Abstract:
Surgical instrumentation in the form of a clamp assembly specifically structured to position and maintain sections of blood vessels, such as veins and arteries, such that open ends of such blood vessel sections are maintained in immediately adjacent relation to one another and properly exposed so that such ends may be sutured or otherwise secured together. The clamp assembly is structured such that the vessel sections to be attached are supported and engaged both interiorly and exteriorly to insure maintenance of the respective open ends of such sections in a substantially outwardly flared and exposed position for attachment to one another.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to a surgical instrument assembly primarily designed for the attachment of blood vessel sections in a manner which assures proper placement and maintenance of open ends of vessel sections to be attached in a properly exposed and attachable position for the application of sutures or like connecting means. 
     2. Description of the Prior Art 
     Vascular surgery or surgery involving blood vessels including both veins and arteries is commonly recognized in the medical profession as being difficult. Such difficulty is due in large part to the fragile nature of the structure of blood vessels and also to the extremely small size of such vessels. Accordingly, instruments including vascular clamps have to be constructed and applied with great precision in order to prevent damage or destruction of portions of the blood vessel being manipulated. 
     Vascular surgery dealing with the attachment or reconnection of blood vessel sections is particularly difficult and frequently time-consuming due to the extreme care which must be taken in the location, positioning and maintenance of vessel sections to be attached in proper position with one another. More specifically, open ends of separated vessel sections must be disposed in aligned and engaging relation to one another and further, such open ends must be maintained in an attachable position or engagement with one another and properly exposed so that the surgeon can suture such open ends together or apply other connectng means. In order to accomplish such positioning and maintenance of the open ends in properly exposed position, many instruments currently in use in the performing of such surgical techniques are less than totally satisfactory. 
     Accoringly, there is a recognized need in the medical profession for proper surgical instrumentation particularly designed and constructed for the positioning and maintenance of blood vessel sections and open ends thereof in an attachable position which is readily exposed for the application of sutures and like connecting means to the open ends. 
     SUMMARY OF THE INVENTION 
     The present invention is directed towards surgical instruments preferably in the form of a clamp assembly which is specifically designed to embrace, position, and maintain blood vessel sections, to be attached to one another, in engaging relation and properly exposed for the application of sutures or like connecting means serving to attach such vessel sections to one another. 
     More specifically, the subject surgical instrumentation comprises a support means having an elongated supporting pin or like structure with a sharpened free end. Such pin and more specifically the elongated portion thereof is disposed on the interior of both vessel sections to be attached. A support platform is formed along the length of the elongated portion and is dimensioned and configured to extend transversely outward from the pin. The pin and the platform are positioned such that the open ends of the vessel sections to be attached engage opposite sides of the platform and are forced to flare outwardly when so positioned. 
     The positioning of the open ends of the vessel sections in the manner described is established and maintained through the provision of two sleeve elements. Each sleeve element is disposed in surrounding relation to one vessel section immediately adjacent the open end thereof. Each sleeve element is structured to define a free end of a clamp. Preferably, the clamp has outwardly extending lever arms structured and disposed to pivot about a fulcrum structure wherein one end of each lever arm is secured to a bifurcated or separable portion of the sleeve element associated with that clamp. Pivotal movement of the lever arms causes the separable sections of the sleeve element to move into and out of surrounding engagement relative to a vessel section. 
     Further, each sleeve element includes a proximal end having an outwardly flared or somewhat funnel-like configuration. This outwardly flared configuration of each proximal end of each sleeve element substantially corresponds to a correspondingly positioned side of the support platform located on the interior of the vessels and positioned to engage the interior surface of open ends thereof. Correspondingly, the interior surface of the proximal flared end of each sleeve element is textured, roughened or specifically structured to somewhat frictionally engage the exterior surface of the vessel section immediately adjacent the open end causing it to be forced and maintained on the corresponding side of the support platform of the support pin and maintained in such outwardly flared position. Maintenance of the respective open ends of the respective vessels in such position serves to position both open ends in exposed and substantially engaging orientation so as to define an attachable position of the open ends. 
     Further, an important feature of the present invention is the maintaining of the respective open ends in such outwardly flared position, while being connected, so as to prevent the formation of any restriction or narrowing of the vessel at the junction of the open ends. Such narrowing or restricted configuration would cause turbulence during blood flow and possible clotting or occlusion of the vessel at this area due to such turbulence. 
     When each clamp is properly positioned relative to the respective vessel sections so as to maintain the open ends thereof in the aformentioned attachable position, a securement means in the form of a securement pin is secured to the clamps so as to maintain such clamps in spaced apart but relatively fixed position relative to one another such that the engaged vessel section may be manipulated and generally oriented into the proper position for accomplishing securement of the open ends together. However, the placement of such securement pin serves to maintain the respective clamps in secured position about the respective vessel sections. 
     The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts which will be exemplified in the construction hereinafter set forth, and the scope of the invention will be indicated in the claims. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which: 
     FIG. 1 is an isometric view of the clamp assembly disposed in engaging relation to vessel sections being attached such that respective open ends thereof are maintained in an attachable position. 
     FIG. 2 is a top plan view along line 2--2 of FIG. 1. 
     FIG. 3 is a front elevational view showing details of a securement pin also represented in FIGS. 1 and 2. 
     FIG. 4 is a side view of a single clamp of the clamp assembly. 
     FIG. 5A is a top plan view of a supporting pin mounted on the interior of the blood vessel sections to be attached. 
     FIG. 5B is a plan view in partial cutaway showing another embodiment of the supporting pin of FIG. 5A. 
     FIG. 6 is another embodiment of a securing pin, being adjustable, and structured for adjusting attachment of the clamps to one another. 
     FIG. 7 is a detail sectional view in partial cutaway showing the structural configuration of the proximal end of each sleeve element of each clamp. 
     FIG. 8 is an isometric view of another embodiment of the present invention. 
     FIG. 9 is a sectional view taken along line 9--9 of FIG. 8. 
     Like reference numerals refer to like parts throughout the several views of the drawings. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     As clearly shown in FIG. 1, the surgical instrumentation of the present invention is generally indicated as 10 and comprises a clamp assembly designed to engage and maintain in an attachable position, blood vessel sections 12 and 14 such that their corresponding open ends 12&#39; and 14&#39; are maintained in an attachable position and exposed so that the surgeon has clear access to apply sutures or any applicable connecting means. 
     More specifically, the assembly 10 comprises a support means generally indicated as 16 having an elongated supporting pin portion 18 and an outwardly extending handle 19 preferably angularly oriented relative to the length of the elongated supporting pin 15. With reference to FIG. 5A, the free end of the elongated portion 18 as at 20 is sharpened or pointed so that it may enter a lateral zone as at 21 of one of the vessels 12 and be oriented in coaxial relation to such vessel. The elongated portion 18 is of such a length as to pass into a similar coaxial position relative to vessel section 14 so as to assume an interior supporting position as represented in broken lines in FIG. 2. The support means 16 further includes a support platform 23 having oppositely disposed and substantially angularly oriented sides 24 and 26. The platform as well as the sides 24 and 26 are dimensioned and structured to extend transversely outward from the elongated portion 18 and longitudinal axis thereof. Such angular orientation of the sides 24 and 26, when mounted on the interior of the vessel sections 12 and 14 position the overlying open ends 12&#39;  and 14&#39; in a substantially outwardly flared position as shown in FIGS. 1 and 2. As also represented therein, positioning and maintenance of the open ends 12&#39; and 14&#39; in this outwardy flared position and substantially adjoining relation to one another define an exposed, attachable position of the respective open ends wherein clear access is provided for the surgeon to secure such open ends together through proper connecting means as set forth above. The embodiment of the elongated portion 18 of support means 16 shown in FIG. 5B includes a rounded or non-sharpened point 20&#39;. When utilizing this embodiment, a small incision is made in the vessel being repaired or connected and the rounded point 20&#39; passes therethrough into the position shown in FIG. 2. 
     In order to position and maintain the vessel sections 12 and 14 in the positions represented in FIGS. 1 and 2, a clamp assembly comprising one clamp for each vessel section and generally represented as 30 and 32. As shown in FIGS. 1, 2 and 4, each clamp is substantially identically structured and includes a sleeve element 33 and 34 disposed in at least partially surrounding and engaging relation to a respective vessel section 12 and 14. The sleeve element of each clamp 30 and 32 defines an end portion thereof and is specifically designed to include a bifurcated construction comprising separable portions 33&#39; and 33&#34; as shown in FIG. 4. For purposes of clarity, detailed structural features of each of the clamps will be made with reference to specific clamp 30 as represented in FIG. 4. However, each of the sleeve elements 33 and 34 include such a bifurcated constuction and separable sleeve portions. 
     Each clamp 30 and 32 further includes two outwardly extending lever arms comprising a first portion 35 and a second portion 37. A fulcrum structure 39 is disposed in substantially sandwiched relation between the interior surfaces of the second portions 37 of each lever arm such that depression of the free ends thereof as indicated by directional arrows 36 causes a pivotal movement of the second portions 37 about fulcrum structure 39 and a separation of the separable portions 33&#39; and 33&#34; of the sleeve element 33. In one embodiment of the present invention as shown in FIG. 4, each of the clamps are specifically constructed such that the separable portions 33&#39; and 33&#34; of the sleeve element 33, the first portion 35 of each lever arm and the fulcrum structure 39 are all of a one-piece construction and may be formed in integral relation to one another. In such an embodiment, ends 39 of each second portion 37 is affixed to the exterior surface of the first portions 35 by welding, tacking, or any type connector means 40. 
     From the structure as set forth above, it is readily seen that depression of free ends of the second section 37 of each lever arm causes pivotal movement of these ends in the direction indicated by directional arrows 36. Concurrently, separable sections 33&#39; and 33&#34; are separated in accordance with directional arrows 36&#39; and the respective sleeve elements 33 and 34 may be secured in surrounding relation to the respective vessel sections 12 and 14 or removed therefrom. 
     Another feature of the present invention is the construction of each proximal end 42 and 44 to have substantially outwardly flared or at east partially funnel-like configuration as clearly shown in FIG. 7. Further, the inner surface 45 of each proximal end 42, 44, is textured so as to facilitate the engagement and maintenance of a correspondingly positioned opened end 12&#39; and 14&#39; of the respective vessel sections 12 and 14. Such &#34;textured&#34; structure of the inner surface as at 45 may be any of a number of specific structural configurations such as roughened, knurled, or ridged. The texture inner surface 45 should be capable of creating at least a minimal frictional engagement with the exterior surface of the vessel sections 12 and/or 14 so as to maintain a firm gripping engagement to accomplish accurate positioning of the respective open ends 12&#39; and 14&#39; onto the respective sides 24 and 26 of the support platform 23 of support pin 18. It should be noted however that the structural configuration of inner surface 45 should not be such as to cause damage to the exterior surface or overall structure of the open ends 12&#39; and 14&#39;. It should be further noted that the sides 24 and 26 are correspondingly configured and the angled surfaces thereof substantially correspond to and are in alignment with the flared inner surface 45 such that the open ends 12&#39; and 14&#39; may be positioned and maintained in the shown outwardly flared position and in adjoined and accessible relation to one another so as to allow the surgeon to apply applicable connecting means to secure such open ends to one another. As set forth above, such outwardly flared positioning at the junction of the open ends, after connection, is important for the purposes of eliminating any restriction at this junction and the attendant clotting and/or occlusion. 
     Once the respective clamps 30 and 32 are positioned in engaging and maintaining relation to the vessel sections 12 and 14, it is important that such clamps be maintained in their relative positions. Accordingly, a securement means 50 is provided in the form of a connecting pin 52 having a head portion 54 and a free end 55. As shown in FIGS. 1 and 2, the securement means 50 is structured and dimensioned to fit on the interior of the fulcrum structure 39, the latter being formed into an at least partially cylindrical configuration and being open as at 49 on the interior thereof. (See FIG. 4) The head portion 54 is disposed in abutting relation with the fulcrum structure 39 as associated with clamp 30. The elongated or shaft portion of the pin 52 extends between the clamps 30 and 32 and the free end 55 is specifically structured and configured to pass into the fulcrum structure 39 associated with clamp 32 and removably lock or &#34;snap-fit&#34; therein. In the embodiment of FIG. 3, this is accomplished by the free end 55 being inherently biased to allow the end sections 57 separated by elongated cutaway space 59 to be forced towards one another against the inherent bias as represented in broken lines in FIG. 3 for proper fitting into the central opening 49 of the fulcrum structure 39 associated with clamp 32. Once the end portions 57 pass through the fulcrum structure 39, the inherent bias causes their outward positioning such that annular ledge 60 abuts against the outer exposed side of the fulcrum structure 39 associated with clamp 32. 
     Another embodiment of the present invention is shown in FIG. 6 and comprises the securement means 50&#39; including connecting pin 52&#39; having head portion 54&#39; and free end 55&#39;. In the embodiment of FIG. 6, an internally threaded connector 64 passes over the free end 55&#39; and engages the externally threaded surface thereof as at 66. Once the connecting pin 52&#39; passes through the respective fulcrum structure 39 of each clamp 30 and 32, the connector element 64 is threadedly secured to the free end 55&#39; and threaded inwardly to accomplish proper tension and relative positioning of the clamps 30 and 32 in the desired orientation as shown in FIGS. 1 and 2 to maintain the respective open ends 12&#39; and 14&#39; in the aforementioned attachable position. 
     With reference to FIG. 8, yet another embodiment of the present invention, includes a clamp assembly operating in the same manner as the clamp assembly shown in FIGS. 1, 2 and 4. However, in the clamp assembly of FIG. 8, generally indicated as 10&#39;, each of the clamps 30&#39; and 32&#39; have an identical construction. Such construction comprises an integral one-piece construction wherein each clamp is formed from a plastic material and is inherently flexible. Accordingly, each clamp includes a lever arm having a free end portion 37&#39; and an oppositely disposed end portion 35&#39; integrally secured to separable sections such as 33&#39; and 33&#34; of the sleeve element 33. However, each of the lever arms are of a solid one-piece construction as versus a two-piece construction as represented in the embodiment of FIG. 1. A fulcrum structure 39&#39; is provided in sandwiched relation between the two lever arms of each clamp assembly 30&#39; and 32&#39; and is centrally apertured so as to allow passage therethrough of connecting pin 52 so as to effectively connect and maintain the two clamp assemblies in fixed, spaced apart relation to one another when vein sections or segments 12&#39; and 14&#39; are secured in the position shown. Further, the fulcrum structure 39&#39; is integrally formed in surrounding relation to the central passage 49&#39; and interconnected in the aforementioned sandwiched relation between the respective lever arms by integrally formed outwardly extending flanges 39&#34;. A biasing spring 70 is disposed between the lever arms and structured to normally force the clamp into a closed position as shown.