Patent USRE35636 - IUD inserting apparatus

IUD INSERTING APPARATUS

Matter enclosed in heavy brackets [ ] appears in the original patent but forms no part of this reissue specification; matter printed in italics indicates the additions made by reissue.

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. 0327,666 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

5 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

10 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

15 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

20 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

25 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 30 methods and apparatus for inserting an IUD into the uterus of a patient are needed.

SUMMARY OF THE INVENTION

35 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 accord

40 ing 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

45 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

so 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

55 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

60 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

65 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 distaUy into the pas

3 4

sageway through the trailing end of the arm retainer and compartment for receiving a flange therein. The flange

toward the leading end thereof. The arm retainer desirably compartment desirably is continuous for precise adjustment

includes a collar formed about the leading end. The collar is of the flange. As can be appreciated, a tray according to this

arranged to abut the outer portion of a patient's cervix during aspect of the present invention can be used for "loading" the

insertion of the IUD into the uterus. 5 expandable arms of an IUD in their folded position in an arm

Another aspect of the present invention provides a tray for retainer immediately prior to insertion into the uterus of a

retaining ad IUD having expandable arms thereon and an patient while the IUD and its associated inserter remain

IUD inserter. The tray according to this aspect of the present within the confines of the tray.

invention includes means for retaining an elongate shaft of Another aspect of the present invention provides a method

an IUD inserter having an IUD thereon so that the arms of 1Q for loading expandable arms of an IUD into an arm retainer

fte IUD are arranged in the tray in an expanded position 0f an IUD inserter while the IUD and the inserter remain in

The elongate shaft includes a proximal end and a distal end a such „ a tQ me

and is disposed m the tray so that tiie expanded arms are ^ embodiments ^ ^ 0f the IUD desirably are

arranged adjacent the distal end of the elongate shaft. The r .„ . „ . . . . . _ . . . . ' ^

tray according to this aspect of the present invention most Pemu^ 0 remam m x,TM T St*e T?

preferably also comprises means for retaining an arm 15 "^mediately prior to insertion of the IUD into a patient. A

retainer of the inserter having a leading end and a trailing method according to this aspect of the present invention

end so that the trailing end lies adjacent the expanded arms. includes the step of advancing the distal end of the elongate

Thus, the arms of the IUD wall become folded as the shaft of me mserter into an arm retainer as discussed above

elongate shaft is advanced distally into the trailing end of the s0 mat me ^ of the IUD are forced from their expanded

arm retainer while the elongate shaft and the arm retainer 20 position to a substantially folded position therein. This

remain in the tray. advancing movement desirably terminates when the IUD

In a particularly preferred arrangement of this aspect of abuts a portion of the tray adjacent the leading end of the arm

the present invention, the tray also includes means for retainer.

retaining a depth stop member, such as a flange, so that the The preferred methods for loading the expandable arms of

flange can be continuously adjusted along the shaft to 25 an IUD in an arm retainer of an inserter in accordance with

correspond with a predetermined uterine depth indicating this aspect of the present invention effectively permits a

the distance between the outer portion of a patient's cervix doctor or other qualified individual to "load" the normally

and the uterine fundus. It is also desirable for the tray to expanded arms of an IUD into their folded position within

include measurement indicia thereon. Most preferably, the an arm retainer immediately prior to insertion of the IUD

indicia represents a preselected range of uterine depths and 30 into a patient. Additionally, this preferred method permits a

is disposed adjacent the means for retaining a flange so that user t0 precisely adjust the stop member to an exact depth of

the flange can be adjusted to a location adjacent the appro- a particular patient's uterine fundus to assure that the IUD

priate indicia which represents the depth of a particular W1n be inserted to the proper depth without injury to the

patient's uterus. It is also preferable for the flange compart- uterine wall. The loading and adjusting operations can be

ment of the tray to include means for preventing the flange 35 performed within the aseptic environment of the tray in

from being adjusted to a uterine depth of less than the which the IUD and its associated inserter were originally

recommended depth for the particular type of IUD therein. packaged.

This means serves as an additional safeguard to prevent the still another as^t of me nt mvention provides a

IUDfrombeinginsertedbeyondapreselecteddepthdefined method for safdy ^ rUD to the proper depth

by a patient's uterine fundus, and therefore, may prevent 40 within a patient's uterus while minimizing the risk of

trauma from occurring thereat. Additionally, it is preferable damaging me uterine wall. A method according to this aspect

for the tray of the present invention to include means for of the invention includes ±e steps Gf placing slidable

receiving at least a portion of the arms of the IUD when the member, such as an arm retainer, of an IUD inserter against

arms are arranged in a substantially folded position and at ^ outer portion of a paSienVs wherein ^e inserter

least partially extend out of the leading end of the arm 45 includes an elongate shaft preferably in the form of an

retainer. elongate tube having distal and proximal ends thereon and

Most preferably, a tray according to this aspect of the an IUD on the distal end. The inserter is then aligned with

present invention comprises a housing having a distal end the cervical opening while the slidable member is main

and a proximal end. The housing should include a cavity for ... in abutment with the outer portion of the cervix. The

receiving the IUD inserter having an IUD therein. It is 50 distal end of the inserter is then advanced through the

desirable for the cavity to be continuous and to include an cervical canal and into the uterus. In this step, the proximal

elongate shaft compartment for retaining the elongate shaft e„d Gf the elongate shaft is advanced toward the slidable

of the IUD inserter. Further, the cavity should include an member until the slidable member abuts a stop member,

expandable arm compartment connected to the elongate sucn as a nange, which is arranged at a predetermined

shaft compartment at the distal end thereof for retaining the 55 location on the elongate shaft The elongate shaft of the

arms of the IUD in their expanded position. It is also inserter is then withdrawn from the uterus and out of the

preferable for the cavity of the tray to include an arm retainer cervical opening while the IUD, with its arms fully

compartment adjacent the expandable arm compartment expanded at the uterine fundus, is left at the proper location

toward the distal end of the housing. The arm retainer within the patient.

compartment may be arranged to receive an arm retainer eo These and other objects of the present invention will be

having a trailing end and a leading end and a passageway mQre clearly understood when read in conjunction with the

therethrough so that the expandable arms can be advanced detailed description and the accompanying drawings which

through the trailing end of the passageway toward the follow leading end of the arm retainer at the distal end of the

housing. 65 BRIEF DESCRIPTION OF THE DRAWINGS

The tray may have a flange compartment connected to the FIG. 1 is a diagrammatic plan view depicting one embodi

elongate shaft compartment proximal to the expandable arm ment of the present invention.

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IUD inserting apparatus