Suturing assembly and method - Patent Review 4809695

The embodiments of the invention in claim which an exclusive property or privilege are claimed are defined as follows:

1. A surgical procedure for suturing tissues with individual staples to be performed with a tissue-suturing assembly comprising a plurality of cartridges, each holding a C-shaped staple having opposite staple legs between cartridge jaws thereof with a mouth of said staple opening outwardly to receive a piece of tissue to be sutured without piercing said tissue, each of said cartridges having movable opposite cartridge jaws including means for retaining said opposite staple legs of said staple therein prior to said cartridge jaws being forced together for closing said staple and an elongated pliers-like clamping tool; said surgical procedure comprising the steps of:

mounting a cartridge with a staple loaded therein on said tool,

manipulating said tool to locate tissue to be sutured within the mouth of the staple located in the cartridge without piercing said tissue prior to the cartridge jaws being forced together for closing the staple;

manipulating the tool to force together said cartridge jaws to close the mouth of the staple on said tissue;

manipulating the tool to open the cartridge jaws to release the staple from the cartridge jaws;

removing the empty cartridge from the tool; and

mounting a new cartridge, loaded with a staple, on the tool for repeating the above steps.

2. A surgical procedure as in claim 1, wherein each of said cartridges has a plurality of staples mounted therein whose mouths can simultaneously receive a piece of tissue to be sutured without piercing said tissue and wherein the step of forcing together the cartridge jaws includes the substep of closing the mouths of all of the staples mounted therein simultaneously on said tissue.

3. A surgical procedure as in claim 1 wherein each of said cartridges comprises a carrier having a linear track thereon and said cartridge jaws ride on said track whereby said step of compressing said cartridge jaws comprises the substep of moving said cartridge jaws linearly toward one another along said track.

4. A tissue-suturing assembly comprising:

a plurality of suturing staples, said staples each comprising two opposite legs coupled together at a central back area to have a substantial C-shape so that the legs can be moved toward one another to form a closable mouth, each of said legs including a tissue piercing tip for piercing and extending through pieces of tissue to be sutured, said staples being constructed of a bendable material for retaining said legs in a closed position once they have been moved together to the closed position;

a plurality of cartridges each for holding a plurality of parallel adjacent, side-by-side, suturing staples with the parts of each staple being beside and aligned with the same respective parts of the other staples, the mouths of said staples opening outwardly to simultaneously receive a piece of tissue to be sutured without piercing said tissue, each said cartridges having movable opposite cartridge jaws including means for retaining opposite legs of staples therein prior to said cartridge jaws being forced together for closing said staples;

an elongated pliers-like clamping tool separate from said cartridges having first and second crossed arms with plier handles at one end and first and second plier jaws at the other end, said first and second plier jaws being forced together in response to said first and second plier handles being forced together, said first and second plier jaws respectively including means for selectively engaging them to said first and second cartridge jaws for thereby allowing a physician to engage the opposite plier jaws to respective opposite cartridge jaws when said cartridge is fully loaded with a plurality of suturing staples for thereafter allowing said physician to manipulate said first and second plier handles so as to move said plurality of staples to a desired position, with said tissue to be sutured located in the mouths of said staples, for thereafter allowing said physician to force said first and second cartridge jaws together to drive said tissue piercing tips of said staple legs through said tissue and further bend said staples into closed positions to form loops on said tissue, and for thereafter allowing said physician to remove said cartridge from said plier jaws and attach a further loaded cartridge to the plier jaws for repeating this procedure;

whereby pluralities of suturing staples can be quickly applied to pieces of tissue by sequentially mounting loaded cartridges on the jaws of the plier-like tool and using the plier-like tool to force the staple legs together on said tissue positioned in their mouths, for suturing the tissues.

5. A tissue-suturing assembly comprising:

a plurality of suturing staples, said staples each comprising two opposite legs coupled together at a central back area to have a substantial C-shape so that the legs can be moved toward one another to form a closable mouth, each of said legs including a tissue piercing tip for piercing and extending through pieces of tissue to be sutured, said staples being constructed of a bondable material for retaining said legs in a closed position once they have been moved together to the closed position;

a plurality of cartridges each for holding a plurality of parallel suturing staples with their central areas being approximately aligned along a central area of alignment with their mouths opening outwardly to apply said suturing staples to said pieces of tissues to be sutured, said cartridges having movable opposite cartridge jaws for retaining opposite staple legs of staples therein, said cartridges being made of a plastic material including indentations therein in which said staples are embedded for holding said staples in said cartridges;

an elongated pliers-like clamping tool separate from said cartridges having first and second crossed arms with plier handles at one end and first and second plier jaws at the other end, said first and second plier jaws being forced together in response to said first and second plier handles being forced together, said first and second plier jaws respectively including means for selectively engaging them to said first and second cartridge jaws for thereby allowing a physician to engage the opposite plier jaws to respective opposite cartridge jaws when said cartridge is fully loaded with a plurality of suturing staples for thereafter allowing said physician to manipulate said first and second plier handles so as to move said plurality of staples to a desired position, with said tissue to be sutured located in the mouths of said staples, for thereafter allowing said physician to force said first and second cartridge jaws together to drive said tissue piercing tips of said staple legs through said tissue and further bend said staples into closed positions to form loops on said tissue, and for thereafter allowing said physician to remove said cartridge from said plier jaws and attach a further loaded cartridge to the plier jaws for repeating this procedure;

whereby pluralities of suturing staples can be quickly applied to pieces of tissue by sequentially mounting loaded cartridges on the jaws of the plier-like tool and using the plier-like tool to force the staple legs together on said tissue positioned in their mouths, for suturing the tissues.

6. A tissue-suturing assembly as in claim 5 wherein said deformable material of said cartridge extends partially over each staple to hold said staple in its embedded position in a respective indentation but wherein said deformable material deforms to allow said staple to leave said indentation.

7. A tissue-suturing assembly as in claim 5 wherein each of said cartridges comprises at least three separate cooperating parts as follows:

a carrier having a track formed thereon; and,

two opposite cartridge jaws mounted on said carrier for sliding linearly along said carrier track toward one another to bend said staple into said closed loops.

8. A tissue-suturing assembly as in claim 7, wherein each cartridge jaw includes a cartridge-jaw plier-tool engagement means for engaging a respective opposite pliers-like tool jaw so that movement of the pliers-like tool jaw causes linear movement of the cartridge jaw along said carrier track.

9. A tissue-suturing assembly as in claim 8 wherein said carrier has indentations therein in which said staples are embedded and said carrier is constructed of deformable material which extends over each staple to hold it in said carrier indentation, and also wherein said jaws include indentations therein for holding opposite legs of each staple.

10. A tissue-suturing assembly as in claim 8 wherein said central back area of said C-shaped staples are relatively long while the legs of said C-shaped staples are rounded along their length, further, wherein said cartridge jaws have cross sections which approximately match the rounded arms of said staples, whereby, as said cartridge jaws are urged together to close the staples, each staple leg is caused to progressively bend in a rolled up loop toward the other.

11. A tissue-suturing assembly as in claim 10 wherein said central portions of said C-shaped staples are sufficiently long that when said staples are rolled up from said rounded legs to the middle of said central area the staples form overlapping loops.

12. A tissue-suturing assembly as in claim 10 wherein said pliers-like tool includes a movement-control means for causing each cartridge jaw to progressively move an approximate equal amount on said carrier when said cartridge jaws are being moved to close said staples.

13. A tissue-suturing assembly as in claim 12 wherein said movement-control means includes a spring member having a centrally converging slot in which followers mounted on opposite plier jaws ride, said followers contacting the edges of said slot to cause the widening of said slot as said followers converge toward one another.

14. A tissue-suturing assembly as in claim 8 wherein said pliers-like tool includes a movement-control means to cause each cartridge jaw to progressively move an approximate equal amount on said carrier when said cartridge jaw are being moved to close said staples.

15. A tissue-suturing assembly as in claim 14 wherein said movement-control means includes a spring member having a centrally converging slot in which followers mounted on opposite plier jaws ride, said followers contacting the edges o said slot to cause the widening of said slot as said followers converge toward one another.

16. A tissue-suturing assembly as in claim 8 wherein said carrier track comprises parallel rails having slots therebetween and said carriage jaws comprise carriage-jaw follower posts, which ride in said slots, said cartridge jaws comprising cartridge jaw-grippers being attached to said follower posts on one side of the carrier and said cartridge-jaw plier-tool engagement means being attached to said follower posts on the other side of said carrier.

17. A tissue-suturing assembly as in claim 16 wherein said pliers-like tool includes prongs extending at the ends of the plier jaws which impinge on the cartridge jaw grippers, said plier-tool prongs being sized to pass through said slots between said rails to thereby follow said cartridge jaw grippers' linear motion along said carrier for evenly urging the cartridge jaw grippers along the carrier.

18. A tissue-suturing assembly as in claim 17 wherein said carrier slots are outwardly open in opposite directions with said rails being interconnected at a central location and wherein there are stops molded on said carrier at the open ends of said slots for contacting said cartridge jaw follower posts to thereby prevent them from exiting from said slots.

19. A tissue-suturing assembly as in claim 16 wherein said carrier slots are outwardly open in opposite directions with said rails being interconnected at a central location and wherein there are stops molded on said carrier at the open ends of said slots for contacting said cartridge jaw follower posts to thereby prevent them from exiting from said slots.

20. A tissue-suturing assembly as in claim 16 wherein the central back area of each C-shaped staple is positioned in an indentation in a carrier rail and opposite legs of each staple are positioned in indentations in opposite cartridge jaw grippers.

21. A tissue-suturing assembly as in claim 20 wherein said carrier is constructed of deformable material which extends over the central back area of each staple to hold it in its carrier-rail indentation.

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BACKGROUND OF THE INVENTION

This invention relates generally to the art of surgical suturing, and more particularly to suturing devices and methods which employ surgical staples.

A major time consumer in performing surgery is suturing tissues together. In this regard, when performing heart surgery, implant surgery, and many other types of surgery, surgeons must often anastomos blood vessels to other blood vessels, which procedure is normally performed by laboriously stitching edges of blood-vessel openings together. Because the blood vessels are so small and delicate, this procedure often takes hours to accomplish. The suturing of blood vessels and other organs together often forms a large part of a surgical operation, and this time factor can limit the development of, and use of, certain procedures. It is an object of this invention to provide an assembly and method for suturing tissues together, especially blood vessels and other organs, in a relatively rapid manner, thereby significantly reducing the time required for carrying out complicated surgical procedures.

Many surgical stapling systems have been suggested and, in fact, a few are commercially available. However, such devices are normally too big and cumbersome to be practically used for blood vessel anastomosis. It is therefore another object of this invention to provide a surgical stapling system which is sufficiently delicate in size, shape and operation that it can be used for blood vessel anastomosis.

It has long been recognized that it is preferable to suture tubular organs such as blood vessels, together with individual, independent, radially-aligned stitches, rather than by using a continuous suturing thread extending circumferentially about the tubular organs. One reason for this is that if a blood vessel, for example, is stitched together with a continuous, circumferential, suture thread and the stitches are pulled tightly during the suturing, it will have a "purse string" effect, which tends to constrict the blood vessel at the point of the suture. This "purse-string" effect is magnified in young patients as the patient and his blood vessels grow, since the continuous suture thread will not allow the vessel's internal size to increase with such growth. Individual, unconnected, radially-aligned stitches placed about blood vessels, on the other hand, will not cause this purse-string effect and will allow blood vessels to grow between the stitches. Another reason individual, radially-aligned, stitches are preferable to circumferential continuous-thread stitches is that the continuous thread stitches tend to restrict blood-flow to isolated tissue positioned radially beyond the suture. In some cases this tissue later dies thereby releasing the suture threads and causing the suture to fail. In spite of these tremendous disadvantages most surgeons still use continuous-thread circumferential stitching for tubular organs because it is much faster than positioning independent, radially aligned stitches about tubular organs. Unfortunately, most prior-art staplers, and/or clamps which have been suggested for tubular organs have the same disadvantages as continuous-filament sutures. In this respect, many of these systems involve staples each having a long back section which is positioned circumferentially about a tubular organ and end legs which pass through everted edges of the tubular organ. When the end legs are folded toward the back section to close these staples they squeeze the everted tissue between the staple legs and the back section thereby restricting blood flow across the staples. Often such staples are applied to overlap with one another. Such an arrangement of staples provides a "purse string" effect because the circumferentially positioned back sections do not allow the tubular organs to grow radially and they tend to cut off circulation in isolated everted edges of the tubular organs which are positioned radially outside of the staples. It is therefore an object of this invention to provide a stapling assembly and method which not only reduces the time for suturing but which allows a surgeon to suture tubularly-shaped organs, such as blood vessels, with individual, radially-aligned stitches so as not to constrict the tubularly-shaped organs and not to cut off circulation to portions of everted tissue of the tubularly-shaped organs positioned radially outside of the stitches.

Yet another problem with many staple systems is that each of the staples thereof, when opposite legs thereof are bent against an elongated back section thereof, forms an elongated member. Such a shape sometimes allows tissues of two organs stapled together to slide along the back section of the staple to opposite ends thereof, thereby separating from one another. In other words, the long, rectangular, shape of many prior-art staples, allows two tissues to pull apart, with one tissue moving to one end of the staple, and the other tissue moving to the other end of the staple. Thus, it is an object of this invention to provide a stapling apparatus and method which provides a substantially round staple which cannot, therefore, reorient itself to allow separation of tissues stapled together therewith.

Yet another difficulty with many prior art suturing staple devices is that the staples themselves either allow tissue stapled therewith to work itself loose or they include complicated fastening devices which prevent the opening thereof. It is an object of this invention to provide a stapling apparatus and method having staples which, once they are stapled onto tissue, do not allow the tissue to easily free itself from the staples but which do not involve the use of complicated catches or the like on the staples to hold legs thereof together.

A relatively important problem with most prior art surgical staplers is that they only allow one staple at a time to be fastened onto tissue. Such an arrangement requires unnecessary repetative alignment of tissue with staples, thereby involving additional work and time. It is an object of this invention to provide a stapler apparatus and method which allows either one, or any number of pluralities of staples to be simultaneously applied to tissue by one operation of a stapler.

Some prior art surgical devices have been suggested for applying a plurality of clamps in one application. However, such devices have involved application tools which hold pluralities of the clamps and which must be individually reloaded at an operation site once they have been used. A difficulty with such a system is that it is time consuming to reload the individual clamps. It would be possible to have a plurality of loaded tools, however, such an arrangement would be impractical and expensive. It is an object of this invention to provide a suturing apparatus and method which allows application of either one suturing staple, or a plurality of suturing staples in one stapling step with a single suturing tool, but yet which does not require the maintaining of many loaded tools.

Another difficulty with most prior art staplers is that they are not shaped to be convenient for surgeons to manipulate staples to proper locations for application of the staples. Thus, it is an object of this invention to provide a surgical staple assembly and method which involves a convenient-to-manipulate pliers-like tool in combination with changable cartridges holding staples.

SUMMARY

A suturing staple assembly and method involves the use of a pliers-like tool and removable cartridges having aligned C-shaped staples embedded therein. Each of the cartridges contains one or more C-shaped staples and comprises a carrier having jaw tracks thereon and linearly movable cartridge jaws which ride in these tracks. Plier-tool jaws engage the cartridge jaws to cause them to slide along the track, thereby rolling up the C-shaped staples from their ends into spiralled, overlapping loops. During this rolling process, pointed tips of legs of the C-shaped staples pass through tissue located in the mouths of the C-shaped staples. Also during this rolling process, the staples are withdrawn from their embedded engagement with the cartridges. Thus, a staple-loaded cartridge can be mounted on a pliers-like tool, the tool can be manipulated to close the cartridge jaws and thereby roll the legs of the staples into tissue mounted in the mouths of the staples, the pliers-like tool can be manipulated to open the cartridge jaws, the empty cartridge can be removed from the pliers-like tool, and a new staple-loaded cartridge can be mounted on the pliers-like tool for repeating the sequence. A jaw-movement compensator is mounted on the pliers-like tool to ensure that opposite pliers-like tool jaws move at substantially uniformly-equal rates.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of the preferred embodiment of the invention, as illustrated in the accompanying drawings in which reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention in a clear manner.

FIG. 1 is an exploded isometric view of a tissue-suturing assembly of this invention;

FIG. 2 is an enlarge isometric view of a staple cartridge loaded with three staples for use in the tissue-suturing assembly of FIG. 1;

FIG. 3 is an exploded view of the cartridge and staples of FIG. 2;

FIG. 4 is a side, partially in section, view of the carriage and staples of FIG. 2;

FIG. 5 is a cross sectional view taken on line 5--5 in FIG. 4;

FIG. 6 is a top view taken on line 6--6 in FIG. 4;

FIG. 7 is an enlarged side view of the jaw end of the elongated pliers-like clamping tool of the tissue-suturing assembly of FIG. 1;

FIG. 8 is an edge view of the structure shown in FIG. 7;

FIG. 9 is an enlarged side sectional view of the jaw end of the pliers-like clamping tool of FIG. 1 with a cartridge having staples therein being mounted thereon, and also showing a cartride removal tool in the background;

FIG. 10 is an enlarged edge view of the structure of FIG. 9;

FIG. 11 is a further-enlarged side sectional view of a cartridge with staples therein mounted in the jaws of a pliers-like clamping tool before the pliers-like clamping tool has been manipulated to begin closing the staples;

FIG. 12 is an isometric view of one of the staples in the cartridge of FIG. 11;

FIG. 13 is a view similar to that of FIG. 11, but with cartridge jaws thereof having been closed to some extent by jaws of a pliers-like clamping tool;

FIG. 14 is an isometric view of one of the staples in the cartridge of FIG. 13;

FIG. 15 is a view similar to that of FIGS. 11 and 13, but with the cartridge jaws being closed to a greater extent and the staples therein being rolled up from their ends to a greater extent;

FIG. 16 is an isometric view of a staple mounted in the cartridge of FIG. 15;

FIG. 17 is an isometric view of two blood vessels which have been anasomosed, end-to-end, with a prior-art stapler;

FIG. 18 is a side sectional view of two pieces of tissue having their edges everted to form a flange which is inserted into the mouth of a staple of the assembly of FIG. 1 before the staple has been closed by the cartridge and pliers-like clamping tool thereof;

FIG. 19 is a view similar to FIG. 18 in which the staple has been closed the cartride and pliers-like tool;

FIG. 20 is a isometric view of two blood vessels being anastomosed, a plurality of staples of the type shown in FIGS. 18 and 19 having already been applied to suture vessel wall edges together;

FIG. 21 is an outside isometric view of an anastomosed seam with six staples of this invention having been applied to form the seam;

FIG. 22 is an isometric view showing two blood vessels anastomosed along a seam by staples of this invention; and.

FIG. 23 is an isometric close up view of staples of this invention applied to a seam, with portions of one staple embedded in tissue being shown in phantom.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the drawings, and particularly to FIG. 1, a tissue suturing assembly 10 of this invention includes a pliers-like clamping tool 12, a plurality of cartridges 14 selectively mountable on the pliers-like clamping tool 12, and a plurality of C-shaped staples 16 being mounted in the cartridges 14. Generally, when a staple-loaded cartridge 14 is mounted on the pliers-like clamping tool 12, the pliers-like clamping tool 12 is manipulated to apply the C-shaped staples 16 onto tissue as will be described below. The pliers-like clamping tool 12 is then manipulated to open the cartridge 14, thereby releasing the applied staples 16 and the unloaded cartridge 14 is removed from the clamping tool 12. A new loaded cartridge is then mounted on the pliers-like clamping tool 12 and a staple or staples therein are applied to tissue. Describing first the cartridge 14, with particular reference to FIGS. 2-6, the cartridge 14 is comprised of a carrier 18 (FIG. 3) for defining a linear track and two opposite cartridge jaws 20 and 22 for moving linearly on the linear track. With regard to the carrier 18, the track thereof includes three parallel rails 24, 26, and 28 defining slots 30 and 32 therebetween and being joined at their middles by cross supports 34 and 36. Each slot 30 and 32 is open toward opposite ends of the carrier 18 but is closed in the middle of the carrier by the cross supports 34 and 36. Generally, each rail 24-28 is rectangular in cross section, having a flat top side 38 and a flat bottom side 40 (FIG. 4). Also, the cross supports 34 and 36 are the same thickness as the rails 24, 26 and 28 so that they form continuous top and bottom sides 38 and 40 with the rails 24-28. However, there are stops 42 and 44 located at opposite ends of the carrier 18 which break the plane of the bottom side 40 as can be seen in FIG. 4. In the top side 38 of each rail is located an elongated indentation, or slot, 46, 48 or 50 whose depth is about the same, or slightly greater, than the thickness of a C-shaped staple 16 so that a back section 52 of a C-shaped staple 16 will fit snugly therein. Although each of the slots 46, 48 and 50 is straight, it is on an angle to the longitudinal axis of its respective rail 24, 26 and 28 as is depicted in FIG. 6. The width of each slot 46, 48 and 50 is about the same as or smaller than the thickness of a C-shaped staple 16 so that a back section 52 of a C-shaped staple 16 is held snugly therein. In this regard, the carrier 18 has integral tabs 53 adjacent the slots 46, 48 and 50 which are pressed over the staple backs 52 to hold them in the slots 46, 48 and 50 but which thereafter deform to allow removal of the staple backs from the slots.

Looking now at the opposite cartridge jaws 20 and 22, it will be understood that these elements are mirror images of one another and it is therefore only necessary to describe one of them. Each ca