US20040167541A1 - Obstetrical vacuum extractor cup with soft molded lip - Google Patents
Obstetrical vacuum extractor cup with soft molded lip Download PDFInfo
- Publication number
- US20040167541A1 US20040167541A1 US10/795,564 US79556404A US2004167541A1 US 20040167541 A1 US20040167541 A1 US 20040167541A1 US 79556404 A US79556404 A US 79556404A US 2004167541 A1 US2004167541 A1 US 2004167541A1
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- Prior art keywords
- cup
- vacuum
- lip
- side wall
- obstetrical
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B17/44—Obstetrical forceps
- A61B17/442—Obstetrical forceps without pivotal connections, e.g. using vacuum
Abstract
The obstetrical vacuum extractor comprising a vacuum cup molded of a first, relatively rigid material, with a lip of a second, relatively soft material secured along the basal opening. An elongated hollow stem which may be coupled to a vacuum source communicates with the interior and, accordingly, the basal opening of the vacuum cup. The first, relatively rigid material of the cup is preferably substantially transparent so that the physician may readily monitor the condition of the fetal scalp throughout delivery.
Description
- This is a continuation of U.S. Ser. No. 08/853,422, filed May 9, 1997, entitled “Obstetrical Vacuum Extractor Cup With Soft Molded Lip.”
- The present invention relates to an apparatus for facilitating the delivery of a child during childbirth, and more specifically relates to vacuum extractors for use during childbirth.
- During childbirth, the birth mother is sometimes unable to deliver the child without assistance. In some cases, all that is required is for a nurse, midwife, or attending physician to push down on the birth mother's upper abdomen when she bears down during delivery. In other cases, it is necessary for a physician to perform a cesarean section. For those cases in between the two extremes, some sort of intermediate assistance is often required. Such intermediate assistance generally entails the use of some sort of device to aid in the delivery of the child. These devices may likewise be required to assist a physician during particularly difficult cesarean sections.
- One example of such a device is forceps. Forceps, however, tend to be bulky and difficult to operate. In addition, the use of forceps, at the very least, is uncomfortable for the mother and child and risks injury to both.
- An alternative device to forceps is a vacuum extractor device, like the one described in U.S. Pat. No. 3,202,152. Such a device comprises a cup, which is placed onto the child's head. The device further comprises an elongated hollow stem, which is used to position the cup onto the child's head and through which vacuum pressure is introduced into the cup. The introduction of vacuum pressure into the cup results in suction between the cup and the child's head. The resultant suction is then used to extract the child from the birth canal by pulling in an appropriate direction on some sort of gripping device coupled to the vacuum extractor. A similar device is manufactured and sold by Prism Enterprises, Inc. of San Antonio, Tex.
- Although vacuum extractor devices, like the one manufactured and sold by PrisTech, are widely used, the relatively flexible edge of the cup, which facilitates the formation of a good seal between the cup and the child's head, could, due to its relative thinness, abrade or injure the child or mother. U.S. Pat. Nos. 5,163,944 and 5,281,229 disclose vacuum extractors which attempted to address this potential problem, by lining the cup with a second cup formed of a soft, pliable material, which, when assembled, wraps around the edge of the cup. Thus, the first cup provided the relatively rigid structure of the extractor cup while the second cup provided a soft, relatively friendly contact with the child's head. While this vacuum extractor design reduced the possibility abrasion or injury to maternal tissues and the child by cushioning the contact between the vacuum extractor cup and the adjacent tissue, the design was not without its disadvantages. Given that the soft material from which the liner is formed is opaque, the liner occludes vision through the cup. Accordingly, the liner may make it difficult to visually determine if the cup is properly positioned on the child's head or to visually monitor the fetal tissue during delivery to ensure that the amount of suction is appropriate. In addition, if the vacuum extractor is not used properly, the liner may roll off the edge of the cup.
- The present invention seeks to overcome the problems of the prior art. Accordingly, it is an object of the present invention to provide a vacuum extractor, which offers the advantages attendant an extractor having a liner, without compromising visibility through the cup and without risking the liner rolling off the edge of the cup. Another object of the present invention is to provide a softer contact between the extractor and child. These and other objects and advantages of the present invention will become apparent from the disclosure herein.
- The present invention provides an obstetrical vacuum extractor comprising a vacuum cup, which is substantially in the shape of a bell with an outwardly flaring edge and a basal opening. A hollow stem adapted for connecting with a vacuum source communicates with the inner cavity and basal opening of the cup. The cup is also provided with at least one handle to facilitate maneuvering of the cup during delivery. In accordance with the invention, the extractor further comprises a secondary lip, which is molded from a relatively soft elastomeric material, and is secured on the outwardly flaring edge of the vacuum cup. The relatively soft lip presents a friendly edge to the maternal and fetal tissue as the cup is positioned and during delivery. Further, because the relatively soft second material is disposed only along the edge of the cup, the physician can better observe the interaction between the cup and the child's head. Accordingly, the physician can readily observe whether the cup is properly positioned and if the level of suction is appropriate.
- Preferably, the edge of the vacuum cup adjacent the basal opening includes a structure which enhances the attachment of the molded lip. While various designs may be appropriate, the vacuum cup may include one or more protrusions, such as annular ridges, which extend about the periphery of the outwardly flaring edge of the cup. The ridges provide additional gripping surfaces for the softer material of the secondary molded lip.
- Alternately, the flaring edge of the cup may be provided with one or more bores which extend through the edge of the cup. The bores are disposed about the periphery of the flaring edge, preferably at substantially regular intervals. When the secondary lip is molded to the flaring edge of the cup, the elastomeric material flows into the bores and along both the inner and outer surfaces of the flaring edge of the cup to secure the secondary lip to the cup.
- FIG. 1 is a plan view of an obstetrical vacuum extractor constructed in accordance with teachings of the present invention.
- FIG. 2 is a cross-sectional view of the obstetrical vacuum extractor of FIG. 1, taken along line2-2 of FIG. 1.
- FIG. 3 is a plan view of the obstetrical vacuum extractor of FIG. 1, taken along line3-3 of FIG. 2.
- FIG. 4 is an enlarged, fragmentary cross-sectional view of the obstetrical vacuum extractor of FIG. 1, taken along line4-4 of FIG. 3.
- FIG. 5 is an enlarged, fragmentary cross-sectional view of the obstetrical vacuum extractor of FIG. 1, taken along line5-5 of FIG. 3.
- FIG. 6 is a plan view of an alternate embodiment of the invention, partially broken away to show the cross-section of a portion of the cup.
- FIG. 7 is an enlarged, fragmentary cross-sectional view of the cup partially broken away in FIG. 6.
- While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. On the contrary, the intent is to cover all alternatives, modifications, and equivalents included within the spirit and scope of the invention as defined by the appended claims.
- Turning now to the drawings, there is shown in FIG. 1 an
obstetrical vacuum extractor 10 for use in assisted delivery techniques. Thevacuum extractor 10 comprises ahollow vacuum cup 12 having abase 13 and anannular side wall 14 which opens into abasal opening 17 for placement against the head of a child. In the embodiment illustrated, thevacuum cup 12 is in the general shape of a bell having an outwardly flaring edge or apron 16 along thebasal opening 17. The overall dimensions of thevacuum cup 12 are such that thevacuum cup 12 may be easily inserted into the birth canal and properly positioned onto the child's head. - To facilitate delivery, the
obstetrical vacuum extractor 10 is provided with ahandle 18, which is coupled to thecup 12 by anelongated stem 20 in the illustrated embodiment. In order to establish a vacuum within thevacuum cup 12 and at thebasal opening 17, theelongated stem 20 is hollow, or includes aninterior bore 22, which opens into the interior of thehollow vacuum cup 12. To facilitate coupling the hollowelongated stem 20 to a vacuum source (not shown), the outer surface of its distal end is provided with a series ofribs 26 which extend about the circumference of thestem 20. It will thus be appreciated that when a suitable vacuum hose, such as flexible plastic tubing (not shown), is disposed about thedistal end 24 of thestem 20, theribs 26 ensure an airtight connection with the vacuum hose. - It will be appreciated by those skilled in the art that the
cup 12 must be sufficiently rigid to withstand the vacuum pressure developed within thecup 12 for extraction of the child during delivery. Typically, the vacuum pressure developed within thecup 12 during use ranges from about 15 to 23 inches Hg (approximately 39-59 cm Hg). Accordingly, thecup 12 must be molded of a sufficiently rigid material and the walls of the cup must be sufficiently thick to withstand the vacuum pressure. A low density polyethylene such as Dow Chemical #722 has been determined to be appropriate. Additional structural strength may be provided byribs 28 molded into the interior of theside wall 14 of thecup 12. - The illustrated
vacuum cup design 12 includes eightribs 28 disposed equidistant about the interior of thecup 12. Theribs 28 run from thebase 13 and along a portion of theside wall 14 of thecup 12. It will be appreciated, however, that the cup could include a greater, or lesser number of ribs, or no ribs, as desired and as allowed by the rigidity of the material from which the cup is molded. - To better distribute the applied vacuum within the
cup 12, thevacuum extractor 10 may be provided with adisk 30 disposed subjacent and spaced slightly away from the opening of thebore 22 of theelongated stem 20 into the interior of thehollow vacuum cup 12. Thedisk 30 is coupled to thebase 13 of thecup 12 by a pair ofpegs 32 which are received withinopenings 34 of thedisk 30. The ends of thepegs 32 extending through theopenings 34 are flattened by sonic welding, or the like to secure thedisk 30 to thecup 12. Thedisk 30 is further provided with acentral opening 36 through which the vacuum communicates with the interior of thecup 12. Additionally, the periphery of thedisk 30 is slightly smaller than the interior of the vacuum cup 12 (as may be seen in FIG. 2) such that the vacuum flow may also be distributed along the interior of theside wall 14 of the cup. - Preferably, the
hollow vacuum cup 12, elongatedstem 20 and handle 18 are unitarily molded from a substantially translucent, flexible plastic, such as polyethylene. Those skilled in the art will appreciate that the cup must be sufficiently flexible to be inserted into the birth canal and properly placed on the child's head, yet sufficiently rigid to withstand the vacuum developed within thebore 22 andcup 12. Further, theextractor 10 must be sufficiently rigid to permit the physician to positively manipulate theextractor 10 during extraction. - In accordance with the invention, the
extractor 10 is provided with alip 40 which is molded of a second relatively softer material and is secured along the outwardly flaringedge 16 of thevacuum cup 12. Thelip 40 is preferably made of an elastomeric material such as Dynaflex® G2735 by GLS Corporation Thermoplastic Elastomer Division. Those skilled in the art will appreciate that the relatively soft moldedlip 40 presents a “friendly” surface for contacting the child's head, as well as maternal tissues. Further, the relativelysoft lip 40 is sufficiently flexible to provide a good seal with the child's head and to conform to any irregularities or hair present on the head. Moreover, because thelip 40 presents a relatively soft contact with the child's head, thecup 12 may be molded of a relatively rigid material without compromising the safety, comfort, or performance. - The
cup 12 andlip 40 may be molded by conventional molding techniques. For example, theextractor 10 may be molded by dual material molding techniques. That is, thecup 12 and stem 20 may be molded in a conventional mold. With the molded cup and stem remaining in the mold assembly, the portion of the mold adjacent thebasal opening 17 may be replaced with a second mold component, and the second material may be introduced into the mold to form thelip 40. Alternately, thelip 40 may be post-molded to a previously moldedcup 12 or separately molded and secured to acup 12. - Preferably, the seal between the
lip 40 andcup 12 is enhanced by chemical or mechanical means. In this regard, a portion of the surface of thevacuum cup 12 may be treated with an appropriate adhesive or the like to enhance adhesion between the softer material of thelip 40 and the relatively more rigid material of thevacuum cup 12. - Alternately, mechanical means may be used to enhance adhesion between the
lip 40 and thevacuum cup 12. For example, as shown in FIGS. 1-5, theside wall 14 may be provided with one ormore bores 42 extending therethrough. In the embodiment illustrated, thecup 12 is provided fortybores 42 which are approximately equally spaced around the outwardly flaringedge 16 and are approximately equally spaced from theend 44 of thecup 12. It will be appreciated, however, that a greater or lesser number ofbores 42 of different shapes may be provided and thebores 42 may be disposed at disparate intervals around theside wall 14 and at varied distances from theedge 44 of thecup 12. - As may be seen in FIG. 4, as the relatively softer material of the
lip 40 is molded along theedge 44 and theside wall 14, the material flows in and through thebores 42 to create a mechanical coupling of thelip 40 to thecup 12. As shown in FIGS. 4 and 5, the soft material of thelip 40 extends about 0.35 inch along the outside and inside surfaces of theside wall 14 of thevacuum cup 12 and approximately 0.25 inch beyond theedge 44 of thecup 12. Thelip 40 preferably extends on the order of 0.20 to 0.40 inch beyond theedge 44 of thecup 12. - An alternate, currently preferred embodiment of the invention is illustrated FIGS. 6 and 7. For clarity, the components of the embodiment shown in FIGS. 6 and 7 which have been previously discussed with regard to the embodiment shown in FIGS.1-5 will be identified using the same numerals followed by the letter “a.” In this embodiment, the
side wall 14 a has aportion 46 with a substantially uniform thickness from which a reducedthickness portion 48 extends outward. In order to enhance adhesion between theside wall 14 a and thelip 40 a, a pair of circumferential ridges are disposed along the outer surface of theside wall 14 a. It will thus be appreciated by those skilled in the art that theridges 50 encircling theside wall 14 a of thecup 12 a increase the surface area for bonding as well as providing an anchor point for the softer molded material of thelip 40 a to evenly and consistently bond to thecup 12 a during the molding process. In this embodiment, the softer material of thelip 40 a extends about 0.38 inch along the outside surface of theside wall 14 a, extends only about 0.015 inch along the inside surface of theside wall 14 a. - While the vacuum extractor according to the current invention has been described in connection with a bell-shaped cup having an outwardly flaring edge, it will be appreciated that the lip molded of the second softer material may be utilized with alternate cup designs. Moreover, alternate methods for enhancing adhesion and bonding of the second material of the lip to the more rigid material of the cup may be used. For example, alternate designs of projections may be utilized, preferably along the outer surface of the
side wall 14. Alternately, a separately molded lip may be bonded to the cup by methods such as adhesion, laser technology, or sonic welding. - In summary, the present invention overcomes disadvantages inherent in currently available obstetrical vacuum extractors. The invention minimizes the potential risk of abrasion or injury to the child or the mother by providing a relatively flexible edge on a relatively rigid cup. Further, the lip may be molded of a relatively opaque material while the cup itself is molded of a relatively transparent material such that the physician may readily monitor the condition of the fetus scalp throughout delivery. Also, inasmuch as the lip is secured, and preferably molded and mechanically coupled, to the side walls of the cup, the risk of the lip rolling off the edge of the cup during improper use is substantially eliminated.
- While this invention has been described with emphasis upon preferred embodiments, it will be obvious to those of ordinary skill in the art that the preferred embodiments may be varied. Accordingly, this invention includes all modifications encompassed within the spirit and scope of the appended claims.
Claims (20)
1. An obstetrical vacuum extractor for placement on a child's head for use during childbirth, the obstetrical vacuum extractor comprising, in combination,
a vacuum cup formed of a first material, the vacuum cup having side wall defining a hollow interior cavity, the side wall having a side wall edge forming a cup opening, the vacuum cup further including a vacuum opening communicating with the interior cavity of the vacuum cup and being adapted for connection to a vacuum source;
a lip formed of a polymeric second material, the second material being flexible relative to the first material, the lip being molded along said side wall edge adjacent the cup opening; and
a handle coupled to the vacuum cup.
2. The obstetrical vacuum extractor of claim 1 wherein the vacuum cup is substantially in the shape of a bell, and the side wall includes a generally outwardly flaring edge, the lip being molded to the outwardly flaring edge.
3. The obstetrical vacuum extractor of claim 1 wherein the lip extends on the order of 0.20 to 0.40 inches beyond the side wall edge.
4. The obstetrical vacuum extractor of claim 1 wherein the lip is molded along a portion of the side wall.
5. The obstetrical vacuum extractor of claim 1 wherein the cup is substantially transparent such that it does not occlude vision through to the interior cavity of the cup.
6. The obstetrical vacuum extractor of claim 1 wherein the lip is postmolded to the vacuum cup.
7. The obstetrical vacuum extractor of claim 1 wherein the second material is an elastomeric material.
8. The obstetrical vacuum extractor of claim 1 further comprising means for enhancing adhesion of the lip to the vacuum cup.
9. The obstetrical vacuum extractor of claim 1 wherein the side wall further comprises at least one opening extending therethrough, said opening being disposed substantially adjacent the side wall edge, the second material of the lip being molded into the opening to mechanically couple the lip to the vacuum cup.
10. The obstetrical vacuum extractor of claim 9 comprising at least two openings, the openings being circumferentially disposed around the side wall.
11. The obstetrical vacuum extractor of claim 1 wherein the side wall further comprises at least one rib, the second material of the lip being molded to the at least one rib.
12. The obstetrical vacuum extractor of claim 11 wherein the side wall includes an outer substantially circumferential surface, and the at least one rib extends about at least a portion of the circumferential surface.
13. The obstetrical vacuum extractor of claim 11 comprising at least two ribs.
14. The obstetrical vacuum extractor of claim 1 further comprising an adhesive applied to a portion of the side wall substantially adjacent the side wall edge such the second material of the lip is molded along the adhesive.
15. The obstetrical vacuum extractor of claim 1 wherein the side wall further comprises at least one projection extending outwardly from the side wall, the lip being molded along the at least one projection.
16. An obstetrical vacuum extractor comprising:
a vacuum cup substantially in the shape of a bell with an outwardly flaring edge and a cup opening;
a post-molded lip molded on the outwardly flaring edge of the vacuum cup;
a hollow, elongated stem integrally formed with the cup and communicating with the cup opening, the distal end of the stem being adapted for connection to a vacuum source; and
a gripping device coupled to the stem.
17. A method of making an obstetrical vacuum extractor for use during childbirth comprising the steps of:
molding a hollow vacuum cup of a first material, the cup having a sidewall terminating in a distal edge forming a cup opening;
molding a lip of a polymeric second material along the distal edge, the second material being flexible relative to the first material.
18. The method of claim 17 wherein the step of molding a hollow vacuum cup of a first material includes the step of molding a substantially transparent cup wall.
19. The method of claim 17 wherein the second material is an elastomeric material.
20. The method of claim 17 wherein the first material is a polyethylene.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/795,564 US20040167541A1 (en) | 1997-05-09 | 2004-03-08 | Obstetrical vacuum extractor cup with soft molded lip |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/853,422 US5935136A (en) | 1997-05-09 | 1997-05-09 | Obstetrical vacuum extractor cup with soft molded lip |
US09/350,438 US6723105B1 (en) | 1997-05-09 | 1999-07-09 | Obstetrical vacuum extractor cup with soft molded lip |
US10/795,564 US20040167541A1 (en) | 1997-05-09 | 2004-03-08 | Obstetrical vacuum extractor cup with soft molded lip |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US09/350,438 Division US6723105B1 (en) | 1997-05-09 | 1999-07-09 | Obstetrical vacuum extractor cup with soft molded lip |
Publications (1)
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US20040167541A1 true US20040167541A1 (en) | 2004-08-26 |
Family
ID=25316000
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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US08/853,422 Expired - Lifetime US5935136A (en) | 1997-05-09 | 1997-05-09 | Obstetrical vacuum extractor cup with soft molded lip |
US09/350,438 Expired - Lifetime US6723105B1 (en) | 1997-05-09 | 1999-07-09 | Obstetrical vacuum extractor cup with soft molded lip |
US10/795,564 Abandoned US20040167541A1 (en) | 1997-05-09 | 2004-03-08 | Obstetrical vacuum extractor cup with soft molded lip |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/853,422 Expired - Lifetime US5935136A (en) | 1997-05-09 | 1997-05-09 | Obstetrical vacuum extractor cup with soft molded lip |
US09/350,438 Expired - Lifetime US6723105B1 (en) | 1997-05-09 | 1999-07-09 | Obstetrical vacuum extractor cup with soft molded lip |
Country Status (5)
Country | Link |
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US (3) | US5935136A (en) |
EP (1) | EP0923348B1 (en) |
AT (1) | ATE253870T1 (en) |
DE (1) | DE69819667T2 (en) |
WO (1) | WO1998049958A1 (en) |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090254096A1 (en) * | 2007-11-08 | 2009-10-08 | Association For Public Health Services | Vacuum delivery extractor |
Also Published As
Publication number | Publication date |
---|---|
DE69819667T2 (en) | 2004-09-30 |
ATE253870T1 (en) | 2003-11-15 |
US6723105B1 (en) | 2004-04-20 |
DE69819667D1 (en) | 2003-12-18 |
EP0923348A1 (en) | 1999-06-23 |
EP0923348B1 (en) | 2003-11-12 |
WO1998049958A1 (en) | 1998-11-12 |
US5935136A (en) | 1999-08-10 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: COOPERSURGICAL, INC., CONNECTICUT Free format text: MERGER;ASSIGNOR:PRISM ENTERPRISES, INC.;REEL/FRAME:020125/0343 Effective date: 20071024 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |