What is claimed is:
1. A process for making a wrapped tampon comprising the steps of:
providing a continuously moving wrapper material having a longitudinal axis, a pair of opposing longitudinal edges and a width;
attaching a tear member to said wrapper material parallel to said longitudinal axis;
positioning said wrapper material in a pre-determined rotational position;
folding said wrapper material along said longitudinal axis to overlap said pair of opposing longitudinal edges;
sealing said pair of opposing longitudinal edges together to form a longitudinal seal;
cutting said wrappper material to form a length and a pair of opposing transverse edges;
maintaining said wrapper material in said pre-determined rotational position;
sealing one of said transverse edges of said wrapper material to form a transverse seal having a width defined by a first end and a second end, said tear member extending into said transverse seal adjacent to said first end;
providing a tampon having an axial length, a radial circumference, and an insertion end opposed to a withdrawal end;
inserting said tampon into said wrapper material; and
sealing said opposing transverse edge of said wrapper material to form a transverse seal having a width defined by a first end and a second end, said tear member extending into said transverse seal adjacent to said first end.
2. The process according to claim 1, wherein the wrapper material is maintained in a pre-determined rotational position by a rotating cam of a wheel.
3. The process according to claim 1, wherein the wrapper material is maintained in a pre-determined rotational position by aligning said wrapper material with a port on a slotted drum.
4. The process according to claim 1, wherein the wrapper material is maintained in a pre-determined rotational position by a applying a means selected from the group consisting of vacuum, brushes, air nozzles and combinations thereof.
5. The process according to claim 1 wherein said wrapper material provided comprises a graphic registered along said tear member.
6. The process according to claim 1 wherein one of said transverse seals is a tear-initiating end, wherein said tampon may be inserted such that the withdrawal end of the tampon is oriented within said wrapper material adjacent to the tear-initiating end.
7. The process according to claim 1 wherein said tear member is a bead of glue.
8. The process according to claim 1 wherein said tear member is a thread.
9. The process according to claim 1 wherein said tear member is located within about 3 mm of said first ends of said transverse seals.
10. The according to claim 1 wherein said tear member is located within about 2 mm of said first ends of said transverse seals.
11. A process for making a wrapped tampon comprising the steps of:
providing a continuously moving wrapper material having a longitudinal axis, a pair of opposing longitudinal edges, a width and an attached tear member, said tear member being parallel to said longitudinal axis;
positioning said wrapper material in a pre-determined rotational position;
folding said wrapper material along said longitudinal axis to overlap said pair of opposing longitudinal edges;
sealing the pair of opposing overlapping longitudinal edges together to form a longitudinal seal;
cutting said wrappper material to form a length and a pair of opposing transverse edges;
maintaining said wrapper material in said pre-determined rotational position;
sealing one of said transverse edges of said wrapper material to form a transverse seal having a width defined by a first end and a second end; said tear member extending into said transverse seal adjacent to said first end;
providing a tampon having an axial length, a radial circumference, and an insertion end opposed to a withdrawal end;
inserting said tampon into said wrapper material;
sealing said opposing transverse edge of said wrapper material to form a transverse seal having a width defined by a first end and a second end, said tear member extending into said transverse seal adjacent to said first end.
12. The process according to claim 11, wherein the wrapper material is maintained in a pre-determined rotational position by a rotating cam of a wheel.
13. The process according to claim 11, wherein the wrapper material is maintained in a pre-determined rotational position by aligning said wrapper material with a port on a slotted drum.
14. The process according to claim 11, wherein the wrapper material is maintained in a pre-determined rotational position by a applying a means selected from the group consisting of vacuum, brushes, air nozzles and combination thereof.
15. The process according to claim 11 wherein said wrapper material provided comprises a graphic registered along said tear member.
16. The process according to claim 11 wherein on2 of said transverse seals is a tear-initiating end, wherein said tampon may be inserted such that the withdrawal end of the tampon is oriented within said wrapper material adjacent to the tear-initiating end.
17. The process according to claim 11 wherein said tear member is a bead of glue.
18. The process according to claim 11 wherein said tear member is a thread.
19. The process according to claim 11 wherein said tear member is located within about 13 mm of said first ends of said transverse seals.
20. The process according to claim 11 wherein said tear member is located within about 2 mm of said first ends of said transverse seals.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A prosthetic device for insertion into an intervertebral space defined by adjacent vertebrae, comprising:
a first articulation member having a first articulating surface and a first attachment surface;
a second articulation member having a second articulating surface and a second attachment surface, the second articulating surface being configured to cooperate with the first articulating surface to permit articulating motion;
connecting means for securing the top and bottom articulation members relative to each other; and
an expandable member connected to the first articulation member and configured to support and position the first articulation member within the intervertebral space.
2. The prosthetic device of claim 1, wherein the connecting means rigidly connects the first and second articulation members.
3. The prosthetic device of claim 1, wherein the connecting means is removably connected to the first and second articulation members.
4. The prosthetic device of claim 1, comprising a second expandable member connected to the second articulation member and configured to support and position the second articulation member within the intervertebral space.
5. The prosthetic device of claim 1, wherein the expandable member is configured to be at least partially disposed between the first attachment surface of the first articulation member and at least one of the adjacent vertebrae.
6. The prosthetic device of claim 1, wherein the first articulation member is a projection and the second articulation member is a recess.
7. The prosthetic device of claim 1, wherein the expandable member is a sack secured to the first articulation member.
8. The prosthetic device of claim 1, wherein the expandable member is formed of a woven material.
9. The prosthetic device of claim 1, comprising a filling material configured to be introduced into the expandable member.
10. The prosthetic device of claim 9, wherein the filling material is polymethylmethacrylate (PMMA).
11. The prosthetic device of claim 9, wherein the filling material includes reinforcing material.
12. The prosthetic device of claim 9, wherein the filling material includes radiographic material.
13. The prosthetic device of claim 12, wherein the radiographic material includes at least one of beads and wires.
14. The prosthetic device of claim 1, wherein the first and second articulation members are ceramic.
15. The prosthetic device of claim 1, wherein the expandable member includes projections configured to engage at least one vertebrae.
16. The prosthetic device of claim 1, wherein the expandable member is semi-permeable.
17. The prosthetic device of claim 1, wherein the expandable member includes a bone growth promoting material.
18. The prosthetic device of claim 1, wherein the expandable member includes:
a ruffle extending about a perimeter; and
stakes configured to connect the ruffle to at least one vertebrae
19. The prosthetic device of claim 1, including tacks configured to extend through at least a portion of the expandable member and connect the expandable member to at least one vertebrae.
20. A prosthetic device for insertion into an intervertebral space defined by adjacent vertebrae, comprising:
a first articulation member having a first articulating surface and a first attachment surface;
a second articulation member having a second articulating surface and a second attachment surface, the second articulating surface being configured to cooperate with the first articulating surface to permit articulating motion;
an expandable member connected to the first articulation member and configured to support and position the first articulation member within the intervertebral space; and
a substance injector associated with at least one of the first and second articulation members and being configured to introduce a filling material into the expandable member to expand the expandable member.
21. The prosthetic device of claim 20, wherein the substance injector is integral with the expandable member.
22. The prosthetic device of claim 20, wherein the substance injector is removably secured to the expandable member.
23. A method of inserting a prosthetic device into an intervertebral space defined by adjacent vertebrae, comprising:
placing an first articulation member having a first articulating surface and a first attachment surface into the intervertebral space with a first instrument;
placing a second articulation member having a second articulating surface and a second attachment surface into the intervertebral space with a second instrument; and
expanding an expandable member connected to the first articulation member to support and position the first articulation member such that the first articulating surface and the second articulating surface cooperate to permit articulating motion.
24. The method of claim 23, including orienting the first and second instruments to locate the first articulation member relative to the second articulation member.
25. The method of claim 24, wherein orienting the first and second instruments includes aligning the instruments adjacent each other.
26. The method of claim 23, including connecting the first and second instruments to locate the first articulation member relative to the second articulation member.
27. The method of claim 26, wherein connecting the first and second instruments includes nesting the first and second instruments together.
28. The method of claim 23, wherein placing the first articulation member and placing the second articulation member are done simultaneously.
29. The method of claim 23, wherein at least one of the first and second instruments are substance injectors.
30. The method of claim 29, including manipulating the first articular member with the at least one substance injector to align the placed first and second articulation members.
31. The method of claim 23, including expanding a second expandable member connected to the second articulation member to support and position the second articulation member.
32. The method of claim 23, wherein expanding the expandable member includes introducing a filling material to an interior of the expandable member.
33. The method of claim 23, wherein expanding the expandable member includes introducing a filling material through a pre-attached substance injector.
34. The method of claim 33, including removing the pre-attached substance injector after expanding the expandable member.
35. The method of claim 23, wherein placing the first and second articulation members includes aligning the articulation members to provide the articulating motion.
36. The method of claim 23, wherein the expandable member is semi-permeable, and expanding an expandable member includes flowing the filling material at least partially through the semi-permeable expandable member.
37. The method of claim 23, including securing the expandable member to an adjacent vertebrae.
38. The method of claim 37, including driving a stake through a ruffle extending about the expandable member and into the vertebrae.
39. The method of claim 37, including forcing tacks through at least a portion of the expandable member to the at least one vertebrae.
40. A kit for a prosthetic device for insertion into an intervertebral space defined by adjacent vertebrae, comprising:
an first articulation member having a first articulating surface and a first attachment surface;
an expandable member connected to the first articulation member and configured to support and position the articulation member within the intervertebral space; and
a filling material for introduction to the expandable member.
41. A system for relieving back pain comprising:
a prosthetic device for insertion into an intervertebral space defined by adjacent vertebrae, including:
a first articulation member having a first articulating surface and a first attachment surface;
a second articulation member having a second articulating surface and a second attachment surface, the second articulating surface being configured to cooperate with the first articulating surface to permit articulating motion; and
an expandable member connected to the first articulation member and configured to support and position the first articulation member within the intervertebral space; and
connecting means configured to selectively secure the first articulation member relative to the second articulation member.
42. The system of claim 41, wherein the connecting means is a clip.
43. The system of claim 41, wherein the connecting means includes a first and a second instrument.
44. The system of claim 43, wherein the first instrument is configured to connect to the first articulation member and the second instrument is configured to connect to the second articulation member.
45. The system of claim 44, wherein the first and second instruments are configured to attach together to locate the first articulation member relative to the second articulation member.
46. The system of claim 45, wherein the first and second instruments are configured to attach together by nesting.
47. A method of inserting a prosthetic device into an intervertebral space defined by adjacent vertebrae, comprising:
placing an first articulation member having a first articulating surface and a first attachment surface into the intervertebral space;
placing a second articulation member having a second articulating surface and a second attachment surface into the intervertebral space; and
driving a securing member from an interior of an expandable member into at least one of the vertebrae.
48. The method of claim 47, including rotating the securing member within the expandable member with an instrument.
49. A prosthetic device for insertion into an intervertebral space defined by adjacent vertebrae, comprising:
a first articulation member having a first articulating surface and a first attachment surface;
a second articulation member having a second articulating surface and a second attachment surface, the second articulating surface being configured to cooperate with the first articulating surface to permit articulating motion, wherein the first and second articulation members are pre-connected to each other; and
an expandable member connected to the first articulation member and configured to support and position the first articulation member within the intervertebral space.
50. The prosthetic device of claim 49, including at least one of a clip and a connector to pre-connect the first and second articulation members.