Patent Publication Number: US-7223229-B2

Title: Surgical instruments

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 10/274,524, filed Oct. 17, 2002, now U.S. Pat. No. 7,037,255, which is a continuation-in-part of U.S. patent application Ser. No. 09/917,445, filed Jul. 27, 2001, now U.S. Pat. No. 6,802,807; U.S. patent application Ser. No. 10/005,837 now abandoned, filed Nov. 9, 2001 and Design patent application Ser. No. 29/160,922 now abandoned, filed May 16, 2002; and claims priority to U.S. Provisional Application Ser. No. 60/343,658, filed Oct. 24, 2001; and U.S. Provisional Application Ser. No. 60/336,884, filed Nov. 2, 2001; and U.S. Provisional Application Ser. No. 60/347,494, filed Jan. 11, 2002. The entire contents of all of these provisional, utility and design patent applications are herein incorporated by reference. 
    
    
     BACKGROUND 
     Surgical centers and hospitals have stocks of surgical instruments commonly used in surgery for treating pelvic floor disorders. In the urology field, needles, suture passers and ligature carriers are commonly available. Examples of such surgical instruments include Stamey needles, Raz needles, and Pereyra needles. See Stamey,  Endoscopic Suspension of the Vesical Neck for Urinary Incontinence in Females , Ann. Surgery, pp. 465–471, October 1980; and Pereyra,  A Simplified Surgical Procedure for the Correction of Stress Incontinence in Women , West. J. Surg., Obstetrics &amp; Gynecology, pp. 243–246, July–August 1959. 
     A pubovaginal sling procedure is a surgical method involving the placement of a sling to stabilize or support the bladder neck or urethra. There are a variety of different sling procedures. Descriptions of different sling procedures and surgical articles used therein are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686; 6,042,534 and 6,110,101. 
     Some prior art needles include a metal needle and an integral metal handle. Some users consider such needles to be top heavy or imbalanced. During some surgical procedures, the needles may be partially inserted in the body and released, as the surgeon concentrates on a different aspect of the surgery. In such instances a top heavy needle may deflect or deviate from its intended placement, potentially damaging tissue or causing other undesirable consequences. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a surgical instrument. The surgical instrument is particularly suitable for addressing pelvic disorders. 
     The surgical instrument includes a handle, and an elongate, preferably curved rod with a distal tip. The length of the rod is preferably between about 6 inches and about 12 inches. The height of the handle is preferably between about 3.25 inches and about 4.75 inches. Preferably, the rod comprises stainless steel and at least one material comprising the handle is a polymer with a density less than the stainless steel density. 
     The handle has a major anterior surface, preferably situated to face a surgeon with the rod extending generally toward the surgeon, a major posterior surface and minor side surfaces. 
     Preferably, the handle has a height more than forty percent of the length of the rod and less than eighty percent of the length of the rod, and the depth of the handle is less than the height of the handle. 
     In curved embodiments, the rod has a radius that is between 4.5 and 5.5 inches. Preferably, the distal tip is substantially blunt. 
     The major anterior surface of the handle preferably includes an elongate channel extending across the width of the handle. Preferably, the anterior surface of the handle has at least four tactile surfaces. In embodiments that include the channel, the tactile surfaces are preferably located distal to the elongate channel. 
     The major posterior surface of the handle preferably includes an elongate depression having an axis that extends substantially parallel to the longitudinal axis of the handle. The anterior surface also preferably has a plurality of tactile surfaces extending in a direction substantially perpendicular to the longitudinal axis of the handle. 
     The handle preferably includes a flare at a proximal end portion. In embodiments with the flare, the major posterior surface includes a substantially concave surface and the major anterior surface includes a substantially convex surface. 
     In a preferred embodiment, at least two thirds of the exterior surface of the elongate rod includes a surface treatment. This can comprise a sandblasted surface. 
     In another aspect, the present invention comprises the ornamental design for a handle for a surgical instrument, as shown in  FIGS. 8 through 14  and described in the Brief Description of the Drawings. 
     The handle may be molded with a single polymeric material. Alternatively, the handle may comprise a plurality of different polymeric materials. Also optionally, the handle may comprise a metal or metal components (e.g. an insert, or a straight portion of the rod). 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other features and advantages of the present invention will be seen as the following description of particular embodiments progresses in conjunction with the drawings, in which: 
         FIG. 1  is a perspective view of the surgical instrument according to the present invention; 
         FIG. 2  is a right side view of the surgical instrument of  FIG. 1 , showing a side surface of the handle; 
         FIG. 3  is a left side view of the surgical instrument of  FIG. 1 , showing a side surface of the handle; 
         FIG. 4  is a top view of the surgical instrument of  FIG. 1 , showing a major anterior surface of the handle; 
         FIG. 5  is a bottom view of the surgical instrument of  FIG. 1 , showing a major posterior surface of the handle; 
         FIG. 6  is a front end view of the surgical instrument of  FIG. 1 ; 
         FIG. 7  is a rear end view of the surgical instrument of  FIG. 1 ; 
         FIG. 8  is a perspective view of a design of a handle for a surgical instrument according to another aspect of the present invention; 
         FIG. 9  is a right side view of the design of a handle for a surgical instrument of  FIG. 8 ; 
         FIG. 10  is a left side view of the design of a handle for a surgical instrument of  FIG. 8 ; 
         FIG. 11  is a top view of the design of a handle for a surgical instrument of  FIG. 8 ; 
         FIG. 12  is a bottom view of the design of a handle for a surgical instrument of  FIG. 8 ; 
         FIG. 13  is a front end view of the design of a handle for a surgical instrument of  FIG. 8 ; 
         FIG. 14  is a rear end view of the design of a handle for a surgical instrument of  FIG. 8 ; 
         FIG. 15  is a side view of another embodiment of a surgical instrument according to the present invention; 
         FIG. 15A  is a rear view of the instrument of  FIG. 15 ; 
         FIG. 16  is a sectional view taken approximately along lines  16 — 16  of  FIG. 15 ; 
         FIG. 17  is another cross section for another embodiment of surgical instrument according to the present invention; 
         FIG. 18  is another cross section for another embodiment of surgical instrument according to the present invention; 
         FIG. 19  is another cross section for another embodiment of surgical instrument according to the present invention; and 
         FIG. 20  is another cross section for another embodiment of surgical instrument according to the present invention. 
     
    
    
     The broken line showing of a needle and surface structures on the design of the handle in  FIGS. 8 through 14  are for illustrative purposes only and form no part of the claimed design. 
     DETAILED DESCRIPTION 
     The following description is meant to be illustrative only and not limiting. Other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description. 
     The present invention is directed to surgical instruments for treating pelvic floor disorders such as incontinence or stress urinary incontinence (SUI) in both men and women. Although the invention as disclosed herein generally refers to SUI, the surgical instruments may be used for treatment of other urological or gynecological disorders, such as prolapse (e.g. vaginal and uterine), enteroceles (e.g. of the uterus or small bowel), rectoceles, cystoceles and other disorders are also included within the scope of the present invention. The present invention is particularly suitable for use in conjunction with concomitant procedures, such as, but not limited to, procedures for addressing cystocele, rectocele, vaginal prolapse and anatomic corrections. 
     Referring now to  FIGS. 1–7 , there is shown a preferred embodiment of surgical instrument  10  according to the present invention. The surgical instrument  10  comprises a handle  12  having a width W, height H and depth D, and an elongate, slender, metal, curved rod  14 . The rod  14  emerges from the handle  12 , and has a proximal end portion permanently fixed within the handle  12 . By slender, it is meant for example, for the embodiments of the present invention with a circular cross sectional shape (e.g. see  FIG. 16 ), the major portion of the rod  14  along its length has a diameter less than about 4 mm, more preferably about 3.2 mm. The handle  12  is preferably rigidly or permanently affixed to the rod  14 . 
     The rod  14  preferably has a curved axis, and a distal end portion  16 . The distal end portion  16  preferably has a substantially blunt distal tip  17 . As used herein, when it is said that the rod  14  is curved or has a curved axis, it is understood that the entire rod  14  need not be curved. Indeed, the rod preferably has at least some straight portions (e.g. preferably the portion within the handle  12 , and optionally portions of the distal end portion  16 ). Thus, it is expressly understood that a curved rod can have segments or portions that are substantially straight, and that the rod need not be uniformly curved along the same radius. 
     In  FIGS. 1–7 , the distal end portion  16  of the instrument  10  includes a reduced diameter portion  7  and a frustoconical portion between the reduced diameter portion  7  and the rest of the rod  14 . The distal end portion  16  optionally has structure for associating the instrument  10  with another surgical article (e.g. a connector, dilator, sling assembly, sling or suture). Optionally, the distal end portion  16  may incorporate specially designed surfaces for cooperating with complementary surfaces on another surgical article, such as the structures described in U.S. patent application Publication No. 2002/0099259, published Jul. 25, 2002 (U.S. patent application Ser. No. 09/917,445, filed Jul. 27, 2001), or U.S. patent application Publication No. 2002/0151762, published Oct. 17, 2002 or U.S. patent application Publication No. 2002/0147382 published Oct. 10, 2002. 
       FIGS. 15 and 15A  show an alternative embodiment of surgical instrument  100  in accordance with the present invention. In this embodiment, the instrument  100  includes an eyelet E in its distal portion with a distal tip  107 . Alternatively, other structures such as a hook, clip, catch, J-shaped groove, channel, slot, hasp, latch, key, bodkin, carbineer-like connector or other structure is within the scope of the present invention. 
     Referring to  FIG. 3 , the rod  14  of the instrument  10  preferably has at least a portion with a radius R and a length L along the curved axis between distal tip  17  of the rod  14  and a point on the rod axis where the rod emerges from the handle (see  FIG. 3 ). The length L is preferably between about 6 inches and about 12 inches, more preferably between about eight inches and about nine inches, even more preferably about 8.25 inches. The radius R is preferably between 4.5 and 5.5 inches. Notably, the entire portion of the rod  14  need not be continuously curved or situated along the same radius R. Preferably, the portion of the rod  14  within the handle  12  and the distal portion  16  are not curved along the same radius R, and instead, these portions are preferably substantially straight. 
     The handle  12  has a major anterior surface  64  that is best seen in  FIG. 4 . The major anterior surface  64  has width W and height H. The height H of the handle  12  is preferably between about 3.25 inches and about 4.75 inches. Referring to  FIG. 1 , the major anterior surface is situated to face a surgeon with the rod  14  extending toward the surgeon. 
     The handle  12  also has a major posterior surface  42  that is best seen in  FIG. 5  that also has a width W and height H. Notably, the width W of the handle  12  is in a direction that is substantially perpendicular to the axis of the rod  14  (see  FIG. 4 ). The major posterior surface  42  of the handle preferably includes an elongate depression having an axis that extends substantially parallel to the longitudinal axis of the handle (see the substantially oval shape in  FIG. 5 ). The depression is preferably substantially concave, but could alternatively be convex. 
     Referring to  FIGS. 2 ,  3  and  6 , the handle  12  also has minor side surfaces having a depth D and height H. The depth D of the handle  12  is less than the height H of the handle  12 . 
     The handle  12  preferably has a height H that is more than forty percent of the length L of the rod  14  and less than eighty percent of the length L of the rod  14 . 
     The rod  14  may be rigid or malleable. Preferably, the rod  14  is a hardened steel component. A variety of different materials may be used to construct the surgical instrument including, but not limited to medical grade plastics and metals. Suitable materials include titanium, stainless steel, other medical grade alloys. Suitable stainless steels include AISI types 316, 3161, 17-4, 302, 303 and 304. 
     The handle  12  has a longitudinal axis A along its height H. The handle  12  preferably includes an elongate channel  32  extending across the width W of the handle  12 . The channel  32  has an axis that extends substantially perpendicular to the longitudinal axis A of the handle  12 . The height (length) of the channel  32  along the longitudinal axis A of the handle  12  is more than 0.5 inches and less than 1 inch, more preferably the length is about 0.9 inches. The depth of the channel  32  is preferably between 25% and 100% of the depth of the handle  12 . 
     The rod  14  preferably comprises stainless steel and at least one material comprising the polymeric handle  12  has a density less than stainless steel. 
     The height H to width W ratio of the handle  12  is preferably greater than 3:1, and the depth D to width W ratio is preferably less than 1:2. 
     Referring to  FIGS. 1 and 4 , the anterior surface  64  preferably has a plurality of tactile surfaces  22 ,  24 ,  26  and  28  extending in a direction substantially perpendicular to the longitudinal axis A of the handle  12 . Preferably, there are at least four tactile surfaces  22 ,  24 ,  26  and  28 . The handle  12  has proximal and distal ends and the rod  14  emerges from the distal end of the handle. The tactile surfaces  22 ,  24 ,  26  and  28  are preferably located distal to the elongate channel  32 . In a preferred embodiment, they are located on the bottom (distal) two thirds of the handle  12 . The tactile surfaces may extend above the major anterior surface  64 , or below the major anterior surface. They may comprise slits, slots, bumps, protrusions, ridges, ribs, grooves or the like. 
     The handle  12  preferably includes a flare  34  at a proximal end portion. In this embodiment, the posterior surface  42  preferably includes a substantially concave surface and the anterior surface  64  includes a substantially convex surface adjacent the proximal end portion of the handle  12 . 
     The surgical instrument  10  may have a portion of the exterior surface of the rod  14  polished and a portion treated. In the embodiment shown in  FIG. 3 , at least two thirds of the exposed, exterior surface of the elongate rod  14  preferably includes a surface treatment for enhancing grasping of the rod  14 . Suitable treatments include but are not limited to peening, sand blasting, knurling, engraving, chemical and laser etching, heat etching, carving, scoring and other techniques. This may be accomplished by masking a portion or portions of a polished rod and bombarding unmasked portions of the rod with silica emerging through a pressurized nozzle (sand blasting). 
     Preferably, at least the portion of the exposed rod  14  nearest the handle  12  is treated to increase its coefficient of friction and the portion or portions of the rod  14  remote from the handle  12  are polished. The portion of the rod  14  treated may include a predetermined pattern or selected areas or zones. The portion of the exposed rod  14  that is treated is preferably between about 5% and 98% of the length of the exposed rod  14 , more preferably, it is between about 50% and 95%. In the embodiment depicted in  FIG. 3 , it is about 66%. 
     Rather than grasping the handle  12 , which may isolate tactile sensation, the surface treatment allows grasping of a surface which allows for better tactile sensation for the physician passing the rod  14  through anatomical structures. Portions or patterns may be treated on the rod  14  to provide the necessary handling or visual characteristics. Specifically, when using cystoscopy to look for surgical trauma caused by the rod  14  to the bladder, by having only a portion of the rod  14  treated creates an altered light diffraction pattern so the otherwise reflective surface of the rod  14  may be more easily seen when immersed in liquid filling the bladder. The pattern of treatment may also identify the instrument by size, length, depth of penetration or other feature useful for facilitating surgical use of the instrument. 
     The surface texturing is preferably sufficiently deep to enhance handling of the surgical instrument, but does not significantly alter the mechanical strength of the material. 
     The surface texturing preferably extends a predetermined distance along the rod. In one embodiment, the leading (distal) end  16  of the rod  14  is free of surface texturing and has a substantially smooth surface. The trailing end of the rod (the portion emerging from handle  12 ) has surface texturing extending a sufficient length to enhance handling of the instrument  10 . The surface texturing does not extend unduly, such as to an extent where the texturing may unduly abrade or damage sensitive tissue during anticipated uses. 
     Referring to  FIG. 5 , the posterior surface  42  has a plurality of tactile surfaces (e.g. protrusions or slots)  41 ,  43 ,  45 ,  47 ,  49 ,  51 ,  53 ,  55 ,  57  and  59  extending in a direction substantially perpendicular to the longitudinal axis A of the handle  12 . Preferably, the posterior surface has at least five tactile surfaces, and more preferably at least ten tactile surfaces. 
     The materials of the handle  12  can comprise any suitable material for a surgical instrument. They are preferably polymeric materials such as, but not limited to polycarbonate, polyethylene, polypropylene, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), delrin, ABS, polyurethane, nylon, acetal, urethane, polyetherimide, polysulfone or other similar sterilizable materials, including combinations thereof. 
     The major anterior and posterior surfaces  42  and  64  may be constructed in a plurality of different fashions. Molding, casting and machining processes may be utilized. The surfaces  42  and  64  may comprise a monolithic, unitary or composite injection molded components. 
     The surgical instrument  10  may be constructed using a two-part molding process. The rod  14  is placed in a first base handle mold. A first polymer is injected molded to form a portion of the handle  12  (e.g. including the periphery of the minor side portions). One or more slots on the portion of the rod  14  designed to be within the handle  12  can help facilitate proper molding between the materials of the handle  12  and the rod  14 . 
     The first base handle mold can form, for example, the portion of the handle  12  that does not include the tactile surfaces  22 ,  24 ,  26 ,  28 ,  41 ,  43 ,  45 ,  47 ,  49 ,  53 ,  55 ,  57  and  59 . The first polymeric material can comprise any suitable polymer such as a copolymer of acrylonitrile, butadiene and styrene (ABS). One suitable material is Bayer&#39;s Lustran ABS. 
     An insert or other portion of the first mold is used to preserve room for a second injection molding (an overmold) of a second polymeric material. For example, the second injection molding may form the tactile surfaces  22 ,  24 ,  26 ,  28 ,  41 ,  43 ,  45 ,  47 ,  49 ,  53 ,  55 ,  57  and  59  on both the major anterior and major posterior surfaces. Any suitable polymeric material may be used for the overmolding process. Suitable examples include, but are not limited to Pellethane urethane, or Santoprene S-79956 from Advanced Elastomer Systems. The second material may run through the handle  12 , connecting the major anterior and posterior surfaces. 
     Referring now to  FIGS. 15 and 15A , the surgical instrument  100  includes an indicator arm  111  which may be sized, shaped and situated to provide information on the path of the distal end of the rod  114 . Optionally, the indicator arm  111  may be deployable (movable) relative to the rest of the handle. Also optionally, as shown with the dashed lines in  FIG. 15 , the handle  112  may include a groove for receiving the arm  111 . In this embodiment, the surface texturing S′ runs about 50% of the length of the rod  114 . 
     Referring now to  FIGS. 16–20 , the cross sectional shape of the rod  114  (and rod  14 ) may comprise any suitable polygonal shape including circular ( FIG. 16 ), oval ( FIG. 17 ), elliptical or egg-shaped ( FIG. 18 ), rectangular ( FIG. 19 ), triangular ( FIG. 20 ) or combinations thereof. 
       FIGS. 8 through 14  show an ornamental design for a handle for a surgical instrument according to another aspect of the present invention. The broken line showing in these Figures of a needle and surface structures on the design of the handle are for illustrative purposes only and form no part of the claimed design. 
     Notably, the surgical instruments  10  and  100  are only embodiments of the present invention, and one of ordinary skill in the art who is exposed to this disclosure will recognize that other embodiments and representations are within the scope of the present invention. For example, the handles  12  and  112  are substantially wedge-shaped. Embodiments of the surgical instrument of the present invention include substantially rectangular shaped handles. In other aspects, the surgical instruments of the present invention can comprise those shown and described in U.S. Provisional Application Ser. No. 60/343,658, filed Oct. 24, 2001; and U.S. Provisional Application Ser. No. 60/336,884, filed Nov. 2, 2001; and U.S. Provisional Application Ser. No. 60/347,494, filed Jan. 11, 2002. 
     The surgical instruments according to the present invention may be reusable, single use, or disposable. 
     All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated. 
     Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.