Obstetric bonnet for assisting childbirth and method of manufacturing the same

• US 5,507,752 A
• Filed: 08/10/1992
• Issued: 04/16/1996
• Est. Priority Date: 09/06/1990
• Status: Expired due to Fees

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Elliott, Byron D.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/928,131
• Time in Patent Office: 1,345 Days
• Field of Search: 606/122, 606/123, 606/124, D 2/510, D 2/511, D 2/251, D 2/256, 446/98, 446/177, 248/363, 248/362, 248/205.5, 248/206.2, 294/64.1, 279/3
• US Class Current: 606/123
• CPC Class Codes: A61B 17/442 without pivotal connections, e.g. using vacuum

Abstract

Flexible, collapsible, dome or cylinder-shaped bonnet that provides a substantially airtight fit to a fetal head and utilizes frictional and internally-created vacuum forces for assisting childbirth. The bonnet is manually inserted and rolled over the cranium of the fetus, stopping short of the eyes and the ears. Friction and internally created vacuum forces are created when the bonnet is pulled, thus securing the bonnet to the fetus'"'"'s head and allowing orientation and delivery. The device is comprised of a dome or cylinder-shaped body made of a collapsible elastic material, an optional raised "lip" located on the exterior of the open end, and may have a mechanical extension attached to the closed end. System embodiments allow for the attachment to the exterior of the closed end grommets and/or mechanical extensions that will irreversibly stretch, lengthen, and expose warning alerts in the event that excessive longitudinal force is applied. The bonnet is a significant improvement because it allows a firmer grip on the fetus'"'"' head with less danger of damage to either the mother or the fetus. Thus traction and rotational forces may be safely applied to a fetus without the need to use forceps or hard suction cups.

Claims

1. A method of manufacturing an obstetric traction delivery bonnet apparatus comprising a smooth, rollable dome or cylinder having an inner surface, an outer surface, an open end with an edge, a completely closed end, walls, and sized to provide a snug fit to a fetal head, wherein said apparatus is fitable around a fetal head to have adherence thereto because of frictional and internally-created vacuum forces, comprising the steps of:

obtaining a mold shaped to match the size and shape of the bonnet;

immersing the mold into a molten coating material bath;

removing the dipped mold from the bath;

drying or allowing the molten coating material to dry on the mold;

removing the coating material from the mold; and

attaching connections, firm disk, raised lip, mechanical extensions or fetal monitoring devices to the bonnet to form the obstetric traction delivery connect apparatus.

2. The method of claim 1, wherein a mold is obtained that matches the size and shape of a bonnet on one end and is elongated on another end.

3. The method of claim 2, wherein the mold is immersed in the molten coating material bath such that an excessive amount of coating material adheres to the mold.

4. The method of claim 3, further comprising the step of forming a raised lip by rolling excess coating material on the elongated end of the mold.

5. The method of claim 1, further comprising the step of coating or wrapping the mold with a non-stick material prior to immersing.

6. The method of claim 1, further comprising the step of forming a bonnet base by wrapping the mold with a reinforcing material prior to immersing.

7. The method of claim 6, further comprising attaching a firm disk, connection, raised lip, or mechanical extension to the bonnet base.

8. The method of claim 1, wherein the mold is repeatedly immersed and dried or allowed to dry.

9. The method of claim 1, wherein the molten coating material bath concentration is adjusted to vary the thickness of the coating material.

10. The method of claim 1, wherein the time period that the mold is immersed is adjusted to vary the thickness of the coating material.

11. The method of claim 1, further comprising the step of stabilizing the bonnet material.

12. The method of claim 11, wherein the step of stabilizing comprises heating the bonnet.

13. The method of claim 12, wherein the bonnet is heated at a temperature of at least 200°

F.

14. The method of claim 12, wherein the bonnet is heated at a temperature range of 200°

-300°

F.

15. The method of claim 12, wherein the bonnet is heated for at least five minutes.

16. The method of claim 12, wherein the bonnet is heated for a time period of ten to thirty minutes.

17. A method of manufacturing an obstetric traction delivery bonnet apparatus comprising a smooth, rollable dome or cylinder having an inner surface, an outer surface, an open end with an edge, a completely closed end, walls, and sized to provide a snug fit to a fetal head, wherein said apparatus is fitable around a fetal head to have adherence thereto because of frictional and internally-created vaccum forces, comprising the steps of:

obtaining an injection mold shaped to match the size and shape of the bonnet;

using a conventional injection-molding process to apply molten coating material and form the bonnet; and

attaching any firm disk, connections, raised lip, mechanical extensions, or fetal monitoring devices to form the obstetric traction delivery bonnet apparatus.

18. The method of claim 17, wherein the mold is shaped to form a firm disk, connection, raised lip, or mechanical extension during the injection-molding process.

19. The method of claim 17, wherein a reinforcing material is applied to the mold prior to the injection-molding process.

20. The method of claim 17, wherein any firm disk, connection, raised lip, or mechanical extension is attached to the mold prior to the injection-molding process.

21. The method of claim 17, wherein the mold is repeatedly immersed and dried or allowed to dry.

22. The method of claim 17, further comprising the step of stabilizing the bonnet material.

23. The method of claim 22, wherein stabilizing comprises heating the bonnet.

24. The method of claim 23, wherein the bonnet is heated at a temperature of at least 200°

F.

25. The method of claim 23, wherein the bonnet is heated at a temperature range of 200°

-300°

F.

26. The method of claim 23, wherein the bonnet is heated for at least five minutes.

27. The method of claim 23, wherein the bonnet is heated for a time period of ten to thirty minutes.

28. Obstetric traction delivery bonnet apparatus, comprising:

a smooth, rollable dome or cylinder having an inner surface, an outer surface, an open end

with an edge, a completely closed end, walls, and sized to provide a snug fit to a fetal head, wherein said apparatus is fitable around a fetal head to have adherence thereto because of frictional and internally-created vacuum forces,

wherein the closed end comprises at least one fetal monitoring device.

29. Obstetric traction delivery bonnet apparatus, comprising:

a smooth, rollable dome or cylinder having an inner surface, an outer surface, an open end

with an edge, a completely closed end, walls, and sized to provide a snug fit to a fetal head, wherein said apparatus is fitable around a fetal head to have adherence thereto because of frictional and internally-created vacuum forces,

wherein the closed end comprises at least one fetal monitoring device, said fetal monitoring device(s) used in conjunction with a mechanical extension.

30. Obstetric traction delivery bonnet apparatus, comprising:

a smooth, rollable dome or cylinder having an inner surface, an outer surface, an open end

with an edge, completely closed end, walls, and sized to provide a snug fit to a fetal head, wherein said apparatus is fitable around a fetal head to have adherence thereto because of frictional and internally-created vaccum forces,

wherein the closed end comprises a fetal monitoring device, said device comprising a fetal scalp electrode or an oximeter.

31. Obstetric traction delivery bonnet apparatus, comprising:

a smooth, rollable dome or cylinder having an inner surface,

an outer surface, an open end with an edge, a completely closed end, walls, and sized to provide a snug fit to a fetal head,

wherein said apparatus is fitable around a fetal head to have adherence thereto because of frictional and internally-created vacuum forces, and wherein the walls of the bonnet are substantially air impermeable, and

wherein the walls of the bonnet become air permeable and leak when a predetermined force is applied to the bonnet.

32. The apparatus of claim 31, wherein said leakage results in an applied bonnet slipping off the fetus'"'"' head.