Abstract:
A surgical suturing device ( 10 ) having an axis extending between a proximal end and a distal end is operable to move a suture ( 32 ) through body tissue ( 34 ). A handle assembly ( 110 ) is coupled to an elongated shaft ( 14 ) having a hollow configuration. An actuating rod ( 16 ) is disposed to extend between the handle assembly ( 110 ) and the shaft ( 14 ). A thumb actuation assembly is coupled to a proximal end of the actuating rod ( 16 ) for moving the rod both axially and rotationally. A needle assembly ( 2 ) at the distal end of the actuating rod ( 16 ) is movable with the actuating rod ( 16 ) between an extended state and a retracted state and at various angular orientations.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of Provisional Application Ser. No. 60/604,243 filed on Aug. 24, 2004, and entitled, “SUTURE MANIPULATION SYSTEM WITH ROTATIONAL FINGERS,” and is a continuation-in-part of prior non-provisional application Ser. No. 10/803,406, filed Mar. 17, 2004, and entitled “EXPANDABLE NEEDLE SUTURE APPARATUS AND ASSOCIATED HANDLE ASSEMBLY,” now pending, which claims the benefit of Provisional Application Ser. No. 60/455,859 filed on Mar. 18, 2003, and entitled, “EXPANDABLE NEEDLE SUTURE APPARATUS AND METHOD,” and Provisional Application Ser. No. 60/500,046 filed on Sep. 3, 2003, and entitled, “EXPANDABLE NEEDLE SUTURE APPARATUS AND ASSOCIATED HANDLE ASSEMBLY,” all of which are fully incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates generally to surgical suture apparatus and, more specifically, to needle and suture manipulating apparatus and methods. 
         [0004]    2. Discussion of Related Art 
         [0005]    One of the more challenging aspects of endoscopy/arthroscopy is to properly place a suture in identified tissue. This task is complicated by the fact that all work must be done through a 5-8 millimeter cannula while viewing one&#39;s efforts on a monitor. 
         [0006]    With these difficult size configurations, it has been a significant challenge to incorporate all of the tasks into a single instrument. As a result, the tasks for initially passing a suture through target tissue and subsequently retrieving the suture from the far side has often required use of more than one instrument, especially when the suture is positioned in an awkward or difficult to reach orientation relative to the instrument being used to retrieve the suture. 
         [0007]    Various needle configurations have been contemplated, some with the needle permanently attached to the suture and others wherein the needle merely engages the suture. Attempts to miniaturize the needle structure have often produced needles that were so small they tended to yield under compressive stresses. 
         [0008]    The handles associated with suturing devices have been limited in the number of functions that could be performed. In some cases, handle assemblies have required two-handed operation. It has also been typical to provide needle assemblies that were permanently attached to the handle rather than assemblies that were removable from the handle and perhaps disposable. 
       SUMMARY OF THE INVENTION 
       [0009]    In one embodiment of the device contemplated, a needle assembly with a sharp tip is shaped from a wire. The wire is partially sliced near the tip so that it has two bifurcated portions that define a slot. The wire is processed in a manner that permits these bifurcated portions to move between two positions. In a first position, the bifurcated portions are biased to extend outwardly in which case the slot is generally open. In the second position, the bifurcated portions can be forced inwardly in which case the slot is substantially closed. As noted, the bifurcated portions are biased outwardly so that the wire, in its relaxed position has an open slot. 
         [0010]    In this expanded state, the open slot can be easily loaded with a suture. The needle assembly can then be pulled into a carrier tube that compresses the two bifurcated sides of the slot to shrink the profile of the distal tip and engage the loaded suture. With its sharp tip, the needle assembly, compressed within the outer tube, can then be easily passed with the suture through the tissue. On the other side of the tissue, the needle assembly can be deployed thereby permitting the slot to automatically expand in the relaxed state. This enlarges the slot thereby enabling the suture to be released. The needle assembly can then be removed from the tissue leaving the suture in place. 
         [0011]    In one aspect of the invention, a surgical device extends along an axis and has a proximal end and a distal end. The device is operable to move a suture through body tissue and includes a shaft having a hollow configuration. A handle assembly is coupled to the shaft, and an actuating rod having a proximal end and a distal end is disposed to extend between the handle assembly and the shaft. A needle assembly is disposed at the distal end of the actuating rod and is movable with the actuating rod between an extended position and a retracted position. Bifurcated portions of the needle assembly define a suture slot and have a proximate disposition when the actuating rod is in the retracted state and a separated state when the actuating rod is in the extended state. The actuating rod is biased to the retracted position while the bifurcated portions are biased to the separated state. 
         [0012]    In another aspect of the invention, a surgical suturing device includes a needle assembly with a needle movable in a needle housing between a free suture state and a captured suture state. A handle assembly includes a longitudinal handle housing sized and configured to releasably receive the needle assembly. A thumb slide assembly is releasably coupled to the needle and movable longitudinally on the handle housing between a distal position and a proximal position. The distal position of the thumb slide assembly is associated with the needle in the free suture state, while the proximal position of the thumb slide assembly is associated with the needle in one of a captured state and a locked state. 
         [0013]    In another aspect, the invention includes a method for placing a suture across a body wall of a patient. Initially, a suturing device is provided that includes a hollow shaft with a proximal end and a distal end, an actuating rod disposed in the shaft, and a needle assembly carried by the rod. The arms are movable between a proximate disposition associated with a first slot size and a spaced disposition associated with a second slot size greater than the first slot size. The body wall is then penetrated, with the needle assembly in the retracted position and the arms in the proximate disposition. The needle assembly can then be advanced to the deployed position to move the arms to the spaced disposition associated with the second slot size. 
         [0014]    These and other features and advantages of the invention will become more apparent with a description of preferred embodiments in reference to the associated drawings. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  is an axial cross section view of one embodiment of the present invention illustrating a bifurcated needle assembly; 
           [0016]      FIG. 2  is an axial cross section view showing the needle assembly in a retracted position; 
           [0017]      FIG. 3  is an enlarged view of the distal end of the device illustrated in  FIG. 2 ; 
           [0018]      FIG. 4-FIG .  9  illustrate steps in a method for using the suture device of  FIG. 1 ; 
           [0019]      FIG. 4  is a side elevation view illustrating the device in a normal state with the needle assembly retracted; 
           [0020]      FIG. 5  is a side elevation view showing operation of a thumb slide to deploy the needle assembly to an extended position characterized by automatic formation of an enlarged slot in the needle assembly; 
           [0021]      FIG. 6  is a side elevation view illustrating the loading of a suture into the slot of the needle assembly; 
           [0022]      FIG. 7  is a side elevation view showing retraction of the needle assembly and capture of the loaded suture; 
           [0023]      FIG. 8  is the side elevation view illustrating passage of the needle assembly and suture through tissue; 
           [0024]      FIG. 9  is a side elevation view illustrating deployment of the needle assembly to the extended position to enlarge the slot and release the suture prior to withdrawal of the device from the tissue; 
           [0025]      FIG. 10  is a side elevation view showing a further embodiment wherein the needle is fabricated at the proximal end of the slot; 
           [0026]      FIGS. 11-14  illustrate a further embodiment wherein the needle is bifurcated at the distal end of the slot; 
           [0027]      FIG. 11  is a side elevation view showing a backing arm and a gathering arm widely separated to receive a suture; 
           [0028]      FIG. 12  is a side elevation view illustrating the needle slightly retracted; 
           [0029]      FIG. 13  is a side elevation view showing the needle further retracted; 
           [0030]      FIG. 14  is a side elevation view showing the needle fully retracted; 
           [0031]      FIG. 15  is a side elevation view of an embodiment similar to  FIG. 11 , but including a built-in stop; 
           [0032]      FIG. 16  is a side elevation view of a further embodiment wherein the needle is tapered to facilitate manipulation through drastically bent tubes; 
           [0033]      FIG. 16A  is a cross section view taken along lines  16 A- 16 A of  FIG. 16  showing an embodiment with two arms; 
           [0034]      FIG. 16B  is a cross section view taken along lines  16 B- 16 B of  FIG. 16  showing an embodiment with four arms; 
           [0035]      FIG. 17  is a side elevation view of a further embodiment wherein a helical slot is cut around the circumference of the needle; 
           [0036]      FIGS. 18-22  illustrate a preferred method particularly applicable to the embodiment of  FIG. 11 ; 
           [0037]      FIG. 18  is a side elevation view showing the needle retracted and passed through the tissue; 
           [0038]      FIG. 19  is a side elevation view showing the needle fully deployed to receive the suture; 
           [0039]      FIG. 20  is a side elevation view showing the needle retracted with the suture disposed in the needle slot; 
           [0040]      FIG. 21  is a side elevation view showing the needle removed from the tissue drawing the suture through the needle hole in the tissue; 
           [0041]      FIG. 22  is a side elevation view showing the needle fully deployed to release the suture from the needle leaving the suture extending through the tissue; 
           [0042]      FIG. 23  is a side elevation view of a further embodiment of a needle assembly including a straight backing arm and a curved gathering arm; 
           [0043]      FIG. 24  is a side elevation view of another embodiment including a curved gathering arm and a curved backing arm; 
           [0044]      FIG. 25  is another embodiment of a needle assembly with angled portions defining a slot; 
           [0045]      FIG. 26  is a further embodiment of the needle assembly with large and small diameter portions; 
           [0046]      FIG. 27  is a side elevation view of another needle assembly including a notch in the needle tube; 
           [0047]      FIG. 28  is a side elevation view illustrating a notch-free needle tube and a needle in a suture-sliding position; 
           [0048]      FIG. 29  is a side elevation view similar to  FIG. 28  with the needle in a suture-locked position; 
           [0049]      FIG. 30  is a side elevation view of a needle assembly having a bendable section; 
           [0050]      FIG. 31  is a perspective view of the needle assembly having a radius to prevent suture fraying; 
           [0051]      FIG. 32  is a side elevation view of a needle assembly having an opening into the suture slot; 
           [0052]      FIG. 33  is a side elevation view illustrating the preferred disposition of the opening; 
           [0053]      FIG. 34  is a side elevation view illustrating a taper in the needle housing; 
           [0054]      FIG. 35  is a cross-section view of a preferred embodiment of a handle assembly; 
           [0055]      FIGS. 36   a - 36   d  are progressive views of a structure and method for coupling the needle assembly and the handle assembly; 
           [0056]      FIGS. 37   a  and  37   b  are side elevation views illustrating use of a pin to restrict movement of a needle rod; 
           [0057]      FIG. 38  is a perspective view of a needle assembly bifurcated by a slot; 
           [0058]      FIG. 39  is a perspective view illustrating the needle of  FIG. 38  in its bifurcated configuration; 
           [0059]      FIG. 40  is a side elevation view of an additional embodiment of a bifurcated needle assembly; 
           [0060]      FIG. 41  is a side elevation view of a further embodiment of a bifurcated needle assembly; 
           [0061]      FIGS. 42-44  show the distal end of a further possible embodiments of a suture device that can retract and deploy the needle assembly and can rotate the needle assembly to different desired orientations after deployment to aid in the grasping of the suture; 
           [0062]      FIG. 42  is a perspective view of the needle assembly in a standard straight position; 
           [0063]      FIG. 43  is a perspective view of the needle assembly after being rotated about 45°; 
           [0064]      FIG. 44  is a perspective view of the needle assembly after being rotated about 135°; 
           [0065]      FIG. 45  is a perspective view of a first embodiment of a suture device that uses a thumb wheel to deploy and rotate the needle assembly as shown in  FIGS. 42-44 ; 
           [0066]      FIG. 46   a  is a perspective view of a second embodiment of a suture device that uses a thumb lever located within a lever channel to deploy and rotate the needle assembly as shown in  FIGS. 42-44 ; 
           [0067]      FIG. 46   b  is a closeup view of the lever channel of the suture device shown in  FIG. 46   a;    
           [0068]      FIG. 47   a  is a perspective view of a third embodiment of a suture device that uses a thumb lever located within a movement-constraining lever channel to deploy and rotate the needle assembly as shown in  FIGS. 42-44 ; 
           [0069]      FIG. 47   b  is a closeup view of the lever channel of the suture device shown in  FIG. 47   a;    
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0070]    A suture device is illustrated in  FIG. 1  and designated by the reference numeral  10 . The device is an elongate structure and includes a handle  12  at its proximal end and a hollow shaft  14  at its distal end. An actuating rod  16  is disposed within the hollow shaft  14  and extends from the handle  12  through the shaft  14 . In the handle  12 , the actuating rod  16  is engaged by a thumb slide  18 . At its distal end, the actuating rod  16  is coupled to a needle assembly  20 . This assembly  20  includes a sharp tip  22  and bifurcated portions  24  and  26 , which define a slit or slot  28  proximately of the tip  22 . 
         [0071]    Operation of the thumb slide  18  relative to the handle  12  moves the actuating rod  16  and the attached needle assembly  20  between an extended position as illustrated in  FIG. 1 , and a retracted position as illustrated in  FIGS. 2 and 3 . In this particular embodiment, a spring  30  is used to bias the rod  16  and needle assembly  20  proximally to the retracted position. It will also be noted with reference to  FIG. 3  that the needle assembly  20  can be provided with shoulder stops  31  which are separated by a width greater than the internal diameter of the shaft  14 . These shoulder stops  31  prevent the distal tip  22  of the needle assembly  20  from entering the shaft  14  in the retracted position. 
         [0072]    The bifurcated portions  24  and  26  are also moveable between two positions. In a first position, the bifurcated portions  24  and  26  are separated radially to enlarge the slot  28 . In a second position, the bifurcated portions  24  and  26  are brought into close proximately by the tube, closing the slot  28 . In a preferred embodiment, these bifurcated portions  24  and  26  are biased to the separated state as illustrated in  FIG. 1  so the slot  28  automatically opens when the needle assembly  20  is in the extended position. 
         [0073]    Operation of the suture device  10  is illustrated in  FIGS. 4-9 . Initially, the device  10  in a relaxed, stored state will have the needle assembly  20  biased to the retracted position as illustrated in  FIG. 4 . In order to initially load the device  10  with a suture  32 , the needle assembly must be moved to the extended position as illustrated in  FIG. 5 . This is accomplished by pushing the thumb slide  18  distally to force the actuating rod  16  and the needle assembly  20  in the distal direction. When the needle assembly  20  clears the distal end of hollow shaft  14 , the bifurcated portions  24  and  26  are free to expand laterally thereby automatically enlarging the slot  28  as illustrated in  FIG. 5 . With the slot  28  enlarged, the suture  32  can now be passed through the slot as illustrated if  FIG. 6 . Releasing the thumb slide  18  permits the spring  30  to move the actuating rod  16  and needle assembly  20  proximally to the retracted position. As the needle assembly is drawn into the hollow shaft  14 , the restricted radial dimension forces the bifurcated portions  24  and  26  to move toward each other thereby closing the slot  28  and fully engaging the suture  32 . In this retracted state, illustrated in  FIG. 7 , the device is now loaded and prepared for disposition through the patient&#39;s tissue, which is designated by the reference numeral  34  in  FIG. 8 . The actuating rod  16  can be biased to the retracted position so that the device in the relaxed state automatically orients itself for use in crossing the tissue  34  as illustrated in  FIG. 8 . 
         [0074]    With the needle assembly  20  and the suture  32  extending through the tissue  34 , it is now desirable to release the suture from the device  10 . This is accomplished by again pushing the thumb slide distally to move the needle assembly from the retracted position to the extended position. As before, the bias of the bifurcated portions  24  and  26  will permit the needle assembly  20  to enlarge the slot  28  thereby facilitating release of the suture  32  from the device  10 . This is illustrated in  FIG. 9 . As a final step, the device  10  can be removed from the tissue  34  leaving the suture  32  operatively disposed across the tissue  34 . 
         [0075]    Notwithstanding the specific features of this embodiment, it will be noted that the needle assembly  20  includes a sharp point which facilitates passage through the tissue  34  even when the assembly  20  is in the retracted state. The bifurcated portions  24  and  26  function as a gripping means which automatically opens to facilitate loading the suture  32 , but which is capable of being closed with a force sufficient to retain the suture in the slot  28  as the device  10  is pushed through the tissue  34 . The hollow shaft  14  in this case functions primarily as a vehicle for moving the bifurcated portions  24  and  26  between the open state and the closed state. In the illustrated embodiment the hollow shaft  14  is shown with a straight configuration; but it can also be provided with many different curved configurations to enhance usage in various anatomically restricted areas. It will be apparent to those skilled in the art that this function can be accomplished by many different structures in other embodiments of the concept. 
         [0076]    In an additional embodiment illustrated  FIG. 10 , elements of structure similar to those previously discussed are designated with the same reference numeral followed by the lower case letter “a.” Thus, this embodiment includes the actuating rod  16   a , needle assembly  20   a  and distal tip  22   a . In this case however, the bifurcated portions  24  and  26  function as a backing arm  36  and gathering arm  38 , respectively. The gathering arm  38  can be integral with the backing arm  36  at the distal end of the slot  28   a , but preferably is separated from the backing arm  36  at the proximal end of the slot  28   a . At this location, the gathering arm  38   a  is cut from the backing arm  36   a  to form a passage  40 , which allows the needle to be more flexible as it is passed thru curves. The passage  40  can also facilitate drawing the suture into the slot  28   a  if the passage  40  is exposed distal of the hollow shaft  14   a  during deployment. 
         [0077]    A similar embodiment is illustrated in  FIGS. 11-14  wherein elements of structure similar to those previously discussed are designated with the same reference numeral followed by the lower case letter “b.” In this embodiment, the hollow shaft  14   b  receives the actuating rod  16   b  in the manner previously discussed. This embodiment also includes the backing arm  36   b  as well as the gathering arm  38   b . However, in this case, the gathering arm  38   b  is integral with the backing arm  36   b  at the proximal end of the slot  28   b . The gathering arm  38   b  is separated from the backing arm  36   b  at the distal end where a passage  42  permits the suture to enter the slot  28   b . This passage  42  is cut along the gathering arm  38   b  so that a small portion of the arm  44  remains with the distal tip  22   b . This enables the needle assembly  20   b  to retain the suture without damage when the needle assembly  20   b  is fully retracted. The gathering arm  38   b  in this embodiment can be shaped in a variety of ways. In the illustrated example, three bends  46 ,  48  and  50  create a wide passage  42  to facilitate capture of the suture. 
         [0078]    In  FIG. 12 , the needle assembly  20  has been slightly retracted into the hollow shaft  14   b  and the bend  46  has been generally straightened. The angle of the bend  50  has created a lip that gathers the suture toward the backing arm  36   b  as the bend  46  is straightened by the hollow shaft  14   b.    
         [0079]    In  FIG. 13 , the needle assembly  20   b  is even further retracted. This has caused the bend  48  to straighten bringing the gathering arm  38   b  into contact with the backing arm  36   b  while still maintaining the passage  42  for the suture. 
         [0080]    When fully retracted as illustrated in  FIG. 14 , the short portion  44  of the gathering arm  38   b  is received in the hollow shaft  14  leaving a small opening  52  to retain the suture. 
         [0081]    A further embodiment is illustrated in  FIG. 15  where elements of structure similar to those previously discussed are designated with the same reference numeral followed by the lower case letter “c.” In this embodiment, the backing arm  36   c  also defines the slot  28   c  with the gathering arm  38   c . In this embodiment, the gathering arm  38   c  is also cut to form the passage  42   c . However, the cut forming this passage  42   c  forms an oblique angle with the length of the needle assembly  20   c  so that a stop  54  is formed at the distal end of the gathering arm  38   c . This stop  54  is formed with a proximal tang  56  on the gathering arm  38   c , which interferes with a distal tang  54  on the short portion  44 . It is the purpose of this stop  54  to prevent the gathering arm  38   c  from contacting the backing arm  36   c  and thereby restricting free movement of a captured suture. 
         [0082]    Another embodiment is illustrated in  FIGS. 16 ,  16 A and  16 B where elements of structure similar to those previously discussed are designated with the same reference numeral followed by the lower case letter “d”. In this embodiment, the horizontal slot  28   d  is formed between the bifurcated portions  36   d  and  38   d . With only the single horizontal slot  28   d , this embodiment has a cross-section such as that illustrated in  FIG. 16   a.    
         [0083]    In a similar embodiment, a vertical slot  60  can be added, leaving the needle assembly  20   d  with four arms which are designated by the reference numerals  36   d ′,  36   d ″,  38   d ′ and  38   d ″ in  FIG. 16B . This particular configuration of the needle assembly  20   d  allows manipulation through drastically bent tubes. Of course, any number of multiple arms could facilitate this advantage. A taper  62  can be formed at the proximal ends of the arms  36   d  and  38   d . This tapered profile keeps the walls of the needle assembly  20   d  relatively consistent and flexible to minimize stress concentrations. 
         [0084]      FIG. 17  illustrates a further embodiment wherein a helical slot  64  is cut around the circumference of a cylindrical needle  66 . In this case the helical slot  64  is adapted to receive the suture and to hide the suture within the needle  66  as it penetrates the tissue. In this particular embodiment, the helical slot  64  may have a depth greater than zero but preferably not greater than 0.75 times the radius of the needle  66 . 
         [0085]      FIGS. 18-22  illustrate a method for using the needle assembly  20  and particularly the needle assembly  20   b  illustrated in  FIG. 11 . 
         [0086]    In  FIG. 18 , the needle assembly  20   b  has been retracted and the hollow shaft  14   b  passed through the tissue  34   b . The suture  32   b  is shown on the far side of the tissue  34   b . With this disposition of the suturing device  10   b , the thumb slide  18   b  can now be moved distally to deploy the bifurcated needle assembly  20   b  as illustrated in  FIG. 19 . In this position, the suture  32   b  can be introduced through the distal passage  42  and into the slot  28   b . As the thumb slide  18   b  is drawn proximally, the needle assembly  20   b  is retracted into the hollow shaft  14   b  in the matter discussed with reference to  FIG. 14 . 
         [0087]    With the suture captured in the opening  52 , as illustrated in  FIG. 20 , the suture device can be withdrawn from the tissue  34   b  pulling the suture  32   b  through the needle hole left in the tissue  34   b . This step in the process is illustrated in  FIG. 21 . Finally, the thumb slide  18   b  can again be moved distally to deploy the needle assembly  20   b . This will produce a wide separation of the backing arm  36   b  and gathering arm  38   b  resulting in release of the suture  32   b  from the suture device  10   b . In this manner, the suture  32   b  can be threaded through the tissue  34   b.    
         [0088]    A further embodiment of the invention is illustrated in  FIG. 23  where the needle assembly  20  is shown with a unique shape that enhances performance in some embodiments. In this case, the needle assembly  20  includes a backing arm  70  and a gathering arm  72 . The gathering arm  72  is curved so that an opening is provided with minimal needle deployment to facilitate capture of the suture. This feature enhances use of the needle assembly  20  where the suture must be engaged in small spaces and the needle cannot be fully deployed. 
         [0089]    In  FIG. 24 , a similar embodiment is illustrated where the backing arm  70  is also curved. In this manner, the needle assembly  20  can be provided with a shape that is closer to that of the hollow shaft  14  ( FIG. 1 ). This embodiment is representative of a concept wherein the hollow shaft can have many different curved configurations, each adapted for a particular anatomical area or indication; and the associated needle assembly including the backing arm  70  and gathering arm  72  can be matched to the configuration of the shaft. 
         [0090]      FIGS. 25 and 26  show two variations where the needle assembly  20  includes a thick needle section  74  that is proximal of a pointed end  76 . In these embodiments, the thick needle section  74  defines a portion of the suture slot  67  that, as previously noted, can have a variety of configurations. Proximal of the thick section  74 , a diameter can be made smaller so that a thinner section  78  is created. This thin section  78  makes it easier for the needle to be moved through the curves of the hollow shaft  14 . 
         [0091]    In the embodiment of  FIG. 27 , a notch  81  is created in the distal end of the hollow tube  63 . This notch  81 , in connection with a needle tip  64 , creates a suture slot  83  which holds the suture. With the notch  81  buried in the hollow tube  63 , the needle tip  64  can be made shorter so that a curved device can have a lower profile adapting it for use in a smaller diameter cannula. 
         [0092]      FIGS. 28 and 29  illustrate two positions of a needle tip  64  relative to a hollow tube  65 . In these two positions, the size of the suture slot  66  can differ. The suture slot  66  in  FIG. 28  is sufficiently large to enable the suture to slide or slip easily relative to the hollow tube  65 . By comparison, the suture slot  66  in  FIG. 29  is relatively small because the needle tip  64  has been retracted slightly into the hollow tube  65 . In this second position, the needle tip  64  is retracted to reduce the size of the suture slot  66  and hold or lock the suture in place against the hollow tube  65 . A variety of mechanisms can be used to provide various detented positions between the first position illustrated in  FIG. 28  and the second position illustrated in  FIG. 29 . A mechanism could also be provided to require a force of progressive magnitude in order to move between the slipping position of  FIG. 28  and the locking position of  FIG. 29 . 
         [0093]    In some cases it is advantageous to provide the hollow shaft  14  with a drastically bent configuration. Under these circumstances, a needle assembly  20  formed from a metal material such a Nitinol, can be made to slide more easily within the drastically bent tube if it is made thinner at those locations where it is to be bent during deployment or retraction. The distal end of the needle assembly  20  can be kept larger so that the diameter of the needle tip is sufficiently thick to withstand any bending stresses. The proximal end need not be made thicker since it functions primarily as a push/pull rod in compression/tension during deployment and retraction. 
         [0094]      FIG. 30  shows an example of a tapered needle that can be provided in a multitude of configurations. Beginning generally at the distal end, the needle  90  can be provided with a distal taper  81 . This taper can start at any location between a point just proximal of the needle point to a location just proximal of the slot. In the latter location, the starting position tends to maximize the amount of material defining the slot. Depending on the strength required, a proximal taper  83  can also be provided back to the diameter of the needle point. This proximal taper  83  would be of particular advantage where a thicker shaft might be required for strength purposes. 
         [0095]    As illustrated in  FIG. 31 , many of the foregoing embodiments can benefit from a radius  92  provided in the distal end of the slot. Such a radius  92  will insure that a sliding suture is less likely to be frayed on a sharp edge. 
         [0096]    In the embodiment of  FIG. 32 , an opening  94  is provided between two tangs  96  and  98 , which also define the needle slot. This opening  94  is preferably defined at a location that is more distal along the slot so that it can be exposed when the needle is only slightly deployed from the needle tube. Thus, even with a slight deployment of the needle, a suture can be slid through the opening  94  and into the slot. This can be of particular importance in an embodiment wherein the suture is very close to where the needle exits the tissue. Under these circumstances, it would be more difficult to capture the suture if the needle had to be fully deployed. Notwithstanding the preferred distal location of the opening  94  relative to the slot, it is desirable that the opening  94  be positioned sufficiently proximally that a basin  96  is formed at the proximal end of the slot, as illustrated in  FIG. 33 . 
         [0097]      FIG. 34  illustrates an embodiment wherein a hollow tube housing  101  is provided with a taper  103  at its distal end. This taper  103  will tend to minimize the insertion forces required for the device. 
         [0098]    A handle assembly  110  is illustrated in  FIG. 35  as a preferred embodiment of the handle  12  discussed with reference to  FIG. 1 . In the manner previously discussed, the handle assembly  110  is adapted to receive the needle assembly  20 , including the hollow shaft  14  and the rod  16 . In addition, the needle assembly  20  in this embodiment is provided with a hub  112  having an enlargement  114  and a cylindrical extension  116  disposed proximally of the enlargement  74 . 
         [0099]    In this embodiment, the handle assembly  110  includes a frame  118 , and the thumb slide  18  that can be moved by a thumb of the user. In this manner, the thumb slide  18  can be moved between a rearward position, to the left in  FIG. 35 , and a forward position, illustrated to the right in  FIG. 35 . 
         [0100]    The thumb slide  18  is part of a unit that moves in combination with a slider  121  and a needle latch  123 . The needle latch  123  is rotatable on the slider  121  about a pivot pin  125 , and includes a leaf spring  127 . A tooth  130  is also carried by the slider  121  and cooperates with a slot  132  and ratchet  134  in the frame  118 . 
         [0101]    A locking lever  136  is pivotal on the frame  118  at a pivot pin  138 . This enables the locking lever  136  to move as shown by an arrow  141  between an unlocking position and a locking position illustrated in  FIG. 35 . 
         [0102]    A lever latch  143  is biased by a spring  145  to lock the locking lever  136  in the locking position illustrated in  FIG. 35 . Movement of the lever latch  143  longitudinally along an arrow  144  and against the bias of the coil spring  145  frees the locking lever  136  to move from the illustrated locking position to the unlocking position under the bias of a coil spring  147 . 
         [0103]    When the locking lever  136  is in the unlocking position, a hub lock  150  is removed from proximity with the hub  112  of the needle assembly  20 . This enables the cylindrical extension  116  of the needle assembly  20  to be inserted into and removed from a channel  152  at the distal end of the handle assembly  110 . With the hub  112  inserted into the channel  152 , the locking lever  136  can be moved to its locking position where the hub lock  150  engages a slot  154  in the cylindrical extension  116 . The lever latch  143  automatically retains the locking lever  136  in the locking position illustrated in  FIG. 35 . 
         [0104]    In order to initially prepare for operation of the suture device  10 , the removable needle assembly  20  must be mounted in the handle assembly  110 . For purposes of discussion, it will be assumed that the thumb slide  18  is pushed forward into the distal position illustrated in  FIG. 35 . 
         [0105]    As an initial step in the mounting process, the locking lever  136  is moved to the unlocked position, downwardly along the arrow  141  in  FIG. 35 . This is accomplished by moving the lever latch  143  rearwardly or proximally to the left in  FIG. 35 . This movement, against the bias of the coil spring  145 , will cause the lever latch  143  to disengage the locking lever  136 , which will then automatically drop to the unlocking position under the bias of the coil spring  147 . 
         [0106]    With the hub lock  150  withdrawn from the slot  154 , the cylindrical extension  152  of the needle assembly  20  can be moved into the channel  152  along with the needle rod  16 . With the needle assembly  20  inserted and the enlargement  114  butted against the handle assembly  110 , a notch  155  at the proximal end of the needle rod  16  will engage the needle latch  123 . At this point, the locking lever  136  can be closed against the bias of the spring  147  causing the hub lock  150  to engage the slot  154  in the cylindrical extension  152 . The closing of the locking lever  136  also provides a positive force through the leaf spring, which maintains the needle latch  123  in the notch  155 . As the locking lever  136  moves upwardly to the locking position, the coil spring  145  will bias the lever latch  143  to engage, lock, and retain the locking lever  136  in the locking position. In this operating position, movement of the thumb slide  18  relative to the frame  118  will cause the needle rod  16  to move relative to the hub  114  of the needle assembly  20 . 
         [0107]    The foregoing procedure for mounting the needle assembly  20  into the handle assembly  110  was begun with the assumption that the thumb slide  18  would be in the forward, distal position. If this is not the case, the needle latch  123  will not initially engage the proximal end of the needle rod  16 . Even under these circumstances, the mounting operation can be completed in the foregoing manner so that the hub  114  is retained by the locking lever  136 , which is in turn locked by the lever latch  143 . With this step completed, the thumb slide  18  can be slid forward in the distal direction to enable the needle latch  123  to engage the notch  155  at the proximal end of the rod  16 . This engagement and locking of the rod  16  by the needle latch  123  will be accommodated by deflection of the leaf spring  127 . In accordance with either of these processes, the needle assembly  20  can be coupled to the handle assembly  110  and prepared for use by the surgeon. 
         [0108]    In operation, the suture  32  can be positioned between the bifurcated portions  24  and  26  of the needle when the needle is deployed. At this point the needle assembly  20  can be fully deployed by moving the thumb slide  10  and the rod  16  distally. In this position of the needle assembly  20 , the suture  32  can be loaded, unloaded, picked up, or dropped off as required in different stages of operation. 
         [0109]    With the suture  32  thus loaded in the needle assembly  20 , the surgeon can pull the thumb slide  18  proximally, rearwardly until the tooth  130  on the slider  121  engages the slot  132  on the frame  118 . In this position, the suture  32  is captured within the needle but is still free to slide laterally in the slot of the needle. Note that the springiness of the thumb slide  18  forces the tooth  130  to remain in the slot  132  where it is held in contact with the frame  78 . 
         [0110]    If it becomes desirable to further engage the suture  32  and eliminate its ability to slide within the needle slot, the thumb slide  18  can be depressed and further retracted causing the tooth  130  to leave the slot  132  and move further rearwardly along the ratchet  134 . This slight movement will cause the rod  16  of the needle assembly  20  to move further rearwardly drawing the needle assembly  20  slightly further into the hollow shaft  14 . In this position, the suture  32  is not only captured within the needle assembly  20 , but is sandwiched and locked between the needle assembly  20  and the hollow shaft  14 . During operation of the device  10 , the thumb slide  18  in this embodiment is not intended to move further rearwardly. 
         [0111]    As it becomes of interest in different stages of operation, the suture  32  can be disengaged by moving the thumb slide  18  from this rearward-most position, forwardly and distally. If the thumb slide is not depressed, the tooth  130  will fall back into the slot  132  where the suture is captured but nevertheless free to slide within the needle eye. In this position, the suture  32  can be removed. By depressing the thumb slide  18  the tooth  130  can be removed from the slot  132  permitting the thumb slide  18  to be moved further in the distal direction. This distal movement will open the bifurcated portions  24  and  26  of the needle assembly  20  and fully releasing the suture  32 . 
         [0112]    Once the fully operative procedure is completed, the needle assembly  20  can be removed from the handle assembly  110  by reversing the mounting steps previously discussed. 
         [0113]    A preferred structure for releasably engaging the needle rod  16  with the needle latch  123  is illustrated in the progressive views of  FIGS. 36A-36D . In these views it is shown that the notch  155  can be formed with a ramp  156  that is machined into the proximal end of the needle rod  16 . This ramp  156  allows the needle rod  16  to be pushed into the handle assembly  110  when the enlargement  114  of the hub  112  butts against the handle assembly  110 , the proximal end of the needle rod  16  can ride up over a ramp  158  on the needle latch  123  as illustrated in  FIG. 36B . When fully seated as illustrated  FIG. 36C , this locking mechanism keeps the needle assembly attached to the handle assembly until the ramp  158  is moved laterally permitting the ramp  156  and associated needle rod  16  to be moved distally. 
         [0114]    Apparatus for restricting the range of needle movement between its retracted position and its forward position is illustrated in  FIGS. 37A and 37B . In this embodiment, a pin  161  is provided for disposition in a transverse slot  163  within the hub  112 . In this embodiment, the rod  16  of the needle assembly  20  is also provided with a channel  165  of predetermined length. In this sub-assembly, the rod  16  is initially positioned to extend longitudinally through the hub  112 . When the channel  165  intersects the slot  163 , the pin  161  can be inserted longitudinally through the slot  163  in the hub  112  and transversely through the channel  165  in the rod  16 . This sub-assembly is illustrated in  FIG. 37B . The restricted movement provided by this sub-assembly is needed so that the needle is always in a position to be loaded into the handle. With the accommodation of this restricted movement, the needle cannot be jammed in the handle assembly  110 . 
         [0115]    Another unique needle configuration is illustrated the prospective views of  FIGS. 38 and 39 . In this embodiment, the distal slot is similar to that previously discussed, but the distal tip is bifurcated by a cut  167  that extends into the slot. In operation, deployment of the needle causes the bifurcated portions  169  and  170  to split, as illustrated in  FIG. 39 . Of course there are many variations of this bifurcated configuration. Two such variations are illustrated in  FIGS. 40 and 41 . By way of comparison, it will be noted that the cut  167  in  FIG. 38  is disposed along the axis of the needle tip so that the tip portions are symmetrical. In the views of  FIGS. 40 and 41 , the cut  167  does not produce symmetrical tip portions. Although the cut is planar in  FIG. 41  and in  FIG. 38 , it is nevertheless offset from the axis of the tip in  FIG. 40 . In the embodiment in  FIG. 41 , the cut  167  is non-planar. 
         [0116]      FIGS. 42-47  relate to alternative embodiments of the present invention that include an actuator assembly that offers a rotational control feature. Here, the needle assembly may be deployed from the distal end of the hollow shaft by manipulating the actuating rod at the proximal end of the hollow shaft using a suitable thumb actuator assembly. Using this same base design, the ability is added such that when the needle assembly is deployed, its arms can also be rotated to get into a better position to grab the suture. The needle assembly can then be rotated back to the original position, if desired, and drawn back in the hollow shaft for withdrawal. 
         [0117]      FIGS. 42-44  show the distal end of a further possible embodiment of a suture device that can retract and deploy the needle assembly and can rotate the needle assembly to different desired orientations after deployment to aid in the grasping of suture. In particular,  FIGS. 42-44  show sample positions of rotation after a needle assembly  220  having two arms  226 ,  228  has been deployed from the hollow shaft  214 . In  FIG. 42 , the needle assembly  220  is in the standard straight position. In  FIG. 43 , the needle assembly  220  has been rotated about 45°, as suggested by the arrow, and in  FIG. 44 , the needle assembly  220  has been rotated about 135°. This rotation can also occur with the needle assembly only partially deployed. 
         [0118]    The rotational action is controlled by providing the user with a suitable control mechanism at the proximal end of the hollow shaft  214  containing the needle assembly  220 . There are a variety of possible methods to rotate the needle assembly. 
         [0119]      FIG. 45  shows one example of a suture device  210  that includes this rotational enhancement. In particular,  FIG. 45  is a perspective view of a first embodiment of a suture device  210  that uses a thumb wheel  218  to deploy and rotate the needle assembly  220  as shown in  FIGS. 42-44   
         [0120]    As shown, a handle  212  is attached to hollow shaft  214 . Running the length of the shaft  214  is an actuating rod  216  which has its proximal end attached to the thumb wheel  218 , and which terminates in split arms  226 ,  228  at its distal end. The thumb wheel  218  can be used to deploy and retract the split arms  226 ,  228  relative to the hollow shaft  214  with the reciprocating motion suggested by arrow  204 . At any time, the thumb wheel  218  can also be rotated as suggested by arrow  205 , which rotation translates along the actuating rod  216  and moves the split arms  226 ,  228  of the needle assembly  220  in a circular motion suggested by arrow  206 . 
         [0121]      FIGS. 46   a  and  46   b  show another embodiment that uses a handle  212  having a thumb lever  318  moveable within a lever channel  319 .  FIG. 46   b  is a blown-up view of the top of the lever channel  319 . The lever  318  can deploy and retract the split arms  226 ,  228  from the hollow shaft  214  when moved in a back-and-forth direction represented by arrow  304 . The lever  318  can also move in a left-and-right direction represented by arrow  305 . As best shown in  FIG. 46   b , the lever  318  can move farther and farther in the left-and-right direction as the lever  318  is moved more distally within lever channel  319 . The side-to-side motion  305  translates to the split arms  226 ,  228  and creates a substantially rotational movement as described by arrow  306 . As the split arms  226 ,  228  are retracted by pulling the lever  318  proximally, the side-to-side motion  305  permitted within lever channel  319  becomes lessened until the proximal slot  311  is reached, at which point the side-to-side movement  305  is near zero. The taper described by the lever channel  319  allows more side-to-side movement  305  when the lever  318  is deployed distally so that the split arms  226 ,  228  can rotate more  306  as they are deployed further. Conversely, as the lever  318  is pulled proximally, the side-to-side movement  305  is restricted to help prevent the split arms  226 ,  228  from being overstressed in the near closed positions. Within the movement defined by the proximal slot  311  there may be one or more detents or over-ridable stops that position and hold the split arms  226 ,  228  at a defined position relative to the hollow shaft  214 . 
         [0122]      FIGS. 47   a  and  47   b  are similar to  FIGS. 46   a  and  46   b  in that they show another embodiment that uses a handle  412  having a thumb lever  418  moveable within a lever channel  419 . Here, however, the lever channel  419  defines the movement of the lever  418 . There are many ways this can be done but, in this example, the lever  418  is allowed to deploy and retract the split arms  226 ,  228  by being moved along a central slot  419   a . At the distal end, a cross slot  419   b  allows side-to-side motion of the thumb lever  419 . The lever channel  419  may also include additional slots for locking the split arms  226 ,  228  in a defined location relative to the hollow shaft  214 . In the illustrated embodiment, the first slot is a suture sliding slot  419   c  and the other is a suture locking slot  419   d . When the lever  418  is positioned in the suture sliding slot  419   c , a small gap is left between the hook of the split arm  226  and the hollow shaft  214  to allow free sliding of captured suture. When the lever  418  is positioned in the suture locking slot  419   d , the gap is lessened so that the captured suture can not move freely. 
         [0123]    Although the invention has been discussed with reference to specific embodiments, it will be apparent that the concept can be otherwise embodied to achieve the advantages discussed.