MEANS AND METHODS FOR THE PREVENTION OF RETAINED SURGICAL ITEMS AND GOSSYPIBOMA

• US 20140257089A1
• Filed: 07/11/2013
• Published: 09/11/2014
• Est. Priority Date: 03/05/2013
• Status: Abandoned Application

• Current Assignee: Aspect Imaging Ltd.
• Original Assignee: Aspect Imaging Ltd.
• Inventors: RAPOPORT, Uri
• Application Number:
  US13/939,625
• Publication Number:
  US 20140257089A1
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 2090/0805 automatically, e.g. by means of magnetic, optical or photoelectric detectors
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: G01R 33/288 Provisions within MR facilities for enhancing safety during MR, e.g. reduction of the specific absorption rate [SAR], detection of ferromagnetic objects in the scanner room

Abstract

A standard of care protocol for preventing gossypiboma during surgery. The protocol including: selecting one or more surgical items from a group consisting of: non-metallic surgical items marked with detectable metal indicia; metallic surgical items; metallic surgical items marked with the detectable metal indicia; providing one or more metal detectors in connection with the selected at least one of the surgical items; and identifying, using at least one metal detector, detectable metal items in the patient.

Claims

1. A standard of care protocol for preventing gossypiboma during surgery, characterized by steps of:

a. selecting one or more surgical items from a group consisting of;

non-metallic surgical items marked with detectable metal indicia (210);

metallic surgical items (220);

metallic surgical items marked with said detectable metal indicia (230) and a combination thereof;

b. providing one or more metal detectors in connection with at least one of said surgical items; and

c. identifying by mean of said at least one metal detector detectable metal items in said patient.

2. The protocol of claim 1, additionally comprising a step of specifying a distinct metal indicium to each said surgical items in a manner selected from a group consisting of:

(a) type of detectable metal;

(b) geometry;

(c) amount of metal and any combination thereof

3. The protocol of claim 1, additionally comprising a step of interconnecting the detectable metal indicia to said surgical item in a way selected from a group consisting of:

welding, affixing, embedding, interweaving, coupling, casting, joining, implanting, attaching, linking, screwing, adhering, stamping, forming, bending and any combination thereof.

4. A standard of care protocol for preventing gossypiboma during open surgery (100), comprising steps of:

a. providing a metal detector (101) comprising;

i. at least one magnetic field sensor for identifying detectable metals;

ii. at least one reporting mechanism adapted to signal data concerned with detection of said detectable metals; and

,

iii. a CPU for processing said data; and

b. identifying detectable metal items in said patient (103),

wherein said identifying comprises steps of processing said data to establish a baseline threshold signal characteristic of pre-surgery detectable metals in said patient (102), and then identifying signals exceeding said baseline threshold in a time resolved manner during and after said surgery procedure, thereby facilitating the prevention of gossypiboma.

5. The protocol of claim 4, wherein said metal detector is hand-held.

6. The protocol of care of claim 4, additionally a comprising step of embedding said metal detector to an object selected from a group consisting of:

(a) within a portable medical device;

(b) a surgical implement proximate to the operating room and any combination thereof.

7. The protocol of claim 4, wherein said metal detector additionally comprises:

a. means for evaluating parameters from a group consisting of (a) type;

(b) distance;

(c) size;

(d) depth;

(e) location; and

(f) amount of detectable metals; and

any combination thereof; and

b. means for reporting said parameters and any of their combination thereof by producing a signal.

8. The protocol of claim 4, additionally comprising a step of selecting said signal from a group of indicators consisting of:

(a) audible indicators;

(b) visual indicators; and

(c) sensible indicators; and

any combination thereof.

9. The protocol of claim 8, additionally comprising a step of characterizing said signal intensity as a function of at least one parameter from a group consisting of (a) type;

(b) distance;

(c) size;

(d) depth;

(e) location;

(f) amount of detectable metals; and

any combination thereof.

10. A standard of care protocol for preventing gossypiboma during a minimally invasive surgery (300), comprising steps of:

a. providing a metal detector adapted to identify detectable metal items in a body cavity of a patient (301);

b. at least partially introducing said metal detector into a body cavity of said patient (302);

c. identifying said detectable metal items in real-time (303); and

d. alerting on identification of said detectable metal items in real-time (304),

wherein said metal detector is characterized by at least one magnetic field sensor for identifying detectable metals embedded within the distal tip of the endoscope and at least one reporting mechanism adapted to signal detection of said detectable metals embedded within the external parts of the endoscope, thereby facilitating the prevention of gossypiboma.

11. A standard of care protocol for preventing gossypiboma while using a toolbox system for interchanging surgical items within a body cavity during a minimally invasive surgery (500), comprising steps of:

a. providing said toolbox system (501) characterized by;

i. at least one anchoring unit adapted to be at least partially reversibly anchored to an internal wall within said body cavity;

ii. at least one interchanging surgical item adapted to be reversibly attached to said anchoring unit; and

iii. a metal detector embedded within said anchoring unit adapted to detect changes in the amount of said interchanging surgical items attached to it and alert on said changes;

b. calibrating the metal detector according to the number of said interchanging surgical items attached to it (502);

c. reversibly anchoring said toolbox system to a tissue within said body cavity (503); and

d. reversibly attaching at least one interchanging surgical items to said anchoring unit;

thereby providing said at least one interchanging metal comprising surgical items within said body cavity (504),

wherein said metal detector is adapted to alert whenever at least one said interchanging surgical items is detached from the anchoring unit, thereby facilitating the prevention of gossypiboma.

12. The protocol according to claim 11, additionally comprising steps of:

a. adapting said a magnetic field sensor to detect changes in the magnetic field in the proximity of said anchoring unit as a result of attaching/detaching said interchanging metal comprising surgical items; and

b. adapting a reporting mechanism to alert upon said changes in the magnetic field.

13. The protocol according to claim 12, additionally a comprising step of detaching said toolbox system from said tissue within said body cavity which activates said metal detector upon said action of detaching.

14. The protocol of claim 11, additionally comprising a step of selecting said interchanging surgical items from a group consisting of:

(a) interchanging non-metallic surgical items marked with detectable metal indicia;

(b) interchanging metallic surgical items;

(c) interchanging metallic surgical items with detectable metal indicia; and

any combination thereof.

15. The protocol of claim 12, additionally comprising a step of selecting said reporting mechanism from a group consisting of:

(a) visual signal; and

(b) audible signal;

(c) sensible signal and any combination thereof.

16. The protocol of claim 12, additionally comprising a step of interconnecting said reporting mechanism to an object, and selecting the same from a group consisting of:

(a) entrance door;

(b) wall;

(c) tool tray;

(d) personnel uniform;

(e) items carried by said personnel; and

any combination thereof.

17. A standard of care protocol for increasing MRI safety by screening subjects for detectable metals prior their entrance to the MRI room utilizing a hand-held metal detector (600), comprising steps of:

a. providing said metal detector (601) comprising;

i. at least one magnetic field sensor for identifying detectable metals; and

ii. at least one reporting mechanism adapted to alert upon the detection by said magnetic field sensor;

b. introducing said metal detector to said subject (602);

c. identifying the presence of said detectable metals by said magnetic field sensor; and

d. alerting on the detection of said detectable metals by at least one action from a group consisting of;

(1) locking the entrance door to the MRI room (702);

(2) shutting down the MRI apparatus (705);

(3) shutting down the protective cover of the MRI bore (703);

(4) producing an audible or visual alert; and

any combination thereof,

wherein said protocol additionally comprising step of embedding said hand-held metal detector within a portable medical device.

18. The protocol of claim 17, further comprising steps of providing said stethoscope with at least one chest piece adapted to be reversibly contacted a subject;

at least one ear tip; and

a tubing interconnecting said chest piece with said ear tips.

19. The protocol of claim 18, further comprising steps of embedding said magnetic field sensor and said reporting mechanism within a stethoscope'"'"'s parts selected from a group consisting of (a) chest piece;

(b) ear tips; and

(c) tubing; and

any combination thereof.