
of a patient.
Description
FIELD OF THE INVENTION
The present invention relates to an intrauterine device ("IUD")
inserter apparatus, to a tray for storing and "loading" an IUD into
a portion of IUD inserter, and to methods of handling and inserting
IUDs.
BACKGROUND OF THE INVENTION
The prior art is replete with IUDs and IUD inserters for placing an
IUD into a uterus of a patient. In the past, many attempts have
been made to safely assure that the IUD will be placed at the
proper depth at the uterine fundus. However, the prior art methods
and apparatus for inserting an IUD have been inadequate in their
attempts to achieve a satisfactory degree of safety while inserting
the IUD. In one known prior art IUD inserter, formerly used by the
applicant, the IUD inserter comprised a tubular cannula in which
the IUD is stored, a flange connected to a portion of the cannula
to indicate the proper depth of a patient's uterus and an elongate
plunger sized and shaped to be inserted within the cannula. While
the cannula containing the IUD is inserted into a patient's uterus
to the uterine fundus, the IUD is forced from the cannula by the
distal end of the associated plunger. This prior art IUD inserter
depends solely on the skill of the operator for proper
placement.
U.S. Pat. No. 3,918,444 to Hoff et al. is directed toward an IUD
inserter apparatus comprising an elongate tube and a slidable cap
having slots disposed therein to receive corresponding arm members
of an associated IUD. The function of the cap is to restrain the
arm members and to facilitate insertion of the IUD. The IUD
inserter disclosed in the '444 patent likewise depends on the skill
of the operator to achieve proper IUD placement and to avoid trauma
to the uterine wall.
U.S. Pat. No. 0,327,666 to Hoff discloses an IUD inserter
comprising an elongate tube having a small diameter section and a
large diameter section for retaining an IUD therein. A collar is
arranged around the circumference of the larger diameter section of
the inserter tube. The collar abuts the cervix to arrest motion of
the tube. Such a collar tends to reduce the likelihood of injury to
the wall of a patient's uterus. The inserter of the '666 patent has
obvious drawbacks in that the expandable arms of an associated
T-shaped IUD must be aligned with the entrance of a patient's
cervix for insertion into the uterus without the aid of an arm
retainer or any guide means whatsoever.
Furthermore, packaging trays for IUDs and IUD inserters, as well as
packaging for other medical instruments, are well-known in the art.
With respect to trays for an IUD inserting apparatus, U.S. Pat. No.
4,019,633 to Roth discloses a package for an IUD and an IUD
inserter comprising a thermoformed plastic tray having a cavity
therein for holding an IUD and an IUD inserter, a cover therefor,
and an adhesive coating for attaching the aforementioned cover to
the plastic tray. As shown in FIG. 2 of the '633 patent, a cavity
permits the arms of an IUD to remain in an expanded T-shaped
position within a cap of an associated IUD inserter device.
However, the foregoing tray is defective in that the IUD and its
associated inserter must be removed from the sterilized environment
of the tray prior to "loading" the arms of the IUD into cap of the
IUD inserter so that the arms can be held in a substantially folded
position.
Another IUD, IUD inserter and tray therefor manufactured by the
German company Nourypharma GmbH and sold under the trade name
MULTILOAD CU250. This device includes a tube-type inserter having a
collar thereon such that the collar can directly abut the cervix
upon insertion. A tray includes four separate compartments for
retaining the collar. Additionally, the tray includes a scale
consisting of the numerical indicia 6, 7, 8 and 9 cm arranged
adjacent a respective compartment for retaining the collar. These
compartments serve the purpose of retaining the collar and aligning
it with a depth in centimeters corresponding to a uterus sounding
measurement of a particular patient. The MULTILOAD CU250 tray
includes several shortcomings which hamper the effectiveness and
usefulness of the tray disclosed therein. In particular, the
MULTILOAD CU250 tray does not include means for "loading"
expandable arms of an IUD into an inserter immediately before
inserting the IUD into the uterus of a patient. Additionally, the
separate compartments for retaining the collar inhibit the precise
setting of the collar to the proper depth for an individual
patient. Furthermore, the MULTILOAD CU250 tray does not prevent the
arms of an IUD from spinning or twisting prior to insertion or
during insertion of the IUD into the cervical os. Thus, the arms of
the IUD may not be properly aligned when the IUD is placed into the
uterus of a patient.
Thus, despite all of the efforts n the prior art, improved methods
and apparatus for inserting an IUD into the uterus of a patient are
needed.
SUMMARY OF THE INVENTION
The present invention addresses the aforementioned shortcomings of
the prior art.
One aspect of the present invention provides an apparatus for
safely inserting an IUD without the risk of causing an injury to
the uterine wall of a patient. The apparatus according to this
aspect of the present invention includes an elongate shaft having a
proximal end and a distal end, wherein the shaft is adapted to
retain the IUD adjacent the distal end. A first member having a
leading end and a trailing end is slidably mounted on the elongate
shaft and is adapted so that the leading end abuts the outer
portion of a patient's cervix during insertion of the IUD into the
uterus. A depth stop member is adjustably mounted on the elongate
shaft and is arranged to abut the trailing end of the leading
member when the distal end of the elongate shaft is advanced
through the cervical canal of a patient to a preselected depth at
the uterine fundus while the leading end of the first member
remains in abutment with the outer portion of the cervix. Thus, a
doctor or other qualified individual will insert the IUD to the
proper depth at the uterine fundus of a patient without the risk of
causing trauma to the wall of the patient's uterus.
In a particularly preferred arrangement, the first member of the
IUD inserter is an arm retainer comprising a body. The body of the
arm retainer is hollow so as to define a passageway therethrough
from the trailing end to the leading end. The elongate shaft may
comprise a hollow tube in which a part of the IUD is retained
during insertion of same. In a particularly preferred arrangement,
the widthwise dimension of the passageway through the arm retainer
is narrower at the leading end that it is at the trailing end.
Thus, the expandable arms on the IUD are gradually folded as the
IUD and inserter tube are advanced distally into the passageway
through the trailing end of the arm retainer and toward the leading
end thereof. The arm retainer desirably includes a collar formed
about the leading end. The collar is arranged to abut the outer
portion of a patient's cervix during insertion of the IUD into the
uterus.
Another aspect of the present invention provides a tray for
retaining ad IUD having expandable arms thereon and an IUD
inserter. The tray according to this aspect of the present
invention includes means for retaining an elongate shaft of an IUD
inserter having an IUD thereon so that the arms of the IUD are
arranged in the tray in an expanded position. The elongate shaft
includes a proximal end and a distal end and is disposed in the
tray so that the expanded arms are arranged adjacent the distal end
of the elongate shaft. The tray according to this aspect of the
present invention most preferably also comprises means for
retaining an arm retainer of the inserter having a leading end and
a trailing end so that the trailing end lies adjacent the expanded
arms. Thus, the arms of the IUD wall become folded as the elongate
shaft is advanced distally into the trailing end of the arm
retainer while the elongate shaft and the arm retainer remain in
the tray.
In a particularly preferred arrangement of this aspect of the
present invention, the tray also includes means for retaining a
depth stop member, such as a flange, so that the flange can be
continuously adjusted along the shaft to correspond with a
predetermined uterine depth indicating the distance between the
outer portion of a patient's cervix and the uterine fundus. It is
also desirable for the tray to include measurement indicia thereon.
Most preferably, the indicia represents a preselected range of
uterine depths and is disposed adjacent the means for retaining a
flange so that the flange can be adjusted to a location adjacent
the appropriate indicia which represents the depth of a particular
patient's uterus. It is also preferable for the flange compartment
of the tray to include means for preventing the flange from being
adjusted to a uterine depth of less than the recommended depth for
the particular type of IUD therein. This means serves as an
additional safeguard to prevent the IUD from being inserted beyond
a preselected depth defined by a patient's uterine fundus, and
therefore, may prevent trauma from occurring thereat. Additionally,
it is preferable for the tray of the present invention to include
means for receiving at least a portion of the arms of the IUD when
the arms are arranged in a substantially folded position and at
least partially extend out of the leading end of the arm
retainer.
Most preferably, a tray according to this aspect of the present
invention comprises a housing having a distal end and a proximal
end. The housing should include a cavity for receiving the IUD
inserter having an IUD therein. It is desirable for the cavity to
be continuous and to include an elongate shaft compartment for
retaining the elongate shaft of the IUD inserter. Further, the
cavity should include an expandable arm compartment connected to
the elongate shaft compartment at the distal end thereof for
retaining the arms of the IUD in their expanded position. It is
also preferable for the cavity of the tray to include an arm
retainer compartment adjacent the expandable arm compartment toward
the distal end of the housing. The arm retainer compartment may be
arranged to receive an arm retainer having a trailing end and a
leading end and a passageway therethrough so that the expandable
arms can be advanced through the trailing end of the passageway
toward the leading end of the arm retainer at the distal end of the
housing.
The tray may have a flange compartment connected to the elongate
shaft compartment proximal to the expandable arm compartment for
receiving a flange therein. The flange compartment desirably is
continuous for precise adjustment of the flange. As can be
appreciated, a tray according to this aspect of the present
invention can be used for "loading" the expandable arms of an IUD
in their folded position in an arm retainer immediately prior to
insertion into the uterus of a patient while the IUD and its
associated inserter remain within the confines of the tray.
Another aspect of the present invention provides a method for
loading expandable arms of an IUD into an arm retainer of an IUD
inserter while the IUD and the inserter remain in a tray such as a
tray according to the aforementioned preferred embodiments. The arm
of the IUD desirably are permitted to remain in their expanded
T-shaped state until immediately prior to insertion of the IUD into
a patient. A method according to this aspect of the present
invention includes the step of advancing the distal end of the
elongate shaft of the inserter into an arm retainer as discussed
above so that the arms of the IUD are forced from their expanded
position to a substantially folded position therein. This advancing
movement desirably terminates when the IUD abuts a portion of the
tray adjacent the leading end of the arm retainer.
The preferred methods for loading the expandable arms of an IUD in
an arm retainer of an inserter in accordance with this aspect of
the present invention effectively permits a doctor or other
qualified individual to "load" the normally expanded arms of an IUD
into their folded position within an arm retainer immediately prior
to insertion of the IUD into a patient. Additionally, this
preferred method permits a user to precisely adjust the stop member
to an exact depth of a particular patient's uterine fundus to
assure that the IUD will be inserted to the proper depth without
injury to the uterine wall. The loading and adjusting operations
can be performed within the aseptic environment of the tray in
which the IUD and its associated inserter were originally
packaged.
Still another aspect of the present invention provides a method for
safely inserting an IUD to the proper depth within a patient's
uterus while minimizing the risk of damaging the uterine wall. A
method according to this aspect of the present invention includes
the steps of placing slidable member, such as an arm retainer, of
an IUD inserter against the outer portion of a patient's cervix,
wherein the inserter includes an elongate shaft preferably in the
form of an elongate tube having distal and proximal ends thereon
and an IUD on the distal end. The inserter is then aligned with the
cervical opening while the slidable member is maintained in
abutment with the outer portion of the cervix. The distal end of
the inserter is then advanced through the cervical canal and into
the uterus. In this step, the proximal end of the elongate shaft is
advanced toward the slidable member until the slidable member abuts
a stop member, such as a flange, which is arranged at a
predetermined location on the elongate shaft. The elongate shaft of
the inserter is then withdrawn from the uterus and out of the
cervical opening while the IUD, with its arms fully expanded at the
uterine fundus, is left at the proper location within the
patient.
These and other objects of the present invention will be more
clearly understood when read in conjunction with the detailed
description and the accompanying drawings which follow.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagrammatic plan view depicting one embodiment of the
present invention.
FIG. 2 is a diagrammatic plan view of a component used in the
embodiment of FIG. 1.
FIG. 3 is a diagrammatic elevational view taken along line 3--3 in
FIG. 2.
FIG. 4 is a top plan view of a further component used in the
embodiment of FIG. 1.
FIG. 5 is a sectional view taken along line 5--5 in FIG. 4.
FIG. 6 is a sectional taken along line 6--6 in FIG. 4.
FIG. 7 is a sectional taken along line 7--7 in FIG. 4.
FIG. 8 is a sectional taken along line 8--8 in FIG. 4.
FIG. 9 is a sectional view taken along line 9--9 in FIG. 4.
FIG. 10 is a sectional view taken along line 10--10 in FIG. 4.
FIG. 11 is a diagrammatic, partially sectional view depicting
certain elements shown in FIG. 1, but at a later stage of
operation.
FIGS. 12 and 13 are further partially sectional views depicting
certain elements shown in FIG. 11, but at still later stages of
operation.
DESCRIPTION OF THE DETAILED EMBODIMENTS
An IUD inserter in accordance with a preferred embodiment of the
present invention includes a generally elongate hollow shaft in the
form of a tube 22 having a proximal end 24 and a distal end 26. The
passageway extending through tube 22 between proximal end 24 and
distal end 26 has a substantially uniform inner diameter of
approximately 3.73 mm. A stop member such as flange 46 is
adjustably mounted on tube 22 by a friction fit between the
interior of flange 46 and the exterior surface of tube 22. Flange
46 has a rear end 48 which faces the proximal end 24 of tube 22,
and a forward end 50 which faces the distal end 26 of the tube.
An arm retainer generally designated 32 is also included in the IUD
inserter. Arm retainer 32 is sized and shaped to be slidably
mountable on elongate tube 22. Arm retainer 32 has a trailing edge
34 and a leading edge 36. As best seen in FIGS. 2 and 3, arm
retainer 32 is generally in the form of a flat, substantially
tapered parallelepipped. Trailing end 34 has a rectangular-shaped
surface with a width W.sub.t of approximately 19.5 mm and a
thickness T.sub.t of approximately 7.5 mm. Arm retainer 32 has a
total length of approximately 20 mm from trailing edge 34 to
leading edge 36. Tapered side walls 44 extend between trailing edge
34 and leading edge 36. A collar 42 protrudes outwardly from these
tapered side walls at leading edge 36. The width and thickness
dimensions of collar 42 at the leading edge are the same as those
of the trailing edge surface.
Arm retainer 32 has a generally flat, slot-like passageway 38
extending between trailing end 34 and leading end 36. The major or
widthwise dimension W.sub.PT of passageway 38 at trailing end 34 is
approximately 15.4 mm. The passageway tapers down to a major or
widthwise dimension W.sub.PL of approximately 8.7 mm where the
passageway 38 intersects leading edge 36. The minor dimension or
thickness Tp of the slot-like passageway 38 is substantially
constant at about 2.5 mm throughout the entire trailing end to
leading end extent of the passageway. The passageway also has a
pair of opposed, generally semicircular groove portions 39
cooperatively defining a generally cylindrical channel 41
intersecting slot-like channel 38 and extending from the trailing
end 34 to the leading end 36. The interior diameter D.sub.c of the
channel 41 desirably is about 4.5 mm, i.e., slightly larger than
the exterior diameter of shaft 22.
The inserter, including elongate tube 22, flange 46 and arm
retainer 32 can be manufactured from any material or compatible
materials which are biologically safe. Most preferably, the
elongate tube 22 can be made of high-density polyethylene such a
Phillips' MARLEX EHM 6007 or PAXON AA60-007. Other preferable
materials include polyethylene and polyproplene. Most preferably,
the flange 46 is manufactured from polyvinyl chloride such as
UNICHEM 7011-C2-02. Other preferable materials which can be used to
make the flange 46 are polypropylene and polyethylene. The arm
retainer 32 is preferably made of crystal polystyrene. However,
other desirable materials include polycarbonate, acrylic,
polypropylene, polyethylene, and polystyrene.
The IUD inserter may be used with an IUD such as the well-known
"copper-tee" IUD. A "copper-tee" IUD (FIG. 1) has flexible arms 30a
and 30b, respectively, and a body 30c located between arms 30a and
30b. These elements cooperatively define a generally T-shaped
structure. In the position shown in FIG. 1, the IUD is arranged
adjacent the distal end 26 of elongate tube 22 with the body 30 of
the IUD extending proximally into the tube from distal end 26.
The inserter and IUD are packaged in a tray 60. Tray 60 preferably
includes a housing 62 having a proximal end 64 and a distal end 66.
Most preferably, the tray 60 is made of crystal polystyrene, as is
the arm retainer 32. Additional materials found to be suitable for
the manufacture of tray 60 include polycarbonate, acrylonitrile,
butadiene, styrene, polyethylene terephthalate, polyethylene
terephthalate glycol, polyvinyl chloride, polypropylene
polyethylene and acrylic. As shown in FIG. 4, housing 62 comprises
a continuous cavity including several compartments for retaining
various portions of an IUD inserter such as inserter 20 described
above, and IUD such as the "copper-tee" also described above.
In particular, tray 60 includes a tube retainer 68 arranged
adjacent proximal end 64 of housing 62 for securing a portion of an
elongate tube such as tube 22 of inserter 20. A flange compartment
70 for retaining a flange, such as flange 46 of inserter 20, if
formed adjacent tube retainer 68 on the distal side thereof. Flange
compartment 70 is sized and shaped to retain flange 46 and to
permit continuous unobstructed adjustment therein. Measurement
indicia 76 are marked on the tray. These indicia begin at distal
end 74 of flange compartment 70 and are increased in increments of
5.0 mm from distal end 74 toward proximal end 72 thereof.
A narrow elongate tube compartment 78 is sized and shaped to retain
tube 22 of inserter 20 within housing 62 of tray 60. Tube
compartment 78 extends distally from flange compartment 70. Further
toward the distal end 66 of housing 62, the tray has a pair of arm
compartments 80 and a groove portion 84 which extends between the
arm compartments 80 so that the arm compartments 80 and elongate
shaft compartment 78 are continuously connected in a T-shape.
An arm retainer compartment 82 has a proximal end 86 and a distal
end 88. The arm retainer compartment is located on the distal side
of compartments 80. As shown in FIG. 4, proximal end 86 of arm
retainer compartment 82 is communicatably connected to expanded arm
compartments 80 and groove 84. A pocket-like receptacle 90 is
connected to distal end 88 of arm retainer compartment 82.
Receptacle 90 has a vertically extending wall extending in an arc
including the distal-most point 92 of the receptacle.
Most preferably, the entire housing of tray 62 and the compartments
of the cavity therein are manufactured as a unitary body from one
composition and therefore, the individual compartments described
above can be formed in a single mold to keep manufacturing costs at
a minimum. Referring to the bottom surface of the tray 60 as a
reference point of ground at 0.0 mm, the flange compartment 70 is
preferably arranged approximately 2.0 mm from the ground reference.
The arm retainer compartment 82 is preferably arranged
approximately 2.5 mm from the ground reference and is thus arranged
in a slightly higher plane than the flange compartment 70. It is
desirable for the tube retainer 68 and the elongate tube
compartment 22 to be raised a distance of approximately 1.9 mm
above the horizontal plane of the arm retainer compartment and
approximately 2.4 mm above the horizontal plane of the flange
compartment. Tube retainer 68 and elongate the compartment 78
should be relatively narrow so as to support elongate tube 22 as
further discussed below.
The cavity defining copper-tee receptacle 90 is also raised a
distance of approximately 2.5 mm above the horizontal plane of arm
retainer cavity 82. In a preferred embodiment, the width of
copper-tee receptacle 90 is approximately 9.5 m in a widthwise
direction transverse the proximal to distal direction of the
tray.
In the preferred embodiment, the arm retainer compartment 82 is
approximately 7.4 mm deep, 20 mm in length between proximal end 86
and distal end 88 thereof and has a width of approximately 20 mm at
both proximal arm compartment 80 has a length of approximately 7.0
mm from the proximal to the distal end thereof, a width of
approximately 34.00 mm and a depth of approximately 4.91 mm.
Furthermore, it is desirable for the groove 84 to have a length of
a proximately 7.00 mm, a width of approximately 3.10 mm and a depth
of approximately 5.51 mm. Moving further toward the proximal end of
the tray 60, the elongate tube compartment 78 preferably has a
length of approximately 46.00 mm, a width of approximately 4.7 mm,
and a depth of approximately 5.51 mm. The flange compartment 80 is
arranged proximately of the elongate tube compartment 78 and is
about 25.00 mm in length, 13.5 mm in width, and 7.91 mm in depth.
Additional sectional views of tray 60 are provided in FIGS.
6-10.
The tray 60, the IUD 30 and the inserter components such as tube
22, arm retainer 32 and flange 46 are prepackaged by the
manufacturer in an envelope 61 (FIG. 1) which is adapted to
maintain the packaged devices in a sterile condition. As packaged,
and as stored prior to use, the tray holds the inserter components
and IUD in the relative positions shown. Thus, the arms 30a and 30b
of the IUD are disposed in arm compartments 80 of the tray, so that
the arms remain in their normal or fully extended position during
storage. As packaged and stored, the body 30c of the IUD extends
proximally into tube 22 from the distal end thereof, so the IUD as
a whole is positioned at the distal end of the tube or shaft 22.
The tray also holds the arm retainer 32 in position, within arm
retainer cavity 82, so that the trailing end 34 of the arm retainer
lies just distally of the IUD 30 and tube 22. In this as-packaged
condition, the receptacle 90 of the tray is unoccupied. Flange 46
is disposed adjacent tube retainer 68 so that the proximal or rear
end 48 of the flange abuts the tube retainer 68.
To "load" the IUD into the arm retainer by a method according to an
embodiment of the invention, the user will open the envelope 60,
grasp the proximal end 24 of tube 22 and then advance the tube
distally toward arm retainer 32 within arm retainer cavity 82. Arms
30a and 30b of the IUD will then enter passageway 38 at trailing
end 34 of the arm retainer. Tube 22 enters the cylindrical channel
41 (FIG. 3) of arm retainer 32, so that the tube and IUD body 30c
are maintained in alignment with the trailing end and leading end
axis of the arm retainer. The arm retainer has a "lead-in" or
conical opening at the trailing end to facilitate entry of the
tube. As best seen in FIG. 11, when distal end 26 of tube 22 is
advanced toward copper-tee receptacle 90, arms 30a and 30b of the
IUD become increasingly folded toward the sides of elongate tube 22
due to the tapered width of the passageway 38. The central portion
28 of the IUD arms 30a and 30b exit passageway 40 at leading end 36
of arm retainer 32. Distal end 26 is continuously advanced until
the central portion 28 of the IUD arms 30a and 30b abut the
distal-most portion 92 of receptacle 90. At this point, tube 22 can
no longer be advanced toward distal end 66 of tray housing 62. In
this condition, the outermost ends of arms 30a and 30b are retained
by arm retainer 32.
After the tube and IUD have been fully advanced, and the distal end
of the tube and IUD are at a fixed, predetermined location relative
to the tray, flange 46 can be freely adjusted in either the
proximal or the distal direction so that forward end 50 of the
flange is aligned with a selected position relative to the tray
based on indicia 76. The desired position corresponds to the uterus
sounding measurement of a particular patient. For example, if a
conventional uterus-sounding measurement for a particular patient
indicates a uterine depth of 7.75 mm, the user will adjust flange
46 so that its forward end 50 lies midway between the "7.5" and
"8.0" indicia on the tray. Once this has been done, the IUD
inserter is fully loaded and adjusted and is ready for insertion
into a particular patient having a uterine depth corresponding to
the set location of flange 46.
The present method of loading the IUD into arm retainer 32 of IUD
inserter 20, has many advantages over the prior art. In particular,
the foregoing method enables a doctor to align forward end 50 of
flange 46 precisely with the exact measurement corresponding to the
uterine depth of a particular patient after arms 30a and 30b have
been loaded into their folded position in arm retainer 32. There
are no obstructions disposed within flange compartment 70 to reduce
the accuracy through which flange 46 can be set. Furthermore, an
important advantage of the present method is that the unit can be
"loaded" while it remains within the confines of the tray. Indeed,
the envelope 61 (FIG. 1) need only be opened partially to provide
access to the proximal end of tube 22 and flange 46. It is not
necessary to touch or expose the IUD itself, or the forward
portions of tube 22, which will ultimately enter the uterus. This
is a particularly important improvement over the prior art, such as
the cartoned medical instrument package disclosed in the '633
patent to Roth, which required the IUD to be completely removed
from the previously sterilized environment of the tray prior to
being loaded in an inserter cap. Often, especially in poorer
countries, the environment outside of the tray is unsanitary, thus
making it entirely undesirable to load the IUD into an inserter
device outside of the confines of its tray.
Moreover, the present method of loading an IUD into an inserter
permits the unit to be precisely set to the measurements of a
particular patient within the tray to assure that a patient is not
injured during insertion of the IUD. The present method also
permits the arms 30a and 30b of the copper-tee IUD to remain in
their expanded state until immediately before inserting the IUD
into a patient. This feature entirely removes the risk of the arms
losing their elasticity due to the retention in a substantially
folded position for an extended period of time.
At this time, the loaded unit is ready to be inserted into a
patient in accordance with the preferred method for inserting an
IUD according to a further aspect of the invention. As discussed
above, in the loaded position, the IUD inserter, including elongate
tube 22, adjustable flange 46 and slidably mounted arm retainer 32
are arranged so that an IUD is situated in its loaded position with
arms 30a and 30b folded to extend substantially parallel with the
outer wall of elongate tube 22. The central portion 28 of arms 30a
and 30b, along with distal end 26 of elongate tube 22, extend a
predetermined spaced distance beyond leading edge 36 of arm
retainer 32. Most preferably, when the IUD is in its loaded
position, distal end 26 of tube 22 will extend approximately 7 mm
from leading edge 36 of arm retainer 32 and central portion 28 of
arms 30a and 30b of the IUD will extend approximately 10 mm from
the outermost portion of leading edge 36.
The loaded IUD inserter is removed from the tray and envelope and
positioned as shown in FIG. 12. The leading edge 36 of slidable arm
retainer 32 is placed against the outer portion 52 of a patient's
cervix. It is desirable at this time to align the inserter and the
loaded copper-tee therein with the cervical opening also as shown
in FIG. 12. The protruding portions of the IUD 30 and tube distal
end 26 aid in this alignment. As best shown in FIG. 3, the arm
retainer 32 has a generally flat, slot-like passageway 38 which
extends between the trailing end 34 and the leading end 36. As can
be appreciated, the foregoing step of aligning the inserter and the
loaded copper-tee IUD with the cervical opening of a patient, is
greatly enhanced since the plane defined by the passageway 38 of
the arm retainer 32 precisely indicates the plane of the arms 30a
and 30b of the IUD immediately prior to insertion of the cervical
os. Thus, the structure and operation of the arm retainer 32
provides a visual reference to the medical personnel inserting the
IUD of the proper alignment position of the arms. Furthermore, the
size and shape of the planar passageway 38 effectively prevents the
arms of the IUD from spinning prior to or during insertion of same
into a patient.
The user then grasps the elongate tube about proximal end 24 and
advances the distal end 26 of tube 22 with the IUD thereon, through
the cervical canal of a patient and into the uterus so that arms
30a and 30b of the IUD are permitted to return to their expanded
position therein. At the same time, leading edge 36 of slidable arm
retainer 32 remains in abutment with the outer portion of a
patient's cervix 52. Thus, as the tube 22 advances, arm retainer 32
is forced proximally along the tube toward flange 46. As elongate
tube 22 is advanced forward toward the uterine fundus 54, the outer
portion of the cervix 52 continues to push arm retainer 32
proximally closer to forward end 50 of flange 46. This advancement
process continues until trailing edge 34 of arm retainer 32 abuts
forward end 50 of flange 46, as seen in FIG. 13. The abutting
flange and arm retainer block further distal movement of tube 22.
At this time, arms 30a and 30b are positioned in their expanded
state against uterine fundus 54. Thus, the user who is inserting
the IUD into the patient is provided with a failure-proof signal
for preventing further advancement of distal end 26 of tube 22 and
the IUD thereon into the uterine wall of the patient.
Finally, elongate tube 22 along with flange 46 and arm retainer 32
is withdrawn from the cervical opening, thereby leaving the
"copper-tee" IUD with its arms 30a and 30b fully expanded at the
uterine fundus of a patient.
The method and apparatus for inserting IUD according to the present
invention will permit a doctor or other qualified individual to
safely insert a "copper-tee" IUD, or other IUD having expandable
arms thereon, to the proper depth within the uterus of a patient
without causing pain due to misalignment during insertion, and
without causing trauma to the uterine wall of a patient, as may
occur in prior art methods and apparatus when the IUD is
accidentally advanced too far.
While the foregoing description and figures are directed toward the
preferred method and apparatus in accordance with the present
invention, it should be appreciated that numerous modifications can
be made to each of the individual steps of the method and
components of the entire apparatus as discussed above, and are
indeed encouraged to be made in the steps, materials, structure and
arrangement of the disclosed steps and embodiments of the present
invention without departing from the spirit and scope of same.
Thus, the foregoing description of the preferred steps and
embodiments should be taken by way of illustration rather than by
way of limitation with respect to the present invention as defined
by the claims set forth below.
* * * * *