Hemostat And Attachment For Suturing Organic Tubular Structures

Abstract

A hemostat provided with a disposable staple-carrying cartridge movably attached thereto. The jaws of the hemostat are parted, through an opening at the forward end of the cartridge, and, for example, a bleeding organic tubular structure is positioned between the hemostat jaws. The jaws of the hemostat are closed, clamping the "bleeder" therebetween, and then the opening at the forward end of the cartridge is closed. The cartridge is subsequently moved so that the closed forward end of the cartridge is displaced away from a position surrounding the hemostat jaws and into a position surrounding the bleeder. The cartridge is activated by the surgeon, and a U-shaped staple is urged forward, made to surround the bleeder and then seals the same. After the seal, the hemostat is removed. Means are provided for preventing misfiring of the cartridge when a staple is in an improper position, or when the cartridge is exhausted of its supply of staples.

Description

BACKGROUND OF THE INVENTION

In the course of surgical operations, blood vessels are often severed, and hence it becomes necessary to seal the open ends thereof to prevent the patient from losing an excessive amount of blood. It is the general practice to use conventional hemostats to seal the open blood vessels until the surgeon can manually ligate, or "tie off" the vessels with suturing material. Recently, in an attempt to facilitate the ligation procedure, devices have been developed to mechanically ligate the bleeders and hence to facilitate the operative procedure. Examples of such mechanical devices can be found in U.S. Pat. No. 3,576,288, and copending U.S. Pat. Application Ser. No. 869,242, both being assigned to the present assignee.

In each of the two above-noted patent documents, there is disclosed a mechanical stapling apparatus associated with a hemostat. The vessel to be ligated is gripped by the jaws of the hemostat, the stapling apparatus is actuated, and a surgical staple is clinched about the vessel to seal the same. While these mechanical devices have contributed some measure in solving the problems associated with the conventional manual ligation of bleeders, all the existing problems have not been eliminated.

A significant drawback of known mechanical ligation apparatus relates to the effectiveness of the staple formation. In the known devices, there exists the threat that the staple will pierce the vessel and/or the surrounding tissue and result in the incomplete sealing thereof. A further drawback relates to the complexity of such known devices. Manufacturing tolerances are very strict, and hence it becomes rather difficult to ensure the proper functioning of the assembled device. And also related to the close tolerances, the known devices tend to be quite susceptible to shock. As an additional drawback, the known ligation devices are somewhat difficult to manipulate and operate. Moreover, an important drawback of the prior art instruments is the lack of total control over the vessel to be ligated. And still a further disadvantage of those devices known to the prior art is that the surgeon is able to activate the stapling assembly even if a staple is out of alignment or if the stapling assembly is void of staples.

It is toward the elimination of the above drawbacks and disadvantages associated with the known hemostat ligation instruments that the present invention is directed.

SUMMARY OF THE INVENTION

The present invention relates to a hemostat and an associated apparatus for clamping an organic tubular structure and ligating same with a surgical stapler in an efficient and effective manner. The inventive apparatus comprises the combination of a specially designed hemostat nd a disposable staple-carrying cartridge movably mounted thereon. The hemostat and cartridge associate in such a manner that when the cartridge is in its retracted position, the hemostat may be freely operated to clamp a "bleeder" between the jaws thereof. Then, once the structure to be ligated is properly positioned in the jaws of the hemostat, the cartridge is moved past the nose of the hemostat and around the "bleeder." Once in its stapling position, the cartridge is actuated, a U-shaped staple is urged toward the "bleeder," and by means of an anvil assembly, the staple is safely and positively clinched about the "bleeder." The cartridge is then retracted, and the hemostat is removed.

The cartridge associates with the hemostat so that the hemostat jaws are free to operate, notwithstanding the presence of the cartridge. And the cartridge jaws are adapted to close before associating with the "bleeder," thereby ensuring complete encirclement of the "bleeder" when the cartridge is in its stapling position. At the same time the mechanics of the stapling operation effectively prevents the occurrence of damage to the structure being ligated.

As should be evident, it is important that the surgeon be made aware of a jammed staple or an empty cartridge before a ligation is attempted. Otherwise, serious damage might result to the structure intended to be ligated. According to one further aspect of the present invention, means are provided in the cartridge to prevent the completion of a stapling operation in the event that the cartridge is empty. Hence, the surgeon is made aware of the need to replace the cartridge before any damage is done to the patient.

Accordingly, it is an object of the present invention to provide a combination of elements for effectively clamping and ligating an organic tubular structure with surgical staples.

It is a more specific object of the present invention to provide a combination of elements for clamping and ligating an organic tubular structure in such a manner that sealing of the structure is ensured.

It is yet a further specific object of the present invention to provide a combination of elements for clamping and ligating an organic tubular structure in a manner which avoids damage to such structure.

Another object of the invention is to provide a combination of elements for clamping and ligating an organic tubular structure in a manner which ensures complete control over the structure to be ligated.

Still a further specific object of the present invention is to provide a combination of elements for clamping and ligating an organic tubular structure, including means for preventing damage to the structure in the event that a staple is misaligned or jammed, or in the event that the cartridge is empty.

Still another object of the present invention is to provide a sterile disposable pre-packaged staple-carrying cartridge which is adapted to be movably mounted on the hemostat, the combination adapted to clamp and ligate an organic tubular structure.

Another specific object of the present invention is to provide the combination of a hemostat and a staple-carrying cartridge for clamping and ligating an organic tubular structure ensuring free operation of the hemostat when the cartridge is in its stored position and positive encirclement of the structure to be ligated when the cartridge is in its stapling position.

These and other objects of the present invention as well as many of the attendant advantages thereof, will become more readily apparent when reference is made to the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a hemostat equipped with a disposable staple-carrying cartridge designed in accordance with the teachings of the present invention;

FIG. 2 is a view of the hemostat-cartridge combination taken along line 2--2 of FIG. 1;

FIG. 3 is a view similar to FIG. 2 illustrating one stage in the operation of the inventive hemostat-cartridge combination;

FIG. 4 is a view similar to FIG. 3 illustrating a later stage in the operation of the inventive hemostat-cartridge combination;

FIG. 5 is a view similar to FIG. 4 but showing the inventive hemostat-cartridge combination in still a later stage of its operation;

FIG. 6 is a front view of the inventive hemostat-cartridge combination;

FIG. 7 illustrates the placement of a staple about a "bleeder;"

FIG. 8 is a view illustrating a hemostat-cartridge combination designed in accordance with a second embodiment of the present invention;

FIG. 9 is a view similar to FIG. 8, but showing the hemostat-cartridge combination in a later stage of its operation;

FIG. 10 is a cross-section of the inventive cartridge taken along line 10--10 of FIG. 8; and

FIG. 11 is an enlarged cross-section of the failsafe structure in the inventive cartridge.

DETAILED DESCRIPTION OF THE DRAWINGS

With reference first to FIGS. 1 through 6, the structure of the first embodiment of the inventive hemostat-cartridge combination will be described. The inventive combination is shown generally at 10 and comprises, basically, a hemostat 12 and an attached disposable staple-carrying cartridge assembly 14. The hemostat 12 comprises a pair of handle portions 16 and 18 integral, respectively, with jaws 20 and 22. A pivot pin 24 maintains the hemostat elements as a unit, and a conventional multi-position lock 26 on the handle portions 16 and 18 allows the hemostat to be clamped in any desired position.

The cartridge assembly 14 is of two-piece design. The first is a mounting element 28 which is removably fastened on the hemostat 12. The second is a staple-carrying cartridge 30 slidably mounted on element 28. Four pins 32 are fixed with respect to the cartridge 30 and are adapted to associate with slots 34 in the mounting elements 28 to guide the cartridge 30 during its movement relative to the mounting element 28 and the hemostat 12. It should be noted that the slots 34 substantially parallel the gripping jaws 20 and 22 of the hemostat 12.

With particular reference now to FIGS. 1, 2 and 6, the association between the mounting element 28 and the hemostat 12 will be described. The rear portion of the mounting element 28 takes the form of an elongated extension 36 terminating in a pair of clips 38 adapted to grip the handle 16 of the hemostat 12. A leaf spring 40 is positioned between the inner surface of extension 36 and the elongated handle portion 16 of the hemostat 12. The side of the mounting element 28 opposite the extension 36 is represented by the numeral 42 which, as best seen in FIGS. 1 and 6, is bent at 44 so as to contact the jaw 20 of hemostat 12. In this manner, the integral handle portion 16 and jaw portion 20 of the hemostat 12 is held between the leaf spring 40 and the surface 44 of the mounting element 28.

The extension 36 of mounting element 28 is supported by an intermediate section 46 which, as can best be seen in FIGS. 1 and 2, is cut back at 48. In this manner, the nose portion 22 of the hemostat 12 is free to open and close without interference from the mounting element. Forward of the intermediate region 46, and defining the respective slots 34, is an upper guide plate 50. A parallel guide plate 52 extends from the mounting element side 42 and serves to define thelower slot 34. The manner in which the plates 50 and 52 guide the cartridge 30 can be seen in FIG. 6.

With reference now to FIGS. 10 and 11, the specific configuration of the cartridge 30 will be described. In this connection, attention is directed to U.S. Pat. Application Ser. No. 64,749 and U.S. Pat. No. 3,665,924, each assigned to the present assignee. In each of these documents, there is described a method and an apparatus for performing a double ligation of tubular structures in an extremely safe and efficient manner. Generally speaking, this is accomplished by the C-shape formation of staples about the tubular structure to be ligated. The cartridge forming a part of the present invention is similar in many respects to the cartridge disclosed in the prior art patent documents.

The inventive cartridge 30 generally comprises a main body 54, preferably of plastic, a three-piece rail assembly 56, the forward nose of which defines an anvil 58, and a staple pusher and ejector 60. The cartridge 30 is further provided with a first leaf spring assembly 62 fixedly attached to the plastic main body 54, and a second leaf spring assembly 64 fixedly attached to the rail assembly 56. A number of surgical staples 66 are housed in the cartridge 30 and are adapted to travel, initially, in a feed track 68, and then in an ejection track 70. And as is the case with the cartridge disclosed in U.S. Pat. No. 3,665,924, the staples are indexed and moved from the feed track 68 to the ejection track 70 for each cycle of operation and by means of the cooperating leaf spring assemblies 62 and 64.

As best seen in FIGS. 1 and 3, the inventive cartridge 30 is fit with a closure sleeve 72 integral with the rear portion of the rail assembly 56. A lock 73 is defined in the forward portion of the closure sleeve 72. The cartridge 30 is also provided with a plunger 76 which associates with the rear portion of the pusher 60. As will be more fully explained below, the closure sleeve 72 and the plunger 76 control, respectively, the rail assembly 56 and the pusher 60, and hence control the operation of the cartridge 30.

With specific reference now to FIGS. 1 through 5 and 11, the operation of the inventive hemostat-cartridge combination will be described. With the closure sleeve 72 in its forwardmost position (FIG. 1), the rail assembly 56 is spaced from the main body 54 and hence defines a gap 78 in the forward end of the cartridge elements. With the cartridge in this position, the hemostat 12 is opened, with the upper jaw 22 passing through the cartridge gap 78 and into the position illustrated in phantom in FIG. 1. Then, the "bleeder" 80 is located and is clamped between the jaws of the hemostat as illustrated in FIG. 2.

Once the "bleeder" is properly secured between the jaws of the hemostat 12, the surgeon pulls back on trigger 74, in the direction of arrow 81 (FIG. 2), so that the rail assembly 56 moves toward the main body 54 of the cartridge 30. The surgeon continues this movement until the gap 78 is completely closed (FIG. 3), and the lock 73 engages the body 54 of the cartridge 30.

With the jaws of the cartridge 30 locked in the closed position, the surgeon slides the cartridge along the slot 34 and in the direction of arrows 84, into the position illustrated in FIG. 4. As should be evident, and because the cartridge jaws are closed when the cartridge is moved about the "bleeder" 80, there is always complete control over the position of the "bleeder" relative to the jaws of the cartridge. Hence, the "bleeder" will always be completely closed by the action of the surgical staple.

The next step in the operation occurs when the surgeon applies a force to the plunger 76, in the direction of arrow 86. In this manner, the pusher 60 moves toward the front of the cartridge 30 and slides the forwardmost staple 66 along the ejection track 70 and the rail assembly 56 ultimately forming the staple 66 around the "bleeder" 80 and against the anvil 58. At this stage, the combination takes the form illustrated in FIG. 5. The staple, as is more fully described in U.S. Pat. No. 3,683,927, takes a C-shape and hence ensures complete sealing of the "bleeder" 80 while minimizing the risk of injury thereto. A stapled "bleeder" is illustrated in FIG. 7.

After the stapling operation is completed, the surgeon retracts the plunger 76, unlocks and advances the closure sleeve 72, and then opens the hemostat jaws 20 and 22 thereby releasing the fully stapled and sealed "bleeder" 80. The cartridge 30 is indexed, as is fully described in U.S. Pat. No. 3,665,924, when the rail assembly 56 is moved away from the main body 54. This movement causes the forwardmost staple in the feedtrack 68 to move into the ejection track 70 in readiness for the next stapling operation, while each remaining staple in the feed track advances to the next forward position.

With reference now to FIGS. 8 and 9, a second and simplified embodiment of the inventive hemostat-cartridge assembly will be described. In this embodiment, the hemostat 12' is equipped with a mounting element 28' identical in most respects to that illustrated in FIGS. 1 through 6. A cartridge 30' also similar in most respects to the cartridge 30 illustrated in FIGS. 1 through 6, is positioned on the mounting element 28'. In this embodiment, the mounting element 28' is equipped with a tab 88 which, by means of pin 90, pivotally secures the cartridge 30' to the hemostat 12'. It should be noted that the jaws 92 of the hemostat 12' are shaped so that the cartridge 30' may pivot from the position illustrated in FIG. 8 to the position illustrated in FIG. 9 without interference from the jaws.

The inventive hemostat-cartridge combination illustrated in FIGS. 8 and 9 operates similar to the combination illustrated in FIGS. 1 through 6. With a gap defined between the main body 54 and the rail assembly 56, the hemostat jaws 92 are opened. The "bleeder" is then positioned between the jaws, and the jaws are closed. Next, the trigger 74 is retracted, and the gap closed and locked in position. Then, the cartridge 30' is pivoted, in the direction of arrow 94, so as to take the position illustrated in FIG. 9. At this point, the plunger 76 is advanced and the pusher 60 ejects and forms the forwardmost staple 66 about the 37 bleeder" 80.

Upon completion of the stapling operation, the plunger is retracted, the lock on the closure sleeve 72 is released, and the sleeve 72 is advanced. Then, with the rail assembly 56 again spaced from the body 54 of the cartridge 30', the hemostat jaws are opened and the stapled "bleeder" is released.

As with the embodiment of the invention illustrated in FIGS. 1 through 6, and in view of the fact that the cartridge is positioned about the "bleeder" with the cartridge jaws closed, the embodiment of the invention illustrated in FIGS. 8 and 9 ensures full control over the "bleeder" in all stages of the positioning and stapling operations. And because of the cartridge design and stapling method, the embodiment of the invention illustrated in FIGS. 8 and 9 also ensures that the "bleeder" is effectively stapled without the fear of damage thereto.

As noted previously, a drawback of the prior art hemostat staplers is that a full stapling operation may be carried out by the surgeon even though a staple is misaligned in the cartridge or the cartridge is void of staples. The inventive cartridge, as will be more fully explained below, is provided with a fail-safe feature to block the full operation of the cartridge unless a properly aligned staple is present in the ejection track 70. This feature of the inventive cartridge will become clear when reference is made to FIGS. 10 and 11.

The fail-safe feature of the inventive cartridge depends upon the interaction of a spring stop 96, the pusher 60 and a staple 66. The spring stop 96 takes the form of an elongated leaf spring adapted to fit, at its rear region, about a projection 98 in the cartridge body 54. Preferably, the projection 98 is integral with and molded simultaneously with the main body 54. At the forward end of the spring stop 96 is a cup-shaped extension 100 having a shape substantially conforming to that of the forward face of the pusher 60. At rest, the spring stop 96 is biased into the ejection track 70 and takes the position illustrated in phantom in FIG. 11.

The operation of the fail-safe mechanism embodied in the inventive cartridge is as follows. With the jaws of the cartridge closed and the plunger 76 activated, the pusher 60 advances in the direction illustrated by arrow 102 of FIG. 11. The pusher freely advances until contact is made with the rear face of the forwardmost staple 66 which, as shown in FIG. 11, lies in the ejection track 70. Then, the pusher 60 advances the forwardmost staple 66 until the bridge 104 thereof contacts the cup-shaped extension 100 of the spring stop 96. While the staple 66 advances, its bridge 104 cams the extension 100 out of the ejection track 70 and into the position illustrated in solid lines in FIG. 11. The pusher 60 continues its forward journey until the staple 66 is ejected from the cartridge and formed about the "bleeder."

In the event that the cartridge 30 is void of staples, of if a staple is out of alignment in the cartridge, the operation of the inventive hemostat-cartridge combination is varied. Under such circumstances, the pusher 60 is prevented from making its full forward thrust, and is hence prevented from contacting and injuring the "bleeder" clamped between the jaws of the hemostat. Without the action of a staple camming the cup-shaped projection 100 of the spring stop 96 out of the ejection track 70, the forward face of the pusher 60 is captured by the projection 100. In the absence of a staple in the ejection track, the spring stop 96 remains in the position illustrated in phantom in FIG. 11. Accordingly, the inventive fail-safe mechanism ensures that the pusher 60 is blocked from the "bleeder" 80 in all circumstances except when the cartridge houses a properly aligned staple in the ejection track.

The foregoing description and drawings have been presented for illustrative purposes only and are not intended to limit the present invention in any way. All reasonable modifications not specifically set forth are intended to be included within the scope of the present invention which is to be limited only by the following claims.

Claims

What is claimed is:

1. The method for ligating tubular structures and tissue masses with surgical staples while the structures to be ligated are clamped between the clamping jaws of a hemostat, and wherein a staple-carrying cartridge is moveably mounted on one of two pivotally connected arms of the hemostat, wherein the cartridge has a closeable opening adapted to surround the clamping jaws of the hemostat at the end adjacent said clamping jaws, the closeable opening allowing for the free passage of the second of the hemostat arms when the closeable opening is open, the method comprising the steps of: clamping a structure to be ligated between the clamping jaws of the hemostat so as to temporarily close the structure; closing the closeable opening in the cartridge so that the closeable opening completely encircles the clamping jaws of the hemostat; moving the closeable opening along the jaws of the hemostat, past the respective ends thereof, and about the temporarily closed structure; and ejecting a surgical staple from the cartridge and clinching the same about the structure clamped between the jaws of the hemostat so as to permanently close the structure with a surgical staple.

2. The method recited in claim 1, wherein the cartridge is pivotally moved with respect to the hemostat.

3. The method recited in claim 1, wherein the cartridge is linearly moved with respect to the hemostat so that the longitudinal axis of the cartridge remains parallel to the longitudinal axis of the hemostat arms.

4. The method recited in claim 1, and further comprising the steps of: blocking the ejection and clinching of the surgical staple if the staple is out of position in the cartridge or if the cartridge is devoid of staples.

5. The method recited in claim 4, wherein said blocking means comprises a spring member biased toward the plane of the ejecting and clinching means and adapted to be biased out of said plane by a surgical staple.