Patent Publication Number: US-10314571-B2

Title: Systems for soft tissue repair

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 13/936,879, filed on Jul. 8, 2013, which is a continuation-in-part of U.S. patent application Ser. No. 13/711,297, now U.S. Pat. No. 9,173,654, filed Dec. 11, 2012, the disclosures of which are incorporated herein by reference in their entireties. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to medical devices and methods used for attaching soft tissues to one another. More particularly, the present invention relates to apparatus and methods for re-attaching a damaged tissue region to one another such as a ruptured Achilles tendon in a minimally invasive manner. 
     BACKGROUND OF THE INVENTION 
     Soft tissue damage, particularly tendon rupture such as the Achilles tendon, is typically a debilitating event. Surgical repair of a ruptured tendon generally requires the torn or ripped ends of the tendon, which are separated from one another, to be coapted by passing one or more sutures through each damaged end. Each of the torn ends are drawn towards one another by tightening of the sutures to restore the connecting muscles and tendon to their original lengths. 
     However, accessing the damaged tissue generally requires relatively large incisions or multiple smaller incisions for effecting adequate purchase and sufficient suturing of the damaged tendon to ensure proper healing of the tendon. Yet relatively large incisions or multiple incisions also increase the likelihood of infections and complications occurring. 
     Moreover, minimally invasive devices which may be inserted through relatively smaller incisions are generally limited in their application for repairing particular tissue regions. For instance, minimally invasive surgical instruments may enable a surgeon to pass sutures through tissue with the instruments introduced through relatively small incisions; however, these instruments are limited in their ability to pass multiple sutures through non-supported tissue structures in an efficacious manner. 
     Moreover, may such devices are insufficient in supporting tissue structures such as ruptured or torn tendons for minimally invasive surgical repair. Thus, tissue repair systems which are able to pass one or more sutures in a minimally invasive manner into tissue structures, such as the Achilles tendons, which are difficult to secure and manipulate are highly desirable. 
     BRIEF SUMMARY OF THE INVENTION 
     A suture delivery assembly may be sized for insertion through a single incision and positioned into proximity with a damaged or ruptured tissue region. Generally, one variation of such a tissue repair system may comprise a handle having an actuator, a suture delivery assembly coupled to the handle and defining a tissue receiving channel along the suture delivery assembly, one or more needles which are curved or arcuate and which are rotatable from a delivery position to a deployment position where the one or more needles are rotatable at least partially through the tissue receiving channel when articulated by the actuator, and one or more lengths of suture which carried by the one or more needles. Additionally, one or more stylets which are translatable through the suture delivery assembly may be inserted into proximity to the one or more needles where each of the needles may define a clearance slot which is sized to partially receive the one or more stylets when each of the one or more needles are aligned relative to one another in the deployment position. 
     In use for repairing a tissue region, generally a suture delivery assembly defining a tissue receiving channel therealong may be introduced through an incision in proximity to a ruptured or torn tissue and positioned relative to a first portion of the ruptured or torn tissue such that the tissue is positioned within the tissue receiving channel. The one or more needles within the suture delivery assembly may be rotated from a delivery position within the suture delivery assembly to a deployment position such that the one or more needles pierce into and through the damaged tissue positioned within the tissue receiving channel. As the one or more needles pierce through the tissue, one or more corresponding lengths of suture may be passed through the tissue via the needles. 
     Then, at least one stylet may be inserted through the suture delivery assembly and through at least one stylet clearance slot defined along the one or more needles to deliver a length of suture, which may be common with the suture passed through the tissue or which may be a separate length of suture. The needles may be retracted and the assembly removed leaving the one or more sutures behind in the tissue in a prescribed suturing pattern. The sutures may then be tightened to the tissue. This process may be repeated on a second portion of the ruptured or torn tissue and the resulting sutures from the second portion may be secured to the sutures from the first portion to reattach the ruptured tissue. 
     Examples of devices and methods which may be used with the devices and methods described herein are further disclosed in detail in U.S. patent application Ser. No. 13/113,505 filed May 23, 2011 (U.S. Pub. 2011/0313454 A1) and U.S. Prov. App. 61/349,025 filed May 27, 2010, each of which is incorporated herein by reference in its entirety for any purpose. 
     In one example, a tissue repair assembly may have a handle housing and an actuator which is actuatable and is operatively coupled to a suture delivery assembly designed for percutaneous insertion through an incision. The suture delivery assembly may be sized for subcutaneous placement while contacting the underlying tissue to be treated. The assembly may have a height, e.g., of less than 2 cm, a width, e.g., of less than 3 cm, and a length, e.g., of less than 7 cm. The suture delivery assembly has an atraumatic distal end and external shell assembly comprised of a first portion of external shell attachable to a second portion of the external shell both which may surround a needle housing assembly. The suture delivery assembly may be generally configured to define a tissue receiving portion for contacting the tissue to be treated where the tissue receiving portion faces away from the handle housing. 
     The needle assembly itself may be comprised of a first set needles, e.g., three curved or arcuate needles, which are positioned adjacent to one another and a second set of needles, e.g., three curved or arcuate needles which are also positioned adjacent to one another. Each of the first set of needles and second set of needles may be positioned in apposition to one another such that each needle is staggered relative to one another. Moreover, each of the first and second set of needles may be rotatably positioned within the needle housing assembly to rotate relative to the housing assembly and traverse through the tissue receiving portion for piercing through and passing suture through the contacted tissue. 
     In one example of use such as with a ruptured or torn tendon such as the Achilles tendon, a single incision, e.g., less than 3 cm in length, may be made in the patient leg in proximity to or between the torn tissue portions. Because the suture delivery assembly may have a housing volume, e.g., of less than 17 cc to 30 cc, the assembly may be inserted through the incision, e.g., up to an insertion distance of less than 5 cm, such that the tissue receiving channel may contact the first portion of tissue, e.g., a proximal portion of a ruptured Achilles tendon. Because the channel diameter may be sized or adjusted, e.g., between 0.5 cm to 2 cm, to accommodate various size tissue diameters, the damaged first portion of tissue may be securely retained by the assembly which may pass the needles through the tissue to deliver one or more lengths of suture in proximity to the first ruptured segment. 
     Once the tissue has been positioned and/or temporarily secured within or against the tissue repair assembly, the handle may be actuated to rotate respective actuation shaft upon which the needles are secured in opposing directions which in turn rotates each of the needle assemblies from within the housing assembly and into and through the tissue. As each of the needles pass through the tissue, they may each pass portions of a common length of suture entirely through the tissue. Moreover, the distal tips of each of needle may rotate through the tissue receiving channel (and through any tissue present) to converge along or in proximity to a common longitudinal axis along the assembly. Once the needles have passed their respective portions of suture through the tissue, a stylet may then pass a terminal suture end (or another length of suture) through each of the suture portions aligned along or in proximity to the common longitudinal axis for further tightening and securement. 
     With the first portion of tissue secured, the tissue repair assembly may be removed from the incision and the same suture delivery assembly with additional lengths of suture (or a second assembly) may be re-introduced in the opposing direction through the incision to contact the second portion of tissue, e.g., the distal portion of ruptured tendon. The suture delivery assembly may then be secured to the second portion of tissue with the resulting second suture configuration in proximity to the second ruptured segment. The suture delivery assembly may then be removed and the terminal ends of the first suture and second suture configuration may be tied to one another through the incision to approximate and secure the first ruptured segment and second ruptured segment against one another to facilitate healing. 
     Each of the needles may be arcuate or otherwise curved, e.g., in a semi-circular manner, such that each of the needles may be positioned entirely within the needle housing assembly during initial insertion and placement within the tissue. The curvature of the needle may allow for the needles to be rotated within a plane which is transverse to a longitudinal axis of the housing assembly such that the needle may be rotated through an angle of needle engagement, e.g., 120° or more. This allows for the needle proximal end to be driven for the needle piercing tip to be rotated from an enclosed position to one where the distal piercing tip of the needle is advanced through a corresponding needle opening defined along tissue receiving channel and into a needle receiving channel. As the piercing tip passes through the tissue receiving channel along a circular needle trajectory, each piercing tip of each needle may pass a length of suture through the tissue. The position of the housing assembly  22  be maintained relative to the tissue to be treated via the handle attachment. 
     The tissue receiving channel may be varied in size or adjusted to facilitate temporarily clamping upon the tissue but may generally have a diameter of about 1.25 cm in one variation. Moreover, the diameters of the curved needles may also vary but generally may range anywhere from, e.g., 1 cm to 1.5 cm, in this and other variations. Additionally, each of the needles may be advanced simultaneously, e.g., each of the first and second needle assemblies along both sides may be advanced through the tissue at the same time. Alternatively, the needles may be deployed sequentially along either side (e.g., sequentially along a single side) or both sides (e.g., sequentially along alternating sides) or any other number of deployment sequences depending upon the desired sequence of needle deployment. Moreover, the order of needle deployment may be varied in this variation as well as any of the other variations described herein. Furthermore, the stylet channel may be defined through the length of the housing where the stylet channel is coincident with the longitudinal axis in proximity to where each of the needle distal tips converges. 
     The needle piercing tips may further define a stylet clearance slot defined along each needle body proximal to the piercing tip. The stylet clearance slot provides for passage of the stylet in proximity to the deployed needles when the stylet is used to pass the suture through the suture loops passed by each needle through the tissue. 
     In another, an adjustable housing assembly may have two adjacent housing assemblies defining a tissue receiving channel therebetween. The housing assemblies may be movably adjusted relatively away or towards one another to accommodate various size tissues to be treated. Moreover, the adjustability of the housing assemblies may also allow for the tissue to be stabilized relative to the housing assemblies by temporarily clamping the assemblies upon the tissue while the needles and suture are driven into and through the tissue. 
     Once the repair device has been inserted in proximity to the tissue region to be treated, the housing may be articulated via actuation handles such that the housing pivots about the one or more biasing members to place the presentation surfaces defining the tissue receiving channel securely around the tissue of interest. With the tissue positioned within the tissue receiving channel, the housing positioning relative to the tissue may be further adjusted, if so desired. Each of the needles may have one or more lengths of suture positioned along each needle body and between each adjacent needle. Once the device has been desirably positioned relative to the tissue, the needles may be actuated (simultaneously or sequentially, as described herein) such that the needles are rotated by the actuation shafts. The piercing tips of the needles may accordingly exit the needle openings defined along the presentation surfaces and traverse through the tissue receiving channel in a circular curve or arc trajectory. 
     As the needles traverse through the channel and tissue, the needles may pass the suture loops through the tissue and into proximity to the stylet channels defined longitudinally through respective housing. As previously described, the needles may define a notched or cut-out section as a stylet clearance slot which aligns with the stylet channels when the needles have been fully rotated into their deployed configuration. Once the needles have carried the suture lengths and suture loops through the tissue and into proximity to the stylet channels, the stylet (which carries a length of the suture) may accordingly be passed through the stylet channel to route the suture through the suture loops for further tightening of the suture upon the tissue. Once the suture loops have been passed via the needles, the needles may be retracted proximally back through the tissue and into the housing for disengaging the tissue and subsequent removal of the device from the tissue region. 
     Turning now to the needle assemblies, the number and relative positioning of the needles may be varied. Although the needles may be in a staggered and alternating configuration, the needles may be more closely aligned such that the needle tips are immediately adjacent to one another. Alternatively, the needles may be arranged in a staggered configuration farther apart from one another depending upon the desired suturing pattern. 
     Regardless of the number of needles used and the relative positioning of the needles, the needles may be configured and positioned relative to the tissue receiving channel such that the needles may penetrate into and through any number of varying tissue sizes. Regardless of the tissue size, the tissue may be positioned within the tissue receiving channel such that when the needle is deployed, its piercing tip may enter the tissue through a tissue entry along a side portion of the tissue and pierce through the tissue at a tissue exit located along a top portion of the tissue where the side and top are relative to the tissue position relative to the tissue receiving channel. 
     The needle may pass a length of suture carried via the suture guide exit entirely through the tissue regardless of tissue size. With the suture passed through, the stylet may be introduced through the suture loop formed by the suture and left when the needle piercing tip is retracted and the suture falls out of the suture guide exit. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a perspective view of an exploded suture delivery assembly attachable to a handle. 
         FIGS. 2A and 2B  illustrate an example of how a suture delivery assembly may be introduced percutaneously for attaching one or more sutures to a first portion of a damaged or ruptured tendon. 
         FIGS. 2C to 2E  illustrate how the suture delivery assembly may be used for attaching one or more sutures to a second portion of a damaged or ruptured tendon and how the damaged ends may be approximated and secured to one another. 
         FIG. 3  illustrates a detailed perspective view of another variation of the suture delivery assembly. 
         FIGS. 4A and 4B  illustrate end views of variations of the suture delivery assembly. 
         FIGS. 5A to 5C  illustrate respective top, side, and end views of another variation of the suture delivery assembly. 
         FIG. 6A  illustrates another variation of the suture delivery assembly. 
         FIG. 6B  illustrates yet another variation of the suture delivery assembly having a relatively smaller housing. 
         FIGS. 7A to 7C  illustrate respective top, side, and bottom views of a variation of the suture delivery assembly. 
         FIGS. 7D and 7E  illustrate respective end views of the assembly of  FIGS. 7A to 7C . 
         FIGS. 8A and 8B  illustrate perspective views of the proximal and distal ends of the assembly of  FIGS. 7A to 7C . 
         FIGS. 9 and 10  illustrate perspective and end views of the assembly housing from the variation of  FIGS. 7A to 7C . 
         FIGS. 11A and 11B  illustrate perspective and detail views of the assembly of  FIGS. 7A to 7C . 
         FIG. 12  illustrates a perspective view of yet another variation of the suture delivery assembly. 
         FIG. 13  illustrates a perspective view of yet another variation of the suture delivery assembly. 
         FIG. 14  illustrates a perspective view of yet another variation of the suture delivery assembly having a dual housing embodiment. 
         FIGS. 15A and 15B  illustrate partial cross-sectional end views showing the adjustment between the dual housing and the actuation of the respective needle assemblies. 
         FIGS. 16A and 16B  illustrate partial cross-sectional end views of another variation for adjusting the dual housing. 
         FIG. 17  illustrates a detail perspective view of one example for routing the suture through the needle assembly between each adjacent needle. 
         FIG. 18  illustrates a perspective view of another variation of the dual housing embodiment with the structure partially removed for clarity. 
         FIGS. 19A and 19B  illustrate end and detail end views of an example of the needle clearance and interaction relative to a stylet carrying a length of suture. 
         FIGS. 20A and 20B  illustrate end views of yet another variation further illustrating an example of how the needle clears the stylet. 
         FIGS. 21A and 21B  illustrate respective end and detail perspective views of yet another variation of a needle having a groove or channel for suture management. 
         FIGS. 22A and 22B  illustrate respective end and detail perspective views of yet another variation of a needle having a suture guide for suture management. 
         FIG. 23  illustrates a side view of yet another variation of a needle incorporating a projection for proximal to the stylet for facilitating suture management. 
         FIGS. 24A and 24B  illustrate partial cross-sectional end views of variations for actuating the needle assembly. 
         FIG. 25  schematically illustrates an example for transferring an actuation force from the handle to the needle assembly. 
         FIG. 26A  illustrates a perspective view for one variation of a handle assembly for securing the suture delivery assembly to the tissue to be treated via a cable tightening mechanism. 
         FIG. 26B  illustrates a perspective view for another variation for securing the device to the tissue via a squeezable handle. 
         FIG. 26C  illustrates a perspective view for another variation for securing the device to the tissue via a translatable handle. 
         FIG. 26D  illustrates a perspective view for another variation for securing the device to the tissue via a ring handle. 
         FIG. 26E  schematically illustrates the rotational range of movement of the suture delivery assembly for adjustment upon the tissue to be treated. 
         FIG. 26F  schematically illustrates an example of a mechanism for translating an actuation force into a clamping force upon the tissue to be treated. 
         FIG. 27  illustrates a perspective assembly view of another variation of the needle assembly and the respective relative placement. 
         FIG. 28  schematically illustrates an end view of an example of how the needle may be used with a range of tissue sizes. 
         FIG. 29  illustrates a side view of another needle variation having a suture guide. 
         FIG. 30  illustrates a side view of yet another needle variation having a dual piercing tip. 
         FIGS. 31A and 31B  illustrate front and detail side views of another needle variation having a stylet clearance channel and suture guide. 
         FIGS. 32A and 32B  illustrate front and detail side views of another needle variation having a relatively greater angle and needle length. 
         FIGS. 33A and 33B  illustrate front and detail perspective views of a needle variation showing how the suture is pulled through the tissue with the suture guide. 
         FIGS. 34A and 34B  illustrate front and detail perspective views of another needle variation showing a needle having a slot for facilitating the temporary securement and release of the suture through the tissue. 
         FIGS. 35A to 35C  illustrate front and perspective views of another needle variation showing a needle having a flexible suture guidance arm. 
         FIGS. 36A to 36C  illustrate front and perspective views of yet another needle variation of a needle having a split piercing tip. 
         FIG. 37  illustrates a perspective view of another needle variation having a dual piercing and cutting tip. 
         FIG. 38  illustrates a perspective view of yet another needle variation having a cutting edge positioned transversely relative to the needle body. 
         FIGS. 39A to 39C  illustrate alternative perspective views of a suture delivery assembly configured to provide a visual indication of when the needles have completely traversed through the tissue being treated. 
         FIG. 40A  illustrates a variation of the tissue repair assembly having a handle assembly which may be used with either a lengthened or shortened suture delivery assembly. 
         FIGS. 40B and 40C  illustrate perspective views of a tissue repair assembly having either a lengthened or shortened suture delivery assembly coupled. 
         FIGS. 41A to 41C  illustrate respective side, end, and top views of the tissue repair assembly. 
         FIGS. 42A to 42C  illustrate side, end, and exploded assembly views of one variation of the handle assembly. 
         FIGS. 43A to 43C  illustrate detail perspective, side, and end views of one of the connector assemblies to which the handle assembly may be coupled. 
         FIG. 44  illustrates a detail perspective view of the repair assembly with the connector assemblies removed for clarity. 
         FIG. 45  illustrates the needle assemblies with their housing removed for clarity. 
         FIG. 46  illustrates an exploded assembly view of one of the housing assemblies. 
         FIGS. 47A and 47B  illustrate bottom and end views of one of the housing assemblies. 
         FIGS. 48A and 48B  illustrate perspective views of the suture basket which may be positioned within the distal end of the receiving channel. 
         FIGS. 49A and 49B  illustrate side and perspective views of one particular variation of the housing assembly. 
         FIGS. 50A to 50C  illustrate end view of the housing assembly variation having the atraumatic tip and further illustrating the respective positioning of the needle actuation shafts. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Ruptured or torn tendons in particular may be difficult to repair due to the fibrous and relative toughness of these tissues. Additionally, ruptured or torn tendons may be unsupported within the body thus requiring the securement and approximation of the torn edges towards one another. A suture delivery assembly may be sized for insertion through a single incision and positioned into proximity with a damaged or ruptured tissue region. A first portion of the damaged tissue region may be positioned within or along a channel defined along the suture delivery assembly and one or more lengths of suture may be secured to the first portion via the device. A second portion of the damaged tissue region may be similarly positioned within or along the channel and one or more additional lengths of suture may be secured to the second portion via the device. The first and second portions may then be approximated and secured to one another via the sutures to facilitate healing of the damaged tissue region. 
     Although described in reference to the suturing and repair of tendons, particularly the Achilles tendon, the devices and methods described herein may be utilized on other tissue regions. Moreover, examples of such devices and methods of use are further described in detail in U.S. patent application Ser. No. 13/113,505 filed May 23, 2011 (U.S. Pub. 2011/0313454 A1) and U.S. Prov. App. 61/349,025 filed May 27, 2010, each of which is incorporated herein by reference in its entirety for any purpose. 
     Turning now to the perspective view of  FIG. 1 , an example of a tissue repair assembly  10  is illustrated having a handle housing  12  and handle grip  14 . An actuator  16  is actuatable relative to the housing  12  and is operatively coupled to a suture delivery assembly  18  which is designed for percutaneous insertion through an incision. The suture delivery assembly  18  may be sized for subcutaneous placement while contacting the underlying tissue to be treated. Hence, the assembly  18  may have a height, e.g., of less than 2 cm, a width, e.g., of less than 3 cm, and a length, e.g., of less than 7 cm. The suture delivery assembly  18  has an atraumatic distal end and external shell assembly  20  comprised of a first portion of external shell  20 A attachable to a second portion of external shell  20 B both which may surround a needle housing assembly  22 . The suture delivery assembly  18  may be generally configured to define a tissue receiving portion for contacting the tissue to be treated where the tissue receiving portion faces away from the handle housing  12  in one variation, as described below in further detail. 
     The needle housing assembly  22  may be comprised of a first portion of needle housing  22 A and a second portion of needle housing  22 B, in one variation, which may at least partially enclose a needle assembly  24 . The needle assembly  24  itself may be comprised of a first set needles  24 A, e.g., three curved or arcuate needles, which are positioned adjacent to one another and a second set of needles  24 B, e.g., three curved or arcuate needles which are also positioned adjacent to one another. Each of the first set of needles  24 A and second set of needles  24 B may be positioned in apposition to one another such that each needle is staggered relative to one another. Moreover, each of the first and second set of needles  24 A,  24 B may be rotatably positioned within the needle housing assembly  22  to rotate relative to the housing assembly  22  and traverse through the tissue receiving portion for piercing through and passing suture through the contacted tissue, as described in further detail below. 
     In one example of use such as the repair of soft tissue,  FIGS. 2A and 2C  illustrate how the tissue repair assembly  10  may be utilized. In the example of a ruptured or torn tendon such as the Achilles tendon, a single incision  30 , e.g., less than 3 cm in length, may be made in the patient leg P in proximity to or between the torn tissue portions. Because the suture delivery assembly  18  may have a housing volume, e.g., of less than 17 cc to 30 cc, the assembly may be inserted through the incision  30 , e.g., up to an insertion distance of less than 5 cm, such that the tissue receiving channel may contact the first portion of tissue AT 1 , e.g., a proximal portion of a ruptured Achilles tendon. Because the channel diameter may be sized or adjusted, e.g., between 0.5 cm to 2 cm, to accommodate various size tissue diameters, the damaged first portion of tissue AT 1  may be securely retained by the assembly  18  which may pass the needles through the tissue AT 1  to deliver one or more lengths of suture in proximity to the first ruptured segment RP 1 . 
     Once the tissue has been positioned and/or temporarily secured within or against the tissue repair assembly  10 , the handle may be actuated to rotate respective actuation shaft upon which the needles are secured in opposing directions which in turn rotates each of the needle assemblies from within the housing assembly and into and through the tissue. As each of the needles pass through the tissue, they may each pass portions of a common length of suture entirely through the tissue. Moreover, the distal tips of each of needle may rotate through the tissue receiving channel (and through any tissue present) to converge along or in proximity to a common longitudinal axis along the assembly. Once the needles have passed their respective portions of suture through the tissue, a stylet may then pass a terminal suture end (or another length of suture) through each of the suture portions aligned along or in proximity to the common longitudinal axis for further tightening and securement. 
     The manner in which the suture lengths are passed through the tissue and secured may be utilized in each of the variations described herein and are not limited to any particular embodiment.  FIG. 2B  illustratively shows the ruptured first portion of tissue AT 1  with the resulting first suture configuration ST 1  secured to the tissue by the delivery assembly  18 . 
     With the first portion of tissue AT 1  secured, the tissue repair assembly  10  may be removed from the incision  30  and the same suture delivery assembly  18  with additional lengths of suture (or a second assembly) may be re-introduced in the opposing direction through the incision  30  to contact the second portion of tissue AT 2 , e.g., the distal portion of ruptured tendon, as shown in  FIG. 2C . The suture delivery assembly  18  may then be secured to the second portion of tissue AT 2  with the resulting second suture configuration ST 2  in proximity to the second ruptured segment RP 2 , as shown in  FIG. 2D . The suture delivery assembly  18  may then be removed and the terminal ends of the first suture ST 1  and second suture configuration ST 2  may be tied to one another through the incision  30  to approximate and secure the first ruptured segment RP 1  and second ruptured segment RP 2  against one another to facilitate healing, as shown in  FIG. 2E . 
     Various embodiments of the suture delivery assembly and needle housing assembly may be utilized. Another example is illustrated in the perspective view of  FIG. 3  which shows a partial cross-sectional needle housing assembly  22  (for clarity) having a curved outer surface symmetrically configured around a tissue receiving channel  40  which may be semi-circular in cross-section or curved into a receiving portion for contacting and at least partially enveloping the tissue to be sutured. The housing assembly  22  may curve into a flared configured which defines the tissue receiving channel  40  such that the first needle assembly  24 A is aligned along a first side of the housing assembly  22  and the second needle assembly  24 B is aligned along a second side of the housing assembly  22  such that each of the needles are aligned to follow a corresponding needle guide  44 A,  44 B such that the needles may rotate along a curved needle channel  42  within the housing assembly  22 . 
     Although three needles  24 A are shown positioned along the first side of housing assembly  22  and three needles  24 B are shown positioned along the second side of housing assembly  22 , additional needles may also be utilized as practicable depending upon the tissue region to be treated. 
     Each of the needles may be arcuate or otherwise curved, e.g., in a semi-circular manner, such that each of the needles may be positioned entirely within the needle housing assembly  46  during initial insertion and placement within the tissue. The curvature of the needle may allow for the needles to be rotated within a plane which is transverse to a longitudinal axis of the housing assembly  22  such that the needle may be rotated through an angle of needle engagement Θ, e.g., 120° or more, as shown in the partial cross-sectional end view of  FIG. 4A . This allows for the needle proximal end  56  to be driven for the needle piercing tip  54  to be rotated from an enclosed position to one where the distal piercing tip  54  of the needle is advanced through a corresponding needle opening  48  defined along tissue receiving channel  40  and into a needle receiving channel  50 . As the piercing tip  54  passes through the tissue receiving channel  40  along a circular needle trajectory  52 , each piercing tip  54  of each needle may pass a length of suture through the tissue. The position of the housing assembly  22  may be maintained relative to the tissue to be treated via the handle attachment  58 . 
     Another variation of the needle housing assembly  60  is illustrated in the end view of  FIG. 4B  which shows a curved and flared housing assembly  60  with a tissue of interest  66  being treated while positioned along the tissue receiving channel  40 . At least a first needle  62  and a second needle  64  are shown as having been advanced from the housing assembly  60  and rotated through tissue  66  along respective opposing side portions and out through a portion of the tissue between the needles and along the receiving channel  40  while carrying lengths of suture along each needle through the tissue for securement. The tissue receiving channel  40  may be varied in size or adjusted to facilitate temporarily clamping upon the tissue but may generally have a diameter of about 1.25 cm in one variation. Moreover, the diameters of the curved needles may also vary but generally may range anywhere from, e.g., 1 cm to 1.5 cm, in this and other variations. 
     Each of the needles may be advanced simultaneously, e.g., each of the first and second needle assemblies along both sides may be advanced through the tissue at the same time. Alternatively, the needles may be deployed sequentially along either side (e.g., sequentially along a single side) or both sides (e.g., sequentially along alternating sides) or any other number of deployment sequences depending upon the desired sequence of needle deployment. Moreover, the order of needle deployment may be varied in this variation as well as any of the other variations described herein. 
       FIGS. 5A to 5C  illustrate top, side, and end views, respectively, of yet another variation of the housing assembly  60 . The distal end  70  is shown as having an atraumatic blunt end as well as the proximal end  72  which is connected to handle attachment  58  to the housing assembly  60  via attachment  74 . Each of the curved needles may travel along a corresponding needle guide  44 A,  44 B and they may be arranged in a staggered pattern which allows for the distal tips of each needle to cross one another such that the lengths of suture carried by each needle may be secured to one another after being passed through the tissue. The partial cross-sectional end view of  FIG. 5C  illustrates how the needles may be advanced into the tissue receiving channel through respective needle openings  76 ,  78 . 
       FIG. 6A  illustrates a perspective view of yet another variation of the tissue repair assembly with a needle housing assembly  80  which is relatively flat. In this variation, two actuation handles may be used to actuate the needle assemblies. A single actuation handle  82  is illustrated as being attached to needle actuation shaft  84  and a second actuation handle is shown removed from needle actuation shaft  86  for clarity. An exposed actuation assembly  88  is also illustrated on a distal end of the device also for clarity. In this variation, a single stylet  89  which may hold a length of suture, such as a free end of the suture which is passed through the tissue via the needle assemblies, may be advanced through the needle housing assembly  80  and between each of the needle ends after being passed through the tissue. The stylet  89  may thus pass the suture through loops of suture passed through and engaged to the tissue for further tightening and/or securement to the corresponding suture on the apposed damaged tissue. 
       FIG. 6B  shows yet another variation of the needle housing assembly  90  which may have a housing which is relatively smaller in size and width than the variation of  FIG. 6A . In this example, the needle receiving channel  92  is illustrated as housing the first needles  96 A and second needles  96 B positioned in apposition relative to one another.  FIGS. 7A to 7C  illustrate respective top, side, and bottom views of the tissue repair assembly and further shows each of the needles  96 A,  96 B having respective first piercing tips  98 A and second piercing tips  98 B in their deployed configuration where the needles  96 A,  96 B have been rotated from their delivery position from within the housing. With the tissue receiving channel  94  positioned along the bottom of the housing assembly  90  for contact against the tissue to be secured, the first and second piercing tips  98 A,  98 B may rotate through the channel  94  (and through any tissue present) to converge along or in proximity to the common longitudinal axis of the assembly as indicated by the stylet channel  100 . The stylet  89  carrying a suture length may be passed through each respective suture loop carried by each needle passed through the tissue. 
       FIGS. 7D and 7E  illustrate proximal and distal end views of the assembly to show how the one or more handles (only one handle  82  is shown for clarity) may be rotated to actuate the rotation of the respective shafts  84 ,  86  which in turn rotates each of the needles  96 A,  96 B. The convergence of the needle tips along with any lengths of suture carried by the needles may be seen particularly converging upon or in proximity to the stylet channel  100  through which stylet  89  may be translated. 
       FIGS. 8A and 8B  further illustrate detail perspective views of the proximal and distal ends of the assembly. The connection between actuation handle  82  to actuation shaft  84  may be seen while a distal end plate  102  is further shown in  FIG. 8B  with the actuation shafts  84 ,  86  passed through the housing  90 . The range of motion through which the actuation handles may rotate may be adjusted via any number of mechanisms such as by set screws as shown in this variation.  FIGS. 9 and 10  also illustrate perspective and end views of the housing  90  in this variation. The tissue receiving channel  94  is shown as well as the needle guides  44 A,  44 B for each of the needles. The stylet channel  100  is also illustrated defined through the length of the housing  90  where the stylet channel  100  is coincident with the longitudinal axis in proximity to where each of the needle distal tips converges. 
       FIGS. 11A and 11B  illustrate perspective views of the housing  90  where each of the needles is partially deployed. The curved or arcuate needles are shown as having been at least partially rotated from their delivery configuration to their deployed configuration. The needle piercing tips are also shown with a stylet clearance slot  110  defined along each needle body proximal to the piercing tip. The stylet clearance slot  110  provides for passage of the stylet  89  in proximity to the deployed needles when the stylet  89  is used to pass the suture through the suture loops passed by each needle through the tissue, as described in further detail below. 
       FIG. 12  illustrates a perspective view of the needle assembly removed from the housing  90 . The individual needles  96 A,  96 B are shown positioned along their respective needle shafts  84 ,  86 . 
       FIG. 13  illustrates yet another variation of an adjustable housing assembly which has two adjacent housing assemblies  112 A,  112 B defining a tissue receiving channel  114  therebetween. The housing assemblies  112 A,  112 B may be movably adjusted relatively away or towards one another to accommodate various size tissues  66  to be treated. Moreover, the adjustability of the housing assemblies  112 A,  112 B may also allow for the tissue  66  to be stabilized relative to the housing assemblies  112 A,  112 B by temporarily clamping the assemblies upon the tissue  66  while the needles and suture are driven into and through the tissue  66 . 
       FIG. 14  illustrates another variation in the perspective view of tissue repair assembly  120 . This variation utilizes an adjustable dual housing configuration having a first adjustable housing  122 A and a second adjustable housing  122 B which are coupled to one another via one or more biasing members  128 , e.g., one or more springs. Each of the adjustable housing  122 A,  122 B may present a rounded or curved atraumatic outer surface with a first tapered member  124 A positioned upon a distal end of the first housing  122 A and a second tapered member  124 B positioned upon a distal end of the second housing  122 B. The tapered members  124 A,  124 B may present a smooth angled surface to facilitate the insertion of the assembly  120  through the incision and into the subcutaneous tissue space. The proximal end of the housing  122 A,  122 B may have any number of actuatable handles attached although the handles are shown with a respective first handle  126 A and second handle  126 B extending transversely relative to the housing  122 A,  122 B. 
     The adjustable tissue receiving channel  130  may be defined between each of the first and second housing  122 A,  122 B where a force F (such as by manual manipulation by the practitioner) may be applied to press the first and second handles  126 A,  126 B towards one another, as indicated by the direction of force application. Force F applied to the handles  126 A,  126 B may urge the housing  122 A,  122 B to pivot about biasing members  128  away from one another and enable the housing  122 A,  122 B to adjust to accommodate various size tissues positioned along the tissue receiving channel  130 . Because the one or more biasing members  128  may apply a constant biasing force, the housing  122 A,  122 B may clamp upon the tissue within the receiving channel  130  to temporarily secure the tissue and inhibit relative movement between the tissue and housing during needle and suture deployment. 
       FIGS. 15A and 15B  illustrate partial cross-sectional end views of the tissue repair assembly  120  to show how the housing  122 A,  122 B may be adjustable relative to one another as well as to show how the needle assemblies may traverse through the tissue receiving channel  130 . As shown, the needles  96 A,  96 B may be formed to have a curved or arcuate shape, e.g., semi-circular, where the needle body curves into a piercing distal tip from a proximal end which forms a needle support arm  140 A,  140 B configured to extend transversely relative to the needle body. The needle support arm  140 A,  140 B may define an opening through which the actuation shaft passes. During device insertion and placement within the patient, the needles  96 A,  96 B may be retracted into their delivery position where the needles  96 A,  96 B are contained entirely (or at least partially) within their respective housing  122 A,  122 B, as shown in  FIG. 15A . 
     Once the repair device has been inserted in proximity to the tissue region to be treated, the housing  122 A,  122 B may be articulated via actuation handles  126 A,  126 B such that the housing  122 A,  122 B pivots about the one or more biasing members  128  to place the presentation surfaces  146 A,  146 B defining the tissue receiving channel  130  securely around the tissue of interest. With the tissue positioned within the tissue receiving channel  130 , the housing  122 A,  122 B positioning relative to the tissue may be further adjusted, if so desired. Each of the needles  96 A,  96 B may have one or more lengths of suture positioned along each needle body and between each adjacent needle, as described in further detail below. Once the device has been desirably positioned relative to the tissue, the needles  96 A,  96 B may be actuated (simultaneously or sequentially, as described above) such that the needles  96 A,  96 B are rotated by the actuation shafts  142 A,  142 B. The piercing tips of the needles  96 A,  96 B may accordingly exit the needle openings  148 A,  148 B defined along the presentation surfaces  146 A,  146 B and traverse through the tissue receiving channel in a circular curve or arc trajectory, as shown in  FIG. 15B . 
     As the needles  96 A,  96 B traverse through the channel  130  and tissue, the needles may pass the suture loops through the tissue and into proximity to the stylet channels  144 A,  144 B defined longitudinally through respective housing  122 A,  122 B. As previously described, the needles  96 A,  96 B may define a notched or cut-out section as a stylet clearance slot  110  which aligns with the stylet channels  144 A,  144 B when the needles  96 A,  96 B have been fully rotated into their deployed configuration. Once the needles  96 A,  96 B have carried the suture lengths and suture loops through the tissue and into proximity to the stylet channels  144 A,  144 B, the stylet (which carries a length of the suture) may accordingly be passed through the stylet channel  144 A,  144 B to route the suture through the suture loops for further tightening of the suture upon the tissue. Once the suture loops have been passed via the needles  96 A,  96 B, the needles may be retracted proximally back through the tissue and into the housing  122 A,  122 B for disengaging the tissue and subsequent removal of the device from the tissue region. 
       FIGS. 16A and 16B  show partial cross-sectional side views of another variation where the respective housing  122 A,  122 B may be coupled to one another and adjusted accordingly via an adjustable hinge or pivot  150 . The hinge or pivot  150  may allow for the pivotal and/or translational adjustment of the housing  122 A,  122 B relative to one another, as shown in this example. 
     Turning now to  FIG. 17 , an example of how the suture may be routed through the housing and between each adjacent needle is shown in the perspective assembly view. As described herein, each of the needles may carry a length of suture and/or suture loops for passage through the tissue. The suture may be comprised of individual lengths of suture or a single contiguous length of suture may be routed through the housing between each adjacent needle. In this variation, with the needle assembly retracted in its delivery configuration within the housing  122 B, a single length of suture  160  may be routed towards a proximal end of a first needle  162  which may define a suture guide channel  166  along an outer circumference of the needle from where the needle body extends from the needle support arm  164  towards the needle tip  168 . The suture  160  may be guided along this suture guide channel  166  such that the suture  160  extends along the needle body towards a suture guide exit  170  which may comprise a channel or groove along the needle body proximal to the needle tip  168 . Although the suture guide exit  170  is shown as a channel which is transverse to the needle body, other configurations may be utilized. 
     As the needle rotates into its deployed configuration, the suture guide channel  166  and suture guide exit  170  helps to maintain the suture position along the needle body, particularly as the needle and suture passes through the tissue. Moreover, the suture guide exit  170  may help to push the suture  160  through the tissue and then enables the suture  160  to be released from the needle guide exit  170  as the needle is retracted to leave the suture  160  length behind. 
     Once the suture  160  passes through the suture guide exit  170  of first needle  162 , the suture  160  is further routed towards the adjacent second needle  172 . The suture  160  may enter suture guide channel  174  and pass along the needle body towards the suture guide exit  178  of the second needle proximal to the needle tip  176 . The suture  160  may then continue to the adjacent third needle  180  where the suture similarly enters the suture guide channel  182 . As with the second needle  172 , the suture  160  may be routed along the suture guide channel  182  until it passes through suture guide exit  186  proximal to the needle tip  184 . The suture  160  may then be further routed proximally where a terminal end (or a portion) of the suture  160  may be passed along the stylet  89  for passage through the stylet channel and for tightening to the tissue. 
       FIG. 18  illustrates a partial assembly view of another variation of the tissue repair assembly having a dual housing  122 A,  122 B configuration. Each housing  122 A,  122 B is shown extending from a respective first housing support  190 A and second housing support  190 B which are pivotably coupled to one another via a pivot  192 . The first and second housing support  190 A,  190 B may enable the housing  122 A,  122 B to be adjusted relative to one another while the actuation handle may be coupled to the needle actuation shaft  194  for deploying the needle assemblies. 
     Also shown is a single needle  196  having piercing tip  198 . As the shaft is actuated, as indicated by the direction of handle actuation  200 , the corresponding direction of needle actuation  202  illustrates how the one or more needles  196  may be actuated to rotate with shaft  194  to traverse the piercing tip  198  and suture carried by the needle into and through the tissue positioned within tissue receiving channel  130 . This variation illustrates an embodiment where each housing  122 A,  122 B may utilize its own corresponding stylet  89 . For a dual housing embodiment, two individual stylets may be used where the needle assembly within a single housing may converge along its respective stylet channel. A single stylet  89  is shown passing through the stylet channel of second housing  122 B while the corresponding stylet which passes through the stylet channel of first housing  122 A is omitted for clarity only. Hence, each needle assembly within each housing  122 A,  122 B may deploy a separate length of suture which may be tightened against the treated tissue. Alternatively, a single length of suture may pass through both needle assemblies within each housing  122 A,  122 B for deploying a single common suture through both needle assemblies. 
       FIGS. 19A and 19B  illustrate end views of another variation where the dual needle assemblies may converge along a single stylet channel for use with a single stylet. In this example, as the first needle  210 A and second needle  210 B are deployed for passage through the tissue receiving channel  214  and the tissue, the first stylet clearance slot  212 A of first needle  210 A and the second stylet clearance slot  212 B of second needle  210 B may align with one another within the housing  216  with the stylet channel and stylet  89  which may pass through each of the clearance slots of each needle. The stylet  89  may be separated at a distance  218  between the stylet  89  and the tissue receiving channel  214  to ensure that adequate spacing is provided between the tissue surface and the suture loops for tightening. 
     Moreover, as shown in the detail end view of  FIG. 19B , when the stylet clearance slot is aligned with stylet  89 , the suture guide exit  224  proximal to the needle tip  222  may be aligned at a distance from the stylet  89  to ensure that adequate suture-to-stylet separation  226  exists to reduce any risk of the suture  160  catching upon the needle during suture release when the needle with withdrawn proximally. Accordingly, as the suture passes over the suture guide channel  220  along the needle body and exits the suture guide exit  224 , the exiting suture  160  may be separated at a distance from the style  89 . 
     Alternative variations of the needle and suture guide are further shown in the end views of  FIGS. 20A and 20B . In this variation, needle  230  is illustrated as having a stylet clearance slot  232  which provides a relatively deeper recess along the needle body as well as a further separation from the suture guide exit  234  to further move the suture away from the stylet to prevent suture puncturing compared to the needle variation of  FIG. 19B . The clearance between the suture guide exit  234  and the clearance slot  232  may accordingly be increased as desired. 
       FIGS. 21A and 21B  illustrate end and perspective views of yet another needle variation where the needle  240  is provided with a deeper suture groove  246  relative to the needle variation of  FIG. 19B . The suture groove  246  may extend between the suture guide exit  244  and stylet clearance slot  242  to further retain the suture to prevent wedging of the suture between the needle body. 
     Yet another variation is illustrated in the end and perspective views of  FIGS. 22A and 22B  which show a needle variation  250  having an additional side cutout to further provide a path for the suture to prevent wedging of the suture. The suture guide exit  254  may be provided distal to the stylet clearance slot  252  but an additional suture groove  256  may be provided along the needle body proximal to the stylet clearance slot  252 . The suture may be routed along the outer channel of the needle body and then pass through the suture groove  256  towards an inner portion (e.g., towards the inner diameter) of the needle body where the suture may then pass through suture guide exit  254 . Alternatively, the suture may be routed either along the inner diameter or outer diameter of the needle body and pass accordingly through both the suture groove  256  and suture guide exit  254  in an alternating manner. 
     In yet another variation, the needle  260  may be provided with a needle projection  264  proximal to the stylet clearance slot  262 , as illustrated in the end view of  FIG. 23 . The needle projection  264  may be an enlarged portion of the needle body extending from an inner diameter of the needle and may function to guide the suture  160  well around the stylet  89  to prevent or minimize contact between the two. 
     Turning now to mechanisms for needle actuation,  FIG. 24A  illustrates an end view of one variation for rotating actuation shaft  84  to in turn rotate the needle assembly  272  within housing  270 . An actuation handle may be directly coupled to a proximal end of the actuation shaft  84 , as described above, but another variation may utilize a pinion gear  274  attached to a portion of the actuation shaft  84 . A rack  276  attached to an actuation handle may have one or more gear teeth  278  which may be operatively coupled to the gear teeth of pinion gear  274 . As the rack  276  is translated along the direction of translation  280  by the actuation handle, the pinion gear  274  may rotate accordingly to deploy and/or retract the needle assembly depending upon the direction of translation  280 . 
       FIG. 24B  illustrates another variation in the end view of actuation shaft  84 . In this variation, at least one cable  292  may be wound around a pulley  290  attached to actuation shaft  84 . The cable  292  may be coupled to an actuation handle which may pull the cable  292  along the direction of actuation  294  to rotate the actuation shaft  84 . Deployment and/or retraction of the needle assembly will depend upon the direction of cable actuation. 
       FIG. 25  schematically illustrates an example of how a cable assembly may be operatively coupled to an actuation handle for deploying and/or retracting the needle assembly. In this example, the actuation handle  16  may be coupled to a pulley  304  via a shaft  302 . Pulley  304  may have cable  292  attached at one or more attachment points  306 . The resulting coupled pulleys  300  may thus transfer a rotational movement from the actuation handle  16  into a linear translation along the attached cable  292 . The length of the cable  292  may be passed or routed over one or more pulleys  308  to alter the direction of the cable  292  so as to accommodate the configuration of the tissue repair assembly. The cable  292  may be wound or otherwise attached to the actuation shaft  84  via pulley  290 , as described above. As the actuation shaft  16  moves the cable  292  in one of two linear directions, the pulley  290  may rotate accordingly and thus rotate actuation shaft  84  in a corresponding manner to deploy and/or retract the needle assemblies. 
     Aside from the rotation of the needles, the handle assembly  310  may itself be adjustable to facilitate placement and securement of the suture assembly relative to the tissue.  FIG. 26A  illustrates a perspective view of one variation for temporarily securing the handle assembly  310  upon a portion of tissue. In this variation, the suture delivery assembly  312  may define the tissue receiving channel  314  between the housing members. Each housing member may be attached to a first handle portion  316 A and a second handle portion  316 B within a housing. A wire or cable  322  may be attached to each of the handle portions  316 A,  316 B where a first end of the wire or cable  322  is attached to an actuator  318 , shown as a rotatable knob in this variation, and the second end of the wire or cable  322  may be an attached to an attachment point  320  along at least one of the handle portions  316 A,  316 B. 
     Once the tissue has been desirably positioned along tissue receiving channel  314 , the actuator  318  may be rotated in the direction of actuation  324  to tighten the wire or cable  322  and draw the handle portions  316 A,  316 B towards one another and thereby securing the suture delivery assembly  312  upon the tissue region, as indicated by the arrows. 
       FIG. 26B  illustrates another variation where the handle portions  316 A,  316 B may be attached to a respective first scissor handle  330 A and a second scissor handle  330 B which may be rotationally coupled to one another via a pivot  332 . As the scissor handles  330 A,  330 B are squeezed along the direction of actuation  334 , the handle portions  316 A,  316 B may correspondingly clamp upon the tissue region. Movement of the scissor handles  330 A,  330 B in the opposite direction may correspondingly release the handle portions  316 A,  316 B from the tissue region. 
       FIG. 26C  illustrates a perspective view of yet another variation where a handle actuation member  340  may be attached to handle portions  316 A,  316 B. An optional handle  342  may be attached to member  340  such that as the handle  342 , e.g., pulled in the direction of actuation  344 , the member  340  may function to draw handle portions  316 A,  316 B towards one another to secure the assembly onto the tissue region.  FIG. 26D  shows another variation where the handle  342  may be replaced with a ring handle  350 . 
     With respect to the variations shown in  FIGS. 26C and 26D , an example is illustrated in the schematic end view of  FIG. 26E  showing the degree of movement sufficient for securely placing the suture delivery assembly  312  upon the tissue region within tissue receiving channel  314 . The adjustable housing members may move relative to one another when functioning as a clamping mechanism for securing the tissue to be treated. The housing members may thus rotate relative to a rotational point  360  where the rotational radius  362  extends from the rotational point  360  to a longitudinal axis of the tissue repair assembly. The degree of rotation  364  that one housing member may rotationally adjust relative to the remaining housing member may vary to less than about 4 degrees to effectively clamp onto the tissue within tissue receiving channel  314 . 
     To effectuate the rotational adjustment, an example of one mechanism is schematically shown in  FIG. 26F  which may be integrated into the handle assembly of a tissue repair assembly. The handle actuation assembly  370  may incorporate the handle actuation member  340  which is manipulatable by the user. The actuation member  340  may be pivotably coupled to a first member  372 A and a second member  372 B via a respective first pivot  374 A and second pivot  374 B. Each of the first and second members  372 A,  372 B are in turn coupled to a first handle coupling member  376 A and a second handle coupling member  376 B which are also coupled to another via a pivot  378 . The first and second handle coupling members  376 A,  376 B may be attached to a respective housing member such that when handle actuation member  340  is translated, each of the first and second members  372 A,  372 B may be urged along a direction of actuation  380  which in turn forces the first and second handle coupling members  376 A,  376 B towards one another in the direction of handle clamping  382  as they rotate about pivot  378 . This variation is illustrative of one mechanism for actuation the housing assembly while other embodiments are also possible. 
     Turning now to the needle assemblies, another variation is shown in the perspective view of needle assembly  390  where the needles  392  may extend in a curved or arcuate configuration from a corresponding base  394  having a guide  396  which may project radially for alignment through the needle housing. The number and relative positioning of the needles may be varied although the three needles are shown along each side. The needles are illustrated in a staggered and alternating configuration; however, the needles may be more closely aligned such that the needle tips are immediately adjacent to one another. Alternatively, the needles may be arranged in a staggered configuration farther apart from one another depending upon the desired suturing pattern. 
     Regardless of the number of needles used and the relative positioning of the needles, the needles may be configured and positioned relative to the tissue receiving channel such that the needles may penetrate into and through any number of varying tissue sizes. As illustrated in the end view of  FIG. 28 , an exemplary needle body  400  which is curved or arcuate (as described herein) may be positioned to penetrate a range of tissue sizes. Shown are representative cross-sectional views of tissues of varying sizes which are superimposed upon one another for comparison. For example, a tissue having a relatively small diameter such as a tendon  406  having 0.5 cm diameter is shown in comparison to a tendon  408  having 1 cm diameter as well a tendon  410  having 2 cm diameter. Regardless of the tissue size, the tissue may be positioned within the tissue receiving channel such that when the needle is deployed, its piercing tip  402  may enter the tissue through a tissue entry  412  along a side portion of the tissue and pierce through the tissue at a tissue exit  414  located along a top portion of the tissue where the side and top are relative to the tissue position relative to the tissue receiving channel. 
     As shown, the needle may pass a length of suture  160  carried via the suture guide exit  404  entirely through the tissue regardless of tissue size. With the suture  160  passed through, the stylet  89  may be introduced through the suture loop formed by the suture  160  and left when the needle piercing tip  402  is retracted and the suture  160  falls out of the suture guide exit  404 . 
     Alternative variations of the needle distal assembly are illustrated in the side views of  FIGS. 29 and 30 .  FIG. 29  shows a needle  420  having a needle body  422  with a piercing tip  424  and a suture guide exit  426  where the suture guide is formed with a split piercing tip  424 .  FIG. 30  shows a needle  430  having a needle body  432  where the suture guide exit  436  may be formed between a dual-pronged piercing tip  434 . 
       FIGS. 31A and 31B  illustrate end and detail side views of yet another variation of a needle where the needle body  440  may curve from a needle base  448  which is configured to abut the needle actuation shaft. The piercing tip  442  extends along a circumference of the needle with the suture guide exit  446  formed proximal to the tip  442  and extends proximally towards the stylet clearance slot  444  where the clearance slot  444  is defined along an inner circumference of the needle body. The piercing tip  442  may be formed over circumference which may extend, e.g., about 180° relative to the needle base  448 . 
       FIGS. 32A and 32B  illustrate yet another variation where the needle body  450  similarly curves from the needle base  448  but where the piercing tip  442  is formed at a distal end of a needle body  450  which is relative longer than the needle body  440  of  FIG. 31A . The increased angle  454  resulting from the extended needle body  450  may extend, e.g., about 20° more than the needle body  440 . Moreover, the suture guide exit  452  may be formed to extend farther proximally within the needle body  450  than the suture guide exit  446  of  FIG. 31A  to facilitate securement of the suture during passage through the tissue. 
       FIGS. 33A and 33B  illustrate detail end and perspective views of a variation of the needle to show the relative positioning. With the needle  460  pierced through the tissue, suture guide  462  may be seen pushing the suture  160  length through the tissue to create a suture loop when needle  460  is retracted. The stylet clearance slot  464  provides a relatively small recess for the stylet  89  to pass under the suture loop. 
       FIGS. 34A and 34B  illustrate detail end and perspective views of yet another variation where the needle body may form a slot  470  which extends at least partially along the needle from a slot opening  472  at the suture guide exit  462 , through the stylet clearance slot  464 , and partially beyond. In this variation, the stylet  89  may be left in place through clearance slot  464  and the needle  460  may be retracted such that the stylet  89  and/or suture along the stylet passes through slot  470  and out through slot opening  472 . 
       FIGS. 35A to 35C  illustrate detail end and various perspective views of another variation where the needle  460  may incorporate a suture guidance arm  480  which extends transversely from an inner circumference of the needle body such that the guidance arm  480  projects radially inwards relative to the needle  460  curvature. The suture guidance arm  480  may be comprised of a variety of materials which are elastic or flexible, e.g., Nickel-Titanium alloys such as Nitinol, spring stainless steels, etc. The guidance arm  480  may be positioned proximal to the suture guidance exit  462  and project at a distance to form a curved suture receiving segment  482 . With the suture  160  positioned along the suture guidance exit  462 , a portion of the suture  160  may pass along the guidance arm  480  which may keep the suture  160  away from the inner surface of the needle body. 
     As the needle  460  is passed through the tissue with the suture  160 , the suture guidance arm  480  may flex or bend proximally along the needle body but when the guidance arm  480  is free from the constraints of the tissue, the guidance arm  480  may reconfigure itself into its unconstrained configuration (as indicated by the direction of arm movement  484 ) and push the suture  160  out. Likewise, when the needle  460  is retracted proximally through the tissue, the suture guidance arm  480  may flex or bend distally along the needle tip releasing the suture  160  as well as facilitating removal of the needle  460  from the tissue. 
       FIGS. 36A and 36B  illustrate yet another variation in the end and perspective views of a needle  490  which may be formed as having a first retractable petal  492 A and a second retractable petal  492 B which are apposed to one another to form a stylet channel  496 . Each of the petals  492 A,  492 B may be formed from extensions of the needle body which curve outwardly and then taper towards one another joining along a contact surface  494  to collectively form a piercing tip. The stylet channel  496  defined between the petals  492 A,  492 B may be sufficiently sized in diameter to receive a stylet  89  passing entirely through the channel  496 . 
     Moreover, each of the petals  492 A,  492 B may further define a suture guide groove  498  which is defines a curved or arcuate groove or channel for receiving the suture  160 , as shown in  FIG. 36C . Hence, as the needle  490  passes through the tissue, suture  160  may reside over suture guide groove  498  to be pushed through the tissue. With the needle tip and suture  160  residing through the tissue, the stylet  89  may be passed through the stylet channel  496  and the needle  490  may be retracted relative to the stylet  89  and/or stylet suture such that the petals  492 A,  492 B open around the stylet  89  and release the stylet  89  and/or suture from the stylet channel  496  thus leaving the suture loop behind. 
     Yet another variation of the needle is illustrated in the perspective view of  FIG. 37  which shows a needle  500  having a piercing tip as well as a cutting edge  502  formed with a secondary cutting edge  504  proximal to the distal tip. The suture guide  506  and stylet clearance slot  508  may be seen proximal to the cutting edges  502 ,  504 . The cutting edge  502  and secondary cutting edge  504  may be formed such that the cutting edges are planarly aligned with the needle body. Moreover, the cutting edges  502 ,  504  may facilitate the cutting through of the tissue to prevent any elastic effects of the tissue from collapsing the pierced opening. 
       FIG. 38  illustrates a perspective view of yet another needle variation. In this example, the piercing tip may also incorporate a cutting edge  510  where the edge is formed transversely relative to the needle body. Having the transverse cutting edge  510  may prevent the tissue during needle retraction from catching on the suture guide exit  506 . Additionally, a sharpened tip  512  may also be incorporated along the suture guide exit  506  to further cut and minimize any tissue that might otherwise catch on the suture guide exit  506 . 
     In yet another variation of the tissue repair assembly,  FIGS. 39A to 39C  show alternative perspective views of a suture delivery assembly  520  which may be configured to provide a visual indication of when the needles have completely traversed through the tissue being treated. The assembly  520  includes first and second housing  522 A,  522 B which may be attached to a respective first and second housing support  524 A,  524 B which are in turn attached to one another via pivot  526 . An adjustment member  534  such as a knob may be provided at pivot  526  to tighten to adjustably maintain a position of the first and second housing supports  524 A,  524 B, e.g., when the housing  522 A,  522 B are to be secured upon the tissue region to be treated along tissue receiving channel  528   
     A respective first and second stylet channels  530 A,  530 B may be defined along a proximal surface of each of the housing  522 A,  522 B through which the respective stylets may be inserted and advanced, as previously described. A first and second rotational stylet guide  532 A,  532 B may be coupled to respective needle actuation shafts and may each define an opening, groove, or channel along a periphery of the guide  532 A,  532 B, as shown in the perspective view of  FIG. 39B . As the needle shafts rotate, the guides  532 A,  532 B may rotate accordingly and align with the respective channels  530 A,  531 B when the needles have passed entirely through the tissue. When the guides  532 A,  532 B have aligned with their respective channels  530 A,  530 B, this may serve as an indicator and confirmation to the practitioner that the assembly  520  is ready to receive the stylets for tightening of the delivered suture lengths. 
     Additionally and/or alternatively, one or more locking screws  536  (or other mechanism) may be provided along either the first or second housing support  524 A,  524 B to provide for manual adjustment of the assembly  520  relative to the tissue. Moreover, each of the guides  532 A,  532 B and/or respective needle actuation shafts may also be adjusted manually as well, e.g., by engaging the guides  532 A,  532 B with an instrument and rotating manually for adjusting one or both the guides, as shown in the perspective view of  FIG. 39C . 
     In yet another variation of the tissue repair assembly,  FIG. 40A  shows a variation of the tissue repair assembly  540  having a handle assembly which may be used with either a lengthened suture delivery assembly  542  (e.g., having an opening length to accommodate 1.5 cm of tissue) for use on the superior tissue portion and a shortened suture delivery assembly  544  (e.g., having an opening length to accommodate 0.75 cm of tissue) for use on the inferior tissue portion connected to the heel of the patient. The suture delivery assembly  542  or  544  may each be coupled to the assembly with a respective first and second connector  556 A,  556 B which may allow for the secure attachment and/or detachment of the suture delivery assembly  542  or  544 . 
     This variation may also provide for an actuation handle assembly  554  which is coupled along a side portion of the assembly  540  so that the practitioner may view the incision and tissue during a repair procedure without the handle assembly obstructing the view. The suture delivery assembly  542  or  544  may be attached to a respective first connector assembly  546  and second connector assembly  548  which are adjustably coupled to one another via an adjustment shaft  550  extending between the two. An adjustment control  552  may be actuated or manipulated at the discretion of the practitioner to adjust a distance between the connectors  546 ,  548  which may also control or adjust a relative width between each of the housing members for placement and securement over the tissue to be treated. Once the width between the housings of the suture delivery assembly has been desirably adjusted and secured upon the treated tissue length, the handle assembly  554  may be actuated to urge the needle assemblies positioned within the suture delivery assembly to rotate and pass through the tissue secured temporarily between the suture delivery assembly. 
       FIG. 40B  shows a perspective view of the tissue repair assembly  540  having the lengthened suture delivery assembly  542  attached via connectors  556 A,  556 B to the respective connector assemblies  546 ,  548 . Similarly,  FIG. 40C  shows a perspective view of the tissue repair assembly  540  having the lengthened suture delivery assembly  542  disconnected and the shortened suture delivery assembly  544  attached instead. Hence, the practitioner may first secure the suture to the proximal tissue length to the treated by using the tissue repair assembly  540  having the lengthened suture delivery assembly  542 . Then the practitioner may decouple the lengthened suture delivery assembly  542  and replace it with the shortened suture delivery assembly  544  for securing the suture to the distal tissue length. The suture lengths may then be tensioned to approximate the torn or damaged tissue ends towards one another and the suture may then be secured to one another once the tissue ends have been suitably positioned in proximity to one another. 
     Alternatively, the shortened suture delivery assembly  544  may be utilized first with the tissue repair assembly  540  to secure the distal tissue length and then the lengthened suture delivery assembly  542  may be utilized to subsequently secure the proximal tissue length. In yet another alternative, the lengthened suture delivery assembly  542  may be used along the distal tissue length while the shortened suture delivery assembly  544  may be used along the proximal tissue length. In yet another alternative, the lengthened suture delivery assembly  542  may be used for both the distal and proximal tissue lengths or the shortened suture delivery assembly  544  may be used along for both the tissue lengths. Other contemplated variations may also be utilized with one or both of the respective suture delivery assemblies  542 ,  544  in other examples. 
       FIGS. 41A to 41C  illustrate respective side, end, and top views of the tissue repair assembly  540  illustrating the connector assemblies  546 ,  548  and attached suture delivery assembly  542 . A connector shaft  558  adjacent to the adjustment shaft  550  may also be seen extending between the connector assemblies  546 ,  548  to facilitate the translation of the assemblies  546 ,  548  relative to one another. The end and top views of  FIGS. 41B and 41C  in particular illustrate how the handle assembly  554  may be aligned to be in parallel with the connector assemblies  546 ,  548  such that the view of the suture delivery assembly  542  remains visually unobstructed for facilitating the procedure. 
     When the tissue repair assembly  540  is actuated into its widened configuration, it may have an extended width W, e.g., about 3.5 in. The width of the adjustable tissue receiving channel  560  may be accordingly adjusted via actuation of adjustment control  552  depending upon the width of the tissue to be treated. The length of the assembly  540  may also vary depending upon whether the shortened or lengthened suture delivery assembly is connected. When the lengthened suture delivery assembly  542  is coupled, the assembly  540  may have an extended length L, e.g., about 5.4 in. Also, the height H between the connector assemblies  546 ,  548  and the height of the handle assembly  554  may have a height H, e.g., about 5.9 in., but this may be adjusted accordingly. 
     An example of the handle assembly  554  is shown in the side, end, and exploded assembly views of  FIGS. 42A to 42C . While the handle assembly  554  may be configured in a number of different embodiments, this particular variation illustrates a first and second handle  570 A,  570 B which may be similarly shaped and sized adjacent to one another with a trigger handle  572  rotatingly positioned between handles  570 A,  570 B. The trigger handle  572  may be coupled to the handles  570 A,  570 B via a pivot  574  at a first end of the handle assembly  554  and slidingly coupled at a second end of the handle assembly  554 . The adjustment shaft  550  may be coupled to both handles  570 A,  570 B and connector shaft  558  may be positioned in proximity to the handle assembly  554 . In use, when the needle assembly is ready to be actuated for passage into the tissue, the trigger handle  572  may be actuated relative to the first and second handles  570 A,  570 B to rotate a transverse shaft through the tissue repair assembly which in turn may rotate the needle actuation shafts and needles through the tissue, as described in further detail below. 
       FIGS. 43A to 43C  show detail perspective, side, and end views of one of the connector assemblies to which the handle assembly  554  may be coupled. As shown in the perspective view of  FIG. 43A , the connector assembly  548  may generally comprise a body having a length (e.g., about 3.94 in.), width (e.g., about 0.85 in.), and height (e.g., about 0.71 in.) which further comprises an angled connector  582  which extends and defines an opening  584  through which a needle actuation shaft may pass through. The connector assembly  548  may define a receiving channel  580  within which a bevel gear  586  may be rotatably secured upon a proximal end of a rotational shaft  588  which extends through the length of the assembly  548 . The bevel gear  586  may be aligned longitudinally to rotate about the shaft  588  and a distal end of the shaft  588  may be attached to a yoke  592  which in turn may be attached to a coupling  590 , as shown in the side view of  FIG. 43B . The yoke  592  may allow for the rotation of the shaft  588  to be transferred to the coupling  590  through the angled connector  582 . A transversely aligned bevel gear  594  may also be positioned at least partially within the receiving channel  580  such that the transversely aligned bevel gear  594  is operatively connected to the bevel gear  586 , as shown in the end view of  FIG. 43C . 
       FIG. 44  shows a detail perspective view of the repair assembly with the connector assemblies removed for clarity. Once the first housing assembly  602 A and second housing assembly  602 B of suture delivery assembly  600  have been desirably secured upon the tissue length to be treated, the handle assembly  554  may be actuated to rotate transverse shaft  604  about its axis, as illustrated. With the rotation of the transverse shaft  604 , the respective transverse bevel gears  594 A,  594 B attached to shaft  604  may rotate and engage the corresponding bevel gears  586 A,  586 B to transfer the rotational movement from transverse shaft  604  to rotational shafts  588 A,  588 B coupled to the respective bevel gears  586 A,  586 B. 
     The respective yokes  592 A,  592 B may accordingly rotate in opposing directions relative to one another and in turn rotate the attached couplings  590 A,  590 B. The couplings in turn may actuate the respective first and second needle actuation shafts  606 A,  606 B and first and second needle assemblies  608 A,  608 B, as shown in the perspective view of  FIG. 45  which illustrates the needle assemblies with their housing removed for clarity. 
       FIG. 46  shows an exploded assembly view of one of the housing assemblies  602 A. The housing  610  is shown defining tissue receiving channel  636  with an atraumatic tip or nose cone  612  at its distal end. A suture basket  614  may be positioned within a distal end of the receiving channel  636 , as also shown in the bottom view of  FIG. 47A . With the needle actuation shaft  618  positioned through the length of the housing  610 , the needles  608 A (three needles shown in this variation) may be positioned along the actuation shaft  618  spaced at uniform distances from one another while a first and second spacer  616 ,  620  may also be positioned along the actuation shaft  618  between the needles  608 A. In this variation, the needles  608 A may be spaced at a distance S 1 , S 2  from one another (e.g., 0.59 in. each). However, in other variations, the number of needles may be decreased or increased and the spacing between needles (if two or more are used) may also be uniform or arbitrary depending upon the desired results. 
     The connector  622  for coupling to the connector assembly may be secured at the proximal end of the housing  610  and two or more securement shafts  624 ,  626  may be positioned along either side of the housing  610  for securing the components of housing  610 , as shown in the bottom and end views of  FIGS. 47A and 47B . A stylet  628  may be seen positioned for insertion through the housing  610 , as previously described above, while stylet catch  638  may also be incorporated within the housing  610  or suture basket  614 . 
     The suture basket  614  which may be positioned within the distal end of the receiving channel  636  is shown in further detail in the perspective views of  FIGS. 48A and 48B . The basket  614  shows the member having a C-shaped configuration which defines a suture receiving channel  630  around an actuation shaft receiving channel  632 . A stylet opening  634  may be further defined through one or both ends of the basket  614 . 
     One particular variation of the housing is illustrated in the side and perspective views of  FIGS. 49A and 49B . As shown, the one or more needles  640 A may be aligned within the receiving channel  636  but the needle actuation shaft  642  may be offset to lie along one of the edges of the receiving channel  636 . 
       FIG. 50A  shows an end view of the housing  610  having the atraumatic tip  612  while  FIG. 50B  illustrates the needles  640 A positioned in its low-profile configuration. With the needle actuation shaft  642  positioned along an edge of the receiving channel  636 , because the actuation shaft  642  is no longer centrally located relative to the needle  640 A but is instead positioned along the periphery, rotating of the actuation shaft  642  results in a rotation of the needle  640 A which is eccentric relative to the housing  610 . This eccentric path of the needle tip allows for a greater purchase of tissue T within the same given volume, as shown in the end view of  FIG. 50C , and also more closely replicates natural human suturing motion. 
     In one variation, the eccentric positioning allows for a cross-sectional area of tissue T purchased by the needle to exceed, e.g., 12-13.5 mm 2  or more. For instance, utilizing a single suture length with three suture loops with a desired pull strength of 22 lb through a cross-sectional area of tissue of, e.g., 6.3 mm 2 , may be insufficient while a similar suturing configuration through a cross-sectional area of tissue of at least, e.g., 9.4 mm 2 , may provide for a sufficient amount of tissue to result in a pull strength of 22 lb. Having the increased amount of tissue T pierced and retained by the needle  640 A may allow for such an increased tensile force in the resulting suture configuration. 
     The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.