1. An apparatus calculating size tolerances of a plurality of parts constituting a structure comprising:
a tentative size tolerance setting section setting tentative size tolerances of the plurality of parts based on design data of the structure and part information of the plurality of parts;
a primary analyzing section calculating a quality of the structure and sensitivities of the plurality of parts based on the tentative size tolerances set by said tentative size tolerance setting section;
a judging section judging whether or not the quality calculated by said primary analyzing section satisfies a desired quality which the structure demands;
a secondary analyzing section calculating, if said judging section judges that the quality calculated by said primary analyzing section does not satisfy the desired quality, the size tolerances of the plurality of parts using the sensitivities calculated by said primary analyzing section such that the structure satisfies the desired quality; and
a restriction setting section for setting restrictions on the size tolerances of one or more of the plurality of parts, wherein
said secondary analyzing section sets the size tolerances of the one or more parts for which said restriction setting section sets the restrictions on the size tolerances such that the restrictions are satisfied.
2. An apparatus according to claim 1, wherein, if said judging section judges that the quality calculated by primary analyzing section satisfies the desired quality, said primary analyzing section outputs the tentative size tolerances set by said size tolerance setting section as the size tolerances.
3. An apparatus according to claim 1, further comprising an obtaining section obtaining the design data of the structure and the part information.
4. An apparatus according to claim 1, wherein said tentative size tolerance setting section sets the tentative size tolerances based on a table showing tentative size tolerances associated with sizes of the plurality of parts which sizes are included in the design data and the part information.
5. An apparatus according to claim 1, further comprising a contribution rate setting section setting contribution rates of the plurality of parts, wherein
said secondary analyzing section calculates the size tolerances based on the contribution rates calculated by said contribution rate setting section.
6. An apparatus according to claim 1, further comprising a production method selecting section selecting a production method in which each of the plurality of parts is to be produced to make the structure satisfy the desired quality.
7. An apparatus according to claim 6, wherein if there are two or more of the production methods for each said part making the structure satisfy the desired quality is to be produced, said production method selecting section selects one that costs the least among the two or more production methods.
8. An apparatus calculating size tolerances of a plurality of parts constituting a structure comprising:
a tentative size tolerance setting section setting tentative size tolerances of the plurality of parts based on design data of the structure and part information of the plurality of parts;
a primary analyzing section calculating a quality of the structure and sensitivities of the plurality of parts based on the tentative size tolerances set by said tentative size tolerance setting section;
a judging section judging whether or not the quality calculated by said primary analyzing section satisfies a desired quality which the structure demands;
a secondary analyzing section calculating, if said judging section judges that the quality calculated by said primary analyzing section does not satisfy the desired quality, the size tolerances of the plurality of parts using the sensitivities calculated by said primary analyzing section such that the structure satisfies the desired quality; and
a limit value setting section for setting limit values on the size tolerances of one or more of the plurality of parts, wherein
said secondary analyzing section calculates the size tolerances of the one or more parts within the limit values set by said limit value setting section.
9. An apparatus according to claim 8, wherein said limit value setting section sets the limit values based on a table showing limit values associated with sizes of the plurality of parts which sizes are included in the design data and the part information.
10. A computer-readable recording medium in which a program for calculating size tolerances of a plurality of parts constituting a structure is recorded, wherein said program instructs a computer to function as:
a tentative size tolerance setting section setting tentative size tolerances of the plurality of parts based on design data of the structure and part information of the plurality of parts;
a primary analyzing section calculating a quality of the structure and sensitivities of the plurality of parts based on the tentative size tolerances set by said tentative size tolerance setting section;
a judging section judging whether or not the quality calculated by said primary analyzing section satisfies a desired quality which the structure demands;
a secondary analyzing section for calculating, if said judging section judges that the quality calculated by said primary analyzing section does not satisfy the desired quality, the size tolerances of the plurality of parts using the sensitivities calculated by said primary analyzing section such that the structure satisfies the desired quality; and
a restriction setting section setting restrictions on the size tolerances of one or more of the plurality of parts, wherein
said secondary analyzing section sets the size tolerances of the one or more parts for which said restriction setting section sets the restrictions on the size tolerances such that the restrictions are satisfied.
11. A computer-readable recording medium according to claim 10, wherein if said judging section judges that the quality calculated by primary analyzing section satisfies the desired quality, said primary analyzing section outputs the tentative size tolerances set by said size tolerance setting section as the size tolerances.
12. A computer-readable recording medium according to claim 10, wherein said program instructs the computer to further function as an obtaining section obtaining the design data of the structure and the part information.
13. A computer-readable recording medium according to claim 10, wherein said tentative seize tolerance setting section sets the tentative size tolerances based on a table showing tentative size tolerances associated with sizes of the plurality of parts which sizes are included in the design data and the part information.
14. A computer-readable recording medium according to claim 10, wherein:
said program instructs the computer to further function as a contribution rate setting section setting contribution rates of the plurality of parts; and
said secondary analyzing section calculates the size tolerances based on the contribution rates calculated by said contribution rate setting section.
15. A computer-readable recording medium according to claim 10, wherein said program instructs the computer to further function as a production method selecting section selecting a production method in which each of the plurality of parts is to be produced to make the structure satisfy the desired quality.
16. A computer-readable recording medium in which a program for calculating size tolerances of a plurality of parts constituting a structure is recorded, wherein said program instructs a computer to function as:
a tentative size tolerance setting section setting tentative size tolerances of the plurality of parts based on design data of the structure and part information of the plurality of parts;
a primary analyzing section calculating a quality of the structure and sensitivities of the plurality of parts based on the tentative size tolerances set by said tentative size tolerance setting section;
a judging section judging whether or not the quality calculated by said primary analyzing section satisfies a desired quality which the structure demands;
a secondary analyzing section for calculating, if said judging section judges that the quality calculated by said primary analyzing section does not satisfy the desired quality, the size tolerances of the plurality of parts using the sensitivities calculated by said primary analyzing section such that the structure satisfies the desired quality; and
a limit value setting section setting limit values on the size tolerances of one or more of the plurality of parts, wherein
said secondary analyzing section calculates the size tolerances of the one or more parts within the limit values set by said limit value setting section.
17. A computer-readable recording medium according to claim 16, wherein said limit value setting section sets the limit values based on a table showing limit values associated with sizes of the plurality of parts which sizes are included in the design data and the part information.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
What is claimed is:
1. A surgical instrument for tissue fixation comprising:
a handpiece constructed to be held by a surgeon during a fixation procedure;
a cannulated tube defining a lumen, mounted on the handpiece;
a delivery device, constructed to be mounted on the handpiece, for delivering a flowable material through the lumen to an opening in bone; and
a suture control device for delivering a suture material from a supply to a distal end of the cannulated tube.
2. The surgical instrument of claim 1 wherein the suture control device is constructed to control the tension applied to a free end of the suture.
3. The surgical instrument of claim 1 wherein the supply of suture material is disposed within the handpiece.
4. The surgical instrument of claim 1 wherein said delivery device comprises a heating element for heating said material to a flowable state.
5. The surgical instrument of claim 4 wherein said delivery device further comprises a reservoir containing a supply of the flowable material, and said heating element is constructed to deliver heat to at least a portion of the reservoir.
6. The surgical instrument of claim 5 wherein the heating element is positioned adjacent at least a portion of the reservoir.
7. The surgical instrument of claim 5 wherein said delivery device further comprises a delivery tube in communication with the reservoir, the delivery tube being constructed to be disposed within the cannulated tube when the delivery device is mounted on the handpiece.
8. The surgical instrument of claim 7 wherein the heating element is constructed to deliver heat to the delivery tube.
9. The surgical instrument of claim 8 wherein the heating clement includes a terminal portion, adjacent a distal end of the delivery tube, which can be turned off while heat is being delivered to the remainder of the heating element, so as to allow the flowable material at the distal end of the delivery tube to solidify and shut off flow from the delivery tube.
10. The surgical instrument of claim 4 wherein said heating element comprises an elongated member having a tip constructed to deliver a polymer pellet through the lumen to the opening, the tip having an area to which heat can be delivered to melt the pellet.
11. The surgical instrument of claim 10 wherein said delivery device further comprises a plunger tube constructed to be disposed within the cannulated tube when the delivery device is mounted on the handpiece, and the elongated member is constructed to be inserted through the plunger tube.
12. The surgical instrument of claim 11, wherein said delivery device further comprises a mechanism for moving said plunger tube between an extended position and a retracted position.
13. The surgical instrument of claim 12 wherein said delivery device further comprises a mechanism for moving said elongated member between an extended position and a retracted position.
14. The surgical instrument of claim 13 wherein the mechanisms for moving the plunger tube and elongated member can be simultaneously activated by the surgeon, and operate counter to one another.
15. The surgical instrument of claim 10 wherein said heating element comprises metal tube and, within the tube, an insulated current-carrying wire, the wire and tube being joined at a distal end to form a circuit, and the metal tube including a first portion having a relatively low resistance and a second, distal portion having a relatively higher resistance.
16. The surgical instrument of claim 1 wherein said delivery device comprises an elongated plunger constructed to be extended through the cannulated tube into the opening to compact the flowable material.
17. The surgical instrument of claim 16 wherein said elongated plunger defines a lumen through which a heating element is inserted into the opening.
18. The surgical instrument of claim 1 wherein said delivery device comprises an elongated nozzle having a distal end constructed to receive a portion of suture, and a mechanism constructed to extend the nozzle out of the distal end of the cannulated tube to push the portion of the suture into the opening and to retract the nozzle after delivery of the suture.
19. The surgical instrument of claim 18 wherein said elongated nozzle is cannulated to provide a path for delivery of the flowable material to the opening.
20. The surgical instrument of claim 7 wherein, prior to initial use of the surgical instrument, the delivery tube contains a supply of the flowable material.
21. The surgical instrument of claim 1 wherein said delivery device comprises a mechanism for metering a predetermined dose of the flowable material.
22. The surgical instrument of claim 4 wherein said heating element is constructed to melt the material prior to delivery to the opening.
23. The surgical instrument of claim 4 wherein said heating element is constructed to melt the material after delivery to the opening.
24. The surgical instrument of claim 1 wherein said delivery device is detachable from said handpiece.
25. The surgical instrument of claim 1 wherein said suture control device comprises nested tubes, surrounding the cannulated tube, which define a path for the suture from the supply to the distal end.
26. The surgical instrument of claim 25 wherein said nested tubes include an outer tube, and a middle tube disposed between the outer tube and the cannulated tube, and the path is defined by a groove extending longitudinally along the length of the middle tube.
27. The surgical instrument of claim 1 wherein said suture control device comprises a suture lock, actuatable by the surgeon, to hold the suture in place at the distal end of the cannulated tube.
28. The surgical instrument of claim 1 wherein said suture control device comprises a suture displacement device for controlling the position of the suture at the distal end.
29. The surgical instrument of claim 1 wherein said suture control device comprises a tensioning device for maintaining tension on the suture.
30. The surgical instrument of claim 29 wherein the tensioning device is constructed to tighten a stitch formed with the suture.
31. The surgical instrument of claim 29 wherein the tensioning device comprises a spring mechanism.
32. The surgical instrument of claim 29 wherein said tensioning device is constructed to be manually actuated by the surgeon.
33. The surgical instrument of claim 1 wherein said surgical instrument is constructed to allow the surgeon to perform a complete fixation procedure at a surgical site without removing the cannulated tube from the surgical site.
34. A surgical instrument for tissue fixation comprising:
a handpiece constructed to be held by a surgeon during a fixation procedure;
a cannulated tube defining a lumen, mounted on the handpiece; and
a delivery device for delivering a flowable material through the lumen to an opening in bone, the delivery device comprising a heating element for heating said material to a flowable state.
35. The surgical instrument of claim 34 wherein the heating element is configured to heat the material within the opening.
36. The surgical instrument of claim 34 wherein said flowable material is delivered through the lumen in solid form.
37. The surgical instrument of claim 34 wherein said delivery device is configured to deliver a metered dose of the flowable material.
38. A surgical instrument for tissue fixation comprising:
a handpiece constructed to be held by a surgeon during a fixation procedure;
a cannulated tube, mounted on the handpiece; and
a suture control device for delivering a suture material from a supply within the handpiece to a distal end of the cannulated tube.
39. A method of securing a tissue to bone, comprising:
forming an opening in the bone at a first location;
delivering a flowable material and a suture to said opening, allowing the flowable material to at least partially solidify and secure a portion of the suture in the opening,
drawing a free portion of the suture that extends from the secured portion across the soft tissue to a second location;
forming a second opening in the bone at the second location;
delivering a flowable material and a portion of the suture to said second opening; and
allowing the flowable material to at least partially solidify, the suture defining a stitch between the first and second locations.
40. The method of claim 39 further comprising repeating the drawing, forming, delivering and allowing steps at subsequent locations to form a line of connected stitches.
41. The method of claim 39 further comprising feeding the suture as a continuous length from a supply of suture material.
42. The method of claim 39 further comprising, between the drawings and delivering steps, tensioning the suture that extends across the soft tissue to the second location.
43. The method of claim 39 further comprising melting the flowable material.
44. The method of claim 39 wherein the flowable material is in the form of a pellet.
45. The method of claim 43 further comprising causing the flowable material to infiltrate the trabecular network.
46. The method of claim 39 wherein the flowable material comprises a thermoplastic polymer.
47. The method of claim 39 wherein the forming step comprises forming an opening having a diameter of less than about 3 mm.
48. The method of claim 39 wherein the flowable material comprises a hydrogel.
49. A surgical instrument constructed to perform the steps of the method of claim 39 endoscopically.
50. A method of fixing soft tissue to bone comprising:
(a) at a first location, piercing through the soft tissue;
(b) forming an opening in the bone underlying the soft tissue;
(c) delivering a fixation device through the pierced tissue to the opening;
(d) delivering a material, in a non-liquid state, to the vicinity of the opening; and
(e) after delivery, liquifying and subsequently resolidifying the material to anchor at least a portion of the fixation device in the opening.
51. The method of claim 50 wherein the fixation device comprises a suture.
52. The method of claim 50 wherein all of the steps are performed endoscopically.
53. The method of claim 50 further comprising causing the material to infiltrate the trabecular network
54. The method of claim 50 further comprising, between the liquifying and resolidifying steps, compacting the liquified polymer.
55. The method of claim 50 wherein the opening has a diameter of less than about 3mm.
56. The method of claim 50 wherein all of the steps are performed through a cannula defined by a single endoscopic surgical instrument, and the instrument is not removed from the patient until after the steps are completed.
57. The method of claim 50, further comprising:
(f) drawing the suture across the soft tissue to a second location, and
(g) repeating steps (a)-(e) at the second location to form a stitch with said suture between the first and second locations, the stitch securing the soft tissue to the bone.
58. The method of claim 50 further comprising gripping the soft tissue to hold it in place against the bone.
59. The method of claim 57 further comprising, after step (g), (h) cutting the suture.
60. The method of claim 57 further comprising repeating steps (f)-(g) at subsequent locations to form a line of connected stitches.
61. The method of claim 51 comprising delivering the suture as a continuous length from a supply of suture material.
62. The method of claim 50 comprising providing said material in the form of a solid, and further comprising melting the material prior to delivery.
63. The method of claim 50 wherein the method comprises performing the forming step in the bone of a human shoulder.
64. The method of claim 63 wherein the method comprises a rotator cuff repair.
65. A method of securing a first layer of soft tissue to a second layer of soft tissue comprising:
forming an opening extending through both layers of soft tissue;
delivering a material, in a flowable state, through the opening so that the flowable material extends beyond the soft tissue at each end of the opening; and
causing the material to change state, to a relatively less flowable state, forming an anchor to secure the two layers of soft tissue together.
66. A method of securing a first layer of soft tissue to a second layer of soft tissue comprising:
forming an opening extending through both layers of soft tissue;
delivering a thermoplastic member to the opening, so that a portion of the member extends beyond the soft tissue at each end of the opening;
softening the extending portions of the member; and
forming each of the softened extending portions so that each extends radially over a portion of the soft tissue to secure the two layers of soft tissue together.
67. The method of claim 66 wherein said member comprises a hollow tube.
68. The method of claim 66 wherein the forming step results in a rivet-like anchor.
69. A method of securing two tissues together comprising:
forming an opening extending through the two tissues,
delivering a material, in a flowable state, to the opening, and
causing the material to change state, to a relatively less flowable state;
wherein the material forms an anchor that secures the two tissues together.
70. The method of claim 69 wherein said anchor comprises a bolt-like anchor.
71. An endoscopic instrument for securing two tissues together comprising:
a piercing device constructed to form an opening extending through the two tissues; and
a delivery device constructed to deliver a material, in a flowable state, and a fixation device, to the opening.
72. The surgical instrument of claim 1 wherein the surgical instrument is constructed for endoscopic use.
73. A method of fixing soft tissue to bone comprising:
(a) inserting a surgical instrument at a first location and approximating the soft tissue with a distal tip of the instrument;
(b) inserting a cutting device through a lumen defined by the surgical instrument and forming an opening in the bone underlying the soft tissue;
(c) delivering a suture material through the pierced tissue to the opening;
(d) delivering a material, in a non-liquid state, to the opening;
(e) after delivery, liquifying and subsequently resolidifying the material to anchor at least a portion of the fixation device in the opening;
(f) drawing the suture across the soft tissue to a second location,
(g) tensioning the suture between the first and second locations, and
(h) repeating steps (a)-(e) at the second location to form a stitch with said suture between the first and second locations, the stitch securing the soft tissue to the bone.