Drug-impregnated encasement

• US 8,900,620 B2
• Filed: 10/12/2006
• Issued: 12/02/2014
• Est. Priority Date: 10/13/2005
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Fulmer, Mark Thomas, Armbruster, David A., Frigg, Robert, Gruskin, Elliott A., Kerr, Sean Hamilton
• Primary Examiner(s): Richter, Johann R
• Assistant Examiner(s): HAGOPIAN, CASEY SHEA
• Application Number:
  US12/089,574
• Publication Number:
  US 20080262630A1
• Time in Patent Office: 2,973 Days
• Field of Search: None
• US Class Current: 424/426
• 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 or resorptive
• 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, hi one embodiment, the sleeve may be made in least in part from caprolactone to add stretchability to the sleeve.

Claims

1. A biologically-compatible sleeve comprising:

a body made of a biologically-compatible, resorbable, material and defining an internal cavity configured to receive a medical implant, the body defining a plurality of apertures extending from the cavity through the body;

a first end openable for receiving the medical implant;

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

a drug impregnated into the biologically-compatible, resorbable material;

wherein the biologically-compatible, resorbable, material is a non-woven resorbable sheet, wherein the resorbable sheet comprises a polymer.

2. The 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 sleeve of claim 2, 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.

4. The sleeve of claim 3, wherein the drug comprises an antibiotic.

5. The sleeve of claim 2, wherein the biologically-compatible, resorbable, material comprises at least two sheets of resorbable material that are laminated together.

6. The sleeve of claim 5, wherein at least one sheet is microporous.

7. The sleeve of claim 5, wherein the at least two sheets include different drugs.

8. The sleeve of claim 5, wherein the at least two sheets contain the same drug.

9. The sleeve of claim 2, wherein the sheet includes two or more layers.

10. The sleeve of claim 9, wherein the two or more layers are configured to release the drug at different rates.

11. The sleeve of claim 9, wherein at least two of the two or more layers are configured to degrade in vivo at different rates.

12. The sleeve of claim 2, wherein the sheet has a thickness of about 0.02 mm to about 0.5 mm.

13. The sleeve of claim 2, wherein the sheet has a thickness of about 0.1 mm.

14. The sleeve of claim 2, wherein the sheet comprises polycaprolactone.

15. The sleeve of claim 2, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sheet.

16. The sleeve of claim 2, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the sheet.

17. The sleeve of claim 2, wherein the sheet is molded.

18. The sleeve of claim 2, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

19. The 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 body.

20. The sleeve of claim 19, wherein the drug comprises an antibiotic.

21. The sleeve of claim 1, 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.

22. The sleeve of claim 21, wherein the biologically-compatible, resorbable, material comprises at least two sheets of resorbable material that are laminated together.

23. The sleeve of claim 22, wherein at least one sheet is microporous.

24. The sleeve of claim 22, wherein the at least two sheets include different drugs.

25. The sleeve of claim 22, wherein the at least two sheets contain the same drug.

26. The sleeve of claim 21, wherein the sheet includes two or more layers.

27. The sleeve of claim 26, wherein the two or more layers are configured to release the drug at different rates.

28. The sleeve of claim 26, wherein at least two of the two or more layers are configured to degrade in vivo at different rates.

29. The sleeve of claim 21, wherein the sheet has a thickness of about 0.02 mm to about 0.5 mm.

30. The sleeve of claim 21, wherein the sheet has a thickness of about 0.1 mm.

31. The sleeve of claim 21, wherein the sheet comprises polycaprolactone.

32. The sleeve of claim 21, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sheet.

33. The sleeve of claim 21, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the sheet.

34. The sleeve of claim 21, wherein the sheet is molded.

35. The sleeve of claim 21, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

36. The sleeve of claim 1, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

37. The sleeve of claim 1, wherein the plurality of apertures are round perforations.

38. The sleeve of claim 1, wherein the plurality of apertures have a form selected from the group consisting of round holes, elliptical holes, slits, slots, and any combination thereof.

39. The sleeve of claim 1, wherein the biologically-compatible, resorbable, material comprises at least two sheets of resorbable material that are laminated together.

40. The sleeve of claim 39, wherein at least one sheet is microporous.

41. The sleeve of claim 39, wherein the at least two sheets include different drugs.

42. The sleeve of claim 39, wherein the at least two sheets contain the same drug.

43. The sleeve of claim 1, wherein the sheet includes two or more layers.

44. The sleeve of claim 43, wherein the two or more layers are configured to release the drug at different rates.

45. The sleeve of claim 43, wherein at least two of the two or more layers are configured to degrade in vivo at different rates.

46. The sleeve of claim 1, wherein the sheet has a thickness of about 0.02 mm to about 0.5 mm.

47. The sleeve of claim 1, wherein the sheet has a thickness of about 0.1 mm.

48. The sleeve of claim 1, wherein the sheet is capable of stretching without breaking up to about 100% of an initial unstretched dimension.

49. The sleeve of claim 1, wherein the sheet comprises polycaprolactone.

50. The sleeve of claim 1, wherein the sheet comprises about 30% polycaprolactone and about 70% polylactic acid.

51. The 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 sheet.

52. The sleeve of claim 1, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the sheet.

53. The sleeve of claim 1, wherein the plurality of apertures each have a diameter of at least 1.5 mm.

54. The sleeve of claim 1, wherein the sheet is molded.

55. The sleeve of claim 1, wherein the sheet is configured to release the drug from only one side of the sheet.

56. The sleeve of claim 1, wherein the drug comprises an antibiotic.

57. The sleeve of claim 51, wherein the biologically-compatible, resorbable, material comprises at least two sheets of resorbable material that are laminated together.

58. The sleeve of claim 57, wherein at least one sheet of the at least two sheets of resorbable material is microporous.

59. The sleeve of claim 57, wherein the at least two sheets of resorbable material include different drugs.

60. The sleeve of claim 57, wherein the at least two sheets of resorbable material contain the same drug.

61. The sleeve of claim 51, wherein the sheet includes two or more layers.

62. The sleeve of claim 61, wherein the two or more layers are configured to release the drug at different rates.

63. The sleeve of claim 61, wherein at least two of the two or more layers are configured to degrade in vivo at different rates.

64. The sleeve of claim 51, wherein the sheet has a thickness of about 0.02 mm to about 0.5 mm.

65. The sleeve of claim 51, wherein the sheet has a thickness of about 0.1 mm.

66. The sleeve of claim 51, wherein the sheet comprises polycaprolactone.

67. The sleeve of claim 51, wherein the sheet is molded.

68. The sleeve of claim 51, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

69. A drug-impregnated sleeve comprising:

at least one bioresorbable sheet comprised of a biologically-compatible material wherein at least one drug is impregnated into the sheet, the sheet further comprising a plurality of apertures;

the sheet folded to create a rolled edge, a pair of free edges opposite the rolled edge, a first end extending between the rolled edge and the pair of free edges, and a second end extending between the rolled edge and the pair of free edges opposite the first end; and

a seam connecting the pair of free edges to one another and closing the second end, wherein the first end defines an opening configured for receiving a medical implant at least partially encased by the sleeve.

70. The sleeve of claim 69, wherein the plurality of apertures are round perforations.

71. The sleeve of claim 69, wherein the sleeve is made from at least two sheets of resorbable material that are laminated together.

72. A method of forming a drug-impregnated sleeve comprising:

providing at least one first generally flat sheet of a biologically-compatible material having at least one drug impregnated into the sheet;

forming a plurality of apertures in the sheet;

folding the sheet to form a rolled edge, an opposite free edge, a first open end, and a second open end opposite the first end;

forming a seam along the free edge to close the free edge; and

forming a seam along the second end to close the second end, wherein the seam forming steps for the free edge and second end may be performed in any order.

73. The method of claim 72, wherein the seams are formed by a method selected from the group consisting of heat fusion, chemical fusion, and adhesives.

74. The method of claim 72, further comprising the step of laminating a second generally flat sheet of a biologically resorbable material having at least one drug impregnated onto the first sheet prior to forming the plurality of apertures.

75. A biologically-compatible sleeve comprising:

a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet;

a first end openable for receiving the medical implant;

a second end; and

a drug impregnated into the biologically-compatible, resorbable material;

wherein the sheet includes two or more layers configured to release the drug at different rates;

wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sheet.

76. A biologically-compatible sleeve comprising:

a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet;

a first end openable for receiving the medical implant;

a second end; and

a drug impregnated into the biologically-compatible, resorbable material;

wherein the sheet includes two or more layers configured to degrade in vivo at different rates;

wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sheet.

77. A biologically-compatible sleeve comprising:

a sheet of a biologically-compatible, resorbable, material comprising about 30% polycaprolactone and about 70% polyactic acid, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet;

a first end openable for receiving the medical implant;

a second end; and

a drug impregnated into the biologically-compatible, resorbable material.

78. A biologically-compatible sleeve comprising:

a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the plurality of apertures have a combined open area that is about 20% of a total surface area of the sheet;

a first end openable for receiving the medical implant;

a second end; and

a drug impregnated into the biologically-compatible, resorbable material.

79. A biologically-compatible sleeve comprising:

a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the plurality of apertures each have a diameter of at least 1.5 mm;

a first end openable for receiving the medical implant;

a second end; and

a drug impregnated into the biologically-compatible, resorbable material.

80. A biologically-compatible sleeve comprising:

a body made of a biologically-compatible, resorbable, material and defining an internal cavity configured to receive a medical implant, the body defining a plurality of apertures extending from the cavity through the body;

a first end openable for receiving the medical implant;

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

a drug impregnated into the biologically-compatible, resorbable material;

wherein the sleeve includes a top and bottom, at least a portion of the top or bottom being substantially planar.

81. The sleeve of claim 80, 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.

82. The sleeve of claim 81, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the body.

83. The sleeve of claim 81, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the body.

84. The sleeve of claim 80, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

85. The sleeve of claim 80, wherein the plurality of apertures are round perforations.

86. The sleeve of claim 80, wherein the sleeve has a thickness of about 0.02 mm to about 0.5 mm.

87. The sleeve of claim 80, wherein the sleeve has a thickness of about 0.1 mm.

88. The sleeve of claim 80, wherein the biologically-compatible, resorbable material comprises polycaprolactone.

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

90. The sleeve of claim 80, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the body.

91. A biologically-compatible sleeve comprising:

a body made of a biologically-compatible, resorbable, material and defining an internal cavity configured to receive a medical implant, the body defining a plurality of apertures extending from the cavity through the body;

a first end openable for receiving the medical implant;

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

a drug impregnated into the biologically-compatible, resorbable material;

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.

92. The sleeve of claim 91, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

93. The sleeve of claim 91, wherein the plurality of apertures are round perforations.

94. The sleeve of claim 91, wherein the sleeve has a thickness of about 0.02 mm to about 0.5 mm.

95. The sleeve of claim 91, wherein the sleeve has a thickness of about 0.1 mm.

96. The sleeve of claim 91, wherein the biologically-compatible, resorbable material comprises polycaprolactone.

97. The sleeve of claim 91, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the body.

98. The sleeve of claim 91, wherein the drug comprises an antibiotic.

99. The sleeve of claim 91, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the body.

100. A biologically-compatible sleeve comprising:

a body made of a biologically-compatible, resorbable, material and defining an internal cavity configured to receive a medical implant, the body defining a plurality of apertures extending from the cavity through the body, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sleeve;

a first end openable for receiving the medical implant;

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

a drug impregnated into the biologically-compatible, resorbable material.

101. The sleeve of claim 100, wherein the sleeve includes a pocket at each end configured and adapted to receive a portion of the medical implant.

102. The sleeve of claim 100, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

103. The sleeve of claim 100, wherein the plurality of apertures are round perforations.

104. The sleeve of claim 100, wherein the sleeve has a thickness of about 0.02 mm to about 0.5 mm.

105. The sleeve of claim 100, wherein the sleeve has a thickness of about 0.1 mm.

106. The sleeve of claim 100, wherein the biologically-compatible, resorbable material comprises polycaprolactone.

107. The sleeve of claim 100, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the body.

108. The sleeve of claim 107, wherein the drug comprises an antibiotic.

109. The sleeve of claim 100 further comprising:

a third end openable for receiving the medical implant and facing the first end; and

a fourth end which is closed for retaining the medical implant,

wherein the fourth end and the second are configured to each form a pocket that is configured and adapted to receive a portion of the medical implant.

110. The sleeve of claim 100, wherein the internal cavity includes a shape that is complementary with a shape of the medical implant.

111. The sleeve of claim 100, wherein the medical implant is an orthopedic implant.

112. The sleeve of claim 111, wherein the orthopedic implant is a tibial nail.

113. The sleeve of claim 111, wherein the orthopedic implant is a femoral nail.

114. The sleeve of claim 111, wherein the orthopedic implant is a spinal implant.

115. The sleeve of claim 100, wherein the medical implant is an uncoated implant.

116. The sleeve of claim 100, wherein the medical implant is a bone fixation plate.

117. The sleeve of claim 100, wherein the medical implant is an intramedullary nail.

118. The sleeve of claim 100, wherein the medical implant is an elongate bone plate.

119. A biologically-compatible sleeve comprising:

a body made of a biologically-compatible, resorbable, material and defining an internal cavity configured to receive a medical implant, wherein the medical implant is an orthopedic implant, the body defining a plurality of apertures extending from the cavity through the body;

a first end openable for receiving the orthopedic implant;

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

a drug impregnated into the biologically-compatible, resorbable material.

120. The sleeve of claim 119, wherein the sleeve includes a top and bottom, at least a portion of the top or bottom being substantially planar.

121. The sleeve of claim 120, wherein the biologically-compatible, resorbable, material is a resorbable sheet, wherein the resorbable sheet comprises a polymer.

122. The sleeve of claim 121, 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.

123. The sleeve of claim 122, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the body.

124. The sleeve of claim 123, wherein the drug comprises an antibiotic.

125. The sleeve of claim 119, 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.

126. The sleeve of claim 125, wherein the sleeve includes a top and bottom, at least a portion of the top or bottom being substantially planar.

127. The sleeve of claim 119, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

128. The sleeve of claim 119, wherein the plurality of apertures are round perforations.

129. The sleeve of claim 119, wherein the sleeve has a thickness of about 0.02 mm to about 0.5 mm.

130. The sleeve of claim 119, wherein the sleeve has a thickness of about 0.1 mm.

131. The sleeve of claim 119, wherein the biologically-compatible, resorbable material comprises polycaprolactone.

132. The sleeve of claim 119, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the body.

133. The sleeve of claim 119, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the body.

134. The sleeve of claim 119, wherein the sleeve includes a pocket at each end configured and adapted to receive a portion of the orthopedic implant.

135. The sleeve of claim 119 further comprising:

a third end openable for receiving the orthopedic implant and facing the first end; and

a fourth end which is closed for retaining the orthopedic implant,

wherein the fourth end and the second are configured to each form a pocket that is configured and adapted to receive a portion of the orthopedic implant.

136. The sleeve of claim 119, wherein the internal cavity includes a shape that is complementary with a shape of the medical implant.

137. The sleeve of claim 119, wherein the orthopedic implant is a tibial nail.

138. The sleeve of claim 119, wherein the orthopedic implant is a femoral nail.

139. The sleeve of claim 119, wherein the orthopedic implant is a spinal implant.

140. The sleeve of claim 119, wherein the orthopedic implant is an uncoated implant.

141. The sleeve of claim 119, wherein the orthopedic implant is a bone fixation plate.

142. The sleeve of claim 119, wherein the orthopedic implant is an intramedullary nail.

143. The sleeve of claim 119, wherein the orthopedic implant is an elongate bone plate.

144. The sleeve of claim 119, wherein the biologically-compatible, resorbable, material is a resorbable sheet, wherein the resorbable sheet comprises a polymer.

145. The sleeve of claim 144, wherein the biologically-compatible, resorbable, material comprises at least two sheets of resorbable material that are laminated together.

146. The sleeve of claim 145, wherein at least one sheet is microporous.

147. The sleeve of claim 145, wherein the at least two sheets include different drugs.

148. The sleeve of claim 145, wherein the at least two sheets contain the same drug.

149. The sleeve of claim 144, wherein the sheet includes two or more layers.

150. The sleeve of claim 149, wherein the two or more layers are configured to release the drug at different rates.

151. The sleeve of claim 149, wherein at least two of the two or more layers are configured to degrade in vivo at different rates.

152. The sleeve of claim 144, wherein the sheet has a thickness of about 0.02 mm to about 0.5 mm.

153. The sleeve of claim 144, wherein the sheet has a thickness of about 0.1 mm.

154. The sleeve of claim 144, wherein the sheet comprises polycaprolactone.

155. The sleeve of claim 144, wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sheet.

156. The sleeve of claim 144, wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the sheet.

157. The sleeve of claim 144, wherein the sheet is molded.

158. The sleeve of claim 144, wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof.

159. The sleeve of claim 144, 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.