This application claims priority to provisional application No. 61/082,852, file Jul. 23, 2008, the entire contents of which are incorporated herein by reference.
BACKGROUND1. Technical Field
The present disclosure relates to a surgical staple for use in surgical procedures. More particularly, the present disclosure relates to a surgical staple and a staple assembly configured to accommodate various thicknesses of tissue by assuming a substantially box-shaped configuration upon formation through tissue. The present disclosure also relates to a method of stapling tissues of various thicknesses with a single, uniform size staple.
2. Background of Related Art
During various surgical procedures it is often necessary to secure one or more tissue sections together or to secure auxiliary structures such as, for example, mesh, buttress material, etc. to tissue. This is typically accomplished by driving a conventional staple, having a backspan and a pair of legs extending from the backspan, through the tissue and/or through the auxiliary structure. Once the conventional staple has been driven through the tissue, the ends of the legs are engaged with an anvil of the type typically having a pair of arcuate anvil pockets. This engagement causes the ends of the legs to be bent or recurved back towards the tissue to secure the tissue sections together and/or to secure the auxiliary material to the tissue. These bent or recurved portions of the staple legs are the tissue clenching portions of the legs.
When attempting to secure relatively thick sections of tissue together or auxiliary material to a relatively thick tissue section, the sizing of the conventional staple is selected to ensure sufficient leg lengths to traverse the tissue. Insufficient leg lengths will result in incomplete stapling of the tissue.
Further, when attempting to secure relatively thin sections of tissue together, or auxiliary material to the relatively thin tissue section, the sizing of the conventional staple is selected to ensure that there is not an excess of leg length. Excess leg length may result in the clenching portions of the legs projecting substantially away from the tissue as well as causing the ends of the leg to recurve back into and penetrate the tissue.
Therefore, it would be desirable to provide a staple having a leg length sufficient for various tissue thicknesses expected to be encountered.
SUMMARYThere is disclosed a staple substantially box-shaped and including a backspan and a first leg extending from the backspan. The first leg is divided into a first traversing leg portion and a first substantially linear clenching leg portion by a first bend. A second leg extends from the backspan and is divided into a second traversing leg portion and a second substantially linear clenching leg portion by a second bend. At least one of the first and second substantially linear clenching leg portions is oriented substantially parallel to the backspan. In one embodiment, both the first and second substantially linear clenching leg portions are oriented substantially parallel to the backspan.
Preferably, at least one of the first and second traversing leg portions is oriented substantially perpendicular to the backspan. In one embodiment, both the first and second traversing leg portions are oriented substantially perpendicular to the backspan.
In one embodiment, a combined length of the first and second clenching leg portions is less than an overall length of the backspan. In an alternative embodiment, the combined length of the first and second clenching leg portions is equal to an overall length of the backspan. In another alternative embodiment, the combined length of the first and second clenching leg portions is greater than an overall length of the backspan.
There is also disclosed a staple assembly for use in tissue which generally includes a substantially box-shaped staple having a backspan and first and second legs extending from the backspan. The first leg is divided into a first traversing leg portion and a first substantially linear clenching leg portion by a first bend. The second leg is also divided into a second traversing leg portion and a second substantially linear clenching leg portion by a second bend. A staple plate is positioned on the first and second legs between the backspan and the first and second linear clenching leg portions. At least one of the first and second substantially linear clenching leg portions is oriented substantially parallel to the staple plate.
The staple plate preferably has first and second holes to receive the first and second traversing leg portions, respectively. In a preferred embodiment, an overall length of the staple plate is greater than an overall length of the backspan and the distance between the first and second holes is substantially equal to the overall length of the backspan.
There is also disclosed a method of forming a substantially box-shaped staple through tissue including the step of providing a substantially box-shaped staple having a backspan, a first leg extending from the backspan and including a first bend zone located between the backspan and a first end of the first leg, and a second leg extending from the backspan and including a second bend zone located between the backspan and a second end of the second leg. The first and second ends of the first and second legs are driven through a tissue section. The first leg is impacted in the first bend zone with a first angled portion of a first anvil to form a first bend within the first bend zone to form a first traversing leg portion and a first substantially linear clenching leg portion.
The method may further include the step of impacting the first clenching leg portion with a first finishing surface of the first anvil to orient the first clenching leg portion substantially parallel to the backspan.
The method may further include the step of impacting the second leg in the second bend zone with a second angled portion of a second anvil to form a second bend within the second bend zone and dividing the second bend zone into a second traversing leg portion and a second substantially linear clenching leg portion.
The second clenching leg portion may be impacted with a second finishing surface of the second anvil to orient the second clenching leg portion substantially parallel to the backspan.
In one embodiment of the disclosed method, the first and second ends are driven through tissue such that the backspan engages an upper surface of the tissue.
In one embodiment of the disclosed method, a staple plate is positioned over the first and second legs and engages an underside of the tissue prior to the step of impacting the first leg in the first bend zone.
DESCRIPTION OF THE DRAWINGSEmbodiments of the presently disclosed staple and staple assembly are disclosed herein with reference to the drawings, wherein:
FIG. 1 is a side view, partially shown in section, of one embodiment of a disclosed substantially box staple formed through a pair of tissue sections;
FIG. 2 is an end view taken along line2-2 ofFIG. 1;
FIG. 3 is a top view taken along line3-3 ofFIG. 1;
FIG. 4 is a bottom view taken along line4-4 ofFIG. 1;
FIG. 5 is a side view, partially shown in section, of the staple ofFIG. 1, inserted through the pair of relatively thick tissue sections, immediately prior to formation;
FIG. 6 is a side view similar toFIG. 5 during formation of the staple through the pair of relatively thick tissue sections;
FIG. 7 is a side view similar toFIG. 6 after formation of the staple through the pair of relatively thick tissue sections;
FIG. 8 is perspective view of the fully formed substantially box staple (when formed in relatively thin tissue sections);
FIG. 9 is a side view, partially shown in section, of the staple ofFIG. 8 formed through a pair of relatively thin tissue sections;
FIG. 10 is a top view taken along line10-10 ofFIG. 9;
FIG. 11 is an end view taken along line11-11 ofFIG. 9;
FIG. 12 is a bottom view taken along line12-12 ofFIG. 9;
FIG. 13 is a side view, partially shown in section, of the staple immediately prior to formation through the pair of relatively thin tissue sections;
FIG. 14 is a side view similar toFIG. 13 during formation of the staple through the pair of relatively thin tissue sections;
FIG. 15 is similar toFIG. 14 after formation of the staple through the pair of relatively thin tissue sections;
FIG. 16 is a perspective view of a staple assembly including a substantially box staple and a staple plate;
FIG. 17 is a side view, partially shown in section, of the staple assembly formed through a pair of relatively thick tissue sections;
FIG. 18 is an end view taken along line18-18 ofFIG. 17;
FIG. 19 is a top view taken along line19-19 ofFIG. 17;
FIG. 20 is a bottom view taken along line20-20 ofFIG. 17;
FIG. 21 is a side view, partially shown in section, of the staple assembly ofFIG. 16 immediately prior to formation through the pair of relatively thick tissue sections;
FIG. 22 is a side view, similar toFIG. 21, during formation of the staple assembly through the pair of relatively thick tissue sections;
FIG. 23 is a side view, similar toFIG. 22, after formation of the staple assembly through the pair of relatively thick tissue sections;
FIG. 24 is side view, partially shown in section, of the staple assembly formed through a pair of relatively thin tissue sections;
FIG. 25 is a top view taken along line25-25 ofFIG. 24;
FIG. 26 is a bottom view taken along line26-26 ofFIG. 24;
FIG. 27 is an end view taken along line27-27 ofFIG. 24;
FIG. 28 is a side view, partially shown in section, of an alternate embodiment of a staple assembly including a staple and an arcuate staple plate shown formed through a pair of relatively thick tissue sections; and
FIG. 29 is a side view, partially shown in section, of the staple assembly ofFIG. 28 formed through a pair of relatively thin tissue sections.
DETAILED DESCRIPTION OF EMBODIMENTSEmbodiments of the presently disclosed staple and staple assembly will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term ‘proximal” refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to that part or component further away from the user.
Referring toFIG. 1-4, and initially toFIG. 1, there is disclosed an embodiment of auniversal staple10 for use in various thickness of tissues.Staple10 is substantially box-shaped and has the further advantage of providing uniform pressure against the underside of the tissues stapled as described in more detail hereinbelow. Substantially box-shapedstaple10 generally includes abackspan12 and first andsecond legs14 and16, respectively, extending frombackspan12. Specifically, afirst end18 offirst leg14 extends downwardly (as viewed inFIG. 1) from afirst end20 ofbackspan12 and asecond end22 ofsecond leg16 extends downwardly from asecond end24 ofbackspan12.First leg14 terminates in atissue penetrating tip26 andsecond leg16 terminates in atissue penetrating tip28. Thelegs14 and16 are shown extending substantially perpendicular to the backspan, although it is also contemplated that thelegs14,16 can extend from other angles.
Substantiallybox staple10 is preferably formed from a length of material having a generally rectangular cross-section, although other cross sections are also contemplated.Staple10 can be formed from any number of biocompatible materials such as, for example, stainless steel, titanium, various malleable plastic materials, various bio-absorbable materials etc. When formed from metallic materials such as stainless steel or titanium,staple10 can be formed by drawing and cutting a length of metallic wire, stampingbox staple10 from a sheet of metallic material, etc. Whenstaple10 is formed from a plastic or bio-absorbable material,staple10 can be formed by injection molding, carvingstaple10 from a block of plastic material, etc.
As noted above,staple10 is designed for use in tissues of various thicknesses, such as, for example, relatively thick tissues A and B. In order to accommodate the various thickness tissues without excessive or insufficient compression of tissues A and B,first leg14 has afirst bend zone30 which extends substantially betweenfirst end18 andtissue penetrating tip26 offirst leg14. Depending upon the thickness of the tissues encountered,first leg14 can be bent at any location withinbend zone30 to accommodate those tissues. This is facilitated by the use of a pair of anvils as described in more detail herein below.Second leg16 also includes asecond bend zone32 which extends substantially betweensecond end22 andtissue penetrating tip28 ofsecond leg16 and can be bent at any location withinbend zone32.
Whenstaple10 is fully formed through relatively thick tissues A and B, backspan12 provides uniform compression on an upper surface C of relatively thick tissue section A (FIGS. 1 and 3).First leg14 is formed with afirst bend34 infirst transition zone30 such thatfirst leg14 is divided into a first, substantially lineartraversing leg portion36 extending through relatively thick tissues A and B (FIG. 1) and a first substantially linearclenching leg portion38 lying substantially flush with an underside D of relatively thick tissue section B (FIGS. 1 and 4). It should be noted thatfirst bend34 formed between first traversingleg portion36 and first clenchingleg portion38 is preferably a substantially sharp or abrupt 90° bend in contrast to the relatively gradually curving bends typically associated with prior art staples. Likewise,second leg16 is formed with asecond bend40 insecond bend zone32 which dividessecond leg16 into a second substantially lineartraversing leg portion42 extending through relatively thick tissue sections A and B (FIGS. 1 and 2) and a second substantially linearclenching leg portion44 lying substantially flush with underside D of relatively thick tissue section B. (FIGS. 1 and 4).Second bend40 also preferably forms a relatively sharp or abrupt 90° transition between second traversingleg portion42 and second clenching likeportion44. By maintaining first and secondclenching leg portions38 and44 in a relatively linear or straight configuration against underside D of relatively thick tissue section B, first clenchingleg portion38 and secondclenching leg portion44 maintain a uniform compression against underside D without the associated pinching or tip penetration of underside D.
As best shown inFIG. 1, whenstaple10 is formed through relatively thick tissue sections A and B, the length L1 ofbackspan12 is preferably greater than or equal to the combined lengths L2 and L3 of first and second linear clenchingleg portions38 and44, respectively.
Referring now toFIGS. 5-7, and initially with respect toFIG. 5, the use and formation ofstaple10 with relatively thick tissue sections A and B will now be described. Initially, the dimensions ofstaple10 are preferably chosen such thatlegs14 and16 have overall lengths L4 and L5 which are substantially greater than the anticipated combined thicknesses of any tissues to be encountered. Furthermore, each of the overall lengths L4 and L5 of first andsecond legs14 and16, respectively, is preferably greater than half the overall length L1 ofbackspan12. This ensures sufficient leg length to traverse and secure both relatively thick and thin tissue sections.Staple10 is initially driven through relatively thick tissue sections A and B by engagingbackspan12 with a staple driver (not shown) thereby driving first and secondtissue penetrating tips26 and28, respectively, through tissue sections A and B.
Referring toFIG. 6, thereafter, a pair of anvils, such as, for example, first and second drivenanvils50 and52, are driven laterally against first and secondstaple legs14 and16 to form staple10 through relatively thick tissue sections A and B. First and second drivenanvils50 and52 generally include respective first and secondangled surfaces54 and56 and respective first and second finishing surfaces58 and60. First and secondangled surfaces54 and56 are provided to initially impact or impinge against first andsecond legs14 and16 within the respective first andsecond bend zones30 and32 to initially create first andsecond bends34 and40. This dividesfirst bend zone30 offirst leg14 into first traversingleg portion36 and first linearclenching leg portion38. Similarly, this dividessecond bend zone32 into secondtraversing leg portion42 and second linear clenchingleg portion44.
Referring toFIG. 7, as first andsecond anvils50 and52 are driven to the final position, first and second linear clenchingleg portions38 and44 are engaged by relatively linear finishing surfaces58 and60 of drivenanvils50 and52, respectively, such that first and second linear clenchingleg portions38 and44 are brought substantially flush into engagement with underside D of relatively thick tissue section B. As noted hereinabove, when substantially boxstaple10 is used in relatively thin tissue sections, the combined lengths L2 and L3 of first and secondclenching leg portions38 and44, respectively, are substantially less than or equal to the overall length L1 ofbackspan12.
Referring now toFIGS. 8-12, and initially with regard toFIG. 8, substantially boxstaple10 is illustrated in the configuration it assumes when used through a pair of relatively thin tissue sections. Specifically, whenstaple10 is formed through relatively thin tissue sections, each of the lengths L2 and L3 of respective first and second linear clenchingleg portions38 and44 are almost equal to or greater than the overall length L1 ofbackspan12.
As shown inFIG. 9, first and secondtraversing leg portions36 and42 pass through thin tissue sections E and F. First and second linear clenchingleg portions38 and44 preferably lie substantially parallel to and substantially flush with tissue section F. As best shown inFIG. 10,backspan12 engages an upper surface G of tissue section E while first and second linear clenchingleg portions38 and44 engage an underside surface H of tissue G.
As best shown inFIGS. 8,11 and12, the excess lengths of first and secondclenching leg portions38 and44 are accommodated by allowing them to lie in substantially parallel relation (side by side) to each other against underside F of tissue H. Thus, staple10 functions as a universal staple suitable for use with both thick and thin tissue sections without risk of penetrating the tissue sections with first and secondtissue penetrating tips26 and28 of respective first andsecond legs14 and16.
Referring now toFIGS. 13-15, in order to form staple10 through pair of relatively thin tissue sections E and F,staple10 is initially driven through tissue sections E and F. Thereafter, drivenanvils50 and52impact staple legs14 and16 to initially begin to bendstaple legs14 and16. As shown inFIG. 14, angled faces54 and56 of drivenstaples50 and52 initially form bends34 and40 to create respective first and secondtraversing leg portions36 and42 and first and second linear clenchingleg portions38 and44. Thereafter, with reference toFIG. 15, finishingsurfaces58 and60 of drivenanvils50 and52 engage first and second linear clenchingleg portions38 and44 to form first and second linear clenchingleg portions38 and44 against underside H of tissue F and, substantially parallel tobackspan12. Thus,staple10 is particularly suited for use with relatively thin tissue sections such that first and second linear clenchingleg portions38 and44 lie substantially flush against the tissue to be stapled.
Referring now toFIGS. 16-20, and initially with regard toFIG. 16 there is disclosed an alternate embodiment having astaple assembly70 including a substantially box-shapedstaple10 and a pledget orstaple plate72.Staple plate72 increases the surface area engaging a tissue being stapled as well as protecting the tissue from engagement withstaple legs14 and16 upon crimping ofstaple10 about tissue.Staple10 is as described herein above includingbackspan12 andlegs14 and16 extending frombackspan12.
Staple plate72 is substantially rectangular as shown (although other shapes are also contemplated) having first andsecond holes74 and76 adjacent first and second ends78 and80, respectively. First andsecond holes74 and76 are configured and dimensioned to receive first andsecond legs14 and16 ofstaple10 therethrough.Staple plate72 has an overall length L7 which is preferably greater than the length L1 of backspan12 (FIG. 1). Additionally, the spacing or length L6 betweenholes74 and76 is preferably substantially identical to the length L1 ofbackspan12 as thelegs14 and16 are preferably substantially perpendicular thereto. Other lengths are also contemplated.
As best shown inFIGS. 17 and 18,staple assembly70 is provided to secure a pair of tissue sections, such as, for example, tissue sections I andJ. Backspan12 engages an upper surface K of tissue section I (FIG. 19) while anupper surface82 ofstaple plate72 engages a lower surface L of tissue section J (FIG. 20).
Referring toFIG. 20, as noted above,staple plate72 protects tissue section J from engagement with first and secondclenching leg portions38 and44 of first andsecond legs14 and16, respectively. Specifically, upon formation ofstaple10 through tissue sections I and J,staple plate72 is interposed between tissue section J and first and secondclenching leg portions38 and44.
Referring toFIGS. 21-23, the use ofstaple assembly70 to secure a pair of relatively thick tissue sections I and J together will now be described. With reference toFIG. 21, initially,staple10 is driven by a staple driver (not shown) toward tissue sections I and J such that first andsecond legs14 and16 penetrate tissue sections I and J untilbackspan12 engages upper surface K of tissue sectionI. Staple plate72 is positioned against undersurface K of tissue section J andlegs14 and16 are extended throughholes74 and76 ofstaple plate72. This bringsupper surface82 ofstaple plate72 into engagement with undersurface K of tissue section J.
With reference toFIGS. 21 and 22, thereafter, first and second drivenanvils50 and52 are moved inwardly toward first andsecond legs14 and16. Upon engagement of first and secondangled surfaces54 and56 with first andsecond legs14 and16, first andsecond legs14 and16 are initially bent withinrespective bend zones30 and32 to form first andsecond bends34 and40 within first andsecond legs14 and16. As noted here in above,first bend34 dividesfirst leg14 into first traversingleg portion36 and first linearclenching leg portion38 whilesecond bend40 dividessecond leg16 into secondtraversing leg portion42 and second linear clenchingleg portion44. Notably, the extension of first andsecond legs14 and16 through first andsecond holes74 and76 instaple plate72 facilitate formingbends74 and76 at substantially right angles relative to first and secondtraversing leg portions36 and38 of first andsecond legs14 and16, respectively.
Finally, with reference toFIG. 23, engagement of first and second finishing surfaces58 and60 of the first and second drivenanvils50 and52 with first and second linear clenchingleg portions38 and44 serve to secure first and second linear clenchingleg portions38 and44 againstunderside84 ofstaple plate72 thereby securingstaple plate84 against underside L of tissue section J.
Referring now toFIGS. 24-27, the use ofstaple assembly70 to secure a pair of relatively thin tissue sections, such as, for example, tissue sections M and N will now be described. The method disclosed herein with respect to relatively thin tissue sections M and N is substantially identical to the method disclosed herein above with respect to relatively thick tissue sections I and J. Initially, with reference toFIG. 24,staple10 is driven by a staple driver (not shown) such that first andsecond legs14 and16 are driven through tissue sections M and N untilbackspan12 engages an upper surface O of tissue section M (FIG. 25). Further movement of the staple driver drives first andsecond legs14 and16 throughholes74 and76 ofstaple plate72. Thereafter, first and second drivenanvils50 and52 (FIGS. 21-23) are moved toward each other as described above to form first and second linear clenchingleg portions38 and44 againstunderside84 of staple plate72 (FIG. 26).
As best shown inFIGS. 26 and 27, similar to that disclosed hereinabove with respect to staple10 inFIGS. 11 and 12, first and second linear clenchingleg portions38 and44 are in a side-by-side and overlapping relation with respect to each other due to the excess lengths oflegs14 and16 when used through relatively thin tissue sections M and N. In this manner, the provision of substantiallybox staple10 having first andsecond legs14 and16 with overall lengths almost equal to or greater then at least the overall length ofbackspan12 allowsstaple10 to function as a universal staple suitable for use with various thicknesses of tissue. As noted hereinabove, the provision ofstaple plate72 provides additional surface bearing area against the tissue section while facilitating forming an abrupt 90° bend within first andsecond legs14 and16.
Referring now toFIGS. 28 and 29, whilestaple plate72 has been disclosed for use withstaple10,staple plate72 may be formed of a material which allowsstaple plate72 to be used with a staple90 similar tostaple10 in situations whereinstaple90 is formed with conventional anvils. As used herein, the term “conventional anvils” refers to those anvils having arcuate anvil pockets resulting in arcuate rather than linear clenching leg portions in the formed staple.
For example, with reference toFIG. 28,staple90 includes a backspan92 having first andsecond legs94 and96 extending frombackspan92. In use,staple90 is driven through relatively thick tissue sections Q and R resulting in first and secondtraversing leg portions98 and100 extending through tissue sections Q and R whilebackspan92 engages an upper surface S of tissue section Q. First andsecond legs94 and96 are extended throughholes74 and76 instaple plate72 and are clenched againststaple plate72 by arcuate anvil pockets formed in an anvil associated with a conventional stapler (not shown).
Similarly, with reference toFIG. 29, when used in conjunction with relatively thin tissue sections U and V, backspan92 engages an upper surface W of tissue section U while traversingleg portions98 and100 extend through tissue sections U andV. Staple plate72 bears against an undersurface X of tissue section V. First and secondclenching leg portions102 and104 of first andsecond legs94 and96 are formed into a roughly arcuate overlapping relation due to the excess length oflegs94 and96.
As shown inFIGS. 28 and 29,staple plate104 is preferably curved, thereby an arcuate top surface of the plate abuts the bottom surface of the tissue section R or V.
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the legs of the disclosed substantially box staple may be heat treated at specific points to facilitate the formation of the abrupt 90° bend between the traversing portion of the leg and the linear clenching portion of the leg. Further, alternative embodiments of anvils may be provided to form the substantially right angle within their respective legs. Additionally, the disclosed staple may be formed from a shape memory alloy such that the substantially right angle between the traversing leg portion and the substantially linear clenching leg portion is formed at a predetermined location along the length of the leg. Also curved or planar plates can be used with the embodiments of the staple disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.