WO2008157283A1

WO2008157283A1 - Improved vessel anastomosis clips and related methods of use

Info

Publication number: WO2008157283A1
Application number: PCT/US2008/066823
Authority: WO
Inventors: Joseph S. Coselli; Xing Li Wang
Original assignee: Baylor College Of Medicine
Priority date: 2007-06-14
Filing date: 2008-06-13
Publication date: 2008-12-24

Abstract

A surgical instrument system for anastomosis of first vessel and second vessel, the surgical instrument including an actuator assembly having distal and proximal ends, a head, and a clip seat, the head and clip seat being detachably mounted to the distal end of the actuator assembly. This device enables anastomosis to be with one action of squeeze with reduced risk of thrombosis, stenosis and time of operation. A surgical instrument of the present invention has the capability to be used in minimally invasive surgery when anastomosis is required through a small surgical excision. Anastomosis capable with embodiments of the present invention include, but are not limited to, end-to-end and end-to-side connections.

Description

IMPROVED VESSEL ANASTOMOSIS CLIPS AND RELATED METHODS OF USE INVENTORS

Joseph S. Coselli of Houston, TX Xing Li Wang of Houston, TX FIELD OF THE INVENTION

[0001] This present invention relates generally to improved vessel anastomosis surgical instrument and related methods of use.

BACKGROUND OF THE INVENTION

[0002] Methods for joining one at least partially hollow organ end-to-side to another at least partially hollow organ, without interrupting fluid flow in the efferent organ has long been desired in the medical practice, particularly in the field of cardiovascular surgery. The most frequent anastomosis include end-to-end, end-to-side and side-to-side, among which end-to-end anastomosis is simple. Conventional methods for joining (anastomosis) two blood vessels in an end-to-side configuration invariably necessitates halting blood flow in the efferent or outflow blood vessel, jeopardizing the viability of tissues perfused by the outflow blood vessel. To overcome this drawback, a surgical technique has been described in medical literature that involves the stitching of a metal ring to the outflow vessel (Tulleken CAF, et al. Acta Neurochir 1995:134, 66-70), and a tubular prosthesis to the inflow or afferent limb of the anastomosis. However, the complexity of the procedure has hindered its adoption by surgeons. As is understood by those skilled in the art, the quality of the anastomosis directly affects the success or failure of the entire operation.

[0003] Currently, there are also several mechanical semiautomatic devices designed and marketed to resolve the problem. They include, but are not limited to, Symmetry Connector System (St. Jude Medical, St. Paul, MN); Corlink Device- ADD (ByPass Ltd, Herzelia, Israel); One-shot Connector (St. Jude Medical) and Heartflo-Perclose (Abbott Labs Inc., IL). However, a common occurrence with these devices is that raw metal is exposed in the inner surface of blood vessels, at times resulting in thrombosis, stenosis, and/or death. [0004] Quite commonly, for reasons related to costs, availability, and/or habit, a manual anastomosis procedure is performed. However, it has been generally reported that the insertion of transmural stitches, even in experienced hands that employ atraumatic techniques and fine sutures, causes significant damage to vessel walls, often resulting in thrombosis. Nataf et ah, "Nonpenetrating Clips for Coronary Anastomosis," Annals of Thoracic Surgery, 1997:63, S137. Likewise, manual anastomosis is time-consuming. Accordingly, there is a need in the art for a simple, time-saving but reliable, automated, semi-automated, or at least facilitated method to replace the process of manually sutured anastomosis.

SUMMARY OF THE INVENTION

[0005] Various embodiments of the present invention, in combination, generally comprise a system for performing a vascular anastomosis, including an anastomosis device, an application instrument and methods for performing a vascular anastomosis. The system is applicable for performing a variety of anastomosis procedures, such as end-to-end, end-to-side, side-to-side, and/or the like. Generally, various embodiments of the present invention are capable of performing any anastomosis procedure.

[0006] Various embodiments of the present invention generally provide the enhancement of at least one of (1) no exposure of foreign material to the blood flow after the anastomosis; (2) Angled clip head so that the blood vessels will be connected with an angle without the risk of kinks for stenosis or blood clot; (3) one action anastomosis will reduce the time required for the connection, minimize the chance of leakage and standardize the procedure; (4) long-handled and disposable device will make the surgical access easier, especially in the era of minimal invasive surgery; (5) a slit open or severable portion on the side of the shaft enables the anastomotic action on both ends of the vessels; (6) a reduction of the incidence of thrombosis and/or clotting; and (7) an adjustable angle of approach for the head of the surgical instrument and clip seat such that a vessel may be approached from an angle other than a 90-degree angle.

[0007] As such, various embodiments comprise a one-shot surgical instrument for joining at least a first vessel and at least a second vessel within a patient's body, said instrument comprising an actuator assembly, a detachable head, and a clip seat, said actuator assembly comprising a tube body and a tubular body received therein and defining a passage extending from about a proximal end of said instrument to about a distal end of said instrument; said detachable head adjustably connected to said tubular body; and, said clip seat comprising at least one clip for joining said first vessel and said second vessel, said clip seat positioned between said actuator assembly and said detachable head, wherein said actuator assembly is either one of separable into at least two halves or comprises a slit allowing access to said passage.

[0008] Further embodiments comprise a surgical instrument for joining at least a first vessel and at least a second vessel within a patient's body, said instrument comprising an actuator assembly means for isolating said second vessel vesel to be grated, a detachable head, and a clip seat means for securing said first vesselo to said second vessel, said detachable head adjustably connected to said tubular body; and, said clip seat means positioned between said actuator assembly means and said detachable head.

[0009] Various embodiments of methods of the present invention comprise methods for performing a one-shot anastomosis procedure to join a first vessel and a second vessel in a patient's body, said method comprising the steps of loading a second vessel in an instrument, said instrument comprising an actuator assembly, a detachable head, and a clip seat, said actuator assembly comprising a tube body and a tubular body received therein and defining a passage extending from about a proximal end of said instrument to about a distal end of said instrument; said detachable head adjustably connected to said tubular body; and, said clip seat comprising at least one clip for joining said first vessel and said second vessel, said clip seat positioned between said actuator assembly and said detachable head, wherein said actuator assembly is either one of separable into at least two halves or comprises a slit allowing access to said passage, everting said second vessel over a dilator apparatus; hooking said everted second vessel on at least one clip of said clip seat; slitting said first vessel; placing said clip seat within said slit in said first vessel; and, actuating said instrument, wherein said first vessel is joined to said second vessel in one actuation and wherein said at least one clip remains outside said first vessel and said second vessel. BRIEF DESCMPTION OF THE DRAWINGS

[0010] In order that the manner in which the above recited and other advantages and objects of the invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope, the invention will be described with additional specificity and detail through the use of the accompanying drawings in which:

[0011] Figure 1 is an illustration of an embodiment of the present invention.

[0012] Figure 2 is an illustration of an exploded view of the embodiment of Figure 1 joining two vessels.

[0013] Figure 3 is an illustration of various component parts of an embodiment of the present invention.

[0014] Figure 4 is an illustration of an alternate view of various component parts of an embodiment of the present invention.

[0015] Figure 5 is an illustration of an embodiment of a clip of an embodiment of the present invention.

[0016] Figure 6 is an illustration of an alternate view of various component parts of an embodiment of the present invention.

[0017] Figure 7 is an illustration of an alternate embodiment of the present invention.

[0018] Figure 8 is a Section view of Section A-A from Figure 7.

[0019] Figure 9 is an illustration of an alternate embodiment of the present invention.

[0020] Figure 10 is an illustration of an alternate view of various component parts of an embodiment of the present invention.

[0021] Figure 11 is an illustration of an alternate view of various component parts of an embodiment of the present invention.

[0022] Figure 12 is an alternate embodiment of a clip of the present invention. [0023] Figure 13 is an illustration of an outline of an alternate embodiment of the present invention.

[0024] Figure 14 is an illustration of a dual alternate embodiment of the present invention.

[0025] Figure 15 is an illustration of a perspective view of an alternate embodiment of the present invention.

[0026] Figure 16 is an illustration of an alternate embodiment of the present invention.

[0027] Figure 17 is a Section view of Section A-A from Figure 16.

[0028] Figure 18 is an illustration of an umbrella device for dilating a blood vessel.

[0029] Figure 19 is an illustration of an alternate embodiment of the present invention.

[0030] Figure 20 is an illustration of an alternate embodiment of the present invention.

[0031] Figure 21 is an illustration of various clips of the present invention.

[0032] Figure 22 is an illustration of a bend line of an embodiment of the present invention.

DESCRIPTION OF THE INVENTION

[0033] Various methods exist to perform the anastomosis. Although some staplers have been reported as providing leaky joints, a variety of staplers have been developed for end-to-end and for end-to-side anastomosis. US 5,366,462 discloses a method of end-to-side vascular anastomosis. According to this method, the end of the graft blood vessel that is to be anastomosed is everted by 180 degrees; one end of the staple pierces both vessels with punctures exposed to the blood flow and the other end of the staple pierces the outside of the receiving vessel. US Pat. No. 5,732,872 discloses a surgical stapling instrument that comprises an expandable anvil for aiding in the stapling of a 180-degree everted end of a graft vessel to a receiving vessel. This patent also discloses a stapling instrument for joining the 180-degree everted second end of a graft vessel whose opposite end has already been anastomosed. To anastomose this second end, this technique requires clearance around the area in which the anastomosis is performed, exposure of the receiving blood vessel, external anatomic identification, and significant external manipulation in the open area around the anastomosis site. US 4,930,674 discloses methods of end-to-end and end-to-side anastomosis and a surgical stapler that comprises a vessel-gripping structure for joining the 180-degree everted end of a graft vessel to another vessel. US 5,695,504 discloses methods and a system for performing an end-to-side vascular anastomosis, where the system is applicable for performing an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly in port- access coronary artery bypass graft surgery. This system includes a staple with a configuration that combines the functions of an anchor member and a coupling member into a one-piece anastomosis staple. US 5,861,005 discloses an arterial stapling method and device for stapling an opening in an anatomical structure, whether the opening is deliberately formed or accidentally caused. This device employs a balloon catheter that helps positioning the stapling mechanism properly on the organ to be stapled.

[0034] Other prior art solutions can be found in Chinese patent application number 20042005936.0 ("the '936 Chinese patent"). The '936 Chinese patent discloses a one-shot anastomostic device. However, the '936 Chinese patent is representative of the issues associated with one-shot or automatic anastomostic devices in general. It is well known in the prior art that one-shot or automatic anastomostic devices have a very high rate or incidence of failure in that the grafts do not hold, such that leakage occurs, thereby hindering the effects of the procedure. Liu, et al, Ann. Thorac. Surg., 2006:82, 303-307. The most common incidence of failure are from occlusions. However, it is accepted that a safe and effective one-shot or automatic anastomostic device would be beneficial to the art field.

[0035] Accordingly, disclosed herein is an improved one-shot or automatic anastomosis device that does not suffer from the problems of the prior art. Desirable characteristics in a new and improved anastomosis device may include, a non-occlusive anastomosis in which the flow of blood and/or matter through the vessel that is joined is not interrupted while the anastomosis is performed. Further, it may be desirable that the device reduce the incidence of thrombosis and/or clotting. An adjustable angle of approach, such that a vessel may be approached from an angle other than a 90-degree angle, may also be desirable. Likewise, a detachable head in the device, to further reduce the incidence of thrombosis and/or clotting may be desirable. Further desirable characteristics may include an anastomosis device capable of grafting both on the proximate end of a vessel and on the distal end of a vessel. Accordingly, a one-shot or automatic anastomosis device with at least one of the previously mentioned improvements is desirable.

[0036] The particulars shown herein are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of various embodiments of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for the fundamental understanding of the invention, the description taken with the drawings and/or examples making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0037] The following definitions and explanations are meant and intended to be controlling in any future construction unless clearly and unambiguously modified in the following Examples or when application of the meaning renders any construction meaningless or essentially meaningless. In cases where the construction of the term would render it meaningless or essentially meaningless, the definition should be taken from Webster's Dictionary, 3^rd Edition.

[0038] As used herein, all percentages are percentages by weight, unless stated otherwise.

[0039] As used herein, the term "anastomosis" means and refers to an operative union of two hollow or tubular structures. Structures capable of being anastomosed are capable of being a variety of systems, such as a portion of a vascular system, a portion of a digestive system, a portion of a genitourinary system, and/or the like. Various common examples of general anastomosic procedures include arteriovenous anastomosis (blood is shunted from an artery to a vein), cavopulmonary anastomosis (blood is shunted from the right pulmonary artery to the superior vena cava), Braun's anastomosis (joining of afferent and efferent loops of jejunum), ureterotubal anastomosis (joining of the ureter and the Fallopian tube), ureterosigmoid anastomosis (joining of the ureter and a segment of the sigmoid colon), and microvascular anastomosis (small blood vessels are anastomosed).

[0040] An anastomosis is termed end-to-end when the terminal portions of tubular structures are anastomosed, and it is termed end-to-side when the terminal portion of a tubular structure is anastomosed to a lateral portion of another tubular or hollow structure. In an end-to-side anastomosis, we often refer to the structure whose end is anastomosed as the "graft vessel" while the structure whose side wall is anastomosed is referred to as the "receiving structure."

[0041] As used herein, the term "anastomotic material" typically includes both autologous material and heterologous material or synthetic material. An autologous graft is a graft in which the donor and recipient areas are in the same individual. Heterologous material is derived from an animal of a different species. The graft can be made of a synthetic material such as expanded polytetrafluoroethylene ("ePTFE"). Brittinger et ah, "Vascular Access for Hemodialysis in Children," Pediatric Nephrology, 1997:11, 87-95.

[0042] As used herein, a "fluid" is a continuous, amorphous substance whose molecules move freely past one another and that has the tendency to assume the shape of its container, for example, a liquid or a gas.

[0043] As used herein, the term "health care provider" is known in the art and specifically includes a physician, a person with authority to prescribe a medication (whether directly or indirectly), and a veterinarian. In certain embodiments, a health care provider includes an individual that provides a medication without prescription, such as in providing an over-the- counter medication.

[0044] As used herein, the terms "identifying subjects" and "diagnosing" are used interchangeably with regard to the detection of a "predisposition," "increased propensity," "risk," "increased risk," and the like. [0045] As used herein, the term "administered to the subject" and/or "to the subject's site" means and refers to delivery of an effective amount of the formulation and/or medicament.

[0046] As used herein, the term "subject" or "patient" refers to any invertebrate or vertebrate species. The methods of the present invention are particularly useful in the treatment of warmblooded vertebrates. Thus, in an embodiment, the invention concerns mammals and birds.

[0047] As used herein, the terms "removable" and "detachable" are used interchangeably.

[0048] As used herein, the term "proximal" will refer to the end of the apparatus which is closer to the user, while the term "distal" will refer to the end which is further from the user.

[0049] Examples of various syringes, anastomosis clips, staplers, and methods that may be capable of use or modification with various embodiments of the present invention include US 7,056,307; US 6,203,553; 6,699,256; 7,112,211; 6,391,039; 5,797,934; 6,066,148; 5,833,698; 5,366,462; US 5,669,918; US application 20050051597; US application 20030065345; US application 20040176786; US application 20040133221; US application 20030208213; US application 20020173809; US application 20050251155; US application 20050192602; and, US application 20050006432, the contents of which are hereby incorporated by reference.

[0050] Referring to the drawings in general, it will be understood that the illustrations are for the purpose of describing a particular embodiment of the invention and are not intended to limit the invention thereto.

[0051] Now referring to Figure 1, in which like reference numerals identify similar or identical elements, one embodiment of the present disclosure is illustrated generally in FIG. 1 and is designated therein as surgical instrument 50. Surgical instrument 50 includes three principal components, namely, an actuator assembly 10, a head 60, and a clip seat 20, to complete an anastomosis between two vessels.

[0052] Various examples of vessels that are common to apply an anastomosis procedure include coronary bypass surgery (end-to-side connection), aortic prosthetic replacement surgery for branch arteries and veins including end-to-end and end-to-side connections, peripheral blood vessels anastomosis in bypass surgery for peripheral vascular disease, establishment of A-V shunt, operations/surgeries that require connection between small to medium blood vessel connections, and/or the like. [0053] The particular surgical instrument 50 shown in the various figures is preferably designed to deform an array of surgical fasteners similar to fastener 30 shown in FIG. 1 which is generally C-shaped and includes a base leg 100 and an upwardly extending support leg 90. Preferably, base leg 100 includes a proximal end 70 which is sufficiently shaped to penetrate the tissue of interest upon deployment. The upwardly-extending support leg 90 is attached to base leg 100 at a pivot point and includes an inwardly-extending prong 60. Fastener 30 generally includes at least one edge per fastener or clip. In various embodiments, edge 80 is beveled or sharpened such that it is capable of penetrating at least one tissue. Further description of a fastener of an embodiment of the present invention can be found in relation to Figure 21.

[0054] In all embodiments, head 60 is at least rotatable through a plurality of angles to at least one axis relative to actuator assembly 10. In an embodiment, head 60 is capable of being locked in at least one of the plurality of angles relative to actuator assembly 10. In various embodiments, the angle is 5 degrees. In an alternate embodiment, the angle is 10 degrees. In an alternate embodiment, the angle is 15 degrees. In an alternate embodiment, the angle is 20 degrees. In an alternate embodiment, the angle is 25 degrees. In an alternate embodiment, the angle is 30 degrees. In an alternate embodiment, the angle is 35 degrees. In an alternate embodiment, the angle is 40 degrees. In an alternate embodiment, the angle is 10 degrees. In an alternate embodiment, the angle is 45 degrees. In an alternate embodiment, the angle is 50 degrees. In an alternate embodiment, the angle is 55 degrees. In an alternate embodiment, the angle is 60 degrees. In an alternate embodiment, the angle is 65 degrees. In an alternate embodiment, the angle is 70 degrees. In an alternate embodiment, the angle is 75 degrees. In an alternate embodiment, the angle is 80 degrees. In an alternate embodiment, the angle is 85 degrees. In an alternate embodiment, the angle is 90 degrees. In general, head 60 is adjustable to any desired angle.

[0055] Enabling the device with a head that has an adjustable angle, in an embodiment, is capable of allowing the device to be used effectively in operative situations when angled side-to- end connections are required, which include but are not limited to blood vessels connection, biliary tube connection, urethra connection in operative, or minimally invasive operative procedures. Figures 7, 9, 10, 11, 12, and 13 illustrate various embodiments of the present invention with a head at an angle from the actuator assembly. For purposes of description, the majority of the Figures illustrate a head extending straight or substantially straight from the actuator assembly.

[0056] In various embodiments, when a desired angle is determined or selected, head 60 is capable of being fixed through a locking mechanism. In various embodiments, the locking mechanism is an interference fit. In various other embodiments, the locking mechanism is a screw-type connection. In various other embodiments, the locking mechanism is a luer lock mechanism.

[0057] hi all embodiments, head 60 is detachably attached to device 50, In various embodiments, an applicator 160 is detachably attached to head 60. In an embodiment, the attachment is through a threaded connection through a interior tubular body 130. In an alternate embodiment, the attachment is through an interference fit. In yet an alternate embodiment, the attachment is through a cam lock or luer lock system. In general, any method for connecting applicator 160 and head 60 is capable of use with varying embodiments of the present invention.

[0058] hi various embodiments with a detachable head, a variety of different clip seats are capable of use. In an embodiment, a clip seat can be chosen with a desired diameter. In an alternate embodiment, a clip seat can be chosen with a desired number of clips for the procedure being performed. In an embodiment, a clip seat of the present invention has two or more clips. In an alternate embodiment, a clip seat of the present invention has three or more clips. In an alternate embodiment, a clip seat of the present invention has four or more clips, hi an alternate embodiment, a clip seat of the present invention has five or more clips, hi an alternate embodiment, a clip seat of the present invention has six or more clips, hi an alternate embodiment, a clip seat of the present invention has seven or more clips. In an alternate embodiment, a clip seat of the present invention has eight or more clips. However, the number of clips will typically be chosen according to the procedure.

[0059] A clip seat 20 of various embodiments of the present invention is detachable as illustrated in Figures 3-6. hi an embodiment, a clip seat of the present invention is disposable. Reference to Figure 3 will more greatly disclose the operations and/or construction of a clip seat of the present invention.

[0060] In various embodiments, a material of the clip is at least one of (1) Chemically inert; (2) anti-eroding; (3) no tissue rejection; and, (4) having minimal tissue injury with high mechanical strength and endurance. Suitable materials for use include at least one of the following: Co-Cr-Ni, Ti-6A1-4V or stainless steel. However, other materials can be used and would be readily identifiable to one of ordinary skill in the art from the teachings of the present invention.

[0061] Likewise, a detachable head allows for the ease of replacing parts. In an embodiment, portions of a surgical instrument of the present invention are capable of being disposed while more costly parts can be reused. In various embodiments, a head of the present invention is designed to be disposable, such that recovery of the head from the patient's body is not necessary. In various embodiments, a head of the present invention is designed to be disposable, such that recovery of the clip seat from the patient's body is not necessary. In various embodiments, a head of the present invention is designed to be disposable, such that recovery of the actuator assembly from the patient's body is not necessary.

[0062] Actuator system 10 generally comprises an apparatus for applying or manipulating instrument 50, such as a handle 150. In various embodiments, handle 150 is connected to a hollow tube body 120.

[0063] In various embodiments, handle 150 is replaced with other structures capable of performing the function, such as a ring or syringe-type handle. In general, any handle common in the art can be used. In an embodiment, a device of the present invention is capable of being operated by a finger rather than an entire hand, thereby allowing for a non-invasive procedure.

[0064] Varying lengths of handles and/or surgical instruments are capable of use with various embodiments of the present invention. Typically, a length of a handle or surgical instrument is selected based at least partially upon the procedure to be performed and/or the desires of the clinician and/or surgeon.

[0065] The handle 150 is connected to a hollow outer tubular body 120 designed to receive an inner tubular body 130. In general, tubular body 130 defines a passage 140 therethrough. Further, outer tubular body 120 together with inner tubular body 130, define passage 140. Inner wall 240 of tubular body 130 is capable of being any desired diameter and/or shape. Generally, passage 140 extends through device 50. In various embodiments, hole 110 extends along a length of tube 120 and tubular body 130 such that a vessel is capable of being slid through hole 110 into device 50. In this manner, a device of the present invention is capable of being deployed for grafting both the proximate and the distal end of a vessel.

[0066] In various other embodiments, Device 50 is capable of being split into 2 parts vertically. Securing the two halves resulting from the split can be by way of an interference fit, latch, thread 85, or other locking mechanism common in the art. Head surface 220 is generally capable of being any desired shape. In various embodiments, surface 220 is designed so at to minimize the occlusion of fluid flow, such that the surface is rounded, slanted or recessed.

[0067] In various embodiments, the vessel is a vein, artery, or other bodily vessel. In various alternate embodiments, the vessel is a synthetic graft material, hi general, any vessel is capable of use with varying embodiments of the present invention.

[0068] Figure 18 illustrates a balloon- or umbrella-type device that can be used with various embodiments of the present invention to assist in connecting a vessel body to a clip seat. Further description is given below in reference to Figure 18. In general, an umbrella device is designed to facilitate the attachment of vessels onto the seat of clips of the clip seat. This is particularly useful for small vessels when eversion can be difficult and challenging.

[0069] Now referring to Figure 2, an exploded view of Figure 1 is illustrated wherein head 60 has been inserted into a vessel 200. Edges 230 of clip 232 are engaging and/or attached to vessel wall 200. In an embodiment, edges 230 completely pierce vessel 200. In an alternate embodiment, edges 230 embed within a tissue of vessel 200. In various embodiments, the degree to which edges 230 are secured to vessel 200 depends on at least one of (1) the length of time the clips are to remain attached, (2) the amount of trauma the vessel can withstand, (3) the graft location, and/or the like.

[0070] As is illustrated, clip seat 20 comprises at least one wing 21. Wing 21 is generally shaped to accommodate clip 232. hi various embodiments, the material for the clip seat and wing that holds the pre-loaded clips will require the alloy metal that has memory, i.e., is deformable and resilient. After the clip is closed, the wing can return to its original position so that it can be detached. [0071] In all embodiments, however, after removal of head 60 and actuator assembly 10, no metallic parts are left in the vessel, thereby reducing the incidence of failure from at least stenosis and thrombosis.

[0072] Now referring to Figure 3, various component parts of an embodiment of the present invention are illustrated separated from one another. Generally, surgical instrument 300 includes three principal components, namely, an actuator assembly 310, a head 360, and a clip seat 320. Here, head 360 is illustrated detached from tubular body 330 by means of a threaded connection 385. However, any type of releasable connection may be utilized, such as, but not limited to a luer lock system.

[0073] Referring to clip seat 320, in various embodiments, clips 325 are preloaded, prepacked and ready to use prior to loading into actuator assembly 310. In general, any number of clips can be used as required for the size of clip seat 320. Typically, the size of clip seat 320 is relative to the size of a vessel to be joined. In general, the number of clips will be 4 or more.

[0074] Now referring to Figure 4, a further illustration of a clip seat 420 is shown. In general, clip seat 420 comprises at least one wing 427 for every clip 425. In various embodiments, clip 425 is positioned within a recess defined by base 421 and at least one wing 427. In an embodiment, clip 425 is C-shaped. Accordingly, the recess defined by base 421 and at least one wing 427 is C-shaped. However, other shapes may be used as desired by the clinician or doctor. Other contemplated shapes include a U-shaped clip, a D-shaped clip, a V-shaped clip, and/or the like.

[0075] Now referring to Figure 5, an enlarged clip seat 495 is illustrated.

[0076] Now referring to Figure 6, an alternate embodiment of a surgical instrument 500 of the present invention is illustrated.

[0077] Now referring to Figure 7, an alternate embodiment of a surgical instrument 600 is illustrated. Device 600 affords a sectional view A-A in Figure 8. An angled head 630 with clip 610 and clip seat 620 is illustrated.

[0078] Figure 8 illustrates a sectional view A-A of the device from Figure 7. Generally, a cavity or passage 670 is illustrated. Such passage is sized to approximate the size of the vessel being grafted such that incidence of occlusion is reduced. [0079] Figure 9 is an illustration of an alternate embodiment of a surgical instrument 700 of the present invention.

[0080] Now referring to Figure 10, a view of a separated surgical instrument 700 from Figure 9 is illustrated.

[0081] Now referring to Figure 11, an alternate embodiment of a separated surgical instrument 800 is illustrated comprising handle 810, clip seat 840, head 860, and tubular body 820.

[0082] Now referring to Figure 12, a clip seat 897 is illustrated.

[0083] Now referring to Figure 13, a cut-away view of an embodiment of a surgical instrument 900 of the present invention is illustrated. As can be seen, the angle of head 910 from actuator assembly 930 does not occlude passage 960.

[0084] Now referring to Figure 14, an illustration of a dual surgical instrument 1100 embodiment. This is a split open design as an alternative to the slit open design on the side of the shaft(as in Figure 3, 310). This design will be particularly useful for large vessels when the slit design may be too small to slide the blood vessel inside the tube.

[0085] Now referring to Figure 15, an alternate embodiment of a surgical instrument 1200 is illustrated.

[0086] Now referring to Figure 16, is an illustration of an alternate embodiment of a surgical instrument 1124 of the present invention with a more narrow handle or actuator system 1126 for accessing a vessel within a patient's body. A slit or opening 1127 is capable of use for receiving a vessel such that an anastomosis is capable of being performed from both the distal and the proximate end of the vessel.

[0087] Now referring to Figure 17, is an illustration of an embodiment of a sectional view of section A-A from Figure 16. Passage 1131 is illustrated. In various embodiments, passage 1131 is about the same diameter as the vessel undergoing anastomosis. In an alternate embodiment, passage 1131 has a diameter greater than that of the vessel undergoing anastomosis. In an alternate embodiment, passage 1131 has a diameter less than that of the vessel undergoing anastomosis. [0088] Now referring to Figure 18, a separate blood vessel dilator/opener 1224 is illustrated. In an embodiment, an umbrella-type dilator 1224 is used for eversion of the vessel end in order to load the anastomosis end on the clip seat. In various embodiments, by opening the umbrella dilator, a circular force will be applied to the end of the vessel. Removing the umbrella device will everse and hook the vessel on the clip seat. In various embodiments, the umbrella dilator can be applied from both directions in the vessel. After the blood vessel is everted onto the clip seat, the umbrella or other dilator will be closed or deactivated before it is detached from the vessel.

[0089] In an embodiment, the design of the umbrella is that it is closed and inserted through the vessel. The umbrella has a flat edge with a slight eversion so that it can hold the vessel edge on the seat of clips when pushed. Towards the end of the vessel, it can be opened to dilate the end of the blood vessel. With a vertical movement towards the clip seat, the umbrella remains open until the vessel edge is hooked onto the lip of the clip seat. The umbrella can then be closed and pulled out. With the plastic and nylon types of materials, the umbrella can be disposable and one-size-fits-all.

[0090] Now referring to Figure 19, an illustration of an alternate embodiment of a surgical instrument 1300 is shown comprising a detachable head 1325, larger clip seat 1335 for containing a larger clip, and alternate actuator system 1345. In various embodiments, a one-ring actuator is capable of being operated with fewer digits or fingers. In an embodiment, the actuator is capable of being operated with 1 thumb and 2 fingers similar to a syringe action. It is further anticipated that a one-ring actuator may be more appropriately sized for minimally invasive procedures.

[0091] Now referring to Figure 20, an illustration of an alternate embodiment of a surgical instrument 1400 of the present invention comprising a handle 1410 and an extended or long actuator system 1425.

[0092] Now referring to Figure 21, a clip 1060 and a clip seat 1000 are illustrated. Clip 1060, in an embodiment, is capable of being characterized by connecting at least two bent pieces of metal to at least one horizontal bar 1065. Two horizontal bars 1065 are capable of use for greater stability. However, various embodiments contemplate the use of one horizontal bar in clip 1060. [0093] In an embodiment, a clip of the present invention is formed by 3 angulated bends. It is made by bending a wire-like piece of metal from the middle to 45-90 degrees, which forms two legs of the clip. At the ends of the legs, at the position of about 1/5 of the leg length, a further bend of 90 degrees is made to form the teeth of the clip. Two clips are connected at the intersection of the teeth and legs by a horizontal bar with variable length. In various embodiments, an clip can be made from a single piece of metal. In various other embodiments, a sheet of metal is punched out to form a clip of the present invention, as is illustrated in Figure 22.

[0094] In various embodiments, a device of the present invention is capable of being deployed with a deployment device such that a vascular coupler is advanced into position and deployed using a catheter or hand-held device. Modifications of the catheter and hand-held deployment devices may be used for endoscopic and laparoscopic procedures. In various embodiments, the tip of the deployment device may have a "screw, or corkscrew" type configuration, so that advancement through tissue can occur without significant forward pressure or force being applied, instead the device can be advanced by rotation of the deployment device, thereby causing less trauma to various tissues of a subject.

[0095] The surgical instrument disclosed herein connects at least a target vessel to at least a graft vessel, hi an embodiment, the graft material is autologous. In an alternate embodiment, the graft material is heterologous. In an alternate embodiment, the graft material is a synthetic material. In yet an alternate embodiment, the graft material is a combination of an autologous material, a heterologous material, and/or a synthetic material. In general, any graft material can be selected that would not adversely affect the anastomosis procedure.

[0096] Synthetic biomaterials that are being developed include polymeric materials with the proteins elastin and fibronectin. Rouhi, "Contemporary Biomaterials," Chemical & Engineering News, 1999:77(3), 51-63. Polytetrafluoroethylene (PTFE) has been used with a variety of coatings. Various coatings capable of use with embodiments of the present invention comprise fibrin glue, fibroblast growth factor, heparin, and/or the like. Further grafts capable of use with embodiments of the present invention comprise a synthetic biodegradable tubular scaffold, such as a vessel made of, for example, and not by way of limitation, a polyglactin/polyglycolic acid coated with autologous cells or heterologous cells. [0097] Various embodiments further comprise a biocompatible contact adhesive or other material to bond or secure the device to the vessel, sealing the anastomosis site. In addition, adhesives may be used to secure or assist in securing the bypass graft to an embodiment of the device. The adhesive/bonding compounds/solutions could be added during the manufacturing process, just prior to deployment, or after the device has been deployed. In various embodiments, the bonding materials are in the form of a liquid, semi-solid, or solid. Suitable bonding materials include gels, foams and microporous mesh. Suitable adhesives include acrylates, cyanoacrylates, epoxies, fibrin-based adhesives, other biological-based adhesives, UV light- and/or heat- activated or other specialized adhesives. The adhesive could bond on initial contact, or longer, to allow repositioning if desired. The preferred adhesive may be a crystalline polymer that changes from a non-tacky crystalline state to an adhesive gel state when the temperature is raised from room temperature to body temperature. Such material is available under the trade name Intillemer.TM. adhesive, available from Landec Corp. as well as composites and combinations thereof and combinations of other materials. Suppliers of surgical adhesives include, but aren't limited to, Plasto (Dijon, France), Haemacure (Montreal, Canada), Cohesion (Palo Alto, Calif.), Cryolife (Kennesaw, Ga.), TissueLink (Dover, N. H.), and others.

[0098] In various embodiments, to increase the work time of the adhesive or allow repositioning of the surgical instrument after it has been deployed, the adhesive can be blended with a material, such as a starch or other material, that dissolves and retards or delays bonding to allow repositioning of the device after it has been deployed. Further, a degradable coating can be placed over the adhesive coating so that it degrades and exposes the adhesive.

[0099] The surgical instrument may incorporate one or more coatings, materials, compounds, substances, drugs, therapeutic agents, etc. that positively affect healing at the site, at and/or near where the device is deployed, either incorporated into the structure forming the device, incorporated into a coating, or both. Antithrombotic materials, antiproliferative materials, or other coatings intended to prevent thrombosis (acute and or chronic), hyperplasia, platelet aggregation, or other negative response, at or near the attachment of the bypass graft, as well as at or near the implantation site of the device through the host vessel. The coatings, materials, compounds, substances, drugs, therapeutic agents, etc. may be used by themselves, and/or contained in a carrier such as a polymeric matrix, starch, or other suitable material or method. The coatings may be liquid, gel, film, uncured, partially cured, cured, combination or other suitable form.

[0100] Coatings on the device which may be used to deliver therapeutic and pharmaceutic agents include (but are not limited to): antiproliferative/antimitotic agents including natural products such as vinca alkaloids (i.e., vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (i.e., etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) Il_t/III_a inhibitors and vitronectin receptor antagonists; antiproliferative/antimitotic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU) and analogs, streptozocin), trazenes-dacarbazinine (DTIC); antiproliferative/antimitotic antimetabolites such as folic acid analogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine (cladribine)); platinum coordination complexes (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, and aminoglutethimide; hormones (i.e., estrogen); anticoagulants (heparin, synthetic heparin salts and other inhibitors of thrombin); fibrinolytic agents (such as tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory; antisecretory (breveldin); anti-inflammatory, such as adrenocortical steroids (Cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (salicylic acid derivatives i.e., aspirin; para-aminophenol derivatives i.e., acetominophen; indole and indene acetic acids (indomethacin, sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac, and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azatbioprine, mycophenolate mofetil); angiogenic agents: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; anti- sense oligonucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, and growth factor signal transduction kinase inhibitors. Alternatively, a clot promoter may be used, such as protamine sulphate or calcium hydroxide. Further, endothelial cells may also be added to the surgical instrument.

[0101] The therapeutic compounds/solutions may be blended with the device base materials during fabrication, applied just prior to deployment, or after the device has been deployed.

[0102] The therapeutic materials may be located on, through, inside, or combination of the device in holes, grooves, slots (or other indentations) or designs. For example, the surface under the vessel reinforcement ridge, as well as the under-ridge hemostatic gasket, may have partial or complete holes, grooves, or other indentations, filled with a therapeutic substance, in contact with the host vessel tissue. In addition, the area of the device that comes in contact with the bypass vessel may also incorporate this feature. The petals may also have partial or complete holes, slots, grooves, or other filled with a therapeutic substance, or simply coated on the outside surfaces. This design allows direct contact of the therapeutic substance while maintaining the functional ability of the device or device component. Combinations of therapeutic substances or coatings may be used on the same device. For example, a more viscous (gel or other) therapeutic substance may be used to fill the partial or complete holes (or other) on the vessel reinforcing ridge and hemostatic gasket under the ridge, while the petals are coated with a less viscous (liquid) material. The therapeutic substance may be the same, or a combination of more than one type used on a single device. The coatings may be designed to provide benefits acutely, and/or over a period of time. The coatings, materials, compounds, substances, therapeutic agents, etc. may be desired to be static and/or eluding. The coatings, materials, compounds, substances, therapeutic agents, etc. elute from the coated (or embedded) device (or component) over time and enter the surrounding tissue. The coatings, materials, compounds, substances, drugs, therapeutic agents, etc. preferably remain on the device for at least three days, and up to approximately six months, and more preferably between seven and thirty days.

[0103] Post-device fabrication coating methods include, but are not limited to, spin coating, RF- plasma polymerization, dipping, spraying, brushing, submerging the devices into a beaker containing a therapeutic solution while inside a vacuum chamber to permeate the device material, etc.

[0104] Alternatively, or in combination with the above therapeutic substances, a material such as platinum, gold, tantalum, tin, tin-indium, zirconium, zirconium alloy, zirconium oxide, zirconium nitrate, phosphatidyl-choline, pyrolytic carbon, combination or other material, may be deposited onto the device surface using electroplating, sputtering vacuum evaporation, ion- assisted beam deposition, vapor deposition, silver doping, boronation techniques, or other coating process.

[0105] In addition to the above therapeutic methods and materials, similar and additional methods of coating and materials are described in detail in U.S. Patent Application No. 2002/0133183, the contents of which are incorporated in their entirety by reference.

[0106] Radiopaque materials such as barium sulfate, bismuth trioxide, tantalum or others can be added to the surgical instruments, reinforcement structure (e.g., the overmold) or bonding material. Additionally, platinum, gold, or other material may be added to the device by sputter coating, ion deposition, vapor deposition, combination, or other process.

[0107] The surgical instruments described above can be used with various accessories, as necessary, to improve the outcome for the patient receiving the device. For example, the bypass graft can be reinforced with a vessel reinforcement device to prevent kinking, collapsing, or other types of restrictions to blood flow. Also, the reinforcement device could prevent bypass graft vessel over expansion once blood flow has been reestablished. The reinforcement device can be used with any anastomosis type, such as a device, staple, suture, etc. Similarly, the vessel reinforcement device can be used with harvested biological grafts such as the internal mammary artery (IMA), radial artery, saphenous vein, or other. Additionally, the vessel reinforcement device can be used with grafts made from other biological materials, or combinations of biological and synthetic materials.

[0108] The vessel reinforcement device may be used on the outside or inside of the bypass graft, and may be fabricated with a contact adhesive, as described herein, and/or therapeutic material, as also described herein, on the tissue-contacting surfaces. The adhesive may be applied after the bypass graft has been secured, before or after blood flow has been reestablished. [0109] The vessel reinforcement device may be of a single-piece configuration, or may be fabricated from multiple pieces that overlap. The reinforcement, or reinforcements may be as long as the entire length of the bypass graft, or only at the two ends of the anastomosis to function as a strain relief. The vessel reinforcement device can be placed around the bypass graft before the second end of the graft is secured, or after both ends of the bypass graft have been secured if using a version of the reinforcement device that allows side access. The vessel reinforcement device may have a consistent diameter and geometry, or the ends (i.e., the site of the anastomosis) may be flared to fit over the anastomosis to thereby function as an anastomosis reinforcement device. The vessel reinforcement device may be used as a side access version that has the ends directly oppose each other, although they may be offset.

[0110] The vessel reinforcement device may be partially or completely made of metal, metal alloy (such as Nitinol), polymer (such as ePTFE), a combination of these or other suitable material. The device materials could be in the form of, for example, a wire, hoop, oval, rod, band, ribbon, tube, sheet, combination of these or other suitable shape. Additionally, the materials could be formed in a wound, coiled, undulated, sinusoidal, braided, combination of these or other suitable configuration.

[0111] The core material, which may be, for example, Nitinol or other suitable material, is annealed as described herein over a mandrel matching the outer diameter of the bypass graft vessel. The geometry of the mandrel may be round, oval, or of another suitable shape, and may have a consistent size and geometry, or a larger diameter and/or shape, at one or both ends.

[0112] The vessel reinforcement device may be partially or completely coated or overmolded using several methods and processes including sintering, molding (such as injection molding), casting, adhesive bonding, laminating, dip coating, or spraying, as well as composites and combinations thereof and combinations of other methods and processes.

[0113] Another accessory to the surgical instrument is a deployment device. Examples of deployment devices have been described above. In general, the surgical instrument is radially compressible in some configurations and can be deployed using fingers, standard surgical instruments (including Rongeur clamp), modified surgical instruments or specially designed tools. Specially designed tools include modified surgical instruments (length, contact area, compression force, compression diameter, etc.), as well as tools/devices specifically designed to compress the cross section of the anastomotic device while being advanced through a hollow, tapered tube. The anastomosis device could be advanced through the deployment tool by an elongated stylet that attaches to the outside of the anastomosis device inside or outside of the deployment tool. Advancement from outside the deployment tool using a stylet or plunger could be accomplished by way of a slot through the wall of the funnel-type deployment tool.

[0114] The deployment tool may be designed to deflect some or all of the interior vessel engagement elements (i.e., inner or outer clips) into a position that assists deployment (i.e., forward, backward, or other suitable position). Once deployed inside the vessel, the tool is detached from the surgical instrument.

[0115] The deployment tools and devices may have the ability for the distal end to be steered (e.g., controllable from the proximal end of the tool or device) while having the ability to compress the surgical instrument during deployment and release the device once it is positioned in the desired location within the vessel. This version of a deployment tool is particularly useful during minimally invasive, endoscopic and robotically-assisted surgery, or other where access space within the chest cavity is limited. Steering capability can be accomplished using one or more pull wires attached to a ring, collar, flat leaf spring, or other member that is designed to deflect when the pull wire is pulled. Alternatively, the distal section of the deployment tool/device can be formed in a curve, and a straight rod or stylet can be advanced from the proximal end, towards the distal end, straightening the distal end. Another option is to advance a preformed curve, or steerable device, into a lumen of the deployment tool/device. A clip that can be detached from the side after deployment also can be used.

[0116] The surgical instrument is versatile and can be deployed in a number of methods, some of which have been described above or are described below. To access the heart, the surgeon uses a thoracotomy, thoracostomy, median sternotomy, or other suitable surgical approach. The surgical instrument and accessories described herein can be used with cardiopulmonary-support, beating-heart, open-field, minimally-invasive, endoscopic, laparoscopic and robotically-assisted surgery, or other cardiovascular technique.

[0117] Further embodiments of the present invention contemplate methods of manufacture. In an embodiment, a device of the present invention is capable of being fabricated using many methods known to those of skill in the art. One representative method is described below. In these methods, the petals and securing members may be produced at the same time, either as individual separate components or connected together. Initially, the desired pattern of the petals and securing members is chemically etched onto a flat sheet of superelastic/shape memory material, such as Nitinol. The etching produces the device components. The resulting cross section geometry of the parts may be round, oval, square, square with rounded corners, or any other suitable shape. The etched pattern then is bent and/or annealed into a specific shape using a suitable fixture. The ends of the etched pattern then are joined together by using one or more of several methods including, for example, (1) inserting an end that includes a tab into a slot, groove, or hole; and (2) soldering, welding, adhesively bonding, or applying any other suitable joining process to the ends. Alternatively, the section or sections may not be joined, or otherwise attached together. The desired shape is imparted by the bending and/or annealing described above. The design that does not incorporate joining may allow additional flexibility at one or more regions of the device.

[0118] The primarily metallic surgical instruments described above may be made of a superelastic or shape memory metal or plastic that can be deformed during deployment to have its cross-sectional profile reduced as described above. For example, the stem can be made of Nitinol. The inner and outer surfaces of the stem also or optionally can be electropolished. The inner and outer surfaces of the stem can be configured to have increased biocompatibility and blood compatibility, such as by having a textured surface that promotes endothelial cell growth and adhesion, as described in more detail below.

[0119] Materials other than superelastic shape memory alloys may be used as the actuator assembly, the clips, and/or the clip seat provided they can be elastically deformed within the temperature, stress, and strain parameters required to maximize the elastic restoring force thereby enabling the device to recover to a specific diameter and/or geometry once deployed over or on top of the vessel or other location. Such materials include other superelastic metal alloys, spring stainless steel 17-7, other spring metal alloys such as ELGILOY, INCONEL, superelastic polymers, etc.

[0120] The surgical instrument could contain a single or multiple superelastic/shape memory metallic alloy component such as a wire, rod, hoop, tube, coil, sheet, strip, band, or other geometry in the middle, outer, in between, side, horizontal and/or vertical plane, or combination on the device. The superelastic/shape memory elements could be located in a single, or multiple plane configuration(s). The thickness could be between 0.005" to 0.040" or other. The superelastic/shape memory alloy material could be annealed in one configuration during manufacture and processed (and packaged) in another configuration. When the material is exposed to normal body temperature (37 degrees C), will expand to engage the vessel wall, recovering to the optimum size, diameter and geometry to provide acute hemostasis and mechanical securement. Alternatively, a superelastic material could be used, being deformed/deflected during deployment, and designed to recover and provide acute hemostasis and mechanical securement to the vessel.

[0121] It is important to understand basic terminology when describing metals with elastic, superelastic, or shape memory behavior. Elasticity is the ability of the metal, under a bending load, for example, to deflect (strain) and not take a permanent "set" when the load (stress) is detached. Common elastic metals can strain to about two percent before they set. Superelastic metals are unique in that they can withstand up to about ten percent strain before taking a set. This is attributed to a "stress-induced" phase change within the metal to allow it to withstand such dramatic levels of strain. This is a desirable feature in anastomosis connection devices. Depending on the composition of the metal, this temperature that allows such a phase change can vary. And if the metal is "set" at one temperature, and then the temperature is changed, the metal can return to an "unset" shape. Then, upon returning to the previous "set" temperature, the shape changes back. This is a "shape memory" effect due to the change in temperature changing the phase within the metal. This summary describes these different metal behaviors, along with the compositions of various shape memory alloys.

[0122] When a metal is loaded (stressed) and undergoes, for example, bending, it may deflect (strain) in a "springy" fashion and tend to return to its original shape when the load is detached, or it may tend to "set" and stay in a bent condition. This ability to return to the original shape is a measure of the elasticity or "resilience" of the metal. This ability for a metal to be resilient is desirable for such things as springs, shock absorbing devices, and even wire for orthodontic braces, where the ability to deflect, but not deform (set) is important to maintain an applied force. Thus, elasticity is a highly desirable feature for a flexible, anastomosis device for connecting arterial grafts. [0123] If, under a bending load, the metal takes a set, it is said to have plastically (versus elastically) deformed. This is because the imposed stress, produced by the bending load, has exceeded the "yield strength" (stress) of the metal. Technically, this level of stress that produces a set, is referred to as the "elastic limit," but is about the same as the yield strength. If the applied load increases past the yield strength of the metal, it will produce more plasticity and can eventually break. The higher the yield strength of the metal, the more elastic it is. "Good" elastic metals can accommodate up to about two percent strain prior to taking a set. But this is not the only factor governing "elasticity."

[0124] Another factor that determines the ability of a metal to deflect to a given, desired amount, but not take a set, is the "elastic modulus," or often called the modulus of elasticity. The "modulus" of the metal is an inherent property. Steels, for example, have a relatively high modulus (30 msi) while the more flexible aluminum has a lower modulus of about 10 msi. The modulus for titanium alloys is generally between 12 and 15 msi.

[0125] Resilience is the overall measure of elasticity or "spring-back-ability" of a metal. The ratio of the yield strength divided by the modulus of the metal is the resilience. Although it is one thing for a metal to be resilient, it must also have sufficient strength for the intended service conditions.

[0126] As discussed above, when a metal is loaded, each increment of load (stress) produces a given increment of deflection (strain) within the metal. And the metal remains elastic if the applied is below the yield stress. However, there is a unique class of metal alloys that behaves in an even more elastic manner. These are the "superelastic" metals, where, for a given applied stress (load) increment, the strain in the metal can reach 5 or 6 percent or more without taking a set. In these type metals, the overall strain required to produce a set can reach an impressive 10 percent. This phenomenon is related to a phase change within the metal, and which is induced by the applied stress. This "stress-induced" phase change can also allow the metal to be set at one temperature and return to another shape at another temperature. This is a "shape memory" effect which is discussed later.

[0127] The most common superelastic metal, used in many commercial applications, is an alloy comprised of about equal parts of nickel (Ni) and titanium (Ti), and has a trade name of "Nitinol." It is also referred to as "NiTi." By slightly varying the ratios of the nickel and titanium in Nitinol, the stability of the internal phases in the metal can be changed. Basically, there are two phases. An "austenite" phase and a lower-temperature, "martensite" phase. When the metal is in an austenitic phase condition and is stressed, then a stress-induced martensite forms, resulting in the superelasticity. This is reversible, and the original shape returns upon release of the applied stress.

[0128] It is preferred that the Ni-to-Ti ratio in the Nitinol be selected so that the stress- induced martensite forms at ambient temperatures for the case of superelastic brace and support devices, which are used in ambient conditions. The specific composition can be selected to result in the desired temperature for the formation of the martensite phase (Ms) and the lower temperature (Mf) at which this transformation finishes. Both the Ms and Mf temperatures are below the temperature at which the austenite phase is stable (As and Af). The performance of an anastomosis connecting device can be further enhanced with the use of superelastic materials such as Nitinol. The superelasticity allows for greatly improved collapsibility, during deployment, such as by finger manipulation, with a surgical tool, or utilizing a delivery device or catheter, and which will return to its intended original shape when released within the vessel. The high degree of flexibility is also more compatible with the stiffness of the engaged vessel.

[0129] By manipulating the composition of Nitinol, a variety of stress-induced superelastic properties can result, and over a desired, predetermined service temperature range. This allows the metal to behave in a "shape memory" or "shape recovery" fashion. In this regard, the metal is "set" to a predetermined, desired shape at one temperature when in a martensitic condition, and which returns to the original shape when the temperature is returned to the austenitic temperature.

[0130] The shape memory phenomena occurs from a reversible crystalline phase change between austenite and the lower-temperature martensite. In addition to this transformation occurring from an induced stress as described previously, it can, of course, also change with temperature variations. This transformation is reversible, but the temperatures at which these phase changes start and finish differ depending on whether it is heated or cooled. This difference is referred to as a hysteresis cycle. This cycle is characterized by the four temperatures mentioned previously, As, Af, Ms, and Mf. Upon heating from a lower-temperature martensite, the transformation to austenite begins at the As, and will be fully austenite at Af. Upon cooling, austenite will begin to transform back to martensite at the Ms temperature, and become fully martensitic at the Mf. Again, the specific composition of the alloy can result in a desired combination of these four transformation temperatures.

[0131] In the malleable martensitic state, the alloy can be easily deformed (set). Then upon heating back to the austenitic temperature, the alloy will freely recover back to its original shape. Then if cooled back to the martensitic state, the deformed shape reform. The typical sequence of utilizing this shape memory property is to set the shape of, for example, a stent or anastomosis device, while in the higher-temperature austenitic state. Then, when cooled, deform the martensite material, and then heat to recover the original shape.

[0132] In the method described above, there are additional optional steps. For example, the etched pattern can be chemically polished or electropolished. hi particular, the elements that will come in contact with blood and/or tissue may be polished. If desired or necessary, the etched pattern may be bent and/or annealed using the fixture one or more additional times to better form the elements' shapes and/or to impart a sharp curve or bend that would not be possible to impart with single annealing. Similarly, an etching or grinding process may be used to reduce the thickness of the sheet or other starting material, which additionally removes any unwanted material.

[0133] Of course, other methods and steps for fabricating the device can be substituted for the above process. For example, alternative machining methods to the chemical etching steps include but are not limited to photo-etching, electron discharge machining (EDM), laser cutting, grinding, traditional cutting. Similarly, alternative substrates or starting materials that can be used instead of the flat sheet include but are not limited to wire, rod, hoop, tube (e.g., having a round, square, or other geometry), coil, strip, or band. Instead of the overmold fabrication method of the stem, strain relief, and ridge, other methods may be used, including but are not limited to extrusion, casting, molding (injection or other), sintering, dip coating, spraying, weaving, laminating, stereo lithography {i.e., 3-D layering).

[0134] The surgical devices described herein may be made from a variety of materials. For example, the actuator system, head, and clip seat are capable of being made of a superelastic or shape memory metal or plastic that can be deformed during deployment to have the cross- sectional profile of the surgical device reduced. One example of a suitable superelastic/shape memory metal is Nitinol, a nickel and titanium alloy. Other suitable similar materials include other superelastic metal alloys, including spring stainless steel 17-7 PH, other spring metal alloys such as Elgiloy.TM., Inconel.TM., platinum-tungsten alloy, and superelastic polymers. The securing members may be made from the same or different materials as the petals.

[0135] Further, the actuator system, head, and/or clip seat are capable of being made of may be partially or completely fabricated from many different types of synthetic biocompatible materials, including silicone, polyurethane, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, Dacron.TM., Mylar.TM., polyethylene, PET (Polyethylene terephthalate), polyamide, polyamide, PVC, Kevlar.TM. (polyaramid), polyetheretherketone (PEEK), polypropylene, polyisoprene, polyolefin, modified starches, gelatins, cellulose, collagen, fibrin, fibrinogen, elastin or other connective proteins or natural materials, polymers or copolymers such as polylactide [poly-L-lactide (PLLA), poly-D-lactide (PDLA)], polyglycolide, polydioxanone, polycaprolactone, polygluconate, polylactic acid (PLA), polylactic acid-polyethylene oxide copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), poly(alpha-hydroxy acid) or related copolymers of these materials, as well as composites and combinations thereof and combinations of other biodegradable/bioabsorbable materials. Some polymer materials could be irradiated in a desired geometry, for the shape to be "set" into that position. A similar process using heat instead of radiation could be used where the thermoplastic polymer is annealed (and cooled) into a particular shape and geometry. The biodegradable and/or adsorbable materials are especially useful in embodiments designed not to be completely removed from a patient's body.

[0136] Additionally, gaskets used in a surgical instrument of the present invention are capable of being partially or completely fabricated from materials that swell or expand when they are exposed to a fluid (such as blood, another body fluid, or an infused fluid). These materials include hydrophilic gels (hydrogels), foams, gelatins, regenerated cellulose, polyethylene vinyl acetate (PEVA), as well as composites and combinations thereof and combinations of other biocompatible swellable or expandable materials.

[0137] Further, various embodiments of an actuator system, head, and/or clip seat of the present invention comprise a textured surface that promotes endothelial cell growth and/or adhesion. [00100] As such, various embodiments disclose various embodiments of an integrated one- shot surgical instrument for connecting at least a target vessel to at least a graft vessel , said instrument comprising an actuator assembly; a detachable head; and a clip seat, said actuator assembly comprises a handle connected to an outer tubular body, said outer tubular body designed to receive an inner tubular body, thereby defining a passage extending from about a proximal end of said instrument to about a distal end of said instrument; and an applicator, wherein said applicator is detachably connected to the detachable head via the inner tubular body; and wherein the clip seat is configured and dimensioned to releasably support a plurality of surgical clips for connecting said target vessel and said graft vessel, and said clip seat is positioned between said actuator assembly and said detachable head.

[00101] Various further embodiments disclose methods for performing a one-shot anastomosis procedure to join a target vessel and a graft, vessel said method comprising the steps of placing a graft vessel in the integrated one-shot surgical instrument as herein disclosed, everting said graft vessel over a distal end of one of the clip seats of said instrument such that the first end of the graft vessel engages the surgical clips retained thereon; everting a second end of a graft vessel over a distal end of the other clip seat of said instrument such that the second end of the graft vessel engages the surgical clips retained thereon; everting said target vessel over a dialtor apparatus; inserting the distal end of both of the clip seats into said target vessel; engaging the target vessel with the surgical clips adjacent to the opening ; actuating said instrument to deform the surgical clips, wherein said actuation secures the graft and the target vesssel, together in fluid communication with one another, in one actuation.

[00102] The invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes to the claims which come within the meaning and range of equivalency of the claims are to be embraced within their scope. Further, all published documents, patents, and applications mentioned herein are hereby incorporated by reference, as if presented in their entirety.

Example

Embodiment of Method of Use [00103] Various embodiments of the vascular anastomosis device are hand activated. Before an end-to-side anastomosis is performed, the graft vessel is placed within the device and the end of the vessel is everted over the staple tips within the device. The everted vessel is placed about the generally circular opening, typically formed immediately prior to or during the anastomosis procedure, in the main vessel, (e.g., aorta) and the staples are placed and compressed by activating the handle. The complete circumferential anastomosis is formed in a single operation and results in a blood vessel anastomosis in which the staples remain outside of the joined blood vessels. This is a key feature of the device.

[00104] In various embodiments, to deploy a device of the present invention, the physician simply uses one hand to hold the device while removing any associated deployment tool from around the device, which exposes the clips to the vessel. Of course, whether necessary or not, the physician can use stay sutures to additionally ensure that the instrument will remain secured to the vessel. Of course, the surgical instruments described herein also can be deployed using a hand held retractor, hemostat, tweezers, or other similar device, including those described above.

[00105] In an alternate embodiment, a device of the present invention is activated by a squeeze on the device handle. In an embodiment, before the anastomosis is conducted, an external jugular vein graft is harvested. The external diameter of the graft is assessed to match with the best-fitting size of the clip seat. The vein graft is then pulled through the central hole of the device, slid through an opening in the side, and/or at least two split sections are joined around the graft.

[00106] The end of the vein graft is then everted over the clips. Eversion of the vein graft over the clips maintains positioning. The device is then capable of being positioned near or adjacent to a vessel to which the graft is to be attached. In various embodiments, a small incision is made on the wall of the vessel to be joined with a punch type or slit type device that detaches a circular piece of tissue.

[00107] The clips are released from the clip seat by squeezing the handle or other actuator so that the entire anastomosis circumference is formed simultaneously. After the clips are released simultaneously, the device is withdrawn with the other parts of the device from the anastomosis procedure. Generally, any size anastomosis circumference can be selected. Preferred sizes range from about 1 mm to about 10 mm. A smaller size is typically preferred to reduce the likelihood of bleeding, leakage, and/or vessel destruction.

[00108] As such various embodiments of the present invention comprise a one-shot surgical instrument for joining at least a first vessel and at least a second vessel within a patient's body, said instrument comprising an actuator assembly, a detachable head, and a clip seat, said actuator assembly comprising a tube body and a tubular body received therein and defining a passage extending from about a proximal end of said instrument to about a distal end of said instrument; said detachable head adjustably connected to said tubular body; and, said clip seat comprising at least one clip for joining said first vessel and said second vessel, said clip seat positioned between said actuator assembly and said detachable head, wherein said actuator assembly is either one of separable into at least two halves or comprises a slit allowing access to said passage. Further embodiments comprise a separate dilating apparatus. Further embodiments comprise a head that is adjustably connected to said tubular body by a connection selected from a luer lock, a threaded connection, an interference fit, a cam lock, and a snap ring. In various embodiments, the surgical instrument has a connection that is capable of being fixed at a selected angle.

[00109] Further embodiments comprise a separate deployment apparatus for deploying the instrument in a patient's body.

[00110] Further embodiments comprise a method for performing a one-shot anastomosis procedure to join a first vessel and a second vessel in a patient's body, said method comprising the steps of loading a second vessel in an instrument, said instrument comprising an actuator assembly, a detachable head, and a clip seat, said actuator assembly comprising a tube body and a tubular body received therein and defining a passage extending from about a proximal end of said instrument to about a distal end of said instrument; said detachable head adjustably connected to said tubular body; and, said clip seat comprising at least one clip for joining said first vessel and said second vessel, said clip seat positioned between said actuator assembly and said detachable head, wherein said actuator assembly is either one of separable into at least two halves or comprises a slit allowing access to said passage, everting said second vessel over a dilator apparatus; hooking said everted second vessel on at least one clip of said clip seat; slitting said first vessel; placing said clip seat within said slit in said first vessel; and, actuating said instrument, wherein said first vessel is joined to said second vessel in one actuation and wherein said at least one clip remains outside said first vessel and said second vessel.

[00111] In various embodiments, the first vessel and the second vessel are to be joined at angles other than 90°, such as 0-90°. In an embodiment, the first vessel, commonly the aorta, will be cut in an oval shape and the connecting or second vessel will be cut at an angle. In an embodiment, the angled end is then loaded on an angled head with the clip seat, wherein said first vessel is joined to said second vessel in one actuation and wherein said at least one clip remains outside said first vessel and said second vessel. Further embodiments comprise a step of deploying said instrument in said patient's body.

[00112] In various embodiments, the anastomosis is performed on the vascular system, the digestive system, the genitourinary system, a combination of the aforesaid, and/or the like. As such, various anastomosis procedures are is selected from arteriovenous anastomosis, cardiopulmonary anastomosis, Braun's anastomosis, ureterotubal anastomosis, ureterosigmoid anastomosis, and microvascular anastomosis, but not limited hereto.

Claims

WHAT IS CLAIMED:

1. An integrated one-shot surgical instrument for connecting at least a target vessel to at least a graft vessel , said instrument comprising: an actuator assembly; a detachable head; and a clip seat, said actuator assembly comprises a handle connected to an outer tubular body, said outer tubular body designed to receive an inner tubular body, thereby defining a passage extending from about a proximal end of said instrument to about a distal end of said instrument; and an applicator, wherein said applicator is detachably connected to the detachable head via the inner tubular body; and wherein the clip seat is configured and dimensioned to releasably support a plurality of surgical clips for connecting said target vessel and said graft vessel, and said clip seat is positioned between said actuator assembly and said detachable head.

2. The integrated one-shot surgical instrument of claim 1, further comprising a separate dilating apparatus.

3. The integrated one-shot surgical instrument of claim 2, wherein said dilating apparatus is a balloon-type or an umbrella type.

4. The integrated one-shot surgical instrument of claim 1, wherein said instrument is either one of separable into at least two halves or comprises a slit allowing access to said passage.

5. The integrated one-shot surgical instrument of claim 4, wherein said two halves are secured by way of an interference fit, latch, or a thread.

6. The integrated one-shot surgical instrument of claim 1, wherein said handle is a ring-type or a syringe-type handle.

7. The integrated one-shot surgical instrument of claim 1, wherein said detachable head is at least rotatable through a plurality of angles to at least one axis relative to the actuator assembly..

8. The integrated one-shot surgical instrument of claim 7, wherein said detachable head has a lock member for retaining the head at a selected angle.

9. The integrated one-shot surgical instrument of claim 8, wherein said selected angle ranges from about 5 degrees to about 90 degrees.

10. The integrated one-shot surgical instrument of claim 1, wherein said detachable head is disposable.

11. The integrated one-shot surgical instrument of claim 1, wherein said detachable head is adjustably connected to said applicator by a connection selected from a goup consisting of luer lock, a threaded connection, an interference fit, a cam lock, or a snap ring.

12. The integrated one-shot surgical instrument of claim 1, wherein said clip seat comprises at least one wing for every clip, wherein said clip seat accommodates said at least one clip.

13. The integrated one-shot surgical instrument of claim 1, wherein said clip seat is detachable.

14. The integrated one-shot surgical instrument of claim 1, wherein said clip seat is disposable.

15. The integrated one-shot surgical instrument of claim 1, wherein said instrument is made of materials selected from a group consisting of materials that are chemically inert, anti-erroding, biocompatible, memory alloy metals and high mechanical strength.

16. The integrated one-shot surgical instrument of claim 1, further comprising a separate deployment apparatus.

17. The integrated one-shot surgical instrument of claim 1, wherein said target vessel is connected to the graft vessel in an end to end, end to side or side to side configuration.

18. The integrated one-shot surgical instrument of claim 17, wherein said vessels connected are veins, arteries, biliary tube connections, urethra connections, other bodily vessels or synthetic graft vessels.

19. The integrated one-shot surgical instrument of claim 1, further comprising a therapeutic agent.

20. The integrated one-shot surgical instrument of claim 19, wherein said therapeutic agent is incorporated in a suitable carrier disposed within said instrument.

21. The integrated one-shot surgical instrument of claim 19, wherein said therapeutic agent is a coating.

22. The integrated one-shot surgical instrument of claim 21, wherein said coating is a liquid, a gel or a film.

23 A method for performing a one-shot anastomosis procedure to join a target vessel and a graft, vessel said method comprising: placing a graft vessel in the integrated one-shot surgical instrument of claim 1, everting said graft vessel over a distal end of one of the clip seats of said instrument such that the first end of the graft vessel engages the surgical clips retained thereon; everting a second end of a graft vessel over a distal end of the other clip seat of said instrument such that the second end of the graft vessel engages the surgical clips retained thereon ; everting said target vessel over a dialtor apparatus; inserting the distal end of both of the clip seats into said target vessel; engaging the target vessel with the surgical clips adjacent to the opening ; actuating said instrument to deform the surgical clips, wherein said actuation secures the graft and the target vesssel, together in fluid communication with one another, in one actuation.

24. The method of claim 23, wherein said step of actuation is facilitated by a physician actuating a handle.

25. The method of claim 23, wherein said anastomosis is performed on a vascular system, a digestive system, a genitourinary system, or a combination of the aforesaid, and/or the like.

26. The method of claim 23, wherein said anastomosis is selected from arteriovenous anastomosis, cavopulmonary anastomosis, Braun's anastomosis, ureterotubal anastomosis, ureterosigmoid anastomosis, and microvascular anastomosis.

27. The method of claim 23, wherein said wherein said target vessel is connected to the graft vessel in an end to end, end to side or side to side configuration.