CN104363838A - Tissue thickness compensator comprised of a plurality of materials - Google Patents

Tissue thickness compensator comprised of a plurality of materials Download PDF

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Publication number
CN104363838A
CN104363838A CN201380027220.7A CN201380027220A CN104363838A CN 104363838 A CN104363838 A CN 104363838A CN 201380027220 A CN201380027220 A CN 201380027220A CN 104363838 A CN104363838 A CN 104363838A
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CN
China
Prior art keywords
nail
compensating part
tissue thickness
tissue
fiber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201380027220.7A
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Chinese (zh)
Other versions
CN104363838B (en
Inventor
F·E·谢尔顿四世
J·S·斯韦兹
J·H·康蒂利亚诺
C·杨
C·E·亨德森
T·W·阿伦霍尔特
C·J·沙伊布
J·L·奥尔德里奇
K·J·施米德
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Publication date
Priority claimed from US13/433,118 external-priority patent/US9414838B2/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Publication of CN104363838A publication Critical patent/CN104363838A/en
Application granted granted Critical
Publication of CN104363838B publication Critical patent/CN104363838B/en
Expired - Fee Related legal-status Critical Current
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    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61B17/0684Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling
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Abstract

In various embodiments, a tissue thickness compensator can comprise a plurality of fibers. In at least one embodiment, such fibers can include a plurality of first fibers comprised of a first material and a plurality of second fibers comprised of a second material. A tissue thickness compensator can comprise a plurality of layers wherein each layer can be comprised of one or more medicaments. Certain embodiments are disclosed herein for manufacturing a tissue thickness compensator comprising fibers, for example.

Description

The tissue thickness's compensating part be made up of multiple material
Background technology
The present invention relates to a kind of surgical instruments, and in various embodiments, the present invention relates to the surgical cutting and suture instruments and nail bin thereof that are designed to cutting and suture tissue.
Summary of the invention
Below for by claims protection or can the incomplete list of claimed embodiments of the invention.
1. can be attached to a compensating part for the anvil block of fastening instrument, wherein said anvil block comprises profiled surface, and described compensating part comprises:
The ground floor be made up of the first fiber and the second fiber, wherein said first fiber is made up of the first material and described second fiber is made up of the second material, wherein said first material is different from described second material, and wherein said first fiber and described second fiber are present in described ground floor according to the first ratio;
The second layer be made up of described first fiber and described second fiber, wherein said first fiber and described second fiber are present in the described second layer according to the second ratio, and wherein said first ratio is different from described second ratio; With
The attachment of described anvil block can be attached to.
2. the compensating part according to embodiment 1, wherein said first material comprises oxidized regenerated cellulose, and described second material comprises absorbable polymer.
3. the compensating part according to embodiment 1 or embodiment 2, described first ratio of wherein said first fiber and described second fiber is about 4:1, and described second ratio of wherein said first fiber and described second fiber is about 1:4.
4. the compensating part according to embodiment 1 or embodiment 3, wherein said ground floor comprises tissue contacting surface, and wherein said second material comprises oxidized regenerated cellulose.
5. the compensating part according to any one of previous embodiment, wherein said second fiber is woven in described first fiber in described ground floor, and wherein said first fiber is woven in described second fiber in the described second layer.
6. the compensating part according to embodiment 1, also comprises and is absorbed in described first intrastitial medicine.
7. can be attached to a compensating part for the anvil block of fastening instrument, wherein said anvil block comprises profiled surface, and described compensating part comprises:
Absorbable skin, described absorbable skin comprise be suitable for main during the first stage of described agglutination absorbed first medicine;
Absorbable intermediate layer, described absorbable intermediate layer comprise be suitable for main during the second stage of described agglutination absorbed second medicine; With
Internal layer, described internal layer comprise be suitable for main during the phase III of described agglutination absorbed 3rd medicine.
8. the compensating part according to embodiment 7, wherein said first medicine comprises hemostatic material, and described second medicine comprises antiinflammatory material, and described 3rd medicine comprises collagen-based materials.
9. the compensating part according to embodiment 7 or embodiment 8, wherein said first medicine comprises hemostatic material, and described second medicine comprises antimicrobial material, and described 3rd medicine comprises collagen-based materials.
10. the compensating part according to any one of embodiment 7-9, at least one intermediate layer wherein said comprises the annulate lamella around described internal layer, and wherein said skin comprises the annulate lamella around at least one intermediate layer described.
11. compensating parts according to any one of embodiment 7-10, wherein said first healing phases is overlapping at least in part with described second healing phases, and wherein said second healing phases is overlapping at least in part with described 3rd healing phases.
12. compensating parts according to embodiment 11, wherein said first healing phases is partly overlapping with described 3rd healing phases.
13. 1 kinds of methods manufacturing tissue thickness's compensating part, described method comprises:
Obtain the fiber comprising substrate and medicine;
Prepare the solution of first liquid and second liquid;
By described fiber mixing in described solution;
Described solution is poured in mould; And
Solution described in lyophilizing.
14. methods according to embodiment 13, wherein by utilizing substrate described in described drug coat to obtain described fiber.
15. methods according to embodiment 13, wherein by extruding described substrate and medicine obtains described fiber simultaneously.
16. methods according to embodiment 13, wherein obtain described fiber by utilizing described medicine to flood described substrate.
17. methods according to any one of embodiment 13-16, wherein by described mould is placed in a vacuum chamber, reduce the atmospheric pressure in described vacuum chamber and the temperature reduced in described vacuum chamber carrys out solution described in lyophilizing.
18. methods according to any one of embodiment 13-17, also comprise the bottom allowing described fiber to be deposited to described mould before solution described in lyophilizing.
19. methods according to any one of embodiment 13-18, material piece is produced in the described lyophilizing of wherein said solution, and described method also comprises the described material piece of chopping.
Accompanying drawing explanation
Carry out the following explanation with reference to the embodiment of the present invention in conjunction with the drawings, feature of the present invention and advantage and acquisition methods thereof will become more apparent, and can understand invention itself better, wherein:
Fig. 1 is the sectional view of surgical instruments embodiment;
Figure 1A is the perspective view of an embodiment of implanted nail bin;
Figure 1B-Fig. 1 E shows the part of the end effector using the clamping of implanted nail bin and suture tissue;
Fig. 2 is the partial cross-sectional side view of another end effector of the part being connected to surgical instruments, and its end effector supports surgery nail bin and its anvil block is in an open position;
Fig. 3 is another partial cross-sectional side view of the end effector of Fig. 2 in the close position;
Fig. 4 is end effector another partial cross-sectional side view when knife bar begins to pass end effector propelling of Fig. 2 and Fig. 3;
Fig. 5 is end effector another partial cross-sectional side view when knife bar is partly advanced through wherein of Fig. 2-Fig. 4;
Fig. 6 A-Fig. 6 D describes according at least one embodiment the distortion being positioned at the surgical staples can collapsed in nail bin body;
Fig. 7 A illustrates that be positioned at can the schematic diagram of nail in conquassation nail bin body;
Fig. 7 B be illustrate Fig. 7 A can conquassation nail bin body by the schematic diagram of anvil block conquassation;
Fig. 7 C be illustrate Fig. 7 A can conquassation nail bin body by the schematic diagram of the further conquassation of anvil block;
Fig. 7 D be illustrate the nail of Fig. 7 A be in complete shaped configuration and Fig. 7 A can be in the schematic diagram of complete conquassation condition by conquassation nail bin;
Fig. 8 is the top view of the nail bin according at least one embodiment, and this nail bin comprises the nail embedding and can collapse in nail bin body;
Fig. 9 is the front view of the nail bin of Fig. 8;
Figure 10 is the decomposition diagram of alternative embodiment of compressible nail bin, this compressible nail bin comprise nail and for driving the system of nail against anvil block;
Figure 10 A is the partial sectional view of alternative embodiment of the nail bin of Figure 10;
Figure 11 is the sectional view of the nail bin of Figure 10;
Figure 12 can traverse the nail bin of Figure 10 and the front view of the sliding part that nail is moved towards anvil block;
Figure 13 is the schematic diagram of staple drivers, and this staple drivers can be promoted towards anvil block by the sliding part of Figure 12;
Figure 14 is the perspective view of the nail bin according at least one embodiment of the present invention, and this nail bin comprises the rigid support part and compressible tissue thickness compensating part that use together with surgery suturing appliance;
Figure 15 is the partial exploded view of the nail bin of Figure 14;
Figure 16 is the complete exploded view of the nail bin of Figure 14;
Figure 17 is another exploded view of the nail bin of Figure 14, and this nail bin does not cover the wrappage of tissue thickness's compensating part;
Figure 18 is the warehouse of the nail bin of Figure 14 or the perspective view of support section;
Figure 19 is the top perspective of sliding part, and this sliding part can move to dispose nail from nail bin in the nail bin of Figure 14;
Figure 20 is the bottom perspective view of the sliding part of Figure 19;
Figure 21 is the front view of the sliding part of Figure 19;
Figure 22 is the top perspective of driver, and this driver can support one or more nail and upwards be promoted to be penetrated from nail bin by nail by the sliding part of Figure 19;
Figure 23 is the bottom perspective view of the driver of Figure 22;
Figure 24 is can at least in part around the wrappage of the compressible tissue thickness compensating part of nail bin;
Figure 25 is the partial sectional view of nail bin, and this nail bin comprises rigid support part and compressible tissue thickness compensating part, show nail during First ray never firing position move to firing position;
Figure 26 is the front view of the nail bin of Figure 25;
Figure 27 is the thin portion front view of the nail bin of Figure 25;
Figure 28 is the section end view of the nail bin of Figure 25;
Figure 29 is the bottom view of the nail bin of Figure 25;
Figure 30 is the thin portion bottom view of the nail bin of Figure 25;
Figure 31 is the longitudinal sectional view of nail bin and anvil block in the close position, and this nail bin comprises rigid support part and compressible tissue thickness compensating part, show nail during First ray never firing position move to firing position;
Figure 32 is the anvil block of Figure 31 and another sectional view of nail bin, it illustrates anvil block in an open position after percussion sequence completes;
Figure 33 is the local detail drawing of the nail bin of Figure 31, it illustrates the nail being in non-firing position;
Figure 34 is the cross-section front view of nail bin, and this nail bin comprises rigid support part and compressible tissue thickness compensating part, shows the nail being in non-firing position;
Figure 35 is the detail drawing of the nail bin of Figure 34;
Figure 36 is the front view of nail bin and anvil block in an open position, and this nail bin comprises rigid support part and compressible tissue thickness compensating part, shows the nail being in non-firing position;
Figure 37 is the front view of nail bin and anvil block in the close position, and this nail bin comprises rigid support part and compressible tissue thickness compensating part, shows the nail being in non-firing position and the tissue be trapped between anvil block and tissue thickness's compensating part;
Figure 38 is the anvil block of Figure 37 and the detail drawing of nail bin;
Figure 39 is the front view of nail bin and anvil block in the close position, and this nail bin comprises rigid support part and compressible tissue thickness compensating part, shows the nail being in non-firing position, shows the thicker tissue be positioned between anvil block and nail bin;
Figure 40 is the anvil block of Figure 39 and the detail drawing of nail bin;
Figure 41 is the anvil block of Figure 39 and the front view of nail bin, it illustrates the tissue with different-thickness be positioned between anvil block and nail bin;
Figure 42 is the anvil block of Figure 39 and the detail drawing of nail bin, as shown in figure 41;
Figure 43 shows the schematic diagram to tissue thickness's compensating part that the different tissues thickness be trapped in different nail compensates;
Figure 44 shows tissue thickness's compensating part to the schematic diagram being applied compression pressure by one or more blood vessel of nail line crosscut;
Figure 45 shows the schematic diagram of the imappropriate situation about being shaped of wherein one or more nails;
Figure 46 shows the schematic diagram of tissue thickness's compensating part that can compensate appropriately not become staple;
Figure 47 shows the schematic diagram of the tissue thickness's compensating part be positioned in tissue regions that wherein multiple nail line intersects;
Figure 48 shows the schematic diagram of the tissue be trapped in nail;
Figure 49 shows the schematic diagram being trapped in tissue in nail and tissue thickness's compensating part;
Figure 50 shows the schematic diagram of the tissue be trapped in nail;
Figure 51 shows the schematic diagram being trapped in thick tissue in nail and tissue thickness's compensating part;
Figure 52 shows the schematic diagram being trapped in thin tissue in nail and tissue thickness's compensating part;
Figure 53 shows the schematic diagram of the tissue thickness's compensating part be trapped in nail and the tissue with interior thickness;
Figure 54 shows the schematic diagram of the tissue thickness's compensating part be trapped in nail and the tissue with another interior thickness;
Figure 55 shows the schematic diagram being trapped in thick tissue in nail and tissue thickness's compensating part;
Figure 56 is the partial sectional view of the end effector of surgery suturing appliance, it illustrates be in retraction, non-firing position trigger shaft and nail percussion sliding part;
Figure 57 is another partial sectional view of the end effector of Figure 56, it illustrates and is in trigger shaft and the nail percussion sliding part that part advances position;
Figure 58 is the sectional view of the end effector of Figure 56, it illustrates the trigger shaft being in propelling or firing position completely;
Figure 59 is the sectional view of the end effector of Figure 56, it illustrates and is being in the trigger shaft of advanced position after being pulled the trigger and is staying the nail percussion sliding part of its complete firing position;
Figure 60 is the detail drawing being in the trigger shaft of advanced position of Figure 59;
Figure 61 is the perspective cross-sectional view of the embodiment just distally advancing the cutter cutting tissue in the end effector of surgical instruments;
Figure 62 illustrates the cross-sectional side view that the material in tissue thickness's compensating part can be directed to the feature on the cutter of Figure 61 of tissue;
Figure 63 is the perspective cross-sectional view of the alternative embodiment just distally advancing the cutter cutting tissue in the end effector of surgical instruments;
Figure 64 is the perspective cross-sectional view of another the alternative embodiment just distally advancing the cutter cutting tissue in the end effector of surgical instruments;
Figure 65 is the cross-sectional side view of the feature illustrated on the cutter of the Figure 64 that the material in first tissue thickness's compensating part can be mixed with the material from minor microstructure thickness compensation part;
Figure 66 is the front view of the feature illustrated on the cutter of the Figure 64 that the material in first tissue thickness's compensating part can be mixed with the material from minor microstructure thickness compensation part;
Figure 67 is the cross-sectional, top view of the feature illustrated on the cutter of the Figure 64 that the material in first tissue thickness's compensating part can be mixed with the material from minor microstructure thickness compensation part;
Figure 68 is the perspective cross-sectional view of another the alternative embodiment just distally advancing the cutter cutting tissue in the end effector of surgical instruments;
Figure 69 is the cross-sectional side view of the feature illustrated on the cutter of the Figure 68 that can spread the material be included in tissue thickness's compensating part; And
Figure 70 is the cross-sectional side view of the cutter of Figure 68 of positive diffusate.
Figure 71 is the broken section perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 72 shows the medicine be just loaded in tissue thickness's compensating part;
Figure 73 is the cross sectional end view of the pipe in tissue thickness's compensating part of the Figure 71 be positioned at wherein containing medicine;
Figure 74 shows tissue thickness's compensating part of the Figure 71 just positioning against patient tissue and compress;
Figure 75 is the cross sectional end view of the end effector of surgery suturing appliance, it illustrates just by the nail of percussion through tissue thickness's compensating part of Figure 71;
Figure 76 is the curve chart of the dissolving that the capsule be included in tissue thickness's compensating part is shown, wherein capsule comprises multiple medicine layer;
Figure 77 shows just by the ground floor of the capsule of Figure 76 that dissolves or skin;
Figure 78 shows just by the second layer of the capsule of Figure 76 dissolved;
Figure 79 shows just by the third layer of the capsule of Figure 76 of dissolving;
Figure 80 shows just by the 4th layer or the internal layer of the capsule of Figure 76 that dissolve;
Figure 81 is the partial sectional view comprising the nail bin of tissue thickness's compensating part according at least one embodiment, and described tissue thickness compensating part comprises multiple vertical capsule;
Figure 82 is the perspective view of the vertical capsule of Figure 81;
Figure 83 is the partial sectional view of the nail bin of Figure 81, it illustrates the nail being in non-firing position be included in nail bin;
Figure 84 is the cross-sectional side view of the nail bin of Figure 81, it illustrates just never firing position and moves to the nail of Figure 83 of firing position;
Figure 85 is the partial sectional view comprising tissue thickness's compensating part of the vertical capsule be positioned at wherein according at least one embodiment;
Figure 86 is the partial sectional view of the tissue thickness's compensating part comprising multiple capsule, and described capsule has the opening be defined in wherein;
Figure 87 is the cross sectional end view of the end effector of surgery suturing appliance according at least one embodiment, and described surgery suturing appliance comprises multiple nail of being in non-firing position and multiple puncture member of the capsule that can make to be included in tissue thickness's compensating part or tracheal rupture;
Figure 88 is the front view of the nail being in the Figure 87 not pulling the trigger configuration;
Figure 89 is the front view of the nail of the Figure 88 being in percussion configuration;
Figure 90 is the front view of the puncture member of Figure 87;
Figure 91 is the cross sectional end view of the end effector of Figure 87, it illustrates the nail and puncture member that are in firing position;
Figure 92 is the cross-sectional side view of the end effector of Figure 87, it illustrates nail and puncture member that just never firing position moves to firing position;
Figure 93 is the top cross-sectional view comprising the nail bin of tissue thickness's compensating part according at least one embodiment, and described tissue thickness compensating part comprises the multiple vertical capsule be positioned at wherein;
Figure 94 is the detail drawing of the nail bin of Figure 93;
Figure 95 is the cross sectional end view of the nail bin of the Figure 93 be positioned in end effector, it illustrates the nail being in firing position be included in nail bin;
Figure 96 is the cross sectional end view of the nail bin of Figure 93 in the end effector of Figure 95, it illustrates the cutting element of the capsule be just advanced through in tissue thickness's compensating part;
Figure 97 is the perspective view comprising tissue thickness's compensating part of longitudinal member according at least one embodiment;
Figure 98 is the sectional view of the mould of the tissue thickness's compensating part can producing Figure 97;
Figure 99 is the cross sectional end view of the mould of Figure 98, it illustrates the longitudinal member of location Figure 97 in a mold;
Figure 100 is the cross sectional end view of the mould of Figure 98, it illustrates the tissue thickness's compensating part material be just poured in the mould of Figure 98;
Figure 101 is the sectional perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 102 is the perspective view that can be embedded in the supporting member in tissue thickness's compensating part according at least one embodiment;
Figure 103 is the sectional perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 104 is the cross sectional end view of the mould of the tissue thickness's compensating part illustrated for the manufacture of Figure 103;
Figure 105 is the cross-sectional view of tissue thickness's compensating part of Figure 103;
Figure 106 is the cross-sectional side view of the mould of Figure 104;
Figure 107 is the cross sectional end view of the tissue thickness's compensating part according at least one embodiment;
Figure 108 is the cross sectional end view of another tissue thickness's compensating part according at least one embodiment;
Figure 109 is the detail drawing of the timbering material of tissue thickness's compensating part according at least one embodiment;
Figure 110 is the detail drawing being in tissue thickness's compensating part of non-extended mode according at least one embodiment;
Figure 111 is the detail drawing of tissue thickness's compensating part of the Figure 110 being in extended mode;
Figure 112 is the sectional perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 113 is according to the broken section perspective view carrying out the tissue thickness's compensating part manufactured just in a mold of at least one embodiment;
Figure 114 is the perspective cross-sectional view of the tissue thickness's compensating part according at least one alternative embodiment;
Figure 115 is the cross sectional end view of the tissue thickness's compensating part according at least one alternative embodiment;
Figure 116 is the fragmentary, perspective view of the tissue thickness's compensating part according at least one alternative embodiment;
Figure 117 is the front view comprising the end effector of the surgery suturing appliance of tissue thickness's compensating part according at least one embodiment;
Figure 118 is the exploded view of tissue thickness's compensating part of Figure 117, and wherein tissue thickness's compensating part comprises multiple layer;
Figure 119 is the sectional view of the layer of tissue thickness's compensating part;
Figure 120 is the sectional view of another layer of tissue thickness's compensating part;
Figure 121 is the partial cross-section front view of tissue thickness's compensating part of the Figure 117 be positioned between the anvil block of surgery suturing appliance and nail bin;
Figure 122 to be trapped in the nail of nail bin injection and to be carried out another partial cross-section front view of tissue thickness's compensating part of the Figure 117 be out of shape by the anvil block of surgery suturing appliance;
Figure 123 is another partial cross-section front view being attached to tissue thickness's compensating part of Figure 117 of tissue by the nail of Figure 122;
Figure 124 is the perspective view of the layer of tissue thickness's compensating part according at least one alternative embodiment;
Figure 125 is the perspective view of the end effector of the surgery suturing appliance comprising tissue thickness's compensating part, and described tissue thickness compensating part comprises the layer of Figure 124;
Figure 126 is the fragmentary, perspective view of the tissue thickness's compensating part according at least one alternative embodiment;
Figure 127 is the perspective view of the end effector of the surgery suturing appliance of the tissue thickness's compensating part comprising Figure 126;
Figure 128 is the perspective view of multiple coated fiber;
Figure 129 illustrates for the preparation of coated fiber and/or cutting can become the perspective view extruding operation of the coating strand of coated fiber;
Figure 130 is the perspective cross-sectional view of coated fiber;
Figure 131 illustrates that use can by deposition of material on fiber and/or the perspective view of the coating operation of intrastitial carrier fluid;
Figure 132 is the perspective view of the nail bin comprising tissue thickness's compensating part, and described tissue thickness compensating part comprises the fiber of Figure 128;
Figure 133 is the broken section perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 134 is the sectional view of the medicine wrapped up by water wetted material according at least one embodiment;
Figure 135 is the perspective view of tissue thickness's compensating part of the Figure 133 be positioned in the end effector of surgical instruments;
Figure 136 is the broken section perspective view of the medicine of Figure 134, and described medicine is just being exposed to liquid and can flowing out from tissue thickness's compensating part of Figure 133 to make medicine;
Figure 137 is the fragmentary, perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 138 is the fragmentary, perspective view of tissue thickness's compensating part after being exposed to liquid of Figure 137;
Figure 139 is the perspective view of the end effector of the tissue thickness's compensating part comprising the Figure 137 being attached to anvil block;
Figure 140 is the broken section perspective view of the tissue thickness's compensating part comprising the medicine of Figure 134 and the fiber of Figure 128;
Figure 141 is the fragmentary, perspective view of the nail bin comprising tissue thickness's compensating part, and described tissue thickness compensating part comprises multiple capsule;
Figure 142 is the side view of the nail bin of Figure 141;
Figure 143 shows the capsule of the Figure 141 be placed in a mold;
Figure 144 shows the capsule of Figure 141 of the bottom of the mould being deposited to Figure 143;
Figure 145 shows the compensating part material of main part be just poured on the capsule of Figure 141;
Figure 146 shows following examples, and wherein the capsule of Figure 141 is finer and close and remain on the bottom of the mould of Figure 143 than compensating part material of main part;
Figure 147 shows following examples, and wherein the capsule of Figure 141 is dense not as compensating part material of main part and can float to the top of the mould of Figure 143;
Figure 148 shows the alternative embodiment comprising and can receive multiple groove of the capsule of Figure 141 or the mould of recess;
Figure 149 is the cross sectional end view of the end effector of surgery suturing appliance according at least one embodiment, and described surgery suturing appliance comprises the tissue thickness's compensating part be positioned in above nail bin;
Figure 150 is the cross sectional end view of the end effector of Figure 149, it illustrates from nail bin percussion and extends through the nail of tissue thickness's compensating part of Figure 149;
Figure 151 shows mould and is positioned at the multiple medicine capsules in mould;
Figure 152 is the cross sectional end view of mould, it illustrates and is poured in mould with the compensating part material of main part of formative tissue thickness compensation part;
Figure 153 is the perspective view of tissue thickness's compensating part of the Figure 152 of the anvil block being attached to surgery suturing appliance;
Figure 154 is the sectional view of the mould of tissue thickness's compensating part that can form Figure 157, it illustrates the ground floor be just poured in mould;
Figure 155 is the sectional view of the mould of Figure 154, it illustrates location capsule on the first layer;
Figure 156 is the sectional view of the mould of Figure 154, it illustrates the second layer be just poured on capsule;
Figure 157 is the perspective view of the tissue thickness's compensating part according at least one embodiment;
Figure 158 is the perspective view of tissue thickness's compensating part of the Figure 157 be positioned in the end effector of surgery suturing appliance;
Figure 159 is the perspective view of the compensating part main body of tissue thickness's compensating part of Figure 162;
Figure 160 is the perspective view of the longitudinal hole be limited in the compensating part main body of Figure 159;
Figure 161 is the figure that the capsule be just positioned in the longitudinal hole of Figure 160 is shown;
Figure 162 is the perspective view comprising the end effector of the surgery suturing appliance of tissue thickness's compensating part according at least one embodiment;
Figure 163 is the perspective view of the compensating part main body of tissue thickness's compensating part of Figure 166;
Figure 164 is the perspective view of the multiple transverse holes be limited in the compensating part main body of Figure 163;
Figure 165 is the figure that the capsule be just positioned in the transverse holes of Figure 164 is shown;
Figure 166 is the perspective view comprising the end effector of the surgery suturing appliance of tissue thickness's compensating part according at least one embodiment;
Figure 167 is the perspective view of the vertical mould that can manufacture tissue thickness's compensating part;
Figure 168 is the perspective view of the capsule be just positioned in the mould of Figure 167;
Figure 169 is the perspective view of the capsule of the Figure 168 be just positioned in the mould of Figure 167;
Figure 170 is the covering that the mould being close to Figure 167 is placed and the perspective view being just positioned in the compensating part material of main part in mould;
Figure 171 is the perspective view of the mould of Figure 167, and the covering of Figure 170 shown in it is removed;
Figure 172 shows the nail bin comprising tissue thickness's compensating part and tissue thickness's compensating part pad according at least one embodiment;
Figure 173 is the partial bottom perspective view of tissue thickness's compensating part pad of Figure 172;
Figure 174 is the fragmentary top perspective view of tissue thickness's compensating part pad of Figure 172;
Figure 175 is the partial sectional view of the nail bin of the Figure 172 just pulled the trigger by firing member, and wherein nail bin is illustrated and does not have location tissue thickness's compensating part thereon;
Figure 176 is the top view of tissue thickness's compensating part pad of the Figure 172 just cut by the cutting element engaged with the firing member of Figure 175, and wherein nail bin is illustrated and does not have location tissue thickness's compensating part thereon;
Figure 177 is the top view of tissue thickness's compensating part pad of the Figure 172 just cut by the cutting element engaged with the firing member of Figure 175, and wherein nail bin is shown having location tissue thickness's compensating part thereon;
Figure 178 comprises according at least one alternative embodiment the plane graph that circle organizes the circular nail bin of thickness compensation part pad;
Figure 179 shows the mould comprising multiple chamber, and described multiple chamber can side by side formative tissue thickness compensation part on multiple nail bin body;
The nail bin body that Figure 180 shows the intracavity being positioned at Figure 179 and the one or more sheet materials be just placed on nail bin;
Figure 181 shows the sheet material of the Figure 180 of the appropriate position be fixed in the mould of Figure 179;
Figure 182 shows the elongate tubular structure around multiple post support members of curling up in the mould of Figure 179;
Figure 183 shows the sheet material of the Figure 180 of the appropriate position be fixed on the nail bin body of Figure 179;
Figure 184 shows the pipe component of the Figure 182 be positioned on the sheet material of Figure 180;
Figure 185 shows the compensating part material of main part be just poured in the mould of Figure 179;
Figure 186 shows the cutting punch die above the mould being positioned at Figure 179;
Figure 187 shows the cutting punch die moving down to cut the compensating part material of main part of Figure 185 and the sheet material of Figure 180;
Figure 188 shows the cutting punch die moved up with the mould away from Figure 179;
Figure 189 is the cross sectional end view of tissue thickness's compensating part of producing according to the manufacturing process by general introduction in Figure 179-188 of at least one embodiment;
Figure 190 is the top view comprising the nail bin of tissue thickness's compensating part according at least one embodiment;
Figure 191 is the perspective view of the nail bin of Figure 190;
Figure 192 is the diagram of the manufacture of tissue thickness's compensating part of the nail bin that Figure 190 is shown;
Figure 193 is with the diagram of the roller of formative tissue thickness compensation part according to the pressing tubes of material of at least one embodiment;
Figure 194 is the diagram of the roller of formative tissue thickness compensation part according at least one alternative embodiment;
Figure 195 is the fragmentary, perspective view of the nail bin comprising the tissue thickness's compensating part produced by the operation described in Figure 194;
Figure 196 is the cross-sectional elevational view of the nail just disposed from the nail bin of Figure 195; And
Figure 197 is the cross sectional end view of the nail just disposed from the nail bin of Figure 195.
Run through multiple view, the parts that corresponding reference marks instruction is corresponding.The example illustrated herein shows some embodiment of the present invention in one form, and this type of example should be interpreted as and limit the scope of the invention by any way.
Detailed description of the invention
The applicant of the application also has following U.S. Patent application, and these patent applications are incorporated to herein by reference separately completely:
Name is called the U.S. Patent Application Serial Number 12/894,311 of " SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS " (attorney END6734USNP/100058);
Name is called the U.S. Patent Application Serial Number 12/894,340 of " SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS " (attorney END6735USNP/100059);
Name is called the U.S. Patent Application Serial Number 12/894,327 of " JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS " (attorney END6736USNP/100060);
Name is called the U.S. Patent Application Serial Number 12/894,351 of " SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS " (attorney END6839USNP/100524);
Name is called the U.S. Patent Application Serial Number 12/894,338 of " IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT " (attorney END6840USNP/100525);
Name is called the U.S. Patent Application Serial Number 12/894,369 of " IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER " (attorney END6841USNP/100526);
Name is called the U.S. Patent Application Serial Number 12/894,312 of " IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS " (attorney END6842USNP/100527);
Name is called the U.S. Patent Application Serial Number 12/894,377 of " SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE " (attorney END6843USNP/100528);
Name is called the U.S. Patent Application Serial Number 12/894,339 of " SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT " (attorney END6847USNP/100532);
Name is called the U.S. Patent Application Serial Number 12/894,360 of " SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM " (attorney END6848USNP/100533);
Name is called the U.S. Patent Application Serial Number 12/894,322 of " SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS " (attorney END6849USNP/100534);
Name is called the U.S. Patent Application Serial Number 12/894,350 of " SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATION MOTIONS WHEN A CARTRIDGE IS NOT PRESENT " (attorney END6855USNP/100540);
Name is called the U.S. Patent Application Serial Number 12/894,383 of " IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS " (attorney END6856USNP/100541);
Name is called the U.S. Patent Application Serial Number 12/894,389 of " COMPRESSIBLE FASTENER CARTRIDGE " (attorney END6857USNP/100542);
Name is called the U.S. Patent Application Serial Number 12/894,345 of " FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT " (attorney END6858USNP/100543);
Name is called the U.S. Patent Application Serial Number 12/894,306 of " COLLAPSIBLE FASTENER CARTRIDGE " (attorney END6859USNP/100544);
Name is called the U.S. Patent Application Serial Number 12/894,318 of " FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTION MATRIX ELEMENTS " (attorney END6860USNP/100546);
Name is called the U.S. Patent Application Serial Number 12/894,330 of " FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX " (attorney END6861USNP/100547);
Name is called the U.S. Patent Application Serial Number 12/894,361 of " FASTENER SYSTEM COMPRISING A RETENTION MATRIX " (attorney END6862USNP/100548);
Name is called the U.S. Patent Application Serial Number 12/894,367 of " FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX " (attorney END6863USNP/100549);
Name is called the U.S. Patent Application Serial Number 12/894,388 of " FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER " (attorney END6864USNP/100550);
Name is called the U.S. Patent Application Serial Number 12/894,376 of " FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES " (attorney END6865USNP/100551);
Name is called the U.S. Patent Application Serial Number 13/097,865 of " SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS " (attorney END6735USCIP1/100059CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,936 of " TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER " (attorney END6736USCIP1/100060CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,954 of " STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION " (attorney END6840USCIP1/100525CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,856 of " STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE PORTION THEREOF " (attorney END6841USCIP1/100526CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,928 of " TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS " (attorney END6842USCIP1/100527CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,891 of " TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN ADJUSTABLE ANVIL " (attorney END6843USCIP1/100528CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,948 of " STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION " (attorney END6847USCIP1/100532CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,907 of " COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY " (attorney END6848USCIP1/100533CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,861 of " TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERTIES " (attorney END6849USCIP1/100534CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,869 of " STAPLE CARTRIDGE LOADING ASSEMBLY " (attorney END6855USCIP1/100540CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,917 of " COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS " (attorney END6856USCIP1/100541CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,873 of " STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION " (attorney END6857USCIP1/100542CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,938 of " STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS " (attorney END6858USCIP1/100543CIP1);
Name is called the U.S. Patent Application Serial Number 13/097,924 of " STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR " (attorney END6859USCIP1/100544CIP1);
Name is called the U.S. Patent Application Serial Number 13/242,029 of " SURGICAL STAPLER WITH FLOATING ANVIL " (attorney END6841USCIP2/100526CIP2);
Name is called the U.S. Patent Application Serial Number 13/242,066 of " CURVED END EFFECTOR FOR A STAPLING INSTRUMENT " (attorney END6841USCIP3/100526CIP3);
Name is called the U.S. Patent Application Serial Number 13/242,086 of " STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK " (attorney END7020USNP/110374);
Name is called the U.S. Patent Application Serial Number 13/241,912 of " STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT " (attorney END7019USNP/110375);
Name is called the U.S. Patent Application Serial Number 13/241,922 of " SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS " (attorney END7013USNP/110377);
Name is called the U.S. Patent Application Serial Number 13/241,637 of " SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION MOTIONS " (attorney END6888USNP3/110378); With
Name is called the U.S. Patent Application Serial Number 13/241,629 of " SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR " (attorney END6888USNP2/110379).
The applicant of the application also has following U.S. Patent application, and these patent applications and the application submit on the same day, and each with way of reference separately entirety be incorporated to herein:
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES " (attorney END6864USCIP1/100550CIP1) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS " (attorney END6864USCIP2/100550CIP2) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " EXPANDABLE TISSUE THICKNESS COMPENSATOR " (attorney END6843USCIP2/100528CIP2) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR " (attorney END6843USCIP3/100528CIP3) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR " (attorney END6843USCIP4/100528CIP4) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT " (attorney END6843USCIP5/100528CIP5) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION " (attorney END6843USCIP6/100528CIP6) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD " (attorney END6843USCIP7/100528CIP7) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD " (attorney END6843USCIP8/100528CIP8) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS " (attorney END6843USCIP9/100528CIP9) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS " (attorney END6843USCIP10/100528CP10) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATORS " (attorney END6843USCIP11/100528CP11) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " LAYERED TISSUE THICKNESS COMPENSATOR " (attorney END6843USCIP12/100528CP12) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS " (attorney END6843USCIP13/100528CP13) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT " (attorney END7100USNP/110601) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR " (attorney END7107USNP/110603) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS " (attorney END7102USNP/110604) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME " (attorney END7103USNP/110605) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS " (attorney END7104USNP/110606) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _;
Name be called the U.S. Patent Application Serial Number of " TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES " (attorney END7105USNP/110607) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _; With
Name be called the U.S. Patent Application Serial Number of " DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS " (attorney END7106USNP/110608) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.
Now some exemplary embodiment will be described, to understand the structure of apparatus and method disclosed herein, function, manufacture and purposes on the whole.One or more examples of these embodiments are shown in the drawings.Those of ordinary skill in the art are to be understood that in literary composition and specifically describe and the apparatus and method be illustrated by drawings are unrestriced exemplary embodiment.The structure illustrated in conjunction with an exemplary embodiment or describe can be combined with the structure of other embodiment.This modification and variations comprise within the scope of the invention.
Disclosed herein or claimed for the manufacture of, any one in the method for formation or in other words article of manufacture or product can be used for manufacturing, what formed or in other words produce in the goods considered or product is all or part of, and these class methods for the manufacture of, when forming or in other words produce the part of goods or the product considered, the remainder of goods or product can by any way (comprise use disclosed herein or claimed for the manufacture of, formed or in other words article of manufacture or product other method in any one) produce, and the various piece of so producing can be combined by any way.Similarly; disclosed herein or claimed any goods or product can individualisms; or can exist in conjunction with other goods disclosed in this invention any or product with its compatibility, or can be used as and exist with other goods disclosed in this invention any of its compatibility or the integral part of product.Therefore, to illustrate in conjunction with a kind of goods, product or method or the special characteristic, structure or the characteristic that describe can completely or partially the feature of (without limitation) and one or more other compatible goods, product or method, structure or characteristic combine.This modification and variations comprise within the scope of the invention.
With reference to certain figures or alternate manner, specific embodiment of the present invention is being disclosed herein, or particular product, when product or method can comprise ad hoc structure, characteristic or feature, reader should be appreciated that and this means that these structures, characteristic or feature can be implemented in considered goods, product or method in any suitable combination.Specifically, this type of disclosure of multiple optional construction, characteristic or feature should be understood to the whole combinations disclosing these structures, characteristic or feature, and exceptional case is the structure of the alternate forms be published as each other, characteristic or feature.When this class formation, characteristic or feature are published as alternate forms each other, this should be understood to open these alternate forms as substitute each other.
Term used herein " nearside " and " distally " are for the clinician of the handle portions of manipulation of surgical apparatus.Term " nearside " refers to the part near clinician, and term " distally " refers to the part away from clinician.It is also understood that for succinct and clear for the purpose of, the spatial terminology of " vertically ", " level ", "up" and "down" and so on can be used such as herein by reference to the accompanying drawings.But surgical instruments uses in many directions and position, and these terms nonrestrictive and/or absolute.
Provide various exemplary means and method to perform abdominal cavity mirror and micro-wound surgical operation operation.But reader will readily appreciate that, various method and apparatus disclosed herein can be used in multiple surgical operation and application (comprise and being combined with open surgery).Continue to consult this detailed description of the invention, reader will be further understood that, various apparatus disclosed herein can by any way in insertosome, such as by nature tract, by being formed at the otch or puncturing hole etc. in tissue.The access to plant that the working portion of apparatus or end effector part can directly be inserted in patient body or by having service aisle inserts, and the end effector of surgical instruments and slender axles advance by described service aisle.
Forward accompanying drawing to, wherein in multiple view, the assembly that similar numeral is similar, Fig. 1 shows the surgical instruments 10 can putting into practice some unique benefit.Surgery suturing appliance 10 is designed to the end effector 12 handling and/or activate various forms and the size be operationally attached on it.In Fig. 1-Fig. 1 E, such as end effector 12 comprises elongated passageway 14, and this elongated passageway forms the lower jaw 13 of end effector 12.Elongated passageway 14 can support " implanted " nail bin 30 and can support the anvil block 20 of the upper jaw 15 as end effector 12 with moving.
Elongated passageway 14 can by such as 300 & 400 series, and 17-4 & 17-7 rustless steel, titanium etc. are made, and can be formed together with isolated sidewall 16.Anvil block 20 can by such as 300 & 400 series, 17-4 & 17-7 rustless steel, titanium etc. are made, and can have nail shaped lower face (being usually labeled as 22), described nail shaped lower face has the multiple nail shaping pits 23 be formed at wherein.See Figure 1B-Fig. 1 E.In addition, anvil block 20 has and is divided into two-part slide assemblies 24 from its proximad projection.Anvil block pin 26, from each side extending projection of slide assemblies 24, to be contained in respective slots in the sidewall 16 of elongated passageway 14 or opening 18, thus is conducive to movable for anvil block pin or be attached to pivotly on described respective slots or opening.
Various forms of implanted nail bin can use together with surgical instruments disclosed herein.Below will discuss specific nail bin configuration and structure in more detail.But, in figure ia, show implanted nail bin 30.Nail bin 30 has main part 31, and this main part is made up of compressible hemostatic material (such as oxidized regenerated cellulose (" ORC ") or can the foam of bio-absorbable), is wherein supported with the unfashioned peg 32 of multirow.For anti-non-magnetic shim influenced and prevent hemostatic material introducing and position fixing process during activated, whole storehouse can be coated with or be enclosed with biodegradable film 38, such as with trade mark the six cyclic ketones films sold or polyglycerol sebacate (PGS) film or by PGA (polyglycolic acid, sell with trade mark Vicryl), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (polyhydroxyalkanoatefrom), PGCL (poliglecaprone 25, sell with trade mark Monocryl) or other biodegradable films of being formed of the complex of PGA, PCL, PLA, PDS, described film is only just permeable when breaking.The size of the main body 31 of nail bin 30 is configured to be supported on removedly in elongated passageway 14 as shown in the figure, make when anvil block 20 be driven to be formed with nail bin 30 contact time, the nail shaping pit 23 that each nail 32 is wherein all corresponding with anvil block aligns.
In use, once the contiguous target tissue of end effector 12 and locating, end effector 12 is just manipulated to be caught target tissue or is clamped between the top surface 36 of nail bin 30 and the nail profiled surface 22 of anvil block 20.Nail 32 is shaped in the following way: anvil block 20 is moved in the path being arranged essentially parallel to elongated passageway 14, to make nail profiled surface 22 and more specifically to make nail shaping pit 23 wherein substantially contact the top surface 36 of nail bin 30 simultaneously.When anvil block 20 continues to move in nail bin 30, the lower limb 34 of nail 32 contacts corresponding nail shaping pit 23 in anvil block 20, and this nail shaping pit is used for making nail lower limb 34 bending to make nail 32 be configured as " B shape ".Anvil block 20 will compress nail 32 further towards the further motion of elongated passageway 14 and makes it be configured as the final forming height " FF " of expectation.
Above-mentioned nail forming process is illustrated in Figure 1B-Fig. 1 E substantially.Such as, Figure 1B illustrates end effector 12, and its target tissue " T " is between anvil block 20 and the top surface 36 of implanted nail bin 30.Fig. 1 C illustrates the initial clamped position of anvil block 20, and wherein anvil block 20 has been closed up on target tissue " T ", between the top surface 36 target tissue " T " being clamped in anvil block 20 and nail bin 30.Fig. 1 D illustrates and initially follows closely shaping, and wherein anvil block 20 has started to compress nail bin 30, makes the lower limb 34 of nail 32 begin through the nail shaping pit 23 in anvil block 20 and be shaped.Fig. 1 E illustrates the nail 32 being in final molding condition through target tissue " T ", has removed anvil block 20 for clarity.Once nail 32 is shaped and is fastened to target tissue " T ", surgeon just makes anvil block 20 move to open position, can keep being attached to target tissue to make warehouse 31 and nail 32 when withdrawing from end effector 12 from patient.When two jaws 13,15 clamp jointly, end effector 12 makes all nails be shaped simultaneously.All the other " by conquassation " material of main parts 31 are used as hemorrhage (ORC) and follow closely line reinforcing agent (PGA, PDS or any other film compositions 38 above-mentioned).In addition, need not leave warehouse 31 owing to following closely 32 at shaping, the probability that therefore nail 32 becomes deformity at shaping is minimized.As used herein, term " implanted " refers to except nail, and the warehouse material of support nail also will be maintained in patient body and also can finally be absorbed by patient body.This type of implanted nail bin is different from previous nail bin structure, and this previous nail bin is configured in it and is still intactly positioned in end effector by after percussion.
In various concrete enforcement, end effector 12 can be connected to the slender axles assembly 40 from shank assembly 100 projection.End effector 12 (when closed) can have similar shape of cross section with axis of elongation assembly 40, and its size is configured to pass sleeve pipe needle tubing or service aisle with another kind of access instruments formal operations.As used herein, term " operationally passes " and refers to that end effector and inserting by passage or tube opening at least partially of slender axles assembly maybe can pass passage or tube opening, and in passage or tube opening, can handle surgery stitching operation to it.When in the closed position, the jaw 13 and 15 of end effector 12 can be end effector provides the shape of cross section of substantial circular to be beneficial to it through circular path/opening.But, end effector of the present invention can be imagined and slender axles assembly is provided with other shape of cross sections, thus can otherwise through inlet passage and the opening with non-circular transverse cross-section.Therefore, the overall dimension of the cross section of closed end effector by end effector intend through passage or the size of opening relevant.Therefore, an end effector such as can be called as " 5mm " end effector, and this refers to that it operationally can be at least the opening of about 5mm through diameter.
Slender axles assembly 40 can have the external diameter substantially equal with the external diameter of end effector in the close position 12.Such as, 5mm end effector can be connected to the slender axles assembly 40 with 5mm cross-sectional diameter.But continue to consult this detailed description of the invention, it is evident that, the present invention can use in conjunction with the end effector of different size effectively.Such as, 10mm end effector can be attached to the slender axles with 5mm cross-sectional diameter.On the contrary, for the application entering opening or passage wherein providing 10mm or larger, slender axles assembly 40 can have the cross-sectional diameter of 10mm (or larger), but also can activate 5mm or 10mm end effector.Therefore, the external diameter of outer shaft 40 can be identical or different with the external diameter of the closed end effector 12 be attached on it.
As shown in the figure, slender axles assembly 40 distad extends along straight line substantially from shank assembly 100, to limit longitudinal axis A-A.Such as, slender axles assembly 40 can be about 9-16 inch (229-406mm) length.But slender axles assembly 40 can be set to other length, or joint can be had wherein or otherwise can be conducive to end effector 12 and carry out joint motions relative to other parts of axle or shank assembly, as hereafter discussed in more detail.Slender axles assembly 40 comprises ridge component 50, and this ridge component extends to end effector 12 from shank assembly 100.The proximal extremity of the elongated passageway 14 of end effector 12 has a pair maintenance lug 17 from its projection, this, in the lug opening keeping the size of lug to be configured to be contained in the correspondence provided in the distal end of ridge component 50 or support 52, can connect slender axles assembly 40 removedly to make end effector 12.Ridge component 50 can be made up of such as 6061 or 7075 aluminum, rustless steel, titanium etc.
Shank assembly 100 comprises pistol grasping type shell, and this pistol grasping type shell can be made into two or more parts for assembling object.Such as, shank assembly 100 as shown in the figure comprise by polymer or plastic material molding or otherwise make and be designed to the right hand housing member 102 that is combined together and left hand housing member (not shown).By molding or the snap in features structure otherwise formed, bolt and pod wherein and/or together with this type of housing member being attached to by binding agent, screw etc.Ridge component 50 has proximal extremity 54, and this proximal extremity is formed flange 56.Flange 56 can rotatably be supported in groove 106, and this groove is by from housing member 102, and each fit ribs 108 to inner process in 104 is formed.This type of is configured with and is beneficial to ridge component 50 and is attached to shank assembly 100, makes ridge component 50 can rotate along 360 ° of paths around longitudinal axis A-A relative to shank assembly 100 simultaneously.
As found out further in FIG, ridge component 50 is through installing axle bush 60 and being supported by installation axle bush 60, and this installation axle bush 60 is rotatably attached to shank assembly 100.Install axle bush 60 and have proximal flange 62 and distal lip 64, it limits rotated trench 65, and the leading edge portion 101 of shank assembly 100 can rotatably be contained in therebetween by this rotated trench.This structure makes installation axle bush 60 can rotate around longitudinal axis A-A relative to shank assembly 100.Ridge component 50 is by ridge pin 66 non-rotatably pin joint extremely installation axle bush 60.In addition, knob 70 is attached to and installs axle bush 60.Such as, knob 70 has hollow mounting flange portion 72, and the size in this hollow mounting flange portion is configured to a part of installing axle bush 60 to be contained in wherein.Knob 70 can by such as glass or carbon filled nylon, Merlon, etc. making, and be also attached to by ridge pin 66 axle bush 60 is installed.In addition, to be formed in mounting flange portion 72 to the maintenance flange 74 of inner process and can to extend in the radial groove 68 being formed at and installing in axle bush 60.Therefore, surgeon by firmly grasping knob 70 and making it rotate relative to shank assembly 100, and makes ridge component 50 (with the end effector 12 be attached on it) rotate around longitudinal axis A-A along 360 ° of paths.
Anvil block 20 remains on open position by anvil block spring 21 and/or another biased configuration.By being substantially marked as the trigger system of 109, anvil block 20 can optionally move to various closed or clamped position and firing position from open position.Trigger system 109 comprises " firing member " 110, and it comprises hollow firing tube 110.Hollow firing tube 110 axially can move on ridge component 50, therefore forms the outside of slender axles assembly 40.Firing tube 110 can be made up of polymer or other suitable materials, and has the proximal extremity of the percussion yoke 114 being attached to trigger system 109.Such as, the moldable proximal extremity to firing tube 110 of yoke 114 is pulled the trigger.But, other securing members also can be adopted to construct.
As can be seen in Figure 1, percussion yoke 114 rotatably can be supported on and support in lining ring 120, and this support lining ring can axially-movable in shank assembly 100.Support lining ring 120 and have the fin extended laterally for a pair, this is set to the size of fin in the fin slit that is slidably received within and is formed in left hand housing member and right hand housing member.Therefore, supporting lining ring 120 can slide axially in shank shell 100, makes percussion yoke 114 and firing tube 110 can rotate around longitudinal axis A-A relative to support lining ring 120 simultaneously.According to the present invention, firing tube 110 is provided with longitudinal slit, through wherein extending in ridge component 50, firing tube 110 can be conducive to simultaneously and axially advances on ridge component 50 to make ridge pin 66.
Trigger system 109 also comprises percussion trigger 130, and this percussion trigger is advanced for controlling the axis of firing tube 110 on ridge component 50.See Fig. 1.Distal direction formation along firing tube 110 is pulled the trigger this type of mutual axially-movable with anvil block 20 and is referred to herein as " firing action ".As can be seen in Figure 1, pull the trigger trigger 130 and be connected to shank assembly 100 movingly or pivotly by pivot pin 132.Adopt torsionspring 135 to be biased percussion trigger 130 and arrive " the opening " or the original position that do not activate away from the pistol grip portion 107 of shank assembly 100.As can be seen in Figure 1, percussion trigger 130 has top 134, and this top is attached (pin joint) movingly to percussion chain link 136, and this percussion chain link is attached (pin joint) movingly to supporting lining ring 120.Therefore, pull the trigger trigger 130 and will cause distally direction " DD " motion of percussion yoke 114 and firing tube 110 from original position (Fig. 1) towards the motion of the final position in the pistol grip portion 107 of adjacent hub parts 100.Percussion trigger 130 will cause percussion yoke 114 and firing tube 110 to move along proximal direction " PD " on ridge component 50 away from the motion (under the bias force of torsionspring 135) in the pistol grip portion 107 of shank assembly 100.
The present invention can use together with the implanted nail bin of configuration with different size.Such as, when using in conjunction with the first percussion adapter 140, surgical instruments 10 can use together with the 5mm end effector 12 of the about 20mm long (or with other length) of support implanted nail bin 30.This end effector size can be particularly well-suited in the dissection and the management of blood vessels that such as realize opposite fine.But, as hereafter institute is described in more detail, such as, also by the first percussion adapter 140 is replaced by the second percussion adapter, the end effector of surgical instruments 10 and other sizes and nail bin are combined.As other alternate forms, slender axles assembly 40 can be attached to the end effector of only a kind of form or size.
Now by a kind of method end effector 12 being connected to removedly ridge component 50 of explaination.Connection process is started by being inserted by the maintenance lug 17 on elongated passageway 14 in the lug support 52 in ridge component 50.Subsequently, the pistol grip 107 of percussion trigger 130 shell component 100 toward the outside advances by surgeon, so that firing tube 110 and the first percussion adapter 140 are distad advanced on the proximal end portions 47 of elongated passageway 14, thus lug 17 is remained in its respective support 52.First percussion adapter 140 this type of position on lug 17 is referred to herein as " coupled position ".The present invention also can have end effector locked component, after being attached to ridge component 50 at end effector 12, percussion trigger 130 is locked in appropriate location.
More particularly, an embodiment of end effector locked component 160 comprises retaining pin 162, and this retaining pin is supported in the top 134 of percussion trigger 130 movingly.As mentioned above, firing tube 110 first distad must be advanced coupled position, and wherein the maintenance lug 17 of end effector 12 remains in the lug support 52 in ridge component 50 by the first percussion adapter 140.Percussion adapter 140 is distad advanced to coupled position by pulling the trigger trigger 130 from original position towards pistol grip 107 tractive by surgeon.When pulling the trigger trigger 130 and first being activated, retaining pin 162 distal motion, until the first percussion adapter 140 is advanced to coupled position by firing tube 110, now retaining pin 162 is biased in the latch well 164 be formed in housing member.Optionally, when retaining pin 162 enters in latch well 164, pin 162 can send " click clatter " sound or other sound that can hear, and for surgeon provide end effector 12 be " locked " on ridge component 50 sense of touch instruction.In addition, only otherwise wittingly retaining pin 162 is biased out latch well 164, surgeon just can not continue unintentionally to activate percussion trigger 130 to start to make the nail 32 in end effector 12 be shaped.Similarly, if surgeon's release is in the percussion trigger 130 of coupled position, then retaining pin 162 can make percussion trigger 130 remain on this position, is back to original position to prevent percussion trigger 130 and therefore discharges end effector 12 from ridge component 50.
The present invention also can comprise trigger system locking press button 137, and this trigger system locking press button is the mode of pivotable can be attached to shank assembly 100.In one form, trigger system locking press button 137 has the breech lock 138 formed in its distal end, and this breech lock is oriented to and engages percussion yoke 114 when pulling the trigger when release-push is in the first position latching.As can be seen in Figure 1, late spring 139 is for being biased to the first position latching by trigger system locking press button 137.In all cases, breech lock 138 is for engaging percussion yoke 114 at following some place: at this some place, and the position of the percussion yoke 114 on ridge component 50 corresponds to wherein the first percussion adapter 140 and is about to distally be advanced to the point on the clamping slideway 28 on anvil block 20.Should be appreciated that, along with the first percussion adapter 140 axially advances on clamping slideway 28, anvil block 20 will, along path movement, make to follow closely the top surface 36 that forming surface portion 22 is arranged essentially parallel to nail bin 30.
After end effector 12 is connected to ridge component 50, start to follow closely forming process by first depressing trigger system locking press button 137, with make percussion yoke 114 can on ridge component 50 further distal motion and the most at last anvil block 20 be compressed in nail bin 30.After pressure trigger system locking press button 137, surgeon continues to activate percussion trigger 130 towards pistol grip 107, thus by the nail shaping slideway 29 being driven into correspondence of the first nail lining ring 140, to force anvil block 20 and nail 32 shaping contact in nail bin 30.Trigger system locking press button 137 prevents from by mistake making nail 32 be shaped before surgeon is ready to start this process.In this embodiment, surgeon must depress trigger system locking press button 137 to start to follow closely forming process before percussion trigger 130 can be further actuated.
Surgical instruments 10 optionally and only can be used as tissue apposition device.But the present invention also can comprise and organizes diced system, and this tissue diced system is marked as 170 substantially.In at least one form, organizing diced system 170 to comprise cutter component 172, by activating cutter trigger 200 of advancing, this cutter component being optionally advanced to actuated position from the unactuated position of the proximal extremity of adjacent side terminal part executor 12.Cutter component 172 is supported in ridge component 50 movingly, and is attached to knife bar 180 or otherwise from knife bar 180 projection.Cutter component 172 can be made up of 420 or 440 rustless steels such as with the hardness being greater than 38HRC (RHC), and can have to be formed at its distal end 174 organizes cutting edge 176, and the slit that can extend through slidably in anvil block 20 and the slit 33 arranged placed in the middle in nail bin 30, to cut the tissue worn and be clamped in end effector 12.Knife bar 180 extends through ridge component 50 and has the proximal end portions joined with the transmission of cutter transporter, and this cutter transporter is operationally attached to cutter and advances trigger 200.Cutter trigger 200 of advancing is attached to pivot pin 132, makes it to carry out pivotable or otherwise to activated when without the need to activating percussion trigger 130.According to the present invention, the first cutter tooth wheel 192 is also attached to pivot pin 132, makes the advance actuating of trigger 200 of cutter also make the first cutter tooth take turns 192 pivotables.Be attached with between first cutter tooth wheel 192 and shank housing 100 and pull the trigger return spring 202, be biased to original position or unactuated position with trigger 200 of being advanced by cutter.
Cutter transporter also comprises the second cutter tooth wheel 194, and this second cutter tooth is taken turns rotatably to be supported on the second gear shaft and to take turns 192 with the first cutter tooth and engaged.Second cutter tooth wheel 194 is taken turns 196 with the 3rd cutter tooth be supported on the 3rd gear shaft and is engaged.Four blade gear 198 is also supported on the 3rd gear shaft 195.Four blade gear 198 transmission can be bonded on a series of gear teeth in the proximal extremity of knife bar 180 or ring.Therefore, this structure makes four blade gear 198 axially can drive knife bar 180 along distal direction " DD " or proximal direction " PD ", makes trigger shaft 180 rotate around longitudinal axis A-A relative to four blade gear 198 simultaneously.Therefore, surgeon is by advancing trigger 200 and make trigger shaft 180 axially advance and final distally promote cutter component 172 towards the pistol grip 107 tractive cutter of shank assembly 100.
The present invention also comprises cutter locking system 210, and this cutter locking system prevents the propelling of cutter component 172, unless percussion trigger 130 has been pulled to complete firing position.Therefore, this structure will prevent the activation of cutter propulsion system 170, unless first nail is pulled the trigger or form in tissue.As can be seen in Figure 1, the various concrete enforcement of cutter locking system 210 comprises cutter securing rod 211, and this cutter securing rod is can the mode of pivotable be supported in the pistol grip portion 107 of shank assembly 100.Cutter securing rod 211 has activated end 212, and when pulling the trigger trigger 130 and being in complete firing position, activated end 212 can be engaged by percussion trigger 130.In addition, cutter securing rod 211 has maintenance suspension hook 214 on the other end thereof, and this maintenance suspension hook can engage the latch bar 216 on the first cutting gear 192 in suspension hook mode.Adopt cutter locking spring 218 that cutter securing rod 211 is biased to " locking " position, wherein keep suspension hook 214 to keep engaging with latch bar 216, thus prevent cutter to advance the actuating of trigger 200, unless pulled the trigger trigger 130 to be in complete firing position.
After nail is " fired " in (shaping) to target tissue, surgeon can depress percussion trigger release-push 167, with make percussion trigger 130 can torsionspring 135 biased under be back to original position, thus make anvil block 20 can bias downwards into open position the biased of spring 21.When in open position, surgeon can withdraw from end effector 12 and leave implanted nail bin 30 and nail 32.In the application that end effector is inserted into through passage, service aisle etc. wherein, surgeon will make anvil block 20 be back to make position by activating percussion trigger 130, can be withdrawn to make end effector 12 by passage or service aisle.But if surgeon wants to cut target tissue after percussion nail, then surgeon activates cutter in the above described manner and to advance trigger 200, arrives the end of end effector to drive knife bar 172 through target tissue.Subsequently, surgeon can discharge cutter and to advance trigger 200, can make percussion transporter that knife bar 172 is back to initial (actuating) position to make percussion return spring 202.Once knife bar 172 is back to original position, surgeon just can open end effector jaw 13,15, also in patient body, withdraws from end effector 12 subsequently to be released in implanted storehouse 30 in patient body.Therefore, this type of surgical instruments is conducive to using the little implanted nail bin be inserted into by relatively little service aisle and passage, simultaneously for surgeon provides following selection: when not cutting and organizing, percussion is followed closely or also cut and organized after percussion nail.
Various uniqueness of the present invention and new embodiment adopt compressible nail bin, described compressible nail bin support be in substantially fixed position for by the nail of anvil block shaping contact.Be driven into by anvil block in unshaped nail, the degree that wherein such as reached nail is shaped depends on how far anvil block is driven in nail.The amount of the shaping that this class formation makes surgeon to regulate to be applied to nail or percussion pressure, thus change the final forming height of nail.In other embodiments of the invention, surgical stapling structure can adopt nail driving element, and nail can lift towards anvil block by this nail driving element.Hereafter these embodiments are described in more detail.
Optionally, with reference to above, the amount being applied to the firing action of removable anvil block depends on the degree of the actuating of percussion trigger.Such as, if surgeon goes for only partially-formed nail, then only need towards pistol grip 107 partially to interior pressure percussion trigger.Obtain and more follow closely shaping, surgeon only needs to compress percussion trigger further, anvil block is driven further and contacts to form with nail.As used herein, term " shaping contact " refers to that nail profiled surface or nail shaping pit have also started be shaped by lower limb or be bent to shaping position in the end of contact stud lower limb.The degree that nail is shaped refers to the degree that nail lower limb is folded and finally refers to the forming height of nail referred to above.Those skilled in the art will be further understood that, because when applying firing action to anvil block 20, anvil block 20 moves with the relation substantially parallel with nail bin, so nail is substantially shaped and has substantially the same forming height simultaneously.
Fig. 2 and Fig. 3 shows alternative end effector 12 ", except the following difference that can hold knife bar 172 ', end effector 12 " be similar to above-mentioned end effector 12 '.Knife bar 172 ' is connected to knife bar 180 or from knife bar 180 projection, and in addition above to operate about the mode described in knife bar 172.But in this embodiment, knife bar 172 ' long enough is to traverse end effector 12 " whole length, therefore end effector 12 " in do not adopt independent distal blade component.Knife bar 172 ' has upper cross member 173 ' formed thereon and lower cross member 175 '.Upper cross member 173 ' is oriented to and traverses anvil block 20 slidably " in respective elongated slit 250, and lower cross member 175 ' be oriented to traverse end effector 12 " elongated passageway 14 " in elongated slot 252.Depart from slit (not shown) and be also arranged on anvil block 20 " in; make when knife bar 172 ' has been driven to end effector 12 " in final position time, upper cross member 173 ' is dropped through corresponding slit to allow anvil block 20 " move to open position with the tissue departing from stitching and cut.Anvil block 20 " can be in addition identical with above-mentioned anvil block 20, and elongated passageway 14 " can be in addition identical with above-mentioned elongated passageway 14.
In these embodiments, anvil block 20 " by spring or other open structure (not shown) be biased to fully open position (Fig. 2).Anvil block 20 " by percussion adapter 150 axial row of carrying out in the above described manner and then at open position and move between clamped position completely.Once percussion adapter 150 is advanced into complete clamped position (Fig. 3), surgeon just distally can advance knife bar 172 subsequently in the above described manner ".If surgeon wants that end effector is used as grasp device carry out manipulating tissue, then percussion adapter proximally can be moved, to allow anvil block 20 " away from elongated passageway 14 " motion, as shown in phantom in figure 4.In this embodiment, along with knife bar 172 " distally move; upper cross member 173 ' pulls anvil block 20 with lower cross member 175 ' together with " and elongated passageway 14 ", with at knife bar 172 " through end effector 12 " realize the nail shaping of expectation when distally advancing.See Fig. 5.Therefore, in this embodiment, nail shaping cut occur simultaneously with tissue, but nail itself can at knife bar 172 " distally driving time be sequentially shaped.
The uniqueness of various surgery nail bin of the present invention and surgical instruments and novel feature structure enables the nail in described nail bin be arranged in one or more linear or nonlinear line.Each side of elongated slot can be provided with many this nail lines, described elongated slot is medially arranged in nail bin, for hold through wherein organize cutting element.In one structure, nail such as into a line can be substantially parallel to the nail in the adjacent lines of nail but depart from it.As other alternate forms, one or more nail line can be essentially nonlinear.That is, the base portion following closely at least one nail in line can along the Axis Extension of the base portion of other nails substantially traversed in same nail line.Such as, the nail line of the every side of elongated slot can have sawtooth appearance.
According to the present invention, nail bin can comprise warehouse and be stored in the multiple nails in warehouse.In use, nail bin can be introduced in operative site and to be located at the side of handled tissue.In addition, nail shaping anvil block can be positioned on the opposite side of tissue.Anvil block can be carried by the first jaw and nail bin can be carried by the second jaw, and wherein the first jaw and/or the second jaw can move towards another jaw.Once nail bin and anvil block are located relative to tissue, then can penetrate nail from nail bin body, make nail can piercing tissue contact stud shaping anvil block.Once dispose nail from nail bin body, then then can remove nail bin body from operative site.Nail bin or nail bin at least partially in implantablely have nail.Such as, as hereafter described in more detail, nail bin can comprise warehouse, and when anvil block moves to make position from open position, this warehouse can be compressed by anvil block, crushes and/or collapse.When warehouse compressed, conquassation and/or collapse time, the nail be positioned in warehouse is out of shape by anvil block.Alternatively, the jaw supporting nail bin can move to make position towards anvil block.Two kinds of situations any one in, when follow closely be positioned in warehouse at least in part time, nail deformable.In some cases, nail can not penetrate from nail bin, and in other cases, nail can penetrate from nail bin together in company with a part for warehouse.
Referring now to Fig. 6 A-Fig. 6 D, compressible nail bin (such as nail bin 1000) such as can comprise compressible, implanted warehouse 1010, and is positioned at the multiple nails 1020 in compressible warehouse 1010 in addition, but Fig. 6 A-Fig. 6 D only illustrates a nail 1020.Fig. 6 A illustrates the nail bin 1000 supported by nail bin support member or nail bin path 10 30, and wherein nail bin 1000 is shown in uncompressed condition.In this uncompressed condition, anvil block 1040 can contact or not contact tissue T.In use, anvil block 1040 can move to contact tissue T from open position, as shown in Figure 6B, and tissue T is located against warehouse 1010.Even if tissue T can be positioned to the tissue contacting surface 1019 against nail bin body 1010 by anvil block 1040, but refer again to Fig. 6 B, nail bin body 1010 now can stand few (if any) compression stress or pressure, and follows closely 1020 and can remain on unshaped or not pull the trigger condition.As shown in Figure 6 A and 6 B, nail bin body 1010 can comprise one or more layer, and the nail lower limb 1021 following closely 1020 upwards can extend through these layers.Warehouse 1010 can comprise ground floor 1011, the second layer 1012, third layer 1013 and the 4th layer 1014, wherein the second layer 1012 can be positioned in the middle of ground floor 1011 and third layer 1013, and wherein third layer 1013 can be positioned in the middle of the second layer 1012 and the 4th layer 1014.Such as, the base portion 1022 of nail 1020 can be positioned in the cavity 1015 in the 4th layer 1014, and follows closely lower limb 1021 and upwards can extend from base portion 1022 and pass the 4th layer 1014, third layer 1013 and the second layer 1012.Optionally, each deformable lower limb 1021 can comprise top, such as sharp top 1023, and such as, when nail bin 1000 is in uncompressed condition, this sharp top can be positioned in the second layer 1012.Such as, top 1023 can not extend to and/or pass ground floor 1011, and wherein when nail bin 1000 is in uncompressed condition, top 1023 can be not projecting through tissue contacting surface 1019.When nail bin is in uncompressed condition, sharp top 1023 can be positioned in third layer 1013 and/or any other suitable layer.Alternatively, the warehouse of nail bin can have any suitable number of layers, such as, be less than four layers or more than four layers.
Optionally, as hereafter described in more detail, ground floor 1011 can by buttress material and/or plastic material (such as, poly-dioxanone (PDS) and/or polyglycolic acid (PGA)) form, and the second layer 1012 can by can the foamed materials of bio-absorbable and/or compressible hemostatic material (such as, oxidized regenerated cellulose (ORC)) form.Optionally, nail 1020 can remain in nail bin body 1010 by one or more in ground floor 1011, the second layer 1012, third layer 1013 and the 4th layer 1014, and nail 1020 can be made in addition to keep mutual alignment.Third layer 1013 can be made up of buttress material or quite incompressible or non-elastic material, and the nail lower limb 1021 of nail 1020 relative to each other can be remained on appropriate location by this material.In addition the second layer 1012 and the 4th layer 1014, be positioned at the second layer 1012 on the opposite side of third layer 1013 and the 4th layer of 1014 Absorbable organic halogens or reduce the motion of nail 1020, even if can be made up of compressible foam or elastomeric material.The screw top end 1023 of nail lower limb 1021 can embed in ground floor 1011 at least in part.Such as, ground floor 1011 and third layer 1013 can collaboratively and firmly nail lower limb 1021 is remained on appropriate location.Ground floor 1011 and third layer 1013 can respectively by such as can bioabsorbable material (such as with the polyglycolic acid (PGA) that trade name Vicryl sells, polylactic acid (PLA or PLLA), poly-dioxanone (PDS), polyhydroxyalkanoatefrom (PHA), with the poliglecaprone 25 (PGCL) that trade name Monocryl sells, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA, the complex of PGCL and/or PCL) thin slice form, and the second layer 1012 and the 4th layer 1014 can be made up of at least one hemostatic material or hemorrhage respectively.
Although ground floor 1011 can be compressible, but the second layer 1012 can be substantially more compressible than ground floor 1011.Such as, the compressibility of the second layer 1012 can be ground floor 1011 about twice, about three times, about four times, about five times and/or about ten times.In other words, for given power, the compression degree of the second layer 1012 can be the about twice of ground floor 1011, about three times, about four times, about five times and/or about ten times.The compressibility of the second layer 1012 such as can between the about twice of ground floor 1011 and about ten times.The second layer 1012 can comprise the multiple air gaps be defined in wherein, and the amount of the air gap wherein in the second layer 1012 and/or size can be controlled to the expectation compressibility providing the second layer 1012.To similar above, although third layer 1013 can be compressible, but the 4th layer 1014 can have more compressibility substantially than third layer 1013.Such as, the compressibility of the 4th layer 1014 can be third layer 1013 about twice, about three times, about four times, about five times and/or about ten times.In other words, for given power, the compression degree of the 4th layer 1014 can be third layer 1013 about twice, about three times, about four times, about five times and/or about ten times.The compressibility of the 4th layer 1014 can between the about twice of third layer 1013 and about ten times.Can comprise the multiple air gaps be defined in wherein for 4th layer 1014, amount and/or the size of the air gap wherein in the 4th layer 1014 can be controlled to the expectation compressibility providing the 4th layer 1014.In all cases, the compressibility of warehouse or warehouse layer is expressed by compression ratio (that is, layer is for the distance of compressing to the power of sizing).Such as, compared with the layer had compared with little compressible, the layer with high compression rate for be applied to this layer to the compression stress of sizing by distance larger for compression.So, the comparable ground floor of the second layer 1,012 1011 has higher compression ratio; Similarly, the 4th layer of 1014 comparable third layer 1013 has higher compression ratio.The second layer 1012 can be made up of identical material with the 4th layer 1014 and can have identical compression ratio.The second layer 1012 and the 4th layer 1014 can be made up of the material with different compression ratio.Similarly, ground floor 1011 can be made up of identical material with third layer 1013 and can have identical compression ratio.Ground floor 1011 and third layer 1013 can be made up of the material with different compression ratio.
When anvil block 1040 is advanced towards its make position, anvil block 1040 can contact tissue T apply compression stress to tissue T and nail bin 1000, as shown in Figure 6 C.In this case, anvil block 1040 can promote top surface or the tissue contacting surface 1019 of warehouse 1010 downwards towards nail bin support member 1030.Nail bin support member 1030 can comprise storehouse stayed surface 1031, its can between the tissue contacting surface 1041 that nail bin 1000 is compressed in storehouse stayed surface 1031 and anvil block 1040 time support nail bin 1000.Due to anvil block 1040 applied pressures, warehouse 1010 can be compressed and anvil block 1040 can contact stud 1020.More particularly, moving downward of the compression of warehouse 1010 and tissue contacting surface 1019 can make the top 1023 of nail lower limb 1021 pierce through the ground floor 1011 of warehouse 1010, piercing tissue T and entering in the shaping pit 1042 in anvil block 1040.When warehouse 1010 is compressed further by anvil block 1040, top 1023 can contact the wall limiting shaping pit 1042, and such as therefore lower limb 1021 can to internal strain or curling, as shown in Figure 6 C.When following closely lower limb 1021 and being deformed, equally as shown in Figure 6 C, the base portion 1022 of nail 1020 can contact nail bin support member 1030 or be supported by nail bin support member 1030.Optionally, as described in greater detail below, nail bin support member 1030 can comprise multiple support feature structure, such as follows closely support trenches, slit or groove 1032, described multiple support feature structure can when nail 1020 is deformed support nail 1020 or at least follow closely 1020 base portion 1022.Equally as shown in Figure 6 C, the compression stress being applied to nail bin body 1010 can make the cavity 1015 in the 4th layer 1014 collapse.Except cavity 1015, nail bin body 1010 also can comprise one or more space (such as space 1016), such as, can comprise or not comprise a part for the nail be positioned at wherein in described one or more space, described one or more space can allow warehouse 1010 to collapse.Can collapse in cavity 1015 and/or space 1016, the wall limiting cavity and/or wall is deflected down and contacts the layer be positioned below cavity and/or space of storehouse stayed surface 1031 and/or contact warehouse 1010.
When comparison diagram 6B and Fig. 6 C, obviously, the second layer 1012 and the 4th layer 1014 compression pressure that applies by anvil block 1040 substantially compress.Also can note, ground floor 1011 and third layer 1013 are also compressed.When anvil block 1040 moves to its make position, anvil block 1040 continues compression warehouse 1010 further by promoting tissue contacting surface 1019 downwards towards nail bin support member 1030.When warehouse 1010 is further compressed, anvil block 1040 can make nail 1020 be deformed into its complete shaping form, as shown in Figure 6 D.See Fig. 6 D, the lower limb 1021 of each nail 1020 can be out of shape downwards towards the base portion 1022 of each nail 1020, so that by tissue T, ground floor 1011, the second layer 1012, being captured at least partially between deformable lower limb 1021 and base portion 1022 of third layer 1013 and the 4th layer 1014.When comparison diagram 6C and Fig. 6 D, more obviously, the second layer 1012 and the 4th layer 1014 further the compression pressure that applies by anvil block 1040 significantly compress.Also can note when comparison diagram 6C and Fig. 6 D, ground floor 1011 and third layer 1013 are also further compressed.After nail 1020 is shaped completely or at least fully, anvil block 1040 can be lifted away from tissue T, and nail bin support member 1030 can away from and/or depart from nail bin 1000 and move.As shown in Figure 6 D and due to mentioned above, warehouse 1010 is implantable nail 1020.In various embodiments, implanted warehouse 1010 can along nail line supporting tissue.In some cases, the hemorrhage that comprises of the warehouse 1010 of implantation and/or any other medicine be applicable to can along with passage of time be to process tissue.Hemorrhage as above can reduce sew up and/or cutting organize hemorrhage, simultaneously bonding agent or tissue adhesive can along with passage of time for tissue provide intensity.The warehouse 1010 implanted can by such as ORC (oxidized regenerated cellulose), extracellular protein (such as collagen), with the polyglycolic acid (PGA) that trade name Vicryl sells, polylactic acid (PLA or PLLA), poly-dioxanone (PDS), polyhydroxyalkanoatefrom (PHA), with the poliglecaprone 25 (PGCL) that trade name Monocryl sells, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA, the material of the complex of PGCL and/or PCL is formed.In some cases, warehouse 1010 can comprise antibiosis and/or the anti-biotic material of the probability that such as can reduce surgical site infection, such as collargol and/or triclosan.
The layer of warehouse 1010 can be interconnected.Such as, can utilize at least one binding agent (such as fibrin and/or protein hydrogel) that the second layer 1012 is adhered to ground floor 1011, third layer 1013 be adhered to the second layer 1012, and adheres to third layer 1013 by the 4th layer 1014.Although not shown, the layer of warehouse 1010 links together by interlocking machine feature structure.Such as, ground floor 1011 and the second layer 1012 can comprise corresponding interlocking features structure separately, such as tenon groove structure and/or dovetail structure.Similarly, the second layer 1012 and third layer 1013 can comprise corresponding interlocking features structure separately, and simultaneously third layer 1013 and the 4th layer 1014 can comprise corresponding interlocking features structure separately.Although not shown, nail bin 1000 can comprise such as one or more rivet, and this one or more rivet can extend across one or more layers of warehouse 1010.Such as, each rivet can comprise the second head of the first end or head that adjacent first layer 1011 locates and contiguous 4th layer 1014 and location, and the 4th layer can be assembled into the second end of rivet or be formed by the second end of rivet.Such as, due to the compressible character of warehouse 1010, the compressible warehouse 1010 of rivet, makes the head of rivet can cave in relative to the tissue contacting surface 1019 of warehouse 1010 and/or lower surface 1018.Such as, rivet can by can the material (complex of the polyglycolic acid (PGA) such as sold with trade name Vicryl, polylactic acid (PLA or PLLA), poly-dioxanone (PDS), polyhydroxyalkanoatefrom (PHA), the poliglecaprone 25 (PGCL) sold with trade name Monocryl, polycaprolactone (PCL) and/or PGA, PLA, PDS, PHA, PGCL and/or PCL) of bio-absorbable be formed.Except the nail 1020 by holding in warehouse 1010, the layer of warehouse 1010 can not be connected to each other.Such as, the layer of warehouse 1010 such as can keep together by the frictional engagement between nail lower limb 1021 and warehouse 1010, and once nail is shaped, then described layer can be trapped in nail 1020.Roughened surface or the rough coatings that can comprise the frictional force that can increase between nail 1020 and warehouse 1010 at least partially of nail lower limb 1021.
As mentioned above, surgical instruments can comprise the first jaw and the second jaw, and the first jaw comprises nail bin support member 1030, second jaw and comprises anvil block 1040.Optionally, as hereafter be described in more detail, nail bin 1000 can comprise one or more holding structure, and this one or more holding structure can engage nail bin support member 1030 and therefore nail bin 1000 be remained to nail bin support member 1030 releasedly.Such as, by least one binding agent (such as, fibrin and/or protein hydrogel), nail bin 1000 is adhered to nail bin support member 1030.In use, in at least one situation, especially in abdominal cavity mirror and/or endoscopic procedure, the second jaw is moveable to the make position relative with the first jaw, such as, make the first jaw and the second jaw be inserted in operative site by the trocar.Such as, the trocar can limit hole or the intubate of about 5mm, and the first jaw and the second jaw are inserted into by it.Second jaw is moveable to the partial closed position between in an open position and make position, and this partial closed position can allow the first jaw and the second jaw to be inserted into through the trocar, and without the need to making the nail 1020 held in nail bin body 1010 be out of shape.Such as, when the second jaw is in the closed centre position of its part, anvil block 1040 can not apply compression stress to nail bin body 1010, but when the second jaw is in the centre position that its part closes, the compressible nail bin body 1010 of anvil block 1040.Although the compressible nail bin body 1010 when anvil block 1040 is in this centre position, but anvil block 1040 can compress nail bin body 1010 by halves, makes anvil block 1040 contact stud 1020 and/or nail 1020 is out of shape by anvil block 1040.Once the first jaw and the second jaw are inserted into by the trocar in operative site, then the second jaw can be opened again, and anvil block 1040 and nail bin 1000 can position relative to target tissue as mentioned above.
Referring now to Fig. 7 A-Fig. 7 D, the end effector of surgical stapling device can comprise the implanted nail bin 1100 be positioned in the middle of anvil block 1140 and nail bin support member 1130.To similar above, anvil block 1140 can comprise tissue contacting surface 1141, and nail bin 1100 can comprise tissue contacting surface 1119, and nail bin support member 1130 can comprise the stayed surface 1131 that can support nail bin 1100.See Fig. 7 A, anvil block 1140 can be utilized tissue T to be positioned to the tissue contacting surface 1119 against nail bin 1100 and not make nail bin 1100 be out of shape, and when anvil block 1140 is in this position, tissue contacting surface 1141 can be oriented to and nail bin stayed surface 1131 distance 1101a, and tissue contacting surface 1119 can be oriented to and nail bin stayed surface 1131 distance 1102a.Subsequently, when anvil block 1140 moves towards nail bin support member 1130, referring now to Fig. 7 B, anvil block 1140 can promote the top surface of nail bin 1100 or tissue contacting surface 1119 downwards and compress ground floor 1111 and the second layer 1112 of warehouse 1110.Along with layer 1111 and layer 1112 are compressed, refer again to Fig. 7 B, the second layer 1112 can by conquassation, and the lower limb 1121 following closely 1120 can pierce through ground floor 1111 and enter into tissue T.Such as, nail 1120 can be positioned in nail chamber in the second layer 1112 or space 1115 at least in part, and when the second layer 1112 is by compression, can collapse in nail chamber 1115 and therefore the permission second layer 1112 is collapsed around nail 1120.The second layer 1112 can comprise cover 1116, and this cover is extensible also to be surrounded or surrounds nail chamber 1115 at least in part on nail chamber 1115.Fig. 7 B shows the covering part 1116 being pressed downward and bursting in nail chamber 1115.The second layer 1112 can comprise one or more weakening part, and it can be conducive to collapsing of the second layer 1112.Optionally, this type of weakening part can comprise cut that such as can be conducive to warehouse 1110 controlled collapse, perforation and/or thin cross section.Ground floor 1111 can comprise and can be conducive to following closely one or more weakening parts that lower limb 1121 penetrates ground floor 1111.Optionally, this type of weakening part can comprise and such as can align with nail lower limb 1121 or at least cut of substantial alignment, perforation and/or thin cross section.
Refer again to Fig. 7 A, when anvil block 1140 is in partly closed non-firing position, anvil block 1140 can be oriented to and storehouse stayed surface 1131 distance 1101a, makes to be limited with gap therebetween.This gap can be filled by the nail bin 1100 and tissue T with nail bin height 1102a.When anvil block 1140 moves downward to compress nail bin 1100, refer again to Fig. 7 B, the distance between tissue contacting surface 1141 and storehouse stayed surface 1131 can be limited by the distance 1101b being shorter than distance 1101a.In all cases, the gap limited by distance 1101b between the tissue contacting surface 1141 of anvil block 1140 and storehouse stayed surface 1131 can be greater than original undeformed nail bin height 1102a.Referring now to Fig. 7 C, when anvil block 1140 moves to closer to storehouse stayed surface 1131, the second layer 1112 can continue to collapse and the distance of following closely between lower limb 1121 and shaping pit 1142 can reduce.Similarly, the distance between tissue contacting surface 1141 and storehouse stayed surface 1131 can be reduced to distance 1101c, and this distance can be greater than, be equal to or less than and original be not out of shape storehouse height 1102a.Referring now to Fig. 7 D, anvil block 1140 is moveable to final firing position, wherein follows closely 1120 and is shaped completely or is at least shaped to Desired Height.In this position, the tissue contacting surface 1141 of anvil block 1140 can with storehouse stayed surface 1131 distance 1101d, wherein distance 1101d can be shorter than and original not be out of shape storehouse height 1102a.Equally as illustrated in fig. 7d, can collapse completely or at least substantially in nail chamber 1115, and follow closely 1120 can completely or at least substantially by the second layer 1112 of collapsing around.In all cases, anvil block 1140 can move away from nail bin 1100 subsequently.Such as, once anvil block 1140 departs from from nail bin 1100, then warehouse 1110 can such as spread in various position (that is, the position between adjacent nail 1120) at least in part again.The warehouse 1110 of conquassation may not resiliently be expanded again.The nail 1120 be shaped and the warehouse 1110 be positioned in addition between adjacent nail 1120 can apply pressure or compression stress to tissue T, and this can provide various treatment benefit.
As mentioned above, refer again to Fig. 7 A, each nail 1120 can comprise the nail lower limb 1121 extended from it.Such as, although nail 1120 is illustrated as comprising two nail lower limbs 1121, but also can utilize the various nails that can comprise a nail lower limb or comprise alternatively more than two nail lower limbs (such as three nail lower limbs or four nail lower limbs).As shown in Figure 7 A, each nail lower limb 1121 all can embed in the second layer 1112 of warehouse 1110, and nail 1120 is fixed in the second layer 1112.Nail 1120 can be inserted in the nail chamber 1115 in warehouse 1110, makes top 1123 the advancing in cavity 1115 at base portion 1122 of following closely lower limb 1121.After top 1123 is inserted into cavity 1115, top 1123 can be pressed against in cover 1116 and to cut the second layer 1112.Nail 1120 can be sat the enough depths put in the second layer 1112, makes nail 1120 not move relative to the second layer 1112 or at least substantially not move.Nail 1120 can be sat the enough depths put in the second layer 1112, makes base portion 1122 be located or embed in nail chamber 1115.Alternatively, base portion 1122 can not be located or be embedded in the second layer 1112.Refer again to Fig. 7 A, base portion 1122 can extend below the lower surface 1118 of warehouse 1110.Base portion 1122 can be bearing on storehouse stayed surface 1130 or directly and locate against storehouse stayed surface 1130.Storehouse stayed surface 1130 can comprise the support feature structure extending from it and/or be limited to wherein, such as, support in one or more support trenches, slit or the groove 1132 that the base portion 1122 of nail 1120 can be positioned in such as nail bin support member 1130 or by this one or more support trenches, slit or groove 1132, as described in more detail below.
Referring now to Fig. 8 and Fig. 9, nail bin (such as nail bin 1200) such as can comprise compressible implanted warehouse 1210, and this warehouse comprises outer 1211 and internal layer 1212.To similar above, nail bin 1200 can comprise the multiple nails 1220 be positioned in warehouse 1210.Optionally, each nail 1220 all can comprise base portion 1222 and the one or more nail lower limbs 1221 from its extension.Such as, follow closely lower limb 1221 can to insert in internal layer 1212 and to be sat the degree of depth of putting and such as making the lower surface 1218 of the adjacent and/or contiguous internal layer 1212 of base portion 1222 of nail 1220 locate.In figs. 8 and 9, internal layer 1212 does not comprise the nail chamber of the part that can receive nail 1220, and alternatively, internal layer 1212 can comprise this type of nail chamber.To being described further above, internal layer 1212 can be made up of the compressible material that warehouse 1210 can be allowed to collapse when applying compressive load to it (such as can the foam of bio-absorbable and/or oxidized regenerated cellulose (ORC)).Internal layer 1212 can be made up of the freeze dried foam such as comprising polylactic acid (PLA) and/or polyglycolic acid (PGA).ORC can trade name Surgicel commercially available and loose Woven fabric (as surgical sponge), loose fiber (as cotton balls) and/or foam can be comprised.Internal layer 1212 can by comprising and/or applied atop have the material of medicine (such as cryodesiccated thrombin and/or fibrin) to form, this medicine such as can by patient body fluid water activation and/or activation.Such as, cryodesiccated thrombin and/or fibrin can remain in such as Vicryl (PGA) substrate.Such as, but in some cases, when being inserted into when nail bin 1200 in the operative site in patient body, activable medicine can by mistake be activated.Refer again to Fig. 8 and Fig. 9, outer 1211 can by fluid-tight or at least substantially material impervious to water form, liquid is not contacted or does not at least substantially contact internal layer 1212, until warehouse 1210 has been compressed and followed closely lower limb penetrated outer 1211 and/or after skin 1211 cut in some manner.Such as, outer 1211 can be made up of buttress material and/or plastic material (such as poly-dioxanone (PDS) and/or polyglycolic acid (PGA)).Outer 1211 can comprise the wrappage around internal layer 1212 and nail 1220.More particularly, follow closely 1220 can be inserted in internal layer 1212 and outer 1211 and to be wrapped around the sub-component comprising internal layer 1212 and nail 1220 and to be sealed subsequently.
As described herein, when anvil block moves to make position, the nail of nail bin can be shaped completely by anvil block.Alternatively, referring now to Figure 10-Figure 13, such as the nail of the nail bin of nail bin 4100 is such as by the anvil block when anvil block moves to make position, and additionally by making nail be out of shape towards the staple drivers system of closed anvil block motion.Nail bin 4100 can comprise compressible warehouse 4110, and this compressible warehouse can be such as made up of foamed materials and the multiple nails 4120 be positioned at least in part in compressible warehouse 4110.Staple drivers system can comprise driver clamper 4160, be positioned at multiple staple drivers 4162 in driver clamper 4160 and nail bin dish 4180, and staple drivers 4162 can remain in driver clamper 4160 by this nail bin dish.Such as, staple drivers 4162 can be positioned in the one or more slits 4163 in driver clamper 4160, and wherein the sidewall of slit 4163 can help to boot up staple drivers 4162 towards anvil block.Nail 4120 can be supported in slit 4163 by staple drivers 4162, and wherein when nail 4120 and staple drivers 4162 are in its non-firing position, nail 4120 can be positioned in slit 4163 completely.Alternatively, when nail 4120 and staple drivers 4162 are in its non-firing position, upwards can extending through the opening 4161 of slit 4163 at least partially of nail 4120.Such as, now main see Figure 11, the base portion of nail 4120 can be positioned in driver clamper 4160, and the top of following closely 4120 can embed in compressible warehouse 4110.The height following closely 4120 about 1/3rd can be positioned in driver clamper 4160, and the height following closely 4120 about 2/3rds can be positioned in warehouse 4110.See Figure 10 A, such as nail bin 4100 also can comprise water impervious wrappage around warehouse 4110 and driver clamper 4160 or film 4111.
In use, such as, nail bin 4100 can be positioned in nail bin passage, and anvil block can move to make position towards nail bin 4100.When anvil block moves to its make position, anvil block can contact and compress compressible warehouse 4110.When anvil block is in its make position, anvil block can not contact stud 4120.When anvil block moves to its make position, anvil block can contact stud 4120 lower limb and make nail 4120 be out of shape at least in part.In arbitrary situation, nail bin 4100 also can comprise one or more sliding part 4170, described one or more sliding part longitudinally can advance at nail bin 4100, makes sliding part 4170 can jointing nail driver 4162 and staple drivers 4162 and nail 4120 are moved towards anvil block subsequently.Sliding part 4170 can slide between nail bin dish 4180 and staple drivers 4162.When anvil block closed has made the forming process of nail 4120 start, nail 4120 has moved upward towards anvil block and can complete forming process and make the height that nail 4120 is deformed into its height be shaped completely or at least expects.When anvil block closed does not make nail 4120 be out of shape, follow closely 4120 and to move upward towards anvil block and can start and complete forming process and make the height that nail 4120 is deformed into its height be shaped completely or at least expects.Sliding part 4170 can be advanced to the distal end of nail bin 4100 from the proximal extremity of nail bin 4100, make before the nail 4120 in the distal end being positioned nail bin 4100 is shaped completely, the nail 4120 be positioned in the proximal extremity of nail bin 4100 is shaped completely.See Figure 12, sliding part 4170 can comprise at least one surface 4711 that is angled or that tilt separately, and it also can promote staple drivers 4162 as shown in figure 13 in staple drivers 4162 slid underneath.
To being described further above, nail 4120 can be formed, so as by tissue T at least partially with the compressible warehouse 4110 of nail bin 4100 be captured in wherein at least partially.After nail 4120 is shaped, the anvil block of surgical stapling device and nail bin passage 4130 can move away from the nail bin 4100 implanted.In all cases, storehouse dish 4180 can engage nail bin passage 4130 regularly, and wherein as a result, when nail bin passage 4130 is pulled away from the warehouse 4110 implanted, storehouse dish 4180 can be separated with compressible warehouse 4110.Refer again to Figure 10, storehouse dish 4180 can comprise relative sidewall 4181, and warehouse 4110 can be positioned between this relative sidewall 4181 removedly.Such as, compressible warehouse 4110 can be compressed between sidewall 4181, and warehouse 4110 during use can be remained on therebetween removedly, and when storehouse dish 4180 is pulled away from, warehouse 4110 departs from releasedly from storehouse dish 4180.Such as, driver clamper 4160 can be connected to storehouse dish 4180, and make when storehouse dish 4180 removes from operative site, driver holder 4160, driver 4162 and/or sliding part 4170 can remain in storehouse dish 4180.Driver 4162 can penetrate from driver clamper 4160 and stay operative site.Such as, driver 4162 can by can the material (complex of the polyglycolic acid (PGA) such as sold with trade name Vicryl, polylactic acid (PLA or PLLA), poly-dioxanone (PDS), polyhydroxyalkanoatefrom (PHA), the poliglecaprone 25 (PGCL) sold with trade name Monocryl, polycaprolactone (PCL) and/or PGA, PLA, PDS, PHA, PGCL and/or PCL) of bio-absorbable be formed.Driver 4162 can be attached to nail 4120, makes driver 4162 be deployed with nail 4120.Such as, each driver 4162 can comprise the groove of the base portion that such as can hold nail 4120, and wherein said groove can hold nail base portion with pressure fitted mode and/or snap fit.
To being described further above, driver clamper 4160 and/or sliding part 4170 can coil 4180 injections from storehouse.Such as, sliding part 4170 can coil between 4180 and driver clamper 4160 in storehouse and slide, make when sliding part 4170 advances upwards to drive staple drivers 4162 and nail 4120, sliding part 4170 also can make driver clamper 4160 move upward to outside storehouse dish 4180.Such as, driver clamper 4160 and/or sliding part 4170 can by can the material (complex of the polyglycolic acid (PGA) such as sold with trade name Vicryl, polylactic acid (PLA or PLLA), poly-dioxanone (PDS), polyhydroxyalkanoatefrom (PHA), the poliglecaprone 25 (PGCL) sold with trade name Monocryl, polycaprolactone (PCL) and/or PGA, PLA, PDS, PHA, PGCL and/or PCL) of bio-absorbable be formed.Sliding part 4170 can integrally form and/or be attached to driving rod or cutting element, and described driving rod or cutting element promote sliding part 4170 through nail bin 4100.In this case, sliding part 4170 can not penetrate from storehouse dish 4180 and can keep together with surgical stapling device, and sliding part 4170 is not attached in other situations of driving rod wherein, and sliding part 4170 can be stayed in operative site.In any case, to being described further above, the compressibility of warehouse 4110 can allow to use thicker nail bin in the end effector of surgical stapling device, this is because when the anvil block of stiching instrument closes, warehouse 4110 is compressible or collapse.As the nail when anvil block closes by the result of being out of shape at least in part, higher nail (such as have about 0.18 " nail of staple height) can be used; such as wherein about 0.12 " staple height can be positioned in compressible stratum 4110, and wherein compressible stratum 4110 can have about 0.14 " uncompressed height.
As described herein, multiple nail can be comprised wherein in nail bin.Optionally, this type of nail can by being deformed into U-shaped configuration substantially and the metal wire rods with two nail lower limbs are formed.The alternate forms that wherein nail can comprise different configuration (be such as joined together and have two or more wire rods that three or more are followed closely lower limbs) can be dreamed up.One or more wire rods for the formation of nail can comprise round or at least substantially round cross section.Nail wire rod can comprise any other suitable cross section, such as the cross section of square and/or rectangle.Nail can be made up of plastic wire.Nail can be made up of the metal wire rod being coated with plastics.According to the present invention, storehouse can comprise except nail or replace the securing member of any suitable type of following closely.Such as, this securing member can comprise pivotable arm, and described arm can be folded when being engaged by anvil block.Two-part securing member can be used.Such as, nail bin can comprise multiple first fastener portion, and anvil block can comprise multiple second fastener portion; When anvil block is compressed against nail bin, the second fastener portion is connected to the first fastener portion.As mentioned above, sliding part or driver can be advanced in nail bin to complete the forming process of nail.Sliding part or driver can be advanced in anvil block, engage with relative nail bin and nail or the securing member be positioned in nail bin to make one or more formed parts move downwardly to.
As described herein, nail bin can comprise four the nail row be stored in wherein.Described four nail row can be configured to two inner side nail row and two outside nail row.Such as, inner side nail row and outside are followed closely row and can be positioned on the first side of cutting element in nail bin or cutter slit; Similarly, inner side nail row and outside nail row can be positioned on the second side of cutting element or cutter slit.Nail bin can not comprise cutting element slit; But substituting as nail bin slit, this nail bin can comprise the specified portions can cut by cutting element.Similarly, can inner side nail row be arranged in nail bin, make itself and cutting element slit equidistantly or at least substantially equidistantly spaced apart.Similarly, can outside nail row be arranged in nail bin, make itself and cutting element slit equidistantly or at least substantially equidistantly spaced apart.According to the present invention, nail bin can comprise be stored in nail bin greater or less than four nail row.Nail bin can comprise six nail row.Such as, nail bin can comprise three nail row on the first side of cutting element slit, and on the second side of cutting element slit, comprise three nail row.Nail bin can comprise odd number nail row.Such as, nail bin can comprise two nail row on the first side of cutting element slit, and on the second side of cutting element slit, comprise three nail row.Nail row can comprise the nail with identical or at least substantially the same unshaped staple height.Alternatively, one or more nail is capable comprises the nail having and follow closely different unshaped staple heights from other.Such as, the nail on the first side of cutting element slit can have the first unshaped height, and the nail on the second side of cutting element slit can have the second unshaped height, and this second unshaped height is different from the first height.
Optionally, as mentioned above, nail bin can comprise warehouse, and this warehouse comprises multiple nail chamber be limited to wherein.Warehouse can comprise platform and top platform surface, and wherein each nail chamber can limit the opening in platform surface.Also described above, nail can be positioned in each nail intracavity, and nail is stored in warehouse until it is penetrated from warehouse.Before being penetrated from warehouse, nail can be accommodated in warehouse, makes nail not projecting above platform surface.In such cases, when nail is positioned in below platform surface, the probability of following closely damaged and/or premature contact destination organization can be reduced.In all cases, nail can move between non-firing position and firing position, and in non-firing position, it is not from warehouse projection, and in firing position, it has exposed from warehouse and can contact the anvil block being positioned in nail bin opposite.Anvil block and/or the shaping pit be defined in anvil block can be oriented to anomaly platform surface preset distance, and make when nail is deployed from warehouse, nail is deformed into predetermined forming height.In some cases, be trapped in the thickness variable of the tissue between anvil block and nail bin, therefore, thicker tissue can be trapped in thinner tissue in some nail and can be trapped in some other nail.In any one situation, be applied to the clamping pressure of tissue by nail or power such as can be different because of nail, or change between nail on the other end of nail on one end of nail row and nail row.In some cases, the gap between anvil block and nail bin platform can be controlled, make nail in each nail, apply a certain minimum clamping pressure.But in some such cases, the significant change of the clamping pressure in different nails may still exist.The U.S. Patent No. 7,380 that surgery suturing appliance was announced on June 3rd, 2008, disclosed in having in 696, whole disclosures of this patent are incorporated herein by reference.To be called the U.S. Patent application No.10/374 of " SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITION INDICATOR AND RETRACTION MECHANISM " at CO-PENDING and the name owned together for surgical stapling and the illustrative multiple-pass shank that cuts off apparatus, describe in more detail in 026, the disclosure of this patent application is incorporated to way of reference accordingly in full.Other application according to the invention can in conjunction with clicking distribution journey, such as be called " SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS " U.S. Patent application No.10/441 at CO-PENDING and the name owned together, described in 632, the disclosure of this patent application is incorporated to way of reference accordingly in full.
As described herein, nail bin can comprise as lower device: this device is used for compensating the thickness of the tissue of the nail IT disposed from nail bin.See Figure 14, nail bin (such as nail bin 10000) such as can comprise Part I (such as support section 10010) and the compressible Part II (such as thickness compensation part 10020) of rigidity.First see Figure 16, support section 10010 can comprise warehouse, top platform surface 10011 and multiple nail chamber 10012.Wherein, be similar to mentioned above, each nail chamber 10012 can limit the opening in platform surface 10011.Nail 10030 such as can be positioned in each nail chamber 10012 removedly.Such as, each nail 10030 can comprise base portion 10031 and the one or more distortion lower limbs 10032 from base portion 10031 extension.Before nail 10030 is deployed, also as described in more detail below, the base portion 10031 of nail 10030 can be supported by the staple drivers be positioned in support section 10010, and simultaneously, the lower limb 10032 of nail 10030 can at least be partly accommodated in nail chamber 10012.Nail 10030 can be deployed between non-firing position and firing position, lower limb 10032 is made to move through tissue thickness's compensating part 10020, the top surface of penetrate tissue thickness compensation part 10020, penetrate tissue T, and contact is positioned in the anvil block on nail bin 10000 opposite.When lower limb 10032 is out of shape against anvil block, the lower limb 10032 of each nail 10030 can the part of tissue T in the part of capture tissue thickness compensation part 10020 and each nail 10030, and compression stress is applied to tissue.To being described further above, the lower limb 10032 of each nail 10030 can be made downwards to be out of shape towards the base portion 10031 of nail, and retain region 10039 to form nail, retain region at this nail, tissue T and tissue thickness's compensating part 10020 can be captured.In all cases, nail retain that region 10039 can be limited at strained lower limb 10032 between inner surface and the inner surface of base portion 10031.The size that nail retains region can be depending on some questions, the width of the length of such as lower limb, the diameter of lower limb, base portion and/or the degree of such as lower limb distortion.
Before this, surgeon usually needs the suitable nail selecting to have suitable staple height for the tissue be just sewn.Such as, surgeon can select high nail to use together with thick organizing and select low nail to use together with thin tissue.But in some cases, organizing of being just sewn does not have consistent thickness, therefore, some nails cannot realize the percussion configuration of expectation.Such as, Figure 48 shows for compared with the higher nail in thin tissue.Referring now to Figure 49, when tissue thickness's compensating part (such as tissue thickness's compensating part 10020) such as uses together with thin tissue, such as larger nail can be configured as the percussion configuration of expectation.
Due to the compression ratio of tissue thickness's compensating part, tissue thickness's compensating part can compensate the thickness of the tissue be captured in each nail.More specifically, referring now to Figure 43 and Figure 44, tissue thickness's compensating part (such as tissue thickness's compensating part 10020) such as can occupy each nail 10030 nail according to the thickness and/or type following closely the tissue retaining accommodation in region 10039 retains the comparatively large of region 10039 and/or smaller portions.Such as, be trapped in the situation in nail 10030 compared to thicker tissue T, if thinner tissue T is trapped in nail 10030, then tissue thickness's compensating part 10020 can occupy the major part that nail retains region 10039.Correspondingly, be trapped in the situation in nail 10030 compared to thinner tissue T, if thicker tissue T is trapped in nail 10030, then tissue thickness's compensating part 10020 can occupy the smaller portions that nail retains region 10039.Like this, tissue thickness's compensating part can compensate for slower thin tissue and/or thicker tissue, and guarantees that compression stress is applied to tissue, no matter no matter and or the tissue thickness be at least substantially trapped in nail.In addition to the above, tissue thickness's compensating part 10020 can compensate the tissue that is dissimilar or different compression ratio be trapped in different nail 10030.Referring now to Figure 44, compression stress can be applied to the vascular tissue T that can comprise blood vessel V by tissue thickness's compensating part 10020, and therefore limit blood flows through not too compressible blood vessel V, but still the compression pressure of expectation is applied to the tissue T of surrounding.In all cases, to being described further above, tissue thickness's compensating part 10020 also can compensate strained nail.See Figure 45, the distortion of various nail 10030 can cause the larger nail be limited in this type of nail to retain region 10039.Due to the resilience force of tissue thickness's compensating part 10020, referring now to Figure 46, even if be limited at this type of nail be out of shape in nail 10030 retain region 10039 can be extended, be positioned at the tissue thickness's compensating part 10020 be out of shape in nail 10030 and still enough compression stresses can be applied to tissue.In all cases, the tissue thickness's compensating part 10020 be positioned in the middle of adjacent nail 10030 can be biased against tissue T by the nail 10030 of the suitable shaping of being out of shape around nail 10030, and therefore compression pressure is applied to such as around and/or be trapped in the tissue be out of shape in nail 10030.In all cases, tissue thickness's compensating part can compensate different tissue densities, and described different tissue density can such as produce due to classification, zone of fiber and/or the tissue previously having sewed up or processed.
According to the present invention, fixing or unmodifiable interstice can be limited between support section and anvil block, no matter how the thickness being therefore trapped in the tissue in nail all can make nail be deformed into predetermined height.When tissue thickness's compensating part is used for this type of situation, tissue thickness's compensating part can adapt to be trapped in the tissue between anvil block and support section nail bin, and due to the resilience force of tissue thickness's compensating part, additional compression stress can be applied to tissue by tissue thickness's compensating part.Referring now to Figure 50-55, nail 10030 has been configured as predetermined height H.With reference to Figure 50, tissue thickness's compensating part is not used, and tissue T occupies whole nail retains region 10039.With reference to Figure 57, a part for tissue thickness's compensating part 10020 has been trapped in nail 10030, tissue T is compressed, and has occupied nail and retain region 10039 at least partially.Referring now to Figure 52, thin tissue T has been trapped in nail 10030.In this embodiment, be there is by the tissue T compressed the height of about 2/9H, and by the tissue thickness's compensating part 10020 compressed, be there is the height of such as about 7/9H.Referring now to Figure 53, the tissue T with interior thickness has been trapped in nail 10030.In this embodiment, be there is by the tissue T compressed the height of about 4/9H, and by the tissue thickness's compensating part 10020 compressed, be there is the height of such as about 5/9H.Referring now to Figure 54, the tissue T with interior thickness has been trapped in nail 10030.In this embodiment, be there is by the tissue T compressed the height of about 2/3H, and by the tissue thickness's compensating part 10020 compressed, be there is the height of such as about 1/3H.Referring now to Figure 53, thick tissue T has been trapped in nail 10030.In this embodiment, be there is by the tissue T compressed the height of about 8/9H, and by the tissue thickness's compensating part 10020 compressed, be there is the height of such as about 1/9H.In all cases, tissue thickness's compensating part can comprise compression height, and this compression height comprises: the such as nail of about 10% retain height, about 20% nail retain height, about 30% nail retain height, about 40% nail retain height, about 50% nail retain height, about 60% nail retain height, about 70% nail retain height, about 80% nail retain height and/or about 90% nail retain height.
Nail 10030 can comprise any suitable unshaped height.Nail 10030 can comprise such as between about 2mm and the unshaped height about between 4.8mm.Nail 10030 can comprise the unshaped height of such as about 2.0mm, about 2.5mm, about 3.0mm, about 3.4mm, about 3.5mm, about 3.8mm, about 4.0mm, about 4.1mm and/or about 4.8mm.Follow closely deformable height H to be decided by the distance between the platform surface 10011 of support section 10010 and relative anvil block.Distance between platform surface 10011 and the tissue contacting surface of anvil block can be such as about 0.097 ".Height H also can be determined by the degree of depth of the shaping pit be limited in anvil block.Shaping pit can such as have the degree of depth recorded from tissue contacting surface.Optionally, as described in more detail below, nail bin 10000 also can comprise staple drivers, and nail 10030 can lift towards anvil block by this staple drivers, and nail is lifted or " excessively drive " above platform surface 10011.In this case, the distance that the forming height H following closely 10030 also can be overdriven by nail 10030 decides.The height that such as, nail 10030 can be overdriven such as about .028 ", and nail 10030 can be caused to be shaped as such as about 0.189 ".Nail 10030 can be shaped as the height of such as about 0.8mm, about 1.0mm, about 1.5mm, about 1.8mm, about 2.0mm and/or about 2.25mm.Nail can be shaped as such as between about 2.25mm and the height about between 3.0mm.To being described further above, the height that the nail of nail retains region by the forming height followed closely and can comprise the width of wire rod of nail and diameter determined.The forming height H that the height that the nail of nail 10030 retains region 10039 can comprise nail deducts two diameter widths of wire rod.Nail wire rod can comprise such as about 0.0089 " diameter.Nail wire rod can comprise the diameter such as between about 0.0069 " and about 0.0119 ".Such as, the forming height H of nail 10030 can be about 0.189 ", and follow closely gauge or diameter of wire can be about 0.0089 ", thus such as produces about 0.171 " nail retain height.
To being described further above, tissue thickness's compensating part can comprise the height of unpressed or pre-deployment, and can be deformed in multiple compression height.Tissue thickness's compensating part can comprise such as about 0.125 " uncompressed height.Tissue thickness's compensating part can comprise and is such as more than or equal to about 0.080 " uncompressed height.Tissue thickness's compensating part can comprise the height of unpressed or pre-deployment, and this is highly greater than not pulling the trigger highly of nail.The comparable nail of height of the unpressed or pre-deployment of tissue thickness's compensating part do not pull the trigger highly such as high by about 10%, height about 20%, height about 30%, height about 40%, height about 50%, height about 60%, height about 70%, height about 80%, height about 90% and/or height about 100%.Not pulling the trigger of the comparable nail of height of the unpressed or pre-deployment of tissue thickness's compensating part is highly high by such as at the most about 100%.Not pulling the trigger of the comparable nail of height of the unpressed or pre-deployment of tissue thickness's compensating part is highly high such as more than 100%.Tissue thickness's compensating part can comprise the uncompressed height of not pulling the trigger height equaling to follow closely.Tissue thickness's compensating part can comprise the uncompressed height of not pulling the trigger height being less than nail.The comparable nail of height of the unpressed or pre-deployment of tissue thickness's compensating part do not pull the trigger highly such as low by about 10%, low by about 20%, low by about 30%, low by about 40%, low by about 50%, low by about 60%, low by about 70%, low about 80% and/or low by about 90%.Compressible Part II can comprise uncompressed height, and this uncompressed height is higher than the uncompressed height of the tissue T be just sewn.Tissue thickness's compensating part can comprise uncompressed height, and this uncompressed height equals the uncompressed height of the tissue T be just sewn.Tissue thickness's compensating part can comprise uncompressed height, and this uncompressed height is lower than the uncompressed height of the tissue T be just sewn.
As mentioned above, no matter be that thick tissue or thin tissue are trapped in nail, tissue thickness's compensating part all can be compressed in multiple one-tenth staple.Such as, can make the nail distortion in nail line or nail row, the height making the nail of each nail retain region to comprise such as about 2.0mm, within wherein tissue T and tissue thickness's compensating part can be compressed to this height.In some cases, tissue T can be included in the compression height that nail retains the about 1.75mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 0.25mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.In some cases, tissue T can be included in the compression height that nail retains the about 1.50mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 0.50mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.In some cases, tissue T can be included in the compression height that nail retains the about 1.25mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 0.75mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.In some cases, tissue T can be included in the compression height that nail retains the about 1.0mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 1.0mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.In some cases, tissue T can be included in the compression height that nail retains the about 0.75mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 1.25mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.In some cases, tissue T can be included in the compression height that nail retains the about 1.50mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 0.50mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.In some cases, tissue T can be included in the compression height that nail retains the about 0.25mm in region, and tissue thickness's compensating part can be included in the compression height that nail retains the about 1.75mm in region, thus the nail obtaining adding up to such as about 2.0mm retains region height.
To being described further above, tissue thickness's compensating part can comprise the uncompressed height of the percussion height being less than nail.Tissue thickness's compensating part can comprise the uncompressed height of the percussion height equaling to follow closely.Tissue thickness's compensating part can comprise the uncompressed height of the percussion height higher than nail.Such as, the uncompressed height of tissue thickness's compensating part can comprise such as following thickness, this thickness be shaping staple height about 110%, shaping staple height about 120%, shaping staple height about 130%, shaping staple height about 140%, shaping staple height about 150%, shaping staple height about 160%, shaping staple height about 170%, about 180% of shaping staple height, about 190% of shaping staple height and/or shaping staple height about 200%.Tissue thickness's compensating part can comprise uncompressed height, and this uncompressed height is more than the twice of percussion height of nail.Tissue thickness's compensating part can comprise compression height, and this compression height is about 85% to about 150% of the staple height that is such as shaped.Optionally, as mentioned above, tissue thickness's compensating part can be compressed between uncompressed thickness and compressed thickness.The compressed thickness of tissue thickness's compensating part can be such as its uncompressed thickness about 10%, its uncompressed thickness about 20%, its uncompressed thickness about 30%, its uncompressed thickness about 40%, its uncompressed thickness about 50%, its uncompressed thickness about 60%, about 70% of its uncompressed thickness, about 80% of its uncompressed thickness and/or its uncompressed thickness about 90%.The uncompressed thickness of tissue thickness's compensating part can such as about twice thicker in its compressed thickness, about ten times, about 50 times and/or about 100 times.The compressed thickness of tissue thickness's compensating part can between about 60% of its uncompressed thickness with about between 99%.Uncompressed thickness its compressed thickness thick at least 50% comparable of tissue thickness's compensating part.Thick 100 times at the most of uncompressed thickness its compressed thickness comparable of tissue thickness's compensating part.Compressible Part II can be elastic, or elastic at least partly, and the distortion lower limb of tissue T against nail can be biased.Such as, compressible Part II can between tissue T and the base portion of nail resilient expansion so that against nail lower limb pushes against tissue T.As described in further detail below, tissue thickness's compensating part can be positioned in the middle of tissue T and distortion nail lower limb.In all cases, due to mentioned above, tissue thickness's compensating part can eliminate any gap of following closely and retaining in region.
Tissue thickness's compensating part can comprise the material by the one or more signs in following characteristic: such as, biocompatibility, bioresorbable, bioresorbability, biological ruggedness, biological degradability, compressibility, fluid absorbency, swellability, self-expanding, biological activity, medicine, pharmaceutically active, Adhesion Resistance, hemostatic, antibiotic property, microbial resistance, antiviral property, trophism, cohesive, permeability, hydrophilic and/or hydrophobicity.According to the present invention, comprise anvil block and can comprise the tissue thickness compensating part relevant to anvil block and/or nail bin with the surgical instruments of nail bin, described tissue thickness compensating part comprises at least one in following material: hemorrhage (such as, fibrin and thrombin), antibiotic (such as, and medicine (such as, matrix metalloproteinase (MMP)) doxycpl).
Tissue thickness's compensating part can comprise synthesis and/or non-synthetic materials.Tissue thickness's compensating part can comprise polymer composition, and described polymer composition comprises one or more synthetic polymers and/or one or more non-synthetic polymer.Synthetic polymer can comprise the absorbable polymer of synthesis and/or the non-absorbable polymer of synthesis.Polymer composition can comprise such as biocompatible foam.Biocompatible foam can comprise the open celled foam of such as porous and/or the closed-cell foam of porous.Biocompatible foam can have uniform pore morphology maybe can have gradient pore form (that is, on the whole depth of foam in a direction, orifice size increases gradually and becomes macropore).Polymer composition can comprise the combination of one or more and they in porous support, porous matrix, gel-type vehicle, hydrogel matrix, solution substrate, thread substrate, tubulose substrate, composite interstitial substance, membrane matrix, Biostatic polymer and biodegradable polymer.Such as, tissue thickness's compensating part can comprise the foam by thread matrix enhancement, maybe can comprise the foam with additional hydrogel layer, and the expansion under body fluid exists of this additional hydrogel layer, to provide compression further organizationally.According to the present invention, tissue thickness's compensating part also can be made up of the coating on material and/or the second layer or third layer, and this coating is expansion under body fluid exists, to provide compression further organizationally.This type of layer can be hydrogel, this hydrogel can be synthesis and/or natural source material, and such as can be biological durable and/or biodegradable.Tissue thickness's compensating part can comprise microgel or nanogel.Hydrogel can comprise coming microgel and/or the nanogel of self-carbon water compound.Can use and the fibrous nonwoven material of additional flexibility, rigidity and/or intensity or fiber mesh type element can be provided to strengthen tissue thickness's compensating part.According to the present invention, tissue thickness's compensating part has porous form, and this porous form shows gradient-structure, such as aperture on a surface and larger hole on the other surface.This type of form is even more ideal for tissue growth or hemostasis behavior.In addition, gradient also can be combined with the bio-absorbable section of change.Short-term absorption profile can be preferably, to solve hemostasis problem, and the problem that Long-term absorption section makes tissue better heal under can solving ne-leakage situation.
The example of non-synthetic materials includes but not limited to lyophilizing polysaccharide, glycoprotein, bovine pericardium, collagen, gelatin, fibrin, Fibrinogen, elastin laminin, Dan Baiduotang proteoglycan PG, keratin, albumin, hydroxyethyl-cellulose, cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, casein, alginate and their combination.
The example of the absorbable material of synthesis includes but not limited to gather (lactic acid) (PLA), PLLA (PLLA), pla-pcl (PCL), polyglycolic acid (PGA), PTMC (TMC), polyethylene terephthalate (PET), polyhydroxyalkanoatefrom (PHA), the copolymer of Acetic acid, hydroxy-, bimol. cyclic ester and 6-caprolactone (PGCL), the copolymer of Acetic acid, hydroxy-, bimol. cyclic ester and trimethylene carbonate, poly-(decanedioic acid glyceride) (PGS), poly-(dioxanone) (PDS), polyester, poly-(ortho esters), poly-esters of oxyacids, polyether ester, Merlon, polyesteramide, condensing model, polysaccharide, poly-(ester-acid amide), tyrosine-based polyarylate, polyamine, tyrosine-based gathers imido-carbonic ester, tyrosine-based polycarbonate, poly-(D, L-lactide-carbamate), poly-(butyric ester), poly-(B-butyric ester), poly-(E-caprolactone), Polyethylene Glycol (PEG), poly-[two (carboxyphenoxy) phosphonitrile], poly-(aminoacid), intend poly-(aminoacid), absorbable polyurethane, poly-(phosphazine), polyphosphazene, polyoxyalkylene, polyacrylamide, poly hydroxy ethyl acrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly-(caprolactone), polyacrylic acid, poly-acetas, polypropylene, aliphatic polyester, glycerol, copolymerization (ether-ester), poly-oxalic acid alkylidene diol ester, polyamide, poly-(iminocarbonic ester), poly-oxalic acid alkylidene diol ester and their combination.Polyester is optional from polylactide, PGA, trimethylene carbonate, poly-dioxanone, polycaprolactone, polybutester and their combination.
Synthesis absorbable polymer can comprise such as can brand name VICRYL (polyglactic910) from Ethicon, Inc. 90/10 commercially available poly-(Acetic acid, hydroxy-, bimol. cyclic ester-L-lactide) copolymer, can brand name DEXON from the commercially available PGA of American Cyanamid Co., can brand name PDS from Ethicon, Inc. commercially available poly-dioxanone, can brand name MAXON from commercially available poly-(Acetic acid, hydroxy-, bimol. cyclic ester-trimethylene carbonate) statistic copolymer of American Cyanamid Co., can brand name MONOCRYL from one or more commercially available 75/25 poly-(glycolide-s-caprolactone-poliglecaprolactone 25) copolymer of Ethicon company.
The non-absorbable material of synthesis includes but not limited to polyurethane, polypropylene (PP), polyethylene (PE), Merlon, polyamide, such as nylon, polrvinyl chloride (PVC), polymethyl methacrylate (PMMA), polystyrene (PS), polyester, polyether-ether-ketone (PEEK), politef (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), PEP (FEP), polyacetals, polysulfones and their combination.The non-absorbable polymer of synthesis can include but not limited to elastomeric foams and porous elastomers, such as siloxanes, polyisoprene and rubber.Synthetic polymer can comprise can brand name GORE-TEX soft-tissue patch from W.L.Gore & Associates, Inc. commercially available expanded PTFE (ePTFE), and can brand name NASOPORE from Polyganics commercially available altogether-polyether ester urethane foam plastic.
Polymer composition can comprise such as by weight about 50% to about 90% PLLA polymer composition and by weight about 50% to about 10% the polymer composition of PCL.Polymer composition can comprise such as by weight about 70% PLLA and by weight about 30% PCL.Polymer composition can comprise such as by weight about 55% to about 85% PGA polymer composition and by weight 15% to 45% the polymer composition of PCL.Polymer composition can comprise such as by weight about 65% PGA and by weight about 35% PCL.Polymer composition can comprise such as by weight about 90% to about 95% PGA polymer composition and by weight about 5% to about 10% the polymer composition of PLA.
The absorbable polymer of synthesis can comprise can bio-absorbable, the elastomer copolymer of biocompatibility.Suitable can bio-absorbable, the elastomer copolymer of biocompatibility includes but not limited to that (mol ratio of 6-caprolactone and Acetic acid, hydroxy-, bimol. cyclic ester is preferably about 30:70 to about 70:30 to the copolymer of 6-caprolactone and Acetic acid, hydroxy-, bimol. cyclic ester, being preferably 35:65 to about 65:35, is more preferably 45:55 to 35:65); The elastomer copolymer (mol ratio of 6-caprolactone and lactide is preferably about 35:65 to about 65:35, and is more preferably 45:55 to 30:70) of 6-caprolactone and lactide (comprising L-lactide, D-lactide, their blend or lactic acid copolymer); To the elastomer copolymer (being preferably about 40:60 to about 60:40 to the mol ratio of dioxanone and lactide) of dioxanone (Isosorbide-5-Nitrae-dioxane-2-ketone) and lactide (comprising L-lactide, D-lactide and lactic acid); 6-caprolactone and the elastomer copolymer (6-caprolactone is preferably about 30:70 to about 70:30 with to the mol ratio of dioxanone) to dioxanone; To the elastomer copolymer (being preferably about 30:70 to about 70:30 to the mol ratio of dioxanone and trimethylene carbonate) of dioxanone and trimethylene carbonate; The elastomer copolymer (mol ratio of trimethylene carbonate and Acetic acid, hydroxy-, bimol. cyclic ester is preferably about 30:70 to about 70:30) of trimethylene carbonate and Acetic acid, hydroxy-, bimol. cyclic ester; The elastomer copolymer of trimethylene carbonate and lactide, comprises L-lactide, D-lactide, their blend or lactic acid copolymer (mol ratio of trimethylene carbonate and lactide is preferably about 30:70 to about 70:30); And their blend.Elastomer copolymer can be the copolymer of Acetic acid, hydroxy-, bimol. cyclic ester and 6-caprolactone alternatively, and elastomer copolymer is the copolymer of lactide and 6-caprolactone.
The name being published in November 21 nineteen ninety-five is called the United States Patent (USP) 5 of " ELASTOMERIC MEDICAL DEVICE ", 468,253 and be published in the calendar year 2001 December name of 4 days be called " FOAM BUTTRESS FOR STAPLING APPARATUS " for United States Patent (USP) 6, the disclosure of 325,810 is incorporated to herein separately in full by reference.
Tissue thickness's compensating part can comprise emulsifying agent.The example of emulsifying agent can include but not limited to water-soluble polymer, such as polyvinyl alcohol (PVA), vinylpyrrolidone (PVP), Polyethylene Glycol (PEG), polypropylene glycol (PPG), pluronic (PLURONICS), tween (TWEENS), polysaccharide and their combination.
Tissue thickness's compensating part can comprise surfactant.The example of surfactant can include but not limited to polyacrylic acid, methylase, methylcellulose, ethyl cellulose, propyl cellulose, hydroxy ethyl cellulose, carboxy methyl cellulose, Polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyoxethylene octylphenyl ether, NONIN HS 240, polyoxyethylene oleyl ether, Tween 20, polyoxyethylene stearyl base ether, ethylene nonyl phenyl ether, dialkyl group phenoxy group gathers (ethyleneoxy) ethanol, and poloxamer.
Polymer composition can comprise pharmaceutically active agents.Polymer composition can discharge the pharmaceutically active agents for the treatment of effective dose.Pharmaceutically active agents can discharge when polymer composition is desorbed or absorb.Pharmaceutically active agents can be released to and flow through on polymer composition or through in the fluid (such as, blood) of polymer composition.The example of pharmaceutically active agents can include but not limited to hemorrhage and medicine, such as fibrin, thrombin and oxidized regenerated cellulose (ORC); Antiinflammatory medicine, such as diclofenac, aspirin, naproxen, sulindac and hydrocortisone; Antibiotic and antimicrobial agents or antimicrobial, such as triclosan, ionic silver, ampicillin, gentamycin, polymyxin B, chloromycetin; And anticarcinogen, such as cisplatin, mitomycin, amycin.
Polymer composition can comprise hemostatic material.Tissue thickness's compensating part can comprise hemostatic material, and it comprises poly-(lactic acid), poly-(glycolic), poly-(butyric ester), poly-(caprolactone), poly-(dioxanone), polyoxyalkylene, copolymerization (ether-ester), collagen, gelatin, thrombin, fibrin, Fibrinogen, FN, elastin laminin, albumin, hemoglobin, ovalbumin, polysaccharide, hyaluronic acid, chondroitin sulfate, hetastarch, hydroxyethyl-cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, agarose, maltose, maltodextrin, alginate, thrombin, methacrylate, polyurethane, acrylate, platelet agonist, vasoconstrictor, vitriol, calcium, RGD peptide, protein, Protamine sulfates., episilon amino caproic acid, iron sulfate, ferric subsulfate, iron chloride, zinc, zinc chloride, aluminum chloride, aluminum sulfate, aluminum acetate, permanganate, tannin, bone wax, Polyethylene Glycol, fucosan and their combination.The feature of tissue thickness's compensating part can be haemostatic properties.
The feature of the polymer composition of tissue thickness's compensating part is such as percent porosity, hole dimension and/or hardness.Polymer composition can have such as by volume about 30% to about 99% percent porosity.Polymer composition can have such as by volume about 60% to about 98% percent porosity.Polymer composition can have such as by volume about 85% to about 97% percent porosity.Polymer composition can comprise such as by weight about 70% PLLA and by weight about 30% PCL, and can comprise such as by volume about 90% porosity.Such as, therefore, the polymer composition copolymer that will comprise by volume about 10%.Polymer composition can comprise such as by weight about 65% PGA and by weight about 35% PCL, and can have such as by volume about 93% to about 95% percent porosity.Polymer composition can comprise the porosity being greater than 85% by volume.Polymer composition can have the hole dimension of such as about 5 microns to about 2000 microns.Polymer composition can have the hole dimension such as between about 10 microns to about 100 microns.Such as, polymer composition can comprise the copolymer of such as PGA and PCL.Polymer composition can have the hole dimension such as between about 100 microns to about 1000 microns.Such as, polymer composition can comprise the copolymer of such as PLLA and PCL.
According to some aspect, the hardness of polymer composition can Shore hardness represent.This Shore hardness can be defined as the toleration of the permanent indenture to material such as measured by sclerometer.In order to assess the durometer value of given material, the ASTM program D2240-00 of " Standard Test Method for Rubber Property-Durometer Hardness " is called according to name, with penetrator foot, pressure is applied to material, it is incorporated to herein in full by reference.Penetrator foot can be administered to material and continue enough a period of times, such as 15 seconds, such as, wherein reading read from suitable scale.According to scale type used, when the complete penetrable material of pressure head foot, reading 0 can be obtained, and when material is not penetrated, reading 100 can be obtained.This reading dimensionless.Can such as any suitable scale (such as, category-A and/or OO class scale) be utilized to decide durometer according to ASTM D2240-00.The polymer composition of tissue thickness's compensating part can have the Shore A Hardness value of about 4A to about 16A, and this Shore A Hardness value is such as in the Shore OO scope of about 45OO to about 65OO.Such as, polymer composition can comprise such as PLLA/PCL copolymer or PGA/PCL copolymer.The polymer composition of tissue thickness's compensating part can have the Shore A Hardness value being less than 15A.The polymer composition of tissue thickness's compensating part can have the Shore A Hardness value being less than 10A.The polymer composition of tissue thickness's compensating part can have the Shore A Hardness value being less than 5A.Polymeric material can have the Shore OO compositions value of such as about 35OO to about 75OO.
Polymer composition can have at least two kinds in the above-mentioned characteristic identified.Polymer composition can have at least three kinds in the above-mentioned characteristic identified.Polymer composition can have such as the porosity of 85% to 97%, the Shore OO hardness value of the hole dimension of 5 microns to 2000 microns and the Shore A Hardness value of 4A to 16A and 45OO to 65OO by volume.Polymer composition can comprise the PLLA of by weight 70% polymer composition and by weight 30% the polymer composition of PCL; Described polymer composition has such as the porosity of 90%, the Shore OO hardness value of the hole dimension of 100 microns to 1000 microns and the Shore A Hardness value of 4A to 16A and 45OO to 65OO by volume.Polymer composition can comprise the PGA of by weight 65% polymer composition and by weight 35% the polymer composition of PCL; Described polymer composition has such as the porosity of 93% to 95%, the Shore OO hardness value of the hole dimension of 10 microns to 100 microns and the Shore A Hardness value of 4A to 16A and 45OO to 65OO by volume.
Thickness organizes compensating part can comprise the material of expansion.As mentioned above, the compression material expanded when tissue thickness's compensating part can be included in uncompressed or deployment.Tissue thickness's compensating part can comprise original position formed from expansion material.Tissue thickness's compensating part can comprise at least one precursor, and described precursor is selected spontaneously to be cross-linked when contacting at least one in other precursors, water and/or body fluid.According to the present invention, the first precursor can contact other precursors one or more to form tissue thickness's compensating part of extendible and/or swellable.Tissue thickness's compensating part can comprise the swollen compositions of fluid-soluble, such as, and the compositions of water-swellable.Tissue thickness's compensating part can comprise hydrogel.
Tissue thickness's compensating part can comprise the biodegradable foam with packaging part, and described packaging part comprises embedding dried hydrogel granule wherein or granule.By the constraint of any concrete theory, the packaging part in foam contacts to form foam by the organic solution of the aqueous solution with biocompatible materials that make hydrogel precursor and is formed.Aqueous solution and organic solution can form micelle.Aqueous solution and organic solution can be dried to encapsulate dried hydrogel precursor in foam or granule.Such as, hydrogel precursor (such as hydrophilic polymer) is dissolvable in water water to form the dispersion of micelle.Aqueous solution can contact the organic solution of the dioxane comprising poly-(glycolic) and polycaprolactone.Aqueous solution and organic solution can be lyophilized thus be formed has dispersion dried hydrogel granule wherein or the biodegradable foam of granule.By the constraint of any concrete theory, but it is believed that micelle formation packaging part, described packaging part has and is dispersed in dried hydrogel granule in foaming structure or granule.This packaging part can break, and hydrogel particle or granule can contacting with fluid (such as body fluid) expanding.
Optionally, as mentioned above, tissue thickness's compensating part can comprise original depth and expansion thickness.The original depth of tissue thickness's compensating part can be such as about 0.001% of its expansion thickness, about 0.01% of its expansion thickness, about 0.1% of its expansion thickness, about 1% of its expansion thickness, about 10% of its expansion thickness, about 20% of its expansion thickness, about 30% of its expansion thickness, about 40% of its expansion thickness, about 50% of its expansion thickness, about 60% of its expansion thickness, about 70% of its expansion thickness, about 80% of its expansion thickness, and/or about 90% of its expansion thickness.The expansion thickness of tissue thickness's compensating part can such as thicker than its original depth about 2 times, about 5 times, about 10 times, about 50 times, about 100 times, about 200 times, about 300 times, about 400 times, about 500 times, about 600 times, about 700 times, about 800 times, about 900 times and/or about 1000 times.The original depth of tissue thickness's compensating part can up to its expand thickness 1%, up to its expansion thickness 5%, up to its expansion thickness 10% and up to 50% of its expansion thickness.Expansion thickness its original depth comparable of tissue thickness's compensating part is thick at least 50%, thicker than its original depth at least 100%, than its original depth thick at least 300% with than its original depth thick at least 500%.As mentioned above, in all cases, tissue thickness's compensating part can eliminate any gap of following closely and retaining in region.
As mentioned above, tissue thickness's compensating part can comprise hydrogel.Hydrogel can comprise homopolymer hydrogel, copolymer aquagel, multipolymer hydrogel, interpenetrating polymer hydrogel and their combination.Hydrogel can comprise microgel, nanogel and their combination.Hydrogel can comprise the hydrophilic polymer network that can absorb and/or retain fluid substantially.Hydrogel can comprise noncrosslinking hydrogel, crosslinked hydrogel and their combination.Hydrogel can comprise chemical cross-linking agent, physical crosslinking agent, hydrophobic fragment and/or the undissolved fragment of water.By polyreaction, micromolecule, crosslinked and/or Polymer-Polymer is cross-linked and is chemically cross-linked hydrogel.Hydrogel is physically cross-linked by ionic interaction, hydrophobic interaction, hydrogen bonded interaction, stereocomplex and/or supramolecular chemistry.Hydrogel can be substantially undissolved because of cross-linking agent, hydrophobic fragment and/or the undissolved fragment of water, but is easily extensible and/or swelling because absorbing and/or keep fluid.Precursor and/or can be organized crosslinked with endogenous material.
Hydrogel can comprise enviromental sensitive hydrogel (ESH).ESH can comprise the material with the fluid swollen characteristic relevant to environmental condition.Environmental condition can include but not limited at the physical condition of operative site, biotic factor and/or electrochemical conditions.Such as, in response to temperature, pH, electric field, ionic strength, enzyme and/or chemical reaction, electricity and/or Neural stem cell, and other physiological and variablees that are environment, hydrogel swellable or contraction.ESH can comprise polyfunctional acrylate, hydroxyethyl methylacrylate (HEMA), elastomeric acrylate and relevant monomer.
The tissue thickness's compensating part comprising hydrogel can comprise at least one in non-synthetic materials mentioned above and synthetic material.Hydrogel can comprise synthetic water gel and/or non-synthetic hydrogel.Tissue thickness's compensating part can comprise multiple layer.Multiple layer can comprise porous layer and/or non-porous layer.Such as, tissue thickness's compensating part can comprise non-porous layer and porous layer.And for example, tissue thickness's compensating part can comprise the porous layer in the middle of the first non-porous layer and the second non-porous layer.And for example, tissue thickness's compensating part can comprise the non-porous layer in the middle of the first porous layer and the second porous layer.Non-porous layer and porous layer can be located relative to the surface of nail bin and/or anvil block in any order.
The example of non-synthetic materials can include but not limited to albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, glucosan, elastin laminin, fibrin, Fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum and starch.Cellulose can comprise hydroxyethyl-cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose and their combination.Collagen can comprise bovine pericardium.Carbohydrate can comprise polysaccharide, such as lyophilizing polysaccharide.Protein can comprise glycoprotein, Dan Baiduotang proteoglycan PG or their combination.
The example of synthetic material can include but not limited to gather (lactic acid), poly-(glycolic), poly-(butyric ester), poly-(phosphazine), polyester, Polyethylene Glycol, poly(ethylene oxide), poly(ethylene oxide)-polypropylene oxide copolymers, copolymerization oxirane, polyoxyalkylene, polyacrylamide, poly hydroxy ethyl acrylate, PVP, polyvinyl alcohol, poly-(caprolactone), poly-(dioxanone), polyacrylic acid, poly-acetas, polypropylene, aliphatic polyester, glycerol, poly-(aminoacid), copolymerization (ether-ester), poly-oxalic acid alkylidene diol ester, polyamide, poly-(iminocarbonic ester), poly-esters of oxyacids, poe, polyphosphazene and their combination.Conventional method can be used to prepare above-mentioned non-synthetic materials synthetically, such as, synthesize hyaluronic acid.
Hydrogel can be made up of one or more hydrogel precursors.Precursor can comprise monomer and/or macromonomer.Hydrogel precursor can comprise electrophile functional group and/or the electrophile functional group of nucleophile.In general, electrophilely can react to form chemical bond with nucleophile.Term used herein " functional group " refers to electrophilic group or the nucleophilic group that can react to be formed chemical bond each other.The example of Qin electricity functional group can include but not limited to N-hydroxy-succinamide (" NHS "), sulfosuccinimide, carbonyl dimidazoles, sulfonic acid chloride, aryl halide, sulfosuccinic ester, N-hydroxy-succinamide ester, succinimide ester, such as succinimidyl succinate and/or succinimidyl propionate, isocyanide ester, sulfocyanic ester, carbodiimides, Benzotriazole carbonate, epoxide, aldehyde, maleimide, imino-ester, their combination etc.Qin electricity functional group can comprise succinimide ester.The example of nucleophilic functional group can include but not limited to-NH 2,-SH ,-OH ,-PH 2with-CO-NH-NH 2.
Hydrogel can be formed by single precursor or multiple precursor.Hydrogel can be formed by the first precursor and the second precursor.First hydrogel precursor and the second hydrogel precursor can original positions or form hydrogel in vivo when contacting.Hydrogel precursor generally can refer to polymer, functional group, macromole, micromolecule and/or can participate in reaction with the cross-linking agent forming hydrogel.Precursor can comprise such as homogeneous solution, solution that is uneven or that be separated in appropriate solvent, such as water or buffer.The pH of buffer can be such as about 8 to about 12, and all according to appointment 8.2 to about 9.The example of buffer can include but not limited to borate buffer solution.Precursor can in emulsion.According to the present invention, the first precursor can with the second precursors reaction to form hydrogel.First precursor spontaneously can be cross-linked when contact the second precursor.According to the present invention, the first Zu Qin electricity functional group on the first precursor can react with group nucleophilic functional group of second on the second precursor.When precursor is blended in the environment allowing reaction (such as, when relevant to pH, temperature and/or solvent), functional group can react to form covalent bond each other.When at least some in precursor and more than other a precursors reaction, precursor can become crosslinked.
Tissue thickness's compensating part can comprise at least one monomer, and described monomer is selected from 3-sulfopropyl acrylic acid potassium salt (" KSPA "), sodium acrylate (" NaA "), N-(three (hydroxymethyl) methyl) acrylamide (" triacryl ") and 2-acrylamide-2-methyl isophthalic acid-propane sulfonic acid (AMPS).Tissue thickness's compensating part can comprise copolymer, and this copolymer comprises two or more monomer being selected from KSPA, NaA, triacryl, AMPS.Tissue thickness's compensating part can comprise the homopolymer deriving from KSPA, NaA, triacryl, AMPS.Tissue thickness's compensating part can comprise can with the hydrophilically modified monomer of its copolymerization.Hydrophilically modified monomer can comprise methyl methacrylate, butyl acrylate, cyclohexyl acrylate, styrene, styrene sulfonic acid.
Tissue thickness's compensating part can comprise cross-linking agent.Cross-linking agent can comprise low-molecular-weight two or polyvinyl crosslinking agents, such as glycol diacrylate or dimethylacrylate, two, three or tetravinyl-glycol diacrylate or dimethylacrylate, pi-allyl (methyl) acrylate, C 2-C 8-alkylidene diacrylate or dimethylacrylate, divinyl ether, divinyl sulfone, two and trivinylbenzene, trimethylolpropane triacrylate or trimethyl acrylic ester, tetramethylol methane tetraacrylate or tetramethyl acrylate, bisphenol a diacrylate or dimethylacrylate, methylene-bisacrylamide or DMAA, ethylene bisacrylamide or ethylene DMAA, triallyl phthalate or diallyl phthalate.Cross-linking agent can comprise N, N'-methylene-bisacrylamide (" MBAA ").
Tissue thickness's compensating part can comprise acrylate and/or methacrylate official energy hydrogel, biocompatibility light trigger, alkyl-cyanoacrylate, at least one in isocyanate-functional macromonomer, optionally comprise amine official energy macromonomer, succinimide ester official energy macromonomer, optionally comprise amine and/or Mercaptofunctional macromonomer, epoxy functional macromonomer, optionally comprise amine official energy macromonomer, the mixture of protein and/or polypeptide and aldehyde cross-linking agent, the carbodiimides of genipin (Genipin) and water dissolvable, anion polysaccharide and polyvalent cation.
Tissue thickness's compensating part can comprise undersaturated organic acid monomer, acrylic acid substituted alcohols and/or acrylamide.Tissue thickness's compensating part can comprise methacrylic acid, acrylic acid, glyceryl acrylate, glycerol methacrylate, 2-HEMA, 2-2-(Acryloyloxy)ethanol, 2-(dimethyl aminoethyl) methacrylate, NVP, Methacrylamide and/or N,N-DMAA poly-(methacrylic acid).
Tissue thickness's compensating part can comprise reinforcing material.Reinforcing material can comprise at least one in above-described non-synthetic materials and synthetic material.Reinforcing material can comprise collagen, gelatin, fibrin, Fibrinogen, elastin laminin, keratin, albumin, hydroxyethyl-cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, alginate, poly-(lactic acid), poly-(glycolic), poly-(butyric ester), poly-(phosphazine), polyester, Polyethylene Glycol, polyoxyalkylene, polyacrylamide, poly hydroxy ethyl acrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly-(caprolactone), poly-(dioxanone), polyacrylic acid, poly-acetas, pla-pcl, polypropylene, aliphatic polyester, glycerol, poly-(aminoacid), copolymerization (ether-ester), poly-oxalic acid alkylidene diol ester, polyamide, poly-(iminocarbonic ester), poly-oxalic acid alkylidene diol ester, poly-esters of oxyacids, poe, polyphosphazene and their combination.
Tissue thickness's compensating part can comprise the layer of reinforcing material.The porous layer of tissue thickness's compensating part and/or non-porous layer can comprise reinforcing material.Such as, porous layer can comprise reinforcing material and non-porous layer can not comprise reinforcing material.Enhancement layer can comprise the internal layer in the middle of the first non-porous layer and the second non-porous layer.Enhancement layer can comprise the skin of tissue thickness's compensating part.Enhancement layer can comprise the outer surface of tissue thickness's compensating part.
Reinforcing material can comprise mesh sheet, monofilament, multifilament weave fabric, fiber, pad, felt, granule and/or powder.Reinforcing material can be attached in the layer of tissue thickness's compensating part.Reinforcing material can be attached at least one in non-porous layer and porous layer.Can use routine techniques (such as knitting, braiding, tatting and/knitting or form the mesh sheet comprising reinforcing material.
According to the present invention, multiple reinforcement material can be oriented to random direction and/or common direction.Common direction can be such as with nail line parallel and the one with nail line vertical centering control.Such as, monofilament and/or multifilament weave fabric can random direction and/or common direction orientations.Monofilament and multifilament weave fabric can be associated with non-porous layer and/or porous layer.Tissue thickness's compensating part can be included in non-porous layer with multiple fortifying fibres of random direction orientation.Tissue thickness's compensating part can be included in non-porous layer with multiple fortifying fibres of common direction orientation.
Fiber can form non-woven material, such as, and pad and felt.Fiber can have any suitable length, such as, from 0.1mm to 100mm and 0.4mm to 50mm.Reinforcing material can be ground into powder.Powder can have such as from the granularity of 10 microns to 1 centimetre.Powder can be attached in tissue thickness's compensating part.
Tissue thickness's compensating part can original position be formed.Hydrogel can original position be formed.Tissue thickness's compensating part is formed by covalency ion and/or hydrophobic bond original position.Physics (non-covalent) is crosslinked can be caused by complexation, hydrogen bonding, desolvation, Van der Waals interaction, ionic bonding and their combination.Chemistry (covalency) is crosslinked to be realized by any one in following number of mechanisms: radical polymerization, polycondensation, anion or cationic polymerization, step growth polymerization, close isoelectric substance-nucleophile reaction and their combination.
Optionally, the original position of tissue thickness's compensating part is formed to comprise and makes two or more precursors reaction, and described precursor is physically separated until original position contacts and/or reacts to environmental condition thus react each other to form hydrogel.The polymerisable polymer of original position can be prepared by precursor, and described precursor can react to form polymer at operative site.Tissue thickness's compensating part is formed by precursor cross-linking reaction in position.Precursor can comprise the initiator of the polyreaction of the formation that can cause for original position tissue thickness compensating part.The precursor that tissue thickness's compensating part can be activated when can be included in the application forming cross-linked hydrogel.The original position of tissue thickness's compensating part is formed to comprise and excites at least one precursor to form chemical bond, thus formative tissue thickness compensation part.Optionally, activate and realize by the change at operative site physical condition, biotic factor and/or electrochemical conditions, described condition change includes but not limited to temperature, pH, electric field, ionic strength, enzyme and/or chemical reaction, electricity and/or Neural stem cell, and other physiological and environmental variables.Precursor can contact body exterior and introduce operative site.
Tissue thickness's compensating part can comprise one or more packaging part or unit that can store at least one component wherein.Packaging part can store hydrogel precursor wherein.Such as, packaging part can store two kinds of components wherein.Packaging part can store the first hydrogel precursor wherein and the second hydrogel precursor.First packaging part can store the first hydrogel precursor wherein and the second packaging part can store the second hydrogel precursor wherein.As mentioned above, packaging part can align with nail lower limb or at least substantial alignment thus pierce through packaging part when following closely lower limb and contacting packaging part and/or otherwise make packaging part break.When disposing nail, this packaging part can be compressed, conquassation, collapse and/or otherwise break.After packaging part breaks, the component stored wherein can flow out packaging part.Store component wherein and can contact other components, the layer of tissue thickness's compensating part and/or tissue.Other components can from identical or different packaging part, provide in the layer of tissue thickness's compensating part and/or by clinician for operative site.As above-described result, the component be stored in packaging part can provide the expansion of tissue thickness's compensating part and/or swelling.
Tissue thickness's compensating part can comprise the layer containing packaging part.Packaging part can comprise be associated with layer space, pit, fornix, pipe and their combination.Packaging part can comprise the space in layer.Layer can comprise two layers that can invest each other, and wherein packaging part can be defined between two layers.Packaging part can comprise the fornix on layer surface.Such as, can being positioned at least partially in the fornix that upwards extends from layer of packaging part.Packaging part can be included in the pit formed in layer.The Part I of packaging part can comprise fornix, and the Part II of packaging part can comprise pit.Packaging part can be included in the pipe that layer is embedded in.Pipe can comprise non-synthetic materials as herein described and/or synthetic material, such as PLA.Tissue thickness's compensating part can comprise the foam of biological absorbable, such as ORC, and the foam of described biological absorbable comprises embedding PLA pipe wherein, and this pipe can encapsulate such as hydrogel.Packaging part can comprise mutual unconnected separate unit.In packaging part one or more can via extend through one or more paths of layer, conduit and/or passage and mutually fluid be communicated with.
Release rate from the component of packaging part can be controlled by the following stated: the thickness of such as tissue thickness's compensating part, the ingredient of tissue thickness's compensating part, the size of component, the hydrophilic of component and/or the physics in component and/or chemical interaction, the ingredient of tissue thickness's compensating part and/or surgical instruments.Layer can comprise one or more thin section or weakening part (such as local perforations), and such as described one or more thin section or weakening part can be conducive to incision layer and packaging part is broken.Local perforations can not extend fully through layer, and in some cases, perforation may extend entirely through layer.
Optionally, anvil block can comprise tissue thickness's compensating part, and described tissue thickness compensating part comprises the encapsulation component with at least one microsphere particle.Tissue thickness's compensating part can comprise packaging part, and described packaging part comprises the first encapsulation component and the second encapsulation component.Tissue thickness's compensating part can comprise packaging part, and described packaging part comprises the first microsphere particle and the second microsphere particle.
Tissue thickness's compensating part can be suitable for using together with surgical instruments.As mentioned above, tissue thickness's compensating part can be associated with nail bin and/or anvil block.Tissue thickness's compensating part can be configured to any shape, size and/or the dimension that are suitable for coordinating nail bin and/or anvil block.As described herein, tissue thickness's compensating part can be attached to nail bin and/or anvil block releasedly.Before sewing process and during sewing process, any machinery that tissue thickness's compensating part can keep tissue thickness's compensating part to contact with nail bin and/or anvil block and/or the mode of chemistry be attached to nail bin and/or anvil block.After nail piercing tissue thickness compensation part, can remove from nail bin and/or anvil block or discharge tissue thickness's compensating part.When nail bin and/or anvil block move away from tissue thickness's compensating part, can remove from nail bin and/or anvil block or discharge tissue thickness's compensating part.
Referring now to Figure 14, nail bin (such as nail bin 10000) such as can comprise support section 10010 and compressible tissue thickness compensating part 10020.Referring now to Figure 16-Figure 18, multiple nail chambeies 10012 that support section 10010 can comprise platform surface 10011 and be limited in support section 10010.The size in each nail chamber 10012 such as can be set to and can store nail removedly wherein, such as follows closely 10030.Nail bin 10000 also can comprise multiple staple drivers 10040, and when nail 10030 and staple drivers 10040 are in its non-firing position, each staple drivers can one or more nails 10030 in support nail chamber 10012.Such as, first see Figure 22 and Figure 23, each staple drivers 10040 can comprise such as one or more support or groove 10041, and this support or groove can support nail the relative motioies limited between nail 10030 and staple drivers 10040.Refer again to Figure 16, nail bin 10000 also can comprise nail percussion sliding part 10050; This nail percussion sliding part can move to the distal end 10002 of nail bin from the proximal extremity 10001 of nail bin, staple drivers 10040 and nail 10030 to be lifted from its non-firing position to the anvil block being positioned in nail bin 10000 opposite successively.First see Figure 16 and Figure 18, one or more lower limbs 10032 that each nail 10030 can comprise base portion 10031 and extend from base portion 10031, wherein each nail can be at least one in such as basic U-shaped and basic V-arrangement.Nail 10030 can make when nail 10030 is in its non-firing position, caves in relative to the platform surface 10011 of support section 10010 in the top of nail lower limb 10032.Nail 10030 can make when nail 10030 is in its non-firing position, and the top of nail lower limb 10032 flushes relative to the platform surface 10011 of support section 10010.Nail 10030 can make when nail 10030 is in its non-firing position, and the top of nail lower limb 10032 or at least certain part of nail lower limb 10032 extend to above the platform surface 10011 of support section 10010.In this case, when nail 10030 is in its non-firing position, nail lower limb 10032 may extend into and enters and be embedded in tissue thickness's compensating part 10020.Such as, follow closely lower limb 10032 and such as can to extend to above platform surface 10011 about 0.075 ".Nail lower limb 10032 such as can extend to the distance above platform surface 10011 between about 0.025 " and about 0.125 ".To being described further above, tissue thickness's compensating part 10020 can comprise the uncompressed thickness between such as about 0.08 " and about 0.125 ".
In use, to be described further above and first see Figure 31, anvil block such as anvil block 10060 is such as moveable to the make position relative with nail bin 10000.As described in more detail below, tissue can be located against tissue thickness's compensating part 10020 and such as tissue thickness's compensating part 10020 be pressed to the platform surface 10011 of support section 10010 by anvil block 10060.Once anvil block 10060 is appropriately located, then can dispose nail 10030, equally as shown in figure 31.Optionally, as mentioned above, nail percussion sliding part 10050 can move from proximal extremity 10001 distal end 10002 of nail bin 10000, as shown in figure 32.When sliding part 10050 is pushed into, sliding part 10050 can contact stud driver 10040 and nail chamber 10012 in staple drivers 10040 is upwards lifted.Sliding part 10050 and staple drivers 10040 can comprise one or more slope or inclined-plane separately, and this one or more slope or inclined-plane can cooperate staple drivers 10040 is moved upward from its non-firing position.Such as, see Figure 19-Figure 23, each staple drivers 10040 can comprise at least one inclined-plane 10042, and sliding part 10050 can comprise one or more inclined-plane 10052, it can make when sliding part 10050 is distally pushed in nail bin, and inclined-plane 10052 is in inclined-plane 10042 lower slider.When staple drivers 10040 is upwards lifted in its respective nail chamber 10012, nail 10030 can upwards lift by staple drivers 10040, and nail 10030 is exposed from its nail chamber 10012 by the opening in nail platform 10011.During exemplary percussion sequence, first see Figure 25-Figure 27, sliding part 10050 can first contact stud 10030a and start nail 10030a upwards to lift.When sliding part 10050 is distally further promoted, sliding part 10050 can start to follow closely 10030b, and 10030c, 10030d, 10030e and 10030f and any other follow-up nail lift in order.As shown in figure 27, nail 10030 can upwards drive by sliding part 10050, makes the lower limb 10032 of the nail contacted with relative anvil block be deformed into the shape of expectation, and is penetrated from support section 10010.In all cases, as a part for percussion sequence, multiple nail can move upward by sliding part 10030 simultaneously.With reference to the percussion sequence shown in Figure 27, nail 10030a and 10030b has moved to its complete firing position and has been penetrated from support section 10010, nail 10030c and 10030d is in and is at least partly accommodated in support section 10010 in the process pulled the trigger, and follows closely 10030e and 10030f and be still in its non-firing position.
As mentioned above and see Figure 33, when nail 10030 is in its non-firing position, the nail lower limb 10032 of nail 10030 may extend into above the platform surface 10011 of support section 10010.With further reference to the percussion sequence shown in Figure 27, nail 10030e and 10030f is depicted as and is in its non-firing position, and its nail lower limb 10032 to extend to above platform surface 10011 and extends in tissue thickness's compensating part 10020.When nail 10030 is in its non-firing position, the top tissue contacting surface 10021 of the top of nail lower limb 10032 or any other part possibility Bu Tuchuan tissue thickness compensating part 10020 of nail lower limb 10032.As shown in figure 27, when nail 10030 moves to its firing position from its non-firing position, the end of nail lower limb convexly can wear tissue contacting surface 10032.The top of nail lower limb 10032 can comprise the sharp top can cut with penetrate tissue thickness compensation part 10020.Tissue thickness's compensating part 10020 can comprise multiple hole, and described multiple hole can hold nail lower limb 10032 and allow nail lower limb 10032 to slide relative to tissue thickness's compensating part 10020.Support section 10010 also can comprise the multiple guiders 10013 extended from platform surface 10011.Guider 10013 can be oriented to the nail chamber opening of contiguous platform surface 10011, and nail lower limb 10032 can be supported by guider 10013 at least in part.Guider 10013 can be positioned in proximal extremity and/or the distal end place of nail chamber opening.According to the present invention, first guider 10013 can be positioned in the first end of each nail chamber opening, and the second guider 10013 can be positioned in the second end of each nail chamber opening, make each first guider 10013 can support nail 10030 first nail lower limb 10032, and each second guider 10013 can support nail second nail lower limb 10032.See Figure 33, each guider 10013 can comprise groove or slit, such as groove 10016, such as, follow closely lower limb 10032 and can be slidingly received in this groove 10016.Optionally, each guider 10013 can comprise and can extend from platform surface 10011 and may extend into anti-skid stud, projection and/or the spike tissue thickness's compensating part 10020.As described in more detail below, anti-skid stud, projection and/or spike can reduce the relative motion between tissue thickness's compensating part 10020 and support section 10010.The top of nail lower limb 10032 can be positioned in guider 10013 and can not to extend to when nail 10030 is in its non-firing position above the top surface of guider 10013.Such as, guider 10013 can limit guiding height, and can not extend to this guiding elevation-over when nail 10030 is in its non-firing position.
According to the present invention, tissue thickness's compensating part (such as tissue thickness's compensating part 10020) such as can be made up of single material piece.Tissue thickness's compensating part can comprise continuous sheet, and this continuous sheet can cover the whole top platform surface 10011 of support section 10010, or alternatively, covers and be less than whole platform surface 10011.Material piece can cover the nail chamber opening in support section 10010, but alternatively, material piece can comprise can with nail chamber register or the opening that aligns at least partly.According to the present invention, tissue thickness's compensating part can be made up of such as multiple material layer.Referring now to Figure 15, tissue thickness's compensating part can comprise compressible core and the wrappage around compressible core.Compressible core can be remained to support section 10010 by wrappage 10022 releasedly.Such as, support section 10010 can comprise such as from one or more protuberances that it extends, such as protuberance 10014 (Figure 18), this protuberance can be contained in one or more hole and/or slit, is such as limited in the hole 10024 in wrappage 10022.Protuberance 10014 and hole 10024 can make protuberance 10014 wrappage 10022 can be remained to support section 10010.The end of protuberance 10014 can be such as out of shape by hot melt process, to expand the end of protuberance 10014, and therefore limits the relative motion between wrappage 10022 and support section 10010.Wrappage 10022 can comprise one or more perforation 10025, and it can be conducive to wrappage 10022 to discharge from support section 10010, as shown in figure 15.Referring now to Figure 24, tissue thickness's compensating part can comprise wrappage 10222, and this wrappage comprises multiple hole 10223, and its mesopore 10223 with the nail chamber register in support section 10010 or can align at least partly.The core of tissue thickness's compensating part also can comprise the hole of aliging with the hole 10223 in wrappage 10222 or aliging at least partly.Alternatively, the core of tissue thickness's compensating part can comprise continuous main body and may extend into below hole 10223, makes the nail chamber opening in continuous main body covering platform surface 10011.
Optionally, as mentioned above, tissue thickness's compensating part can comprise the wrappage for compressible core being remained to releasedly support section 10010.Such as, see Figure 16, nail bin also can comprise keeper fixture 10026, and this keeper fixture can suppress wrappage and compressible core to be separated with support section 10010 prematurely.Optionally, each keeper fixture 10026 can comprise the hole 10028 that can hold the protuberance 10014 extended from support section 10010, makes keeper fixture 10026 can be held support section 10010.Keeper fixture 10026 can comprise at least one flat of bottom 10027 separately, and this flat of bottom to may extend into below support section 10010 and keeps staple drivers 10040 in support section 10010 inner support.As mentioned above, tissue thickness's compensating part is attached to support section 10010 removedly by following closely 10030.More particularly, also as mentioned above, when nail 10030 is in its non-firing position, the lower limb of nail 10030 may extend in tissue thickness's compensating part 10020, and therefore tissue thickness's compensating part 10020 is remained to support section 10010 releasedly.The lower limb of nail 10030 can the sidewall contact in its corresponding nail chamber 10012, and wherein, due to the friction between nail lower limb 10032 and sidewall, nail 10030 and tissue thickness's compensating part 10020 can be maintained at appropriate location, until nail 10030 is deployed from nail bin 10000.After nail 10030 is deployed, tissue thickness's compensating part 10020 can be trapped in nail 10030 and to be kept against the tissue T sewed up.When anvil block moves to open position subsequently to discharge tissue T, the movable tissue thickness's compensating part 10020 away from being fixed to tissue of support section 10010.Binding agent can be used removedly tissue thickness's compensating part 10020 is remained to support section 10010.Two-part adhesive can be used, wherein, the Part I of binding agent can be placed on platform surface 10011, and the Part II of binding agent can be placed on tissue thickness's compensating part 10020, make when tissue thickness's compensating part 10020 be close to platform surface 10011 place time, Part I can contact Part II to enable binding agent and tissue thickness's compensating part 10020 is bonded to support section 10010 separably.Optionally, any other suitable method can be used tissue thickness's compensating part to be remained to separably the support section of nail bin.
To being described further above, sliding part 10050 proximally can be advanced to distal end 10002 to dispose all nails 10030 be accommodated in nail bin 10000 completely by end 10001.Referring now to Figure 56-Figure 60, sliding part 10050 distally can be advanced by the knife bar 10052 of firing member or surgical stapling device in the longitudinal cavity 10016 in support section 10010.In use, nail bin 10000 can be inserted in the nail bin passage in the jaw of surgical stapling device, and such as, in nail bin path 10 070, and firing member 10052 can be advanced to and contacts with sliding part 10050, as shown by the circuit diagram of figure 56.When sliding part 10050 is distally advanced by firing member 10052, sliding part 10050 can contact staple drivers or the driver 10040 of recent side, and nail 10030 is pulled the trigger from warehouse 10010 or penetrated, as mentioned above.As shown by the circuit diagram of figure 56, firing member 10052 also can comprise cutting blade 10053, and when nail 10030 is by percussion, this cutting blade is distally pushed into by the cutter slit in support section 10010.According to the present invention, corresponding cutter slit can extend across the anvil block being positioned in nail bin 10000 opposite, cutting blade 10053 can be extended between anvil block and support section 10010 and cut the tissue and tissue thickness's compensating part that are positioned in therebetween.In all cases, sliding part 10050 distally can be advanced by firing member 10052, until sliding part 10050 arrives the distal end 10002 of nail bin 10000, as shown in Figure 58.Now, firing member 10052 can proximally bounce back.Sliding part 10050 proximally can bounce back with firing member 10052, but referring now to Figure 59, when firing member 10052 bounces back, sliding part 10050 can be left in the distal end 10002 of nail bin 10000.Once firing member 10052 fully bounces back, anvil block can be opened again, and tissue thickness's compensating part 10020 can be separated with support section 10010, and has exhausted the remaining non-implanted portion of nail bin 10000, comprise support section 10010, can be removed from nail bin path 10 070.
When exhausting after nail bin 10000 is removed from nail bin passage, to being described further above, new nail bin 10000 or any other suitable nail bin can be inserted in nail bin path 10 070.To being described further above, nail bin path 10 070, firing member 10052 and/or nail bin 10000 can comprise cooperative structures, and this cooperative structures can prevent firing member 10052 again or to be subsequently distally pushed in new not pulling the trigger when nail bin 10000 is not positioned in nail bin path 10 070.More particularly, refer again to Figure 56, when firing member 10052 be advanced to contact with sliding part 10050 time, and when sliding part 10050 is in the non-firing position of its nearside, the support nose 10055 of firing member 10052 can be positioned on the support lugn 10056 on sliding part 10050 and/or on, make firing member 10052 be maintained at enough positions upwards, fall into prevent the lock that extends from firing member 10052 or crossbeam 10054 the lock groove be limited in nail bin passage.Due to lock 10054 can not fall into lock groove time, in such cases, when firing member 10052 is pushed into, lock 10054 can not adjoin locks the distally sidewall 10057 of groove.When sliding part 10050 distally promotes by firing member 10052, firing member 10052 can be supported on its upwards firing position due to the support nose 10055 leaned against on support lugn 10056.When firing member 10052 bounces back relative to sliding part 10050, as mentioned above also as shown in Figure 59, when supporting nose 10055 and not relying on the support lugn 10056 of sliding part 10050, firing member 10052 upwards can fall position from it.Such as, surgical staples can comprise and firing member 10052 can be biased to it to the spring 10058 of upper/lower positions and/or any other suitable biasing element.Once firing member 10052 bounces back completely, as shown in Figure 60, firing member 10052 can not distally be pushed into through the nail bin 10000 used up again.More particularly, when the sliding part 10050 being now in operating sequence has been left on distal end 10002 place of nail bin 10000, firing member 10052 can not have been remained on its upper position by sliding part 10050.Therefore, as mentioned above, if firing member 10052 is advanced again when not replacing nail bin, then lock crossbeam 10054 by the sidewall 10057 of contact lock groove, this will prevent firing member 10052 to be again distally advanced in nail bin 10000.In other words, once the nail bin 10000 used up is replaced by new nail bin, new nail bin will have the sliding part 10050 of nearside location, and firing member 10052 can be remained on its upwards position by the sliding part of this nearside location, and firing member 10052 is distally pushed into again.
As mentioned above, staple drivers 10040 can move by sliding part 10050 between the first non-firing position and the second firing position, to be penetrated from support section 10010 by nail 10030.After nail 10030 is penetrated from support section 10010, staple drivers 10040 can be accommodated in nail chamber 10012.Support section 10010 can comprise one or more holding structures that staple drivers 10040 can be stoped to penetrate or drop out from nail chamber 10012.Alternatively, staple drivers 10040 can penetrate by sliding part 10050 from the support section 10010 with nail 10030.Such as, staple drivers 10040 can by such as can bio-absorbable and/or biocompatible materials form, such as Polyetherimide (Ultem).Staple drivers can be attached to nail 10030.Such as, on the base portion that staple drivers can be molded into each nail 10030 and/or around, driver and nail are integrally formed.The name of JIUYUE in 2006 submission on the 29th is called " SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME " U.S. Patent application No.11/541, and 123 are incorporated herein by reference in full.
As mentioned above, surgery suturing appliance can comprise can hold nail bin nail bin passage, be rotatably connected to the anvil block of nail bin passage and comprise the firing member of blade, this firing member can relative to anvil block and the motion of nail bin passage.In use, nail bin can be positioned in nail bin passage, and after nail bin is consumed at least in part, nail bin can remove from nail bin passage and be replaced by new nail bin.Such as, the nail bin passage of surgery suturing appliance, anvil block and/or firing member can be reused together with replacement nail bin.Alternatively, nail bin can comprise the disposable loading unit assembly of part, this disposable loading unit assembly such as can comprise nail bin passage, anvil block and/or firing member, and these can be used as a part of replacing disposable loading unit assembly and are replaced with nail bin.Some disposable loading unit assembly is disclosed in the U.S. Patent application No.12/031 that the name submitted on February 15th, 2008 is called " END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT ", in 817, whole disclosures of this patent application are incorporated herein by reference.
Tissue thickness's compensating part can comprise can be extruded, can cast and/or mouldable compositions, and it comprises at least one in synthetic material as herein described and/or non-synthetic materials.Tissue thickness's compensating part can comprise the film or sheet with two-layer or more layer.Tissue thickness's compensating part can use conventional method to obtain, such as mix, blended, combination, spraying, wicking, solvent evaporation, dipping, brushing, gaseous phase deposition, extrude, roll, cast, molding etc.When extruding, the form that opening can comprise the mould of at least one opening is that the extrudate exposed gives shape.During calendering, opening can comprise the roll gap between two rollers.Conventional molding methods can include but not limited to blowing, injection moulding, foam injection, compression moulding, hot forming, extrude, foam extrude, thin film blowing, calendering, spinning, solvent welding, coating process such as dip-coating and spin coating, solution casting and film casting, plastisol processing (comprising scraper for coating, roller coat and casting), and their combination.During injection moulding, opening can comprise nozzle and/or passage/runner and/or cavity body of mould and feature structure.During compression moulding, compositions can be positioned in cavity body of mould, is heated to suitable temperature, and by being compressed at relatively high pressure and being shaped.During casting, compositions can comprise liquid or serosity, and it injects or is otherwise provided to the inside of mould or object, and/or around above, with the feature structure of copy mold or object.After casting, compositions can dried, cooling and/or solidification to form solid.
According to the present invention, the method manufacturing the tissue thickness's compensating part comprising at least one preservation and/or be absorbed in medicine wherein can comprise substantially provides tissue thickness's compensating part, and makes tissue thickness's compensating part and medicament contact to retain the dose in tissue thickness's compensating part.Manufacture the method comprising antibacterial materials microstructure thickness compensation part can comprise hydrogel, dried hydrogel are provided, in silver nitrate aqueous solution swollen hydrogel, hydrogel is contacted, to form tissue thickness's compensating part with antibacterial characteristics with sodium chloride solution.Tissue thickness's compensating part can comprise the silver be dispersed in wherein.
Referring now to Figure 71, tissue thickness's compensating part 21020 can comprise compensating part main body 21022 and the multiple capsule be positioned at wherein or pipe 21024.Each in pipe 21024 can comprise the cavity 21026 be limited to wherein, and described cavity 21026 can comprise one or more medicines wherein.As described in more detail below, can such as by pipe 21024 to be placed in a mold and the compensating part main body 21022 formed around pipe 21024 manufactures tissue thickness's compensating part 21020.Pipe 21024 can placed come one or more medicines to be placed in pipe 21024 in a mold, make such as to harden in compensating part main body 21022, after lyophilizing and/or solidification, pipe 21024 can be encapsulated in compensating part main body 21022.Alternatively, referring now to Figure 72, tissue thickness's compensating part 21120 can comprise and is positioned at multiple capsule in compensating part main body 21122 or pipe 21124, wherein can be formed in being loaded in pipe 21124 by one or more medicines afterwards around pipe 21124 in compensating part main body 21122.Such as, tissue thickness's compensating part 21120 can comprise port 21123, and described port 21123 can be communicated with pipe 21124 fluid and can such as allow to utilize syringe 21125 by one or more drug injections in pipe 21124.In some cases, one or more medicines can only load in inlet pipe 21124 tissue thickness's compensating part 21120 being inserted coming in patient by surgeon or other clinicians.When can wish or need tissue thickness's compensating part 21120 to have long storage time or storage life, these can be and are particularly useful.
Referring now to Figure 73, the compensating part main body 21022 of tissue thickness's compensating part 21020 can by such as can forming by bioabsorbable material.Compensating part main body 21022 can be made up of any suitable material, such as, PGA and/or PCL.Pipe 21024 can by such as any suitable can forming by bioabsorbable material.Pipe 21024 can be made up of any suitable material, such as, and hyaluronic acid, gelatin, PDS and/or oxidized regenerated cellulose (ORC).One or more medicines 21025 be included in cavity 21026 can comprise fluid, such as, and doxycycline.Such as, each in pipe 21024 can be sealing, and medicine 21025 can be stored in pipe 21024, until such as being dissolved and/or bio-absorbable at least partially of pipe 21024.During use, referring now to Figure 74, pipe 21024 can be made to be exposed to can contact and dissolve the body fluid of pipe 21024, such as, blood.See Figure 75, when such as by anvil block 21060 and/or multiple nail 21030 compress tissue T and tissue thickness's compensating part 21020, body fluid can be squeezed out from tissue T.According to the present invention, can utilize and can encapsulate or encapsulate compensating part main body 21022 at least in part by bio-absorbable wrappage.Such as, wrappage can be made up of such as hyaluronic acid and/or ORC.
Referring now to Figure 77, capsule or pipe 21224 can comprise such as multiple layers of 21224a-21224d.Each pipe 21224 can comprise such as outer or ground floor 21224a, second layer 21224b, third layer 21224c and internal layer 21224d.Outer 21224a can be made up of hemostatic material, such as, and thrombin.Second layer 21224b can be made up of antimicrobial and/or anti-biotic material, such as, and doxycycline and/or gentamycin.Third layer 21224c can be made up of antiinflammatory material, such as, and diclofenac and/or NSAIDS.Internal layer 21224d can be made up of Healing material, such as, and Powdered collage synthesis material.Refer again to Figure 77, pipe 21224 can be constructed and arranged to make outer 21224a dissolve or dissolve at least significantly before second layer 21224b dissolves or dissolves at least in part.See Figure 76, outer 21224a can start to dissolve once being exposed to body fluid.This moment is illustrated as time t0.Outer 21224a can several minutes, fully dissolve in time period of a few hours and/or a couple of days, the material wherein forming outer 21224a can show for the moment of time t1 reaches maximum effect or concentration.In certain moment after a while, outer 21224a can fully or at least significantly dissolving to during the moment indicated by time t2.
When outer 21224a is just by dissolving, body fluid can arrive second layer 21224b, and starts to dissolve second layer 21224b at least in part.Be similar to mentioned above, second layer 21224b can several minutes, fully dissolve in time period of a few hours and/or a couple of days, the material wherein forming second layer 21224b can show for the moment of time t3 reaches maximum effect or concentration.In all cases, body fluid can, through outer 21224a to arrive second layer 21224b, make outer 21224a and second layer 21224b can side by side or at least substantially side by side start to dissolve.Under any circumstance, reader should be noted, the time t1 that the material forming outer 21224a arrives its maximum effect or concentration can occur before a time t 3.In certain moment after a while, second layer 21224b can fully or at least significantly dissolving to during the moment indicated by time t5.Reader notes also, time t5 can occur after the time t 2.When second layer 21224b is just by dissolving, body fluid can arrive third layer 21224c, and starts to dissolve third layer 21224c at least in part.Be similar to mentioned above, third layer 21224c can several minutes, fully dissolve in time period of a few hours and/or a couple of days, the material wherein forming third layer 21224c can show for the moment of time t6 reaches maximum effect or concentration.In all cases, body fluid can, through outer 21224a and second layer 21224b to arrive third layer 21224c, make outer 21224a, second layer 21224b and/or third layer 21224c can side by side or at least substantially side by side start to dissolve.Under any circumstance, reader should be noted, the time t3 that the material forming second layer 21224b arrives its maximum effect or concentration can occur before time t 6.In certain moment after a while, third layer 21224c can fully or at least significantly dissolving to during the moment indicated by time t8.Reader notes also, time t8 can occur after time t 5.
When third layer 21224c is just by dissolving, body fluid can arrive the 4th layer of 21224d, and the moment indicated by time t4, dissolve the 4th layer of 21224d at least in part.Be similar to mentioned above, the 4th layer of 21224d can several minutes, fully dissolve in time period of a few hours and/or a couple of days, the material wherein forming the 4th layer of 21224b can show for the moment of time t7 reaches maximum effect or concentration.In all cases, body fluid can pass outer 21224a, second layer 21224b and third layer 21224c to arrive the 4th layer of 21224c, makes outer 21224a, second layer 21224b, third layer 21224c and/or the 4th layer of 21224d can side by side or at least substantially side by side start to dissolve.Under any circumstance, reader should be noted, forms before time t6 that the material of third layer 21224c arrives its maximum effect or concentration can occur in time t7.In certain moment after a while, the 4th layer of 21224d can fully or at least significantly dissolving to during the moment indicated by time t9.Reader notes also, time t9 can occur after time t 8.Optionally, due to above-mentioned situation, the stage release of medicine can be there is.
Referring now to Figure 81 and Figure 83, nail bin 21300 can comprise warehouse 21310, multiple nails 21330 that described warehouse 21310 comprises multiple nail chamber 21312 and is positioned at wherein.Nail bin 21300 also can comprise tissue thickness's compensating part 21320, and described tissue thickness compensating part 21320 can comprise can be close to the compensating part main body 21322 that warehouse 21310 is located and the multiple discrete capsule 21324 be positioned in compensating part main body 21322.Capsule 21324 can carry out orientation vertically, and when nail 21330 be in its do not pull the trigger configuration time, as shown in Figure 83, each capsule 21324 can be positioned between the nail lower limb 21322 of nail 21330.Such as, when nail 21330 is in its non-firing position, nail lower limb 21322 can to extend at least in part in tissue thickness's compensating part 21320 and capsule 21324 to be broken.When nail 21330 is moved to its firing position from its non-firing position, referring now to Figure 84, nail 21330 can make capsule 21324 break and thus discharge at least one medicine be stored in wherein.More particularly, when upwards being promoted by nail 21330, nail 21330 is out of shape by the shaping pit 21062 be limited in anvil block 21060, and making to follow closely lower limb 21332 can downward and the inwardly curling or distortion towards the capsule 21324 be positioned at therebetween.Trigger system by comprising driver 21340 and sliding part 21345 upwards promotes nail 21330, and wherein sliding part 21345 can longitudinally traverse nail bin 21000 and promote and pull the trigger the staple drivers 21340 and nail 21330 of all locating thereon subsequently.Under any circumstance, nail lower limb 21332 can pierce through and/or conquassation capsule 21324, the inner chamber 21326 be limited in capsule 21324 can be broken and one or more medicines be included in inner chamber 21326 can discharge from it.One or more medicines described can comprise one or more powder and/or fluid of such as comprising in the inner.Nail bin 21300 also can comprise cutting element 21380, and described cutting element 21380 distally can advance so that crosscut is positioned at the tissue T such as between nail bin 21300 and anvil block 21060 together with sliding part 21345.Cutting element 21380 can through the cutter slit 21314 be limited in warehouse 21310, wherein, such as, one or more capsule (such as, capsule 21324) to can be positioned within cutter slit 21314 and/or on, make cutting element 21380 can this type of capsule 21324 of crosscut.Under any circumstance, tissue thickness's compensating part 21320 also can comprise be positioned at warehouse 21322 top and/or bottom on layer 21321, described layer 21321 such as can be made up of such as hyaluronic acid and can make warehouse 21322 and/or nail 21330 stabilisations.Such as, cutting element 21380 can when cutting element 21380 is advanced through nail bin 21300 crosscut layer 21321, as mentioned above.
Referring now to Figure 85, multiple capsules 21444 that tissue thickness's compensating part 21420 can comprise compensating part main body 21422 and be positioned at wherein.Be similar to mentioned above, each capsule 21444 can comprise the seal chamber 21446 that wherein can store one or more medicines releasedly.Each in capsule 21444 can comprise such as taper and/or wedge shaped end 21447.Such as, when warehouse 21422 is just formed around capsule, wedge shaped end 21447 can be used for making capsule 21444 keep fixing.According to the present invention, mould can comprise can be received and multiple hole of stationary wedge end 21447 and/or impression, makes when pouring into compensating part material around capsule 21444, and mould can make capsule 21444 keep fixing.To being described further above, capsule 21444 such as can be located and is arranged so that they can not break or burst, until pulled the trigger by nail between the operating period into and/or pull the trigger through tissue thickness's compensating part 21420.
Alternatively, referring now to Figure 86, tissue thickness's compensating part 21520 can comprise the multiple capsules 21524 be positioned in compensating part main body 21522.Capsule 21524 can comprise the one or more holes 21528 be limited in its outer wall separately, and its mesopore 21528 can allow one or more medicines 21525 to overflow from the cavity 21526 be defined in capsule 21524.The size in hole 21528 and structure can be set to the speed controlling medicine 21525 and overflow from cavity 21526.Such as, the very fast release of medicine 21525 can be allowed compared with macropore 21528, and such as can allow the comparatively On The Drug Release of medicine 21525 compared with aperture 21528.The outer wall of each capsule 21524 can be made up of pipe, and described pipe has the end 21527 closed and/or seal.The outer wall of capsule 21524 can be made up of such as one or more Bioabsorbable polymerics, and such as can utilize rivet hot Welding, thermal weld technique and/or laser welding process is closed and/or seal end 21527.Injection molding process can be utilized to manufacture outer wall or the shell of capsule 21524, wherein after forming shell, by one or more opening, one or more medicines are navigated in shell.Then, such as polymer solution can be utilized to carry out the opening in coated shell.When capsule 21524 wall by can bioabsorbable material form, the hole 21528 be defined in wherein can be passed in time and increase.Such as, the speed that medicine 21525 discharges from cavity 21526 can be passed in time and increase.
Compensating part main body 21522 can be made up of such as gelatin, and such as freeze-dry process can be utilized to manufacture foamed materials.Can insert in compensating part main body 21522 by capsule 21524, wherein, such as, compensating part main body 21522 can be formed to have can the hole of admission capsules agent 21524.Such as, then layer or film can be placed on compensating part main body 21522 with coated or encapsulating capsule 21524 wherein.Capsule 21524 can be positioned in mould, and compensating part material can be formed to form compensating part main body 21522 around capsule 21524 at least in part.Under any circumstance, compensating part main body 21552 can comprise one or more keying or index feature, and described keying or index feature can make tissue thickness's compensating part 21520 aligning and orientation to the warehouse of nail bin, make capsule 21524 be positioned at desired location.
Referring now to Figure 87, surgical stapling system can comprise nail bin 21600 and anvil block 21060, and wherein nail bin 21600 and anvil block 21060 can be positioned on the opposite side of tissue T.Be similar to other nail bins disclosed herein, nail bin 21600 can comprise warehouse 21310, and described warehouse 21310 can comprise multiple nail chamber 21312 and location multiple nails 21330 wherein.During use, see Figure 91, by driver 21340 by nail 21330 never firing position rise to firing position, they are out of shape, more particularly, in shaping pit 21062 internal strain near anvil block 21060.When nail 21330 is just by percussion, do not pull the trigger between configuration (Figure 88) and its percussion configuration (Figure 89) before distortion at nail 21330 at it, nail 21330 can piercing tissue T and the tissue thickness's compensating part 21620 being attached to anvil block 21060.Such as, nail 21330 can be made up of any suitable material of such as rustless steel and/or titanium and so on, and can apply compression stress or chucking power near tissue thickness's compensating part 21620 and tissue T.As shown in Figure 87, nail 21330 can be arranged to multirow, wherein can arrange a nail 21330 in each nail chamber 21312.Nail bin 21300 also can comprise puncture member 21635 (Figure 90), one or more medicine capsules that described puncture member 21635 could engage and pierce through such as tissue T, tissue thickness's compensating part 21620 and/or be positioned in tissue thickness's compensating part 21620.Such as, puncture member 21635 can be positioned in nail chamber 21312, wherein makes puncture member 21635 pull the trigger from nail chamber 21312 or penetrate by driver 21340.To being described further above, some nail chambeies 21312 of nail bin 21600 can comprise the nail 21330 be positioned at wherein, and other nail chambeies 21312 can comprise the puncture member 21635 be positioned at wherein.Nail bin 21600 can comprise the nail chamber 21312 of embarking on journey, some of them row only has the nail 21330 be positioned at wherein, some row only have the puncture member 21635 be positioned at wherein, and/or some row have the nail 21330 and puncture member 21635 that are positioned at wherein.As shown in the figure, see Figure 91, the inner side four lines in nail chamber 21312 can only comprise nail 21330 wherein, and the outer row of following closely chamber 21312 can comprise nail 21330 and puncture member 21635 wherein.Nail 21330 in the outer row in nail chamber 21312 and puncture member 21635 such as can be arranged to alternate configuration.Referring now to Figure 92, nail 21330 and puncture member 21635 can pattern be arranged as follows, described pattern comprise such as two nails 21330, be afterwards puncture member 21635, be afterwards another two follow closely 21330, be puncture member 21635 etc. afterwards.
Main see Figure 90, the lower limb 21637 that each puncture member 21635 can comprise base portion 21638 and upwards extend from the opposite side of base portion 21638.Referring now to Figure 91, driver 21340 can comprise groove 21348 separately, and the base portion 21638 of puncture member 21635 can be received and support to described groove 21348.When by sliding part 21345 upwards pressing actuator 21340 time, referring now to Figure 92, sliding part 21345 pulls the trigger nail 21330 and puncture member 21635 serially.Referring now to Figure 91, nail 21330 can be out of shape near anvil block 21060, and puncture member 21635 can not contact anvil block 21060.Main see Figure 90, such as, one or two comprised tip 21639 in the lower limb 21636 of each puncture member 21635 and at least one agnail 21637, described most advanced and sophisticated 21639 can piercing tissue T and/or tissue thickness's compensating part 21620, and lower limb 21636 can remain in such as tissue T and/or tissue thickness's compensating part 21620 by least one agnail 21637 described.Can completely non-using-system thickness compensation part.The lower limb 21636 of puncture member 21635 can be not sufficiently long, thus is not enough to pass completely through tissue T, let alone contacts anvil block 21060.Lower limb 21636 can be sufficiently long, makes them can contact anvil block 21060, and may be deformed to different configurations.
Puncture member 21635 can be made up of the material different from the material forming nail 21330.Puncture member 21635 can be made up of at least one Bioabsorbable polymeric, such as, and PGA.Puncture member 21635 can comprise at least one medicine separately, such as, and antibacterial, antiinflammatory, pain medication and/or MMP inhibitor.Although puncture member 21635 can be positioned on nail line in, such as when puncture member 21635 is just being dissolved and/or bio-absorbable time, puncture member 21635 one or more medicines can be provided to nail line in and/or nail line near tissue T.Puncture member 21635 can be coated with one or more medicines.Puncture member 21635 can comprise one or more medicines be embedded in structured substrate, and described structured substrate comprises puncture member 21635.Such as, some puncture member 21635 can be made up of the first structured substrate and/or the first medicine, and other puncture member 21635 can by second or different structure substrate and/or second or different pharmaceutical form.Such as, injection molding process can be utilized to manufacture puncture member 21635.
Referring now to Figure 93 and Figure 94, nail bin 21700 can comprise warehouse 21710 and tissue thickness's compensating part 21720, on the platform surface 21711 that described tissue thickness compensating part 21720 is positioned at warehouse 21710 or near.Be similar to mentioned above, multiple capsules that warehouse 21710 can comprise multiple nail chamber 21312 and be positioned at wherein.Such as, warehouse 21710 also can comprise slit 21714, and described slit 21714 can receive cutting element wherein, such as cutting element 21380 (Figure 95) and so on.During use, as shown in Figure 95, cutting element 21380 crosscut can be positioned at tissue T between anvil block 21060 and nail bin 21700.Refer again to Figure 93 and Figure 94, tissue thickness's compensating part 21720 can comprise compensating part main body 21722 and multiple pharmaceutical pack of being positioned in compensating part main body 21722 or capsule 21724.Capsule 21724 can locate or be arranged in compensating part main body 21722, capsule 21724 is placed in and is limited on the slit 21714 of warehouse 21710.During use, mainly see Figure 96, cutting element 21380 can cut capsule 21724 when cutting element 21380 is advanced through nail bin 21700.Such as, capsule 21724 can be what seal before cut component 21380 is cut, and after capsule 21724 is by incision, one or more medicines be contained in wherein can be released.Because capsule 21724 is positioned on slit 21714, one or more medicines can be released in the part of the tissue T of cut component 21380 crosscut.One or more medicines be contained in capsule 21724 can comprise the biological reagent of such as powder type.One or more medicines in capsule 21724 can comprise such as oxidized regenerated cellulose, alginate esters and/or calcium.
Refer again to Figure 93 and Figure 94, capsule 21724 can comprise identical medicine wherein.Alternatively, one or more in capsule 21724 can comprise one or more different medicines wherein.More than first capsule 21724 can comprise the first medicine wherein, and more than second capsule 21724 can comprise the second medicine wherein.Such as, capsule 21724 can be arranged along the longitudinal path of cutting element 21380 with alternate configuration, make the capsule 21724 such as comprising the first medicine can be the capsule 21724 comprising the second medicine afterwards, can be capsule 21724 comprising the first medicine etc. afterwards.Cutting element 21380 can when cutting element 21380 is advanced through nail bin 21300 by the first medicine together with the second medicament mixed.Refer again to Figure 93 and Figure 94, tissue thickness's compensating part 21720 also can comprise from the outward extending one or more passage 21726 of each capsule 21724.Passage 21726 can allow the medicine in capsule 21724 after capsule 21724 is cut-off, moves to tissue thickness's compensating part 21720 and is close in the tissue T of its location.Capsule 21724 can be constructed such that it can not break when being applied compressive load by anvil block 21060.Main see Figure 93 and Figure 96, warehouse 21710 can comprise multiple groove 21715, described groove 21715 can separately can admission capsules agent wherein 21724 at least partially.Such as, groove 21715 can allow capsule 21724 slide downward when being applied in compressive load, and capsule 21724 can not be broken.Alternatively, one or more in capsule 21724 can only just be broken when the compression stress applied it meets or exceeds to a certain degree.Such as, capsule 21724 can stand the clamping pressure applied by anvil block 21060, but can break when the clamping pressure applied it increases because such as cutting element 21380 is advanced through nail bin 21700.Capsule 21724 can comprise lubricant wherein, and described lubricant can be conducive to the motion of cutting element 21380 when advancing in nail bin 21700 and/or retracting.
Referring now to Figure 97, tissue thickness's compensating part 21820 can comprise compensating part main body 21822 and run through the longitudinal pipe 21824 of extension.Be similar to mentioned above, pipe 21824 can comprise the longitudinal cavity 21826 be defined in wherein and one or more medicines 21825 be positioned in cavity 21826.Longitudinal pipe 21824 also can comprise from its outward extending one or more lower limb 21827, and described lower limb 21827 can stay pipe 21824.Such as, referring now to Figure 98, pipe 21824 can be supported in mould 21890 by supporting leg 21827, forms compensating part main body 21822 around pipe 21824 simultaneously.Referring now to Figure 99 and Figure 100, the material (such as, PGA and/or PCL) forming compensating part main body 21822 can be poured into around pipe 21824, and such as lyophilizing subsequently, foamed and/or solidification.Refer again to Figure 98, can be poured in the cavity 21891 around pipe 21824 by the material forming compensating part main body 21822, wherein cavity 21891 can be closed by covering 21892 subsequently.See Figure 97, the end of supporting leg 21827 can not covered by the material poured into, and can flush with the lower surface 21821 of compensating part main body 21822.Supporting leg 21827 and/or pipe 21824 can by soluble and/or can the material of bio-absorbable form, such as, and gelatin, hyaluronic acid, PDS and/or ORC.Lower limb 21827 can be dissolved rapidly by such as body fluid and/or saline solution, wherein can leave the groove or passage that extend between the neighboring and inside of tissue thickness's compensating part 21820.This type of passage can be produced dissolved rapidly to allow one or more medicines 21825 be positioned in pipe 21824 and/or absorb.Alternatively, tissue thickness's compensating part 21920 such as can comprise compensating part main body 21922 and have the pipe 21924 of multiple supporting leg 21927, as shown in Figure 101.See Figure 102, supporting leg 21927 can be and can extend across the larger supporting network of compensating part main body 21922 or the part of structuring grid 21928.
Refer again to Figure 97, the lower limb 21827 extended from pipe 21824 also can comprise one or more medicines wherein.When lower limb 21827 is dissolved and/or absorbs, as mentioned above, one or more medicines in lower limb 21827 can provide the first medication reaction to stitching and/or incision tissue, and one or more medicines 21825 in pipe 21824 can provide second or subsequent administrations reaction.Referring now to Figure 103 and Figure 105, tissue thickness's compensating part 22020 can comprise compensating part main body 22022 and extend through longitudinal medication tube 22024 of compensating part main body 22022.Be similar to mentioned above, pipe 22024 can limit longitudinal cavity 22026a, and described longitudinal cavity 22026a comprises one or more medicines 22025a be positioned at wherein.Be similar to mentioned above in addition, pipe 22024 can comprise multiple longitudinal lower limb support member 22027 that can extend along the length of pipe 22024.Optionally, each in lower limb support member 22027 can limit longitudinal cavity (such as, cavity 22026b and 22026c) wherein, and described longitudinal chamber can comprise one or more medicines separately wherein, such as, and medicine 22025b and 22025c.Lower limb support member 22027 can, by being formed by the material of rapid solution and/or absorption, make medicine 22025b and 22025c to be discharged rapidly.Then, supporting leg 22027 and pipe 22024 can be dissolved and/or are absorbed further, and medicine 22025a can be released subsequently.Medicine 22025a, 22025b and/or 22025c can be made up of identical material.Alternatively, medicine 22025a, 22025b and/or 22025c can be made up of different materials.Medicine 22025b with 22025c can be made up of identical material, and described material can be different from the material forming medicine 22025a.
To being described further, injection molding process can be utilized to the cavity 22026a-22026c manufacturing pipe 22024, lower limb 22027 and/or be limited to wherein above.Such as expressing technique can be utilized to manufacture pipe 22024, lower limb 22027 and/or cavity 22026a-22026c, and wherein, therefore, this category feature can comprise the continuous cross section along its length.This type of technique thus, pipe 22024 and lower limb 22027 can form.Then, can respectively medicine 22025a-22025c be positioned in cavity 22026a-22026c.Such as, medicine 22025a-22025c can be such as made up of one or more powder and/or one or more fluids separately.Referring now to Figure 106, the end 22029 of cavity 22026a-22026c can be sealed to comprise medicine 22025a-22025c wherein.Under any circumstance, such as subsequently pipe 22024 can be positioned at mould (such as, mould 21890 as above) in, wherein the material forming compensating part main body 22022 can be poured into the surrounding (as shown in Figure 104) of pipe 22024 with formative tissue thickness compensation part 22020.Various alternative replacement scheme is shown in Figure 107 and Figure 108.See Figure 107, multiple longitudinal pipes 22124 that tissue thickness's compensating part 22120 can comprise compensating part main body 22122 and link together.Each in pipe 22124 can limit longitudinal cavity 22126 wherein, and described longitudinal cavity 22126 can comprise one or more medicines 22125 separately wherein.Longitudinal cavity 22126 can each other not fluid be communicated with, or one or more in longitudinal cavity 22126 can fluid communication with each other.Be similar to mentioned above, compensating part 22120 also can comprise lower limb 22127, and described lower limb 22127 is from pipe 22124 to downward-extension and can comprise longitudinal cavity 22126 and at least one medicine 22125 separately wherein.Pipe 22124 and/or supporting leg 22127 can by being formed with the material of different rates dissolving and/or bio-absorbable.Such as, supporting leg 22127 can be made up of such as following material, and the dissolving of described material and/or absorption rate can faster than the materials forming pipe 22124.Referring now to Figure 108, tissue thickness's compensating part 22220 can comprise compensating part main body 22222 and longitudinal pipe 22224, and wherein pipe 22224 can comprise the multiple supporting legs 22227 extended from it.Single longitudinal cavity 22226 can be limited in pipe 22224 and to may extend in supporting leg 22227.Be similar to mentioned above, cavity 22226 can comprise one or more medicines 22225 be positioned at wherein.
Refer again to Figure 97, supporting leg 21827 can be made up of one or more following materials, and described material can absorption fluids, such as, and blood and/or saline solution.One or more medicines 21825 that fluid can be wicked into pipe 21824 and comprise wherein by supporting leg 21827.This wicking can allow medicine 21825 to dissolve earlier and/or bio-absorbable in agglutination.The end of supporting leg 21827 can not covered by compensating part main body 21822 and can be exposed to fluid.This wicking process such as can be undertaken by capillarity and can carry out under the prerequisite of the orientation regardless of tissue thickness's compensating part 21820.
Referring now to Figure 112, multiple pipes 22324 that tissue thickness's compensating part 22320 can comprise compensating part main body 22322 and be positioned at wherein.Such as, compensating part main body 23222 can be made up of reproducibility organization bracket foam, such as, and acellular nethike embrane bio-matrix, epiploic branches frame material and/or ACell.Epiploic branches frame material can comprise the hydrophilic foam manufactured by Skeleton nethike embrane, and can be compressible in some cases.When exposed to a fluid, epiploic branches frame material easily extensible and to be close to its location tissue apply pressure.ACell is for providing extracellular matrix or support network to impel the reproducibility product of cell proliferation and migration.The organization bracket forming compensating part main body 22322 can be loaded with such as stem cell, PRP or somatomedin.The organization bracket forming compensating part main body 22322 can apply in such as collagen stroma.The tissue scaffolding matrix of compensating part main body 22322 can be made up of fibre substrate, and fibre substrate can be made up of randomly-oriented fiber.In some cases, elasticity or resilience force needed for the fibre substrate be made up of randomly-oriented fiber can afford redress in part main body 22322.For head it off, randomly-oriented fiber can be made up of hydrophilic material and/or be coated with hydrophilic material, makes like this can expand after being exposed to liquid and provides required elasticity to fibre substrate and/or provide required compression stress to tissue.In all cases, fibre substrate can not be exposed in liquid, until it is caught by multiple nail near tissue, as mentioned above.Such as, compensating part main body 22322 can comprise the impermeable wrappage of liquid, and described wrappage can such as be destroyed, pierce through, cut and/or tear during use, enters compensating part main body 22322 to allow liquid and touches hydrophilic fibre.Under any circumstance, when the backing substrate that liquid is trapped in nail absorbs, backing substrate easily extensible, to apply compression stress and the tissue ingrowth adapted to along with passage of time in tissue scaffolding matrix to the tissue be also captured in nail.
To being described further above, the pipe 22324 of tissue thickness's compensating part 22320 can be made up of degradation material, and described degradation material can be dissolved and/or bio-absorbable.Be similar to mentioned above, each pipe 22324 can comprise comprising having the closed cavity of one or more medicines and one or more supporting leg 22327, and described supporting leg 22327 can be degraded and for liquid carrying is for arriving the passage or flow path that are stored in medicine in pipe 22324.This type of degraded of supporting leg 22327 can expend time in, and therefore, the medicine be included in pipe 22324 can be not what discharge immediately.In some sense, fluid degradation lower limb 22327 can need the time cycle, and wherein, therefore, lower limb 22327 can be used as the insurance thing of the release being designed to the medicine delayed in pipe 22324.Therefore, in all cases, the lower limb 22327 with length and/or thicker cross section can provide longer delaying, and the lower limb 22327 with shorter length and/or thinner cross section can provide shorter delaying.Pipe 22324 can be made up of the material dissolved fast and/or at a slow speed; But in either case, can there is a period of time in the degraded of pipe 22324, this can delay the release of one or more medicines be contained in pipe 22324.According to the present invention, the first pipe 22324 can be made up of first material of degrading with first rate, and the second pipe 22324 can be made up of second material of degrading with second or different rates.In such cases, the first medicine be contained in the first pipe 22324 can such as discharge before being contained in the second medicine in the second pipe 22324.First pipe 22324 can have the outer wall thinner than the second pipe 22324, this such as the first pipe 22324 to the second pipe 22324 can be allowed to degrade faster and discharge before the medicine that the medicine allowing to be contained in the first pipe 22334 is in the second pipe 22324.Due to mentioned above, such as, the first pipe 22324 can put release first medicine in the very first time, the second pipe 22324 can second or after a while time point discharge the second medicine, and the 3rd pipe 22324 can the 3rd or even more late time point release the 3rd medicine.
Referring now to Figure 113 and Figure 114, the sealed container 22424 that tissue thickness's compensating part 22420 can comprise compensating part main body 22422 and be positioned in compensating part main body 22422.Be similar to mentioned above, one or more medicines 22425 that container 22424 can limit longitudinal cavity 22426 and be positioned in longitudinal cavity 22426.Container 22424 can be elastic, and to make when tissue thickness's compensating part 22420 is compressed or flattens, as shown in Figure 114, container 22424 can be attempted resilience or keep its initial undeformed shape.Such as, container 22424 can comprise the spring member be positioned in compensating part main body 22422.Container 22424 can change shape and not break.Such as, container 22424 can such as be degraded when being exposed to liquid, as described herein.
Referring now to Figure 115, tissue thickness's compensating part 22520 can comprise compensating part main body 22522 and multiple sealed container 22524a-22524c.Such as, each the limited neighboring in container 22524a-22524c, the surface area of the container that described neighboring can increase, minimizes and/or optimize and liquid (such as, blood and/or saline solution) contacts.In all cases, the container with large surface area can be exposed to relatively large liquid, and therefore can speed carry out dissolving and/or bio-absorbable faster.Therefore, the container with small surface area can be exposed to the liquid of comparatively a small amount of, and speed that therefore can be slower carries out dissolving and/or bio-absorbable.Container 22524a-22524c can be made up of such as gelatin, hyaluronic acid, PDS and/or ORC.Be similar to mentioned above, container 22524a-22524c can be elastic and can provide resilience or elastic bias force.Referring now to Figure 116, tissue thickness's compensating part 22620 can comprise compensating part main body 22622 and be positioned at the fit component 22624 of multiple elastic layers in compensating part main body 22622.The inner passage of each the comprised sealing in lamilated body component 22624, described inner passage comprises one or more medicines be positioned at wherein.
Referring now to Figure 117, the end effector of surgery suturing appliance can comprise anvil block 21060 and nail bin 22700.Anvil block 21060 can comprise the tissue thickness's compensating part 22770 be attached on it, and nail bin 22700 can comprise warehouse 22710 and tissue thickness's compensating part 22720.Referring now to Figure 118, tissue thickness's compensating part 22770 can comprise multiple layer, and wherein tissue thickness's compensating part 22720 can comprise ground floor 22771 and the second layer 22772, but can dream up the alternate forms that wherein tissue thickness's compensating part can comprise more than two layers.Optionally, one or more layers of tissue thickness's compensating part can comprise weaving material.Ground floor 22771 can be made up of multiple First Line 22773 and the second line 22774, and described First Line 22773 is made up of the first material, and described second line 22774 is made up of second or different materials.Similarly, the second layer 22772 can be made up of multiple First Line 22773 and multiple second line 22774.First Line 22773 in ground floor 22771 can be identical with the concentration of the second line 22774 with the First Line 22773 in the second layer 22772 with the concentration of the second line 22774.First Line 22773 in ground floor 22771 can be different from the concentration of the First Line 22773 in the second layer 22772 and the second line 22774 with the concentration of the second line 22774, as will hereafter described in more detail.
To being described further above, First Line 22773 can be made up of such as Bioabsorbable polymeric (such as, PGA, PDS, PCL and/or PLA), and the second line 22774 can be made up of such as oxidized regenerated cellulose (ORC).Ground floor 22771 can comprise the skin of tissue thickness's compensating part 22770, and can comprise tissue contacting surface.Ground floor 22771 can comprise First Line 22773 more more than the second line 22774.Such as, ground floor 22771 can comprise the ratio of the First Line 22773 of such as about 80% and second line 22774 of about 20%.Ground floor 22771 can comprise the First Line 22773 of such as about 60% and the ratio of second line 22774 of about 40%, the First Line 22773 of about 67% with about 33% the ratio of the second line 22774, the First Line 22773 of about 70% with about 30% the ratio of the second line 22774, the First Line 22773 of about 75% with about 25% the ratio of the second line 22774 and/or the First Line 22773 of about 90% with about 10% the ratio of the second line 22774.
To being described further above, First Line 22773 can be made up of following material, and described material dissolves with the speed being slower than the material of formation second line 22774, bio-absorbable and/or change state.Such as, the second line 22774 can be made up of ORC line, and described ORC line can such as become gel when being exposed to liquid from solid-state and can such as react when being exposed to platelet and become gel from solid-state.But, in such cases, ground floor 22773 can primarily of can bio-absorbable polymer line form, describedly the polymer line of bio-absorbable can be much slower than the speed of ORC line and liquid reacts, therefore, ground floor 22773 can on multiple position contact tissue or body fluid and do not lose its overall shape and structure.In other words, the ORC line of ground floor 22773 is at first contact liq and/or can react when organizing; But ORC gel can remain in ground floor 22773 at least in part or mostly.
The second layer 22772 can comprise the internal layer of tissue thickness's compensating part 22770, and can not comprise direct tissue contacting surface.The second layer 22772 can comprise the First Line 22773 more less than the second line 22774.Such as, the second layer 22772 can comprise the ratio of the First Line 22773 of such as about 20% and second line 22774 of about 80%.The second layer 22772 can comprise the First Line 22773 of such as about 40% and the ratio of second line 22774 of about 60%, the First Line 22773 of about 33% with about 67% the ratio of the second line 22774, the First Line 22773 of about 30% with about 70% the ratio of the second line 22774, the First Line 22773 of about 25% with about 75% the ratio of the second line 22774 and/or the First Line 22773 of about 10% with about 90% the ratio of the second line 22774.
To being described further above, the second layer 22772 can comprise such as ORC line more more than Bioabsorbable polymeric line.The second layer 22772 can comprise ORC line more more than ground floor 22771.When the second layer 22772 is not skin, liquid can not contact the second layer 22772 immediately, because liquid will be had to first through ground floor 22771 before the contact second layer 22772.In such cases, the second layer 22772 can comprise the ORC line of higher density because second, ORC line in protected layer 22772 will not become gel immediately.Even if the ORC line in the second layer 22772 is by contact liq and become gel, ORC gel is also included in tissue thickness's compensating part 22770 by ground floor 22771, described ground floor 22771 can at least keep its overall shape initial and provide support net for the second layer 22772, as mentioned above.Although optionally use ORC fiber and can bioabsorbent fiber, other suitable materials can be used.
To being described further above, referring now to Figure 121 to Figure 123, tissue thickness's compensating part 22770 can be positioned in the middle of anvil block 21060 and tissue T, and wherein before being pulled the trigger by nail 21330 nail bin 22700, tissue thickness's compensating part 22770 can compress near tissue T.After nail 21330 has been pulled the trigger with capture tissue T wherein and tissue thickness's compensating part 22720 and 22770, the anvil block 21060 of nail bin 22700 and warehouse 22710 is removable can remove from operative site away from compensating part 22720,22770 and tissue T.Referring now to Figure 119, the layer 22871 of tissue thickness's compensating part can comprise woven wire 22873, and described woven wire 22873 can comprise such as cross section that is elongated or that flatten.Referring now to Figure 120, the layer 22971 of tissue thickness's compensating part can comprise woven wire 22973, and described woven wire 22973 can comprise such as circular cross section.
Various alternative replacement scheme is shown in Figure 124-127.Referring now to Figure 125, the end effector of surgery suturing appliance can comprise anvil block 21060 and location tissue thickness's compensating part 22770 ' thereon.See Figure 124, tissue thickness's compensating part 22270 ' can comprise layer 22771 ', and described layer 22771 ' can comprise multiple first fibers 22773 ' together with being woven in multiple second fiber 22774 '.Such as, the first fiber 22773 ' can dissolve and/or bio-absorbable with the speed faster than the second fiber 22774 '.Gap, opening and/or pit can be limited to the first fiber 22773 ' and the second fiber 22773 " between, thus liquid can be allowed to flow through layer 22771 '.Referring now to Figure 127, the end effector of surgery suturing appliance can comprise the tissue thickness's compensating part 22770 being attached to anvil block 21060 ".See Figure 126, tissue thickness's compensating part 22770 " can comprise and can embed and/or be encapsulated in substrate 22772 " in line 22771 " weaving layer.Although line 22771 can be made " expose, alternatively, make line 22771 " expose before, can have to dissolve and/or bio-absorbable substrate 22772 " at least partially.Such as, form substrate 22772 " material can fill online 22771 " between limit any gap, in opening or pit.
Referring now to Figure 132, nail bin 23000 can comprise tissue thickness's compensating part 23020.As described herein, tissue thickness's compensating part can utilize such as freeze-dry process to manufacture.Can be poured in mould by the solution such as comprising PGA and/or PCL, wherein said solution can allow to become open celled foam under the existence of vacuum atm environment and/or low temperature.Such as, PGA material can relative to PLA material with by weight about 64/36 ratio exist in solution.See Figure 128, fiber and/or filament 23021 such as can be mixed in solution.PGA fiber such as can be dispersed in solution before solution is poured into mould, and PGA fiber such as can be evenly distributed in whole tissue thickness compensating part 23020 equably or at least substantially.In other cases, can such as PGA fiber be placed in solution and/or directly be placed in mould, to make PGA fiber precipitable or be deposited to the bottom of such as mould.In other cases, PGA fiber can float to the top of solution.Under any circumstance, the solvent of such as dioxane and so on can exist in solution, and described solution can contribute to freeze-dry process.Dioxane can not with or at least substantially do not react with the PGA fiber in solution.
To being described further above, fiber 23021 can utilize one or more medicines to apply before being mixed in solution or mixing with solution.See Figure 130, each fiber 23021 can comprise substrate 23022, and described substrate 23022 can utilize any suitable manufacturing process to carry out applying coating 23023 at least in part.See Figure 129, expressing technique can be utilized to manufacture fiber 23021, wherein such as at least one medication coat is arranged in PGA substrate.These substrates especially can be used for the medicine of the high temperature that can stand expressing technique.See Figure 131, carrier fluid (such as, supercritical carbon dioxide) can be such as utilized to apply and/or impregnation of fibers 23021.Under any circumstance, the fiber 23021 being coated with medicine can be mixed with solution, fiber 23021 is embedded in tissue thickness's compensating part 23020.Therefore, in all cases, the coating of fiber 23021 can start to dissolve and discharge one or more medicines be contained in wherein.The fiber 23021 being positioned to the periphery of closer tissue thickness compensating part 23020 can start to dissolve before the fiber 23021 of inside being positioned to closer tissue thickness compensating part 23020.In such cases, the fiber 23021 of dissolving can leave multiple cavity or cavity network in tissue thickness's compensating part 23020, and wherein this type of cavity can allow the cell or tissue in tissue thickness's compensating part 23020 inwardly to grow up.Tissue thickness's compensating part can comprise multiple first fiber, and described first fiber can dissolve faster than the speed of multiple second fiber.Such as, the first fiber can comprise such as through the PGA fiber of gamma-radiation.Optionally, the PGA fiber through gamma-radiation can such as dissolve with the speed faster than the PGA fiber without gamma-radiation.
Optionally, one or more coloring agent can be added in above-mentioned solution, make the tissue thickness's compensating part obtained by solution can have suitable color.Can expect that tissue thickness's compensating part has and form with its surrounding the color contrasted.Such as, tissue thickness's compensating part can be such as green and/or blueness.
Referring now to Figure 133 and Figure 135, multiple drug particles 23121 that tissue thickness's compensating part 23120 can comprise compensating part main body 23122 and be distributed in whole compensating part main body 23122.Compensating part main body 23122 can be made up of hydrophobic material.Such as, compensating part main body 23122 can be made up of the material such as comprising PCL/PGA, wherein PCL and PGA can according to by weight 65/35 ratio be present in material.Referring now to Figure 134, drug particles 23121 can comprise one or more medicines 23123, such as, doxycycline, percarbonate and/or ascorbic acid phosphate, described medicine 23123 can encapsulate and/or be attached in the housing or shell 23124 that are made up of such as hydrophilic material.Shell 23124 can be made up of such as low molecular weight gelatine, hyaluronic acid and/or CMC.Medicine 23121 can be manufactured microparticle, described microparticle can be distributed in solution and described solution is poured in mould, in the mold can the such as described solution of lyophilizing subsequently, as mentioned above.Once tissue thickness's compensating part 23120 is exposed to liquid during use, fluid 23129 (Figure 136) just can enter compensating part main body 23122 and dissolve and/or absorb the hydrophilic shell 23124 of such as drug particles 23121.Referring now to Figure 139, tissue thickness's compensating part 23220 can comprise ground floor 23222 and the second layer or outer 23224, and the described second layer or outer 23224 such as can comprise the drug particles 23221 of the multiple coatings be dispersed in wherein.Be similar to mentioned above, granule 23221 can be dissolved from the second layer 23224 and/or be absorbed and such as can be left such as opening or capillary pathway 23225 in the second layer 23224.Referring now to Figure 140, tissue thickness's compensating part 23320 can comprise compensating part main body 23322, and described compensating part main body 23322 comprises the multiple drug particles 23121 and multiple fiber 23021 that are such as distributed in wherein.
Referring now to Figure 141 and Figure 142, nail bin 23400 can comprise such as warehouse 23410 and location tissue thickness's compensating part 23420 thereon.Tissue thickness's compensating part 23420 can comprise the multiple capsules 23421 be positioned in compensating part main body 23422.Such as emoulism or capstan technique can be utilized to manufacture capsule 23421, and capsule 23421 can comprise the metrological microsphere of such as solid and/or liquid bio.Capsule 23421 can comprise one or more binding agents, and described binding agent can contribute to fixing organization sealing when discharging from capsule 23421.Capsule 23421 can comprise such as hemorrhage.Under any circumstance, capsule 23421 can be distributed in compensating part main body 23422 in any suitable manner.Referring now to Figure 143, capsule 23421 such as can be placed in the cavity body of mould 21891 be defined in mould 21890, wherein capsule 23421 can be deposited to the bottom 21893 of mould 21890.See Figure 144, can swing die 21890 to make capsule 23421 can be formed uniformly on bottom 21893 or uniform layer at least substantially.Referring now to Figure 145, the material forming compensating part main body 23422 can be poured into and have in the cavity body of mould 21891 of capsule 23421.Capsule 23421 comparable compensating part material of main part is finer and close, and therefore capsule 23421 can remain on the bottom 21893 of mould 21890, as shown in Figure 146.Such as, see Figure 148, the bottom 21893 of mould 21890 can comprise can multiple grooves of admission capsules agent 23421, indenture and/or recess 21899.Alternatively, see Figure 147, capsule 23421 can be fine and close not as compensating part material of main part, and can float to the top of mould 21890.Optionally, as described in greater detail below, the density of capsule 23421 can be selected as capsule 23421 can be floated in whole compensating part material of main part.
After the mixture comprising capsule 23421 and compensating part material of main part is suitably poured in mould 21890, mixture can be made to stand such as freeze-dry process with formative tissue thickness compensation part 23420.Such as, capsule 23421 can be fixed with lyophilizing to the appropriate location in compensating part main body 23422.Then, refer again to Figure 141, tissue thickness's compensating part 23420 can be removed from mould 21890, and be assembled to the warehouse 23410 of nail bin 23400 subsequently.As shown in Figure 141, tissue thickness's compensating part 23420 can be located and be arranged so that capsule 23421 can limit or be oriented to tissue contacting surface or the top layer 23425 of adjacent tissue's thickness compensation part 23420.Capsule 23421 can be made up of such as hydrophilic material at least in part, and described hydrophilic material can such as be dissolved rapidly and/or bio-absorbable after tissue thickness's compensating part 23420 positions near tissue.Each in capsule 23421 can be dissolved by passing in time and/or multiple material layers of bio-absorbable are formed.Such as, the skin of capsule 23421 can comprise the first medicine, described first medicine can be dissolved and/or bio-absorbable to expose the second layer or internal layer, the described second layer or internal layer comprise and such as can be dissolved subsequently and/or the second medicine of bio-absorbable.Some in capsule 23421 can be positioned such that when distally advancing cutting element to cut tissue and/or tissue thickness's compensating part 23420, and these capsules are cut component incision, as herein elsewhere as described in.Capsule 23421 can reduce the density of tissue thickness's compensating part 23420, and this can reduce and such as advances cutting element through power needed for tissue thickness's compensating part 23420 or energy.
As mentioned above, tissue thickness's compensating part 23420 can comprise and is positioned at the one side or the multi-lateral in compensating part main body 23422 or the capsule 23421 on one or more top layer.Described above in addition, tissue thickness's compensating part 23420 can comprise the capsule 23421 be dispersed in whole compensating part main body 23422.Such as, capsule 23421 can have the density identical with compensating part material of main part, and capsule 23421 can be floated in compensating part material of main part.Capsule 23421 dispersibles or is evenly distributed in whole compensating part material of main part, wherein can subsequently capsule 23421 sedimentation or be deposited at least in part mould bottom come to cool described mixture.
Referring now to Figure 149, multiple movable units 23524 that tissue thickness's compensating part 23520 can comprise shell 23522 and be positioned in shell 23522.The space (such as, cavity 23523) that shell 23322 can limit encapsulating and/or sealing can within it be moved for movable units 23524.Movable units 23254 can be such as spherical, and can such as relative to each other slide and/or roll.Above the warehouse 21310 that tissue thickness's compensating part 23520 can be positioned at nail bin, wherein following closely 21330 can from nail bin from percussion and through tissue thickness's compensating part 23520, as shown in Figure 150.In all cases, movable units 23524 can move to just by the side of percussion through the nail 21330 of tissue thickness's compensating part 23520, and unit 23524 can not broken in percussion process.Such as, shell 23522 can be made up of elastomeric material, and described elastomeric material can bend and/or offset to adapt to the motion of movable units 23524 and the power produced in the inner that dynamically distributes again.Shell 23522 can encasement medium.Such as, medium can comprise such as one or more powder, liquid, other, fluid and/or gel can within it move for movable units 23524.Movable units 23524 by such as solubilized and/or can the material of bio-absorbable and one or more medicines be contained in wherein can be formed.Such as, this class formation can provide delaying of one or more medicines and/or sustained release.Alternatively, although not shown, tissue thickness's compensating part 23520 can be positioned on such as between tissue T and anvil block 21060.Under any circumstance, tissue thickness's compensating part 23520 can comprise " bean bag " structure of encapsulating.Shell 23522 can be constructed such that it does not break or does not at least substantially break, until cutting element (such as, cutting element 21380) extends there through.Now, one or more in movable units 23524 can overflow from shell 23522.
Referring now to Figure 153, multiple capsules 23624 that tissue thickness's compensating part 23620 can comprise compensating part main body 23622 and be at least partially contained within wherein.Referring now to Figure 151, mould 23690 can be utilized to manufacture tissue thickness's compensating part 23620.Such as, multiple ball-type capsule agent 23624 can be positioned in the cavity 23691 that is defined in mould 23690, wherein the transverse movement of capsule 23624 in mould 23690 can such as be stoped by the lateral sidewalls 23694 of mould 23690 and the transverse stop 23693 extended between lateral sidewalls 23694 or stop.Lateral sidewalls 23694 and transverse stop 23693 can limit multiple pit, can locate and hold capsule 23624 in described pit.Capsule 23624 can rest in the lower surface 23699 of mould 23690.Alternatively, see Figure 151 and Figure 152, mould 23690 also can comprise one or more vertical supports 23692, and described vertical supports 23692 can floating capsules 23624, makes them can not contact the lower surface 23699 of mould 23690.Such as, vertical supports 23692 can be positioned in lower surface 23699, and alternatively, see Figure 152, vertical supports 23692 can be positioned on horizontal support piece 23693 simultaneously.
Refer again to Figure 151 and Figure 152, the material forming compensating part main body 23622 can be poured in the cavity 23691 of mould 23690, capsule 23624 is surrounded by described material at least in part.Main see Figure 153, the part of capsule 23624 can be given prominence to from the compensating part main body 23622 of tissue thickness's compensating part 23620.Horizontal support piece 23693 and/or vertical supports 23692 can such as compensating part main body 23622 by during freeze-dry process and/or withdrew from from mould 23691 afterwards.Now, can there is not the situation low suspension of structural support part in compensating part main body 23622 in capsule 23624.Alternatively, horizontal support piece 23693 and/or vertical supports 23692 can remain in compensating part main body 23622.Such as, horizontal support piece 23693 and/or vertical supports 23692 can by such as can forming by bioabsorbable material.Support member 23692 and/or support member 23693 can comprise the elastic component be positioned in compensating part main body 23622, and described elastic component can increase the elasticity of such as compensating part main body 23622.
Referring now to Figure 157, tissue thickness's compensating part 23720 can comprise compensating part main body, and described compensating part main body has Part I 23722a and Part II 23722b and is positioned at least one capsule 23724 between both.Such as mould 21890 can be utilized to manufacture tissue thickness's compensating part 23720.Referring now to Figure 154, the first material can be poured in mould 21890 to form the Part I 23722a of compensating part main body.Then, see Figure 155, capsule 23724 can be positioned on Part I 23722a.Can after such as a period of time and/or the first material by afterwards capsule 23724 being positioned on Part I 23722a of freeze-dry process.Referring now to Figure 156, the second material can be poured in mould 21890 to form the Part II 23722b of compensating part main body.Can after such as a period of time and/or the second material by after freeze-dry process, tissue thickness's compensating part 23720 to be shifted out and the nail bin 23700 combined such as shown in Figure 158 uses from mould 21890.Second material can be different from the first material, and alternatively, the second material can be identical with the first material simultaneously.In either case, the first material and/or the second material can by forming by bioabsorbable material, and capsule 23724 can be made up of such as at least one medicine.
Referring now to Figure 162, nail bin 23800 can comprise tissue thickness's compensating part 23820, longitudinal capsule 23824 that described tissue thickness compensating part 23820 can comprise compensating part main body 23822 and be positioned at wherein.Referring now to Figure 159 and Figure 160, longitudinal hole 23821 is formed in compensating part main body 23822 by any appropriate process by such as mechanical drilling process and/or laser drilling process and so on.Once form longitudinal hole 23821, just can longitudinal capsule 23824 be positioned in longitudinal hole 23821, as shown in Figure 161.Referring now to Figure 166, nail bin 23900 can comprise tissue thickness's compensating part 23920, multiple capsules 23924 that described tissue thickness compensating part 23920 can comprise compensating part main body 23922 and be positioned at wherein.Referring now to Figure 163 and Figure 164, transverse holes 23921 is formed in compensating part main body 23922 by any appropriate process by such as mechanical drilling process and/or laser drilling process and so on.Once form transverse holes 23921, just can multiple capsule 239824 be positioned in transverse holes 23921, as shown in Figure 165.
Figure 167-171 shows and utilizes vertical mould 24090 to manufacture alternative method of tissue thickness's compensating part 23820.Main see Figure 167, mould 24090 can comprise the cavity 24091 limited by sidewall 24092 and bottom end wall 24093.See Figure 168, end wall 24093 can comprise hole 24094, and described hole 24094 can be received the end of longitudinal capsule 23824 and capsule 23824 is remained on erection position, as shown in Figure 169.Then, referring now to Figure 170, close by covering 24095 and/or the open side of seal chamber 24091, the material forming compensating part main body 23822 is poured in cavity 24091 by the opening by mould 24090.Such as harden at the material forming compensating part main body, solidify and/or after lyophilizing, tissue thickness's compensating part 23820 can be shifted out from mould 24090.
Referring now to Figure 172, nail bin 24100 can comprise warehouse 24110, tissue thickness's compensating part 24120 at tissue thickness's compensating part pad 24170 of locating near the platform surface 24111 of warehouse 24110 and the top that is positioned at tissue thickness's compensating part pad 24170.Tissue thickness's compensating part 24120 and tissue thickness compensating part pad 24170 can together with or compensate the change of thickness of the tissue in the nail (such as, following closely 21330 (Figure 175)) that is captured in and pulls the trigger from nail bin 24100 independently.Main see Figure 172 and Figure 173, compensating part pad 24170 can comprise can the lower surface 24171 on abutment platforms surface 24111 and the attachment flange extended from lower surface 24171 or guide rail 24174, and described attachment flange or guide rail 24174 can be received in the cutter slit 24114 that is defined in warehouse 24110 securely.Compensating part pad 24170 also can comprise multiple package 24172, and described package 24172 can extend transversely through compensating part pad 24170.Such as, can along axis of pitch limit in package 24172 each, described axis of pitch transverse to and/or perpendicular to the longitudinal axis limited by cutter slit 24114, as shown in Figure 176.Compensating part pad 24170 can comprise multiple layer, can limit package 24172 between described multiple layer.Such as, described layer can be made up of such as PDS and/or collagen.Each package 24172 can store one or more medicines wherein, such as, and doxycycline, coagulating agent and/or antimicrobial material.
Refer again to Figure 175, tissue thickness's compensating part pad 24170 can position relative to warehouse 24110, package 24172 is placed in and is limited on the nail chamber 21312 of warehouse 24110.More particularly, each package 24172 can be located and is arranged to make it extend between the nail lower limb 21332 of nail 21330.Compensating part pad 24170 can comprise multiple hole and/or through hole, and described hole and/or through hole such as can receive the end of nail 21330.These through holes can such as be positioned near package 24172.When never firing position moves to firing position to nail 21330, as shown in Figure 175, nail 21330 can catch package 24172 wherein.Such as, nail 21330 and package 24172 can be constructed and arranged to make package 24172 be not just punctured or not break by during percussion at nail 21330.In such cases, package 24172 can provide resilience force or compression stress and can consume the gap such as between tissue T and nail 21330 to the tissue T be captured in nail 21330.Refer again to Figure 176, when cutting element 21380 is pushed into through the cutter slit 24114 be defined in warehouse 24110, tissue T and/or compensating part pad 24170, cutting element 21380 can cut package 24172.Reader should be noted, tissue thickness's compensating part 24120 is not shown in Figure 175 and Figure 176.Following various embodiment can be dreamed up, wherein nail bin 24100 comprises tissue thickness's compensating part pad 24170 and does not comprise tissue thickness's compensating part 24120, alternatively simultaneously, referring now to Figure 177, nail bin 24100 can comprise such as tissue thickness's compensating part pad 24170 and tissue thickness's compensating part 24120.
Alternative embodiment of nail bin is shown in Figure 178.According to the present invention, circular nail bin 24200 can comprise circular warehouse 24210, and described circular warehouse 24210 comprises and is such as arranged to concentrically ringed multiple nail chamber 21312.Such as, nail bin 24200 also can comprise the circle be positioned on warehouse 24210 and organize thickness compensation part pad 24270, and wherein compensating part pad 24270 can comprise the package 24272 such as extended radially outwardly.Be similar to mentioned above, package 24272 can extend along the direction be placed on nail chamber 21312, and package 24272 can be extended between the lower limb being positioned at the nail 21330 in nail chamber 21312.Be similar to mentioned above in addition, nail 21330 can catch package 24272 wherein when nail 21330 is pulled the trigger from nail bin 24200.
Referring now to Figure 189, nail bin 24300 can comprise warehouse 24310 and tissue thickness's compensating part 24320, multiple tubular elements 24324 that described tissue thickness compensating part 24320 comprises compensating part main body 24322 and is positioned in compensating part main body 24322.Such as, nail bin 24300 also can comprise the tissue thickness's compensating part layer or sheet material 24370 that are such as positioned at tissue thickness's compensating part 24320 and warehouse 24310 centre.Referring now to Figure 179, mould 24390 can be utilized to manufacture multiple nail bin 24300 simultaneously.Mould 24390 can comprise multiple cavity 24391, and described cavity 24391 can receive warehouse 24310, as shown in Figure 180 separately wherein.Then, the one or more large material piece comprising tissue thickness's compensating part layer 24370 can be placed on warehouse 24310.Mould 24390 can comprise the multiple supporting pin or post 24392 that upwards extend, and wherein sheet material 24370 can position near post 24392, then pushes downwards, makes post 24392 can pierce through sheet material 24370, as shown in Figure 181 and Figure 183.Referring now to Figure 182 and Figure 184, elongated tubular 24324 can to curl up around post 24392 and between, make pipe 24324 through each warehouse 24310 at least one times.Pipe 24324 can to curl up around post 24392 and between, make pipe 24324 through each warehouse 24310 such as six times.Pipe 24324 can be allowed to rest on sheet material 24370, simultaneously can around post 24392 and between curl up pipe 24324 tightly, pipe 24324 is tightened up and can be suspended on sheet material 24370.Once pipe 24324 is suitably located, mainly see Figure 185, just the material forming compensating part main body 24322 can be poured in the mould 24390 at sheet material 24370 top.Warehouse 24310 be protected or be sheltered to sheet material 24370 can, and compensating part material of main part 24322 can be stoped to enter such as be defined in the nail chamber 21312 in warehouse 24310.According to the present invention, can the compensating part material of main part 24322 of q.s be poured in mould, make compensating part material of main part 24322 cover elongated tubular 24322.
To being described further above, compensating part material of main part 24322 can such as solidify subsequently, harden and/or lyophilizing with the top formative tissue thickness compensation part 24320 at warehouse 24310.Then, referring now to Figure 186, cutting punch die 24395 can be utilized to cut compensating part material of main part 24322, tissue thickness's compensating part sheet material 24370 and elongated tubular 24322.Referring now to Figure 187, cutting punch die 24395 can comprise multiple cutter 24396, and described cutter 24396 can be split and chorista thickness compensation part 24320 and tissue thickness's compensating part sheet material 24370.Cutting punch die 24395 can comprise multiple well recessed 24397, and described well recessed 24397 can remove any excess material between tissue thickness's compensating part 24320 of segmentation and tissue thickness's compensating part sheet material 24370, as shown in Figure 188.Cutting punch die 24935 and/or any other suitable punch die can comprise such as one or more heating element heater, and described heating element heater can the end of seal tissue thickness compensation part 24320 and/or edge.Pipe 24324 can be filled with one or more fluids.In such cases, cutter 24396 can cut pipe 24324, and sealed packet is contained in the end of the tube portion in tissue thickness's compensating part 24320 simultaneously.Then, described multiple nail bin 24300 can be shifted out from mould.
Referring now to Figure 190 and Figure 191, nail bin 24400 can comprise warehouse 24410, and described warehouse 24410 can store multiple nail wherein removedly.In addition, nail bin 24400 also can comprise tissue thickness's compensating part 24420.Tissue thickness's compensating part 24420 can comprise the compensating part main body be made up of multiple layer 24422, and wherein said layer 24422 can be made up of such as cellulose membrane.As shown in Figure 192 a, material 24424 can be positioned between two or more adjacent layers 24422, wherein material 24424 can make adjacent layer 24422 be spaced apart from each other.Material 24424 can comprise polyblend biomedics extrudate, and material 24424 can comprise such as hemostatic material, antiinflammatory material and/or anti-biotic material.Referring now to Figure 192, by allotter 24490, material 24424 is administered to layer 24422 with such as waveform pattern, wherein said waveform pattern can be constructed such that material 24424 can be positioned on above one or more nail chambeies of being defined in warehouse 24410.In such cases, material 24424 can be trapped in from the nail of nail chamber injection, and can provide elastic bias force to the tissue be also trapped in nail.Under any circumstance, in layer 24422 one or more can such as vacuum formed and/or be heat sealed on material 24424 to produce tissue thickness's compensating part 24420.Tissue thickness's compensating part 22420 can be cut into length-specific subsequently.Can dream up following various embodiment, wherein tissue thickness's compensating part 22420 positions near the platform surface of nail bin and another tissue thickness's compensating part 22420 positions near anvil block.
Referring now to Figure 195, nail bin 24600 can comprise the one or more tissue thicknesses compensating part 24620 be positioned at above warehouse 24610.Main see Figure 194, each tissue thickness compensating part 24620 can comprise multiple layer 24622 and be positioned at the compressible component 24624 of maybe can collapsing between layer 24622.Component 24624 of can collapsing can comprise corrugated component, and described corrugated component comprises the multiple pits be defined in wherein, wherein can by one or more medicament storage in pit.Such as, the first medicine can be placed in the pit of the first side of corrugated component, and the second medicine can be placed in the pit of the second side of such as corrugated component.Can formative tissue thickness compensation part 24620 when such as layer 24622 and compressible member 24624 being compressed together by roller 24590.Referring now to Figure 193, tissue thickness's compensating part 24520 can be formed by such as tubes of material, and described tubes of material is such as rolled into the smooth shape of part by roller 24590.Referring now to Figure 196 and Figure 197, the nail 21330 be positioned in warehouse 24610 can penetrate from warehouse, such that nail 21330 can capture tissue thickness compensation part 24620 be at least partially wherein.In such cases, compressible member 24624 can apply elastic bias force near the tissue T be also trapped in nail 21330.The layer 24622 of tissue thickness's compensating part 24620 can also apply elastic bias force near tissue T.Nail 21330 can pierce through the pit of corrugated component 24624 and discharge one or more medicines be contained in wherein.
Tissue thickness's compensating part mentioned above can comprise material wherein.Described material can comprise such as coagulating agent, medicine and/or antiinflammatory.Described material can be liquid, but also can present other forms, such as, and solid and/or gel.For comprising the surgical device of this type of tissue thickness's compensating part, maybe advantageously surgical device comprises feature material being guided out tissue thickness's compensating part.Such as, the tissue that material can be directed to incision from tissue thickness's compensating part and sew up.And for example, first tissue thickness's compensating part can comprise the first material, and the second thickness compensation part can comprise the second material, wherein mixes the first material and the second material by surgical device.And for example, the anvil block of such as nail bin and/or surgical device is directed to while material can be deviated from each other.
Figure 39 0-391 shows surgical stapling system, and described surgical stapling system comprises cutter 19000 (it comprises cutting edge 19016), nail bin 19002, anvil block 19008, the minor microstructure thickness compensation part 19006 that is positioned at first tissue thickness's compensating part 19004 on nail bin 19002 and is positioned on anvil block 19008.During use, cutter 19000 distally move along the direction of arrow D, to cut patient tissue T and first tissue thickness's compensating part 19004 and minor microstructure thickness compensation part 19006.First tissue thickness's compensating part 19004 comprises the material S be included in wherein, and minor microstructure thickness compensation part 19006 comprises the material S ' be included in wherein.First tissue thickness's compensating part 19004 comprises encapsulation object, and described encapsulation object comprises material S wherein.Encapsulation object can comprise the material membrane that the cutter 19000 by cutting film are opened, and wherein material S is released when film is opened.Minor microstructure thickness compensation part 19006 can comprise similar encapsulation object, and when being cut the encapsulation object of minor microstructure thickness compensation part 19006 by cutter 19000, can discharge the second material S '.When cutter 19000 distally moves, guider 19030 and 19022 can lead or shift material S from first tissue thickness's compensating part 19004 and minor microstructure thickness compensation part 19006 and material S ' respectively.Such as, material S and S ' can be directed to the tissue T of incision.Cutter 19000 can be connected to axle 19012, and described axle 19012 can be connected to actuating mechanism then, and described actuating mechanism distally direction D and the proximal direction that indicated by arrow P carrys out movable knife 19000.
Material S from first tissue thickness's compensating part 19004 can be directed to the tissue T of incision by guider 19030.The mirror image of guider 19030 can be positioned on the opposite face of cutter 19000.Guider 19030 can comprise two boss ridge 19032 and 19034 limiting channel C therebetween.When surgical staples is located near tissue T, the distal end 19035 of channel C can be close to first tissue thickness's compensating part 19004 and the proximal extremity 19037 of channel C can be close to tissue T.During use, when distally direction D moves cutter 19000, from the material S of first tissue thickness's compensating part 19004 at distal end 19035 place admission passage C, flow through channel C and at the proximal extremity 19037 place leaving channel C of adjacent tissue T.
Material S ' from minor microstructure thickness compensation part 19006 can be directed to the tissue T of incision by guider 19022.Guider 19022 comprises the projection 19025 with inclined surface 19023.As shown in Figure 61, projection 19025 can pierce through or cut minor microstructure thickness compensation part 19006 with h substance S '.When distally D moves cutter 19000, material S ' can be directed to tissue T by inclined surface 19025.
Material S and S ' can mix when being directed into tissue T.Material S and S ' can be different and can react when mixing.Such as, can there is chemical reaction to form novel substance S in material S and S ' when mixing ".Novel substance S " can be the material of any other suitable type of such as medicine, antibiotic, coagulating agent and/or material.After distally direction D suitably advances cutter 19000, cutter 19000 moves by proximally P and returns, and wherein move also can compounding substances S and S ' for the nearside of cutter 19000.
Alternatively, material S and S ' can guide away from tissue T by guider 19022 and 19030.Such as material S can be directed to nail bin 19002 by guider 19030, and material S ' can be directed to anvil block 19008 by guider 19022.This structure can be favourable in the following cases, such as, first tissue thickness's compensating part 19004 remains to nail bin 19002 by the binding agent at junction surface 19005 place and minor microstructure thickness compensation part 19906 remains to anvil block 19008 by the binding agent at such as junction surface 19007 place.Material S and S ' solubilized or in and binding agent, thus discharge first tissue thickness's compensating part 19004 and minor microstructure thickness compensation part 19006 at least in part from nail bin 19002 and anvil block 19008 respectively.
Figure 63 shows alternative guider 19030 ', wherein channel C ' limited by the depression on the surface of cutter 19014 or groove.Channel C ' single passage can be comprised maybe multiple passage can be comprised.
Figure 64-67 shows another surgical stapling system comprising cutter 19060 and cutting edge 19056, first tissue thickness's compensating part 19004 and minor microstructure thickness compensation part 19006.Cutter 19060 can comprise the first projection 19062 be positioned on the first side of cutter 19060, and wherein the first projection 19062 limits the aperture 19064 of the second side walking cutter 19060 from the first side of cutter 19060.First projection 19062 and spray orifice 19064 can be aimed at first tissue thickness's compensating part 19004.During use, when cutter 19060 distally moves, the material S in tissue thickness's compensating part 19004 can pass the first aperture 19064 at least partially.Optionally, material S can be directed to the second side and/or the tissue T of cutter 19060 by the profile of the first projection 19062.
Cutter 19060 also can comprise the second projection 19066 be positioned on the second side of cutter 19060, and wherein the second projection limits the aperture 19068 of the first side walking cutter 19060 from the second side of cutter 19060.Second projection 19066 and the second aperture can be aimed at minor microstructure thickness compensation part 19006.During use, when cutter 19060 proximally moves, the material S ' in tissue thickness's compensating part 19006 can pass the second aperture 19068 at least partially.Optionally, material S ' can be directed to the second side and/or the tissue T of cutter 19060 by the profile of the second projection 19066.
Main see Figure 64 and Figure 65, axle 19059 can comprise surface character, and such as, recess 19070, described surface character can increase turbulent flow and/or the movement of material S and material S '.The turbulent flow of this increase and/or movement can such as cause the greater part of material S with S ' to contact to each other.Recess 19070 can be positioned at nearside relative to aperture 19064 and 19068.When distally advancing cutter 19000, recess 19070 can be positioned at the downstream in aperture 19064 and 19068; But, when proximally bounce back cutter 19000 time, recess 19070 can be positioned at the upstream in aperture 19064 and 19068.
Figure 68-70 shows another surgical stapling device comprising cutter 19100 and cutting edge 19108, first tissue thickness's compensating part 19120 and minor microstructure thickness compensation part 19122.First tissue thickness's compensating part 19120 can comprise the first material S and the second material S '.Such as, the first material S can be included in the first encapsulation object, as mentioned above.Second material S ' can be loaded in the second encapsulation object, and the first encapsulation object is close to and/or be surrounded to described second encapsulation object can.Minor microstructure thickness compensation part 19122 can comprise the 3rd material S ".Minor microstructure thickness compensation part 1922 can comprise the 4th material S " '.3rd material S " and the 4th material S " ' can be loaded in encapsulation object, encapsulation object as described above.Cutter 19100 can comprise the texturizing surfaces 19110 be positioned on the first side 19102 of cutter 19100, wherein material S, S ', S " and S " ' can spread on described texturizing surfaces 19110.Another texturizing surfaces can be positioned on the second relative side (not shown) of cutter 19100.Texturizing surfaces 19110 can comprise a series of fracture characteristic, such as, and the groove being cut, delineating, etch and/or be otherwise formed in first surface 19102.Fracture characteristic also can comprise a series of protruding features on first surface 19102, such as, and convex ridge.As shown in Figure 68-70, the fracture characteristic of texturizing surfaces 19110 can comprise the regular repeating pattern of fracture characteristic.Fracture characteristic also can non-repeating pattern be carried out arranging or arranging with random fashion.
Cutter 19100 also can comprise the second surface 19104 being positioned at nearside relative to first surface 19102.Second surface 19104 can be protruding relative to first surface 19102.Junction surface between first surface 19102 and second surface 19104 can limit the 3rd surface 19106, and wherein the 3rd surface 19106 can position at angle relative to the longitudinal axis of cutter 19100.Cutter 19100 is along second end 19109 that first end 19107 on the 3rd surface 19106 can be caused to lead over the 3rd surface 19106 that moves of distal direction D.Therefore, as shown in figure 70, the 3rd surface 19106 can make material S and S ' from first tissue thickness's compensating part 19120 be directed to the tissue T of incision.The surface 19105 being similar to second surface 19104 can be positioned on the second relative side of cutter 19100.
Cutter 19100 shown in Figure 68-70 can be used in following surgical device, and described surgical device comprises first tissue thickness's compensating part 19004 shown in Figure 61-67 and minor microstructure thickness compensation part 19006.As mentioned above, texturizing surfaces 19110 can, by being distributed on the first surface 19102 of cutter from the material S of tissue thickness's compensating part 19004 and 19006 and material S ' respectively, make them can mix and can be positioned near tissue T.
Cutter 19100 shown in Figure 68-70 also can be used in following surgical device, and described surgical device comprises first tissue thickness's compensating part 19120 shown in Figure 68-70 and minor microstructure thickness compensation part 19122.First tissue thickness's compensating part 19120 can comprise the interior section 19121 containing the first material S.When first tissue thickness's compensating part 19120 is cut by the cutting edge 19108 of cutter 19100, can from interior section 19121 h substance S.When cutter 19100 moves relative to tissue thickness's compensating part 19120, material S can spread on texturizing surfaces 19110, and material S can be directed to tissue T by the 3rd surface 19106.As mentioned above, first tissue thickness's compensating part 19120 can comprise the second material S ' be positioned at outside interior section 19121.When first tissue thickness's compensating part 19120 is cut by the cutting edge 19108 of cutter 19100, the first material S and the second material S ' can be made to be distributed on texturizing surfaces 19110.Distribution on texturizing surfaces 19110 can cause the first material S and the second material S ' to mix.First material S and the second material S ' can react (such as, chemical reaction) to form novel substance when mixing.First material S and the second material S ' can be directed to tissue by the 3rd surface 19106.As mentioned above, minor microstructure thickness compensation part 19122 can comprise the 3rd material S ".When minor microstructure thickness compensation part 19122 is cut by the cutting edge 19108 of cutter 19100, the 3rd material S can be made " be distributed on texturizing surfaces 19110, wherein the 3rd material can mix with the first material S and/or the second material S ' and be directed to tissue T.As mentioned above, minor microstructure thickness compensation part 19122 can comprise the 4th material S " '.When minor microstructure thickness compensation part 19122 is cut by the cutting edge 19108 of cutter 19100, the 3rd material S can be made " and the 4th material S " ' be distributed on texturizing surfaces 19110, wherein the 3rd material and the 4th material can mix with the first material S and/or the second material S ' and be directed to tissue T.
To being described further above, tissue thickness's compensating part can be made up of biocompatible materials.Biocompatible materials (such as, foam) can comprise viscosifier, surfactant, filler, cross-linking agent, pigment, dyestuff, antioxidant and other stabilizing agent and/or their combination, thus provides required characteristic for material.Biocompatible foam can comprise surfactant.Surfactant can be administered to the surface of material and/or dispersible in material.Not by the constraint of any concrete theory, the surfactant being administered to biocompatible materials can reduce the surface tension of the fluid of contact material.Such as, surfactant can reduce the surface tension of the water of contact material, to promote that water permeation is in material.Water can serve as catalyst.Surfactant can increase the hydrophilic of material.
Surfactant can comprise anion surfactant, cationic surfactant and/or non-ionic surface active agent.Surface active agents includes but not limited to polyacrylic acid, methalose, methylcellulose, ethyl cellulose, propyl cellulose, hydroxyethyl-cellulose, carboxymethyl cellulose, polyoxyethylene cetyl base ether, polyoxyethylene lauryl ether, polyoxethylene octylphenyl ether, NONIN HS 240, polyoxyethylene oleyl ether, polyoxyethylene sorbitol monolaurate, polyoxyethylene stearyl base ether, ethylene nonyl phenyl ether, dialkyl group phenoxy group gathers (ethylene oxy) ethanol, poloxamer, and their combination.Surfactant can comprise the copolymer of Polyethylene Glycol and polypropylene glycol.Surfactant can comprise non-phospholipid surfactants.Non-phospholipid surfactants can provide antibacterial stability characteristic (quality), and/or can by other dispersion of materials in biocompatible materials.
Tissue thickness's compensating part can comprise at least one medicine.Tissue thickness's compensating part can comprise in natural material as herein described, non-synthetic materials and/or synthetic material one or more.Tissue thickness's compensating part can comprise biocompatible foam, and described biocompatible foam comprises gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, poly-dioxanone, polyhydroxy-alkanoates, poliglecaprone and their combination.Tissue thickness's compensating part can comprise the film containing at least one medicine.Tissue thickness's compensating part can comprise the biodegradable film containing at least one medicine.Medicine can comprise liquid, gel and/or powder.Medicine can comprise anticarcinogen, such as, and cisplatin, mitomycin and/or amycin.
Tissue thickness's compensating part can comprise Biodegradable material, to provide the controlled eluting of described at least one medicine when Biodegradable material is degraded.When the agent of Biodegradable material contact activation (such as, activator fluid), Biodegradable material degradable, decomposable asymmetric choice net or loss structure integrity.Activator fluid can comprise such as saline solution or other electrolyte solution any.Biodegradable material carrys out contact activation agent fluid by routine techniques (include but not limited to spraying, dipping and/or brush).During use, such as, surgeon can be impregnated into comprising such as, in activator fluid (comprise saline solution, sodium chloride, calcium chloride and/or potassium chloride) containing the end effector of tissue thickness's compensating part of at least one medicine and/or nail bin.When tissue thickness's compensating part degraded, tissue thickness's compensating part releasable medicaments.Medicine can by initial elution rates and slower lasting elution rate characterize fast from the eluting of tissue thickness's compensating part.
According to the present invention, tissue thickness's compensating part such as can be made up of biocompatible materials, and described biocompatible materials can comprise oxidant.Oxidant can comprise organic peroxide and/or inorganic peroxide.The example of oxidant can include but not limited to hydrogen peroxide, urea peroxide, calper calcium peroxide and Magnesium dioxide and SODIUM PERCARBONATE.Oxidant can comprise peroxy oxidant and hypochlorous acid base oxidant, such as, and hydrogen peroxide, hypochlorous acid, hypochlorite, hypocodites and percarbonate.Oxidant can comprise alkali metal chlorite, hypochlorite and perborate, such as, and chloritization sodium, sodium hypochlorite and Dexol.Oxidant can comprise vanadate.Oxidant can comprise ascorbic acid.Oxidant can comprise active oxygen product.According to the present invention, organization bracket can comprise the biocompatible materials containing oxidant.
Biocompatible materials can comprise liquid, gel and/or powder.Oxidant can comprise such as microgranule and/or nano-particle.Such as, oxidant can be ground to form microgranule and/or nano-particle.Be suspended in polymer solution by making oxidant and oxidant is incorporated in biocompatible materials.In lyophilized process, oxidant can be incorporated in biocompatible materials.After lyophilized, oxidant can be attached to the cell-wall of biocompatible materials, with contact time and tissue interaction.Oxidant not can be chemically bonded to biocompatible materials.Can percarbonate dry powder be embedded in biocompatible foam, to provide long-acting biological effect by the slow releasing of oxygen.Percarbonate dry powder can be embedded in has in the polymer fiber of non-woven structure, to provide long-acting biological effect by the slow releasing of oxygen.Biocompatible materials can comprise oxidant and medicine, such as, and doxycycline and ascorbic acid.
Biocompatible materials can comprise the oxidant of release and/or the oxidant of slower sustained release fast.Oxidant can by initial elution rates and slower lasting elution rate characterize fast from the eluting of biocompatible materials.When oxidising agent body fluid (such as, water), oxidant can produce oxygen.The example of body fluid can include but not limited to blood, blood plasma, peritoneal fluid, cerebrospinal fluid, urine, lymph fluid, synovial fluid, vitreous humor, saliva, gastrointestinal cavity content and/or bile.Be not subject to the constraint of any concrete theory, oxidant can reduce cell death, enhancing organizational vitality and/or keep the mechanical strength of the tissue-tissue that can damage during cutting and/or stitching.
Biocompatible materials can comprise at least one microgranule and/or nano-particle.Biocompatible materials can comprise in natural material as herein described, non-synthetic materials and synthetic material one or more.Biocompatible materials can comprise and has about 10nm to about 100nm and/or the about 10 μm of granule of average diameter to about 100 μm (such as 45-50nm and/or 45-50 μm).Biocompatible materials can comprise biocompatible foam, and described biocompatible foam comprises embedding at least one microgranule wherein and/or nano-particle.Microgranule and/or nano-particle not can be chemically bonded to biocompatible materials.Microgranule and/or nano-particle can provide the controlled release of medicine.Microgranule and/or nano-particle can comprise at least one medicine.Microgranule and/or nano-particle can comprise such as hemorrhage, antimicrobial and/or oxidant.Tissue thickness's compensating part can comprise biocompatible foam, and described biocompatible foam comprises the hemorrhage containing oxidized regenerated cellulose, the antimicrobial containing doxycycline and/or gentamycin and/or the oxidant containing percarbant.Microgranule and/or nano-particle can provide such as the controlled drug of three days at the most to discharge.
Microgranule and/or nano-particle can be embedded in biocompatible materials during manufacture process.Such as, biocompatible polymer (such as, PGA/PCL) can solvent contact (such as, dioxane) to form mixture.Biocompatible polymer can carry out grinding to form granule.Containing or not containing ORC granule dried particles can contact mixture to form suspension.Can lyophilizing suspension to form biocompatible foam, described biocompatible foam comprises PGA/PCL, and described PGA/PCL has dried particles and/or embeds ORC granule wherein.
Tissue thickness disclosed herein compensating part or layer can be made up of such as absorbable polymer.Tissue thickness's compensating part can be made up of such as following material: foam, film, fiber weaving thing, fiber non-woven thing PGA, PGA/PCL (poly-(glycolic-altogether-caprolactone)), PLA/PCL (poly-(lactic acid-altogether-polycaprolactone)), PLLA/PCL, PGA/TMC (poly-(glycolic-altogether-trimethylene carbonate)), PDS, PEPBO, or other absorbable polyurethane, polyester, Merlon, poe, polyanhydride, polyesteramide, and/or poly-esters of oxyacids.According to the present invention, tissue thickness's compensating part is made up of such as PGA/PLA (poly-(glycolic-altogether-lactic acid)) and/or PDS/PLA (poly-(p-dioxanone-altogether-lactic acid)).According to the present invention, tissue thickness's compensating part can be made up of such as organic material.Tissue thickness's compensating part can be made up of such as carboxymethyl cellulose, sodium alginate, cross-linked-hyaluronic acid and/or oxidized regenerated cellulose.According to the present invention, tissue thickness's compensating part can comprise the durometer in such as 3-7 Xiao A hardness (30-50 Shore OO hardness) scope, and wherein maximum rigidity is 15 Xiao A hardness (65 Shore OO hardness).Can be there is the compression of 40% in tissue thickness's compensating part, the compression of 60% can occur under 6lbf load under 3lbf load, and/or the compression of 80% can occur under 20lbf load.One or more gases (such as, air, nitrogen, carbon dioxide and/or oxygen) can be blasted in tissue thickness's compensating part and/or can be contained in tissue thickness's compensating part.Tissue thickness's compensating part can comprise granule wherein, and described granule can account for about 50% of the material hardness forming tissue thickness's compensating part to being greater than 75%.
According to the present invention, tissue thickness's compensating part can comprise such as hyaluronic acid, nutrient, fibrin, thrombin, is rich in hematoblastic blood plasma, sulfasalazine ( – 5ASA+ sulfapyridine azo bond)) – Qian body Yao Wu – colon bacteria (azo reductase), aminosalicylic acid (having for delaying the 5ASA of different prodrug structures discharged), (5ASA+ acrylic resin-S is coated with – pH>7 (coating dissolution)), (5ASA+ ethyl cellulose coating – time/pH dependent sustained release), (5ASA+ acrylic resin-L is coated with – pH>6), Olsalazine (5ASA+5ASA – colon bacteria (azo reductase)), balsalazide (5ASA+4 amino benzoyl-B-alanine)-colon bacteria (azo reductase)), granular aminosalicylic acid, Lialda (slow release of aminosalicylic acid and SR preparation), HMPL-004 (can forbid TNF-α, Interleukin-1β, with the herbal mixture that core-κ B activates), CCX282-B (interference T lymphocyte is transported to the oral chemokine receptor anagonists in intestinal mucosa), rifaximin (broad ectrum antibiotic of nonabsorable), infliximab, (in the monoclonal antibody of TNF-α, described TNF-α is checked and approved for reducing sign/symptom targeting murine chymieric, keep/the clinical remission of child patient of growing up taking moderate/severe amount phenobarbital, and to the sick fistulation of the Crohn of insufficient reaction conventional therapy), adalimumab, human IgG1's (anti-TNF-alpha monoclonal antibodies-by sign/symptom of checking and approving for reducing Crohn disease and can be used for reducing and keep suffering from the active Crohn of the moderate of insufficient reaction conventional therapy/severe sick or do not tolerate the clinical remission of adult patients of infliximab), Certolizumab pegoll, the anti-TNF FAB ' of peopleization (be linked to the monoclonal antibody fragment of Polyethylene Glycol-by sign/symptom of checking and approving for reducing Crohn disease and can be used for reducing and keep to suffer from the reaction of the adult patients of the moderate/severe disease of insufficient reaction conventional therapy), natalizumab, first non-TNF-alpha inhibitor (by checking and approving the biologic artifact being used for Crohn disease), the monoclonal IgG4 antibody of peopleization (targeting in α-4 integrin-checked and approved for inducing and keeping suffering from moderate/severe disease of there is inflammatory signs and insufficient reaction maybe can not tolerate conventional Crohn treats and the clinical response of patient of TNF-alpha inhibitor and alleviation by FDA), may the concomitant immunity modulator of administration together with infliximab), azathioprine-6-MP (purine synthetic inhibitor-prodrug), (in conjunction with dihydrofolate reduction (DHFR) enzyme, it participates in tetrahydrofolic acid Lipase absobed to methotrexate, suppress all purine synthetics), allopurinol and azathioprine treatment, PPI, the H2 to protect healing line is suppressed for acid, C-Diff – Flagyl, vancomycin (feces transposition process, probiotics, breeding again of normal intracavity flora) and/or the rifaximin (treatment (significantly hepatic encephalopathy) of bacterial overgrowth, not by gastrointestinal absorption and do not act on antibacterial in tube chamber).
As described herein, tissue thickness's compensating part such as can compensate the change of tissue thickness, and described tissue is trapped in the nail of nail bin injection and/or is accommodated in nail line.In other words, some nail in nail line can the thicker of capture tissue divide, and follows closely other nail in line and can the thinner of capture tissue divide.In such cases, tissue thickness's compensating part can present different height or thickness in nail, and compression stress can be applied to the tissue be captured in nail, and organizing of no matter catching is thick or thin.According to the present invention, tissue thickness's compensating part can compensate the change organizing hardness.Such as, some nail in nail line can the high compression part of capture tissue, and follow closely other nail in line can the comparatively low compression part of capture tissue.In such cases, tissue thickness's compensating part such as can present less height catching in the nail had compared with the tissue of little compressible or higher hardness, and accordingly, present larger height catching to have in higher compression ratio or the nail compared with the tissue of soft.Under any circumstance, no matter whether tissue thickness's compensating part such as compensate and organize varied in thickness and/or organize firmness change all to can be described as such as " tissue compensating part " and/or " compensating part ".
Can be namely process apparatus design disclosed in this invention after single uses, or they can be designed to can repeatedly use.But in any one situation, described device all can be repaired, to reuse after using at least one times.Again the combination in any that can comprise the steps is recovered: dismantle this device, then cleaning or substitute some part and assemble subsequently.Particularly, described device can be dismantled, and combination in any optionally can substitute or remove specific component or the part of this device arbitrary number.Cleaning and/or alternative specific part after, this device can re-assembly to use subsequently at restoration facilities place, or is re-assemblied by surgical team before being about to carry out surgical operation.One skilled in the art will appreciate that the reparation of device can utilize the multiple technology for dismantling, cleaning/substitute and re-assembly.The use of these technology and the prosthetic device of gained are all within the scope of the invention.
Preferably, the present invention as herein described will process before the surgery.First, obtain new or with the device crossed, and where necessary device is cleaned.Then device is carried out disinfection.In a kind of disinfection technology, this device is placed in and closes and the container sealed, such as, in plastics or TYVEK bag.Then container and device are placed in the radiation area that can penetrate this container, such as gamma-radiation, x-ray or high energy electron.Antibacterial on device and in container kills by radiation.Then the device after sterilizing is kept in disinfecting container.Apparatus is kept aseptic by sealing container, until open this container in armarium.
With way of reference in full or be partly incorporated to open or other the open material of any patent herein, patent and all only with in existing definition of the present invention, statement or the afoul scope of other open material be not incorporated to herein at be incorporated to material.Thus, under the degree of necessity, the disclosure clearly set forth herein will replace any afoul material be incorporated herein by reference.If according to state be incorporated herein by reference but with existing definition as herein described, statement or the afoul any material of other open material or its part, be incorporated to herein under only not producing the degree of conflict between be incorporated to material and existing open material.
Although by the present invention exemplarily property design be described, in spirit and scope of the present disclosure, other amendment can also be carried out to the present invention.Therefore present patent application is intended to contain any modification, purposes or the adaptive version that adopt its general principles.In addition, present patent application be intended to contain in field belonging to the present invention come from known or used have deviate from pattern of the present disclosure in practical framework.

Claims (19)

1. can be attached to a compensating part for the anvil block of fastening instrument, wherein said anvil block comprises profiled surface, and described compensating part comprises:
The ground floor be made up of the first fiber and the second fiber, wherein said first fiber is made up of the first material and described second fiber is made up of the second material, wherein said first material is different from described second material, and wherein said first fiber and described second fiber are present in described ground floor according to the first ratio;
The second layer be made up of described first fiber and described second fiber, wherein said first fiber and described second fiber are present in the described second layer according to the second ratio, and wherein said first ratio is different from described second ratio; And
The attachment of described anvil block can be attached to.
2. compensating part according to claim 1, wherein said first material comprises oxidized regenerated cellulose, and described second material comprises absorbable polymer.
3. according to compensating part according to claim 1 or claim 2, described first ratio of wherein said first fiber and described second fiber is about 4:1, and described second ratio of wherein said first fiber and described second fiber is about 1:4.
4. according to claim 1 or compensating part according to claim 3, wherein said ground floor comprises tissue contacting surface, and wherein said second material comprises oxidized regenerated cellulose.
5. according to compensating part in any one of the preceding claims wherein, wherein said second fiber is woven in described first fiber in described ground floor, and wherein said first fiber is woven in described second fiber in the described second layer.
6. compensating part according to claim 1, also comprises and is absorbed in described first intrastitial medicine.
7. can be attached to a compensating part for the anvil block of fastening instrument, wherein said anvil block comprises profiled surface, and described compensating part comprises:
Absorbable skin, described absorbable skin comprise be suitable for main during the first stage of agglutination absorbed first medicine;
Absorbable intermediate layer, described absorbable intermediate layer comprise be suitable for main during the second stage of agglutination absorbed second medicine; With
Internal layer, described internal layer comprise be suitable for main during the phase III of agglutination absorbed 3rd medicine.
8. compensating part according to claim 7, wherein said first medicine comprises hemostatic material, and described second medicine comprises antiinflammatory material, and described 3rd medicine comprises collagen-based materials.
9. according to claim 7 or compensating part according to claim 8, wherein said first medicine comprises hemostatic material, and described second medicine comprises antimicrobial material, and described 3rd medicine comprises collagen-based materials.
10. the compensating part according to any one of claim 7-9, wherein at least one intermediate layer comprises the annulate lamella around described internal layer, and wherein said skin comprises the annulate lamella around at least one intermediate layer described.
11. compensating parts according to any one of claim 7-10, wherein said first healing phases is overlapping at least in part with described second healing phases, and wherein said second healing phases is overlapping at least in part with described 3rd healing phases.
12. compensating parts according to claim 11, wherein said first healing phases is partly overlapping with described 3rd healing phases.
13. 1 kinds of methods manufacturing tissue thickness's compensating part, described method comprises:
Obtain the fiber comprising substrate and medicine;
Prepare the solution of first liquid and second liquid;
By described fiber mixing in described solution;
Described solution is poured in mould; And
Solution described in lyophilizing.
14. methods according to claim 13, wherein by utilizing substrate described in described drug coat to obtain described fiber.
15. methods according to claim 13, wherein by extruding described substrate and medicine obtains described fiber simultaneously.
16. methods according to claim 13, wherein obtain described fiber by utilizing described medicine to flood described substrate.
17. methods according to any one of claim 13-16, wherein by described mould is placed in a vacuum chamber, reduce the atmospheric pressure in described vacuum chamber and the temperature reduced in described vacuum chamber carrys out solution described in lyophilizing.
18. methods according to any one of claim 13-17, also comprise the bottom allowing described fiber to be deposited to described mould before solution described in lyophilizing.
19. methods according to any one of claim 13-18, material piece is produced in the described lyophilizing of wherein said solution, and described method also comprises the described material piece of chopping.
CN201380027220.7A 2012-03-28 2013-03-27 The tissue thickness compensation part being made up of multiple material Expired - Fee Related CN104363838B (en)

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US13/433,118 US9414838B2 (en) 2012-03-28 2012-03-28 Tissue thickness compensator comprised of a plurality of materials
PCT/US2013/034081 WO2013148820A2 (en) 2012-03-28 2013-03-27 Tissue thickness compensator comprised of a plurality of materials

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