Radiopaque marker for a surgical sponge

• US 7,465,847 B2
• Filed: 08/29/2003
• Issued: 12/16/2008
• Est. Priority Date: 08/29/2003
• Status: Expired due to Fees

• Current Assignee: Carl E. Fabian
• Original Assignee: Carl E. Fabian
• Inventors: Fabian, Carl E.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Bogart; Michael G
• Application Number:
  US10/650,376
• Publication Number:
  US 20050049563A1
• Time in Patent Office: 1,936 Days
• Field of Search: 604/362, 600 3- 8, 128/899, 340/573.1
• US Class Current: 604/362
• CPC Class Codes: A61F 13/44 with radio-opaque material or signalling means for residual material
• CPC Class Codes: A61F 2013/8497 having decorations or indicia means

Abstract

A surgical sponge comprises a plurality of radiopaque markers having a high radiographic density and a distinctive, visually recognizable shape. The markers have an x-ray density equivalent to at least about 0.1 g/cm² of BaSO₄. The markers produce an x-ray image with high contrast and a shape that is readily recognizable and differentiated from the images produced by other items and structures commonly seen in x-rays of post-operative patients. Owing to the distinctive, high contrast image produced by the markers, the sponge is reliably and unambiguously detected. This is so even in situations where the sponge is inadvertently left in the surgical wound. Discomfort, trauma, and possibly fatal consequences that might otherwise occur are virtually eliminated. The surgical procedure is carried out with decreased likelihood of a sponge being retained inadvertently.

Claims

1. A surgical sponge comprising:

a) three substantially spherical radiopaque markers;

b) all three of said markers being closely grouped, proximate and directly contiguous to one another;

c) each of said markers having an x-ray density equivalent to at least about 0.1 g/cm² of BaSO₄; and

d) said radiopaque markers being disposed in a relationship that is substantially fixed both in spacing and in orientation, whereby said markers produce an x-ray image having a distinctive, visually recognizable shape.

2. A surgical sponge as recited by claim 1, wherein each of said markers has an x-ray density equivalent to at least about 0.1 g/cm² of BaSO₄ for x-rays incident on said target in any direction.

3. A surgical sponge as recited by claim 1, wherein said x-ray density is equivalent to at least about 0.2 g/cm² of BaSO₄.

4. A surgical sponge as recited by claim 2, wherein said x-ray density is equivalent to at least about 0.2 g/cm² of BaSO₄.

5. A surgical sponge as recited by claim 1, wherein each of said markers has an area of at least 5 mm² in at least one projection.

6. A surgical sponge as recited by claim 5, wherein each of said markers has an area of at least 5 mm² in any projection.

7. A surgical sponge as recited by claim 1, further comprising a remotely detectable electronic article surveillance tag.

8. A method of detecting a surgical sponge within a surgical patient, said surgical sponge comprising three substantially spherical radiopaque markers, all three of said markers being closely grouped, proximate and directly contiguous to one another, each of said markers having an x-ray density equivalent to at least about 0.1 g/cm² of BaSO₄, said radiopaque markers being disposed in a relationship that is substantially fixed both in spacing and in orientation, whereby said markers produce an x-ray image having a distinctive, visually recognizable shape, and said method comprising the steps of:

(a) obtaining at least one x-ray of at least a portion of said patient likely to contain said radiopaque markers; and

(b) examining said x-ray to detect and locate an image of said sponge.

9. A method of detecting a surgical sponge within a surgical patient and treating said surgical patient, said surgical sponge comprising three substantially spherical radiopaque markers, all three of said markers being closely grouped, proximate and directly contiguous to one another, each of said markers having an x-ray density equivalent to at least about 0.1 g/cm² of BaSO₄, said radiopaque markers being disposed in a relationship that is substantially fixed both in spacing and in orientation, whereby said markers produce an x-ray image having a distinctive,

visually recognizable shape, and said method comprising the steps of:

(a) obtaining at least one x-ray of at least a portion of said patient likely to contain said radiopaque markers;

(b) examining said x-ray to detect and locate an image of said sponge; and

(c) carrying out a surgical procedure to remove said sponge from said patient.