Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. In the description of the present invention, the terms "first", "second", "third", ". Thus, a feature defined as "first," second, "" third, "". In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
FIG. 1 is a schematic sectional view of a partial structure of a motorized stapler according to the present invention; FIG. 2 is a cross-sectional schematic view of a distal portion of a powered stapler according to the invention; fig. 3 is a schematic cross-sectional view of a proximal portion of a motorized stapler according to the invention.
As shown in fig. 1-3, theelectric stapler 100 of the present invention includes anoperating handle 10, afirst housing 20, asecond housing 40, anelongated shaft 30, anend effector 50, and a driving mechanism 60. The drive mechanism 60 is received in the receiving space formed by thefirst housing 20 and thesecond housing 40, the distal assembly of the drive mechanism 60 is coupled to the proximal side of theelongate shaft 30, and theend effector 50 is coupled to the distal side of theelongate shaft 30. The terms "proximal" and "distal" are defined herein with respect to a clinician manipulating poweredstapler 100, with "proximal" referring to the portion closer to the clinician and "distal" referring to the portion further from the clinician.
Anoperating handle 10 is connected to thefirst housing 20, and theoperating handle 10 includes afiring button 11, and thefiring button 11 can control the driving mechanism to operate, so as to implement the closing and opening operations of thefirst jaw 51 of theend effector 50 of theelectric stapler 100 relative to thesecond jaw 52, and the feeding and retracting operations of thecutting knife 31. Theoperating handle 10 may be formed by injection molding, and in a preferred embodiment, theoperating handle 10 is, for example, a split structure, and along the central axis C of theelongated shaft 30, theoperating handle 10 may include left and right handle portions, which may be respectively formed integrally with thefirst housing 20.
Thefirst housing 20 and thesecond housing 40 are connected to each other, and the far side of thefirst housing 20 is received in the accommodating space of the near side of thesecond housing 40, or the near side section of thesecond housing 40 covers the far side section of thefirst housing 20. In this embodiment, in order to improve the assembling convenience of thefirst casing 20 and thesecond casing 40, along the central axis C of theelongated shaft 30, thefirst casing 20 and thesecond casing 40 respectively include a left casing and a right casing, and the left casing and the right casing can be engaged with each other through a convex pillar and a concave groove, so as to respectively form thefirst casing 20 and thesecond casing 40. In this embodiment, thefirst housing 20 is always stationary;second housing 40 extends asnap 41 towardelongate shaft 30, andsnap 41 and the outer surface ofelongate shaft 30 are secured to one another, thereby providing a secure connection betweensecond housing 40 andelongate shaft 30.Second housing 40 can be rotated about a central axis C ofelongate shaft 30, which rotateselongate shaft 30 and, in turn,end effector 50 distal toelongate shaft 30 about central axis C. That is,second housing 40 is rotatable relative tofirst housing 20 about a central axis C ofelongate shaft 30.
Theelongate shaft 30 includes acutting blade 31, amandrel 32, ablade holder 33 and asleeve 34, wherein the proximal side of thecutting blade 31 is connected to the distal side of themandrel 32, thecutting blade 31 and themandrel 32 are respectively accommodated in theaccommodating cavity 331 of theblade holder 33, and thesleeve 34 is sleeved outside theblade holder 33, or theblade holder 33 is accommodated inside thesleeve 34. Thetool holder 33 is a hollow cylinder structure, thesleeve 34 is another hollow cylinder structure, thesleeve 34 is sleeved outside thetool holder 33, and themandrel 32 and thecutting blade 31, which are connected to each other, are accommodated in theaccommodating cavity 331 of thetool holder 33. The proximal section of theelongate shaft 30 is accommodated in thesecond housing 40, or the distal section of thesecond housing 40 is combined to the proximal side of thesleeve 34, so that the proximal portion of thesleeve 34 is accommodated in the accommodating space of thesecond housing 40, wherein theengaging member 41 extending from thesecond housing 40 is combined to the outer surface of theelongate shaft 30, i.e. the outer surface of thesleeve 34, so that when thesecond housing 40 rotates around the central axis C of theelongate shaft 30, thesecond housing 40 drives theelongate shaft 30 to rotate around the central axis C together, so as to change the position of theend effector 50.
Anend effector 50 is disposed adjacent the distal sleeve side of thesleeve 34, theend effector 50 including afirst jaw 51 and asecond jaw 52 pivotally coupled to each other, thesecond jaw 52 having a cartridge assembly disposed therein, staples exiting the cartridge assembly being formed by thefirst jaw 51 to staple tissue. Thecannula 34 has a cannula distal end movably connected to thefirst jaw 51. Upon operation of thefiring button 11, the drive mechanism acts to push thesleeve 34 in the direction of the central axis C toward theend effector 50, which causes the sleeve of thesleeve 34 to pivot thefirst jaw 51 distally toward thesecond jaw 52 to close on thesecond jaw 52. The connection structure and the actuation manner between theend effector 50 and thesleeve 34 are disclosed in the prior art, and reference may be made to the related description in the prior art. In order to improve the support capability of thetool holder 33 on themandrel 32, aprojection 332 is arranged in the receivingcavity 331 of thetool holder 33, and theprojection 332 extends from the inner side of thetool holder 33 towards themandrel 32, contacts themandrel 32 and provides a support force for themandrel 32. When themandrel 32 slides in the receivingcavity 331, theprotrusion 332 can provide a supporting force to prevent themandrel 32 from shaking.
Compared with the existing electric anastomat, theelectric anastomat 100 provided by the invention can realize automatic closing operation, feed cutting and withdrawal operation only through the driving mechanism.
Specifically, fig. 4 is a sectional view schematically showing a driving mechanism of an electric stapler according to the present invention, fig. 5 is a sectional view schematically showing a screw of the electric stapler according to the present invention, and fig. 6 is a partial structure schematically showing the screw of the electric stapler according to the present invention.
As shown in FIGS. 1-6, the driving mechanism 60 includes a main threaded sleeve 61, an outer threaded sleeve 62 and a threaded rod 63, the proximal side of the main threaded sleeve 61 is fixedly connected to a driving motor 80, the driving motor 80 is electrically connected to the firing button 11, and the driving motor 80 can drive the main threaded sleeve 61 to rotate around the central axis C. The main threaded sleeve 61 is a hollow tube body, the hollow tube body includes a cavity 611, the screw 63 is inserted into the cavity 611, a first internal thread 613 is disposed on an inner wall 612 of the hollow tube body, the first internal thread 613 is disposed on the entire inner wall 612 of the hollow tube body, and the inner wall 612 surrounds the cavity 611; the hollow tubular body further comprises an outer wall 614 opposite the inner wall 612, the outer wall 614 is provided with a first external thread 615 and a groove 616, the first external thread 615 and the groove 616 are respectively close to the far side of the hollow tubular body, the first external thread 615 is adjacent to the groove 616, the groove 616 is positioned between the end of the far side of the hollow tubular body and the first external thread 615, the first external thread 615 is only arranged on a part of the outer wall 614, the first external thread 615 has a first length L1, and the second length L2 of the groove 616 of the first length L1 is approximately equal. Wherein the first length L1 extends in a direction parallel to the direction of the central axis C; the second length L2 also extends in a direction parallel to the direction of the central axis C. A bearing 90 is disposed between the main threadedsleeve 61 and thefirst housing 20 for supporting thefirst housing 20, and thebearing 90 may be located near a proximal side of the outer threadedsleeve 62. In the present invention, the central axis C of theelongated shaft 30 is coaxial with the central axis of the hollow tube, that is, the central axis C of the elongated shaft is also the central axis of the hollow tube (or the main screw sleeve 61). In this embodiment, the firstinternal threads 613 are disposed on the entireinner wall 612, but not limited thereto. In other embodiments of the present invention, the firstinternal thread 613 may also be disposed on the partialinner wall 612, wherein when the firstinternal thread 613 is disposed on the partialinner wall 612, the length of the firstinternal thread 613 along the central axis C is equal to or greater than the minimum distance required for thescrew 63 to move in thecavity 611 so that thecutting blade 31 can complete the cutting and anastomosis operation, and the minimum distance can be regarded as the sum of the moving distance of thecutting blade 31 from the initial position to the farthest end of theend effector 50 and the first length L1.
Theouter sleeve 62 is disposed on the distal side of themain sleeve 61, a secondinternal thread 621 is disposed on the inner surface of theouter sleeve 62, the secondinternal thread 621 corresponds to the firstexternal thread 615, when the driving mechanism 60 is in the initial state, theouter sleeve 62 is coupled to the distal side of themain sleeve 61, and the secondinternal thread 621 and the firstexternal thread 615 are engaged with each other.
Fig. 10 is a schematic view showing the structure of an outer sheath of a driving mechanism of the electric stapler according to the present invention.
As shown in fig. 1, 3 and 10, theouter sleeve 62 is fitted to thefirst housing 20, arecess 622 is provided on the outer surface of theouter sleeve 62, aboss 21 is provided on thefirst housing 20 corresponding to therecess 622, theboss 21 falls into therecess 622 after theouter sleeve 62 and thefirst housing 20 are assembled with each other, theboss 21 is close to afirst wall 6221 of therecess 622 in an initial state, and thefirst wall 6221 is close to the distal side of theouter sleeve 62. When theouter sleeve 62 is moved in the direction of the central axis C, theboss 21 can slide in therecess 622. Wherein therecess 622 has a first width W1, the first width W1 extending in a direction parallel to the central axis C; theboss 21 has a second width W2, the second width W2 extending in a direction parallel to the central axis C. In order that the proximal side of theboss 21 does not protrude from the proximal side of therecess 622 such that theboss 21 is entirely located in therecess 622 thereby ensuring a limited rotational action of theboss 21 on therecess 622, the first width W1 is greater than the sum of the first length L1 of the firstexternal thread 615 and the second width W2 of theboss 21. In this embodiment, theconcave portion 622 is formed by, for example, milling the outer surface of theouter sleeve 62, the second wall of theconcave portion 622 opposite to thefirst wall 6221 is removed to form ahollow portion 6222, thehollow portion 6222 is located at the proximal side of theouter sleeve 62, and thehollow portion 6222 makes theconcave portion 622 an open type groove, and the open type groove is, for example, a rectangular groove, but not limited thereto.
In the present invention, theboss 21 of thefirst housing 20 is inserted into therecess 622 of theouter nut 62, after the driving mechanism 60 is started, themain nut 61 rotates around the central axis C, theboss 21 and therecess 622 are matched to restrict and limit the rotation of theouter nut 62 around the central axis C, that is, theboss 21 and therecess 622 are designed to restrict and limit the rotation of theouter nut 62 around the central axis C, thereby ensuring that theouter nut 62 can only move linearly along the central axis C under the action of themain nut 61.
Fig. 11 is a schematic view showing the structure of an outer screw sheath of a driving mechanism of an electric stapler according to another embodiment of the present invention.
As shown in fig. 3 and 11, the outer surface of the outer sleeve 62 'is provided with a recess 622', and the recess 622 'may be a closed groove (relative to the above open groove having a hollow portion) formed by milling the outer surface of the outer sleeve 62', the closed groove having a first width W1 ', and the extending direction of the first width W1' is parallel to the central axis C. After the outer thread 62 ' and thefirst housing 20 are assembled with each other, theboss 21 falls into the recess 622 ', and in the initial state, theboss 21 is close to the first wall 6221 ' of the recess 622 ', and the first wall 6221 ' is close to the distal side of theouter thread 62. Theboss 21 is slidable in the recess 622 'when the outer sleeve 62' is moved along the central axis C. In order that the proximal side of theboss 21 does not abut against thesecond wall 6223 of the recess 622 ' when sliding, avoiding the limitation of the sliding of theboss 21, the first width W1 ' of the recess 622 ' is greater than the sum of the first length L1 of the firstexternal thread 615 and the second width W2 of theboss 21. In this embodiment, the recess 622 ' includes asecond wall 6223 opposite the first wall 6221 ', the first wall 6221 ' being proximal to the distal side of the outer sleeve 62 ' and thesecond wall 6223 being proximal to the proximal side of the outer sleeve 62 '. The concave portion 622 'and theconvex portion 21 cooperate to restrict and limit the rotation of theouter sleeve 62 around the central axis C, that is, theconvex portion 21 and the concave portion 622' are designed to restrict and limit the rotation of the outer sleeve 62 'around the central axis C, so as to ensure that the outer sleeve 62' can only move linearly along the central axis C under the action of themain sleeve 61.
With continued reference to fig. 4 and 5, thescrew 63 includes a screwproximal end 631, a screwmain body 632, and a screwdistal end 633, which are connected in sequence, and the screwproximal end 631 and the screwdistal end 633 are respectively connected to two opposite ends of the screwmain body 632, wherein the screwproximal end 631 is located at a proximal side of thescrew 63, and the screwdistal end 633 is located at a distal side of thescrew 63. Theproximal end 631 of the screw has a secondexternal thread 6311, and the secondexternal thread 6311 is engaged with the firstinternal thread 612, so that thescrew 63 is engaged with themain nut 61. Theproximal end 631 of the screw is, for example, a cylinder, and the annular outer surface of the cylinder is provided with a secondexternal thread 6311. The connection among the screwproximal end 631, the screwmain body 632 and the screwdistal end 633 comprises an integral molding or a fixed connection.
Thescrew body 632 and the screwdistal end 633 respectively have smooth outer surfaces, that is, no thread structure is disposed on thescrew body 632 and the screwdistal end 633, and the radial width of thescrew body 632 and the radial width of the screwdistal end 633 are respectively smaller than the radial width of the screwproximal end 631, so that thescrew body 632 and the screwdistal end 633 are suspended in thecavity 611, the outer surfaces of thescrew body 632 and the screwdistal end 633 are prevented from contacting the firstinternal thread 612, friction between thescrew body 632 and the screwdistal end 633 and themain barrel 61 can be reduced, and thescrew 63 can move linearly in theinner cavity 611 of themain barrel 61.
In this embodiment, when the driving mechanism 60 is in an operating state, the drivingmotor 80 drives themain screw sleeve 61 to rotate around the central axis C, themain screw sleeve 61 is fixedly connected with the drivingmotor 80, thebearing 90 is arranged between themain screw sleeve 61 and thefirst housing 20, and the drivingmotor 80 is fixed in thefirst housing 20, so that themain screw sleeve 61 performs a rotational motion around the central axis C after the drivingmotor 80 is started. When themain screw sleeve 61 performs a rotational movement, due to the mutual engagement between the firstinternal thread 612 of themain screw sleeve 61 and the secondexternal thread 6311 on the screwproximal end 631 of thescrew 63, the screwproximal end 631 is screwed forward or backward along the central axis C in thechamber 611 toward the distal side of themain screw sleeve 61 or toward the proximal side of themain screw sleeve 61 by the constraint of the pushingframe 70 on the screw distal end 633 (the constraint of the pushingframe 70 on the screwdistal end 633 will be further described below), that is, thescrew 63 can be screwed forward or backward in thechamber 611 along the direction of the central axis C under the action of themain screw sleeve 61; in the process of screwing in or screwing out thescrew 63, thescrew 63 always moves linearly.
As shown in fig. 4 to 6 and 12, the screwdistal end 633 includes anopening 635 and a slidinggroove 634, theopening 635 and the slidinggroove 634 are communicated with each other, themandrel 32 includes a proximal end 321 (shown in fig. 12) and a stopper 322 (shown in fig. 12), theproximal end 321 and thestopper 322 can be received in the slidinggroove 634 across theopening 635, theopening 635 has a first width S1, the slidinggroove 634 has a second width S2, an extending direction of the first width S1 is perpendicular to a direction of the central axis C, and an extending direction of the second width S2 is perpendicular to the direction of the central axis C; the first width S1 is smaller than the second width S2, so that theopening 635 and the slidinggroove 634 form a narrow front and wide rear channel. Wherein, the stopping portion 322 is disposed on the proximal end portion 321, the stopping portion 322 has a third width S3, the extending direction of the third width S3 is perpendicular to the direction of the central axis C, the third width S3 is greater than the first width S1 and smaller than the second width S2, the opening 635 has a first width S1 greater than the outer dimension of the proximal end portion 321, therefore, when the proximal side of the mandrel 32 is combined with the distal end 633 of the screw, the stopping portion 322 is located in the sliding groove 634, and since the third width S3 of the stopping portion 322 is greater than the first width S1 of the opening 635 and smaller than the second width S2 of the sliding groove 634, the stopping portion 322 on the proximal end portion 321 of the mandrel 32 cannot be separated from the sliding groove 634, thereby enabling the mandrel 32 to be reliably connected with the distal end 633 of the screw, and when the stopping portion 322 is located in the sliding groove 634, when the driving mechanism 60 is in the initial state, the stopping portion 322 is located at a distance, the distance is set such that the sliding groove 634 can slide relative to the stopping portion 322 when the driving mechanism 60 is switched from the initial state to the first working state. Theproximal end 321 of thecore shaft 32 is the end of thecore shaft 32 close to the doctor.
With continued reference to fig. 4-6, in the present embodiment, themandrel 32 is substantially cylindrical in configuration, and theopening 635 at thedistal end 633 of the screw is circular; the shape of the stoppingportion 322 on theproximal end 321 of thecore shaft 33 is matched with the slidinggroove 634 on the screwdistal end 633 of thescrew 63, including but not limited to, the stoppingportion 322 is a cylindrical stopping block, and the slidinggroove 634 is a cylindrical sliding groove; alternatively, the stoppingportion 322 is a rectangular parallelepiped stopping block, and the slidinggroove 634 is a rectangular parallelepiped sliding groove. In order to facilitate the assembly of themandrel 32 and the screwdistal end 633, the screwdistal end 633 further includes afirst notch 6341 and asecond notch 6351, and thefirst notch 6341 and the slidinggroove 634 are communicated with each other, so that the slidinggroove 634 is an open sliding groove; thesecond gap 6351 is in communication with theopening 635, such that theopening 635 is an open opening. Theproximal end 321 of themandrel 32 enters the slidinggroove 634 through thefirst notch 6341, enters theopening 635 through thesecond notch 6351, and thestopper 322 enters the slidinggroove 634 through thefirst notch 6341. Thefirst notch 6341 has a fourth width S4, the extending direction of the fourth width S4 is perpendicular to the direction of the central axis C, and the fourth width S4 is slightly larger than the third width S3. In addition, the screwdistal end 633 is further provided with areset bump 636, and thereset bump 636 acts on the pushingframe 70.
As shown in fig. 5, thechute 634 has a first and a secondopposing slot wall 6342, 6343, thesecond slot wall 6343 is adjacent to theopening 635, theopening 635 extends through thesecond slot wall 6343 such that theopening 635 and thechute 634 are in communication, wherein thestop portion 322 on theproximal end 321 of thespindle 32 is located distal to thechute 634 when the driving mechanism 60 is in the initial state shown in fig. 4, i.e., thestop portion 322 is now adjacent to thesecond slot wall 6343. In this embodiment, the distance between thefirst groove wall 6342 and thesecond groove wall 6343 of the slidinggroove 634 is a third length L3, and the third length L3 is equal to the sum of the first length L1 and the height of the stoppingportion 322, i.e., when the driving mechanism 60 is in the initial state shown in fig. 4, the distance between the proximal surface of the stoppingportion 322 and thefirst groove wall 6342 is the "idle stroke" of the slidinggroove 634. The height of thestopper portion 322 refers to its dimension in the direction of the central axis C. When the driving mechanism 60 enters the first working state shown in fig. 9A from the initial state, theouter sleeve 62 moves relative to themain sleeve 61 by a distance equal to the distance thescrew 63 moves in thecavity 611 of themain sleeve 61 in the direction of the central axis C, and the distances are equal to the first length L1 and the third length L3 minus the height of thestopper 322. When the driving mechanism 60 is switched from the initial state to the first working state, thescrew 63 moves linearly in thecavity 611 along the central axis C, and the slidinggroove 634 moves relative to the stoppingportion 322, that is, thefirst groove wall 6342 of the slidinggroove 634 gradually approaches the stoppingportion 322 and abuts against the stoppingportion 322, at this time, the stoppingportion 322 is not displaced by the first groove wall 6342 (or the screw 63), that is, themandrel 32 is in an unfired state.
Fig. 7A and 7B are schematic structural views of a pushing frame of the electric stapler according to the present invention.
As shown in fig. 4 and fig. 6 to 7B, a pushingframe 70 is disposed at the distal side of the driving mechanism 60 of theelectric stapler 100 according to the present invention, the distal side of the pushingframe 70 is coupled to thesleeve 34 of theelongated shaft 30, and the proximal side of the pushingframe 70 is coupled to the screwdistal end 633 of thescrew 63. In order to improve the assembly convenience of the pushingframe 70, the pushingframe 70 is a split structure, and includes a first pushingframe 70a and a second pushingframe 70b, and the first pushingframe 70a and the second pushingframe 70b have the same structure.
As shown in fig. 7A and 7B, the first pushingframe 70a has afirst edge 751 and asecond edge 761, thefirst edge 751 is parallel to and opposite to thesecond edge 761, two opposite ends of thefirst edge 751 are respectively connected to the first end of thefirst sidewall 711 and the second end of thesecond sidewall 721, two opposite ends of thesecond edge 761 are respectively connected to the third end of thefirst sidewall 711 and the fourth end of thesecond sidewall 721, wherein the first end is opposite to the third end, and the second end is opposite to the fourth end. Thefirst edge 751 is provided with a first engagingpost 75, and thesecond edge 761 is provided with a firstengaging hole 76. Similarly, the second engagingpost 78 is provided on thefirst side portion 751, the secondengaging hole 77 is provided on thesecond side portion 761 of thesecond push frame 70b, and when thesecond push frame 70b is rotated 180 degrees around the central axis C, the secondengaging hole 77 corresponds to the first engagingpost 75, and the second engagingpost 78 corresponds to the firstengaging hole 76. The first engagingpost 75 is engaged with the secondengaging hole 77, and the second engagingpost 78 is engaged with the firstengaging hole 76, so that the first pushingframe 70a and the second pushingframe 70b are combined to form the pushingframe 70. The connection comprises fixed connection and integral forming.
As shown in fig. 7A and 8, the first pushingframe 70a includes afirst side wall 711 and asecond side wall 721, thefirst side wall 711 is located on the far side of the first pushingframe 70a, thesecond side wall 721 is located on the near side of the first pushingframe 70a, and thefirst side wall 711 is parallel to and opposite to thesecond side wall 721. Thefirst side wall 711 is provided with a first combiningportion 71, and when the distal side of the pushingframe 70 is connected to thesleeve 34, the first combiningportion 71 is combined in the recessedstructure 341 of thesleeve 34, and the recessedstructure 341 is located at the proximal side of thesleeve 34. As can be seen from fig. 2, thesecond side wall 721 is provided with a second combiningportion 72, the screwdistal end 633 enters the interior of the first pushingframe 70a (or the interior of the pushing frame 70) from the second combiningportion 72, and the second combiningportion 72 is combined with the screwmain body 632, preferably, the second combiningportion 72 is combined with the screwmain body 632 at a position adjacent to the screwdistal end 633. Wherein the screwdistal end 633 passes the second joint 72 and enters the interior of the first pushingframe 70a, and the reset bump 636 (shown in fig. 6) on the screwdistal end 633 abuts against theinner side 7211 of thesecond side wall 721; alternatively, the screwdistal end 633 enters the interior of the pushingframe 70 formed by the first pushingframe 70a and the second pushingframe 70b, and the reset protrusion 636 (shown in fig. 6) on the screwdistal end 633 abuts against theinner side 7211 of thesecond side wall 721 of the first pushingframe 70a and the second pushingframe 70b at the same time.
In addition, the present invention restricts thescrew 63 from rotating around the central axis C by the cooperation between the pushingframe 70 and the screwdistal end 633, and to achieve this purpose, the second combiningportion 72 on thesecond side wall 721 includes an arc-shapedbottom 724, a first limitingplane 722 and a second limitingplane 723, and the first limitingplane 722 and the second limitingplane 723 are respectively disposed at two opposite ends of the arc-shapedbottom 724, so that the arc-shapedbottom 724, the first limitingplane 722 and the second limitingplane 723 form a U-shaped structure, that is, the second combiningportion 72 is U-shaped. When thesecond coupling portion 72 is coupled to the screwdistal end 633, the first limitingplane 722 is located above the central axis C, the second limitingplane 723 is located below the central axis C, and thescrew body 632 is located between the first limitingplane 722 and the second limitingplane 723. In addition, the first pushingframe 70a further includes athird sidewall 731, thethird sidewall 731 is located between thefirst sidewall 711 and thesecond sidewall 721, and thethird sidewall 731 is disposed adjacent to thefirst sidewall 711, thethird sidewall 731 has a third combiningportion 73, a receivingportion 74 is located between thethird sidewall 731 and thefirst sidewall 711, the receivingportion 74 corresponds to theproximal end section 342 of the sleeve 34 (as shown in fig. 8), and theend section 342 is located between the recessedstructure 341 and theproximal end 343 of thesleeve 34. The third engagingportion 73 is configured to receive theblade holder 33, and theblade holder 33 is slidable in the third engagingportion 73. In this embodiment, the second pushing frame 70B shown in fig. 7B has the same structure as the first pushingframe 70a shown in fig. 7A, and elements having the same reference numerals in fig. 7B have the same functions as those in fig. 7A, and are not repeated herein.
With continued reference to fig. 7A to 8, when the push frame 70 (shown in fig. 2) is assembled with thesleeve 34, first, thefirst push frame 70a is assembled to one side of thesleeve 34, the first combiningportion 71 of thefirst push frame 70a is combined with the partially recessedstructure 341, theend section 342 partially enters theaccommodating portion 74, and the partiallyproximal end 343 abuts against thefirst surface 732 of thethird side wall 731; continuing, thesecond push frame 70b is assembled to the opposite side of thesleeve 34, the first combiningportion 71 of thesecond push frame 70b is combined with the partialconcave structure 341, theend section 342 enters theaccommodating portion 74 of thesecond push frame 70b partially, and theproximal end 343 of the rest portion abuts against thefirst surface 732 of thethird side wall 731 of thesecond push frame 70 b. The first engagingpost 75 of the first pushingframe 70a enters the secondengaging hole 77 of the second pushingframe 70b, the firstengaging hole 76 of the first pushingframe 70a is combined with the second engagingpost 78 of the second pushingframe 70b, that is, the second pushingframe 70b and the first pushingframe 70a form the pushingframe 70, and the pushingframe 70 is assembled to thesleeve 34.
As shown in fig. 2-4 and 6, the distal side of the pushingframe 70 is assembled to thesleeve 34, and the proximal side of the pushingframe 70 is assembled to thescrew body 632 adjacent to thedistal end 633 of the screw. The second combiningportion 72 of the first pushingframe 70a and the second combiningportion 72 of the second pushingframe 70b form an annular hole, the screwdistal end 633 passes through the annular hole and enters the inside of the first pushingframe 70a and the second pushingframe 70b (or the inside of the pushing frame 70), and thereset bump 636 on the screwdistal end 633 abuts against theinner side 7211 of thesecond side wall 721. In order to restrict and limit the rotation of thescrew 63 in the process of screwing in or screwing out thecavity 611 of themain screw sleeve 61, thescrew body 632 is provided with a firstflat part 6321 and a secondflat part 6322 which are opposite, the firstflat part 6321 and the secondflat part 6322 are distributed above and below the central axis C, wherein the firstflat part 6321 is in contact with thefirst limit plane 722 on the second combiningpart 72, and the secondflat part 6322 is in contact with thesecond limit plane 723 on the second combiningpart 72. When thescrew 63 is screwed in or out of thecavity 611, thescrew 63 can only move linearly along the central axis C and cannot rotate around the central axis C due to the mutual restriction between thefirst plane 6321 and thefirst limit plane 722 and between thesecond plane 6322 and thesecond limit plane 723.
In order to more accurately understand the driving process of the driving mechanism of the present invention, the initial state, the first operating state, and the second operating state of the driving mechanism 60 will be described in detail with reference to fig. 2, 4, 9A, and 9B.
FIG. 9A is a schematic cross-sectional view of a driving mechanism of the electric stapler according to the present invention in a first working condition; fig. 9B is a schematic cross-sectional view of the driving mechanism of the electric stapler according to the present invention in a second working condition.
As shown in fig. 2 and 4, themain screw sleeve 61 is fixedly connected to the drivingmotor 80, and the drivingmotor 80 is fixed in thefirst housing 20. When the driving mechanism 60 is in the initial state, the outer thread sleeve 62 is coupled to the distal side of the main thread sleeve 61, the second internal thread 621 of the outer thread sleeve 62 is engaged with the first external thread 615 of the main thread sleeve 63, and the boss 21 of the first housing 20 is fitted into the recess 622 of the outer thread sleeve 62; the screw 63 is positioned in the cavity 611 of the main nut 61, and the second external threads 6311 on the proximal end 631 of the screw engage the first internal threads 612 of the main nut 61; preferably, screw proximal end 631 is engaged to the proximal side of chamber 611 near operating handle 10 (shown in FIG. 1); the distal end 633 of the screw is connected to the proximal end 321 of the spindle 32, the stop portion 322 on the proximal end 321 of the spindle 32 is received in the sliding groove 634 of the distal end 633 of the screw, and the stop portion 322 is close to the second groove wall 6343 of the sliding groove 634 (as shown in fig. 5); the distal side of push frame 70 is connected to the proximal side of sleeve 34, and the proximal side of push frame 70 is connected to the distal side of screw body 632; the pushing frame 70 is fixedly connected with the outer sleeve 62, and the pushing frame and the outer sleeve can be fixedly connected through screw locking or welding.
When the driving mechanism 60 is in the first working state, theelectric stapler 100 correspondingly performs the operation that the pushingframe 70 pushes thesleeve 34 to move toward theend effector 50 along the central axis C, so as to drive thefirst jaw 51 of theend effector 50 to pivot relative to thesecond jaw 52, so that thefirst jaw 51 is closed on thesecond jaw 52; that is, when theelectric stapler 100 is in the first working state, theend effector 50 performs the closing operation. Wherein, after theend effector 50 performs the closing operation, the drivingmotor 80 automatically stops working, and when the driving mechanism 60 needs to enter the second working state from the first working state, thefiring button 11 of the operating handle 10 needs to be fired again to restart the drivingmotor 80. When the driving mechanism 60 is in the second working state, theelectric stapler 100 correspondingly performs the operation that thescrew 63 pushes themandrel 32 to move along the central axis C toward theend effector 50, and themandrel 32 pushes the cuttingknife 31 to enter the cartridge assembly of theend effector 50, so as to perform the cutting and stapling operation; that is, when theelectric stapler 100 is in the second working state, the cutting and stapling operation is performed.
Wherein, the driving motor is in a first working state, thefiring button 11 in thefiring operation handle 10 and electrically connected to the drivingmotor 80 is started, so that the main threadedsleeve 61 rotates around the central axis C along a first direction, since the drivingmotor 80 is fixed in thesecond housing 20 and the main threadedsleeve 61 is fixedly connected with the drivingmotor 80, abearing 90 is arranged between the main threadedsleeve 61 and thesecond housing 20, so that the main threadedsleeve 61 only rotates around the central axis C along the first direction; themain nut 61 rotates in a first direction around the central axis C, and theouter nut 62 and thescrew 63 are simultaneously driven and move toward theend effector 50 along the direction of the central axis C by the restriction of thefirst housing 20 to the rotation of theouter nut 62 and the restriction of thepush bracket 70 to the rotation of thescrew body 632.
For the purpose of clearly illustrating the moving processes of theouter screw 62 and thescrew 63 in the driving mechanism 60, the present invention will be described below with reference to the accompanying drawings, wherein theouter screw 62 and thescrew 63 move separately, but it should be understood that in the first operating state, theouter screw 62 and thescrew 63 move simultaneously.
As shown in FIGS. 4 and 9A, thefiring button 11, such as by pulling thefiring button 11 toward the operatinghandle 10, rotates themain nut 61 in a first direction about the central axis C for theouter nut 62, rotates the firstexternal thread 615 on theouter wall 614 of themain nut 61 in the first direction about the central axis C, and restricts and limits the rotation of theouter nut 62 about the central axis C by the engagement of therecess 622 on the outer surface of theouter nut 62 with theboss 21 of thefirst housing 20, such that the secondinternal thread 621 engaged with the firstexternal thread 615 moves linearly, and such that theouter nut 62 moves linearly relative to themain nut 61 along the central axis C toward theend effector 50, until the firstexternal thread 615 and the secondinternal thread 621 move linearly from the engaged state shown in FIG. 4 to the disengaged state shown in FIG. 9A. At this time, the secondinternal thread 621 enters therecess 616, the secondinternal thread 621 hangs up in therecess 616, and the secondinternal thread 621 does not contact with the bottom of therecess 616. Therecess 616 is not provided with a thread structure, and theouter sleeve 62 stops moving linearly along the center axis C due to the lack of the thread structure engaged with the secondinternal thread 621 and the transition of the firstexternal thread 615 and the secondinternal thread 621 from the engaged state to the disengaged state. During the above-mentioned movement of theouter sleeve 62, theouter sleeve 62 pushes thepush frame 70 fixedly connected thereto to move linearly along the central axis C toward theend effector 50, the first engagingportion 71 inside thepush frame 70 acts on the recessedstructure 341 of thesleeve 34, and thefirst surface 732 of thethird side wall 731 acts on theproximal end 343 of thesleeve 34, so that thepush frame 70 can push thesleeve 34 to move along the central axis C toward theend effector 50, the end of thesleeve 34 at the far side pushes against thefirst jaw 51 of theend effector 50, so that thefirst jaw 51 pivots relative to thesecond jaw 52, and thefirst jaw 51 is closed on thesecond jaw 52. In this embodiment, when theouter sheath 62 moves from the first position P1 to the second position P2, thesleeve 34 is pushed by the pushingframe 70 fixedly connected thereto so that theend effector 50 performs a closing operation, and the first position P1 is defined as a position where theouter sheath 62 is located when the firstexternal thread 615 is fully engaged with the secondinternal thread 621; the second position P2 is defined as the position of theouter sleeve 62 when the secondinternal thread 621 is completely dropped into therecess 616, i.e. the firstexternal thread 615 is separated from the secondinternal thread 621.
With continued reference to fig. 4 and 9A, for thescrew 63, during the process that themain screw 61 rotates in the first direction to drive theouter screw 62 to move from the first position P1 to the second position P2, thescrew 63 disposed in thecavity 611 of themain screw 61 simultaneously moves from the third position P3 to the fourth position P4, which defines the third position P3 as the position of the screwproximal end 631 of thescrew 63 in the initial state of the driving mechanism 60; the fourth position P4 is defined as the position of theproximal end 631 of thescrew 63 when the driving mechanism 60 is in the first working state. In detail, the firstinternal thread 613 on theinner wall 612 of themain screw sleeve 61 rotates in the first direction, and the rotation of thescrew 63 around the central axis C is restricted and limited by the first and second limit planes 722 and 723 of thesecond coupling portion 72 of thepush bracket 70 and the first andsecond plane portions 6321 and 6322 of thescrew body 632, respectively, so that the screwproximal end 631 of thescrew 63 having the secondexternal thread 6311 engaged with the firstinternal thread 613 moves linearly along the central axis C toward theend effector 50, that is, thescrew 63 moves linearly along the central axis C toward the end effector relative to themain screw sleeve 61. In this embodiment, in the first working state of the driving mechanism 60, the screwproximal end 631 is located in thecavity 611 of themain nut 61, and the screwproximal end 631 moves from the third position P3 to the fourth position P4, wherein the distance that the screwproximal end 631 moves from the third position P3 to the fourth position P4 relative to themain nut 61 is equal to the distance that theouter nut 62 moves from the first position P1 to the second position P2 relative to themain nut 61. This is because the pitches of the firstinternal thread 612, the firstexternal thread 615, the secondinternal thread 621, and the secondexternal thread 6311 are the same.
It should be noted that, after the screwproximal end 631 moves from the third position P3 to the fourth position P4, the corresponding screwdistal end 633 also moves by the same distance, at this time, the first groove wall 6342 (as shown in fig. 5) of the slidinggroove 634 of the screwdistal end 633 abuts against thestop portion 322 on the spindledistal end 321 of thespindle 32, and thestop portion 322 is not displaced by thefirst groove wall 6342, and thespindle 32 is not fired when the driving mechanism 60 is in the first working state. In the first operating state, the sliding stroke of the slidinggroove 634 relative to thestopper 322 may be regarded as an "idle stroke", that is, after the driving mechanism 60 enters the first operating state from the initial state, thescrew 63 is driven by themain screw 61 to move linearly along the central axis C toward theend effector 50, and in the process of this linear movement, only thescrew 63 itself moves, and thescrew 63 does not displace thespindle 32, so the process of the above movement of thescrew 63 is referred to as an "idle stroke" of thescrew 63.
In addition, theelectric stapler 100 of the present invention further includes a conversion stopper (not shown). The conversion limiter is electrically connected to the drivingmotor 80, and meanwhile, the conversion limiter is electrically connected to thetrigger button 11 or a conversion button (not shown), and the conversion limiter can be triggered by thetrigger button 11 or the conversion button. The switching limiter is used for controlling the drivingmotor 80 to rotate reversely, so that themain thread insert 61 rotates around the central axis C along a second direction, and the second direction is opposite to the first direction.
Specifically, before the present powered stapler 100 enters into a cutting operation, if an operator needs to open the first and second jaws 51 and 52 which are closed to each other, the firing button 11 is pushed in a reverse direction, for example, toward the end effector 50 to trigger a switching limiter which controls the driving motor 80 to rotate in a reverse direction, the main screw 61 rotates in a second direction around the central axis C, unlike the first working state in which the outer screw 62 and the screw 63 are simultaneously driven to move linearly along the central axis C, and at this time, since the second outer thread 6311 of the proximal screw 631 is engaged with the first inner thread 613 of the main screw 61, the proximal screw 631 is first driven to move linearly from the fourth position P4 toward the third position P3 by the main screw 61 rotating in the second direction, or the screw 63 is first driven to move linearly along the central axis C toward the operating handle 10 by the main screw 61 rotating in the second direction Moving; while the outer sleeve 62 is in the second position P2, the second internal thread 621 of the outer sleeve 62 is disengaged from and does not engage the first external thread 615 of the main sleeve 61, and therefore, the outer sleeve 62 cannot be driven from the second position P2 toward the first position P1 by the main sleeve 61 rotating in the second direction. In this embodiment, the rotation of thescrew 63 around the central axis C is also restricted by the first and second limit planes 722 and 723 of thesecond coupling portion 72 of the pushingframe 70 respectively cooperating with the first andsecond plane portions 6321 and 6322 of thescrew body 632.
As can be seen from fig. 4 and fig. 9A, in the driving mechanism 60 of the present invention, the screwdistal end 633 of thescrew 63 is provided with thereset protrusion 636, and when the driving mechanism 60 is in the initial state and the first working state, thereset protrusion 636 always abuts against theinner side 7211 of thesecond side wall 721 of the pushingframe 70. To allow theouter sleeve 62 to return from the second position P2 to the first position P1, the screwdistal end 633 moves in response to the movement of the screwproximal end 631, at which time thereturn projection 636 pushes against theinner side 7211 of thesecond side wall 721 of thepush bracket 70, causing thepush bracket 70 to move in the direction of the operating handle 10 (as shown in fig. 1), thepush bracket 70 further pushes theouter sleeve 62 fixedly connected thereto to move, and theouter sleeve 62 is pushed such that the secondinternal thread 621 re-engages with the firstexternal thread 615 on themain sleeve 61. After the secondinternal thread 621 is re-engaged with the firstexternal thread 615 of themain nut 61, theouter nut 62 is driven by themain nut 61 to move linearly along the central axis C from the second position P2 toward the first position P1, i.e., theouter nut 62 is driven to move from the second position P2 toward the first position P1 by rotating themain nut 61 in the second direction, and the pushingframe 70 moves together with theouter nut 62 toward the operating handle 10 (shown in fig. 1), at this time, the pushingframe 70 moves thesleeve 34 toward the operating handle 10 (shown in fig. 1), so that thesleeve 34 pivots thefirst jaw 51 to open, and thefirst jaw 51 retracts back to the initial position and is completely separated from thesecond jaw 52. Thefirst jaw 51 is in an initial position, i.e. thefirst jaw 51 is completely separated from thesecond jaw 52. The pivotal connection between thefirst jaw 51 and thesecond jaw 52 is the same as the connection between the jaw assemblies in the anastomat already disclosed, and reference may be made to the description of the related art, which is not repeated herein. In this embodiment, rotation of theouter sleeve 62 about the central axis C is also restricted by the cooperation of theboss 21 on thefirst housing 20 and therecess 622 on the outer surface of theouter sleeve 62.
When thefirst jaw 51 and thesecond jaw 52 are completely separated, the drivingmotor 80 is turned off to stop the operation, and the driving mechanism 60 stops the driving.
As can be seen from the above description, the present invention provides a powered stapler 100 having a driving mechanism 60, wherein, on one hand, the main screw 61 rotates in a first direction around the central axis C to drive the outer screw 62 to linearly move along the central axis C toward the end effector 50 so as to pivot the first jaw 51 of the end effector 50 toward the second jaw 52 for closing on the second jaw 52, wherein the operation of pivoting the first jaw 51 toward the second jaw 52 for closing on the second jaw 52 is accompanied by the linear movement of the screw 63 along the central axis C toward the end effector 50 for "idle stroke"; on the other hand, the main screw 61 is rotated about the central axis C in a second direction opposite to the first direction, by first driving the screw 63 in the chamber 611 of the main screw 61 to move linearly along the central axis C toward the operating handle 10, the screw distal end 633 indirectly causes the outer screw 62 to re-engage with the main screw 61, the outer screw 62 is driven by the main screw 61 to move linearly toward the operating handle 10, and the pushing frame 70 and the sleeve 34 are driven to move linearly toward the operating handle 10, so that the first jaw 51 pivots relative to the second jaw 52 to separate from the second jaw 52. That is, the driving mechanism 60 of theelectric stapler 100 according to the present invention is rotated in the first and second opposite directions by themain screw 61, respectively, to perform the closing and opening operations of thefirst jaw 51 of theend effector 50 with respect to thesecond jaw 52.
Further, the driving mechanism 60 of theelectric stapler 100 provided by the present invention further includes ascrew 63 driven by themain screw 61 to move linearly to perform a cutting and stapling operation.
Fig. 9B is a schematic cross-sectional view of the driving mechanism of the electric stapler according to the present invention in a second working condition.
Referring to fig. 9A and 9B, in the first operating state, after the driving mechanism 60 completes the closing operation of theend effector 50, the drivingmotor 80 is in the off state, and the drivingmotor 80 needs to be started again by re-firing thefiring button 11 of theoperating handle 10, for example, by pulling thefiring button 11 toward the operatinghandle 10. Thedrive motor 80 is activated such that themain nut 61 continues to rotate in the first direction about the central axis C, theouter nut 62 is in the second position P2, i.e. the secondinternal thread 621 of theouter nut 62 is disengaged from the firstexternal thread 615 of themain nut 61 and is no longer engaged with each other, and themain nut 61 cannot drive theouter nut 62 to move linearly, i.e. in the second operating state, theouter nut 62 is relatively stationary and does not displace. Since the firstinternal thread 613 is provided throughout theinner wall 612 of themain nut 61, the secondexternal thread 6311 of the screwproximal end 631 and the firstinternal thread 613 of themain nut 61 are always engaged with each other, that is, the screwproximal end 631 of thescrew 63 and themain nut 61 are engaged with each other. In the second working state, themain screw sleeve 61 rotates, and the first and second limitingplanes 722 and 723 of the second combiningpart 72 of the pushingframe 70 are matched with the first andsecond plane parts 6321 and 6322 on thescrew body 632 to restrict or limit the rotation of thescrew 63 around the central axis C, so that thescrew 63 can continue to move linearly along the central axis C in the direction of theend effector 50. Wherein thescrew 63 moves linearly along the central axis C toward theend effector 50, thefirst groove wall 6342 of the slidinggroove 634 at thedistal end 633 of the screw pushes against the stoppingportion 322 of themandrel 32, so that themandrel 32 moves linearly along the central axis C toward theend effector 50, themandrel 32 pushes the cutting knife 31 (shown in fig. 1) disposed at the distal side thereof and fixedly connected thereto into theend effector 50 to cut tissue, and simultaneously the cuttingknife 31 drives the staple pushing plate of the cartridge assembly in thesecond jaw 52, the staple pushing plate pushes staples to be ejected from the cartridge assembly, and the staples are formed by thefirst jaw 51 to staple the cut tissue. Thecutting blade 31 is advanced into theend effector 50, pushed out of the staples and formed into the staples are known in the art, and reference is made to the related description in the prior art, which is not further described herein. In this embodiment, the position of the screwproximal end 631 after thecutting blade 31 has performed the cutting operation is defined as a fifth position P5.
The driving mechanism comprises a main threaded sleeve, an outer threaded sleeve and a screw rod, wherein the main threaded sleeve is fixedly connected to a driving motor, the driving motor drives the main threaded sleeve to rotate around a central axis, and the outer threaded sleeve sleeved outside the main threaded sleeve is driven to linearly move along the central axis so as to enable a first jaw of an end effector of the electric anastomat to be closed or opened relative to a second jaw; and the driving motor drives the main threaded sleeve to rotate around the central axis, and drives a screw rod arranged in a cavity of the main threaded sleeve to linearly move along the central axis so that a cutting knife of the electric anastomat realizes the operation of feeding, cutting, suturing or back-cutting.
When the cutting operation of the cutting knife is to be performed after the tissue cutting is completed, the switching stopper may be triggered, for example, by a cutting-back button (not shown) disposed on the first housing 20, the switching stopper controls the driving motor 80 to rotate in a second direction, which is opposite to the first direction, and further the main screw sleeve 61 rotates in the second direction, the second external thread 6311 of the proximal end 631 of the screw rod is engaged with the first internal thread 613 of the main screw sleeve 61, so that the main screw sleeve 61 can drive the screw rod 63 to move linearly along the central axis C toward the operating handle 10, the sliding groove 634 of the distal end 633 of the screw rod first moves toward the operating handle 10 until the second groove wall 6343 of the sliding groove 634 contacts the stopping portion 322 of the mandrel 32 during the linear movement of the screw rod 63 toward the operating handle 10, at this time, the screw rod 63 continues to move linearly toward the operating handle 10 under the action of the main screw sleeve 61, the second slot wall 6343 of the sliding slot 634 at the distal end 633 of the screw pushes against the stop 322 (as shown in fig. 4), so that the mandrel 32 moves linearly toward the operating handle 10, the mandrel 32 drives the cutting blade 31 to move toward the operating handle 10 and exit the end effector 50 until the screw 63 returns to the third position P3 shown in fig. 4, the driving motor 80 stops, the main screw sleeve 61 stops rotating, and the screw 63 stops moving.
It should be noted that the knife retracting operation is also accompanied by the operation of thefirst jaw 51 and thesecond jaw 52 of theend effector 50 returning from closed to open, and the operation of opening thefirst jaw 51 relative to thesecond jaw 52 can be referred to the above description. Briefly, along the central axis C, thescrew 63 is linearly moved toward the operatinghandle 10 until thereset protrusion 636 at the screwdistal end 633 contacts theinner side 7211 of thesecond side wall 721 of thepush frame 70, and as thescrew 63 continues to move toward the operatinghandle 10, thereset protrusion 636 pushes thepush frame 70, and thepush frame 70 simultaneously acts on thesleeve 34 and theouter sleeve 62, such that the secondinternal thread 621 of theouter sleeve 62 is re-engaged with the firstexternal thread 615 of themain sleeve 61, and themain sleeve 61 drives thescrew 63 and theouter sleeve 62 to linearly move toward the operatinghandle 10, such that the distal end of thesleeve 34 drives the proximal end of thefirst jaw 51 to pivot thefirst jaw 51, thereby separating thefirst jaw 51 from thesecond jaw 52.
In summary, the pushing frame of the present invention is used as an important bridging element between the driving mechanism and the operation distal end, and the pushing frame restricts the distal end of the screw rod through the second joint portion, so that the screw rod can be screwed in or screwed out of the cavity along the direction of the central axis C under the action of the main thread sleeve; wherein, the screw rod always moves linearly in the process of screwing in or screwing out; in addition, the first side wall at the far side of the pushing frame is combined at the near side of the sleeve of the slender shaft, the near side of the pushing frame is fixedly connected with an outer sleeve of the driving mechanism, and after the driving mechanism is started, the pushing frame acts on the sleeve of the slender shaft to close the end effector connected at the far side of the slender shaft; upon reverse actuation of the drive mechanism, the push frame acts upon the outer sleeve to return the outer sleeve to interengage with the main sleeve, which opens an end effector coupled to the distal side of the elongate shaft. According to the electric anastomat, the end effector of the electric anastomat is closed and opened, and the cutting, sewing and knife returning of the cutting knife are achieved through the group of driving mechanisms, so that compared with the existing anastomat which needs a plurality of groups of different driving mechanisms, the electric anastomat provided by the invention is smaller in size, and the driving mechanism is simpler in structure.
Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.