WO2007081309A1 - Marqueur radio-opaque d’eponge chirurgicale - Google Patents

Marqueur radio-opaque d’eponge chirurgicale Download PDF

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Publication number
WO2007081309A1
WO2007081309A1 PCT/US2006/000331 US2006000331W WO2007081309A1 WO 2007081309 A1 WO2007081309 A1 WO 2007081309A1 US 2006000331 W US2006000331 W US 2006000331W WO 2007081309 A1 WO2007081309 A1 WO 2007081309A1
Authority
WO
WIPO (PCT)
Prior art keywords
sponge
marker
ray
surgical
recited
Prior art date
Application number
PCT/US2006/000331
Other languages
English (en)
Inventor
Carl E. Fabian
Original Assignee
Fabian Carl E
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 Fabian Carl E filed Critical Fabian Carl E
Priority to US11/908,682 priority Critical patent/US20090240210A1/en
Priority to PCT/US2006/000331 priority patent/WO2007081309A1/fr
Publication of WO2007081309A1 publication Critical patent/WO2007081309A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/44—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with radio-opaque material or signalling means for residual material

Definitions

  • the present invention relates to a surgical sponge, and more particularly, to a
  • the patient may suffer pain, infection, intestinal obstruction,
  • surgical instruments are composed of metal, and are relatively easily visible on x-ray.
  • intraoperative x-rays generally
  • the present invention provides a radiopaque marker suitable for association with a
  • the marker has a high radiographic density
  • the marker produces an x-ray image with high contrast
  • the marker is
  • suitable for association with a surgical sponge has an x-ray density equivalent to at least
  • the marker produces an x-ray image having a distinctive, visually
  • the shape is selected from the group consisting of
  • ovals polygons, astroids, epicycloids, lobed shapes, alphabetic and numeric characters, and dingbats.
  • the invention further provides a surgical sponge comprising a radiographic marker.
  • Such a marker has an x-ray density equivalent to at least about 0.1 g/cm 2 of BaSO 4 , and a
  • the invention also provides a method of detecting a surgical sponge within a
  • the surgical sponge comprising a radiopaque marker having an x-ray
  • the method comprises the steps of:
  • Fig. 1 is a plan view of a prior art surgical sponge including a sheet-form radiopaque
  • Fig. 2 is a plan view of a surgical sponge of the invention including a radiopaque
  • Fig. 3 is a plan view of a surgical sponge of the invention including both a sheet-
  • Fig. 4 is a plan view of a surgical sponge of the invention including both a radiopaque marker of the invention and an electronic article surveillance
  • Fig. 5 is a plan view of an astroid-like radiopaque marker of the invention having
  • Fig. 6 is a plan view of an astroid-like radiopaque marker of the invention having
  • Fig. 7 is a plan view of an epicycloid-like radiopaque marker of the invention having
  • Fig. 8 is a plan view of a diamond-shaped radiopaque marker of the invention
  • Fig. 9 is a plan view of a radiopaque marker of the invention having a bullseye-like
  • Fig. 10 is a plan view of a radiopaque marker of the invention comprising a plurality
  • Fig. 11 is a perspective view depicting a marker oriented obliquely to an incident x-
  • the present invention provides a radiopaque marker that is adapted to be attached to
  • FIG. 1 there is depicted a prior art surgical sponge 9 composed of
  • gauze 12 and having a fabric loop 14 to facilitate identification and location of the sponge.
  • the sponge bears a generally rectangular, sheet-form radiopaque element 16.
  • each sponge includes an optional fabric or thread loop 14 to facilitate identification and location of the
  • Sponge 10 further comprises a radiopaque marker 18 of the invention.
  • Fig. 3 may also be used in the embodiments of Figs. 2-4.
  • the aspect shown in Fig. 3 further be used in the embodiments of Figs. 2-4.
  • the aspect shown in Fig. 3 further be used in the embodiments of Figs. 2-4.
  • the aspect shown in Fig. 3 further be used in the embodiments of Figs. 2-4.
  • the aspect shown in Fig. 3 further be used in the embodiments of Figs. 2-4.
  • Fig. 4 depicts a sponge 10 that further comprises a remotely detectable electronic
  • the radiographic marker 18 may be attached to the surface of
  • marker 18 may be enclosed within the
  • marker 18 be
  • a radiograph, or "x-ray image" as the term is commonly used, is obtained using a
  • the body is interposed between the x-ray source and the detector.
  • the x-ray source is activated
  • the beam is directed at some part of the body of diagnostic
  • resulting image may be regarded as a shadow of the various body structures traversed by the
  • the degree of the attenuation depends on a number of factors, including the
  • Radiodensity is dependent on the atomic structure of the object and
  • metallic iron within the body is much denser than a chemical compound of which iron is merely one component diluted by other atoms, such as
  • tissue density There are five broad categories of tissue density
  • a radiographic image is a pattern of lighter and darker shades and basically
  • Soft tissue such as muscle, blood, fluid
  • the marker of the present invention may be visualized using CAT scanning
  • the preponderance of tissue in the human body is comprised of atoms of relatively
  • H 2 O water
  • the human body also contains bones and teeth, each containing a higher
  • I 0 exp (- ⁇ z) wherein "I 0 " is the incident intensity and 1/ ⁇ is a characteristic attenuation length.
  • the value of ⁇ depends on several factors, which include the atomic weight of the
  • a sample of total thickness "t" such that ⁇ t is at least 5-10 is substantially opaque to
  • a radiopaque element allows a sponge that is inadvertently left within a patient during a
  • U.S. Patent 5,112,325 discloses such a surgical sponge fabricated with a locator thread
  • radiopaque elements comprise BaSO 4 in a polymeric matrix.
  • Such elements would have an areal mass density of less than
  • the marker of the invention have a radiographic density equivalent to
  • the x-ray image of a radiopaque object is a two-dimensional shadow projection.
  • the exposure of the x-ray at each point of the image reflects the total x-ray density
  • Fig. 11 depicts the simple case of
  • An attenuated beam 104 emerges below element 102 and creates a projected
  • shadow image 106 i.e., a region of reduced exposure on x-ray film 108.
  • the beam 100 is
  • the effective thickness of the element 102 in this orientation is increased by a factor [l/cos( ⁇ )], in which cos( ⁇ ) is the cosine of the angle ⁇ .
  • sponge may be located at any orientation within a patient's body and thus subject to the
  • projected on the x-ray may thus take on a shape that is unpredictable and unexpected
  • radiopaque element may be located in close
  • the element may be positioned along
  • implantable electronic devices such as cardiac pacemakers and defibrillators with associated
  • the radiopaque marker of the present invention has a shape that markedly enhances
  • one- or two-dimensional shape For example, one or more elongated threads comprising a
  • radiographically dense material have been used as a radiopaque element in a surgical
  • Such an element produces a one-dimensional x-ray image, i.e., a straight or curved
  • sutures, staples, wires, and catheters that are also expected in a surgical patient.
  • the present marker incorporates a radiopaque component adapted to produce an x-
  • distinctive shape means a
  • a wide variety of such shapes are suitable for incorporation in the marker of the invention, including, but not limited to, ovals including circles and ellipses, polygons;
  • astroid-like or star-like shape which has a plurality of pointed vertices 32 at its periphery, is
  • An epicycloid-like shape has a plurality of rounded lobes at its periphery.
  • Fig. 7 depicts an epicycloid structure 36 similar to a typographic asterisk symbol and having
  • Fig. 8 depicts a polygonal structure, in particular a four-sided diamond 40.
  • Fig. 9 depicts a bullseye-like structure comprising two concentric rings of radiopaque
  • marker 18 comprises a plurality of components having the
  • shapes be disposed in a relationship that is substantially fixed both in spacing and in
  • Such a marker 48 as depicted by Fig. 10, comprises a plurality of closely proximate or contiguous spheres 50. Other similar markers will suggest themselves to the
  • a radiographic marker comprising at least one spherically shaped component
  • a marker comprising at least one
  • radiographic thickness in each of the Cartesian directions e.g., a rectangular prism or cube
  • Markers comprising at least one such component having substantial radiographic thickness in each Cartesian direction are thus within the scope of
  • the radiopaque marker of the invention also has an area of at least about 5 mm 2 to
  • the marker comprise components having a
  • the marker have
  • Such an area is easily achieved, for example, using a marker comprising a plurality of
  • the marker of the invention has, in combination, a
  • a surgical sponge comprises
  • Such a sponge advantageously may be detected by the electronic means
  • the marker further enhances the detectability of
  • the marked surgical sponge of the invention may be used in conjunction with any of
  • EAS system capable of sensing and remotely detecting an EAS tag and compatible with the
  • EAS systems are currently known, including microwave, RF, and magnetic systems.
  • Patents 4,510,489 and 4,510,490 Another system is the harmonic-responsive article
  • tags suitable for use in the practice of the present invention comprise an active
  • tag is used herein to refer
  • a tag may include more than one active

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Apparatus For Radiation Diagnosis (AREA)

Abstract

La présente invention concerne une éponge chirurgicale qui comprend un marqueur radio-opaque ayant une haute densité radiographique et une forme distincte reconnaissable visuellement. Le marqueur a une densité de rayons X équivalente à au moins environ 0,1 g/cm2 de BaSO4. Il produit une image à rayons X à contraste élevé et une forme aisément reconnaissable et différenciée des images produites par d’autres éléments et structures communément vus dans les rayons X de patients post-opératoires. Dû à l’image distincte à contraste élevé produite par le marqueur, l’éponge est détectée de manière fiable et sans ambiguïté. C’est le cas même dans des situations où l’éponge est laissée par mégarde dans la blessure chirurgicale. La gêne, le traumatisme et les conséquences possiblement fatales qui risquent d'en découler sont donc virtuellement éliminées. La procédure chirurgicale est effectuée avec une réduction de l’éventualité d’un oubli accidentel de l’éponge dans la blessure.
PCT/US2006/000331 2005-03-14 2006-01-06 Marqueur radio-opaque d’eponge chirurgicale WO2007081309A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US11/908,682 US20090240210A1 (en) 2005-03-14 2006-01-06 Auto retractable syringe
PCT/US2006/000331 WO2007081309A1 (fr) 2006-01-06 2006-01-06 Marqueur radio-opaque d’eponge chirurgicale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2006/000331 WO2007081309A1 (fr) 2006-01-06 2006-01-06 Marqueur radio-opaque d’eponge chirurgicale

Publications (1)

Publication Number Publication Date
WO2007081309A1 true WO2007081309A1 (fr) 2007-07-19

Family

ID=38256608

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/000331 WO2007081309A1 (fr) 2005-03-14 2006-01-06 Marqueur radio-opaque d’eponge chirurgicale

Country Status (1)

Country Link
WO (1) WO2007081309A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102008014874A1 (de) * 2008-03-11 2009-09-17 Hartmann, Paul Textiler oder auf Vliesbasis hergestellter OP-Artikel, insbesondere Kompresse, Tupfer, Bauchtuch
CN114831805A (zh) * 2022-04-22 2022-08-02 上海长征医院 腹腔镜/机器人手术用海绵及其制造方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3736935A (en) * 1971-02-17 1973-06-05 Codman & Shurtleff Surgical sponge
US4718897A (en) * 1985-09-18 1988-01-12 Chicopee Nonwoven surgical sponge with x-ray detectable element
US4935019A (en) * 1986-12-22 1990-06-19 Johnson & Johnson Medical, Inc. Radiopaque polymeric composition
US6777623B2 (en) * 2002-04-17 2004-08-17 M. Daniel Ballard System and method of tracking surgical sponges
US20050038355A1 (en) * 2003-08-13 2005-02-17 Gellman Barry N. Marking biopsy sites

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3736935A (en) * 1971-02-17 1973-06-05 Codman & Shurtleff Surgical sponge
US4718897A (en) * 1985-09-18 1988-01-12 Chicopee Nonwoven surgical sponge with x-ray detectable element
US4935019A (en) * 1986-12-22 1990-06-19 Johnson & Johnson Medical, Inc. Radiopaque polymeric composition
US6777623B2 (en) * 2002-04-17 2004-08-17 M. Daniel Ballard System and method of tracking surgical sponges
US20050038355A1 (en) * 2003-08-13 2005-02-17 Gellman Barry N. Marking biopsy sites

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102008014874A1 (de) * 2008-03-11 2009-09-17 Hartmann, Paul Textiler oder auf Vliesbasis hergestellter OP-Artikel, insbesondere Kompresse, Tupfer, Bauchtuch
CN114831805A (zh) * 2022-04-22 2022-08-02 上海长征医院 腹腔镜/机器人手术用海绵及其制造方法

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