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EP0525175A1 - Disposable cervical dilators - Google Patents

Disposable cervical dilators

Info

Publication number
EP0525175A1
EP0525175A1 EP92906992A EP92906992A EP0525175A1 EP 0525175 A1 EP0525175 A1 EP 0525175A1 EP 92906992 A EP92906992 A EP 92906992A EP 92906992 A EP92906992 A EP 92906992A EP 0525175 A1 EP0525175 A1 EP 0525175A1
Authority
EP
European Patent Office
Prior art keywords
dilator
recited
disposable cervical
cervical dilator
diameter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP92906992A
Other languages
German (de)
French (fr)
Inventor
Mary Ellen Buckley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc filed Critical Baxter International Inc
Publication of EP0525175A1 publication Critical patent/EP0525175A1/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00477—Coupling
    • A61B2017/00482—Coupling with a code

Definitions

  • the invention relates generally to dilators and more specifically to disposable, non-reusable cervical dilators
  • Cervical dilation is required for procedures such as D&C, endometrial biopsy, endometrial ablation, surgical removal of myomas, fibroids, a variety of other tumors, hys- ⁇ o teroscopy, etc.
  • Most cervical dilators that are currently in use are reusable.
  • these devices are hollow or solid metal cylindri ⁇ cal rods.
  • a set of rods are used having diameters that are graduated in series. Additionally, each rod has a tapered end. The rods are sequentially inserted in increasing size into the cervix to ⁇ gradually dilate the cervical canal.
  • metal dilators have several disadvantages. For example, metal dilators are generally undesirably heavy unless they are hollow. However, if the dilator is hollow, it is more subject to incur undesir ⁇ able dents or disruptions in the surface of the dilator as the dilators 20 are repeatedly resterilized. Also, metal dilators may become scratched as they are cleaned or otherwise processed. These scratches and dents can produce trauma to the delicate friable cervi ⁇ cal tissue during the dilation procedure.
  • reusable dilators have been manufactured in the past that 25 are made of a polymer material such as Teflon. Since these dilators are reusable dilators, the materials chosen to form the dilator are al ⁇ ways materials that can be resterilized using conventional steam, ETO or flash sterilization techniques. Accordingly, these dilators tend to be too expensive to consider to be disposable dilators even though 30 they are made of a polymer material.
  • each rod in the series has at least one tapered end.
  • Each rod is formed of a plastic material that is deformable when subjected to steam or flash 5 sterilization.
  • each rod has first and sec ⁇ ond tapered ends. The first tapered end is connected to a midsection having a first constant diameter and the second tapered end is con ⁇ nected to a midsection having a second constant diameter.
  • the second constant d ⁇ meter is greater than 0 the first constant diameter. The diameter of the tip of the second ta-
  • SUBSTITUTE SHEET pered end is less than the constant diameter of the first midsection to provide for gradual dilation of a patient's cervical canal.
  • Fig. 1 is a perspective view of a single cervical dilator in the pre- ferred embodiment of the invention
  • Fig. 2 is a side view of a single dilator
  • Fig. 3 is a perspective view of a set of cervical dilators illustrat ⁇ ing the graduations in size between each cervical dilator.
  • Each dilator 10 has a first tapered end 12 and a second tapered end 14, both of which are cylindrical in cross section.
  • the first tapered end is connected to a first midsection 16 and the second tapered end is connected to a second midsection 18.
  • Each of the midsections are also cylindrical and have a constant diameter.
  • the dilators are sold as a set and the diameter of each midsection of each dilator is graduated in size with respect to the midsection of each prior and subsequent dilator in the set.
  • the increase in diameter between each dilator midsection in the set is one millimeter.
  • the diameter of the tip 20 of the second end is always slightly smaller than the diame ⁇ ter of the first midsection 16.
  • the diameter of the tip 20 is at least 50% smaller than the diameter of the preceding midsection 16 in the set of dilators.
  • first and second mid ⁇ sections 16, 18 are connected to form a ridge 22 at the juncture of the first and second midsections.
  • This ridge always slants inwardly from the larger midsection 18 toward the smaller midsection 16. The purpose of this ridge will be discussed in greater detail below.
  • each end of the cervical dilator 10. includes a slight curve between the juncture of the tapered end 12, 14 and its corresponding midsection 16, 18. The purpose of the curve is to more easily ac- 5 commodate for any curves in the course of the cervical canal.
  • Fig. 3 illustrates a set of cervical dilators.
  • each dilator is slightly larger than its proceeding dilator in the set.
  • a physician typically begins a dilation procedure by inserting the smallest tip of the smallest dilator io in the set into a patient's cervical canal and advances the dilator until the corresponding midsection has been introduced into the cervical canal.
  • the dilator is then withdrawn and rotated to introduce the op ⁇ posite end of the dilator into the canal to gradually dilate the canal.
  • This dilator is then removed and the next larger dilator in the set is in- i5 troduced; the process is repeated until the desired dilation is obtained.
  • the ridge discussed above provides a simple means of allowing a doctor to determine whether o the opposite end of the same dilator is to be subsequently inserted into the cervical canal or whether a separate dilator in the set should be obtained for insertion. Since the ridge always slopes downwardly from the larger end of the dilator to the smaller end, a physician can feel which end of the dilator is the smaller end simply by running his 5 or her finger over the ridge of the dilator prior to insertion to deter ⁇ mine which end of the dilator should normally be inserted first.
  • Another method to assist a physician in determining which dila ⁇ tor tip should be inserted into the cervical canal is to provide an indi ⁇ cation of the diameter in millimeters of each midsection. This is ilius- 0 trated in the preferred embodiment of Fig. 3.
  • each dilator is formed of a plastic material which is deformable when subjected to
  • the plastic chosen is a polyolefin material.
  • a particularly preferred polyolefin is a random copolymer polypropylene. It is preferred that the material have a deflection tem ⁇ perature (or deformation temperature) of not greater than 250° F. In other embodiments, the deflection temperature of the material chosen may range from 150° F to 250° F. In the preferred embodiment, the deflection temperature is 189° F.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Est décrit un dilatateur du col utérin à usage uique. Dans le mode préféré de réalisation, ce dilatateur comprend des première et deuxième extrémités éffilées qui sont reliées par des première et deuxième sections médianes adjacentes de diamètres constants. Le diamètre de la deuxième section médiane est supérieure à celui de la première section médiane. Le dilatateur est constitué d'un matériau qui se déforme lorsqu'il est stérilisé à la vapeur, afin de décourager toute réutilisation dudit instrument.Disclosed is a cervical dilator for single use. In the preferred embodiment, this dilator includes first and second tapered ends which are joined by adjacent first and second midsections of constant diameters. The diameter of the second middle section is greater than that of the first middle section. The dilator is made of a material which deforms when sterilized by steam, in order to discourage any reuse of said instrument.

Description

DISPOSABLE CERVICAL DILATORS
BACKGROUND OF THE INVENTION
The invention relates generally to dilators and more specifically to disposable, non-reusable cervical dilators
ε In the gynecological field, it is sometimes necessary for a physi¬ cian to increase the diameter of the cervix through a dilation process in order to access the uterine cavity. Cervical dilation is required for procedures such as D&C, endometrial biopsy, endometrial ablation, surgical removal of myomas, fibroids, a variety of other tumors, hys- ιo teroscopy, etc. Most cervical dilators that are currently in use are reusable. Generally, these devices are hollow or solid metal cylindri¬ cal rods. Usually, a set of rods are used having diameters that are graduated in series. Additionally, each rod has a tapered end. The rods are sequentially inserted in increasing size into the cervix to ιε gradually dilate the cervical canal.
Many metal dilators have several disadvantages. For example, metal dilators are generally undesirably heavy unless they are hollow. However, if the dilator is hollow, it is more subject to incur undesir¬ able dents or disruptions in the surface of the dilator as the dilators 20 are repeatedly resterilized. Also, metal dilators may become scratched as they are cleaned or otherwise processed. These scratches and dents can produce trauma to the delicate friable cervi¬ cal tissue during the dilation procedure.
Other reusable dilators have been manufactured in the past that 25 are made of a polymer material such as Teflon. Since these dilators are reusable dilators, the materials chosen to form the dilator are al¬ ways materials that can be resterilized using conventional steam, ETO or flash sterilization techniques. Accordingly, these dilators tend to be too expensive to consider to be disposable dilators even though 30 they are made of a polymer material.
SUBSTITUTE SHEET Whenever dilators are resterilized using any of the conventional sterilization techniques, the possibility of scratching the dilators exists. It is possible for microorganisms to be harbored within these scratches and potentially survive a sterilization cycle thus exposing ε the patient to potential cross-contamination. Therefore, a need exists to provide a low-cost disposable dilator which cannot be accidently resterilized using conventional techniques and reused.
OBJECTS OF THE INVENTION
It is an object of the invention to provide a disposable cervical 10 dilator.
It is another object of the invention to provide a dilator which is deformable when subjected to steam sterilization.
It is an object of the invention to provide a series of dilators having tapered ends that are connected to a midsection which has a ιε constant diameter such that each dilator in the series^has a tip which is smaller than the constant diameter of the prior dilator in the series.
It is a further object of the invention to provide a cervical dilator which is simple and low-cost to manufacture.
These and other objects of the invention will become apparent 0 based on the description of the invention as set forth below.
BRIEF DESCRIPTION OF THE INVENTION
A series of disposable cervical dilators is described in which each rod in the series has at least one tapered end. Each rod is formed of a plastic material that is deformable when subjected to steam or flash 5 sterilization. In the preferred embodiment, each rod has first and sec¬ ond tapered ends. The first tapered end is connected to a midsection having a first constant diameter and the second tapered end is con¬ nected to a midsection having a second constant diameter. In the preferred embodiment, the second constant dβmeter is greater than 0 the first constant diameter. The diameter of the tip of the second ta-
SUBSTITUTE SHEET pered end is less than the constant diameter of the first midsection to provide for gradual dilation of a patient's cervical canal.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of a single cervical dilator in the pre- ferred embodiment of the invention;
Fig. 2 is a side view of a single dilator;
Fig. 3 is a perspective view of a set of cervical dilators illustrat¬ ing the graduations in size between each cervical dilator.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Refer now to Figs. 1 and 2. Each dilator 10 has a first tapered end 12 and a second tapered end 14, both of which are cylindrical in cross section. The first tapered end is connected to a first midsection 16 and the second tapered end is connected to a second midsection 18. Each of the midsections are also cylindrical and have a constant diameter.
Generally, the dilators are sold as a set and the diameter of each midsection of each dilator is graduated in size with respect to the midsection of each prior and subsequent dilator in the set. In the pre- ferred embodiment of the invention, the increase in diameter between each dilator midsection in the set is one millimeter. The diameter of the tip 20 of the second end is always slightly smaller than the diame¬ ter of the first midsection 16. In the preferred embodiment of the in¬ vention, the diameter of the tip 20 is at least 50% smaller than the diameter of the preceding midsection 16 in the set of dilators.
In one embodiment of the invention, the first and second mid¬ sections 16, 18 are connected to form a ridge 22 at the juncture of the first and second midsections. This ridge always slants inwardly from the larger midsection 18 toward the smaller midsection 16. The purpose of this ridge will be discussed in greater detail below.
SUBSTITUTE SHEET As can be seen in Fig. 1, in the preferred embodiment of the in¬ vention, each end of the cervical dilator 10. includes a slight curve between the juncture of the tapered end 12, 14 and its corresponding midsection 16, 18. The purpose of the curve is to more easily ac- 5 commodate for any curves in the course of the cervical canal.
Refer now to Fig. 3 which illustrates a set of cervical dilators. As can be seen in the figure, each dilator is slightly larger than its proceeding dilator in the set. In use, a physician typically begins a dilation procedure by inserting the smallest tip of the smallest dilator io in the set into a patient's cervical canal and advances the dilator until the corresponding midsection has been introduced into the cervical canal. The dilator is then withdrawn and rotated to introduce the op¬ posite end of the dilator into the canal to gradually dilate the canal. This dilator is then removed and the next larger dilator in the set is in- i5 troduced; the process is repeated until the desired dilation is obtained.
It is important that the physician have an easy way of identifying which dilator end should be inserted into a patient's cervix at any given time during the dilation procedure. The ridge discussed above provides a simple means of allowing a doctor to determine whether o the opposite end of the same dilator is to be subsequently inserted into the cervical canal or whether a separate dilator in the set should be obtained for insertion. Since the ridge always slopes downwardly from the larger end of the dilator to the smaller end, a physician can feel which end of the dilator is the smaller end simply by running his 5 or her finger over the ridge of the dilator prior to insertion to deter¬ mine which end of the dilator should normally be inserted first.
Another method to assist a physician in determining which dila¬ tor tip should be inserted into the cervical canal is to provide an indi¬ cation of the diameter in millimeters of each midsection. This is ilius- 0 trated in the preferred embodiment of Fig. 3.
In the preferred embodiment of the invention, each dilator is formed of a plastic material which is deformable when subjected to
SUBSTITUTE SHEET steam or flash sterilization. This prevents accidental resterilization and subsequent reuse of a dilator.
in the preferred embodiment, the plastic chosen is a polyolefin material. A particularly preferred polyolefin is a random copolymer polypropylene. It is preferred that the material have a deflection tem¬ perature (or deformation temperature) of not greater than 250° F. In other embodiments, the deflection temperature of the material chosen may range from 150° F to 250° F. In the preferred embodiment, the deflection temperature is 189° F.
While the invention has been described in detail and with refer¬ ence to specific embodiments thereof, it will be apparent for those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention.
SUBSTITUTE SHEET

Claims

I claim:
1. A disposable cervical dilator, comprising:
2 a single rod having a tapered end, said rod being formed of a
3 plastic material being deformable when subjected to steam steriliza- * tion.
ι 2. A disposable cervical dilator as recited in Claim 1 wherein:
2 said plastic is a polyolefin material that is deformable when
3 subjected to steam sterilization.
ι 3. A disposable cervical dilator as recited in Claim 2 wherein:
2 said polyolefin is a polypropylene material.
ι
4. A disposable cervical dilator as recited in Claim 3 wherein:
2 said polypropylene material is radiation sterilizable.
5. A disposable cervical dilator as recited in Claim 4 wherein:
2 said polypropylene material has a deflection temperature of not
3 greater than 250° F.
1 6. A disposable cervical dilator as recited in Claim 3 wherein:
2 said polypropylene material is a random copolymer.
ι 7. A disposable cervical dilator as recited in Claim 1 said rod fur-
2 ther includes:
3 a first cylindrical midsection adjacent said first tapered end, said first cylindrical midsection having a first constant diameter,
s a second tapered end, and
e a second midsection adjacent said second tapered end, said
7 second cylindrical midsection having a second constant diame- s ter,
SUBSTITUTE SHEET 9 said first constant diameter being smaller than said second con- ιo stant diameter and said tapered end having a tip having an initial ι diameter less than said first constant diameter said first and i2 second midsections being adjacent to one another.
8. A disposable cervical dilator as recited in Claim 7 wherein said
2 first and second midsections join one another to form a ridge resulting
3 from the difference in diameter of said first and second midsections.
SUBSTITUTE SHEET
EP92906992A 1991-02-15 1992-02-10 Disposable cervical dilators Ceased EP0525175A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US65635391A 1991-02-15 1991-02-15
US656353 1991-02-15

Publications (1)

Publication Number Publication Date
EP0525175A1 true EP0525175A1 (en) 1993-02-03

Family

ID=24632678

Family Applications (1)

Application Number Title Priority Date Filing Date
EP92906992A Ceased EP0525175A1 (en) 1991-02-15 1992-02-10 Disposable cervical dilators

Country Status (6)

Country Link
EP (1) EP0525175A1 (en)
JP (1) JPH05506387A (en)
AU (1) AU1425092A (en)
IE (1) IE920328A1 (en)
NZ (1) NZ241610A (en)
WO (1) WO1992014396A1 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1415679B1 (en) 2002-10-31 2016-04-20 Smiths Group plc Dilator
GB2429156B (en) * 2005-08-16 2010-04-28 Nicola Regan Greenwood Vaginal dilator
GB2438373B (en) * 2006-05-26 2011-07-13 Abdelfattah Amin Taha Uterine dilators set
ITRM20090289A1 (en) * 2009-06-09 2010-12-10 Service 2001 S R L DILATOR FOR GYNECOLOGICAL USE.
US10485524B2 (en) 2011-10-25 2019-11-26 Essential Medical, Inc. Instrument and methods for surgically closing percutaneous punctures
WO2014150154A1 (en) 2013-03-15 2014-09-25 Essential Medical, Inc. Vascular closure devices and methods of use
EP3086716B1 (en) 2013-12-23 2021-04-07 Arrow International LLC Vascular closure device
US10555727B2 (en) 2015-06-26 2020-02-11 Essential Medical, Inc. Vascular closure device with removable guide member
US11020224B2 (en) 2017-07-11 2021-06-01 Teleflex Life Sciences Limited Methods for exchanging devices
US10668253B2 (en) 2017-07-11 2020-06-02 Teleflex Life Sciences Limited Methods for exchanging devices

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3747603A (en) * 1971-11-03 1973-07-24 B Adler Cervical dilators
CH656312A5 (en) * 1983-05-18 1986-06-30 Wilson Cook Medical Inc Expansion of instrument.
CA1237619A (en) * 1984-01-30 1988-06-07 Shute Surgical Instruments Ltd. Surgical instrument, namely uterine cell collector
US4862891A (en) * 1988-03-14 1989-09-05 Canyon Medical Products Device for sequential percutaneous dilation
US4790314A (en) * 1988-03-16 1988-12-13 Kenneth Weaver Orifice dilator

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9214396A1 *

Also Published As

Publication number Publication date
AU1425092A (en) 1992-09-15
WO1992014396A1 (en) 1992-09-03
NZ241610A (en) 1994-06-27
IE920328A1 (en) 1992-08-26
JPH05506387A (en) 1993-09-22

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