Inserter for contraceptive device
[451 Apr. 29, 1975 1 INSERTER FOR CONTRACEPTIVE DEVICE Seymour Hoff, 5339 Brenda Ave, San Jose, Calif. 95124 [22] Filed: Nov. 21, 1972 [21] Appl. No.: 308,596  
 [76] Inventor:  
 Primary ExaminerRichard A. Gaudet Assistant Examiner-G. F. Dunne Attorney, Agent, or Firm-Parrott, Bell, Seltzer, Park &amp; Gibson [57] ABSTRACT A one piece inserter for a medical device such as an intrauterine contraceptive device is provided. The inserter has a leading end and a trailing end with the leading endicomprised of a smaller cross sectional area than the trailing end. The leading end has both a notch and a hollowed internal area for receiving a part of an intrauterine device in cooperation with the smaller area adapted to receive in axial alignment the remainder of the device in nested relation with the inserter The inserter intrauterine contraceptive device combination provides an assembly of reduced volume that permits easy movement through the cervical canal into the uterus for effectively positioning the intrauterine contraceptive device.  
 4 Claims, 7 Drawing Figures mmwmz ms 3.880.156  
 SHEET 2 OF 2 FIG.5 4 32 FIGS INSERTER FOR CONTRACEPTIVE DEVICE BACKGROUND OF THE INVENTION The present invention relates to a novel and useful inserter for placing an intrauterine device within a uterus. More specifically, the invention relates to an improved one piece inserter which can be easily loaded with an intrauterine device with little handling and inserted within the uterus for easily positioning an intrauterine device in the uterus with both a minimum of trauma and risk of perforation of the uterine wall.  
  Inserters for placing an intrauterine device in a uterus are known to the prior art. Generally, these inserters were of various shapes and they consisted of two pieces, a tube or cannula and a plunger or rod. While these inserters have enjoyed wide usage, several major disadvantages were associated with their use. For example, one disadvantage is that the inserters were hard to load because they required that the intrauterine device be collapsed and forced into the cannula which is often time consuming and difficult. Another disadvantage inherent in the two piece inserters is that they required a high degree of manual dexterity to assure that the intrauterine device is effectively pushed from the cannula without changing the preselected shape of the device. The major disadvantage associated with the use of a two piece inserter is that they do not provide for the automatic self release of the device from the inserter in the uterus. That is,- with a two piece inserter it is always necessary that the device be pushed from the inserter with the rod. Frequently, the rod is pushed too far which leads to perforation of the uterine wall. Additionally, these prior art assemblies comprised of an inserter and device have a large volume, and when they are presented to the cervical canal and the uterus there is a resultant unwanted incident of pain and trauma accompanying their use.  
 SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide an inserter for placing an intrauterine device in the uterus that overcomes the disadvantages associated with the prior art.  
  It is a further object of the invention to provide a one piece inserter for placing an intrauterine contraceptive device in a female uterus which inserter is easily loaded, is easy to handle, and easy to use for positioning the intrauterine device in the uterus.  
  Another object of the invention is to provide an inserter for holding an intrauterine contraceptive device which inserter self releases the device in the uterus as the inserter is withdrawn therefrom.  
  Yet still another object of the invention is to make available to the art a novel and useful unit construction inserter that can be used with safety and with a minimum of risk of perforation of the uterine wall, and essentially free from pain and trauma.  
  Still a further object of the invention is to provide an inserter that can be easily manufactured from either a single use disposable material or from a material that lends itself to repeated use.  
  It is another object of the invention to provide an inserter that can be easily removed after placing a device in the uterus.  
  Yet another object of the invention is toprovide an inserter intrauterine device dombinationthat has a smaller volume thereby requiring a space smaller than the cervical os, cervical canal and the uterus to substantially iessen the incident of pain and trauma associated with placing within the female uterus an intrauterine contraceptive device.  
  These and other objects of this invention will become more apparent from the following detailed description of the invention taken in connection with the drawings and the accompanying claims.  
 BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, which are not drawn to scale, but rather are set forth to illustrate various embodiments of the invention, the drawings are as follows:  
  FIG. 1 is a view illustrating the improved inserter of the invention.  
  FIG. 2 is an illustration of one type of intrauterine device that can be placed in a uterus with the inserter of the invention.  
  FIG. 3 illustrates an intrauterine device nested in a notch located in the leading end of an inserter.  
  FIG. 4 illustrates an intrauterine contraceptive device nested in the inserter.  
  FIG. 5 depicts a method of placing an intrauterine contraceptive device in a female uterus illustrating an inserter intrauterine contraceptive device combination with the arms of the device moving toward the smaller area of the inserter as the combination enters the cervical os.  
  FIG. 6 illustrates in combination an inserter intrauterine contraceptive device with part of the device nested in the inserter and the remainder thereof linearly received by the smaller end of the inserter.  
  FIG. 7 is a sketch of the inserter of the invention positioning an intrauterine contraceptive device in a uterus as the inserter is withdrawn therefrom.  
 In the drawings and specification, like parts in related figures are identified by like numbers. The terms appearing earlier in the specification and in the description of the drawings, as well as embodiments thereof, are further described elsewhere in the disclosure.  
 DETAILED DESCRIPTION OF THE INVENTION Turning now to the drawings in detail, which are examples of the article of manufacture of the invention and which are not to be construed as limiting, one embodyment of an inserter is indicated in FIG. 1 by the numeral 10. Inserter 10 is a tubular member or rod member having a leading end 11 and a trailing end 16. Inserter 10 at leading end 11 has a receiving area 12, shaped like a notch, a half square, a half rectangle, a half circle, or other geometric configuration suitable for holding and freely releasing an intrauterine device. Inserter 10 at end 11 has an internal hollow area 13 continuous with recess area 12 for slidably receiving within the inserter an intrauterine device. Hollow area 13 is seen in dashed lines and it can have various embodiments. For example, in an inserter manufactured from a tubular material hollowed area 13 can extend the length of the inserter, as seen in FIG. 1, or in an inserter manufactured from a rod like material hollowed area 13 internally extends at least a distance continuous from the recess area, not shown in FIG. 1, sufficient to internally house and easily release an intrauterine device.  
  lnserter 10 is further uniquely characterized as comprised of two integrally formed sections with each section having a different diameter. That is, inserter 10 has a section of larger diameter 14 and a section of smaller diameter 15 that merge to form a single piece inserter l0. Larger diameter 14 extends substantially throughout the length of the inserter from the trailing end 16 to the point where it merges with the section of smaller diameter 15. Smaller diameter 15 arises at leading end 11 and it extends toward larger diameter 14 and trailing end 16. Smaller diameter 15 is of a smaller circumference and occupies a lesser amount of space since it is designed for closely receiving parts of an intrauterine device, not seen in FIG. I, in close contact to inserter 10. This closeness or effective use of space facilitates the advance of the device through the cervical canal and positioning in the uterus of the intrauterine device, while at the same time it minimizes the likelihood of injury or pain which frequently occurs with prior art devices. That is, inserter 10, at area 15, has a smaller mass, thereby requiring a smaller space as the inserter travels through the cervical os, the cervical canal into a female uterus.  
  lnserter 10 of the invention can be manufactured from any suitable material, and the material can be of naturally occurring or synthetic origin. Exemplary materials include poly(olefins) such as poly(ethylene), poly(propylene), nylon, or any suitable commercially available plastic, surgical steel, or the like. The inserter can be made by techniques standard in the art such as parison forming, extrusion, casting and the like. Inserter 10 is about 20 to 40 cm long with the larger section having a diameter of about 4 to 8 mm, and the smaller section having a diameter of 2 to 3.5 mm, with the length of the smaller section about 12 to 20 mm. Of course these dimensions are representative of a presently preferred inserter, as other inserters of larger or smaller dimensions in like proportions are embraced within the scope of the invention.  
  FIG. 2 illustrates a conventional intrauterine device that can be easily and efficiently positioned in a uterus with inserter 10 of the invention. In FIG. 2, there is depicted an intrauterine device 20 shaped like a T, and it is similar to the T&#34; described in US. Pat. No. 3,533,406. The T&#34; is comprised of a top cross bar identified by 21 and 22 of about 3 to cm in length and a depending leg 23 of about 3 to 5 cm in length. The inserter of the invention can be used for inserting a T of the solid filament type or for inserting a T&#34; intrauterine contraceptive device that contains at least one anti-contraceptive or anti-fertility agent that is administered from the T&#34;. While the T is a presently preferred embodiment for use with inserter 10, it is to be understood that inserter can be used with other intrauterine devices for placing them in a uterus; that is, intrauterine contraceptive devices having a part that can be housed in the hollowed area and a part that can rest in the notch.  
  FIG. 3 illustrates another view of inserter 10 of the invention. In FIG. 3 there is seen inserter 10, formed of a single, unit piece of biologically acceptable material. lnserter 10 is comprised of notch 12 and inserter 10 is seen holding an intrauterine device 20 comprised of cross members 21 and 22 continuous with shaft 23. Shaft 23 is slidably housed in leading end 11 of inserter 10. Device 20 is positioned in notch 12 and the smaller section of inserter 10.  
  FIG. 4 illustrates an intrauterine device housed in an inserter l0. lnserter 10 is similar to the inserter of FIG. 1 and it has an additional embodiment illustrated in FIG. 4 of a stop member or collar 24. lnserter 10 in FIG. 4 is about 20 to 30 cm long and member 24 is spaced about 4 to 8 cm from lead end 11. Member 24 aids in preventing unnecessary penetration beyond the cervical canal and this reduces the likelihood of injury to a warm blooded uterus. In FIG. 4 at leading end 11, a section of wall 25 is removed for illustrating device 20 received in notch 12. Top cross bars 21 and 22 of device 20 are seen nested against smaller area 15 for decreasing the volume of the inserter 10 intrauterine contraceptive device 20 assembly. Top cross bars 21 and 22 nested against smaller area 15 in side-by-side generally linear relation present a smaller volume to the cervical os and the cervical canal during insertion and positioning of intrauterine device 20. The smaller section 15, which is a means adapted for receiving the intrauterine device has in the embodiment shown a length of about I to 3 cm. Depending member 23 of device 20 is illustrated by dashed lines and it is housed in hollowed area 13 as seen in FIG. 1. Device 20 is freely nested therein, and it is easily, slidably released from inserter 10.  
  FIGS. 5, 6 and 7 collectively illustrate a method for using inserter 10 for positioning intrauterine contraceptive device 20 in a uterine cavity 30. In FIG. 5, inserter 10 is seen loaded with intrauterine device 20 and inserter 10 carries device 20 in nested relation to inserter 10. In actual operation, inserter 10 is first gently moved against the cervical os 33 that blends and leads into cervical canal 31. Members 21 and 22 of intrauterine device 20 initially are spread in open T formation and abutt inserter 10. As inserter 10 enters cervical os 33, members 21 and 22 move toward smaller area 15 of inserter 10 to eventually position in axial alignment with inserter 10.  
  In FIG. 6, inserter 10 slidably carrying intrauterine contraceptive device 20 is seen traveling through cervical canal 31 in route to uterus 30. In FIG. 6, members 21 and 22 are now positioned in side-by-side linear relation with inserter 10. Members 21 and 22 are in proximate contact with the wall of inserter 10 in smaller area 15 which area 15 is a means adapted for receiving members 21 and 22. This novel design of the invention, comprised of the inserter intrauterine device combination presents a smaller volume to the cervical canal and substantially reduces the incident of pain and trauma. Members 21 and 22 are held in smaller area 15 by the walls of the cervical canal until the inserter enters uterus 30. In uterine cavity 30 members 21 and 22, free from the restrain of the cervical wall return to their original T&#34; spaced relation.  
  In FIG. 7, there is seen inserter 10 positioning an intrauterine contraceptive device 20 in uterus 30. In this illustration, members 21 and 22 are now in their original open spaced T form. In actual insertion of an intrauterine device, inserter 10 is gently moved through uterus 30 until intrauterine device 20 contacts fundus uteri 32. Then, inserter 10 is easily withdrawn from uterus 30, while simultaneously slidably self-releasing and positioning intrauterine device 20 in uterus 30. Inserter 10 is finally, totally withdrawn from the host.  
  It will be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained and, since certain changes may be made in carrying out the above method and in the article set forth without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawing shall be interpreted as illustrative and not in a limiting sense.  
 What is claimed is:  
  l. A one piece inserter for an intrauterine contraceptive device comprising a transverse member and a leg member depending therefrom, wherein the inserter essentially consists of:  
 a. an elongated rounded member having a leading end and a trailing end distant from the leading end,  
 b. a receiving notch in the terminus of the rounded member at its leading end, said notch adapted to orient the intrauterine device and to receive a part of the intrauterine contraceptive device,  
 c. a hollowed area continuous with the notch internally extended within the rounded member a sufficient length and adapted to receive internally a part of the intrauterine contraceptive device when a device is positioned in the notch,  
 d. and wherein the rounded member at its leading end has a smaller circumference than the trailing end which smaller circumference is extended along a section of the member, with the smaller circumference exteriorly forming a reduced leading end adapted to exteriorly receive a part of the intrauterine contraceptive device in nested relation to the reduced leading end of the rounded member when an intrauterine contraceptive device is placed in the notch and hollowed area of the single piece inserter.  
  2. The inserter for inserting an intrauterine contraceptive device according to claim 1 wherein the inserter further comprises a stop member on the elongated rounded member for limiting the depth of the intioning an intrauterine contraceptive device in a uterus;  
  3. The inserter for inserting an intrauterine contra ceptive device according to claim 1 wherein the elonj gated member is hollowed from its leading end to its trailing end. I  
 4. A single piece inserter for an intrauterine contraceptive device and an intrauterine contraceptive device essentially shaped like a T&#34; essentially consisting of in combination:  
 a. a tubular member having a leading end and a trailing end distant from the leading end and made from a biologically inert acceptable material,  
 b. a notch in the leading end at the terminus of the tubular member as a means for positioning and housing a part of an intrauterine contraceptive device in the inserter,  
 c. a hollowed internal area formed by the inner surface of the wall of the tubular member with the area extended from the notch at the leading end for internally receiving in cooperation with the notch a part of an intrauterine contraceptive device,  
 (I. a section of smaller circumference extended along the exterior of the tubular member from its leading end for exteriorly closely receiving in cooperation with the notch and the internal hollowed area a part of an intrauterine contraceptive device, and wherein the inserter houses in nested relation.  
 e. an intrauterine contraceptive device shaped like a T having a cross bar and depending leg with the depending leg in the hollowed area, the cross bar in the notch and for downwardly positioning along the smaller circumference of the one piece inserter.  
 &#39;serte r when the inserter is subsequently used for posi UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION PATENT NO. 3,880,156  
 DATED April 29, 1975 INVENTOR(S) Seymour Hoff It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:  
 On title page, right hand column, &#34;Attorney, Agent or Firm&#34; should read, -Paul L. Sabatine, Edward L. Mandell, William H. Benz--.  
 Signed and Sealed this nineteenth 21 Of A D y ugusl1975 A He: 1:  
 RUTH C. MAfiSON Co MARSHALL DANN .trresrrng ()j/rrer (&#39;mnmr&#39;ssr&#39;uner uj&#39;larenls and Tradcmurkx