PARANASAL SINUS ACCESS IMPLANT DEVICES AND RELATED PRODUCTS AND METHODS

Abstract

A paranasal sinus access implant device may include one or more material or geometric features that may enhance performance of one or more portions of the implant device, for example an exposed surface including an antimicrobial agent. Various products and methods may include or use such an implant device.

Claims

1. A paranasal sinus access implant device useful for implantation in a human to fluidly connect a lacrimal apparatus to a paranasal sinus through a fistula formed between the lacrimal apparatus and the paranasal sinus, the implant device comprising: a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted; a length longitudinally along the implant device between the proximal end and the distal end in a range of from 2 millimeters to 50 millimeters; a conduit, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted, the conduit comprising a distal portion to be disposed in the paranasal sinus when the implant device is implanted; a head located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted; an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters; wherein at least one of the head and the distal portion of the conduit comprises an exposed surface of exposed material, the exposed surface having an average roughness (Ra) of not larger than 200 nanometers.

2. An implant device according to claim 1, wherein a said exposed surface has an area of at least 3 square millimeters.

3. An implant device according to either one of claim 1 and claim 2, wherein a said exposed surface is on an exterior of the distal portion of the conduit, which distal portion of the conduit is to be disposed in the paranasal sinus when the implant device is implanted.

4. An implant device according to claim 3, wherein a said exposed surface extends for at least 2 millimeters along a longitudinal length of the conduit adjacent to the distal end.

5. An implant device according to either one of claim 3 or claim 4, wherein a said exposed surface extends entirely around an exterior circumference of the distal portion of the conduit.

6. An implant device according to any one of claims 1-5, wherein a said exposed surface is on an exterior of the head.

7. An implant device according to claim 6, wherein a said exposed surface is on a surface of the head to be disposed toward tissue adjacent the fistula when the implant device is implanted.

8. An implant device according to either one of claim 6 and claim 7, wherein a said exposed surface is on a surface of the head to be disposed away from tissue adjacent the fistula when the implant device is implanted.

9. An implant device according to any one of claims 6-8, wherein a said exposed surface extends over essentially all of the exterior of the head.

10. An implant device according to any one of claims 6-9, wherein the exposed material has a hardness of not larger than Shore A 45 durometer.

11. An implant device according to any one of claims 1-10, wherein a said exposed surface extends over essentially all of the exterior of the conduit.

12. An implant device according to any one of claims 1-11, wherein a said exposed surface extends over essentially all of the exterior of the implant device.

13. An implant device according to any one of claims 1-12, wherein the Ra is as determined by optical non-contact profilometry.

14. An implant device according to any one of claims 1-13, wherein the Ra is not larger than 50 nanometers.

15. An implant device according to any one of claims 1-14, wherein the Ra is at least 1 nanometer.

16. An implant device according to any one of claims 1-15, wherein the Ra is not larger than 35 nanometers.

17. An implant device according to any one of claims 1-16, wherein the exposed material comprises a silicone material.

18. An implant device according to any one of claims 1-17, wherein the conduit comprises a first material having a first hardness and the head comprises a second material having a second hardness that is smaller than the first hardness.

19. An implant device according to any one of claims 1-17, wherein the distal portion of the conduit comprising a structural portion of a first material having a first hardness and a skin portion supported by the structural portion, the skin portion including an a second material having a second hardness that is smaller than the first hardness.

20. An implant device according to any one of claims 1-17, wherein the head comprises a structural portion of a first material having a first hardness and a skin portion supported by the structural portion, the skin portion including a second material having a second hardness that is smaller than the first hardness.

21. An implant device according to either one of claim 19 or claim 20, wherein the skin portion has a depth below the exposed surface in a range of from 10 microns to 200 microns.

22. An implant device according to any one of claims 19-21, wherein the head and the distal portion of the conduit each includes a said structural portion and a said skin portion supported by a said structural portion.

23. An implant device according to any one of claims 18-22, wherein the exposed material is a said second material.

24. An implant device according to any one of claims 18-23, wherein the first material has a hardness in a range of from Shore A 50 durometer to Shore A 100 durometer.

25. An implant device according to any one of claims 18-24, wherein the first material comprises a silicone material.

26. An implant device according to claim 25, wherein the silicone material comprises polydimethylsiloxane.

27. An implant device according to any one of claims 18-26, wherein the first material comprises a polyurethane.

28. An implant device according to any one of claims 18-27, wherein the first material has a hardness that is at least 20 Shore A durometer units larger than a hardness of the second material.

29. An implant device according to any one of claims 18-28, wherein the second material has a hardness in a range of from Shore A 5 durometer to Shore A 45 durometer.

30. An implant device according to claim 29, wherein the second material comprises a silicone material.

31. An implant device according to claim 30, wherein the second material comprises a silicone hydrogel.

32. An implant device according to any one of claims 18-31, comprising a third material disposed between the first material and the second material, the third material having a third hardness that is smaller than the first hardness and larger than the second hardness.

33. An implant device according to claim 32, wherein the third hardness is at least 10 Shore A durometer units smaller than the first hardness and the second hardness is at least 10 Shore A durometer units smaller than the third hardness.

34. An implant device according to either one of claim 32 or claim 33, wherein the third harness is in a range of from Shore A 20 durometer to Shore A 50 durometer.

35. An implant device according to any one of claims 32-34, wherein the third material comprises a silicone material.

36. An implant device according to any one of claims 1-35, wherein the Ra is in a range of from 1 nanometer to 20 nanometers.

37. An implant device according to any one of claims 1-36, wherein at least a portion of the conduit is of a radiopaque material.

38. An implant device according to claim 37, wherein the radiopaque material comprises a polymeric material mixed with a radiopaque additive.

39. An implant device according to claim 38, wherein the radiopaque additive is selected from the group consisting of barium sulfate, titanium metal, tantalum metal, gold metal, platinum metal, iodine, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten metal and combinations thereof.

40. An implant device according to either one of claim 38 or claim 39, wherein the radiopaque material comprises the radiopaque additive in an amount in a range of from 1 weight % to 90 weight %.

41. An implant device according to any one of claims 37-40, wherein the radiopaque material has a radiodensity in a range of from 100 Hounsfield units to 900 Hounsfield units.

42. An implant device according to any one of claims 37-41, wherein the conduit has a radiopaque portion made of the radiopaque material, the radiopaque portion of the conduit extending for at least 5 millimeters of a longitudinal length of the conduit.

43. An implant device according to claim 42, wherein a proximal end of the radiopaque portion of the conduit is spaced at least 0.5 millimeter from the head.

44. An implant device according to claim 42, wherein the radiopaque portion of the conduit extends over the entire longitudinal length of the conduit.

45. An implant device according to any one of claims 37-44, wherein the head does not contain a radiopaque additive.

46. An implant device according to any one of claims 37-45, wherein the head is visible light translucent.

47. An implant device according to any one of claims 37-46, wherein at least a portion of the head has a radiodensity of no larger than 50 Hounsfield units.

48. An implant device according to claim 47, wherein the entire head has a radiodensity of not larger than 75 Hounsfield units.

49. An implant device according to any one of claims 37-48, wherein the head comprises flanged portions having a refractive index across the thickness of the flanged portions of no larger than 1.45.

50. An implant device according to any one of claims 1-49, wherein the head has a length dimension and a width dimension transverse to the length dimension with a ratio of the length dimension to the width dimension in a range of from 1.5 to 4 and the length dimension is in a range of from 2 millimeters to 8 millimeters.

51. An implant device according to any one of claims 1-50, wherein an exterior of the conduit comprises an anchoring surface feature including protrusion areas and recess areas and the protrusion areas are on a longitudinal portion of the conduit having a proximal end that is disposed at least 3 millimeters distal of the head.

52. An implant device according to any one of claims 1-51, wherein the length between the proximal end and the distal end of the implant device is in a range of from 8 millimeters to 30 millimeters.

53. An implant device according to any one of claims 1-52, comprising an antimicrobial agent exposed at a said exposed surface.

54. An implant device according to claim 53, wherein the antimicrobial agent comprises an antimicrobial peptide.

55. An implant device according to claim 53, wherein the antimicrobial agent comprises a member selected from the group consisting of silver, poly(ethylene oxide), polyethylene glycol and combinations thereof.

56. An implant device according to any one of claims 53-55, wherein the exposed material comprises a polymeric material impregnated with the antimicrobial agent.

57. An implant device according to any one of claims 1-56, comprising a wetting agent exposed at a said exposed surface to impart hydrophilicity to the exposed surface.

58. An implant device according to claim 57, wherein the wetting agent is selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, hyaluronic acid and combinations thereof.

59. An implant device according to claim 1, wherein: a said exposed surface is on an exterior of the head, and the said exposed surface on the head has an area of at least 2 square millimeters; and the Ra of the said exposed surface on the head is in a range of from 1 nanometer to 35 nanometers

60. An implant device according to claim 59, wherein the exposed material of the said exposed surface on the head has a hardness in a range of from Shore A 5 durometer to Shore A 45 durometer.

61. An implant device according to claim 60, wherein the conduit comprises a first material having a first hardness in a range of from Shore A 50 durometer to Shore A 100 durometer and the head comprises the exposed material as a second material.

62. An implant device according to claim 61, wherein the first material has a hardness that is at least 20 Shore A durometer units larger than a hardness of the second material.

63. An implant device according to claim 62, wherein the second material is in a skin layer of the head that has a depth below the exposed surface in a range of from 10 microns to 200 microns.

64. An implant device according to claim 62, wherein the second material comprises a silicone hydrogel.

65. An implant device according to claim 62, wherein the second material comprises a silicone material.

66. An implant device according to any one of claims 59-65, wherein the Ra is as determined by optical non-contact profilometry.

67. An implant device according to claim 66, comprising an antimicrobial peptide exposed at the said exposed surface on the head.

68. An implant device according to claim 66, comprising a wetting agent exposed at the said exposed surface on the head, wherein the wetting agent is selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, hyaluronic acid and combinations thereof.

69. An implant device according to claim 66, wherein: the conduit has a radiopaque portion made of radiopaque material, the radiopaque portion of the conduit extending for at least 5 millimeters of a longitudinal length of the conduit; the radiopaque material has a radiodensity in a range of from 100 Hounsfield units to 900 Hounsfield units; the head comprises flanged portions having a radiodensity of no larger than 50 Hounsfield units and having a refractive index of not larger than 1.45.

70. A method of making a paranasal sinus access implant device according to any one of claims 18-35, the method comprising: providing a preliminary form including a preliminary head structure and a preliminary conduit structure; and forming at least one said second material supported by one or both of the preliminary head structure and the preliminary conduit structure.

71. A product, comprising: a paranasal sinus access implant device according to any one of claims 1-69; sterile storage liquid in contact with the implant device; sterile packaging, wherein the implant device and the storage liquid are disposed within the sterile packaging.

72. A product according to claim 71, wherein all exterior surfaces of the implant device are in contact with the storage liquid; the implant device is disposed within the sterile packaging in a reservoir of the storage liquid; and the storage liquid comprises a wetting agent.

73. A product according to claim 72, wherein the wetting agent comprises hyaluronic acid.

74. A product according to any one of claims 71-73, wherein the product comprises a plurality of said implant devices and the sterile packaging comprises a plurality of sealed compartments each having disposed therein a said implant device in contact with a said storage liquid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0088] The drawings are included to aid in the understanding of various aspects of the disclosure and possible feature refinements and additional features applicable thereto. Features shown in the drawings are presented for purposes of illustration only, and are not necessarily to scale and are not necessarily detailed in every respect.

[0089] FIG. 1 is an illustration showing some example routes for an implant to provide fluid access from the lacrimal apparatus to a paranasal sinus.

[0090] FIG. 2 shows perspective, top, side and end views of an embodiment of an implant device.

[0091] FIG. 3 shows perspective, top, side and end view of an embodiment of an implant device showing some possible example dimensions.

[0092] FIG. 4 shows perspective, top, side and end views of an embodiment of an implant device.

[0093] FIG. 5 shows perspective, top, side and end view of an embodiment of an implant device showing some possible example dimensions.

[0094] FIG. 6 is a perspective view of an embodiment of an implant device.

[0095] FIG. 7 is a side view of an embodiment of an implant device.

[0096] FIG. 8 is a side view of an embodiment of an implant device.

[0097] FIG. 9 is a side view of an embodiment of a preliminary implant device form.

[0098] FIG. 10 is a side view of an embodiment of a modified implant device form prepared by modification of the preliminary implant device form of FIG. 9.

[0099] FIG. 11 is a side view of a further modified implant device form prepared by modification of the modified implant device form of FIG. 10.

[0100] FIG. 12 is a sectional view of a portion of the head of the modified implant device form of FIG. 11.

[0101] FIG. 13 is a side view of a further modified implant device form prepared by modification of the modified implant device form of FIG. 11.

[0102] FIG. 14 is a sectional view through a portion of the conduit of the modified implant device form of FIG. 13.

[0103] FIG. 15 is a further modified implant device form prepared by modification of the modified implant device form of FIG. 13.

[0104] FIG. 16 is sectional view of an embodiment of a preliminary implant device form.

[0105] FIG. 17 is a sectional view of an embodiment of a modified implant device form prepared by modification of the preliminary implant device form of FIG. 16.

[0106] FIG. 18 is a sectional view of an embodiment of an implant device.

[0107] FIGS. 19 and 20 are side views of an embodiment of an implant device including a conduit extension portion in a fully contracted and fully extended configuration, respectively.

[0108] FIGS. 21-26 illustrate another embodiment of an implant device.

[0109] FIG. 27 is an illustration showing an embodiment for placement of an implant device with a head of the implant device located within the lacrimal apparatus in the orbit.

[0110] FIG. 28 is an illustration showing use of a surgical tool, in the form of a carrier tool, for implantation of an implant device during a surgical procedure.

[0111] FIG. 29 is an illustration showing placement of an implant device following implantation during a surgical procedure.

DETAILED DESCRIPTION

[0112] The terms “lacrimal apparatus” and “lacrimal system” are used interchangeably herein to refer to the collection of physiological components that accomplish the production and secretion of lacrimal fluid to lubricate the eyeball, containment of lacrimal fluid in a reservoir of lacrimal fluid in the orbit and drainage of lacrimal fluid from the orbit to the nasal cavity. The lacrimal apparatus includes the lacrimal glands, the tear drainage system and the reservoir of lacrimal fluid located between the lacrimal glands and the tear drainage system. The reservoir of lacrimal fluid includes the eyelid margins and the conjunctival sac (and including the pool of tears in the lower conjunctival cul-de-sac that is sometimes referred to as the lacrimal lake). The tear drainage system includes the puncta, canaliculi and nasolacrimal duct (including the so-called lacrimal sac located at the top of the nasolacrimal duct) through which excess tears drain to Hasner's valve and into the nasal cavity. FIG. 1 shows generally the lacrimal apparatus. Lacrimal fluid is produced and secreted from lacrimal glands 102 to lubricate the surface of the eyeball 104 disposed within the orbit. Lacrimal fluid forms a coating over the eyeball 104 and is generally contained within the conjunctival sac (the space between the lower eyelid 106, upper eyelid 108 and eyeball 104 that is lined by the conjunctiva). Excess lacrimal fluid is conducted to the vicinity of the medial canthus (medial corner of the eye) and drains through the lacrimal puncta 110 into the lacrimal canaliculi 112 and into the lacrimal sac 114 of the nasolacrimal duct 116. The lacrimal fluid then drains from the nasolacrimal duct 116 through Hasner's valve and into the nasal cavity.

[0113] As used herein, a fistula between the lacrimal apparatus and a paranasal sinus refers to an artificially-created passage that fluidly connects the lacrimal apparatus with a paranasal sinus. Such a fistula may be surgically created. The paranasal sinuses include the frontal sinuses, maxillary sinuses, ethmoid sinuses and sphenoid sinuses, which are cavities contained within frontal, maxilla, ethmoid and sphenoid bones, respectively. The paranasal sinuses drain into the nasal cavity. FIG. 1 also shows the general proximity of the frontal sinus 122, maxillary sinus 124 and ethmoid sinus 126 relative to features of the lacrimal apparatus and some example fistula routes shown by dashed lines. A first example fistula route 130 is from the orbit to the frontal sinus. A second example fistula route 132 is from the orbit to the ethmoid sinus 126. A third example fistula route 134 is from the orbit to the maxillary sinus 124. A fourth example fistula route 136 is from the lacrimal sac 114 at the top of the nasolacrimal duct 116 to the ethmoid sinus 126. A fifth example fistula route 138 is from the nasolacrimal duct 116 at a location below the lacrimal sac 114 to the ethmoid sinus 126. A sixth example fistula route 140 is from the nasolacrimal duct 116 at a location below the lacrimal sac 114 to the maxillary sinus 124. The example fistula routes shown in FIG. 1 are for purposes of general illustration only and not to show precise locations where a fistula might be formed to connect a part of the lacrimal apparatus with the corresponding paranasal sinus. Although not shown in FIG. 1, example fistula routes to the sphenoid sinus include from the orbit to the sphenoid sinus and from the nasolacrimal duct 116 to the sphenoid sinus.

[0114] FIG. 2 shows an implant device 700 with a head 702 and a conduit 704. The conduit 704 includes a first longitudinal portion 706 and a second longitudinal portion 708 disposed distal of the first longitudinal portion 706. The first longitudinal portion 706 includes a smooth exterior surface and the second longitudinal portion 708 includes an anchoring surface feature including anchor protrusions 710, in the form of spaced circumferential ridges, and recess areas 712 between the anchor protrusions 710. The length of the first longitudinal portion 706, located before the beginning of the anchoring surface feature of the second longitudinal portion 708, may advantageously be disposed in conjunctival tissue adjacent the head 702 when implanted to “float” for patient comfort and to facilitate performance of post-implantation medical procedures without disruption of implant anchor stability. The anchoring features of the second longitudinal portion 708 may advantageously be located a distance from the head 702 so that one or more of the anchor protrusions 710 are located in the vicinity of the paranasal sinus bone wall that is penetrated by the implant device 700 when implanted, preferably with one or more of the anchor protrusions disposed on each side of the bone. In the embodiment shown in FIG. 2, the exterior width of the conduit 704 is substantially the same for the whole length of the first longitudinal portion 706 and in the recess areas 712 of the second longitudinal portion 708. The conduit 704 has a circular cross-section, so that the exterior width of the conduit 704 at any location along the conduit 704 is represented by the diameter of the circular cross-section of the conduit 704 at that location. As shown in FIG. 2, the implant device 700 has a length 714 from a proximal end 716 to a distal end 718 of the implant device 700. The beginning of the second longitudinal portion 708 is located a distance 720 distal from the proximal end 716. The anchor protrusions 710 have a width 722 at the base of the anchor protrusions 722 and a height 724 above the adjacent recess areas 712. The anchor protrusions 710 are spaced on a center-to-center spacing 726. The conduit 704 has a maximum exterior width 728 corresponding with the tops of the anchor protrusions 710, equal to the diameter of the circle of the cross-section through the conduit 704 at the top of the anchor protrusions 710. The conduit 704 has a minimum exterior width 730 along the length of the first longitudinal portion 706 and in the recess areas 712 of the second longitudinal portion 708 of the conduit 704, and which is equal to the diameter of the circular cross-section at those locations. The head 702 has a length dimension 732, a width dimension 734 and a depth dimension 736. The implant device 700 has an internal passage 738 extending between the proximal end 716 and the distal end 718 and through the length of the conduit 704. The internal passage 738 has a width 740, which in this embodiment is equal to a diameter of the circular cross-section of the internal passage 738. FIG. 3 shows the same implant device 700 as shown in FIG. 2 with some exemplary dimensions, in millimeters, for one nonlimiting example for a configuration for the implant device 702.

[0115] FIG. 4 shows an implant device 800 that is similar to the implant device 700 shown in FIGS. 2 and 3, except including a first longitudinal portion of a conduit having a thicker wall than recess areas of the anchoring surface feature of a second longitudinal portion of the conduit. The thicker wall in the first longitudinal portion of the conduit provides added rigidity to that portion of the conduit to facilitate pushing the implant device 800 into place during an implantation procedure, while the thinner wall in the recess areas of the second longitudinal portion of the conduit permit that portion to more easily deform and fit through a fistula during implantation and then to expand to engage tissue and anchor the implant device 800. More specifically as shown in FIG. 4, the implant device 800 includes a head 802 and a conduit 804. The conduit 804 has a first longitudinal portion 806 and a second longitudinal portion 808 located distal of the first longitudinal portion 806. The first longitudinal portion 806 includes a substantially smooth exterior surface with a substantially constant exterior width, which is the diameter of the circular cross-section of the conduit 804 along the first longitudinal portion 806. The second longitudinal portion 808 includes an anchoring surface feature including anchor protrusions 810, in the form of circumferential ridges, and recess areas 812 in the spaces between the anchor protrusions 810. Various dimensions of the implant device 802 are illustrated in FIG. 4, similar to the illustration provided for the implant device 700 in FIG. 2. The implant device 800 has a length 814 from a proximal end 816 to a distal end 818 of the implant device 800. The beginning of the second longitudinal portion 808 is located a distance 820 distal of the proximal end 816. The anchor protrusions have a width 822 at the base and a height 824 above the adjacent recess areas 812. The anchor protrusions are spaced on a center-to-center spacing 826. The conduit 804, and also the second longitudinal portion 808, has a maximum exterior width 828 occurring at the tops of the anchor protrusions 810, and equal to the diameter of the circular cross-section of the conduit 804 through the tops of the anchor protrusions 810. The conduit 804, and the second longitudinal portion 808, of the conduit 804 have a minimum exterior width 830 located at the recess areas 812. The head 802 has a length dimension 832, a width dimension 834 and a depth dimension 836. The implant device 800 has an internal passage 838 extending between the proximal end 816 and the distal end 818 and through the length of the conduit 804. The internal passage 838 has a width 840, which in the embodiment shown in FIG. 4 is equal to a diameter of the circular cross-section of the internal passage 838.

[0116] With continued reference to FIG. 4, the wall thickness of the conduit 804, (thickness of the wall between the internal passage 838 and the exterior surface of the conduit 804) is greater along the first longitudinal portion 806 than in the recess areas 812 of the second longitudinal portion 808. The internal passage 838 has a constant width along the length of the conduit 804, such that the greater wall thickness of the conduit 804 along the first longitudinal portion 806 results in an exterior width 842 that is larger than the minimum exterior width 830 in the recess areas 812. The maximum exterior width 828 at the anchor protrusions 810 is larger than the exterior width 842 along the first longitudinal portion 806. FIG. 5 shows some exemplary dimensions, in millimeters, for one nonlimiting example for a configuration of the implant device 800.

[0117] FIG. 6 shows a variation on the implant device 800 of FIG. 4. The implant device 800′ variation of FIG. 6 has the same features as the implant device 800 of FIG. 4, except that the implant device 800′ includes a plurality of side openings 850 (which may also be referred to as holes, apertures or ports) through the wall of a distal portion of the conduit 804′. The side openings 850 may be located on a portion of the conduit wall that would be disposed in the paranasal sinus when the implant device 800′ is implanted, such that the side openings 850 may provide a passage for fluid communication between the internal passage of the implant device 800′ and the paranasal sinus even if the distal opening of the internal passage at the distal end of the conduit 804′ were to become blocked or restricted for some reason. In the particular implementation shown in FIG. 6 for the implant device 800′, the side openings 850 are located in a recess area between a pair of circumferential ridges of an anchoring surface feature of the conduit 804′. FIG. 6 shows the side openings 850 located in only one recess area between one pair of circumferential ridges, but one or more similar side openings could also or alternatively be located in a more proximal recess area between a different pair of the circumferential ridges.

[0118] FIG. 7 shows another example variation on the implant device 800 of FIG. 4. The implant device 800″ variation shown in FIG. 7 has the same general features as the implant device 800 of FIG. 4, but with a different head design. The head 802″ shown in FIG. 7 has flanged portions with a distal side having concave surfaces 852 disposed towards the distal end of the implant device 800″. The flanged portions of the head 802″ have a proximal side with convex surfaces 854 disposed away from the distal end of the implant device 800″. The concave surfaces 852 may provide an advantage of better conforming with soft tissue within the orbit engaged by the distal side of the flanged head portions when the implant device 800″ is implanted to fluidly connect the lacrimal apparatus in the orbit with a paranasal sinus. The convex surfaces 854 also may better conform with the surface of such soft tissue when the implant device 800″ is implanted. The head 802″ may thus help reduce possibility for a foreign body sensation when the implant device 800″ is implanted.

[0119] FIG. 8 shows another example variation on the implant device 800 of FIG. 4. The implant device 800′″ variation shown in FIG. 8 has the same general features as the implant device 800 of FIG. 4, but includes a conduit 804′″ including a radiopaque portion 856 extending over a significant length of the conduit 804′″. The conduit 804′″ also includes a radiotransparent portion 858 located adjacent the proximal end of the conduit 804′″. The head 802′″ is also radiotransparent. The head 802′″ in particular is preferably clear and substantially transparent or translucent to visible light so that when the implant device 800′″ is implanted with the head 802′″ disposed in the orbit, the head 802′″ is not highly visible. In contrast, the radiopaque portion 856 of the conduit 804′″ may be easily imaged by radiation, for example by x-ray imaging, to verify the positioning of the conduit 804′″ in a patient's body when the implant device 800′″ is implanted or at any time post implantation, for example to verify proper implant placement. As an alternative to the variation shown in FIG. 8, such an implant device could be made to be entirely radiopaque, however such a variation may be not preferred for some applications due to enhanced visibility of the head 802′″, which may be generally less aesthetically pleasing to patients in which the implant device is implanted. The implant device 800′″ may be made, for example, by introducing a radiotransparent resin composition into a proximal end of a mold and a radiopaque resin composition into a distal end of the mold, with an interface between the different resin compositions forming at an intermediate location in the mold based on the relative proportions of the different resin compositions introduced into the mold. For example, such a radiopaque portion may be a resin composition including a radiopaque agent (e.g., particulate radiopaque filler), while the radiotransparent composition may include the same or a different resin (e.g., silicone or polyurethane resin).

[0120] Reference is now made to FIGS. 9-15 in relation to various examples of methods of making a paranasal sinus implant device in which a preliminary form is modified to make a modified implant device form, which modified implant device form may be a final implant device product or may be a new preliminary form to be further processed in the manufacture of a further intermediate form or a final product. FIG. 9 shows a preliminary form 860 including a preliminary head structure 862 and a preliminary conduit structure 864. The preliminary conduit structure 864 includes a first longitudinal portion 866 and a second longitudinal portion 868. First longitudinal portion 866 has a substantially smooth exterior surface with a substantially constant exterior width of circular cross-section. The second longitudinal portion 868 includes an anchoring surface feature including anchor protrusions 870, in the form of circumferential ridges, and recess areas 872 in the spaces between the anchor protrusions 870. The first longitudinal portion 866 of the preliminary conduit 864 may have a larger minimum wall thickness than the second longitudinal portion 808. The preliminary conduit 864 is illustrated with features substantially as described with respect to the conduit of the implant device shown in FIG. 4, but could be of a different design, for example with one or more features shown in any of FIG. 2-3, 6-8 or 16-26. The preliminary head structure 862 is also illustrated with features substantially as shown in FIG. 4, but could be of a different design, for example with one or more features shown in any of FIG. 2-3, 6-8 or 16-26. As shown in FIG. 9, the preliminary head structure 862 includes flash 874 around the perimeter of the preliminary head 862. For example, the preliminary implant device form 860 may be an initial mold product (e.g., from injection molding, compression molding or transfer molding) of one or more resin compositions (e.g., silicone or polyurethane resin), and the flash 874 may be formed at a joint between parts of the mold. Presence of such flash 874 may contribute to a patient experiencing a foreign body sensation when implanted. Such flash 874 may be removed to smooth the surface of the head and reduce potential for such a foreign body sensation and may also help to reduce potential for biofilm formation on the smoother surface. Such removal of the flash 874 may be effected by any removed technique, for example by trimming, cryogenic tumbling or laser ablation.

[0121] FIG. 10 shows a modified implant device form 860′ with a modified head structure 862′ after removal of the flash 874 from the preliminary implant device form 860 of FIG. 9. The preliminary conduit 864 is unaltered in FIG. 10. The modified implant device 860′ may be used as a final implant device product, or may be used as a further preliminary form that is further modified. For example, following removal of the flash 874, the modified head structure 862′ may be further modified by forming a thin layer of softer material over the modified head structure 862′, for example a layer of a silicone material that is softer than the initial structural material of the preliminary head structure 862. Such a layer of softer material may be formed, for example, by dip molding or spray molding a softer layer of material on top of the modified head structure 862′.

[0122] FIG. 11 shows an example following formation of such a softer material layer, with the implant device form now designated as a further modified form 860″. The modified implant device form 860″ includes a modified head structure 862″ that is slightly enlarged by addition of such a thin layer of softer material. As shown in the sectional view of FIG. 12, the modified head structure 862″ includes a layer of softer material 876 formed over original structural material 878 of the original head form 862 of FIG. 9. The presence of the softer material 876 may further enhance compatibility with soft tissue within the orbit when implanted, which may further help to avoid a foreign body sensation following implantation. Moreover, such a carefully applied layer of softer material 876, such as may be formed by dip coating, may have a significantly smoother exterior surface than the exterior surface of the original preliminary head structure 862 of FIG. 9 or the modified head structure 862′ of FIG. 10. Such smoother exterior surface may further assist in reducing potential for a foreign body sensation following implantation and may also reduce potential for biofilm formation on exposed surfaces of the modified head structure 862″. The modified implant device form 860″ may be used as a final implant device product, or may be used as a further preliminary form that is further modified.

[0123] In a similar manner to the formation of the layer of softer material 876 shown in FIGS. 11 and 12, the conduit may be similarly modified by forming a thin layer of softer material over a portion of the preliminary conduit structure 864. FIG. 13 shows a further modified implant device form 860′″ including a modified conduit structure 864′ including such a layer of softer material formed over a distal portion of the initial preliminary conduit structure 864 shown in FIG. 9. As shown in the sectional view of FIG. 14, the modified distal portion of the modified conduit structure 864′ includes a layer of softer material 880 over the original structural material 882 of the initial preliminary conduit structure 864. Such a layer 880 could, for example, be of a silicone material that is softer than the initial structural material of the preliminary conduit structure 864. Such a layer of softer material 880 may advantageously be provided only on a distal portion of the conduit that extends into the paranasal sinus when the implant device is implanted, although such a softer layer could be placed over other portions of the conduit as well if desired. In some preferred implementations, the harder structural material 882 would remain exposed along the portion of the conduit that passes through the wall of the paranasal bone (e.g., the ethmoid bone) and that engages soft tissue immediately proximal of such bone. The harder structural material 882 provides better mechanical interaction for anchoring an implant device. However, the softer material and smoother surface of the layer 880 may provide a reduced susceptibility to formation of biofilms thereon relative to the unmodified distal portion of the initial preliminary conduit structure 864. The modified implant device form 860′″ may be used as a final implant device product or may be used as a further preliminary form that is further modified.

[0124] Such a modified head form 862″ or modified conduit form 864′ may be further modified, for example, by applying one or more additive materials to one or both of the softer material layers 876 and 880. Such additive materials may include, for example, a wetting agent, an antimicrobial agent and/or other additive materials. FIG. 15 shows the conduit form 860′″ of FIG. 13 after further modification to apply an additive material to each of the layers of softer material 876 and 880. FIG. 15 shows the further modified implant device form 860″″ with shading on a further modified head structure 862′″ and a further modified conduit structure 864″ to show addition of such an additive material to the layer of softer material 876 and the layer of softer material 880. Depositing a wetting agent (e.g., polyvinylpyrrolidone, polyethylene glycol or hyaluronic acid) may further help to prevent biofilm formation on the modified head form 862′″ and the distal portion of the modified conduit form 864″. Such a wetting agent may be deposited from a solution, for example, by dipping or spraying, followed by drying and optionally heating to cure the composition or to improve adhesion of the wetting agent. Addition of an antimicrobial agent may further assist to reduce potential formation of biofilms on the modified head form 862′″ and the distal portion of the modified conduit form 864″. For example, a silver salt may be deposited from the solution applied by dripping or spraying, followed by drying and optionally heating. As another example, silver metal may be deposited by physical vapor deposition or chemical vapor deposition. As another example, an antimicrobial peptide may be deposited from a solution or slurry or may be covalently bonded to exposed polymer (e.g., silicone) of one or both of the softer material layers 876 and 880. As a further example, a polymeric antimicrobial agent (e.g., polyethylene oxide or polyethylene glycol) may be deposited by dip or spray coating from a solution contrary they polymeric antimicrobial agent. In some preferred implementations a wetting agent (e.g., PVP, PEG, hyaluronic acid) and antimicrobial agent (e.g., a polymeric antimicrobial agent and/or an antimicrobial peptide) may be applied together to the same surface.

[0125] Reference is now made to FIGS. 16 and 17 in relation to an example of modifying a preliminary internal passage structure of a preliminary implant device form to apply a lubricity agent to the internal passage. FIG. 16 shows an initial implant device form 884 including a head 886 and a conduit 888 and having a preliminary internal passage 890 passing through the head 886 and the conduit 888. The preliminary implant device form 884 is illustrated as having features of the implant device of FIG. 4, but it could alternatively be of a different design, for example with one or more features shown in any of FIG. 2-3, 6-15 or 18-26. FIG. 17 shows a modified implant device form 884′ with a modified internal passage structure 890′ following formation of a thin layer of or including a lubricity agent. Such a thin layer of lubricity material may be formed, for example, by casting a film of or including the lubricity agent or precursor therefore onto the walls of the preliminary internal passage 890 and then curing the cast film as necessary to form a final coating with high lubricity. Such a lubricity agent may, for example, be a fluorosilicone polymer or a very smooth silicone film (e.g., similar to layers 876 and 880). One example silicone material for such a smooth film is a film formed by reaction of ethyltriacetoxysilane. As another example, the layers of lubricity material may be deposited by chemical vapor deposition, for example a poly(p-xylylene) polymer (e.g., Parylene N or Parylene C). An internal passage could also be treated to apply an antimicrobial agent, with or without applying a lubricity agent, similar to as described in relation to FIGS. 14-15.

[0126] Reference is now made to FIG. 18 showing a cross-section of an implant device 892 having a head 894 and a conduit 896 and with an internal passage 897 extending through the head 894 and the conduit 896. The implant device 892 is illustrated with features of the implant device of FIG. 4, but it could be of a different design, for example including one or more features shown in any of FIG. 2-3, 6-17 or 19-26. The internal passage 897 of the implant device 892 has a surface geometry including rifling 898 in the form of a spiraling recess extending the along the length of the internal passage 897.

[0127] Reference is now made to FIGS. 19 and 20 illustrating one example of an extension portion on a conduit that is extendable and collapsible, or contractible, to lengthen and shorten, respectively, a longitudinal length of a distal portion of a conduit of an implant device. As shown in FIGS. 19 and 20, an implant device 500 includes a head 502 and a conduit 504, and which may have a design similar to that or including any features of an implant device shown in any of FIG. 2-18 or 21-26, except that on a distal portion of the conduit 504, the implant device 500 includes an extension portion 506 of a pleated, or accordion, structure that may be extended and contracted to lengthen and shorten, respectively, a distal portion of the conduit 504 that is to be disposed within the paranasal sinus when the implant device 500 is implanted. The extension portion 506 is shown in a fully contracted, or collapsed, configuration in FIG. 19 and in a fully extended configuration in FIG. 20.

[0128] FIGS. 21-26 show another embodiment of a paranasal sinus access implant device. The implant device 510 has a head 512 and a conduit 514 with a first longitudinal portion 516 having a larger minimum wall thickness and a second longitudinal portion 519 having a smaller minimum wall thickness. The implant device 510 has seven anchor protrusions 518 in the form of circumferential ridges and recess areas 520 between pairs of adjacent ridges. The implant device 510 has a proximal end 522 and a distal end 524 and an internal passage 526 that extends from the proximal end 522 through the head 512 and the conduit 514 to the distal end 524. Various details and dimensions for the implant device 510 are shown in FIGS. 22-26. Dimensions are shown in FIGS. 22-26 in inches and in millimeters, with the dimensions in millimeters being in brackets. As will be appreciated, compared to the implant device 800 of FIG. 4, the implant device 510 of FIGS. 21-26 has more circumferential ridges with a closer spacing between the ridges and a smaller head, and with the head 512 having concave surfaces 528 on the distal side of the flanged portions of the head 512 and having convex surfaces 530 on the proximal side of the flanged portions of the head 512 (seen best in FIG. 26). The concave surfaces 528 on each of the flanged portions of the head are in the form of a cup-shaped depression that may trap and hold liquid between soft tissue (e.g., in the orbit) and the concave surfaces 528 to maintain a hydration buffer between the flanged portions of the head 512 and the soft tissue when the implant device is implanted.

[0129] In one variation of the implant device 510, the conduit 514, or a portion of the conduit 514, may be made of a radiopaque material. For example a polymer composition containing a filler of particles of a radiopaque material. For example the conduit 514 may be made of a 70-90 Shore A durometer silicone containing 20-30% of barium sulfate particles. The head 512 may be made of a similar polymer material, but not containing radiopaque material, so that the head 512 may be clear and transparent. The head 512, conduit 514 and/or internal passage 526 may be modified in any manner as discussed previously, for example with respect to any one or more of FIGS. 9-17.

[0130] FIG. 27 shows an example of an implant device with a conduit passing through a fistula formed from the orbit subconjunctivally between the lacrimal caruncle 142 and the plica semilunaris 144, and showing an example location for the head 304 of the implant device disposed in the orbit, shown for example between the lacrimal caruncle 142 and the plica semilunaris 144.

[0131] FIGS. 28 and 29 show an example implementation of an implant device 630 to fluidly connect between the lacrimal apparatus in the orbit and the ethmoid sinus 126. To facilitate implantation, the implant device 630 is mounted on a surgical tool, in the form of an implant tool 624. The implant tool may also be referred to as a carrier tool. The implant tool 624 includes a hollow working member 626 and a hand-manipulable handle 628. The implantation tool 624 is shown with the hollow working member 626 advanced through a previously formed fistula between the lacrimal apparatus in the orbit and the paranasal sinus 126. The working member 626 may also be referred to as a carrier member. The implant tool 624 includes an internal passage passing through the handle 628 and the hollow working member 626. As shown in FIG. 28, a guide wire 620 has been threaded through the internal passage of the implant tool 624 to guide the hollow working member 626 to and through the fistula and into the ethmoid sinus 126. The implant device 630 is mounted on the hollow working member 626 of the implant tool 624. FIG. 28 shows the implant tool 624 advanced to a point where the distal end of the implant device 630 is in the vicinity of the proximal end of the fistula opening into the conjunctival sac. From this position, the implant device 630 may be advanced into the fistula with a head of the implant device 630 disposed adjacent the conjunctiva in the conjunctival sac and a distal end of the implant device 630 extending into the ethmoid sinus 626. For example, a surgeon may slide the implant device 630 down the hollow working member 626 for placement through the fistula for implantation or the surgeon may advance the handle 628 to have the handle push the implant device 630 into the fistula for implant placement. The outside diameter of the hollow working member 626 may be sized to closely fit within the inside diameter of the implant device 630 to help prevent the implant device 630 from bunching-up and laterally deforming as the implant device is pushed into the fistula. The handle 628 and the hollow working member 626 form a carrier for the implant device 630. The handle 628 may be retracted and the hollow working member 626 disengaged from the implant device 630 after the implant device has been appropriately positioned for implantation through the fistula. FIG. 29 shows the implant device 630 as implanted and following disengagement of the hollow working member 626 of the implantation tool 624. As implanted, a head 632 at the proximal end of the implant device 630 is located adjacent the conjunctiva in the conjunctival sac within the lacrimal apparatus in the orbit, and the conduit passes through the fistula across tissue including conjunctiva and a wall of the ethmoid bone in which the ethmoid sinus 126 is located. A distal end 634 of the implant device 630 is located in the ethmoid sinus 126. Some anchor protrusions 636 of the conduit of the implant device 630 are disposed within the fistula to engage tissue and help anchor the implant device 630. The implant device 630 may be used to provide access to the ethmoid sinus 126 to perform medical procedures or treatments, for example to administer a treatment composition to the ethmoid sinus or to aspirate fluid from the ethmoid sinus.

[0132] A variety of medical treatments and procedures may be performed through a paranasal sinus access implant device implanted to provide access to a paranasal sinus. Fluid treatment compositions may be administered to a paranasal sinus through the implant device. Fluid may be aspirated from a paranasal sinus through the implant device. One or more medical devices may be inserted into the paranasal sinus through the implant device.

[0133] Some example implementation combinations, and for various types of implementation applications, which may be the subject of claims with or without additional features as disclosed above, are disclosed as follows:

[0134] 1. A paranasal sinus access implant device useful for implantation in a human to fluidly connect a lacrimal apparatus to a paranasal sinus through a fistula formed between the lacrimal apparatus and the paranasal sinus, the implant device comprising:

[0135] a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted;

[0136] a length longitudinally along the implant device between the proximal end and the distal end in a range of from 2 millimeters to 50 millimeters;

[0137] a conduit, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted;

[0138] a head located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted;

[0139] an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters;

[0140] wherein the implant device comprises at least one of the following: [0141] (i) the conduit comprises a first material having a first hardness and the head comprises a second material having a second hardness that is smaller than the first hardness; [0142] (ii) the conduit comprises a distal portion to be disposed in the paranasal sinus when the device is implanted, the distal portion of the conduit comprising a structural portion of a first material having a first hardness and a skin portion supported by the structural portion, the skin portion including an a second material having a second hardness that is smaller than the first hardness; [0143] (iii) the head comprises a structural portion of a first material having a first hardness and a skin portion supported by the structural portion, the skin portion including a second material having a second hardness that is smaller than the first hardness; [0144] (iv) the head has an exposed surface of a second material having a hardness of not larger than Shore A 45 durometer; [0145] (v) the head comprises an exposed surface of a second material, the exposed surface having an average roughness (Ra) of not larger than 200 nanometers, or even not larger than 50 nanometers; [0146] (vi) the conduit comprises a distal portion to be disposed in the paranasal sinus when the device is implanted, the distal portion of the conduit comprising an exposed surface of a second material, the exposed surface having an average roughness (Ra) of not larger than 200 nanometers, or even not larger than 50 nanometers; [0147] (vii) the head comprises an exposed surface of a second material comprising a wetting agent to impart hydrophilicity to the exposed surface; [0148] (viii) the conduit comprises a distal portion to be disposed in the paranasal sinus when the device is implanted, the distal portion of the conduit comprising an exposed surface of a second material comprising a wetting agent to impart hydrophilicity to the exposed surface; [0149] (ix) the head comprises an exposed surface of a second material comprising an antimicrobial agent; [0150] (x) the conduit comprises a distal portion to be disposed in the paranasal sinus when the device is implanted, the distal portion of the conduit comprising an exposed surface of a second material comprising an antimicrobial agent; [0151] (xi) the head comprises a distal side having a concave surface disposed toward the distal end of the device; [0152] (xii) the internal passage has a surface of a second material comprising a lubricity agent; [0153] (xiii) at least a portion of the conduit is of a radiopaque material; [0154] (xiv) the internal passage has a surface geometry comprising rifling; [0155] (xv) the conduit comprises a distal extension portion that is extendable and collapsible to lengthen and shorten a longitudinal length of a distal portion of the conduit disposed in the paranasal sinus when the device is implanted; and [0156] (xvi) the implant device is packaged in sterile packaging in contact with a storage liquid.

[0157] 2. An implant device according to example implementation combination 1, comprising one or more of (i)-(iii) and wherein the first material has a hardness in a range of from Shore A 50 durometer to Shore A 100 durometer.

[0158] 3. An implant device according to example implementation combination 2, wherein the first material comprises a silicone material.

[0159] 4. An implant device according to example implementation combination 3, wherein the silicone material comprises polydimethylsiloxane.

[0160] 5. An implant device according to example implementation combination 2, wherein the first material comprises a polyurethane.

[0161] 6. An implant device according to any one of example implementation combinations 2-5 wherein the first material has a hardness that is at least 20 Shore A durometer units larger than a hardness of the second material.

[0162] 7. An implant device according to any one of example implementation combinations 1-6, comprising one or more of (i)-(x) and wherein the second material has a hardness in a range of from Shore A 5 durometer to Shore A 45 durometer.

[0163] 8. An implant device according to example implementation combination 7, wherein the second material comprises a silicone material.

[0164] 9. An implant device according to example implementation combination 7, wherein the second material comprises a silicone hydrogel.

[0165] 10. An implant device according to any one of example implementation combinations 7-9, comprising one or both of items (ii) and (iii) and wherein the skin portion has a depth below the exposed surface in a range of from 10 microns to 200 microns.

[0166] 11. An implant device according to any one of example implementation combinations 7-10, comprising one or both of (v) and (vi) and wherein the average roughness (Ra) is in a range of from 1 nanometer to 20 nanometers.

[0167] 12. An implant device according to any one of example implementation combinations 7-11, comprising one or both of (vii) and (viii) and wherein the wetting agent is selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, hyaluronic acid and combinations thereof.

[0168] 13. An implant device according to any one of example implementation combinations 7-12, comprising one or both of (ix) and (x) and wherein the antimicrobial agent comprises a member selected from the group consisting of silver, poly(ethylene oxide), polyethylene glycol and combinations thereof.

[0169] 14. An implant device according to any one of example implementation combinations 7-13, comprising one or both of (ix) and (x) and wherein the antimicrobial agent comprises an antimicrobial peptide.

[0170] 15. An implant device according to any one of example implementation combinations 7-14, comprising one or both if (ix) and (x) and wherein the second material comprises a polymeric material impregnated with the antimicrobial agent.

[0171] 16. An implant device according to any one of example implementation combinations 1-15, comprising one or more of (i)-(iii), wherein a third material is disposed between the first material and the second material, the third material having a third hardness that is smaller than the first hardness and larger than the second hardness.

[0172] 17. An implant device according to example implementation combination 16, wherein the third hardness is at least 10 Shore A durometer units smaller than the first hardness and the second hardness is at least 10 Shore A durometer units smaller than the third hardness.

[0173] 18. An implant device according to either one of example implementation combinations 16 or claim 17, wherein the third harness is in a range of from Shore A 20 durometer to Shore A 50 durometer.

[0174] 19. An implant device according to any one of example implementation combinations 16-18, wherein the third material comprises a silicone material.

[0175] 20. An implant device according to any one of example implementation combinations 1-19, comprising (xii) and wherein the lubricity agent is selected from the group consisting of a fluorosilicone, a smooth silicone film having an average roughness Ra of not larger than 50 nanometers, a poly (p-xylylene) and combinations thereof

[0176] 21. An implant device according to any one of example implementation combinations 1-20, comprising (xii) and wherein the lubricity agent is in the form of a coating on walls of the internal passage.

[0177] 22. An implant device according to example implementation combination 21, wherein the coating has a thickness in a range of from 1 micron to 50 microns.

[0178] 23. An implant device according to any one of example implementation combinations 1-22, comprising (xiii) and wherein the radiopaque material comprises a polymeric material mixed with a radiopaque additive.

[0179] 24. An implant device according to example implementation combination 23, wherein the radiopaque additive is selected from the group consisting of barium sulfate, titanium metal, tantalum metal, gold metal, platinum metal, iodine, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten metal and combinations thereof.

[0180] 25. An implant device according to either one of example implementation combination 23 or example implementation combination 24, wherein the radiopaque material comprises the radiopaque additive in an amount in a range of from 1 weight % to 90 weight %.

[0181] 26. An implant device according to any one of example implementation combinations 1-25, comprising (xiii) and wherein at least a portion of the conduit has a radiodensity in a range of from 100 Hounsfield units to 900 Hounsfield units.

[0182] 27. An implant device according to any one of example implementation combinations 1-26, comprising (xiii) and wherein the conduit has a radiopaque portion made of the radiopaque material, the radiopaque portion of the conduit extending for at least 5 millimeters of a longitudinal length of the conduit.

[0183] 28. An implant device according to example implementation combination 27, wherein a proximal end of the radiopaque portion of the conduit is spaced at least 0.5 millimeter from the head.

[0184] 29. An implant device according to example implementation combination 27, wherein the radiopaque portion extends over the entire longitudinal length of the conduit.

[0185] 30. An implant device according to any one of example implementation combinations 1-29, comprising (xiii) and wherein the head does not contain a radiopaque additive.

[0186] 31. An implant device according to any one of example implementation combinations 1-30, comprising (xiii) and wherein at least a portion of the head has a radiodensity of no larger than 50 Hounsfield units.

[0187] 32. An implant device according to example implementation combination 31, wherein the entire head has a radiodensity of not larger than 75 Hounsfield units.

[0188] 33. An implant device according to any one of example implementation combinations 1-32, wherein the head has a length dimension and a width dimension transverse to the length dimension with a ratio of the length dimension to the width dimension in a range of from 1.5 to 4.

[0189] 34. An implant device according to any one of example implementation combinations 1-33, wherein the head has a length dimension and a width dimension transverse to the length dimension, the length dimension being in a range of from 3 millimeters to 8 millimeters.

[0190] 35. An implant device according to any one of example implementation combinations 1-34, wherein an exterior of the conduit comprises an anchoring surface feature including protrusion areas and recess areas.

[0191] 36. An implant device according to either one of example implementation combination 34 or example implementation combination 35, wherein the protrusion areas are on a longitudinal portion of the conduit having a proximal end that is disposed at least 3 millimeters distal of the head.

[0192] 37. An implant device according to any one of example implementation combinations 1-36, wherein the length between the proximal end and the distal end of the device is in a range of from 8 millimeters to 30 millimeters.

[0193] 38. An implant device according to any one of example implementation combinations 1-37, wherein the extension portion comprises a pleated structure.

[0194] 39. A method of making a paranasal sinus access implant device according to any one of example implementation combinations 1-38 and 78-83, wherein the paranasal sinus access implant device comprises at least one said second material, the method comprising:

[0195] providing a preliminary form including a preliminary head structure and a preliminary conduit structure; and

[0196] forming at least one said second material supported by one or both of the preliminary head structure and the preliminary conduit structure.

[0197] 40. A method according to example implementation combination 39, wherein the implant device comprises (i), the preliminary conduit structure of the preliminary form comprises the first material as recited in (i) and the forming at least one said second material comprises:

[0198] forming over at least a portion of the preliminary head structure a said second material as recited in (i) with the exposed surface as recited in (i).

[0199] 41. A method according to either one of example implementation combination 39 or example implementation combination 40, wherein the implant device comprises (ii), the preliminary conduit structure comprises the first material as recited in (ii) and the forming at least one said second material comprises:

[0200] forming over at least a portion of said first material as recited in (ii) of the preliminary conduit structure a said second material as recited in (ii) with the exposed surface as recited in (ii).

[0201] 42. A method according to any one of example implementation combinations 39-41, wherein the implant device comprises (iii) and the preliminary head structure of the preliminary form comprises the first material as recited in (iii), and the forming at least one said second material comprises:

[0202] forming over at least a portion of said first material as recited in (iii) of the preliminary head structure a said second material as recited (iii) with the exposed surface as recited in (iii).

[0203] 43. A method according to any one of example implementation combinations 39-42, wherein the implant device comprises (iv) and the forming at least one said second material comprises:

[0204] forming over at least a portion of the preliminary head structure a said second material as recited in (iv) with the exposed surface recited in (iv).

[0205] 44. A method according to any one of example implementation combinations 39-43, wherein the implant device comprises (v) and the forming at least one said second material comprises:

[0206] forming over at least a portion of the preliminary head structure a said second material as recited in (v) with the exposed surface as recited in (v).

[0207] 45. A method according to any one of example implementation combinations 39-44, wherein the implant device comprises (vi) and the forming at least one said second material comprises:

[0208] forming over at least a portion of the preliminary conduit structure a said second material as recited in (vi) with the exposed surface as recited in (vi).

[0209] 46. A method according to any one of example implementation combinations 39-45, wherein the implant device comprises (vii) and the forming at least one said second material comprises:

[0210] forming over at least a portion of the preliminary head structure a said second material as recited in (vii) with the exposed surface as recited in (vii).

[0211] 47. A method according to any one of example implementation combinations 39-46, wherein the implant device comprises (viii) and the forming at least one said second material comprises:

[0212] forming over at least a portion of the preliminary conduit structure a said second material as recited in (viii) with the exposed surface as recited in (viii).

[0213] 48. A method according to any one of example implementation combinations 39-47, wherein the implant device comprises (ix) and the forming at least one said second material comprises:

[0214] forming over at least a portion of the preliminary head structure a said second material as recited in (ix) with the exposed surface as recited in (ix).

[0215] 49. A method according to any one of example implementation combinations 39-48, wherein the implant device comprises (x) and the forming at least one said second material comprises:

[0216] forming over at least a portion of the preliminary conduit structure a said second material as recited in (x) with the exposed surface as recited in (x).

[0217] 50. A method according to any one of example implementation combinations 39-49, wherein paranasal sinus access implant device comprises (xii), the preliminary form comprises a preliminary internal passage through the preliminary conduit structure and the preliminary head structure and the method comprises:

[0218] forming over a wall of the preliminary internal passage a said second material as recited in (xii) with the exposed surface recited in (xii).

[0219] 51. A method according to any one of example implementation combinations 39-50, wherein the providing a preliminary form comprises:

[0220] molding a polymeric composition in the shape of the preliminary form.

[0221] 52. A method according to example implementation combination 51, wherein the molding comprises a molding technique selected from the group consisting of injection molding, compression molding and transfer molding.

[0222] 53. A method according to any one of example implementation combinations 39-52, wherein the providing a preliminary form comprises:

[0223] extruding a first preliminary form and then molding additional features onto the first preliminary form to form a second preliminary form.

[0224] 54. A method according to only one of example implementation combinations 51-53, wherein the providing a preliminary form comprises:

[0225] removing flash from a molded article resulting from the molding.

[0226] 55. A method according to any one of example implementation combinations 39-54, wherein the forming at least one said second material comprises:

[0227] dip molding a said second material over at least a portion of said preliminary head structure.

[0228] 56. A method according to any one of example implementation combinations 39-55, wherein the forming at least one said second material comprises:

[0229] dip molding a said second material over at least a portion of said preliminary conduit structure.

[0230] 57. A method according to either one of example implementation combination 55 or example implementation combination 56, wherein the dip molding comprises:

[0231] applying at least a portion of the preliminary form with a precursor solution comprising at least one precursor for a said second material;

[0232] drying the applied precursor solution to leave the at least one precursor on the preliminary form; and

[0233] curing the at least one precursor to form a polymeric composition of a said second material.

[0234] 58. A method according to example implementation combination 57, wherein the polymeric composition is a thermoset composition, and the curing comprises heating the at least one precursor on the preliminary form.

[0235] 59. A method according to any one of example implementation combinations 39-58, wherein the forming at least one said second material comprises:

[0236] forming an intermediate material over at least a portion of one or both of the preliminary head structure and a preliminary conduit structure; and

[0237] after the forming an intermediate material, forming the second material over at least a portion of the preliminary material.

[0238] 60. A method according to any one of example implementation combinations 39-59, wherein the forming at least one said second material comprises:

[0239] forming a preliminary material over at least a portion of one or both of the preliminary head structure and a preliminary conduit structure; and

[0240] after the forming a preliminary material, modifying the preliminary material to form a said second material.

[0241] 61. A method according to example implementation combination 60, wherein the modifying the preliminary material comprises adding to the preliminary material an additive material.

[0242] 62. A method according to example implementation combination 61, wherein the additive material is selected from the group consisting of a said wetting agent, a said antimicrobial agent and combinations thereof.

[0243] 63. A method of treating a condition of a paranasal sinus of a patient having the implant device of any one of example implementation combinations 1-38 and 78-83 implanted to fluidly connect a lacrimal apparatus of the patient to a paranasal sinus of the patient, the method comprising the administering a treatment composition to the patient to be delivered to the paranasal sinus through the internal passage of the implant device.

[0244] 64. A product, comprising:

[0245] a paranasal sinus access implant device;

[0246] sterile storage liquid in contact with the implant device;

[0247] sterile packaging, wherein the implant device and the storage liquid are disposed within the sterile packaging.

[0248] 65. A product according to example implementation combination 64, wherein the implant device comprises:

[0249] a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted;

[0250] a length longitudinally along the implant device between the proximal end and the distal end in a range of from 2 millimeters to 50 millimeters.

[0251] a conduit, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted;

[0252] a head located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted;

[0253] an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters.

[0254] 66. A product according to either one of example implementation combination 64 and example implementation combination 65, wherein all exterior surfaces of the implant device are in contact with the storage liquid.

[0255] 67. A product according to any one of example implementation combinations 64-66, wherein all surfaces of the implant device are in contact with the storage liquid.

[0256] 68. A product according to any one of example implementation combinations 64-67, wherein the implant device is disposed within the sterile packaging in a reservoir of the storage liquid.

[0257] 69. A product according to any one of example implementation combinations 64-68, wherein the storage liquid comprises an aqueous liquid.

[0258] 70. A product according to any one of example implementation combinations 64-69, wherein the storage liquid comprises a buffer solution.

[0259] 71. A product according to any one of example implementation combinations 64-70, wherein the storage liquid comprises a wetting agent.

[0260] 72. A product according to example implementation combination 71, wherein the wetting agent comprises hyaluronic acid.

[0261] 73. A product according to any one of example implementation combinations 64-72, wherein the product comprises a plurality of said implant devices and the sterile packaging comprises a plurality of sealed compartments each having disposed therein a said implant device in contact with a said storage liquid.

[0262] 74. A product according to any one of example implementation combinations 64-73, wherein the implant device is according to any one of example implementation combinations 1-38 and 78-83.

[0263] 75. A product according to example implementation combination 74, wherein the implant device comprises (xvi).

[0264] 76. A method for implanting a paranasal sinus access implant device to fluidly connect a lacrimal apparatus and a paranasal sinus, the method comprising:

[0265] from the product of any one of example implementation combinations 64-75, removing the implant device from the sterile packaging; and

[0266] implanting the implant device with a proximal end disposed in the lacrimal apparatus and a distal end disposed in the paranasal sinus to fluidly connect the lacrimal apparatus and the paranasal sinus through an internal passage of the implant device.

[0267] 77. A method according to example implementation combination 76, wherein after the removing and at the commencement of the implanting, at least a portion of the implant device is covered with at least a residual portion of the storage liquid.

[0268] 78. An implant device according to any one of example implementation combinations 1-38, comprising a said exposed surface having has an area of at least 1 square millimeter.

[0269] 79. An implant device according to any one of example implementation combinations 1-38 and 78, comprising a said exposed surface on an exterior of the distal portion of the conduit, which distal portion of the conduit is to be disposed in the paranasal sinus when the implant device is implanted.

[0270] 80. An implant device according to example implementation combination 79, wherein a said exposed surface extends for at least 2 millimeters along a longitudinal length of the conduit adjacent to the distal end.

[0271] 81. An implant device according to either one of example implementation combination 77 and example implementation combination 80, wherein a said exposed surface extends entirely around an exterior circumference of the distal portion of the conduit.

[0272] 82. An implant device according to any one of example implementations 1-38 and 78-81, wherein the Ra is as determined by optical non-contact profilometry or by laser profilometry.

[0273] 83. An implant device according to any one of example implementations 1-38 and 78-82, wherein the head comprises flanged portions having a refractive index across the thickness of the flanged portions of not larger than 1.5.

[0274] 84. An implant device according to any one of example implementation combinations 1-38 and 78-83, wherein the implant device is implanted in a human and fluidly connects a location in the lacrimal apparatus with a paranasal sinus.

[0275] The foregoing discussion of the invention and different aspects and different example implementation combinations thereof has been presented for purposes of illustration and description. The foregoing is not intended to limit the invention to only the form or forms specifically disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and the skill or knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain best modes known for practicing the invention and to enable others skilled in the art to utilize the invention in such, or other, embodiments and with various modifications required by the particular applications or uses of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art. Although the description of the invention has included description of one or more possible implementations and certain variations and modifications, other variations and modifications are within the scope of the invention, e.g., as may be within the skill and knowledge of those in the art after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter. Furthermore, any feature described or claimed with respect to any disclosed implementation may be combined in any combination with one or more of any other features of any other implementation or implementations, to the extent that the features are not necessarily technically incompatible, and all such combinations are within the scope of the present invention.

[0276] The terms “comprising”, “containing”, “including” and “having”, and grammatical variations of those terms, are intended to be inclusive and nonlimiting in that the use of such terms indicates the presence of some condition or feature, but not to the exclusion of the presence also of any other condition or feature. The use of the terms “comprising”, “containing”, “including” and “having”, and grammatical variations of those terms in referring to the presence of one or more components, subcomponents or materials, also include and is intended to disclose the more specific embodiments in which the term “comprising”, “containing”, “including” or “having” (or the variation of such term) as the case may be, is replaced by any of the narrower terms “consisting essentially of” or “consisting of” or “consisting of only” (or the appropriate grammatical variation of such narrower terms). For example, a statement that some thing “comprises” a stated element or elements is also intended to include and disclose the more specific narrower embodiments of the thing “consisting essentially of” the stated element or elements, and the thing “consisting of” the stated element or elements. Examples of various features have been provided for purposes of illustration, and the terms “example”, “for example” and the like indicate illustrative examples that are not limiting and are not to be construed or interpreted as limiting a feature or features to any particular example. The term “at least” followed by a number (e.g., “at least one”) means that number or more than that number. The term “at least a portion” means all or a portion that is less than all. The term “at least a part” means all or a part that is less than all.

[0277] The features in the drawings are shown for illustration purposes and to generally show relative positioning and interaction, and the features shown are not necessarily to scale.