Thursday, March 12, 2020

Oh, patents! The InfaClip™

Copyright © Françoise Herrmann

Whether due to unsafe socio-cultural practices, inadequate access to healthcare or a combination of both, two-thirds of neonatal deaths occur in the developing world. To prevent neonatal death in the developing world, specifically due to umbilical cord infections, University of Tulane spinoff, at Novate Medical Technologies, has developed the InfaClip (formerly designated the SafeSnip).

The InfaClip is a patented invention, recited in the UN WIPO (World Intellectual Property Organization) patent, WO2012129317A1, titled Multi-component detachable jaw tools and methods of using and making same. Specifically, the InfaClip is a 3-inch, disposable, plastic obstetric device, intended to clamp, severe and disinfect the umbilical cord. The InfaClip actually consists of two identical clips, made from the same plastic injection mold, one of which breaks off, after the cord has been severed from the placenta. The clip left in place then seals the wound, protecting it from infection.

In contrast to existing obstetrical devices for clamping and severing umbilical cords, consisting within medical settings of several instruments (metal clamps and scissors, plus plastic clamp), or in non-medical settings of strings and a blade, the InfaClip offers a two-step process. The two-step process comprises 1. disengaging a hinge-locking mechanism for the purpose of unlocking the open jaws of the InfaClip to clamp/cut the cord, and  2. breaking off the InfaClip part connected to the severed cord and placenta, leaving the other half in place. The part that stays to protect the wound is also removable, without the use of any extra cutting tools,  just applying downward pressure on a disengageable lip and lever closure of the two jaws, at the opposite end of the hinge. Finally, the InfaClip grip is specifically designed to distribute the forces applied when closing the jaws, at the center of the clip, thereby facilitating severance, while protecting for against blood splatter, to prevent Hepatitis B &C and HIV contamination.

The patent recites various embodiments of this invention applied to the severance of an umbilical cord, but it is also disclosed that the scope of the invention is in fact much larger. Indeed, variations, known to persons skilled in the art, might be designed for other vascular, gastrointestinal, gynecological (e.g.; tubal ligations) or respiratory purposes, without departing from the spirit of the invention.  In this regards the detailed description of the invention also contains a detailed section on the definition of terms. For example, the patent recites the regulatory “open-ended” definitions of such terms as “comprising” and the indefinite articles “a/an”,  respectively used  within the patent to mean: “at least” and “one or more”, precisely for the purpose of construing the broadest possible claims, without limitations (unless nonsensical).

The abstract of this invention is included below together with the patent Figure 2, and a corresponding image of the separated InfaClip. The patent Figure 2 shows the two symmetrical components, Unit A and Unit B, of the InfaClip device 1, that separate after clamping/cutting of the cord. The hinge 50 brings both units together, while comprising hinge portions 52 and 54 on each unit. The Units A and B, working together as unitary jaw members, are designated 40 and 30. Figure 2 further depicts the sawtooth blades 91, 92, configured to receive one another when the jaws are closed, and the chamfered clamping surfaces, comprising working surfaces 34 and 44, on Unit B, and working surfaces 32 and 42 on Unit A, each abutting one another when the jaws are closed.
Provided is a jaw tool formed from two separable units and which includes a fastening device that attaches the two units together when the jaw tool is in use and which may automatically separate the units after the device performs its function such as clamping and/or cutting. Also provided is a jaw tool having a cutting blade wherein the contours of the device are shaped so that force is concentrated on the cutting bade when the device is closed. The jaw tool may be manufactured from a single injection molded-component that is used in duplicate to form the jaw tool. The jaw tool may be used in various applications in which it may be beneficial to simultaneously clamp and cut an object, such as various medical applications including vascular, gastrointestinal, respiratory, and placental. [Abstract WO2012129317A1]
References
Brannon, K. (2009) Student's invention aids safe childbirth. 
http://www2.tulane.edu/news/newwave/081809_safesnip.cfm
WHO - Innovation in umbilical cord severance
https://www.who.int/medical_devices/global_forum/3rd_gfmd/umbilicalcordseverance.pdf
Youtube - Infaclip™ - Novate Medical Technologies
https://www.youtube.com/watch?v=J1TSi6iMbR8

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