Patent Publication Number: US-2017347997-A1

Title: Suture Passer Needle

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/346,664, filed on Jun. 7, 2016, the entire contents of which are hereby incorporated by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to surgical suturing devices and methods by which suture may be passed through tissue during surgery, and, more particularly, to an improved blade of a suture passer needle. 
     BACKGROUND 
     Suturing is a simple procedure when it is performed on external tissues because the needle and suture can be easily manipulated. However, in endoscopic or other minimally invasive surgical procedures that require suturing of internal tissues, access to the suturing area is limited and this limits the ability to manipulate the needle and suture. Instruments and methods for suturing remotely are especially important in these minimally invasive surgical procedures such as laparoscopic and endoscopic procedures. 
     Minimizing the steps and instrument manipulation required to pass a suture through an internal tissue body and reliably retrieve the suture for subsequent manipulation may result in more streamlined and reliable surgical procedures, shorter surgery duration, and improved patient outcomes. In addition, reduction of the number of access cannulas or instrument ports necessary to perform a procedure will result in decreased tissue trauma. Accordingly there is a need to minimize the number of steps, the repositioning of instruments, and the number of access points during endoscopic suturing procedures. 
     Systems exist that address this need. For example, U.S. Pat. No. 8,177,796 is directed to surgical suturing devices and methods by which suture may be passed through tissue during surgery. The surgical suturing devices include, in part, a suture passer  100  with a needle  250 . See, e.g., FIGS. 1, 3A-3C, 10A-10B and 11D. As shown, the needle  250  includes, in part, a blade  256 , notch  260 , a side cutout proximal to the notch, and an offset point  258 . 
     Turning to  FIG. 1A , a schematic representation of an alternative conventional blade  256 ′ is shown. Blade  256 ′ is part of and works in conjunction with an alternative conventional surgical suturing device, as should be understood by a person of skill in the art in conjunction with a review of this disclosure (although, the alternative conventional surgical suturing device is similar in several respects to suture passer device  100  of U.S. Pat. No. 8,177,796 including the general movement of the blade in the device, i.e., movement in the distal direction followed by movement in a direction at an angle to the distal direction to an extended position as discussed briefly below). Blade  256 ′ has a centered point  258 ′, as opposed to an offset point  258  of blade  256 , and does not have a side cutout. The centered point is intended to allow the needle to move in a straight line thought tissue. 
     However, when either blade  256 ,  256 ′ is moved to an extended position through a window/jaw of its respective surgical suturing device, it is subject to a relatively large compression load on the notch  260  upon making an approximately 90 degree turn from moving in the distal direction (as shown, for example, in FIGS. 10A, 10B and 11D). This compression load on the needle can weaken, break or crack the blade  256 ,  256 ′. 
     Turning to  FIG. 1B  of the instant disclosure, a schematic representation of the alternative conventional blade  256 ′ of the alternative conventional surgical suturing device is shown in a partially deployed position through the device&#39;s jaw/window (the window is not shown in this Figure in order to show an unobstructed blade  256 ′). Areas of high strain  261  are shown on blade  256 ′ near the notch  260 . The region distal of the notch  261  is in a portion of the jaw/window where the curvature, and thus pressure and strain on the blade  256 ′, is high. However, the blade  256 ′ remains straight relative to the material near the notch. Accordingly there is a need to minimize the stress/strain placed on the blade  256  and to decrease the breakage/crack formation when it is moved to an extended position through the window. 
     Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Background Section or elsewhere in this Application, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/products are discussed above in this Background Section and/or throughout the application, the descriptions/disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies). 
     SUMMARY OF THE INVENTION 
     The present disclosure is directed to inventive devices and methods for passing suture through tissue during surgery. Various embodiments and implementations herein are directed to an improved blade of a needle of a surgical suturing device. The blade can be designed to be more flexible, bend more evenly, have reduced stress/lowered compression load on the distal tip near the notch as compared to conventional surgical suturing device blades upon deployment through a jaw/window at a distal end of the device. This functionality can be accomplished by removing material from the blade proximately and/or distally of the notch in the blade, as further discussed in the Detailed Description of the Embodiments section below in conjunction with the referenced Figures. Further, the blade can include non-linear edge portions leading to a distal point or tip. The non-linear edge portions can include a radius of curvature that can be the same or can be different from each other. 
     In one embodiment, the suture passer needle can include a first side, a second side, and a blade disposed at a first (e.g., distal) end of the needle. The blade has a first edge extending from the first side of the needle and a second edge extending from the second side of the needle, each of which converge to a tip of the blade (which can be centered or offset). A notch is disposed in the blade and forms an opening in the first side of the blade. The blade can also have one or more cutout portions distal and/or proximal to the notch, which are configured to minimize the stress and strain placed on the blade while in use. The cutout portions are preferably completely surrounded by a portion of the body of the blade. 
     In an alternative embodiment, the notch of the previously described suture passer needle can have a distal end and a proximal end. The distal end of the notch converges to a point with the first edge of the blade. Further, the first edge and the second edge of the blade are both nonlinear, can be curved, and can preferably have an equal radius of curvature (but do not need to have an equal radius of curvature, i.e., one edge can have a radius of curvature larger than the other). 
     In another embodiment, the suture passer needle can be incorporated into a surgical suturing device (or suture passer device). The system can include a jaw member disposed at a distal end of a suturing apparatus, which has an aperture extending therethrough. The suture passer needle can be extended through the aperture of the suturing apparatus to carry a portion of suture through the aperture. The system can also include a capture feature formed on the distal end of the suturing system, which is actuatable to releasably grip and retain suture. The suturing system can be actuatable by a single actuation of an actuation mechanism to move the needle through a tissue body and the aperture, and to actuate the capture feature to firmly and releasably grip the portion of suture after the portion of suture has been carried by the needle through the tissue body and the aperture. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments. 
       Reference is now made briefly to the accompanying drawings, in which: 
         FIG. 1A  is a schematic representation of an alternative conventional blade of an alternative surgical suturing device; 
         FIG. 1B  is a schematic representation of the alternative conventional blade in a partially deployed position through a jaw/window of the alternative surgical suturing device; 
         FIG. 1C  is a schematic representation of the SPECTRUM® AUTOPASS™ suture passer; 
         FIG. 2A  is a schematic side view representation of an improved blade of a surgical suturing device according to an embodiment; 
         FIG. 2B  is a schematic side view representation of an improved blade of a surgical suturing device according to an embodiment; 
         FIG. 3A  is a schematic side view representation of an improved blade of a surgical suturing device according to an alternative embodiment; and 
         FIG. 3B  is a magnified schematic representation of the embodiment shown in  FIG. 3A . 
     
    
    
     Where applicable, like reference characters designate identical or corresponding components and units throughout the several views, which are not to scale unless otherwise indicated. Moreover, the embodiments disclosed herein may include elements that appear in one or more of the several views or in combinations of the several views. 
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Embodiments of the improved blade  100  of a needle, described with respect to  FIGS. 2A and 2B  herein, and an improved blade  300  of a needle, described with respect to  FIGS. 3A and 3B , are designed to be a part of and be used in conjunction with surgical suturing devices (or suture passer devices) such as the SPECTRUM® AUTOPASS™ suture passer (as should be understood and appreciated by a person of ordinary skill in the art in conjunction with a review of this disclosure), the structure and design of which is incorporated by reference herein in its entirety. For example, the SPECTRUM® AUTOPASS™ suture passer  400  shown in  FIG. 1C  includes, generally, a jaw member  402  at a distal end of the suture passer  400 , a needle  408  which can be retracted and extended through the jaw member  402  relative to the distal end of the suture passer  400 , and a capture feature  404  on the distal end of the suture passer  400 , which is actuatable to releasably grip and retain suture. Upon a single actuation of an actuation mechanism  406 , the needle  408  moves from a retracted position to an extended position through the aperture of the jaw member  402  and the tissue body. Certain aspects such as the proximal and distal “cutout” portions can also be incorporated into blade  256  as described and shown in U.S. Pat. No. 8,177,796 (as should be understood and appreciated by a person of ordinary skill in the art in conjunction with review of this disclosure), which is incorporated by reference herein in its entirety. The descriptions of the positioning and use of needle  250  and blade  256  in U.S. Pat. No. 8,177,796 can generally apply to the embodiments of the improved blade portions of a needle described herein, and only the improved structure of the embodiments of the improved blade and resultant functionality will be additionally described herein. 
     Referring to  FIG. 2A , in one embodiment, a schematic side view representation of an improved blade  100  of needle  250  (shown and described in U.S. Pat. No. 8,177,796) is shown. The blade  100  can include, but is not limited to, a notch  102 , and a plurality of “cutout” portions—distal cutout portion  104  and proximal cutout portion  106  (“distal” and “proximal” with respect to the notch  102 ). The cutout portions ( 104 ,  106 ) can be formed by first forming the blade  100  and then removing material from the blade  100 , or the blade  100  with the cutout portions ( 104 ,  106 ) can be formed in the first instance per a molding procedure (as should be understood by a person of skill in the art in conjunction with a review of this disclosure). The actual geometry and size of the region or regions of removed material may vary, and it can be optimized based on application and the geometry of the device it interacts with (as should be understood by a person of skill in the art in conjunction with a review of this disclosure). Blade  100  is also shown with a centered point  258 ′, as opposed to an offset point  258  of blade  256 , and does not have a side cutout (although, Blade  100  can include an offset point). Blade  100  (and blade  300 , described below) can be made from any material with sufficient ability to bend at an angle within the suture passer (as described herein), and with enough stiffness to pierce and be pushed through tissue (as should be appreciated by a person of skill in the art in conjunction with a review of this disclosure) including steel, plastics, or other shape memory or super-elastic materials. In a particular example, blade  100  (and blade  300 ) can be made from nitinol (a nickel-titanium alloy with shape memory and super-elastic properties). 
     Referring to  FIG. 2B , in another embodiment, a schematic side view representation of an improved blade  100  of needle  250  is shown. The blade  100  shown in  FIG. 2B  includes only a distal cutout portion  104 . Alternatively, blade  100  could have only a proximal cutout portion  106 , or a plurality of proximal cutout portions  106  and/or a plurality of distal cutout portions  104 . 
     Providing the cutout portions ( 104 ,  106 ) on the interior of the blade  100  without disrupting the outer surface, as opposed to the blade shown in U.S. Pat. No. 8,177,796, has the particular advantage of not changing the primary contact surfaces that interact with the surgical suturing device. Removing material from the outer edges can cause the needle to deflect side-to-side in the surgical suturing device, to catch on surfaces of the device and get stuck/jammed, or to be deflected by tissue when it is used with the device. 
     In both  FIGS. 2A and 2B , the notch  102  is formed through a first side  108  of the blade  100 . The tip of the blade  100  has a first edge  110  that converges with the first side  108  at a point (P). Similarly, the tip of the blade  100  has a second edge  114  that converges with a second side  112  of the blade  100 . As depicted in the embodiment shown in  FIGS. 2A-2B , the first side  108  of the blade  100  converges with the first edge  110  of the tip of blade  100  at a point (P) distal with respect to the notch  102 . 
     Referring now to  FIGS. 3A-3B , there are shown schematic representations of an alternate embodiment of a blade  300  of needle  250 . Similar to the embodiments shown in  FIGS. 2A-2B , the blade  300  comprises a first side  308 , which is opposite a second side  312  of the blade  300  and comprises a notch  302  having an opening for receiving suture material. A first edge  310  extends from the tip of the blade  300  to a distal end (T) of the first side  308  of the blade  300 . Similarly, a second edge  314  extends from the tip of the blade  300  to a distal end (S) of the second side  312  of the blade  300 . In the embodiment shown in  FIG. 3A , the first edge  310  can be non-linear and include a radius of the curvature that can be equivalent to a radius of the curvature of the second edge  314 . 
     As previously discussed, the distal ends (S, T) are located opposite each other on their respective sides of the blade  300 . The notch  302  on the first side  308  of the blade  300  is positioned proximal to the distal end (T) of the first side  308  of the blade  300  and extends to the distal end (T) of the first side  308  of the blade  300 . The notch  302  also extends to a proximal end (R) positioned on the first side  308  of the blade  300  proximal to the opening of the notch  302 . When viewed along an axis extending from a proximal end to a distal end of the blade  300  in a direction toward the needle tip, proximal end (R) and distal end (T) are aligned in that direction along the first side  308  of the blade  300 . Stated differently, distal end (T) and proximal end (R) extend the same distance in a perpendicular direction from a central longitudinal axis extending along the length of the blade  300 . Cutout portions ( 104 ,  106 ) as shown in  FIGS. 2A-2B  can be incorporated into the blade  300  shown in  FIGS. 3A-3B  (as should be understood and appreciated by a person of ordinary skill of the art in conjunction with a review of this disclosure). 
     While embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements.