CA1208094A

CA1208094A - Method and apparatus for anastomosing blood vessels

Info

Publication number: CA1208094A
Application number: CA000421934A
Authority: CA
Inventors: Harry P. Weinrib; Robert R. Schenck
Original assignee: Individual
Current assignee: Individual
Priority date: 1982-02-18
Filing date: 1983-02-18
Publication date: 1986-07-22
Also published as: US4553542A; WO1983002886A1; JPS59500301A; EP0103005A1; EP0103005A4; US4474181A

Abstract

METHOD AND APPARATUS FOR ANASTOMOSING SMALL BLOOD VESSELS
ABSTRACT OF THE DISCLOSURE
To effect a simple anastomosis of a pair of severed blood vessel portions in a manner which insures patency of the anastomozed blood vessel, a member, preferably in the form of a ring, has means for tethering the blood vessel portions thereto under radial stress with the intima of the blood vessel portions apposed. During surgery, the ring is disposed around an end of one of the severed blood vessel portions, and the blood vessel portions are tethered to the ring at at least three spaced apart locations stressing the blood vessel portions radially outward in several directions to evert the intima and hold the intima of the two portions against each other.
To hold blood vessel portions in close proximity during anastomosis, a pneumatic clamping device is provided which grips the blood vessel portions with a precise force according to the fluid pressure supplied thereto. Precise control of gripping force assures a firm grip that is not excessive and does not damage the blood vessel portions. Preferably a portion of the clamping device is integrally formed with the ring and is frangible therefrom permitting the clamping device and ring to be prepackaged in a sterile container with the ring prepositioned relative to the clamping device and separated upon completion of the anastomosis.

Description

1.

METHOD AND APPARATUS FOR AN~STOMOSING BLOOD VE~SELS

The pre~ent invention relates to methods and apparatus for ~oining severed ends of blood vessels.
Among the important and time consuming tasks in surgical procedures is the anastomosis or joining of severed blood vessels, and the success of a surgical procedure may depend on the degree of circulation which is restored through such anastomosis. Anastomosing of blood vessels is a tedious procedure, particularly in blood vessels of small diameter including blood vessels less than one mm. in diameter. Conventional blood vessel suturing techniques are time consuming, extending the duration of a surgical procedure and successful anastomosing of blood ve_sels is highly dependent on the proper placement of sutures by the surgeon. Particular difficulty is o~ten encountered in anastomosing children's vessels which are small and prone to spasm.
~o To aid in anastomosing blood vessels, implantable devîces which connect severed ends of blood vessels have been described previously, e.g., U.S.
Patent Nos~ 3,254,650 and 4,055?186, British Patent Specification No. 1,181,563, German Fed. Rep. Patent No.

2,101,282 and Nakayama et al. Surgery December 1962, pp.
918-931. Devices have also been described for everting severed ends of blood vessels to facilitate their suturing, e.g., U.S. Patent No. 2,180,337. The need continues for improved methods and apparatus for anastomo~in~ blood vessels, particularly tiny blood vessels~
Blood vessels of all but the largest size, i.e., the aorta and vena cava în humans, have a naturally occuring contractility, identified as circumferential compressive stress, that resists dilation. These forces become proportionately larger as the vessel diameter decreases and the relative wall thicknes~ increases~ Radial tethering forces of tissues do exist around the vessel, but these are o lesser significance than longitudinal vessel motion tethering.
Successful suturing of blood vessels does not assure their ~ontinued patency, i.e., their ability to conduct blood flow. Thrombosis (clotting of blood) may act to block blood flow through an anaætomosed vessel.
In addition to inaccurate placement of ~utures, several other factors--spasm, stenosis, and microclamp damage--may be additive in causing thrombosis after microvasuclar repair. It has been found that continuity of flow during the first twenty minutes after anastomosiE is critical in preventing ~hrombus formation. It has al80 been found that platelet aggregation, and later resolution occur~ in the first several hours after a microvascular ana~tomosis.
It is a general object of the present invention to provide methods and apparatus which simplify surgical anastomosis techniques and which effect an anastPmosis with substantial assurance of patency.
Herein, an external ring is provided which is placed around one end of a blood vessel portion to be joined. ~eans, such as sutures or hooks, are provided to radially tether the blood vessel portions to the ring at various circumferal locations to apply outward radial tress to the portions. The tethering holds the intima of the severed end~ together forming a fluid-tight seal and promoting healing while minimizing both the number and exposure of the sutures, thereby reducing the likelihood of significant thrombosis occurring at the anostomosis site. The outward radial stress maintains an open blood flo~ passageway at the junction during healing.
Anastomosis of severed blood vessel portions reguires that the severed portions be held in close proximity to permit the surgeon to perform the necessary ~oining operation. A fre~uently used type of clamp for thiE purpose consists of a pair of sprlng clamp~ mounted at spaced apart intervals along a bar, ea~h clamp pinching one of khe severed blood vessel portions to hold them in place Eor anastomosis. The force with which the clamps grip the blood vessel must be sufficient to hold them in place, and generally the clamp must exert about 15 gm~ pressure. On the other hand, excessive pressure of the metal clamps will damage the blood vessel portions and it is considered very undesirable that a clamp exert over about 35 gm.
pressure to the blood vessel~ Thus the clamp should grip the blood vessel portions applying pressure within a very narrow range that is difficult to achieve with conventional microclamps.
It is another general object of the invention to provide clamping devices whose gripping force can be precisely adjusted to grip the blood vessel with a predetermined amount of force and with less damage to the blood vessel.
The clamping device comes into intimate contact with the internal regions of the body and must be presterilized. During surgery the anastomosis device must be positioned relative to the clamping device.
Time could be saved during surgery if the anastomosis device were prepositioned relative to the clamping device.
It is another general object of the invention to provide an anastomosis device which is attached to a clamping device prepositioned therein and easily removable from the clamping device after surgery so that the clamping device can be disposed of.
The invention provides apparatus for anastomosing a first living vessel of an external diameter having a prepared end and an open ~irst passageway therein to a second living vessel having a second passageway and a prepared opening. The apparatus comprises a substantially encircling anastomosis member of biocompatible material having an internal wall with , .~ ,~ I

- 3a -at least three locations spaced from the axial center of the member a distance at least about 50~ greater than the external radius of the first vessel prepared end.
At least three stretching connecting means are spaced circumferentially about the anastomosis member and connected thereto ~or joining the end of the first vessel and the second vessel to the encircling member at the locations with the end of the first living vessel stretched radially outward to tent the same to enlarge the passageway therein and to assist in holding the end of the first vessel in sealing apposition against the second vessel. The encircling member is sufficiently rigid to maintain its shape while serving as the sole support of the joined vessels connected thereto.
These and other objectives and advantages of the invention will become more apparent from the following detailed description of the invention in reference to the accompanying drawings in which:
FIGURE 1 is a perspective view of an anastomosis ring, embodying various ~eatures of the invention, disposed around a severed end o~ a blood vessel portion and sutures threaded through two blood .~

~931~

vessel end portions to be anastomosed;
F~GURF, 2 is a perspecti~e view of an anastomosis ring of FIGURE 1 showing ~he sutures tied to connect the blood vessel end portions by sutures:
FIGURB 3 is a perspective view of the ring of FIGURE 1 with the suture~ tethered to the ring:
FIGVR~ 4 is a plan view showing one of the two ~evered ends ~tured and tethered to the ring;
FIGURE 5 is a bar graph representing patency of rat blood ve~sels ~utured using the ring of the present invention as compared with suturing by conventional techniques;
FIGURE 6 is electron micrograph of a rat's blood vessel which has been severed and rejoined by the method and apparatus of the present invention;
FIGURE 7 is a perspective view of an alternative embodiment of an anastomosis zing ha~ing means for tethering four blood ve~sel-connecting sutures;
FIGURE 8 is a perspective view of an end of one blood vessel prepared for anastomosis to a prepared side of another blood veEsel;
~IGURE 9 is a perspective view of the end-to-side anastomosis performed with the ring of FIGURE 7 on the prepared blood vessel of FIGURE 8;
~IGURE 10 is a photo micrograph o~ an end-to-side rat blood vessel anastomosis;
~IGURE 11 is a perspective view of a further alternative embodiment of an anastomosis ring having pxeattached s~tures and surgical needles;
FIGURE llA is a perspective view of the ana~tomosis ring of FIGURE 11 w~th a pair of blood vessel portions ~utured thereto;
FIGURE 12 is a perspectiYe view of the suture and surgical needles of FIGURE 11;
FIGURE 13 is a perspective view of a still further embodiment of an anastomosis ring;

FIGURE 14 is a perspective view of the suture ring of FIGURE 13 having one blood vessel end portion tethered thereto;
FIGURE 15 is a perspective view of the suture 5 ring of FIGURE 13 having two blood vessel end portions tethered thereto;
FIGURE 16A is a further alternative embodiment of an anastomosis device having a triangular configuration;
FIGURE 16B is a further alternative embodiment of an anastomosis device having a square configuration;
FIGURE 16C is a fragmentary perspective view of a still further embodiment of an anastomosis device having a triangular configuration and a protuding 15 hooking means;
FIGURE 17 is a perspective view of an anastomosis ring attached to a pneumatic or hydraulic clamping device embodying various features of the present invention, a pair of blood vessel portions shown 20 clamped thereto;
FIGVRE 18 is an exploded perspective view of parts of an alternative embodiment of a pneumatic or hydraulic clamping device shown in FIGURE 19;
FIGUR~ 18a is a reduced size cross-sectional 25 view taken through the device of FIG~RE 19.
FIGURE 19 is a perspective view of another embodiment of the invention.
In accordance with the present invention, severed blood vessel portions are ~econnected with 30 outward radial stress applied to the blood vessel at the anastomosis site to keep blood flow passageways dilated and otherwise maintain patency of the connected blood vessel portions. The portions are anastomosed by placing an external (to the blood vessel) member 10 35 around an end 12a of one of the severed blood vessel portions 12, tethering the portions 12a, b, at three or -5a-more locations with means such as sutures 14 or hooks 214 (FIG. 13) to radially outwardly stress the vessel portions everting their intima and holding their intima in fluid-tight apposition. (It is to be understood that 5 the blood vessel portions need not originally be portions of the same blood vessel).

.:

The member 10, illustrated in FIG. 1, is in the form of an annular ring formed of material which is biocompatible for implantation in a living body of an animal, such as a human~ The ring 10 has means 19, such as grooves or notches, at spaced-apart locations for tethering sutures 14~ The tethering of the connected blood vessel 12 not only holds the blood flow passageway 20 open but dilates the blood vessel portions at the ana~tomosis site enlarging the blood flow passageway, thereby reducing the ~hance of thrombosis occurring and clogging the passageway. The stretching also serves to evert the interior ~urfaces or intima 22 of the blood ve~sel tightly appocing the intima to aid prompt healin~.
The annular ~hape of the ring 10 corresponds to the generally circular cross section of blood vessels 12. In order to provide for stretching of the connected blo~d vessel end portions 12a, 12b toward the ring, the interior surface 16 of the ring has an inside diameter at least 25 percent longer than the outside diameter of the blood ve~sel which the ring is adapted to Eurround, and preferably the inside diameter of the ring is between 50 percent and 200 percent larger than the diameter of the blood vessel Although there is no inherent upper llmit on ring size as compared to the size of the blood ve~sel for anastomosis purposes, the ring, being a foreign object within the body, is preferably as small as possible consistent with suture attachment providing radial tethering stress~ The ring need be no longer or no thicker than is consistent with its structural integrity.
External anastomosis rings 10 may be formed of any material of sufficient ~trength to support the tethered blood vessels and i8 biocompatible or can be made biocompatible with an appropriate coating.
Suitable biocompatible materials include but are not limited to stainless steel, graphite, pyrolytic carbon, tungsten, tantalium and polymeric material, such as polytetrafluorethylene. In a preferred embodiment, the ring 10 is formed or a material, which is not only ~2~)8~

biocompatible bu~ is di~solved or otherwise degraded after a period of time by the body of the animal.
Suitable biocompatible materi~ls for rings which are dissolved or degraded after a healing period include collagen, polyglycolic acid, polylactic acid and combinations of polyglycolic and polylactic aoid.
The attachment means 19 provided at spaced-apart locations on the ring 10 facilitate tethering of the su~ures 14 to the ring and maintain the positioning of suture ties 26 (FIGURE 3) around the ring. At least three such attachment means 19 are provided for tethering the connected blood vessel ends 12a,b at three locations and so insure an open passageway 20 in the connected, tethered blood vessel.
The attachment means 19 are preferably evenly spaced, an arrangement which maximizes the passageway size for the number of sutures used, for example, if three attachment means are used, they are disposed about 120 apart around the ring. Increasing the number of attachment means 19, to which are tethered a corresponding number of sutures, tends to enlarge the passageway 20 at the anastomosiE #ite while permitting the use of a ~maller tethering ring; however, each additional suture increases the time needed for anastomociE, and accordingly, it is preferred for smaller ~lood vessels, that only three attachment means 19 be provided for tethering three sutures 14. However, ~or larger blood vessels, a ring having up to six or more attachment means might be provided~
In the embodiment illustrated in FIG 1, notches 19 in the ring 10 provide the means for attaching and positioning the sutures 14 during tethering. Three pairs of notches 19 are illustrated~ the notches of each pair being formed in opposite ends of the ring lOo Notches 19 are simply formed and conveniently utilized during surgery, re~uiring no threading or other tedious and time consuming techn~gues~ The surgeon need not lZ0~4 tether the sutures 14 initially in the notches 19 but may shift loosely tethered sutures into the notches after the tie8 26 have been initially knotted around unnotched portions of the ring 10.
5To end-to-end anastomose a blood vessel 12, the end portions of the blood vessel are prepared for suturing in a medically acceptable manner, and the ring 0 i6 placed around one of the severed ends 12a as seen ~n FIGURE 1. The suture~ 14, corresponding in number to the notches 19, are then threaded through the walls of the blood vessel portions at spaoed apart locations (FIGURE 1), each suture being threaded through both of the severed end portions 12a,b in adjacent circumferential locations. The threaded sutures are then tied into a knot 30 [FIGURE 2) connecting the severed end portions 12a,b of the blood vessel and leaving a free end 32 of ea~h suture with sufficient length for tethering to the surrounding ring 10.
Thereafter, the free ends 32 of the sutures 14 are looped around the ring 10, drawn outward to pull the blood vessel end portions radially outward toward the ring and tied into knots 26 located within the notches 19. The tethered euture~ 14 stretch the blood vessel end portions 12a,b providing a polygonal blood passageway, e.g., ~here three sutures are u6ed, the passageway is generally triangular as best seen in FIGURE 4. Bec~use the walls of the blood vessel portlons 12a,b are stretched, the blood vessel end portions are dllated, and the polygonal opening provides a blood flow passageway 20 which is typi~ally as large or larger than the natural circular passageway of the blood vessel.
The ~tretching of the blood vessel portions ~y the tethering sutures 14 also everts the intima 22 of the blood vessel end portions 12a, 12b and hold them in tight apposition to each other, as seen in FIGURE 4, so that a fluid-tight seal is formed therebetween, and flowing blood primarily contacts the intima of the connected blood vessel end portions. Fewer suture 14 are used than are generally used in conventional anastomosis techni~ueE, and the tenting effect achieved by tethering minimi~es the exposure of the sutures 14 to flowing blood, thereby reducing suture-induced thrombosis.
Illustrated in FIGURE5 7-9 is an end-to-side anastomosis, ~uch as may be used to form a shunt between one blood vessel portion and another. The illutrated anactomosis uses an anastomosis ring 10' having four notch pairs 19' spaced 90 from each other for attaching ~our tethering sutures 140 In this case, a prepared end portion 12c of one blood vessel is connected to another blood vessel portion 12d which has been prepared for ana~tomosis by cutting a generally circular opening 60, substantially the same size as the passageway 22, through side wall of the blood vessel end portion 12c.
The interior diameter o~ the ring 10' i6 significantly larger than the exterior diameter of the blood vessel end portion 12c so that when the blood vessel portions 12c,d are ~oined, the ring is ~paced radially outward from the anastomo~is site, whereby the tethering sutures 14 apply outward radial stress to the connected portions.
Four discontinuou~ sutures are used ~o connect the prepared portions 12ctd (FIG. 8) by threading them throuyh locations, indicated at A, B, C, and D, generally evenly spaced around the circumference of the end portion 12c and corresponding locations A', B', C', and D', generally evenly spaced around the opening 60.
The sutures 14 are tied to connect the vessel por~ions 12c,d and then tethered to the four pairs of notches 19' to form the generally ~quare anastomosi s illustrated in FIG~RE 9.
Further convenience for the surgeon permittin~
faster ~urgery i6 provided by pre-attaching sutures 101 and needles 102 to an anastomosis ring 100 ~8 .. .. .. . . . . . . . . . . . . .

illustrated in the embodiment shown in FIGURE 11. The ring 100 is a section of a tube formed of a bioabsorbable or biodegradable material, ~uch as polyglycolic acid, has an exterior surface 104 and an interior opening 106. ~he exterior and interior surfaces may be cir~ular, as in FIGURE 11; or they may be triangular, as ~hown in FIGURE 16Ar or they may be rectangular or square as shown in FIGUR~ 16B. At the corners of the interior opening 106, a suture holder 101 is fastened with an adherent. The ho~der is a small ~heet of paper or light plastic with two slits 108 to keep needles 102 ~FIG~. 12) with a preformed loop of suture 110. Needles 102 will be used just for one stitch and disposed 80 it can be made from the hard plastic or steel. When the needle end 103 has been inserted and passed through the two vessel walls, it is then projected into and passed through the preformed loop 110, and when traction on the needle end and the tail 109 is given, a knot is automatically formed under the ring. The two ends are then tied around the ring in the usual fashion.
The ring 100 with four threaded sutures is packaged as a unit in a sterile manner. During surgery, the physician merely had to place the ring 100 around one severed blood veQsel end portion 112a and then pierce ea~h needle end 103 through adjacent locations of two blood vessel portions 112a, 112b, extend ea~h needle through the suture loop 110 and tie a surgical knot using the preformed loop. After the knot 114 is tied, the free ends of the suture 101 are cut to remove the needles 102, which are disposed of, and the holders 101 also may be detached and disposed of.
Three or four knots are used to tether the joined blood vessel portions 112 under radial tension to the corners of the sguare or trian~ular interior opening 106 holding the intima of the blood vesRel portions 112 in fluid tight apposition to each other. Between the . .

cOrnerB of the opening 106, the edges 118 of the dilated, joined blood vessel portions 112 are stretched So extend closely adjacent the ~ide edges 120 whereby the ring 100 and blood vessel portions mutually support each other in axial alignment helping to maintain patency of the blood vessel during healing.
Illustrated in FIGURES 13-15 is an embodiment of a suture ring 200 in which ~evered blood vessel portions 212a, 212b are intimately apposed through radial tethering without the use of sutures. Instead, the blood vessel portions are tethered to the ring 200 by means of hook. 214 integrally formed with the ring and disposed at evenly spaced locations at point~ along a circle of greater diameter than the diameter of the blood vessel portions 212. The illustrated ring ~00 has a circular exterior 210, a circular interior 218 and flat end faces 219, 220~ The hooks 214 are formed as protuberances raised from one end face 220 and have portions 222 that extend outward beyond the ring exterior 216. Each outwardly extending portion 222 has a ~oubled backed segment 224 with a po~nted end 226 for puncturing the blood vessel portions 212. Doubling the end segment 224 back ~o that the point 226 extends inward toward the body of the ring 200 orms a fish hook to hold the blood vessel portions against removal and minimizes irritation of the hooks 214 to surrounding tissue.
Because the hooks 214 are integrally formed with the ring 200, the ring cannot be fomed merely by segmenting a tubular piece of ring material, and manu~acture of the hoo~ed ring is somewhat more difiicul~ than ~anufacture of the ring embodiment~
described above. A ring 200 having integrally formed hooks 214 may be ~ormed by molding a bioabsorbable or b~odegradable material, such as polyglycolic acid. To prevent the ring material from sticking in the mold, a relea~e agent is used to coat the mold. The release agent is selected for biocompatibility so that any release agent adhering to the ring will not induce adverse reactions.
The sutureless tethering ring 200 is disposed 5 around one severed blood vessel end portion 212a with its hooked face 220 outward relative to the blood vessel end portion 212a as seen in FIG. 14 so that the blood vessel end portion extends entirely through its central opening 230. With forceps, the surgeon drapes a portion 10 of the severed blood vessel end portion 212a over one hook 214 so that the hook punctures the blood vessel wall from its exterior 232 to its intima 234. The surgeon then repeats the procedure hooking the blood vessel portion 212a at evenly spaced locations until the 15 blood vessel portion 212a is tethered under tension over the hooked face 220 of the ring 200 exposing a broad region of its intima 234. Next, the surgeon grasps a portion of the end of another severed blood vessel portion 212b and draws it over one hook 214 so that the 20 hook punctures the blood vessel portion from its intima to its exterior 232. The procedure is repeated hooking the other blood vessel portion 212b at evenly spaced locations, tethering the blood vessel portion under tensions to the hooks 214 and bringing a broad portion 25 of the intima of the blood vessel portion 212b into apposed contact with the intima 234 of the blood vessel end portion 212a that was initially tethered to the ring 200, thereby completing the anastomosis. Similar hooks can also be placed in the triangular and quadrangular 30 configurations shown in FIGURES 16A and 16B. These are shown in Figure 16C.
Illustrated in FIGVRES 16A and 16B are alternative embodiments of anastomosis devices, 270, 270' which instead of being ring shaped are configured 35 as polygons with polygonal shaped central openings 272, 272'~ The number of verticies 274' of the polygon correspond directly to the number of sutures that are to be used for tethering the connected blood vessel portions, and the su~ure~ are tethered to the verticiec of the polygon which represent the points most remote from the geometric center. Thus the embodiment of an S anastomosis device 270 shown in ~IGURE 16A is configured as an isosceles triangle and i~ used for anastomosing blood vessel portions with three sutures while the device 270' $n FXGU~E 16B is s~uare and i~ used for anastomosing blood vessel portions with four suture.
As a means for attaching the sutures, the vertices are machined to provide concave gr oove s 27 6 facing outward. Under certain circumstances, it ic found that such grooves 276 provide better resistance to suture slipping during surgery than do notches at the ends of rings. ~ike in the circular embodiments, the locations where the sutureC are attached lie along a circle of substantially greater radius than the unstretched radii of the openings of the blood vessel end portions.
An advantage of polygonal shaped devices 270, 270' over a ring ~haped deviGe is that the polygonal central openings of the devices correspond to the shape that the blood vessel ends as6ume when they are tethered under radial stress allowing an anastomosis device of minimum size to be used. A polygonal anastomosis device i selected according to the radii of the openings 80 that when stretched, the end edges of the tethered vessel portions extend to the side~ of the polygonal shaped interior opening 272.
Although s~uare and triangular devices 270, 270' are shown for tying three and four sutures respectively, polygonal devices having more vertice~ 274 for attaching additional sutures can be formed.
However, the si2e advantage relat$ve to a circular configuration diminishes as the number of vertices increase. A1EO these 6haped devices can be used for the sutureless technique by adding thereto the additional hooks 214 as shown in FIG. 15.
In accordance with another aspect of the invention, an anastomosis ring 300 is prepositioned 5 within a clamping device 301 such as that shown in FIGURE 17, which holds the severed blood vessel portions 12a, 12b in close proximity to each other. The clamping device 301 provides a pair of clamps 302, one for holding each of the blood vessel portions 12a, 12b to be 10 joined and base assembly 304 which carries the clamps 302 spaced apart a predetermined longitudinal distance.
The anastomosis ring 300 is preferably integrally formed with a member or bar 306 of the base assembly 304, connected thereto by a frangible-web 308 allowing the 15 ring 3no to be easily detached from the base bar 306 after anastomosis~
In accordance with a still further aspect of the invention, the clamping device, indicated generally at 301, for use with an anastomosis ring 300 has clamps 20 302 which are pneumatically actuated to grip the blood vessel portions 12a, 12b with a suturing force that is a function of fluid or air pressure supplied to the clamps 302.
In the embodiment of the ring 300 and attached 25 clamping device 301 illustrated in FIGURE 17, a base bar 306 is generally in the shape of a triangular prism, and the anastomosis ring 300 is similar to the ring shown in FIGURE 13 or in FIGURES 16A, or 16B. The base bar 306 and ring 300 as well as the frangible connecting web 308 30 extending between the base bar and the ring are integrally formed of bioabsorbable or biodegradable material, although only the ring is intended to be implanted in the bodyO The relative simplicity of the base bar 306 and ring 300 permit them to be formed by 35 molding followed by some minor machining of the molded device.

, ~

~z~

As a means to adjurt the axial or longitudinal spacing between the clamps 302 according to urgical requirements~ the clamps are not directly joined to the base member but are carried by a pair of end caps or hou~ings 310 which are interfitted to ~he base bar 306 and are slidable relative thereto. Thus, each housing 310 may ~e slid along the stationary bar 306 to adjust the spacing between houcings.
The pneumatically or hydraulically operated clamps 302, which each extend from a front wall 316 of the end cap~ 310, are in this instance of the illustrated embodiment of the invention generally U-shaped in order to hold or grip the blood ves~el portions 12a. The shape of each clamp 302 is defined by a rigid hollow tube 314 with a U-shaped cradle portion 315 extending from the front wall 316 of the end cap 310~ The hollow tube 314 extends through the end cap 310 above the base bar 306, and a portion 320 extends outward from the rear wall 314 of the end cap 310 providing a port means for connection to flexible tubing 322 through which a pre~surized fluid, ~uch as air, iE
introduced from a source 324. Extending forward of the end cap 310 surrounding the cradle portion 315 of each hollow tube 314 is an elongated inflatable hollow, flexible tu~e or bladder 330 to which fluid is introduced via an spen end 332 of the hollow tube 314.
The degree of inflation of each bladder 330 determines the size of the cradle 336 and thereby the force of the clamp 302 on the blood vessel portion 12. By connecting flexible tubing 322 from the rearward portion 320 of the hollow tube 314 to a conduit 322 from the pressurized fluid source 324 having a control valve 342, the gripping force cf the clamp 302 is very precisely predetermined and typically ad~usted to provide between about 15 and about 25 gm. of force. With such precise adjustment, a firm grip can be assured without danger of microclamp damage to the blood vessel portions.

During surgery, the blood vessel portion 12a, 12b to be ~oined are loosely positioned in the cradles 336 of the clamps 302 providing ~uffisient blood vessel lengths inward of the clamps to bring ~heir ends into close proximity. Then the bladders 330 are inflated by opening the valve 342 from the pressurized fluid source 324 to the degree necessary to provide the pressure corresponding to the desired gripping force of the clamps. With the blood vessel portions 12a,b clamped and the anastomosis ring 300 positioned in axial alignment with the clamp cradles 336, anastomosis is effected as described above, and upon ~ompletion, the b~adders 330 are depressurized releasing the grip of the clamps from the anastomosed blood vessel. ~he web 308 is broken, and the clamping device 301 is removedO
The clamping device 301 is prepackaged with the attached ring 300 in a sterile manner, and upon opening the package (not shown), the device 1s immediately ready for use except perhaps for a quickly effected clamp spacing ad~ustment. The simple design of the clamping device 301 allows it to be manufactured relatively cheaply, an important consideration as it is intended that the entire clamping device be disposed s~bsequent to use.
Illustrated in FIGURES 18 and 19 is another embodiment of a pneumatically or hydraulically actuated clamping device, indicated generally at 401, which provides ~or precise determination of clamping force and which may be preattached for sterile packaging to an anastomosis ring 400. A base ba~r 402 is shaped as a rectangular bar on which is sliaably mounted a pair of box-like hollow housings or chambers 403 each having a top 404, bottom 405, front 406, back 407 and a hollow rectangular interior region 408. Within the interior region 408 a pair of clamps 420 is placed. The base bar 402 is sized to fit snugly and intimately in slots 412 in the housing 403 and friction will hold the housing in adjusted positions on the base bar.

The slidable clamps 420 each include a bottom segment 422, an upwardly extending front flange 424, and an upwardly extending rear ~lange 426. The clamps 420 are interfitted to the chambers 403 with their bottom flanges 422 located over the base bar 402 with the rear flange 426 fully within the interior region ~08. A
blood vessel holding cradle 431 is defined between the chamber' 8 front wall 406 and the front flange 424 of each clamp 420.
As a means to ~lide the clamps 420 rearward within the chamber 403, an elongated inflatable tube or bladder 432 is placed between the Pront wall 406 of the housing 403 and the upward rear flange 426. When pressurized with fluid or air, the bladder expands in size and acts to move the upward rear flange 426 and sliding the clamps 420 rearward and reducing the distance between the front side wall 406 of the chambers and the front cradle flange 424. The bladder 432 is pressurized from a source 471 through a conduit 433 extending through an aperture 413 in the rear wall 407 and rear flange 426 of the clamps 420. A valve 473 in the fluid or air conduit 433 is adjustable to inflate bladder 432 to the degree necessary to obtain the desired clamping for~e.
The anastomosis ring 400 extends forwardly ~rom the base bar 402 and i 8 oonnected thereto by a frangible web 434 which holds the prepositioned r~ng 4C0 in alignment with the vessels being clamped or gripped in the respective cradles~
Clamping is preformed by positioning the blood vessel 12, in the cradles and pressurizing the bladder 43~ to effect clamping. The clamped vessQl positions 12 are anastomosed by u~e of the prepositioned ring 400, and then the clamping pressure is released and frangible web 434 broken to release the anastomosed blood vessel.
After surgery this simplistic clamping device can be disposed.

~2~8~
The clamping or gripping members are preferably formed of soft plastic tubing which provides a softer and more forgiving clamping or gripping pressure than the metal clamps heretofore used~ With the pneumatic pressure and these softer materials the pressure and force application to the blood vessels are such as should reduce damage to the latter.
The anastom~sis memhers and their surfgical uses will now be described in greater detail by way of specific example.
EXAMPLE I
~ onventional and external ring technique anastomoses were performed on the superficial epigastric arteries on alkernate sides of each of thirty male Sprague-Dawley strain rats weighing between 200 and 250 grams. Group 1 consisted of twenty external ring technique and twenty conventional technique anastomoses that ware explored at one week, and again at four to six weeks. Group 2 consisted of ten external ring tec~nique and ten conventional technique anastomoses that we.re left undisturbed until exploration at six weeks.
The rats were anesthetized with intraperitoneal pentobarbital, and the superficial epigastric artery was exposed through a transverse inguinal incisiGn.
External vessel diameters were 0~3 to 0.5 mm., measured prior to arterial isolation to avoid diameter variation induced by spasm or dilation due to smooth muscle relaxation by topical lidocaine. It was observed that an artery measuring 0.4 mm. in its undisturbed state could vary from 0.2 to 0.6 mm., from maximum vasoconstriction to maximum relaxation.
Three sutures 14 were used for the external ring technique, four to six sutures were used for the conventional anastomoses, dependent upon vessel diameter. Monofilament 100 nylon Ethilon (trademark), Ethicon (trademark), tapir point BV75 needle) was used for all anastomoses, and the operations were performed a-t 25x to 50x -19'--magnification. The pattern of arterial pulsation was observed9 and a radical patency test was performed thirty minutes after completion of each anas~omosis to confirm initial patency.
The anastomosi~ rings lU comprised 1 mm lengths of lB gauge polytetrafluorethylene tubing having pairs of trapezoidal notches 19 formed at three locations 120 apart. For the external ring technique, the blood vessel 12 was placed in an adjustable double microclamp and transected. The loose adventitia was resected and the vessel ends irri~ated with heparinized saline solution. Prevention of spasm was aided by the external application of 1% lidocaine. The ring 10 was slipped over one vessel end 12a, and three interrupted sutures 14 were placed through the full thickness of the vessel wall at 120~ intervals~ leaving the suture ends 32 untied. The vessel ends 12a,b were apprcximated by tying a surgeon' 8 knot 20, and a free end 32 of all three ~utures 14 were passed underneath the ring (FIGURE

3~. The ring 10 was centered over the anastomosis site, and each of the sutures 14 were tied around the ring 10 at the location of the preformed notches 19 ~FIGURE 4).
In crosE section, the vessel 12 then assumed a triangular pattern at the anastomosis site, with the natural elastlc forces aiding tight apposition of the edges of the vessel intima between the three sutures 14~ Distal release o~ the double microvascular clamp allowed retrograde flow, followed by proximal release and restoration of anterograde pulsatile flow.
In Group 1, all twenty externa~ ring technique arterial anastomoses were patent both at one week and a~
our to 8iX weeks. Howeverl three ~f the twenty conventional anastomoses were thrombosed at one week, and an add~tional seven were thrombosed at four to 8iX
weeks ~FIGURE 5). Even among the originally patent, in seventeen of the twenty conventional anastomoses, diminished flow during radical patency testing was '~Z0~ 4 observed as compared to flow through anastomoses effected with the external ring technique. This may have been a factor ~n the cases of la~er thrombosis.
~he difference bewteen the 50% late patency rate by the conventional technique and the 100% patency rate by the external ring technique was statistically ignificant (p O .01) .
In Group 2, all ten external ring technique arterial anastomoses were patent at ~ix weeks. In contrastp at six weeks, three of the ten conventional anastomoses were thrombosed and two o~hers demonstrated diminished flow during radical patency testing. The difference between the 70~ patency rate by the conventional technigue and the 100% rate by ~he external ring techni~ue again was stat;stically significant (P 0.02~. In neither group was there any occurrence of aneurysms, hematomas, or wound infections.
FIGUR~ 6 is a scanning elec ron micrograph portraying one o~ the patent rat anastomosis performed by the external ring technique with normal intimal healing. It will be noted that slight tipping of the ring occurred; however, in no case did such tipping impede blood flow.
EXAMPLE II
Rat inferior epigastric veins ~generally C.7 mm. in diameter) were anastomosed end-to-side to femoral veins (generally 1.5 mm. in diameter) by conventional technique~ in twenty control rats, using 6-8 sutures per anastomosis, and in an experimental group of twenty rats by the external ring technique using rings 1 mm. long of 18 gauge polytetrafluorethylene with our notch pairs spaced 90 apart. The ~urgical technique was substantially ident~cal to that used in ~xample I, except that the femoral vein~ were prepared for anastomosiE by cutting 6 mm. openings in their side wall 8~

~0810~

After five days, the control group had a 65~
success rate whereas the experimental group exhibited 100% patency (P 0.01).
FIGURE 10 is a photo micrograph portraying one S of the paten~ rat end-to-side anastomosis performed by the external ring technique with normal intimal healing.
The external ring technique provides a direct approach to overcome the vessel's inherent circumferential compressive stress, provide maximal radial tethering force~ at the site of anastomosis, and actually dilates the vessel at the very location platelet aggregation occurs in the early post-operative phase. These important factors explain the increased success rate in the difficult model of the 0.4 mm. size lS ~nferior epiga~tric artery of the ratc With any constant level o~ surgical ~kill, the success rate of microvascular repair falls as the vessel size decreases. Of course, the degree of skill ac~uired by the surgeon i5 an important factor in the 8uccess rate of microvasucl~r repair, and the use o~ the external ring technique may ~ctually ~mprov2 any given level of surgical skill.
The external ring provided by the application i~ ~imply formed and easy to use. In surgery, where several anastomoses need be performed, the external ring technique will substantially reduce the time of the operation. The multidirectional radial tethering helps to assure dilfltion of the passageway at the interconnection, and interconnect~on with a large blood passageway is generally assured. The technique draw~
the intima of the severed ends in ti~ht apposition to each other providing a fluid-tight interconnection and exposure of blood substantially entirely with the intima, reducing the chance of significant post operative thrombosi~.
The use of pneumatically actuated and adjustable clamping devices~ as described with reference to the above embodiments, permits vascular surgery with subs~antially no microclamp damage to blood vessels.
Prepositioning of the anastomosis device within the ~lamping device can be expected to significantly shorten ~urgery, particularly where a large number of blood vessels need to be joined.
While the invention has been described in terms of a preferred embodimen~, modifications obvious to one with ordinary skill in the art may be made withou~
depar~ing ~rom the scope of the invention. The embodiment of the external ring, described herein, is simple; however, modifications in ring design will be made depending upon the material used and surgical considerations. Although the invention has been described in terms of a $ully encircling member or ring, an incomplete, but substantially encircling ring member might be used instead allowing it to be slipped around the blood vessel after sutureæ have interconnected the blood vessel ends, and the tethering forces in the seqeral radial directions could be relied upon to hold such an incomplete ring in place around the blood vessel.
Various features of the invention are set forth in the following claims.

Claims

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

1. Apparatus for anastomosing a first living vessel of an external diameter having a prepared end and an open first passageway therein to a second living vessel having a second passageway and a prepared opening comprising a substantially encircling anastomosis member of biocompatible material having an internal wall with at least three locations spaced from the axial center of said member a distance at least about 50% greater than the external radius of said first vessel prepared end and at least three stretching and connecting means spaced circumferentially about said anastomosis member and connected thereto for joining the end of the first vessel and the second vessel to said encircling member at said locations with the end of the first living vessel stretched radially outward to tent the same to enlarge the passageway therein and to assist in holding the end of the first vessel in sealing apposition against the second vessel, said encircling member being sufficiently rigid to maintain its shape while serving as the sole support of the joined vessels connected thereo.

2. An apparatus according to Claim 1 with said substantially encircling member having no more than four connecting means.

3. An apparatus according to Claim 1 wherein said connecting means include at least three sutures tethering said vessels to said member.

4. An apparatus according to Claim 3 wherein said connecting means also include attachment means at said locations for positioning said sutures at said locations.

5. An apparatus according to Claim 4 wherein said encircling member has an outer wall and a pair of radially extending sidewalls between said internal wall and said outer wall, and said attachments means are indentations in said sidewalls at said locations that reduce the axial dimension of said member at said locations.

6. An apparatus according to Claim 5 wherein said attachment means are indentation pairs in said sidewalls at said locations.

7. An apparatus according to any one of Claims 1-3 with said substantially encircling member formed of material that is dissolved or degraded within a living body.

8. An apparatus according to any one of Claims 1-3 with said substantially encircling member having an annular configuration.

9. Apparatus for anastomosing a first living vessel of an external diameter having a prepared end and an open first passageway therein to a second living vessel having a second passageway and a prepared opening comprising a substantially encircling anastomosis member of biocompatible material having an internal wall with three or four connecting locations spaced from the axial center of said member a distance substantially greater than the external radius of said first vessel prepared end and a like number of stretching and connecting means for joining the end of the first vessel and the second vessel to said encircling member at said locations with the end of the first living vessel stretched radially outward to tent the same to enlarge the passageway therein and to assist in holding the end of the first vessel in sealing apposition against the second vessel, said encircling member being sufficiently rigid to maintain its shape while serving as the sole support of said joined vessels connected thereto.

10. An apparatus acccording to Claim 9 with said substantially encircling anastomosis member having three connecting means at three locations.

11. An apparatus according to Claim 9 wherein said connecting means includes three or four sutures tethering said vessels to said member.

12. An apparatus according to Claim 11 wherein said connecting means includes attachments means at said locations for positioning said sutures at said locations.

13. An apparatus according to Claim 12 wherein said encircling member has an outer wall and a pair of radially extending sidewalls between said internal wall and said outer wall, and said attachments means are indentations in the sidewalls at said locations that reduce the axial dimension of the member at said locations.

14. An apparatus according to Claim 13 wherein said attachment means are indentation pairs in the sidewalls at said locations.

15. An apparatus according to any one of Claims 9-11 with said substantially encircling member formed of material that is dissolved or degraded within a living body.

16. An apparatus according to any one of Claims 9-11 with said substantially encircling member having an annular configuration.

17. A unitary member formed of biocompatible material for microvascular anastomosis of a prepared living vessel end portion and a second prepared living vessel portion, which member is formed to substantially surround the living vessel end portion, said member having holders at at least three spaced apart locations and a suture mounted in each of said holders for tethering the prepared living vessel portions thereto, said holders being positioned generally along a circle of substantially greater diameter than the diameter of the living vessel end portion, said sutures within said holders being adapted for applying outward radial stress to the living vessel portions to dialate the living vessel portions, everting their intima and bringing their intima into fluid-tight apposition to each other.

18. A member according to Claim 17 formed of a material that is dissolved or degraded within a living animal after a period of time.

19. A member according to Claim 17 or Claim 18 wherein said ring has three to six holders at generally evenly spaced radial locations.

20. A member according to Claim 17 or Claim 18 each of said suture means comprising a length of surgical suture having a loop at one end and a surgical needle preattached to said suture at the other end.

21. A member according to Claim 17 or Claim 18 wherein each holder is detachable from said member.

22. A unitary member formed of biocompatible material for microvascular anastomosis of a prepared living vessel end portion and a second prepared living vessel portion, which member is formed to substantially surround the living vessel end portion, said member having hooks at at least three spaced apart locations for penetrating the walls of said vessel portions, said hooks being adapted for tethering the prepared living vessel portions thereto, said hooks being positioned generally along a circle of substantially greater diameter than the diameter of the living vessel end portion, said hooks being adapted for applying outward radial stress to the living vessel portions to dialate the living vessel portions, everting their intima and bringing their intima into fluid-tight apposition to each other.

23. Apparatus for anastomosing a first living vessel of an external diameter having a prepared end and an open first passageway therein to a second living vessel having a second passageway and a prepared opening, the apparatus comprising a substantially encircling anastomosis member of biocompatible material having an internal wall with at least three connecting locations that are spaced from the axial center of said member, said anastomosis member being a one-piece integral member, non-bendable hooking means integrally formed on said anatomosis member at each of said connecting locations, said hooking means being adapted for joining said first vessel end to said second vessel with said first vessel end extending through said opening and everted and with said hooking means penetrating its wall, and the wall of said second vessel being likewise penetrated by said integrally formed hooking means to hold said second vessel in sealing apposition against said everted first vessel end, said anastomosis member having an exterior surface and said member being adapted for both of said vessel ends to be secured thereto by said hooking means, said hooking means on said encircling member being sufficiently rigid to maintain their shape while the one-piece integral member is serving as the sole support of said opposed vessels connected thereto.