Sterilization container and instrument holder therefor

• US 6,193,932 B1
• Filed: 12/17/1998
• Issued: 02/27/2001
• Est. Priority Date: 12/17/1997
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Bankert, Charles S., Gamsarian, Anahid, Wu, Su-Syin, Merhazion, Abraham
• Primary Examiner(s): Warden, Sr., Robert J.
• Assistant Examiner(s): Snider, Theresa T.
• Application Number:
  US09/213,792
• Time in Patent Office: 803 Days
• Field of Search: 422/28, 422/292, 422/297, 422/300, 206/205, 206/207, 206/210, 206/305, 206/363, 206/370, 206/438, 206/439
• US Class Current: 422/28
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

A sterilization container has an improved elastomeric instrument holder. The instrument holder comprises a panel of elastomer having a projection depending downwardly therefrom and received within an perforation through a perforated surface within the container to hold the panel thereto. An aperture through the panel is adapted for receiving and holding an instrument to be sterilized. An inner surface of the aperture is adapted to have a reduced area of contact with an instrument received within the aperture. For example, the surface may comprise chamfers which meet to form a sharp ridge which contacts the instrument. The contact surface may also be textured to reduce the area of contact with the instrument. Alternatively, the surface may be formed of a material which is sufficiently permeable to a sterilizing gas so as to allow the area of the instrument in contact with the surface to receive a sufficient amount of sterilizing gas to become sterilized.

Claims

1. A sterilization container comprising:

an enclosure;

a perforated surface within the enclosure comprising a plurality of perforations through the surface; and

an instrument holder affixed to the surface, the instrument holder comprising;

a panel;

at least one aperture through the panel, whereby an instrument may be placed through the aperture for holding the instrument; and

wherein the panel has a first face and a second face with the at least one aperture extending therebetween, the aperture being defined by an inner aperture surface between the panel first face and panel second face and wherein the inner aperture surface has a contact surface against which the instrument received within the aperture can contact and wherein said contact surface has an area less than the inner aperture surface and wherein the inner aperture surface comprises a first chamfer extending from the first face, tapering toward the second face and terminating in a ridge, whereby the contact surface is limited to the ridge.

2. A sterilization container according to claim 1 wherein the ridge is formed by the intersection of the first chamfer and another surface so as to form the contact surface as being substantially linear.

3. A sterilization container according to claim 2 wherein the inner aperture surface further comprises a second chamfer extending from the second face and wherein the first chamfer terminates at and intersects with the second chamfer to form the ridge.

4. A sterilization container according to claim 1 where in the holder is formed of material selected from the following group:

silicone rubber, fluorinated rubber, thermoplastic elastomeric olefins, styrenic block copolymers, fluorinated polyolefins, chlorinated-fluorinated polyolefins, and liquid crystal polymers.

5. A sterilization container according to claim 1 wherein the panel has a third face between its first and second face and wherein a slot leads from the third face to the aperture whereby an instrument may be inserted radially into the aperture through the slot.

6. A sterilization container according to claim 5 wherein the at least one aperture has a diameter and the slot has a width in a plane with the aperture and the diameter of the aperture exceeds the width of the slot.

7. A sterilization container according to claim 1 wherein the inner aperture surface arcs in convex fashion from the first face to intersect the second face whereby to form the contact surface, the contact surface being substantially linear.

8. A sterilization container according to claim 1 wherein the panel has at least one projection depending therefrom into at least one perforation of the perforated surface to affix the panel thereto.

9. A sterilization container according to claim 8 wherein the panel has a width between the first face and the second face, and wherein the holder further comprises at least one pad adjacent to the at least one projection and abutting the perforated surface, the pad having a width exceeding the width of the panel.

10. A sterilization container according to claim 1 wherein the contact surface is no more than 40% of the area of the inner aperture surface.

11. A sterilization container according to claim 10 wherein the contact surface is no more than 20 percent of the area of the inner aperture surface.

12. A sterilization container according to claim 11 wherein the contact surface is no more than 5 percent of the area of the inner aperture surface.

13. An instrument holder for use with a sterilization container comprising:

a panel having at least one projection thereon, the projection adapted to extend into a perforation in the sterilization container to hold the panel thereto;

at least one aperture through the panel, whereby an instrument may be placed through the aperture for holding the instrument; and

wherein the panel has a first face and a second face with the at least one aperture extending therebetween, the aperture being defined by an inner aperture surface between the panel first face and panel second face and wherein the inner aperture surface has a contact surface against which the instrument received within the aperture can contact and wherein said contact surface has an area less than the inner aperture surface and wherein the inner aperture surface comprises a first chamfer extending from the first face, tapering toward the second face and terminating in a ridge, whereby the contact surface is limited to the ridge.

14. An instrument holder according to claim 13 wherein the ridge is formed by the intersection of the first chamfer and another surface so as to form the contact surface as being substantially linear.

15. An instrument holder according to claim 13 wherein the instrument holder is formed of elastomeric silicone.

16. A method for sterilizing a surgical instrument comprising the steps of:

enclosing the instrument within a sterilization container which comprises an enclosure, and an instrument holder within the enclosure, wherein the instrument holder comprises a panel having at least one aperture therethrough and wherein the panel has a first face and a second face with the at least one aperture extending therebetween, the aperture being defined by an inner aperture surface between the panel first face and panel second face;

placing the instrument into said aperture into contact with said inner aperture surface;

admitting a sterilizing gas into said enclosure; and

adapting the inner aperture surface to enhance penetration of the sterilizing gas to a portion of the instrument within the aperture between the first and second faces by providing a chamfer extending from the first face, tapering toward the second face and terminating in a ridge which contacts the instrument and contacting said portion with the sterilizing gas.

17. The method according to claim 16 wherein at least 40 percent of that portion of the instrument disposed within the aperture between the first and second faces is out of contact with the inner aperture surface and is contacted with the sterilizing gas in the contacting step.

18. The method of claim 16 wherein at least 80 percent of that portion of the instrument disposed within the aperture between the first and second faces is out of contact with the inner aperture surface and is contacted with the sterilizing gas in the contacting step.

19. The method of claim 16 wherein at least 95 percent of that portion of the instrument disposed within the aperture between the first and second faces is out of contact with the inner aperture surface and is contacted with the sterilizing gas in the contacting step.