Patent Document

[0001]    This application claims the benefit of priority to Provisional Application No. 60/301,105, filed Jun. 25, 2001. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The invention can be used advantageously to suture vessels, ducts, and the like, in a patient body. The invention can be used particularly advantageously in suturing blood vessels together during cardiac surgery, for example. Accordingly, the invention can be used during coronary artery bypass graft surgery (CABG), and the like. However, it is to be appreciated that the field of the invention is not to be limited to such uses only, but extends to suturing patient tissue together in general. For example, the invention can be used also to form sutures in bowel connections, femoral-popliteal artery anastomoses, and the like. It can also be used in the field of trauma closure, and the like.  
           [0003]    It is often required to connect a vessel, duct, or the like, such as a hollow organ, or blood vessel, or the like, to a target piece of tissue, such as another vessel, duct, or the like. This is especially true in the case of certain types of cardiac surgery, such as CABG surgery. Often during such CABG surgery it is required to connect, or join, one blood vessel to another so that the vessels are joined together to be in fluid flow communication with each other. A joint formed between blood vessels in this fashion is often referred to as an anastomosis.  
           [0004]    As is well known, the heart pumps blood through the body. The heart comprises a plurality of muscles which cooperate with one another to cause contractions of the heart thereby to provide a pumping action. The heart requires blood flow to its muscles to provide its muscles with the necessary oxygen, nutrients, and the like, necessary for muscular contraction. It often happens that one or more of the blood vessels which feed the heart muscles becomes diseased and develops a blockage, or becomes occluded, or the like. When this happens, a region of the heart normally fed by that diseased blood vessel can experience a depletion, or interruption, of blood supply. If such a condition is not treated in a timely fashion, the patient may suffer a heart attack with often fatal results.  
           [0005]    CABG procedures are often performed to circumvent such a blockage, or occlusion, in a diseased blood vessel, thereby to provide the region of the heart normally fed by the diseased vessel with blood. This procedure normally involves tapping blood from an appropriate blood source, such as a donor blood vessel such as, for example, the aorta, saphenous vein, mammary artery, or the like, and routing the tapped blood to the diseased vessel downstream of the occlusion or blockage. A variety of procedures are currently employed to provide tapped blood downstream of an occlusion, or blockage, in a diseased blood vessel. One procedure involves making use of a graft. In such a case, an end of the graft is typically sutured to an appropriate blood source to be in fluid flow communication therewith and an opposed end of the graft is typically sutured to a side of the diseased vessel to be in fluid flow communication therewith downstream of the occlusion, or blockage. Another procedure involves suturing a side of a healthy vessel to a side of a diseased vessel downstream of the blockage, or occlusion, so that blood can flow from the healthy vessel to the diseased vessel. A joint between an end of a vessel, or graft, and a side of another vessel, or graft, is often referred to as an end-to-side anastomosis. A joint between a side of a graft, or vessel, and a side of another graft, or vessel, is often referred to as a side-to-side anastomosis.  
           [0006]    During CABG surgery, a patient is often connected to a cardiopulmonary bypass machine so that the heart can be stopped temporarily, thereby to ease the task of suturing the various grafts, and/or vessels, together. Furthermore, blood vessels, such as the aorta, for example, are often closed, or clamped, so as to interrupt blood flow through that vessel when that vessel is to be used as a donor vessel or blood source.  
           [0007]    When CABG procedures are performed on a patient, the patient normally suffers a great deal of trauma. Accordingly, it would be beneficial if such CABG procedures could be improved so as to decrease patient trauma. In conventional CABG surgery, there are at least three factors that affect the degree of trauma suffered by a patient. These factors include: (1) the time the patient spends on a cardiopulmonary bypass machine, (2) the time the patient spends with a clamped blood vessel, such as the aorta, or the like, and (3) the quality of the anastomoses formed between the blood vessels and/or grafts. It is generally recognized that the risk of patient morbidity rises significantly after the patient has been placed on a cardiopulmonary bypass machine for a period of about one hour. Passage of blood through a cardiopulmonary bypass machine tends to damage blood cells consequently causing degradation in blood quality. Accordingly, the longer a patient is subjected to cardiopulmonary bypass, the more the blood cells become damaged and the higher the degradation in the quality of the blood. A complication often associated with prolonged placement on a cardiopulmonary bypass machine, is distal thrombosis. Distal thrombosis can give rise to embolization in the neurovasculature and can lead to the patient suffering a stroke. Accordingly, it would be beneficial if the period a patient spends on a cardiopulmonary bypass machine during CABG surgery could be reduced.  
           [0008]    A factor by which the amount of time a patient spends on a cardiopulmonary bypass machine can be reduced is by reducing the time taken suturing the vessels and/or grafts together to form anastomoses. The average time taken to suture two vessels together to form an anastomosis in accordance with traditional suturing methods, is typically about seven to ten minutes. An average CABG procedure can involve the formation of about five anastomoses. Accordingly, the time spent on suturing during an average CABG procedure can be between about thirty-five to fifty minutes. Therefore, since the task of suturing can constitute a major portion of the one hour period, it would be advantageous if the time spent on such suturing could be reduced. By doing so, the time a patient is subjected to cardiopulmonary bypass would also be reduced, thereby reducing patient trauma and the risks of morbidity.  
           [0009]    In so-called “off-pump” procedures, patients are not placed on cardiopulmonary bypass machines. Accordingly, the negative effects associated with cardiopulmonary bypass mentioned above are inhibited. However, the task of suturing is made more difficult since the task of suturing is normally then performed while the heart is beating. This can lead to the formation of anastomoses with reduced integrity. Improperly suturing blood vessels and/or grafts together may lead to post operative complications. Incorrect suturing during surgery requiring correction during the surgery, may unnecessarily extend the time taken to complete the surgery.  
           [0010]    Suture placement devices have been proposed which enable a surgeon, or the like, to place suture elements in patient tissue without manually holding and manipulating a suture needle, as has traditionally been the case. It has been found that the management of opposed ends of suture elements after having been placed in patient tissue with such a device can be rather tedious. This is especially true where the device is arranged to place a plurality of suture elements in patient tissue simultaneously. In such a case, opposed portions of each individual suture element are typically secured together to form a suture. It has been found that the opposed portions can become mixed up, or entangled, with one another, thereby unnecessarily complicating the suturing procedure and delaying its completion.  
           [0011]    One such suture placement device is shown an described in U.S. patent application Ser. No. 09/784,704, filed Feb. 14, 2001 and entitled “Device and Method for Deploying and Organizing Sutures for Anastomotic and Other Attachments,” the entirety of which is herein incorporated by reference.  
           [0012]    Accordingly, it would be advantageous to provide systems, devices and methods for enabling suturing operations to be conducted with greater accuracy and in a shorter period of time. This is especially true if several vessels and/or grafts are to be sutured together during a CABG procedure.  
         SUMMARY OF THE INVENTION  
         [0013]    According to one aspect of the invention, there is provided a suturing device including a suture guid and a needle holder. The suture guide includes a foot portion having an axis defined along a length of the foot portion. The foot portion includes a plurality of apertures, each aperture holding a suture. The needle holder movably holds at least one needle relative to a first side of the foot portion and movably holds at least one needle relative to a second side of the foot portion. The needles are movable into respective apertures, and the at least one needle on the first side of the foot portion is at an angle relative to the at least one needle on the second side of the foot portion. In another aspect of the invention, the device includes a body having a driving mechanism. At least one needle holder is adapted to be received by the body. The needle holder includes a plurality of needles wherein the needles are operatively coupled to the driving mechanism. The device may further include a suture holder having a first end and a second end. The first end is adapted to slidably engage the needle holder, and the second end further includes a plurality of apertures adapted to receive a plurality of sutures. The driving mechanism drives the needles into the second end of the suture holder at an angle relative to an axis extending along the first and second end of the suture holder.  
       
    
    
     DETAILED DESCRIPTION OF THE DRAWINGS  
       [0014]    The objects and advantages of the invention will become apparent from the following detailed description of preferred embodiments thereof in connection with the accompanying drawings in which like numerals designate like elements in which:  
         [0015]    [0015]FIG. 1 is a side view of a needle deployment device in accordance with the present invention;  
         [0016]    [0016]FIG. 2 is a side view of a drive shaft of the needle deployment device in accordance with the present invention;  
         [0017]    [0017]FIG. 3 is a side view of a locking body of the needle deployment device in accordance with the present invention;  
         [0018]    [0018]FIG. 4 is a side view of a needle block assembly of the needle deployment device in accordance with the present invention;  
         [0019]    [0019]FIG. 5 is a side view of a guide assembly of the needle deployment device in accordance with the present invention;  
         [0020]    [0020]FIG. 6 is an isometric expanded front view of the guide assembly of the needle deployment device in accordance with the present invention;  
         [0021]    [0021]FIG. 7 is an isometric front view of the guide assembly of the needle deployment device in accordance with the present invention;  
         [0022]    [0022]FIG. 8 is a isometric side view of the suture guide of the needle deployment device in accordance with the present invention;  
         [0023]    [0023]FIG. 9 is an isometric bottom view of the suture guide of the needle deployment device in accordance with the present invention;  
         [0024]    [0024]FIG. 10 is a cross-sectional side view of the needle deployment device in accordance with the present invention;  
         [0025]    [0025]FIG. 11 is a partial cross-sectional side view of the distal end portion of the needle deployment device in accordance with the present invention illustrating the guide assembly installed thereupon;  
         [0026]    [0026]FIG. 12 is an isometric partial cut-away view of the guide assembly of the needle deployment device in accordance with the present invention;  
         [0027]    [0027]FIG. 13 is a cross-sectional side view of the foot of the suture guide illustrating the cuff and suture disposed therein;  
         [0028]    [0028]FIG. 14 is a top view of the foot of the suture guide illustrating the cuff disposed therein;  
         [0029]    [0029]FIG. 15A is a side view illustrating the distal end of the needle deployment device in accordance with the present invention disposed within a vessel prior to use;  
         [0030]    [0030]FIG. 15B is a side view illustrating the distal end of the needle deployment device in accordance with the present invention disposed within a vessel wherein the needles have been deployed;  
         [0031]    [0031]FIG. 15C is a side view illustrating the distal end of the needle deployment device in accordance with the present invention disposed within a vessel wherein the needles have been received within the cuffs of the device;  
         [0032]    [0032]FIG. 15D is a side view illustrating the distal end of the needle deployment device in accordance with the present invention disposed within a vessel wherein the needles have been partially retracted thereby withdrawing the cuffs from the suture guide;  
         [0033]    [0033]FIG. 15E is a side view illustrating the distal end of the needle deployment device in accordance with the present invention disposed within a vessel wherein the needles have been fully retracted and the suture has been drawn through the vessel wall;  
         [0034]    [0034]FIG. 16 is a side view of a system for performing side to side anastomoses utilizing the needle deployment device according to the present invention;  
         [0035]    [0035]FIG. 17 is a side view of a system for performing end to side anastomoses utilizing the needle deployment device according to the present invention;  
         [0036]    [0036]FIG. 18 is a isometric view of the device for deploying sutures through the end of a vessel or graft;  
         [0037]    [0037]FIG. 19 shows, at an enlarged scale, part of the device shown in FIG. 18, a suture holder retainer of the suture placement device being shown in an open condition;  
         [0038]    [0038]FIG. 20 shows, at an enlarged scale, a schematic part sectional side view of part of a vessel support shaft of the suture placement device, a needle of the suture placement device being shown in a dormant position within a passage defined in the shaft;  
         [0039]    [0039]FIG. 21 shows a schematic part sectional side view corresponding to FIG. 20, the needle of the suture placement device having been displaced from its dormant position to an extended position;  
         [0040]    [0040]FIG. 22 shows a schematic three-dimensional view corresponding to FIG. 18, a suture holder retainer of the suture placement device being shown in an open condition and further showing a plurality of suture elements, end portions of which are attached to ends of needles;  
         [0041]    [0041]FIG. 23 shows a schematic three-dimensional view corresponding to FIG. 22, and shows an end portion of a vessel or graft received on the vessel support shaft of the suture placement device;  
         [0042]    [0042]FIG. 24 shows a schematic three-dimensional view corresponding to FIG. 23 and shows the suture holder retainer in a closed condition after the end portion of the vessel or graft has been positioned on the vessel support shaft;  
         [0043]    [0043]FIG. 25 shows a schematic three-dimensional view corresponding to FIG. 24, the suture holder retainer being shown in an open condition and further showing the needles having been passed through the vessel or graft adjacent a mouth of the vessel or graft supported on the vessel support shaft;  
         [0044]    [0044]FIG. 26 shows a schematic three-dimensional view of the end portion of the graft, after the needles of the suture placement device have been passed through the graft adjacent its mouth, the needles being held on suture holders of the suture placement device, the suture holders having been removed from the suture holder retainers of the suture placement device;  
         [0045]    [0045]FIG. 27 shows a schematic three-dimensional view of one of the suture holders normally retained on an associated suture holder retainer of the device, the suture holder being shown having a shape corresponding to its shape when retained on its associated suture holder retainer;  
         [0046]    [0046]FIG. 28 shows a schematic three-dimensional view of the suture holder of FIG. 27 having a shape corresponding to its shape when in a relaxed condition after having been removed from its associated suture holder retainer; and  
         [0047]    [0047]FIG. 29 is a cross-sectional side view illustrating a end to side anastomosis.  
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0048]    In accordance with the present invention there is shown and described a needle deployment device. The needle deployment device includes a main body having a driving mechanism therein. A pair of needle holder assemblies, wherein the needle holder assemblies include needles and needle guides. A suture holder having a first end and a second end, wherein the first end is operatively coupled to the driving mechanism and the second end is adapted to receive the needles, wherein the needles received sutures disposed within the suture holder.  
         [0049]    Referring now to FIG. 1 there is shown a representative embodiment of the needle deployment device  10  according to the present invention. The needle deployment device  10  includes a main body  20  including a fluid inlet  15  and a fluid outlet  16  (not shown), a needle holder assembly  40  and a suture holder  60 . The needle deployment device  10  will be described in greater detail below with reference to FIGS.  1 - 15 .  
         [0050]    The main body  20  of the needle deployment device  10  may be constructed of any bio-compatible material such as titanium, stainless steel, or plastics. In a preferred embodiment, the main body  20  is constructed of plastic such as polyvinyl chloride or nylon or delrin.  
         [0051]    The main body  20  may be constructed as a unitary body utilizing manufacturing processes such as injection molding or milling. Alternatively, the main body  20  may be constructed of multiple pieces which may then be assembled utilizing a bio-compatible adhesive. The main body  20  includes a chamber  22  wherein the fluid inlets  15  and the fluid outlet  16  are in fluid communication with the chamber  22 . The chamber  22  is adapted to slidably receive a driving assembly  90 . The driving assembly includes a wiper seal, a piston cap, a return spring, an end cap, a locking frame, and a drive shaft, each of which will be described in greater detail below with reference to FIGS.  2 - 14 .  
         [0052]    Referring now to FIG. 2 there is shown the drive shaft  50  of the driving assembly  90 . The drive shaft  50  comprises an elongated body  52  having a proximal end portion  51  and distal end portion  53 , a first slot  54 , grooves  56 , projections  58 , and pins  59  extending from the projections  58 . The proximal end portion  51  of the drive shaft is adapted to be fixedly attached to the wiper seal  95  of the driving assembly  90 . The drive shaft  50  may be constructed as a unitary member of may be constructed of multiple parts which may then be assembled.  
         [0053]    The drive shaft may be constructed of bio-compatible materials such as titanium, stainless steel, or plastics. Preferably, the drive shaft  50  is constructed of a bio-compatible plastic such as delrin or nylon.  
         [0054]    Referring now to FIG. 3 there is shown the locking frame  60  of the driving assembly  90 . The locking frame includes a body  62 , wherein the body  62  includes a first projection  64  and a second projection  64 ′ (not shown). The body  62  further includes a plurality of apertures  63  and  65  disposed therethrough. The apertures  63  are adapted to receive and retain a tab disposed upon the needle guide assembly as will be described in greater detail below. Additionally, the locking frame further includes biasing members  67 . The biasing members  67  are fixedly attached to a first side  66  of the body  62  of the locking frame  60  and extend into the aperture  65  of the locking frame  60 . The distal end portion  61  of the first and second projections is adapted to receive the needle guide assembly as will be described in greater detail below.  
         [0055]    The locking frame may be constructed of bio-compatible materials such as stainless steel, titanium or plastics. In a preferred embodiment the locking frame  60  is constructed of nylon. The locking frame may be constructed utilizing known manufacturing processes such as machining or injection molding. The biasing members  67  may be constructed of a bio-compatible material such as stainless steel, titanium or plastics. In a preferred embodiment the biasing members  67  are constructed of a nickel-titanium alloy Nitinol. In accordance with the present invention the biasing members  67  may be integrally formed with the locking frame  60 .  
         [0056]    As previously noted, the needle deployment device  10  includes guide assemblies  40 , wherein the guide assemblies  40  will be described in greater detail below with reference to FIGS. 4 through 7.  
         [0057]    Referring now to FIG. 4 there is shown a guide assembly  40  in accordance with the present invention. The guide assembly  40  includes a needle block assembly  70  having a plurality of needles  78 , and a core  80 . The needles  78  include a distal end portion  77  (not shown) and a proximal end portion  79 , wherein the distal end portion  77  is adapted to be received within apertures  73  formed within the needle block  72 . The proximal end portion  79  of the needles  78  contain a reduced cross-sectional area  75  as shown in FIG. 4. The needles  78  extend from the needle block  72 , wherein the outer needles do not extend from the needle block  72  as far as the inner needles.  
         [0058]    The needle block  72  further includes a chamber  74  and at least one aperture  76  disposed therethrough, wherein the chamber  74  and aperture  76  are disposed about an axis perpendicular to an axis which the needles  78  extend along. Furthermore, the aperture  76  is adapted to receive the pins  59  extending from the projections  58  of the drive shaft  50  as will be described in greater detail below.  
         [0059]    The needle block  72  may be constructed of bio-compatible materials such as titanium, stainless steel, Nitinol, or plastics. In a preferred embodiment the needle block  72  is constructed of nylon. The needles  78  may be constructed of bio-compatible materials such as stainless steel or titanium. In a preferred embodiment the needles are constructed of a nickel-titanium composite (Nitinol). Additionally, the needles are constructed wherein the needles are sufficiently resilient and are capable of being readily deformed. The needles in a preferred embodiment have a round cross-sectional profile, though it is contemplated that the needles may have other cross-sectional profiles. For example, the needles may have a square, rectangular, oval or similar cross-sectional profile.  
         [0060]    As discussed above the distal end portion of the needles are fixedly attached within the apertures  73  of the needle block  72 . The needles may be fixedly attached within the apertures  73  using bio-compatible adhesives. Alternatively, the needles  78  may be inserted within the molding process if the needle block  72  is molded. Still further, it is contemplated that other methods may be utilized to affix the needles within the needle block  72 , for example, the needles may be fixed within the needle block by melting the needle block.  
         [0061]    As previously noted, the needle deployment device  10  of the present invention includes a plurality of guide assemblies  40 . The guide assemblies  40  include a housing, a core, and a needle block assembly wherein the needle block assembly includes a plurality of flexible needles. The guide assemblies  40  will be described in greater detail with reference to the FIGS.  5 - 8 .  
         [0062]    Referring now to FIG. 5, there is shown a front view of a guide assembly  40 , wherein the guide assembly  40  includes a housing  41 , a biasing member  47  (not shown), a locking pin  48 , and a needle block  80 . A detailed description is provided below with reference to a single guide assembly  40 , wherein it shall be understood that the second guide assembly in a preferred embodiment is a mirror image thereof, excluding the biasing member and locking pin of the first guide assembly wherein the second guide assembly is adapted to receive the locking pin projecting from the first guide assembly.  
         [0063]    Referring now to FIGS. 6 and 7 there are shown an expanded view and an assembled isometric view of the guide assembly  40  in accordance with the present invention, wherein the guide assembly  40  and the core  80  have been assembled within the body  41  of the guide assembly  40 . A needle block assembly  70  (not shown), as described in detail above, may be slidably disposed within the chamber  44  of the body  41  of the guide assembly  40 . The needles  78  are adapted to be received within a plurality of needle guides  50 , as will be described in greater detail below. The core  80  as assembled within the body  41  of the guide assembly  40  retains the biasing member  47  and the locking pin  48 , wherein the locking pin  48  may be biased between a retracted position and an extended position.  
         [0064]    Referring now to FIG. 6 and the core  80  shown therein. The core  80  further includes a recessed area  82  and an aperture  83  wherein the aperture  83  is adapted to slidably receive the locking pin  48  therein. The core  80  further includes a first cavity  84  and a second cavity  86 , wherein the first cavity  84  and the second cavity  86  are adapted to receive the distal end portion  61  of the locking frame  60  as will be described in greater detail below.  
         [0065]    Referring now to FIG. 7, there is shown an isometric view of the guide assembly  40  according to the present invention. As shown in FIG. 7, the body  41  of the guide assembly  40  further includes a tab  43  projecting from the proximal end portion  45  of the body  41 . The tab  43  is adapted to be received within the locking frame  60  as will be described in greater detail below. In addition, the body  41  is adapted to slidably receive the needle block assembly  70 , wherein the needles  78  are slidably received within the needle guides  50 . As shown in FIG. 6, the needle guides are adapted to direct the flexible needles  78  at an angle relative to the direction of motion of the needle block assembly. The function of the needle guides will be described in greater detail below.  
         [0066]    The core  80 , body  41  and locking pin  48  may be constructed of bio-compatible materials such as titanium, stainless steel, or plastics. In a preferred embodiment, the core  80  and body  41  are constructed of plastic. In a preferred embodiment, the locking pin  48  is constructed of stainless steel. The core  80  and body  41  may be constructed using known manufacturing methods such as machining or injection molding. In a preferred embodiment, the core  80  and body  41  are constructed using injection molding. The locking pin  48  may be constructed using any of the methods described above, in a preferred embodiment the locking pin  48  is machined.  
         [0067]    The core  80  may be secured to the body  41  using a plurality of pins  81  as shown in FIG. 7. Alternatively, in accordance with the present invention, the core may be fixedly attached to the body using a bio-compatible adhesive. In accordance with the present invention, the core and body may be integrally formed wherein the needle guides are formed therein during the manufacturing process.  
         [0068]    Referring now to FIG. 8 there is shown the suture guide  100  in accordance with the present invention. The suture guide  100  includes a foot portion  110  and a shaft portion  120 . The shaft portion  120  of the suture guide  100  includes an aperture  122  disposed therethrough adjacent a proximal end portion  121  and a second aperture  123  disposed adjacent the foot  110 . Additionally, the shaft portion  120  further includes a groove  125  disposed therein adjacent the foot portion  110  of the suture guide  100 , wherein the groove  125  is adapted to receive a suture hook  150  (shown in FIG. 10). The foot  110  of the suture guide  100  further includes a plurality of a suture holders  112 , wherein the suture holders  112  are adapted to receive cuffs  130  as shown in FIG. 13. The cuffs  130  are fixedly attached to suture  170 , wherein the suture is guided through a suture guide  113  of the foot  110 . Additionally, the cuffs  130  are further adapted to receive the proximal ends  79  of the needles, wherein the proximal ends  79  of the needles  78  engage the cuffs  130  as will be described in greater detail below with reference to FIGS. 15A through 15D.  
         [0069]    Referring now to FIGS.  10 - 12 , there are shown partial cross-sectional views or cut-away views of the needle delivery device  10  as assembled. Referring now to FIG. 10, there is shown a cross-sectional side view of the needle delivery device  10  in accordance with the present invention. As shown in FIG. 10, the driving assembly  90  is disposed within the chamber  22  of the main body  20 . The wiper seal  95  sealingly engages the wall of the chamber  22 , thereby providing a fluid tight seal between the chamber and the proximal end of the wiper seal  95 . The end cap  97  is disposed at the distal end of the chamber  22 , whereby the end cap  97  may be fixedly attached to the main body  20  with a bio-compatible glue or alternatively, the end cap  97  may be removably attached to the main body  20  through the use of mechanical fasteners or molded fasteners.  
         [0070]    The wiper seal  95  may be constructed of a suitable pliable material such as rubber, silicone, urethane or preferably of polyisoprene. The piston cap (not shown), end cap  97 , drive shaft  50 , and locking frame  60  may be constructed of a bio compatible material such as titanium, stainless steel, or plastics, preferably they are constructed of polycarbonate according to known manufacturing methods such as injection molding or machining. The return spring  98  and locking tabs  67  are preferably constructed of stainless steel, though it is contemplated that other bio-compatible materials may be utilized.  
         [0071]    As fluid force acts on the proximal end of the wiper seal  95 , the driving assembly  90  is advanced within the chamber  22  of the main body  20 , thereby advancing the locking frame along the length of the drive shaft  50 . At least one locking tab  67  disposed upon the locking frame  60  is received within a slot  56  on the drive shaft  50  as shown in FIG. 11. After the locking tab  67  has engaged the drive shaft  50  as shown in FIG. 11, the guide assembly  40  can no longer advance along the length of the drive shaft  50 . At this point, the guide assembly  40  is positioned at a pre-determined height above the vessel wall for deployment of the needles. After the guide assembly  40  engages the drive shaft  50  as described above, further force acting on the driving assembly  90  causes the drive shaft  50  to advance the needles  78 . The needles are operatively coupled to the drive shaft  50  through pins  59  extending from the projections  58  of the drive shaft  50  which are disposed within the aperture  76  of the needle block assembly  70  as shown in FIG. 11.  
         [0072]    As shown in FIG. 1 the tab  43  disposed on the proximal end portion of the body  41  of the guide assembly  40  is received within the aperture  63  of the locking frame  60  and the distal end portion  61  of the locking frame  60  is received within the first chamber  84  of the core  80 , thereby removably attaching the guide assembly to the distal end portion of the needle deployment device  10 .  
         [0073]    Referring now to FIG. 12, there is shown a cut-away isometric view of the distal end portion of the needle deployment device  10 . As shown in FIG. 12, the core  80  is adapted to guide the needles  78  such that the proximal end portion  79  of the needles  78  are received within the cuff holders  112  of the foot  110 . Referring now to FIGS. 13 and 14 there are shown a side view and a top view of the proximal end portion  79  of the needle  78  as received within the cuff holder  112  and cuff  130 . As shown, the proximal portion of the cuff holder  112  is adapted to direct the proximal end portion  79  of the needle  78  towards the chamber  132  of the cuff  130 . Therefore, when the needles  78  are driven into the cuff holders  130  the cuff holders  112  will ensure that the proximal end portion  79  of the needles are received within the chamber  132  of the cuff  130 , thus ensuring capture of the cuffs  130  by the needles  78 . Furthermore, this feature allows for greater manufacturing tolerances as well as for variables which are unforseen during use. For example, if a needle is slightly deflected due to plaque buildup within a vessel, the proximal portion of the cuff holder  130  will ensure that the needle  78  will be received within the cuff  130  for capture.  
         [0074]    The cuffs  130  may be manufactured of a bio-compatible material such as titanium, stainless steel, or plastics. The cuffs  130  have a generally cylindrical cross-sectional profile with an aperture disposed therethrough. The proximal end portion of the cuff  130  is adapted to receive the proximal end portion  79  of the needle  78 . The distal end portion of the cuff  130  is adapted to receive suture  170 , wherein the suture may be fixedly attached within the aperture  171  of the cuff with a bio-compatible adhesive, fusing the cuff with the suture, crimping the cuff, or similar methods of attachment. The suture may be any one of the known sutures available from various suppliers and known to one skilled in the art. As shown in FIG. 9, the suture S extending from the distal end of the cuffs is gathered and arranged to run along the distal surface of the foot  110  from the distal end portion through a suture channel  113  disposed within the proximal end portion of the foot  110 . The suture S then extends along the elongated shaft within the groove of the suture holder  100 , wherein the suture hook  150  retains the suture within the groove as shown in FIG. 10. The suture hook  150  may be constructed of bio-compatible materials such as stainless steel, titanium or Nitinol.  
         [0075]    In accordance with the present invention, referring now to FIGS.  15 A- 15 D there is shown in sequence the needle deployment device  10  in use. Referring now to FIG. 15A there is shown a partial front view of the needle deployment device  10 , wherein the distal end portion of the needle deployment device has been inserted into a vessel. A fluid force F is applied to the drive shaft  50  by applying force to a fluid source that is operatively coupled to the chamber  22  of the main body  20 , wherein the fluid force F acts upon the driving assembly  90  as described above. In response to the fluid force F applied to the driving assembly  90 , the guide assemblies  40  are driven along the length of the suture guide  100  until the locking tabs  67  are received within a recessed area  56  of the drive shaft  50 , whereby the locking tabs  67  prevent further motion of the guide assemblies  40  as well as placing the guide assemblies  40  at a pre-determined height above the surface of the vessel in which the needles are to be deployed. Referring now to FIG. 15B, wherein the guide assemblies  40  have become locked, the force F subsequently drives the needle block assemblies  70  and needles  78  through the vessel wall V, wherein the proximal end  79  of the needles  78  are received within the cuffs  130  of the foot  110  as shown in FIG. 15C. The needles are driven in a predetermined path defined by the needle guides within the body and core of the needle assembly. The path which the needles are driven along is at an angle relative to a vertical axis of the foot  110 . The curved needle path allows for greater tissue capture during deployment of the device. The term tissue capture shall be understood as the amount of tissue between the incision through which the foot has been placed and the location within the vessel wall where the needles enter. The needle deployment device exhibits good tissue capture because the needles are driven through the vessel wall at a distance from the incision through which the foot is placed.  
         [0076]    After the proximal ends  79  of the needles  78  have been received within the needle cuffs  130  as shown in FIG. 15D, a vacuum force is applied to the chamber  22  of the main body  20 , wherein the vacuum and return spring act to withdraw the needles from the foot  110  and through the vessel wall as shown in FIG. 15E. As described in detail above, the foot is adapted to receive and align the proximal end portion of the needles such that the needles are axially received within the cuff  130 . As the needles are retracted into the guide assemblies  40 , the suture  170  previously retained within the suture track  113  on the foot  110  of the needle deployment device  10  is drawn through the vessel wall V. After the needles have been fully retracted within the guide assemblies  40 , the guide assemblies  40  may be removed from the distal end portion of the needle deployment device  10  and the foot may be removed from the vessel.  
         [0077]    Referring now to FIG. 16 there is shown an anastomosis assembly  15 , the assembly includes a first needle deployment device  10  connected with a second needle deployment device  10 ′. As shown in FIG. 16 the two needle deployment devices  10  and  10 ′ are connected with a flexible belt  200 . The flexible belt  200  includes at least one lumen extending therethrough, wherein a first end  202  of the belt  200  is connected to the first needle deployment device  10  and the second end  204  of the belt is connected to the second needle deployment device  10 ′. A first end of the suture  270  extends from the suture support  100  of the first needle deployment device  10 , through the lumen of the belt  200  to the suture support  100 ′ of the second needle deployment device  10 ′ as shown. As shown in FIG. 16, the belt may further include a buckle  230  as shown, wherein the buckle  230  includes a first aperture  231  and a second aperture  232  wherein the belt is threaded therethrough, and the buckle  230  being slidably disposed upon the belt  200 .  
         [0078]    The anastomosis assembly  15  is suitable for performing side to side anastomosis between two vessels, wherein the first needle deployment device  10  and the second needle deployment device  10 ′ are inserted into a first and second vessel respectively. After each of the devices have been deployed as described in detail above, the belt is opened, thereby releasing the sutures from the lumen therein. The belt may be opened by splitting the casing along a perforated line, or other means may be employed to open the belt, such as having a sealable closure or other device disposed upon the belt. Once the belt is removed and the two vessels have been brought together, the buckle is utilized to organize the sutures and to enable a surgeon to then tie off the sutures in a conventional manner.  
         [0079]    Referring now to FIG. 17 there is shown a second anastomosis system  18  in accordance with the present invention. As shown in FIG. 17 the anastomosis system  18  includes a needle deployment device, a belt, and a suture placement device.  
         [0080]    Referring to FIG. 18, the suture placement device  312  comprises a body  314  and two suture holder retainers  316 ,  318 . Each retainer  316 ,  318  is mounted on the body  314  by means of a pivotal connection  320 ,  322  respectively. The device  312  further comprises a vessel support shaft  324  for receiving an end portion of a vessel, or graft, or the like, thereon. The shaft  324  is mounted on the body  314 . The shaft  324  is arranged to be passed through the mouth of the vessel so that the vessel can be supported at an operative position on the shaft  324  at which position the device  312  can pass a plurality of suture elements through the wall of the vessel adjacent its mouth.  
         [0081]    The body  314  comprises a piston and cylinder arrangement similar to that of the needle deployment device  10  described above. The piston and cylinder arrangement is indicated schematically and generally by reference numeral  326 . A socket for receiving an end of the conduit portion  421  of the flexible elongate member  420  is indicated at  327 . When the conduit portion  421  is connected to the socket  327 , a chamber within the body  314  is connected in fluid flow communication with a female Luer-type connector.  
         [0082]    Referring now to FIGS.  19  to  21  of the drawings, the shaft  324  defines a plurality of longitudinally extending passages indicated schematically by reference numeral  328 . The passages  328  have bends  330  leading to mouths  332  opening at an outer surface  334  of the shaft  324 . As can best be seen with reference to FIGS. 20 and 21, a needle  335  is received in each of the passages  328 . Each needle  335  defines a pointed end  435 . An actuation member in the form of an elongate pin or rod formation  336  is received in each of the passages  328  immediately behind the needles  335 . The pin formations  336  are operatively associated with the piston on the body  314  so that the formations  336  are caused to advance, as indicated by arrow K, in response to the piston being caused to advance within its associated cylinder. It will be appreciated that the piston of the device  312  is caused to advance within its associated cylinder in a manner similar to that of the piston and cylinder arrangement of the needle deployment device  10 , as described above, namely, by depressing a plunger of a syringe connected in fluid flow communication with the female Luer-type connector  140 , as can best be seen with reference to FIG. 18.  
         [0083]    With reference to FIG. 21, upon advancement of the pin formations  336  along the passages  328 , the needles  335  are caused to advance along the passages  328  also. The needles  335  are caused to advance such that their pointed ends  435  are pushed out of the mouths  332  and laterally outwardly from the surface  334  of the shaft  324 .  
         [0084]    Referring now to FIG. 22 of the drawings, ends  438  of a plurality of suture elements  338  are operatively engaged to end portions of the needles  335  adjacent the ends  435  of the needles  335 . The ends  438  of the suture elements  338  can be operatively engaged to the end portions of the needles  335  in any appropriate manner. For example, the end portions of the needles  335  can have laterally extending apertures through which end portions of the suture elements  338  can be threaded. The suture elements  338  typically extend along the outer surface  334  of the shaft  324 , along an outer surface of the body  314  and into the suture container portion  421  of the elongate flexible member  120 , as can best be seen with reference to FIG. 17 of the drawings, in a fashion similar to that described above with reference to the system  15 . It will be appreciated that opposed ends of the suture elements  338  are held on the suture support  118  of the device  112  of the system  310  in a fashion similar to that of the ends  460  of the suture elements  160  of the system  110 .  
         [0085]    The operation of the device  312  will now be described with reference to FIGS.  23  to  25  of the drawings. It will be appreciated that opposed ends of the suture elements  338  are placed through a vessel wall by means of the needle deployment device  10  and adjacent an incision in that vessel wall in a manner similar to that described above with reference to the system  15 .  
         [0086]    Referring to FIG. 23, an end portion  450  of a vessel, or graft, indicated generally by reference numeral  350 , is shown in a received condition on the shaft  324 . The end portion  450  of the vessel  350  was positioned on the shaft  324  by displacing the suture holder arrangements  316 ,  318  angularly about the pivotal connections  320 ,  322  into open positions and then passing the end portion  450  of the vessel  350  over the shaft  324 . Conveniently, marks  352  are provided on the shaft  324  to indicate an appropriate position of an end  450  of the vessel  350  on the shaft  334  so as to enable the suture elements to be passed through a vessel wall  451  of the vessel  350  at an appropriate distance from the end  452 . In FIG. 23, only the suture holder retainer  318  is shown in an open condition. Typically, both retainers  316 ,  318  are opened so as to pass the vessel portion  450  over the shaft  324 . When the end portion  450  of the vessel  350  has been positioned such that its end  452  is in register with the marks  352  on the shaft  324 , the retainers  316 ,  318  are displaced angularly about the pivotal connections  320 ,  322  into a closed condition in which the end portion  450  of the vessel  350  is embraced between the retainers  316 ,  318  and the shaft  324 . FIG. 25 shows the retainer  316  having been displaced from an open condition into a closed condition after the portion  450  of the vessel  350  has been appropriately positioned on the shaft  324 .  
         [0087]    Conveniently, the vessel  350  is shaped to have an angled, or inclined, end  452  so as to permit an end-to-side anastomosis to be formed in which the one vessel extends from the other at an acute angle, as can best be seen with reference to FIG. 28 of the drawings. The marks  352  are formed on the shaft  324  to extend circumferentially around the shaft  324  so as to align with a vessel having such an inclined end  452 .  
         [0088]    [0088]FIG. 24 shows the portion  450  of the vessel  350  having been received on the shaft  324  and further shows both retainers  316 ,  318  in closed conditions. As can best be seen with reference to FIG. 23 of the drawings, the retainers  316 ,  318  are provided with cooperating engaging formations so as to lockingly engage with each other when in their closed conditions. Conveniently, the engaging formations comprise tongue members  354 ,  354  and slot arrangements  356 ,  356  for snap-lockingly receiving the tongue members  354 ,  354 . After the end portion  450  of the vessel  350  has been received on the shaft  324  and the retainers  316 ,  318  have been closed so as to engage lockingly with each other, the needles  335  bearing the ends  438  of the suture elements  338  are caused to advance along the passages  328 . This is achieved by means of the pin formations  336  being displaced along the passages  328  in response to actuating a syringe connected in fluid flow communication with the female Luer-type connector  140  operatively associated with the device  312 . As the needles  335  are caused to advance in this fashion, the ends  435  of the needles  335  are driven through the wall  451  of the vessel  350  adjacent its mouth. The ends  438  of the suture elements  338  are passed through the vessel wall  451  together with the ends  435  of the needles  335 , since the ends  438  of the suture elements  338  are appropriately attached to the ends of the needles. After the ends  435  of the needles  335  have passed through the vessel wall  452 , the ends  435  are driven into suture holders  358 ,  360  releasably mounted on the suture holder arrangements  316 ,  318  to be held captive by the holders  358 ,  360 . The retainers  316 ,  318  are then angularly displaced about the pivotal connections  320 ,  322  into their open conditions to enable the vessel  350  to be removed from the shaft  324 . The suture holders  358 ,  360  are removed from the retainers  316 ,  318 , while the needle ends  435 , and consequently also the ends  438  of the suture elements  338 , are held captive on the suture holders  358 ,  360 . To remove the holders  358 ,  360  from the retainers  316 ,  318 , hand grippable portions  450 ,  360 . 1  of the holders  358 ,  360  are typically manipulated to cause the holders  358 ,  360  to be slid along slots  362  defined by the retainers  316 ,  318 . As can best be seen in FIG. 22 of the drawings, each retainer  316 ,  318  has a part annular shoulder formation  364  arranged to retain the holders  358 ,  360  in a mounted condition on the retainers  316 ,  318 . When the holders  358 ,  360  are removed from their associated retainers  316 ,  318 , the hand grippable portions  458 ,  460  are manipulated resiliently to urge the holders over the annular shoulder formations  364 . FIG. 26 shows the end portion  450  of the vessel  350  having been removed from the shaft  324  and further shows the holders  358 ,  360  having been removed from the associated retainers  316 ,  318 .  
         [0089]    Referring now to FIGS. 27 and 28 of the drawings, the suture holder  358  is shown in greater detail, and after it has been removed from its associated retainer  316 . In FIGS. 27 and 28, the holder  358  is shown after the needles  335  have been passed through the portion of the vessel  350  and into engagement with the holder  358 . In FIG. 27, the suture holder is shown having a shape corresponding to the shape which it has when mounted on its associated retainer  316 . When mounted on the retainer  316 , opposed flange portions  358 . 2  of the suture holder  358  are held in a resiliently deformed condition such that an inner surface  459  defined by the flange portions  458  extends generally along a circular circumference so as to extend snugly around the vessel portion  450  when held between the retainers  316 ,  318  and the shaft  324 . The suture holder  358  is typically made from a resilient material, such as silicone, or the like. In FIG. 27, the suture holder  358  is shown after having been removed from its associated retainer  316 . After having been removed, the flange portions  459  take up a relaxed condition in which they have a straighter profile than in the case when mounted on the retainer  316 . In this relaxed condition, the spacing between the needle ends  335  on which the ends  435  of the suture elements  338  are carried is greater than in the case when the holder  358  was mounted on the retainer  316 . The holder  358  is designed so that when in its relaxed condition, the spacing between adjacent suture element ends  435  on the needles  335  generally corresponds with the spacing between adjacent suture element ends when held on the needle block assembly  70  and  70 ″ of the suture guide  40  and  40 ′ of the needle deployment device  10 .  
         [0090]    To form the end-to-side anastomosis, the needle deployment device  10  is used to place the opposed ends of the suture elements  338  through another vessel wall adjacent an incision in the other vessel wall in a fashion similar to that described above with reference to the system  15 .  
         [0091]    After the suture elements  338  have been placed through the wall of the portion  450  of the vessel  350  adjacent its mouth, as described above, and after opposed ends of the suture elements  338  have been placed through a vessel wall adjacent an incision in the vessel wall by the needle deployment device  10 , in a manner similar to that described above, the suture holders  358 ,  360  are paired up with the suture attached to the proximal end portion of the needles  78  of the needle deployment device  10 . Conveniently, the holders may be distinctively colored to indicate to the user which of the holders is to be matched up with which of the holders. Accordingly, in this fashion, opposed ends of the same suture elements are paired up with each other. The paired up end portions of the suture elements can then be passed into the slots of a suture handling device as described above, for example. After having been received in the slots of the suture handling device as described above, the suture elements can be removed from the suture handling device and can be tied, or otherwise secured together, so as to form sutures between the vessels thereby to form an end-to-side anastomosis between the vessels.  
         [0092]    Although the present invention has been described in considerable detail with reference to certain preferred embodiments, it is contemplated that one skilled in the art may make modifications to the device herein without departing from the scope of the invention. Therefore, the scope of the amended claims should not be considered limited to the embodiments described herein.

Technology Category: 1