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, e.g. tourniquets
  • 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.

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• 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)
• Media Introduction/Drainage Providing Device (AREA)
• Materials For Medical Uses (AREA)

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• 1992
  • 1992-02-10 AU AU14250/92A patent/AU1425092A/en not_active Abandoned
  • 1992-02-10 JP JP92506657A patent/JPH05506387A/ja active Pending
  • 1992-02-10 EP EP92906992A patent/EP0525175A1/de not_active Ceased
  • 1992-02-10 WO PCT/US1992/001112 patent/WO1992014396A1/en not_active Application Discontinuation
  • 1992-02-11 IE IE032892A patent/IE920328A1/en unknown
  • 1992-02-13 NZ NZ241610A patent/NZ241610A/xx unknown

Non-Patent Citations (1)

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