MEDICAL DEVICE PACKAGE

• US 20090209031A1
• Filed: 04/29/2009
• Published: 08/20/2009
• Est. Priority Date: 01/26/2006
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Stopek, Joshua B.
• Application Number:
  US12/431,837
• Publication Number:
  US 20090209031A1
• Time in Patent Office: Days
• US Class Current: 435/307.100
• CPC Class Codes: A61B 17/06114 Packages or dispensers for needles or sutures packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24
• CPC Class Codes: A61B 17/06133 of parallelepipedal shape, e.g. made of rectangular or slightly oval panels
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61B 2050/0014 Cooling means
• CPC Class Codes: A61B 2050/0016 Heating means
• CPC Class Codes: A61B 2050/005 with a lid or cover
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3005 containing a preservative liquid, e.g. an antiseptic liquid
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 2050/316 double- or multiple-walled
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• 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: A61C 8/0087 Means for sterile storage or manipulation of dental implants
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: B01F 33/452 using independent floating stirring elements

Abstract

A package for a medical device, the package capable of sustaining viable cells, wherein the package includes a first container, which is configured to receive a medical device and to sustain at least one viable cell, and a fluid port in communication with the first container for allowing sterile passage of an agent to the medical device and for maintaining cell viability.

Claims

1. A package for a medical device, the package capable of sustaining viable cells, the package comprising:

a first container configured to receive a medical device and to sustain at least one viable cell;

a fluid port in communication with the first container for allowing sterile passage of an agent to the medical device and for maintaining cell viability.

2. The package of claim 1, wherein the at least one viable cell is sustained in a constant sterile environment inside the package.

3. The package of claim 1, wherein the at least one viable cell is sustained in a constant sterile environment without the need for removal of the medical device or the at least one viable cell from the sterile environment prior to implantation.

4. The package of claim 1, wherein the medical device includes a biologically derived material.

5. The package of claim 4, wherein the biologically derived material is selected from the group consisting of heart valves, bypass grafts, tendons, ligaments, skin grafts, cartilage, bone grafts, vascular grafts, dialysis grafts, aortic grafts, tissue scaffolds, ocular implants, retinal implants, optic nerve implants, corneal implants, organ transplants, autografts, allografts, and xenografts.

6. The package of claim 1, wherein the medical device is selected from the group consisting of sutures, staples, clips, pledgets, buttresses, suture anchors, cables, wires, pacemakers, stents, catheters, inflatable devices, adhesives, sealants, meshes, sternum closures, pins, screws, tacks, rods, plates, adhesion barriers, bioelectronic devices, dental implants, surgical tools, buttresses, drug delivery devices, scaffolds, films, foams, synthetic graft materials, cannulas, trocars, and combinations thereof.

7. The package of claim 1, wherein the medical device includes a suture.

8. The package of claim 1, wherein the at least one viable cell is selected from the group consisting of stem cells, red blood cells, white blood cells, cancerous cells, epithelial cells, secretory cells, contracile cells, blood and immune system cells, sensory transducer cells, autonomic neuron cells, glial cells, lens cells, pigment cells, germ cells, nurse cells, basal cells, hematapoetic cells, muscle cells, cartilage cells, tendon cells, ligament cells, cardiac cells, and combinations thereof.

9. The package of claim 1, where the at least one viable cell is a stem cell.

10. The package of claim 1, further comprising a second container.

11. The package of claim 10, wherein the medical device and the at least one viable cell are separately positioned in the first and second containers.

12. The package of claim 1, wherein the agent is growth medium, cell nutrients, and combinations thereof.

13. The package of claim 1, wherein the agent is selected from the group consisting of growth medium, viable cells, growth factors, peptides, proteins, enzymes, antibodies, cell receptors, fibronectin, laminin, morphogenic factors, cell matrix proteins, deoxyribonucleic acids, ribonucleic acids, modified genetic materials, viral vectors, nucleic acids, lymphokines, plasmids, and drugs.

14. The package of claim 13, wherein the drug is selected from the group consisting of antiseptics, anesthetics, muscle relaxants, antihistamines, decongestants, antimicrobial agents, anti-viral agents, anti-fungal agents, antimalarials, amebicides, antituberculosal agents, antiretroviral agents, chemotherapeutics, leprostatics, antiprotazoals, antihelmitics, antibacterial agents, steroids, hematopoietic agents, antiplatelet agents, anticoagulants, coagulants, thrombolytic agents, hemorrheologic agents, hemostatics, plasma expanders, hormones, sex hormones, uterine-active agents, bisphosphonates, antidiabetic agents, glucose-elevating agents, growth hormones, thyroid hormones, inotropic agents, antiarrhythmic agents, calcium channel blockers, vasodilators, sympatholytics, antihyperlipidemic agents, vasopressors, angiotensin antagonists, sclerosing agents, anti-impotence agents, urinary alkanizers, urinary acidifiers, anticholinergics, diuretics, bronchodilators, surfactants, antidepressants, antipsychotics, antianxiety agents, sedatives, hypnotics, barbiturates, antiemetic agents, analgesics, stimulants, anticonvulsants, antiparkinson agents, proton pump inhibitors, H₂-antagonists, antispasmodics, laxatives, antidiarrheals, antiflatulents, digestive enzymes, gallstone solubilizing agents, antihypertensive agents, cholesterol-lowering agents, radiopaque agents, immune globulins, monoclonal antibodies, antibodies, antitoxins, antivenins, immunologic agents, anti-inflammatory agents, antineoplastic agents, alkylating agents, antimetabolites, antimitotic agents, radiopharmaceuticals, vitamins, herbs, trace elements, amino acids, enzymes, chelating agents, immunomodulatory agents, immunosuppressive agents, and combinations thereof.

15. The package of claim 1, further comprising a temperature controller to heat or cool the package to a selected temperature set point or temperature range.

16. The package of claim 1, further comprising a humidity controller to control a moisture level inside the package to a set humidity level or a range of humidity.

17. The package of claim 1, further comprising an agitator to facilitate a mixing action.

18. The package of claim 1, further comprising a window to allow visual observation of at least a portion of the medical device or the at least one cell.

19. The package of claim 1, further comprising a gas exchange portal.

20. The package of claim 19, wherein the gas exchange portal is removable from the package.