Disposable speculum with membrane bonding ring

• US 5,179,936 A
• Filed: 04/30/1987
• Issued: 01/19/1993
• Est. Priority Date: 10/23/1984
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG, Zila Pharmaceuticals Incorporated (TOLMAR Holding, Inc.)
• Original Assignee: Intelligent Medical Systems, Inc. (Pfizer Inc.)
• Inventors: Hingorani, Kishan G., Phillips, David B., O'Hara, Gary J.
• Primary Examiner(s): GRAHAM, MARK S
• Application Number:
  US07/045,603
• Time in Patent Office: 2,091 Days
• Field of Search: 128/9, 128/763, 128/664, 128/666, 128/4, 128/5, D10/57, 250/338, 374/126, 374/129, 374/158, 374/209, 374/120, 374/121
• US Class Current: 600/200
• CPC Class Codes: A61B 1/00142 with means for preventing contamination, e.g. by using a sanitary sheath
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: G01J 2005/528 Periodic comparison
• CPC Class Codes: G01J 5/02 Constructional details
• CPC Class Codes: G01J 5/021 Probe covers for thermometers, e.g. tympanic thermometers; Containers for probe covers; Disposable probes
• CPC Class Codes: G01J 5/04 Casings
• CPC Class Codes: G01J 5/046 Materials; Selection of thermal materials
• CPC Class Codes: G01J 5/049 Casings for tympanic thermometers
• CPC Class Codes: G01J 5/08 Optical arrangements
• CPC Class Codes: G01J 5/0818 Waveguides
• CPC Class Codes: G01J 5/12 using thermoelectric elements, e.g. thermocouples
• CPC Class Codes: G01J 5/52 using comparison with reference sources, e.g. disappearing-filament pyrometer

Abstract

A sanitary protective cover or sheath for the ear canal probe of a tympanic thermometer. The speculum has a generally tubular body portion and an infrared transparent membrane attached to and sealing the forward end of the body portion. While the tubular body portion is being injection molded of plastic material such as polypropylene or polyethylene, a film of a similar plastic materil is mated to the forward end of the membrane and is thus severed from the film and one side thereof thermally bonded to the tubular body portion. At the same time a bonding ring of roughly the same diameter as the forward end of the tubular body portion is injection molded. The ring is thermally bonded to the opposite side of the film in alignment with the forward end of the tubular body portion.

Claims

1. A speculum comprising:

a generally tubular body portion having forward and rearward ends;

a membrane extending across the forward end of the tubular body portion, the membrane having a maximum thickness of approximately 0.001 inches and being substantially transparent to infrared radiation; and

a bonding member ring joined to the membrane on a first side thereof opposite a second side which is bonded to the forward end of the tubular body portion.

2. A speculum comprising:

a generally tubular body portion;

a thin membrane attached to and extending across a forward end of the tubular body portion;

the tubular body portion and the membrane being made of a material selected from the group consisting of polypropylene and polyethylene; and

the membrane being wrinkled and having a thickness selected to minimize attenuation of infrared radiation passing therethrough when stretched tight.

3. A speculum comprising:

a generally tubular body portion;

a bonding member;

a thin membrane having a first side extending across and connected to a forward end of the tubular body portion;

the membrane being substantially transparent to infrared radiation;

the bonding member being connected to a second side of the membrane in alignment with the forward end of the tubular body portion;

the membrane, tubular body portion and bonding member being made of a plastic material; and

the tubular body portion being injection molded, the membrane being formed of a separate film bonded to the forward end of the tubular body portion and the bonding member being injection molded and bonded to the membrane.

4. A speculum for a tympanic thermometer that rapidly senses infrared emissions in an external ear canal of a patient via a sensing probe, comprising:

a generally tubular body portion configured and dimensioned to be inserted into an external ear canal of a patient after being removably mounted over a probe;

an infrared transparent thin film membrane bonded to and extending across a forward end of the body portion;

the body portion and the membrane being made of a same plastic material; and

means for establishing a predetermined longitudinal relationship between the body portion and the probe such that the film membrane is stretched over a forward end of the probe to substantially remove any wrinkles otherwise present therein.

5. A speculum according to claim 4 wherein the means for establishing a predetermined longitudinal relationship includes a plurality of ears that project from an inner wall of the body portion and mate with a plurality of corresponding detents formed in an outer wall of the probe.

6. A speculum according to claim 4 and further comprising a bonding member joined to the membrane on a first side thereof opposite a second side which is bonded to the forward end of the body portion.

7. A speculum according to claim 6 wherein the bonding member is made of the same plastic material as the body portion and the membrane.

8. A speculum according to claim 6 wherein the bonding member is configured in the shape of a ring.

9. A speculum comprising:

a generally tubular body portion;

a bonding member;

a thin membrane having a first side extending across and connected to a forward end of the tubular body portion;

the membrane being substantially transparent to infrared radiation;

the bonding member being connected to a second side of the membrane in alignment with the forward end of the tubular body portion; and

the membrane, tubular body portion and bonding member being made of a plastic material.

10. A speculum for a tympanic thermometer that rapidly determines an internal body temperature of a patient by sensing infrared emissions in an external ear canal of the patient, comprising:

a pliant, tubular, frusto-conical body portion configured and dimensioned to be inserted into an external ear canal of a patient after being removably mounted over a probe of the thermometer, the body portion being formed of an annular wall having a thickness of approximately 0.01 to 0.02 inches, the body portion including a plurality of circumferentially spaced ears that project radially inwardly from an inner wall of the body portion and adapted to mate with a plurality of corresponding detents formed in an outer wall of the probe to retain the body portion over the probe, and the body portion further having a forwardly facing shoulder that projects radially outwardly from a rearward end of the body portion;

a thin film membrane thermally bonded to and extending across a forward end of the body portion and having a substantially uniform thickness of between approximately 0.005 and 0.001 inches, the film membrane being substantially transparent to infrared radiation in the seven to fifteen micron wavelength range;

a longitudinal dimension of the body portion being at least twice a transverse dimension of the membrane;

a bonding ring thermally bonded to the membrane on a first side thereof opposite a second side which is thermally bonded to the forward end of the body portion, the bonding ring aiding in securing the membrane to the forward end of the probe;

the body portion, the membrane and the ring being made of a material selected from the group consisting of polypropylene and polyethylene;

the membrane being capable of withstanding approximately 1.2 PSI without rupturing, leaking or unbonding from the forward end of the body portion;

the ears being located on the inner wall of the body portion at positions such that when the ears mate with the detents formed in the outer wall of the probe, the film membrane is stretched over the forward end of the probe to substantially remove any wrinkles otherwise present in the membrane whereby distortion in a measurement process of the tympanic thermometer will be minimized; and

the longitudinal dimension of the body portion being sufficient to prevent direct contact between the probe and the ear canal to thereby inhibit contamination of the probe.