WO2000071039A1

WO2000071039A1 - Amniotomy glove

Info

Publication number: WO2000071039A1
Application number: PCT/US1999/024844
Authority: WO
Inventors: Helio Zapata
Original assignee: Helio Zapata
Priority date: 1999-05-24
Filing date: 1999-10-27
Publication date: 2000-11-30

Abstract

The present invention, in the form of a glove to be worn by a physician, is a means of performing an amniotome in the early stages of labor, and even before labor starts. The glove, formed of latex material includes a small plastic hook at the tip of the middle finger allowing for the rupture of the fetal membranes.

Description

TITLE OF THE INVENTION:

AMNIOTOMY GLOVE

CROSS-REFERENCE TO RELATED APPLICATIONS:

Not applicable

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

REFERENCE TO A MICROFICHE APPENDIX:

Not applicable

BACKGROUND OF THE INVENTION

Amniotomy, the artificial rupturing of the fetal membranes, is a routine practice in the care of laboring patients. Amniotomy is also performed, whenever possible, as an integral part of labor induction. At present, amniotomy is done with a plastic stick, 10 1/2 inches long, with a small, plastic hook at its narrower end. If seen under a magnifying glass, this small hook looks like a small, inverted falcon's beak. This instrument, commonly referred to by its trade name, the AmniHook, is, however, notoriously ineffective in many cases at accomplishing its intended purpose. In order to perform an amniotomy with an AmniHook, the cervix should be in an advanced state of effacement and should also be dilated. When the cervix, a hollow tube of fibrous tissue (whose axis is normally at an angle from that of the vagina), is neither effaced nor dilated, the AmniHook is totally useless. The straight, inflexible AmniHook cannot have access to an uneffaced cervix because of the curvature needed to overcome the angle between the intersecting axis of the vagina and the cervix.

The inability to perform an amniotomy in these extremely common circumstances, when the head is already engaged, becomes a frequent cause of frustration. The physician is faced with the alternative of waiting several hours for the cervix to open and efface before this AmniHook stick can be used to break the amnion. Often times, the desired dilation and effacement never takes place in spite of many hours of Prostaglandings or labor contractions. The process of labor has a statistically higher chance of success with amniotomy than without it. Not infrequently, a Cesarean section is done for a dead fetus because all conventional means to deliver vaginaily failed and in most of those cases an amniotomy could not be done because of an uneffaced cervix. Another problem with using the AmniHook is its unpleasant and almost frightening appearance, causing apprehension in the patient when she sees the physician approaching her with a sizable stick to be inserted deep into her vagina. All these problems associated with the use of the AmniHook for amniotomy are solved quickly and successfully with the use of the Amniotomy Glove, an ordinary examining glove that has a small plastic hook at the tip of its middle finger. Regardless of the cervical effacement, orientation, or consistency, if the physician can insert the gloved middle finger into the cervix and reach the amnion, the process is easily accomplished. The only limitations to the Amniotomy Glove, then, would be a closed cervix or one that can not be reached at all.

BRIEF SUMMARY OF THE INVENTION:

The Amniotomy Glove is an ordinary Latex (Surgeon's) glove which has been provided with a small plastic hook at the tip of the middle finger, intimately bonded to the Latex material of the glove. This hook has a height of 3 mm. and a round base which is 3 mm. in diameter. The hook is attached to a small base underneath the Latex surface. The base is 8 mm. wide, 15 mm. long, and 1 mm. thick. The Latex material of the Amniotomy Glove is sealed to the base of the hook, isolating the inner from the outer surface of the glove. The Amniotomy Glove can perform an amniotomy in a great many situations where the current instrument employed for this purpose, the AmniHook, cannot. When the uterine cervix is long, either non effaced or partially effaced, the current instrument, the AmniHook, is useless, unfit and incapable of accomplishing its job because it cannot be inserted inside the cervix. Even with an effaced cervix, if it is only dilated 1 to 2 cm., the AmniHook, again, cannot be used for the very same reason. The Amniotomy Glove solves all of these problems very easily and effortlessly. All that is needed is a cervix that can be reached and that admits the middle finger, regardless of its effacement, position, direction, or consistency. The advantage of the Amniotomy Glove over the stick called the AmniHook is, therefore, enormous.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

The Amniotomy Glove is made of two components: (1 ) the Latex glove (also called a surgeon's glove), and (2) a plastic device attached to the tip of the middle finger of the glove. The latter consists of a base that is 8 mm. wide, 15 mm. long, and 2 mm. Thick. This hook's base is 3 mm. in diameter. The hook's height is 3 mm. This plastic hook like component is bonded to the inner surface of the Surgeon's glove at the position shown in the photographs. The only portion of the plastic hook-like component that is outside the glove is the small hook. The orifice in the glove through which the hook protrudes is sealed to the hook, isolating the outside from anything inside the glove, thereby preserving sterility.

The Amniotomy Glove is 'unisize' but can be manufactured in large, medium, and small sizes. The plastic material of the second component, the hook, is similar to that of the currently used tool, the AmniHook.

DETAILED DESCRIPTION OF THE INVENTION

Amniotomy, the artificial rupturing of the fetal membranes, is a routine practice in laboring patients. Amniotomy is also performed, whenever possible, as an integral part of labor induction.

Normally, Amniotomy is done with a plastic stick 10 1/2 inches long, shaped with a small hook at its narrower end. If seen under a magnifying glass, this small hook looks like a small, inverted falcon's beak. This instrument, commonly referred to by its trade name, the AmniHook, is, however, notoriously ineffective in many cases at accomplishing its intended purpose.

If the fetal head is engaged and the uterine cervix is dilated 1 to 2 centimeters, it is impossible to rupture the bag of water with an AmniHook. Even with a dilation of 3 cm., a long cervix makes this maneuver difficult, if not impossible. The same can be said of a posterior cervix, partially or not effaced but capable of admitting one finger. In all these situations, the physician using the AmniHook can not perform an amniotomy because it can not be inserted through the cervix.

The inability to perform an amniotomy in these extremely common circumstances becomes a frequent cause of frustration. The physician is faced with the alternative of waiting several hours for the cervix to open and efface before this stick can be used to break the amnion. Often times, the desired dilation and effacement never takes place in spite of many hours of Prostaglandings or labor contractions. The process of labor has a statistically higher chance of success with amniotomy than without it. Effortlessly and quickly, the Amniotomy Glove solves all those apparently unsolvable obstacles and thus makes amniotomy possible in the eariy stages of labor and even before labor starts. The Amniotomy Glove is an ordinary examining glove that has a small hook at the tip of the middle finger. Regardless of the effacement, if the physician can insert the gloved middle finger into the cervix and reach the amnion, the process is easily accomplished. The only limitations to the Amniotomy Glove, then, would then be a closed cervix or one that can not be reached at all. A prerequisite for any amniotomy is an engaged head, an event granted throughout this discussion.

Being a more attractive and more effective means of performing an amniotomy, the Amniotomy Glove should replace the AmniHook in most situations. The advantages are clear: it is easier to use and it avoids a patient's feelings of unpleasantness or apprehension when the physician approaches her with a sizable stick that will be inserted deep into her vagina.

Another advantage of the Amniotomy Glove is that in an advanced cervical dilation and a partially engaged head, the physician can direct the middle finger to any position of the bulging bag of water that he wants to break. For example, he may choose to break the bag of water as more anteriorly as possible, beneath the anterior lip of the cervix, to prevent a sudden gush of amniotic fluid and to allow a more gradual descent of the presenting part.

Claims

What I claim as my invention are:

1. The Amniotomy Glove, which is an ordinary Surgeon's examining glove that has a small, plastic hook at the tip of its middle finger.

Regardless of the cervical effacement, if the physician can insert the gloved middle finger into the cervix and reach the amnion, the process of amniotomy is done.

The only limitation to the Amniotomy Glove would then be a closed cervix or one that cannot be reached at all.

A prerequisite for any amniotomy is an engaged head (an event granted throughout all of this discussion).

2. The Amniotomy Glove effortlessly and quickly solves all those apparently unsolvable obstacles noted above, making amniotomy possible in the early stages of labor and even before labor starts.

3. Using the Amniotomy Glove in an advanced cervical dilation and a partially engaged head, the physician can conveniently rotate his middle finger to any position on the bulging bag of water that needs to be broken a lot easier than with the AmniHook, which must be held with the left hand 10 1/2 inches away from the site of the intended rupture.

For example, the physician may choose to rupture the amniotic sac at the farthest anterior as possible, even underneath the anterior lip of the cervix, to prevent a sudden gush of amniotic fluid and to allow a more gradual descent of the presenting part, a tactic that could not be accomplished with the rigid, inflexible AmniHook.

4. Because of the flexibility of the Amniotomy Glove, with its hook.at the tip of its middle finger, it can be manipulated in the most delicate fashion, preventing unnecessary scratches to the fetal scalp.

5. In the armamentarium of current obstetrics practice, with the use of the Amniotomy Glove, the physician will be able to perform an amniotomy in the very eariy stages of labor and even before labor starts, as long as there is an engaged head.

6. An early amniotomy with the use of the Amniotomy Glove may also reduce the incidence of Cesarean sections significantly as a consequence of the above (Claim number 5).

If labor is not progressing and an amniotomy can not be done because the physician does not have an Amniotomy Glove, chances are the patient may require a Cesarean section.

An amniotomy could have made the difference between vaginal birth or Cesarean section. Already a more attractive and more effective means of performing an amniotomy, the

Amniotomy Glove should replace the AmniHook for additional reasons: it is easier to use, and it avoids both the unpleasantness and the apprehension of patients who see the physician approaching her with a sizable stick to be inserted deep into her vagina.

AMENDED CLAIMS

[received by the International Bureau on 06 April 2000 (06.04.00) ; original claims 1-7 cancelled ; new claims 1 1-21 (3 pages)]

Claims Amendment

Claims: Cancel all claims of record 1 to 7 and substitute new claims 11 to 21 as follows.

11. An innovative obstetrical instrument for rupturing the amniotic membranes, comprising: a latex examination glove, provided with a plastic hook continuous with its base that has a substantial, strategic and exact location: the tip of the middle finger.

said plastic base, curved to conform to the tip of the middle finger, measures 15 mm. high, 8 mm. wide, and 1 mm. thick, extending into a plastic hook, and is fused to the glove's latex material in a strategic, substantial and exact location: the tip of the middle finger.

said 2 mm. plastic hook, the only protruding part of the plastic component of the Amniotomy Glove, is continuous with its base and is substantially, strategically and exactly located at the tip of the gloved middle finger.

12. An obstetrical instrument which has a plastic hook that is strategically, substantially and exactly located at the tip of the middle finger, and because of this advantageous location, it brings new and unexpected results: it solves the long-felt need in laboring patients of making amniotomy possible in the early stages of labor and even before it starts when the cervix is not dilated or effaced but admits only one finger.

13. An improved obstetrical instrument for amniotomy which is very simple and easy to use because the physician does not have to rotate or push forward an additional, adapted device to extend the hook so it can reach the amniotic membrane.

14. An amniotomy instrument that, having the hook substantially, strategically and exactly at the tip of the middle finger, is functionally a virtual extension of the finger itself and as such it can be manipulated in the most delicate fashion preventing unnecessary scratches in the fetal scalp.

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15. An innovative obstetrical instrument for amniotomy that, because of the strategic, substantial and exact location of its hook at the tip of the middle finger combined with the natural curvature and flexibility of the middle finger itself, easily overcomes the angle between the vaginal and cervical canals.

16. An innovative amniotomy instrument that, benefiting from the mobility of the middle finger and the strategic, substantial, and exact location of the hook, can break the amniotic membrane at any desired point, even underneath the anterior lip of the cervix, thus preventing a sudden gush of amniotic fluid and a more gradual descent of the fetal head.

17. A new obstetrical instrument where the physician does not have the problem of adapting an accessory device to the gloved finger because it is not finger-carried and also does not have to be glued or bonded to the gloved middle finger since the Amniotomy Glove is the instrument itself.

18. A new obstetrical instrument that, because of its ability to break the bag of water in unfavorable cervical conditions at the very beginning of labor, could reduce the rate of cesarean delivery.

19. An improved obstetrical instrument that uses the same examining hand thus eliminating the problems of distant manipulation of a plastic stick and using a different hand.

20. An innovative obstetrical instrument that can perform an amniotomy easily, simply, and quickly.

21. An innovative obstetrical instrument for rupturing the amniotic membranes, comprised of the following structures and physical features: a latex examination glove which has a 2 mm. plastic hook with a base measuring 15 mm. high, 8 mm. wide, and 1 mm. thick, that is fused to the latex material of the glove at the tip of the middle finger so that the glove, base, and the hook all become a single unit; the Amniotomy Glove's plastic hook, being substantially, strategically and exactly located at the tip of the middle finger, accomplishes long-felt and needed objectives with unexpected results such as:

the ease and simplicity of its use, easily reaching the amnion to break the bag of water.

the capability of rupturing the amnios when the unfavorable cervix admits only one finger. the avoidance of unnecessary devices adapted to the gloved middle finger and the freedom from complex manipulation or rotation by an adjacent finger to extend it so that it can reach the amniotic membrane.

the Amniotomy Glove, being capable of breaking the amnios to accelerate labor in its eariy stages under most cervical conditions, may reduce the incidence of cesarean sections.

the natural curvature and flexibility of the middle finger where the hook is located makes amniotomy possible in many cervical conditions when the rigid straight plastic stick cannot.

the Amniotomy Glove, being an ordinary surgeon's glove with a small, unnoticeable plastic hook at the tip of the middle finger, will eliminate the fears of the patient to the process of amniotomy when the straight, rigid, plastic 10-inch stick is used.