VASCULAR GRAFT AND BLOOD SUPPLY METHOD

ÆB381.53 -IVASCULAR GRAFT AND BLOOD SUPPLY METHOD FIELD OF INVENTION:

The invention relates to implants used in the body to replace natural blood vessels to supply arterial blood to organs and tissues throughout the body. More particularly, the implants are vascular grafts used to supply blood to the tissue of the heart.

BACKGROUND OF INVENTION:

The autogenous saphenous vein is used successfully as a vascular conduit for coronary artery revascularization. Although the search for a suitable prosthetic graft for aortocoronary bypass continues, nothing better than the autogenous saphenous vein is available. Surgeons have been reluctant to use synthetic grafts in aortocoronary bypass because of few proved instances of long-term patency.

Although saphenous veins are used in aortocoronary bypass procedures, there are certain disadvantages:

(I) unavailability, (2) small size, (3) non-uniform caliber, (4) varicosities, (5) large diameter» (6) sclerosis, (7) obstruction due to intimal hyperplasia, (8) aneurysm formation, (9) considerable time required for harvesting, {10) leg discomfort and swelling, and (Ii) possible leg infection.

A significant number of patients requiring aortocoronary bypass do not have suitable veins, or the veins have been used for previous aortocoronary bypass or for peripheral vascular bypass procedures. On occasion, the need for a graft may have been unforeseen prior te surgery, and the legs not prepared for harvesting of the vein. The cephalic vein from the arm has been used when the saphenous vein is not available. However) it 3S -Eis usually thin-walled and often of poor caliber. Furthermore, the cosmetic effect of harvesting the cephalic vein is unacceptable for some patients.

The internal mammary artery is widely accepted as suitable for myocardial revascularisation, in that it has an excellent patency ratio, but is useful only for the left anterior descending and diagonal coronary arteries. Experience with free grafts of the internal mammary and radial arteries has been disappointing, since long-term patency has been poor.

The importance of the velocity of blood flow in autogenous vein grafts has been emphasized. There is evidence of an inverse relationship between the velocity of blood flow in venous grafts and the amount of intimal proliferation observed. Autopsy studies indicate that occlusion of aortocoronary saphenous vein grafts more than one month after operation is most commonly caused by fibrous intimal proliferation.

Although the cause of this lesion has not been definitely established, studies would suggest that it is probably related to a low velocity of flow through the graft. Thìs suggests that every effort should be made to achieve a high velocity of flow in coronary artery bypass grafts.

Synthetic vascular implants are disclosed by Liebig in U. S. Patents Nos. 5,096,560; 5,805,301 and 5,945,052.

These grafts are elongated knit fabric tubes made of yarn, such as polyester fiber. Dardik in U. S. Patent No. 3,894,$30 discloses the use of an umbilical cord for a vascular graft. Holman et al in U. S. Patent No.

4,240,794 disclose a method of preparing human and other animal umbilical cords for use as a vascular replacement.

The fabric tubes and umbilícal cords have been used to replace the saphenous vein implant. The ends of the tubes and cords are anastomosed to ends of arteries to by-pass diseased areas of the arteries. They replace the diseased portions of the arteries.

íz3815 SUMMARY OF INVENTION:

The goal of vascular reconstructive surgery is to effectively supply blood to organs and tissues whose blood vessels integrity are compromised by congenital defects or acquired disorders, such as arteriosclerosis, trauma, and other diseases. The invention is a graft and a method employing the graft for supplying arterial blood to organs and tissues throughout the body.

According to the invention, there is provided a graft for supplying blood to one or more blood receivers, such as blood vessels. The graft includes an elongated means having a continuous passage for carrying blood from a supply of blood under pressure to one or more blood receivers. The elongated means has a body providing a first passage for carryìng of blood. The body has one or more openings and is connectable to at least one blood vessel for supplying blood to the opening to the blood vessel. The body has an inlet end means adapted to be connected to a supply of blood under pressure, whereby blood flows into the first passage and from the first passage into the blood vessel. The flow of blood and pressure of the blood in the first passage is controlled with a means having a restricted second passage connected to the distal portion of the body remote from the inlet end means. An outlet end means connects the means having the restricted second passage to blood receiving means. A pressure differential between the blood supply means nd the blood receiving means maintains continuous and adequate blood flow at a desired pressure through the first and second passages and provides a continual supply of blood for the blood vesseìs that are attached to the body.

The graft is used to supply blood to one or more coronary artery branches in a primate heart. The heart has two atria for receiving blood from the vena cava and pulmonary veins and is connected to an aorta to carry blood under pressure from the heart. The graft comprises an elongated generally U-shaped tubular means i0 1Z38153 having a continuous longitudinal passage for carrying blood from the aorta to the atrium. A tubular means has an inlet end anastomosed to the aorta so that blood under pressure flows from the aorta into the passage and is discharged through an outlet end into the atríum.

The outlet end of the tubular means is anastomosed to the heart tissue around an opening in communication with the atrium. The tubular means has one or more openings used to provide blood to one or more coronary artery branches. The coronary artery branches are sutured to the tubular means whereby blood flows through the openings in the tubular means into the coronary artery branches. The flow and pressure of the blood in the passage is controlled by a restriction located remote from the inlet end of the tubular means. The restriction is a second throat passage having a diameter that ìs less than one-half the diameter of the main or first passage of the tubular means. The tubular means is generally U-shaped and encircles the critical areas of the heart beginning at the aorta and ending at either the right or left atrium or pulmonary artery. The pressure differential between the aorta and the atrium, approximately 90 mm Hg, causes a continuous flow of blood in quantities and at velocities that inhibit clottìng, and provides a continuous supply of blood at a desired pressure to the artery branches connected to the tubular means.

In one embodiment of the invention, the tubular means is an elongated generally U-shaped synthetic tube, such as a polytetrafluoroethylene tube or a Dacron tube.

The tube is continuous and has a reduced diameter section proximal to the distal or outlet end thereof. The reduced diameter section provides the restricted passage for controlling the blood flow and sustaining the pressure of the blood in the first passage of the tubul r means.

A second embodiment of the invention utilizes a human umbilical cord as the elongated means. The umbiliI; .38153 cal cord is formed to a generally U-shape to encircle the critical areas of the heart. The outlet or distal end of the cord has a reduced diameter to provide a restriction for the flow of blood through the cord.

Selected arteries are anastomosed to the body of the cord and are provided with openings whereby blood from the lumen oÆ the cord can flow into the arteries.

In a third embodiment o£ the invention, the elongated tubular means comprises an autogenous saphenous vein having a large enough caliber to assure adequate blood flow. The vein encircles the heart from the aorta and extends to the atrium. The distal or outlet end section of the vein accommodates an adjustable blood flow restrictor operable to reduce the cross sectional area oÆ the vein passage to form a throat passage. The throat passage restricts the flow of blood in the vein passage while maintaining a continuous flow of blood at a desired pressure. Selected portions of the vein are anastomosed to coronary branch arteries to provide continuous flow of blood to these arteries.

According to a fourth embodiment of the invention, there is provided a graft for supplying blood to one or more blood receivers, such as blood vessels. The graft includes an elongated tubular means having a continuous passage for carrying blood from a supply of blood under pressure to one or more blood vessels and blood receiver means. The flow of blood and pressure of the blood in the continuous passage is controlled with reinforced means having a restricted passage connected to the distal portion oÆ the elongated tubular means remote from the inlet end means. The reinforced means maintains the cross sectional and longitudinal dimensions oÆ the restricted passage over an extended period of time. The reinforcing means has an annular reinforcing sleeve surrounding the body to maintain the shape and size of the restricted passage. Other means can be used to reinforce the tubular means to ensure the shape and size o£ the restricted passage. The reìnÆorcing means can be an increased i0 i 38158 wall thickness of the tubular means surrounding the restricted passage, or thread or tape surrounding the tubular means. An outlet end means connects the reinforced means having the restricted passage to blood receiving means. A pressure differential between the blood supply means and the blood receiving means maintains continuous and adequate blood flow at a desired pressure through the passages and provides a continual supply of blood for the blood vessels that are attached to the elongated tubular means over a long period of time.

The elongated tubular means can be synthetic tube, such as a polytetrafluoroethylene tube or a Dacron tube.

The tube is continuous and has a reduced cross sectional area or throat section proximal to the distal or outlet end thereof. An elongated annular sleeve of reinforcing material surrounds the throat section to maintain the cross sectional area of the passage throughthe throat section. The reinforcing material can be a fiber plastic.

fiber mesh, a carbon tubular member, or metal tubular member attached to the outside of the throat section.

The fiber can comprìse a plurality of substantially non-elastic interconnected strands or wire-like members of metal, plastic, or carbon. The reinforcing material can be incorporated into the material of the throat section. The reinforcing material can be thread or tape wound around the throat section. A sleeve of rigid materla1, such as molded plastic, metal or carbon can be located about the throat section. The wall thickness of the throat section can be enlarged to províde for reinforcement thereof. The reduced cross sectional area provides a restricted passage for controlling the blood flow and sustaining the pressure of the blood in the first passage of the tubular means.

A fifth embodiment of the invention utilizes a human umbilical cord as the elongated means for carrying blood to the blood receiving vessels. The umbilical cord can be formed and cured to a generally U-shape to encircle the critical areas of the heart. The outlet or distal l0 2S I 3Sî58 end of the cord has a reduced size to provide a restriction or throat passage for controlling the flow of blood through the cord. The size of the throat passage is maintained with an annular sleeve of ròinforcing material mounted on the umbilical cord. The reinforcing material can be a fiber plastic, tape, a carbon tubular member, or metal tubular member surrounding a distal section of the umbilical cord. Selected arteries are anastomosed to the body of the cord and are provided with openings whereby blood from the lumen of the cord flows into the arteries.

The invention includes a method of providing a continuous supply of flowing blood at a desired pressure to one or more blood receiving vessels, such as coronary branch arteries of a primate. A graft having a blood flow restricting throat passage in the distal end section thereof is anastomosed to the aorta. The graft is placed adjacent the heart to locate portions thereof in proximity to selected coronary branch arteries.

Selected portions of the graft are anastomosed to coronary branch arteries. The distal end of the graft is anastomosed to the atrium or low blood pressure section of the blood circulatory system. Blood under pressure continuously flows from the aorta into the graft, since there is a substantial blood pressure difference between the aorta and atrium. The throat passage prevents the flow of blood from being excessive and maintains the blood pressure in the graft passage at substantially the same as the aorta blood pressure. The coronary arteries are perfused with sufficient quantities of blood.

IN THE DRAWINGS:

Figure 1 is an anterior view of a human heart; Figure 2 is a schematic longitudinal sectional diagram of the heart of Figure l; Figure 3 is an anterior view of a human heart having the graft of the invention; Figure 4 is an enlarged partly sectioned plan view of the graft of Figure 3; S , Z5 Figure 5 is an enlarged sectional vîew taken along the line 5-5 of Figure 4; Figure 6 is an enlarged sectional view taken along the line 6-6 of Figure 4; Figure 7 is an enlarged sectional view taken along the line 7-7 of Figure 4; Figure 8 is an enlarged sectional view taken along the line 8-8 of Figure 4; Figure 9 is an enlarged sectional view taken along the line 9-9 of Figure 3; Figure 10 is an enlarged sectional view taken along the line 10-10 of Figure 3; Figure 11 is an enlarged sectional view taken along the line 11-11 of Figure 3; Figure 12 is a plan view, partly sectioned, of a saphenous vein and distal and tubular blood flow restrictor anastomosed to the vein, usable as a graft of the invention; Figure 13 is an enlarged sectional view taken along the line 13-13 of Figure 12; Figure 14 fs an enlarged sectional view taken along the line 14-14 of Figure 12; Figure 15 is an enlarged sectional view taken along the line 15-15 of Figure 12; Figure 16 s an enlarged sectional view taken along the line 16-16 of Figure 12; Figure 17 Is an enlarged sectional view taken along the line 17-17 of Figure 12; Figure 18 is a plan view, partly sectioned, of a graft and adjustable blood flow restrictor therefor; Figure 19 is an enlarged sectional view taken along the line 19-19 of Figure i; Figure 20 is an enlarged sectional view taken along the line 20-20 of Figure 18; Figure 21 is an enlarged sectional view taken along the line 21-21 of Figure 18; Figure 22 is an enlarged sectional view taken along the line 22-22 of Figure 18 3S r) I«.8815 Figure 23 is an anterior view of a human heart having a reinforced vascular graft of the invention; Figure 24 is an enlarged partly sectioned plan view of the vascular graft of Figure 23; Figure 25 is an enlarged sectional view taken along the line 25-25 of Figure 24 Figure 26 is an enlarged distal end view of the vascular graft of Figure 24 Figure 27 is an enlarged sectional view taken along the line 27-27 of Figure 26 Figure 28 fs an enlarged sectional view taken along the line 28-28 of Figure 26 Figure 29 Is an enlarged sectional view taken along the lìne 29-29 of Figure 26 Figure 30 ms an enlarged sectional view taken along the line 30-30 of Figure 26; ç! Figure 31 zs an enlarged sectional view taken along the line 31-31 of Figure 26; and » Figure 52 is an enlarged sectional view taken along the line 32-32 of Figure 26. • DESCRIPTION OF PREFERRED EMBODIMENTS:

Referring to Figures I, 2 and 3, there is shown an anterior view of a human heart indicated generally at i0. Heart I0 has a right atrium ii, right ventricle 12, left atrium 13, and left ventricle 14. Blood from the body flows through vena cava 16 into right atrium II. The pressure of the blood in right atrium ii is low as the blood flows into atrium II. A heart valve 17 controls the flow of blood from atrium II into right ventricle 12. The blood is pumped from right ventricle 12 through valve 18 into pulmonary artery 19, which is connected te the lungs. The blood returns from the lungs via the pulmonary vein 20 to left atrium 13. The blood flows from left atrium 13 through heart valve 21 into a left ventricle 14 and is pumped from the left ventricle 14 through valve 22 into aorta 23. The pressure differential of the blood between aorta 25 and the atrium ii is approximately 90 mm Hg. The muscle tissue 2S -I0o oÆ the heart is provided with a supply of blood Ærom two coronary arteries 24 and 26. Left coronary artery 24 extends from aorta 23 along the left side of the heart toward the apex 27. Coronary artery 24 has a number of branches 28, 29, 30 and 51, which supply blood to the muscle tissue. Left coronary artery 24 has a short common stem which bifurcates or trifurcates into branches 28-51. One branch 51, tlm anterior interventricular branch, moves downward to the anterior interventricular groove and rounds the acute margin of the heart just to the right of apex 27 and ascends a short distance up the posterior interventricular groove.

Portions of the branch 51 anastomose with branches from the right coronary artery. These branches are very small in normal hearts. They may enlarge considerably in persons suffering Ærom coronary arteriosclerosis in whom coronary arterial branches become obstructed or occluded. The right coronary artery 26 extends down the right side of the heart toward the apex or crux 27.

Artery 26 has a number of branches 32, 33, 34 and 35, which feed blood to the heart tissue.

The right coronary artery 26 arises from the right anterior sinus of aorta 25 and runs along the right atrìoventricular sulcus. It rounds the acute margin to reach the crux. It has a number of branches 52-55 to the anterior right ventricle wall. The rìght arterial branches o£ the right coronary artery 26 oríginate from the right coronary artery shortly after its take-off and ascends along the anteromedial wall of the right atrium. Variations of the branching pattern of the arterìes 24 and 26 are common in the human heart. In about 67 of the cases, the right coronary artery 26 is dominant and supplies part of the left ventricle wall and ventricle septum. In 15 of the cases, the left coronary artery 19 is dominant and supplies all of the left ventricle and the ventricle septum and part of the right ventricle wall, with blood. In about 18 oÆ the cases, both coronary arteries 24 and 26 reach the l0 3S :1Z38153 -llcrux 27. It is common for the first, second and third branches of the right coronary artery 26 to originate independently from the right sinus» rather than the parent artery.

Referring to Figures 4-8, there is shown a vascular graft of the invention indicated generally at 36. Graft 36 is an elongated member 37 having a generally U-shape and a continuous passage for carrying blood, Member 37 has a continuous cylindrical wall 38 having an inside surface 39 forming an elongated longitudinal passage Tubular member 37 has a proximal aortic or inlet end 41 and a distal atrial or outlet end 42. A main generally U-shaped trunk 43 extends from inlet end 41 to a restricted or reduced diameter sectíon 44. Restricted section 44 is connected to a distal end section 46.

Preferably, restricted section 44 is about 2 to 5 cm from outlet end 42 when it is attached to the heart tissue. As shown in Figures 5-7, restricted section 44 has a cylindrical wall 47 integral with cylindrical wall 38 of the main trunk 43 and atrial end section 46. Wall 47 surrounds a throat passage 48 having a cross sectional area substantially smaller than the crosssectional area of passage 40. The cross sectional area of passage is preferably more than four times larger than the cross sectional area of throat passage 48. Cylindrical wall 47 is joined to wall 38 with a converging conical wall portion 49 which directs the flow of blood into passage 48° The opposite ends of wall 47 are joined to a diverging conical wall portion 51 forming part of the atrial end section 46. Wall portion 51 surrounds an outlet passage 52 leading to the distal outlet end 42.

The cross sectional area of outlet passage 52 is substantially the same as the cross sectional area of passage of main trunk 43. The cross sectional area of outlet passage 52 can be larger than the cross sectional area of passage 40. Conical wall portions 49 and 51 each have a longitudinal length and an inside wall surface that has a gradual smooth taper to minimize turbulence in i0 $5 I 38153 the blood flow. Preferably, cylindrical wall 47 surrounding passage 48 ]las a longitudinal length that is shorter than the longitudinal length of the wall portions 49 and 51. Other length and size relationships can be used.

The longer the length of restriction section 44, the greater the blood pressure drop for a given cross sectional area of passage 48. Passage 52 provides a chamber wherein the velocity of the blood flow is decreased before it flows into the atrium of the heart. Distal end section 46 is of a size to permit easy attachment thereof to the heart tissue or blood receiving vessel.

The entire member 57 is a tubular structure, preferably made from a human umbilical cord. The umbilical cord can be pre-curved and tapered to form the desired restricted section 44 by processing. In use, it will not kink and is intimally lined. Other tubular structures» such as a polytetrafluoroethylene tube, can be used for vascular graft 36.

Referring to Figure 5, vascular graft 56 is located adjacent the heart 10. Body 45 descends toward the midportion on the anterior surface of the heart and then encircles about to the posterior surface and ascends toward the right atrium. Restricted section 44 and atrial end section 46 are located adjacent atrium II.

As shown in Figure 9, proximal or aerial end 41 of tubular member 57 is implanted into an aortic osmium SS and anastomosed thereto with sutures 54. As shown in Figure 10» the outlet or atrial end 46 is implanted into an ostium $6 in heart 10 open to atrium Ii and anastomosed thereto with sutures 57. The blood continuously flows through passage 40 of tubular member 57, since the blood pressure difference between aorta 23 and atrium II is about 90 mm Hg. Restrictive throat 48 prevents the f10w of blood through passage 40 from being excessive.

The distal end section 46 of tubular member 57 can be anastomosed to the left atrium 15, whereby the blood flows from aorta 23 through passage 40 and tubular member 37 and into left atrium 13.

I ',38153 i0 The body 43 of graft 36 is located adjacent one or more of the coronary branches 28-31 and 32-35. The surgeon has the option to anastomose and, therefore, perfuse one or more of the coronary branches along the path of the graft 36. Referring to Figure 11, graft 36 is anastomosed to coronary branch 35 with sutures 58.

The cylindrical wall 38 is provided with an opening 59 to allow blood to flow from passage 40 into the coronary artery passage õl. The restricted passage 48 adjacent the atrial end of the graft allows the coronary arteries to be perfused with sufficient quantities of blood at pressures within a few mm Hg of the aortic blood pressure.

The flow of blood through restriction 48 is laminar and continues as a laminar flow through the passage 52 into atrium 11. There is a minimum of turbulence of the blood in graft 36. The interior surface 39 of the tubular member 37 is smooth and continuous. It does not have any nitrics which can stagnate and coagulate the blood.

An adequate flow of blood through the graft passage is insured by the diameter of the aortic anastomosis of approximately 2500 ml per minute. Tests indicate that, using a 5 mm diameter tubular graft with a simulated aortic flow of approximately 6000 ml per minute and pressure of 100 mm Hg, approximately 500 ml per minute will flow through a 2 mm restriction into the right atrium.

Since the cardiac output is limited only by the venous return, the left ventricle will have an additional load of about 8 per cent. Each coronary artery supplied with blood will require about 50 to 150 ml per minute of blood for adequate perfusion. Since the blood flow through an unrestricted 5 mm graft anastomosed to an aorta with blood flowing at 6000 ml per minute will provide blood flow well in excess of 2000 ml per minute, an adequate blood supply is available for up to I0 coronary branches, each carrying 150 mm per minute. Calculations of blood flow through the throat passage 48 show a Reynold's range of between 500 and 1000. The blood flow is laminar in passages 40 and 48.

i0 I 38i53 In certain cases, a surgeon may choose to use the autogenous saphenous vein in lieu of synthetic graft 36 over the umbilical cord, as described herein. Referring to Figures 12-17, there is shown a segment of an autogenous saphenous vein indicated generally at comprising an elongated member 71. Member 71 has a continuous cylindrical wall 72 surrounding a passage or lumen 73 for accommodating flowing blood. The inlet or proxilaal end 74 of member 71 has an opening 75. The saphenous vein 70 has a generally U-shape and follows a path about the heart to reach occluded arteries in the manner of graft 36, as shown in Figure 3. Lumen 73 has a generally uniform diameter from the inlet or aorta end 74 to the distal end 76.

A blood flow restrictor or tubular segment indicated generally at 77 is anastomosed to distal end 76 of vein 70. Blood flow restrictor 77 has an inlet end section 78 and an outlet end section 79 joined to an intermediate throat section 81. Section 78 has an inlet passage 82 longitudinally aligned with lumen 73. Inlet passage 82 communicates with a restricted or Venturi passage 83 in throat section 81, Venturi passage 83 opens to an outlet passage 84 in outlet end section 79. The cross sectional area of outlet passage 84 is substantially the same as the cross sectional area of the inlet passage 82. The size of Venturi throat 83 can vary relative to the size of inlet passage 82. Preferably, the diameter of inlet passage 82 is more than twice the diameter of Venturi passage 85. The cross sectional area of passage 82 is more than four times the cross sectional area of throat passage 83. Venturi passage 83 allows blood to continuously flow through lumen 73 at a desired blood pressure in lumen 77 so that one or more coronary artery branches can be perfused. The distal or atrial end section 79 has an open outlet 86 allowing blood to flow into the atrium of the heart when section 79 has been anastomosed to the atrium section of the heart.

In use, the surgeon harvests a section of the I', 8Sî53 saphenous vein from the leg of the patient. A blood flow restrictor 77 having the desired size Venturi passage 83 is secured with sutures 87 to distal end 76 of tubular member 71. The aorta end 74 is anastomosed to aorta 23. Tubular member 71 encircles the heart to locate atrium end 79 of restrictor 77 adjacent atrium II. End 79 is anastomosed to the atrium section of the heart so that a continuous and adequate flow of blood is maintained through tubular member 70 and restrictor 77. The blood is at a desired pressure so that one or more coronary artery branches can be perfused. The surgeon can anastomose one or more coronary branches along the path of tubular member 70 in a manner, as shown in Figure ll.

This allows the continuous flow of blood under pressure from passage 73 into the lumen of the coronary branches.

Referring to Figures 18-22, there is shown a tubular graft indicated generally at 90 usable to continuously supply blood to one or more coronary artery branches of a human heart. Graft 90 has an elongated generally U-shaped member 91 having a continuous cylindrical wall 92. Wall 92 forms a generally uniform diameter passage 93. Member 91 has an aortic or proximal end 94 having an inlet opening 96 for receiving a continuous supply of blood from the aorta. The blood flows through passage 93 to a distal end 97 having an outlet opening 98.

Distal end 97 is adapted to be anastomosed to the atrium section of the heart or a vein to receive blood therefrom.

As shown in Figures 18-22» an adjustable blood flow restrictor indicated generally at 99 is mounted on member 91 adjacent distal end 97 for restricting the flow of blood into distal end 97 while maintaining a continuous and adequate flow of blood at a desired pressure so that one or more coronary artery branches can be perfused.

Restrictor 99 also reinforces the tubular member forming the restricted passage, Blood flow restrictor 99 is a clamp unit having a first member 101 adjustably connected to a second member 102 with a pair of self-locking screws 103 and 104. Member I01 has an outwardly curved center Z0 IZ38158 section 10lA located about an arcuate sector of member 91. Second member 102 has an oppositely outwardly curved center section 102A facing the curved center section 10lA and engageable with an arcuate segment of member 91.

Screws 103 and 104 are adjustable to move the first and second members 101 and 102 toward each other to adjust the size of the Venturi throat passage 106, thereby adjusting the rate of flow of blood through passage 93 and adjusting the pressure of the blood in passage 93.

A cylindrical mandrel having a desired cross sectional area is used to provide the throat passage with a desired size or cross sectional area. The mandrel is inserted into the distal end section of member 91.

Restrictor 99 is placed over the distal end section and clamped onto member 91. The curved center sections 101A and 102A move toward each other and force the wall of the member about the mandrel. This mandrel is then removed from the member 91. Restrictor 99 maintains the selected cross section of throat passage 106, as shown in Figure 22.

Referring to Figure 23, there is shown an anterior view of a human heart indicated generally at 210. Heart 210 has a right atrium 211, right ventricle 212, left atrium ZlB, and left ventricle 214. Blood from the body flows through vena cava 216 into right atrium 211. The pressure of the blood in right atrium 211 is low as the blood flows into atrium 211. A heãrt valve controls the flow of blood from atrium 211 into right ventricle 212. The blood is pumped from right ventricle 212 through a vàlve into pulmonary blood returns from the lungs via the pulmonary vein to left atrium 213. The blood flows from lefZ atrium 213 through the heart valve into a left ventricle 214 and is pumped from the left ventricle 214 through the valve into aorta 223. The pressure differential of the blood between aorta 225 and the atrium 211 is approximately 90 mm Hg. The muscle tissue of the heart is provided with a supply of blood from two coronary arteries 224 and 226. Left coronary artery 224 extends i0 2S IZ3815 from aorta 2Z3 along the left side of the heart toward apex 227. Coronary artery 224 has a number of branches 228) 229) 230 and 231, which supply blood to the muscle tissue. Left coronary artery 224 has a short common stem which bifurcates or trifurcates into branches 228231. One branch 251, the anterior interventricular branch, moves downward to the anterior interventricular groove and rounds the acute margin of the heart just to the right of apex 227 and ascends a short distance up the posterior interventricular groove. Portions of branch 251 anastomose with branches from the right coronary artery. These branches are very small in normal hearts. They may enlarge considerably in persons suffering from coronary arteriosclerosis in whom coronary arterial branches become obstructed or occluded. The right coronary artery 226 extends down the right side of the heart toward apex or ŒErux 227. Artery 226 has a number of branches 232) 233, 234 and 235, which feed blood to the heart tissue.

Referring to Figures 24-28) there is shown a reinforced vascular graft of the invention indicated generally at 236. Graft 236 is an elongated tubular member 257 having a generally U-shape and a continuous passage 240 for carrying blood. Member 237 has a continuous cylindrical wall 238 having an inside surface 239 forming elongated longitudinal passage 240. Tubular member 237 has a proximal aortic or inlet end 241 and a distal atrial or outlet end 242. A main generally U-shaped trunk 243 extends from inlet end 241 to a restricted or reduced section indicated generally by member 244. Restricted section 244 is connected to a distal end section 246.

Preferably, restricted section 244 is about 2 to 5 cm from outlet end 242 when it is attached to the heart tissue. As shown in Figures 25-27, restricted section 244 has a cylindrical wall 247 integral with cylindrical wall 238 of main trunk 243 and atrial end section 246.

Wall 247 surrounds a throat or Venturi passage 248 having a cross sectional area substantially smaller than the i0 lZ38îo3 cross sectional area of passage 240. The cross sectional area of passage 240 is preferably more than four times larger than the cross sectional area of throat passage 248. Cylindrical wall 247 is joined to wall 238 with a converging conical wall portion 249 which directs the flow of blood into passage 248. The opposite ends of wall 247 are joined to a diverging conical wall portion 251 forming part of the atrial end section 246.

Wall portion 251 surrounds an ourlet passage 252 leading te the distal outlet end 242. The cross sectional area of outlet passage 252 is substantially the same as the cross sectional area of passage 240 of main trunk 243.

Conical wall portions 249 and 251 each have a longitudinal length and an inside wall surface that has a gradual smooth taper to minimize turbulence in the blood flow.

Preferably, cylindrical wall 247 surrounding passage 248 has a longitudinal length that is shorter than the longitudinal length of the wall portions 249 and 251. Other length and size relationships can be used. The longer the length of restricted section 244, the greater the blood pressure drop for a given cross sectional area of passage 248. Passage 252 provides a chamber wherein the velocity of the blood flow is decreased before it flows into the atrium of the heart. Distal end section 246 is of a size to permit easy attachment thereof to the heart tissue or blood receiving vessel.

Vascular graft 236 is an elongated tube of synthetic material that is biologically inert and does not deteriorate in the body over an extended period of time.

Examples of suitable materials are Polytetrafluoroethylene and Dacron plastics. Other materials and combinations of materials can be used for vascular graft 236.

The restricted or throat section 244 is reinforced with a sleeve 245 to insure that the cross sectional area and length of Venturi passage 248 is maintained over a long period of time. The material of wall 247 does not expand in use when reinforced with sleeve 245 whereby the size and length of passage 248 is kept substantially i0 IZ38Æ53 -ì9constant during use of vascular graft 236. Sleeve 245 is a reinforcing structure for wall 247 to inhibit ìts dilation or expansion, contraction, and elongation so as to maintain desired dimensions of passage 248 over an extended period of time. This insures continuous and controlled flow of blood through vascular graft 236 and maintains the pressure of blood in passage 240 at a level to perfuse the coronary branches attached to trunk 38. Sleeve 245 can be a tubular fiber member of metal, plastic, or carbon fibers formed into a mesh surrounding restricted section 244. Tape and thread can be used to form sleeve 245. Sleeve 245 can be bonded or otherwise secured to the outer surface of restricted section 244.

The reinforcing structure can be incorporated into the material of restricted section 244. The thickness of the wall of the restricted section can be increased to strengthen the restricted section. The sleeve can be a rigid plastic carbon or metal tubular member located about the restricted section.

As shown in Figures 24, 26, 29 and 31, sleeve 245 surrounds wall 247 and conical wall portions 249 and 251 joined to wall 247. Sleeve 245 is continuous from conical wall portion 249 to conical wall portion 251 so as fo reinforce both converging and diverging portions of the walls forming the Venturi passage 248.

The entire vascular graft 256 can be a tubular structure, made from a human umbilical cord. The umbilical cord is cured) pre-curved and tapered to form the desired restricted section 244. The restricted section is reinforced with mechanical reinforcing means as described herein. In use, the umbilical cord will not kink and is intimally lined.

Referring to Figure 23, vascular graft 236 is located adjacent heart 210. Body 243 descends toward the midportion on the anterior surface of the heart and then encircles about to the posterior surface and ascends toward the right atrium. Restricted section 244 and atrial end section 246 are located adjacent atrium 211.

122S152 As shown in Figure 30, proximal or corral end 241 of tubular member 237 is implanted into an aortic ostium 253 and anastomosed thereto with sutures 254. As shown in Figure 31, the outlet or atrial end 245 is attached to the heart 30 around ostium 256 open to atrium 211 and anastomosed thereto with sutures 257. The blood continuously flows through passage 240 of tubular member 237) since the blood pressure difference between aorta 223 and atrium 211 is about 90 mm Hg. Throat passage 248 prevents the flow of blood through passage 240 from being excessive. Restricted section 244 reinforced with sleeve 245 maintains a controlled flow of blood through Venturi passage 248. The cross sectional area and length of Venturi passage 248 is retained during prolonged use by the reinforcing sleeve 245 in cooperation with wall 247. The distal end section 246 of tubular member 237 can be anastomosed to left atrium 215, whereby the blood flows from aorta 223 through passages 240, 248 and 252 and into left atrium 213.

The body 243 of vascular graft 236 is located adjacent one or more of the coronary branches 228 to 231 and 232 to 235. The surgeon has the option to anastomose and, therefore, perfuse one or more of the coronary branches along the path of vascular graft 236. Referring to Figure 31, vascular graft 236 is anastomosed to coronary branch 235 with sutures 258. The cylindrical wall 238 is provided with an opening 259 to allow blood to flow from passage 240 into the coronary artery passage 261.

The restricted passage 248 adjacent the atrial end of the vascular graft allows the coronary arteries to be perfused with sufficient quantities of blood at pressures within a few mm Hg of the aortic blood pressure. The flow of blood through restriction 248 is laminar and continues as a laminar flow through the passage 252 into atrium 211. There is a minimum of turbulence of the blood in graft 236. The interior surface 239 of the tubular member 237 is smooth and continuous. It does not have any nitrics which can stagnate and coagulate the blood.

tZ38153 The grafts of the invention can be used to carry blood in peripheral revascularisation procedures of the lower extremities. The graft would be interposed between the most distal arterial anastomosis and the popliteal vein or one of its major branches. The source of blood would be the femoral artery and the anastomosis would be made in the popliteaì artery and/or its distal branches, the anterior tibia» posterior tibia, or peroneal arteries.

The blood flow restricting passage or throat passage located between these arteries and the distal end of the graft controls the blood flow through the graft. The control of blood flow allows adequate perfusion of blood pressure to these arteries and at the same time insures continuous blood flow to maintain patency of the graft.

While there has been shown and described the preferred embodiments of the graft of the invention, and method of supplying a continuous blood flow to one or more arteries, it is understood that changes in the materials, size, length of the graft, and location of the graft may be made by those skilled in the art without departing from the invention. The invention is defined in the following claims.

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