Drug-impregnated encasement

• US 9,579,260 B2
• Filed: 10/01/2014
• Issued: 02/28/2017
• Est. Priority Date: 10/13/2005
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Fulmer, Mark Thomas, Armbruster, David A., Frigg, Robert, Gruskin, Elliott A., Kerr, Sean Hamilton
• Primary Examiner(s): Azpuru, Carlos
• Assistant Examiner(s): HAGOPIAN, CASEY SHEA
• Application Number:
  US14/503,594
• Publication Number:
  US 20150018969A1
• Time in Patent Office: 881 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/8028 Cushions, i.e. elements forming interface between bone plate and bone
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61C 8/0013 with a surface layer, coating
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/30919 Sleeves
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61J 2200/00 General characteristics or adaptations
• CPC Class Codes: A61J 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/416 : Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 156/1051 : by folding

Abstract

A drug-impregnated sleeve for encasing a medical implant is provided. In one embodiment, the sleeve may include a body made of a biologically-compatible material that defines an internal cavity configured to receive the medical implant. In one embodiment, the biologically-compatible material is bioresorbable. The body may include a plurality of apertures, such as perforations or holes, extending from the cavity through the body. The sleeve may further include a first end, a second end, and a drug impregnated into the resorbable sheet. In one possible embodiment, the first end of the sleeve may be open for receiving the medical implant therethrough and the second end may be closed. The implant may be encased in the sleeve and implanted into a patient from which the drug is dispensed in vivo over time to tissue surrounding the implantation site. In one embodiment, the body is made from at least one sheet of a biologically-compatible material.

Claims

1. A medical implant sleeve comprising:

a textile body made of one or more biologically-compatible polymer fibers, the body comprising at least one bioresorbable coating layer on the one or more fibers, the body defining an internal cavity configured to receive a non-orthopedic medical implant, and the body defining a plurality of apertures extending from the cavity through the textile body;

a first end openable for receiving the medical implant;

a second end which is closed for retaining the medical implant; and

a drug contained in the sleeve;

wherein the sleeve includes a first edge having a seam closing the first edge and the second end includes a seam closing the second end.

2. The medical implant sleeve of claim 1, wherein the sleeve includes a top and bottom, at least a portion of the top or bottom being substantially planar.

3. The medical implant sleeve of claim 1, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the textile body.

4. The medical implant sleeve of claim 3, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the textile body.

5. The medical implant sleeve of claim 1, wherein the drug comprises an antibiotic.

6. The medical implant sleeve of claim 1, wherein the sleeve has a thickness of about 0.02 mm to about 0.5 mm.

7. The medical implant sleeve of claim 1, wherein the one or more polymer fibers are biodegradable.

8. The medical implant sleeve of claim 7, wherein the one or more biodegradable polymer fibers are selected from the group consisting of caprolactone, glycolide, lactide, trimethylene carbonate, and copolymers of the same.

9. The medical implant sleeve of claim 1, wherein the at least one bioresorbable coating layer contains the drug.

10. The medical implant sleeve of claim 9, wherein the drug is an antibiotic.

11. The medical implant sleeve of claim 9, wherein the at least one bioresorbable coating layer comprises a biodegradable polymer selected from the group consisting of caprolactone, glycolide, lactide, trimethylene carbonate, and copolymers of the same.

12. The medical implant sleeve of claim 1, wherein the at least one bioresorbable coating layer consists of two bioresorbable coating layers.

13. The medical implant sleeve of claim 12, wherein the drug is contained within only one of the two bioresorbable coating layers.

14. The medical implant sleeve of claim 12, wherein the drug is an antibiotic.

15. The medical implant sleeve of claim 12, wherein the two bioresorbable coating layers comprise different polymer compositions from one another.

16. The medical implant sleeve of claim 12, wherein the two bioresorbable coating layers are configured to degrade in vivo at different rates.

17. The medical implant sleeve of claim 1, wherein the at least one bioresorbable coating layer consists of a single bioresorbable coating layer, and wherein the drug is contained within the single bioresorbable coating layer.

18. The medical implant sleeve of claim 1, wherein the non-orthopedic implant is a pacemeaker.

19. The medical implant sleeve of claim 1, wherein the non-orthopedic implant is a dental implant.

20. The medical implant sleeve of claim 1, wherein the drug is impregnated in the one or more biologically-compatible polymer fibers.