Systems and methods for enhancing preparation and completion of surgical and medical procedures

• US 9,186,217 B2
• Filed: 06/03/2013
• Issued: 11/17/2015
• Est. Priority Date: 06/05/2012
• Status: Active Grant

• Current Assignee: MG Stroke Analytics, Inc.
• Original Assignee: Mayank Goyal
• Inventors: Goyal, Mayank
• Primary Examiner(s): GEHMAN, BRYON P
• Application Number:
  US14/005,167
• Publication Number:
  US 20140231302A1
• Time in Patent Office: 897 Days
• Field of Search: 206363-370, 206/438, 206570-572, 600562-567, 604/28, 604/35, 606/1, 606/159, 606167-185
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/28 Surgical forceps for holding suture needles or materials A61B17/0483; for removing or smashing calculi A61B17/221; surgical scissors A61B17/3201 ; obstetrical forceps A61B17/44; for inserting intraocular lenses A61F2/1662; hand-held gripping tools in general B25B7/00 ]
• CPC Class Codes: A61B 17/3215 Packages or dispensers for scalpel blades for sharps A61B50/3001
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2050/005 with a lid or cover
• CPC Class Codes: A61B 2050/3007 Stackable casings
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/229 Stopcocks
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 5/178 : Syringes

Abstract

The present invention relates to systems and methods for preparing and completing surgical and medical procedures. In particular, the invention relates to kits for improving preparation and completion time for a medical or surgical procedure in which the kit includes modularized compartments containing sterilized medical or surgical equipment and wherein the medical or surgical equipment is organized and/or ordered within the kit to generally correspond to the sequence of steps of the medical or surgical procedure. The kit is particularly applicable to recanalization procedures for stroke patients as well as revascularization procedures for acute myocardial infarction patients where a kit enables faster preparation and completion of these procedures.

Claims

1. A modular kit for decreasing preparation and surgical time for a recanalization or revascularization procedure in the treatment of acute stroke and acute myocardial infarction patients comprising:

at least one tray having a plurality of compartments containing a plurality of equipment modules containing sterilized surgical equipment to conduct individual steps of the procedure, wherein the plurality of equipment modules include;

a surgical site preparation module for a surgical site preparation step of the procedure;

a tube and catheter flushing module for a tube and catheter flushing step of the procedure;

an arterial access module for an arterial access step of the procedure;

a procedure equipment module for a recanalization or revascularization step of the procedure, the procedure equipment module including tube and catheter equipment and at least two clot retrieval devices individually sealed within the procedure equipment module to enable collection and re-use of equipment unused in the procedure; and

an equipment return module having labeling and packaging for packaging unused equipment for return to a manufacturer.

2. The kit as in claim 1 further comprising outer packaging providing a sterile seal to the at least one tray and the equipment modules.

3. The kit as in claim 1 wherein the at least one tray includes a lower tray stackable with an upper tray and the upper tray includes the surgical site preparation module.

4. The kit as in claim 1 wherein the at least one tray includes a lower tray stackable with an upper tray and wherein the lower tray includes the surgical site preparation module.

5. The kit as in claim 1 wherein the at least one tray is a single tray.

6. The kit as in claim 1 wherein the at least one tray includes a combination of stacked and unstacked trays.

7. The kit as in claim 1 wherein the tube and catheter flushing module includes at least one catheter flushing manifold, the catheter flushing manifold including a first port for operative connection to a flushing system and at least two catheter openings for connection to catheters and wherein activation of the flushing system enables simultaneous flushing of each connected catheter.

8. The kit as in claim 7 wherein the at least two catheter openings have different diameters.

9. The kit as in claim 1 wherein the at least one tray includes a bowl compartment integrally formed with the at least one tray.

10. The kit as in claim 9 wherein the bowl compartment supports a separable bowl.

11. The kit as in claim 9 wherein the bowl compartment includes a sterile seal on an upper surface of the at least one tray and the bowl compartment supports liquid within the tray.

12. The kit as in claim 1 wherein each of the surgical site preparation module, tube and catheter flushing module and arterial access module are separate trays separable from one another.

13. The kit as in claim 12 wherein the surgical site preparation module includes cleaning and draping equipment.

14. The kit as in claim 12 wherein the tube and catheter flushing module includes catheter flushing equipment.

15. The kit as in claim 1 wherein the procedure equipment module includes intra-arterial recanalization equipment, the intra-arterial recanalization equipment including a plurality of catheters for accessing neck and brain vessels and clot retrieval.

16. The kit as in claim 1 wherein the procedure equipment module includes an acute myocardial infarction (MI) equipment module, the acute MI equipment including a plurality of catheters for accessing neck and coronary arterial vessels and a plurality of microcatheters, microwires, angioplasty balloons and stents for dilating of stenosed coronary vessels.

17. The kit as in claim 1 wherein each catheter within the procedure equipment module includes a pre-attached rotating hemostatic valve (RHVs) or three-way stop-cock.

18. The kit as in claim 1 wherein surgical equipment in each of the surgical site preparation module, the tube and catheter flushing module and the arterial access module include module packaging only and are not individually packaged.

19. A method for decreasing preparation and surgical time for a recanalization or revascularization procedure in the treatment of acute stroke and acute myocardial infarction patients comprising the steps of:

a. accessing a modular kit having at least one tray having a plurality of compartments containing a plurality of equipment modules containing sterilized surgical equipment to conduct individual steps of the recanalization or revascularization procedure, the plurality of equipment modules comprising a surgical site preparation module including cleaning and draping equipment;

a tube and catheter flushing module including tube and catheter flushing equipment;

an arterial access module comprising arterial access equipment; and

a procedure equipment module including recanalization or revascularization equipment;

the modular kit comprising outer packaging providing a sterile seal to the at least one tray and the plurality of equipment modules;

b. preparing the surgical site using the equipment in the surgical site preparation module; and

c. conducting tube and catheter flushing of the recanalization or revascularization equipment.

20. The method as in claim 19 wherein step c. includes conducting simultaneous flushing of at least two tubes or catheters of the recanalization or revascularization equipment.

21. The method as in claim 19 further comprising the step of providing an equipment return module within the kit having labelling or packaging and returning unused procedure equipment to a manufacturer using the labelling or packaging.

22. A modular kit for decreasing preparation and surgical time for a recanalization or revascularization procedure in the treatment of acute stroke and acute myocardial infarction patients comprising:

at least one tray having a plurality of compartments containing sterilized surgical equipment to conduct individual steps of the procedure, the plurality of equipment modules including;

a surgical site preparation module including cleaning and draping equipment for a surgical site preparation step of the procedure;

a tube and catheter flushing module including catheter flushing equipment for a tube and catheter flushing step of the procedure;

an arterial access module for an arterial access step of the procedure; and

a procedure equipment module including tube and catheter equipment to conduct a recanalization or revascularization step of the procedure; and

outer packaging providing a sterile seal to the at least one tray and the equipment modules.

23. The kit as in claim 22 wherein the tube and catheter flushing module includes at least one catheter flushing manifold, the catheter flushing manifold including a first port for operative connection to a flushing system and at least two catheter openings for connection to catheters and wherein activation of the flushing system enables simultaneous flushing of each connected catheter.

24. The kit as in claim 22 wherein the procedure module includes intra-arterial recanalization equipment, the intra-arterial recanalization equipment including a plurality of catheters for accessing neck and brain vessels and clot retrieval.

25. The kit as in claim 22 wherein the procedure module includes an acute myocardial infarction (MI) equipment module, the acute MI equipment including a plurality of catheters for accessing neck and coronary arterial vessels and a plurality of microcatheters, microwires, angioplasty balloons and stents for dilating of stenosed coronary vessels.