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IUD4A
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IUD4A (Intrauterine Devices For All)

LEGAL PRELUDE

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License: CC-BY-SA-4.0

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Some Background

Now more than ever, effective contraception is important

…in the US because of the recent overturning of Roe v Wade

…in the developing world in order to allow women to benefit from education, and engage in the workforce

…everywhere to allow women to understand and control their bodies!

IUD Basics

Figure 1. A diagram of an IUD in place in the uterus. [Attribution: Blausen.com staff (2014). "Medical gallery of Blausen Medical 2014". WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436. CC BY 3.0]

Figure 2. A commercial copper IUD (Paragard T 380A). [Attribution: Wikipedia User:LeiaWonder CC BY-SA 4.0]

In a nutshell:

But:

So:

One of the reasons that IUDs have a bad reputation is that the standard insertion practice involves a highly invasive and often painful process. After a first appointment with a doctor, the procedure is scheduled (if available, legal, and covered by insurance). During the procedure, you are placed in stirrups, and your vagina is probed. A speculum is inserted to open your vagina. Tenaculum forceps are used to grab and pull on your cervix (Figure 3). Puncture wounds in the cervix from the tenaculum are common. Then your cervix may be dilated with probes, your uterus is probed with a metal rod (Figure 4), and only then is the IUD inserted.

Figure 3. A tenaculum forceps, used to grasp and apply traction to the cervix during standard IUD insertion. [Attribution: Wikipedia دماوندی  CC BY-SA 3.0]

Figure 4. Other gynecological instruments used during IUD insertion, top-to-bottom: a Teales vulsellum forceps, a Hegar uterine dilator, a Galabin uterine sound, and a Sims speculum.

We are not qualified to judge the medical niceties of this procedure, but from a layperson’s perspective it appears to be primitive and rough. It is understandable that IUD insertion has a bad reputation! As one doctor puts it: “The technique of IUD insertion as described in most textbooks and journals is unnecessarily complex and based on ritual rather than good clinical evidence.”[2] We know insertion through the cervix can be done without tenaculums, thanks to procedures like vaginoscopic (or “no touch”) hysteroscopy.

We think there is a better way, which will let women take control of their bodies and insert (and remove) IUDs themselves, in a much less painful and invasive fashion, and at a fraction of the cost.

Investigation Areas

We are exploring several areas to address the challenges with IUDs and IUD insertion and removal, including devices that can be printed, assembled, and used by anyone using cheap and common materials.

Importantly, it’s not required that all of these ideas be used at once: it would be possible for a doctor to print a custom IUD and insert it using the standard procedure. Or for a trained practitioner to do the insertion using the ID and an off-the-shelf IUD. Any of these would be an improvement on the status quo!

Key Questions

  1. Are 3D printed IUDs effective as contraception, and do they stay in place?
  2. Is insertion through the cervical canal really feasible without traction on the cervix?
  1. The newer vaginoscopic approach to hysteroscopies indicates this is feasible.
  1. Is insertion through the cervical canal so intrinsically painful that self-insertion is impractical?
  1. There is strong evidence that self-removal of IUDs is not prohibitively painful, and removal appears to be a rougher operation (due to folding up the arms by brute strength) than insertion.
  2. In vaginoscopies, which use a similar diameter as our insertion tube, “90.5% of the women referred that what they felt was equal or less than their normal menstruation.”[3]
  1. Can we develop practical and effective antiseptic methods for the self-insertion process?
  1. We describe preliminary antiseptic methods below, still a work in progress.

Building the Devices

Note: our printer is not high quality, or particularly well-calibrated. The community routinely produces higher-quality prints than those shown here.

See also Appendix: Bill of Materials.

Insertion Device (ID)

The insertion device (ID), including the camera can be assembled for a few dollars. It consists of three main parts: the body, the insertion mechanism, and the camera.

Figure 5. The assembled ID, showing the IUD poking out of the insertion tube to the right, and the insertion plunger to the left.

The ID Body

The ID body is assembled from 3D-printed pieces. We used PETG for its safety and cleanability. The handle is designed to be manipulated by the user, and has holes for the camera cable and for the insertion tube. The central tube length and curvature can be printed depending on the user’s vaginal anatomy, based on what you find comfortable. The head has a straight hole for the camera, and a curved hole/guide for the insertion tube to angle it up into the cervix. The angle of curvature for the insertion tube guide can be printed depending on the user’s cervical anatomy (for example if you have a tilted cervix). We used an electric drill to clean up the holes, since our 3d printer isn’t very precise. The handle and shaft can be glued together, but we do not recommend gluing the head to the shaft at least until you have practiced the insertion process several times.

Figure 6. The pieces of the ID body. Top row, left to right: the handle, a coupling ring to join the handle to the main tube, and the head (with holes for camera and insertion tube). Bottom row: the ID main tube.

Figure 7. The “exploded” ID body, showing how the pieces fit together, and how the camera and insertion tube are plumbed through.

The Insertion Mechanism

The insertion mechanism is a 3d-printed plunger, and a length 2 mm inner-diameter, 3 mm outer-diameter silicone tube. They should be approximately the same length, and approximately 7 centimeters longer than the overall ID device, to allow 5 cm insertion into the cervical canal and 2 cm for keeping a grip at the handle.

Figure 8. The insertion mechanism consists of a plunger (top) and insertion tube (bottom), which are threaded through the body of the ID.

The insertion tube may also have an optional holder, to improve control. We printed out the tube holder, drilled out the hole to 3 mm, and then super-glued the tube into the holder, as shown in the photo. Note: you don’t have to apply very much superglue, it gets pulled in by capillary action.

Figure 9. The insertion tube holder (optional), attached to the insertion tube, and with the plunger inserted into the tube.

The Camera

The camera is just a cheap USB earwax removal camera (search Amazon or Ebay). Tape can be used to expand the diameter of the camera barrel and ensure a tight fit in the head. Standard Windows/MacOS/Linux or Android software can be used to display the camera image on a laptop or phone.

Figure 10. Left: the camera. Right: the face of the camera, as installed in the ID head.

IUD V1 – “back-to-back arch”

The body of the IUD is printed in a c-shape with a small joint in the center. The arms are bent back-to-back to form the familiar T-shape.

We use ~40 cm of 0.13 mm MONOFILAMENT nylon fishing line as the strings. Monofilament MUST be used to avoid infections traveling up the cervical canal (see the Dalkon shield history for a cautionary tale). The monofilament strings are tied in the center of the printed c-shape.

We use ~20 cm of 0.25 mm 99.99% pure copper wire, yielding about 157 mm2 of copper surface area. A small loop in the end of the copper wire goes around the strings. The strings are then knotted around both the wire and plastic body.

Then the wire is wound around the shaft of the IUD.

We formed a small loop of wire at the arm end of the IUD, extending a short distance between the arms, to avoid any sharp ends.

IUD v2 – “Thin V”

The design goals of an IUD are to not cause pain or damage during insertion, to stay safely in the uterus, and to be easy to remove. IUD v2 is an attempt to innovate along these lines. In particular, it has a thinner profile, and the arms more gently conform to the shape of the uterus. With about 18 cm of 0.38 mm diameter copper wire, it has about 215 mm2 of copper surface area. The copper wire is only wrapped around one of the arms, in order to reduce the overall diameter of the IUD when it is loaded into the insertion tube.

General IUD Notes

For any type of IUD, there are several key considerations.

A Theoretical Insertion Process

A theoretical insertion process is outlined below. Regular precautions include:

We recommend starting by just using the ID with the camera (and no insertion tube), in order to take a look around, and become familiar with the ID. For example, you may find that you would prefer a curved ID (for comfort), or that you have a tilted cervix, and so would need to print an ID head with a different insertion tube guide angle.

Steps

Overview image

ID camera image

Clean everything with antiseptic, especially the IUD and the insertion tube.

1. Insert the IUD strings into the head end of the insertion tube.

NOTE: a short tube is used here as an example. The full insertion tube should be used.

2. Use the plunger (or some other thin rod) to thread the strings into the insertion tube.

3. Either (a) Pull the strings to pull the IUD into the insertion tube until the arms are fully in the tube or (b) push the IUD into the tube until the arms are fully in the tube.

IMPORTANT: make sure that the final IUD fits within the 2 mm inner-diameter insertion tube, and slides smoothly, so that the plunger will be able to push it out!

Retract the insertion tube until it is slightly recessed inside the head – this will help keep it clean as the ID is inserted into the vagina.

4.  If desired, add lubricant to the outside of the ID before insertion into the vagina.

Insert the ID into the vagina, and use the camera to locate the cervix.

NOTE: “internal” images are simply the inside of a hand curled into a fist.

5. Thread the insertion tube ~5 cm into the cervix by pushing it into the handle.

TODO: we do not know how often the cervix is straight enough to enable this step.

NOTE: this can be difficult with a flexible silicone tube. We may need to use a stiffer tube, or more guides within the ID.

NOTE: “internal” images are simply the inside of a hand curled into a fist.

6. Insert the IUD by ejecting it from the insertion tube by pressing on the plunger while holding the insertion tube fixed.

NOTE: this would not be visible in the camera due to the cervix.

7. Give the arms a few seconds to recover their curvature.

NOTE: this would not be visible in the camera due to the cervix.

8. Retract the plunger fully. Make sure the plunger does not put tension on the IUD strings, or pull the IUD out.

9. Retract the insertion tube from the cervical canal, using the camera to make sure that the IUD strings are threaded through the cervix, but do not pull the IUD out of the uterus.

10. Remove the ID from the vagina.

TODO: outline a procedure to trim the strings to length, if they are not already cut to the final desired length (~7 cm)

A Theoretical Removal Process

Use the ID, together with the removal plunger (ID_removal_plunger.blend / stl) to snag the strings and pull out the IUD.

Note the small hook at the tip of the removal plunger (which can be improved by carving the slot in the plunger with a knife, depending on your print quality). Or just use your fingers!

Appendix: Bill Of Materials

Tools:

Optional Tools:

Insertion Device

IUD

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[1]https://www.researchgate.net/publication/10974531_Mechanisms_of_action_of_intrauterine_devices_Update_and_estimation_of_postfertilization_effects

[2] A minimalist technique for insertion of intrauterine devices | Healthcare in Low-resource Settings 

[3] Office Hysteroscopy without Anesthesia, Is it Really Possible? - MedCrave online