Surgical instruments for addressing pelvic disorders

A novel surgical instrument is shown and described. The surgical instrument is useful in pelvic floor repair procedures such as sling procedures for treating incontinence. Also, a novel, ornamental design for a handle for a surgical instrument is shown and described.

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 & 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 inFIGS. 8 through 14and 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).

The broken line showing of a needle and surface structures on the design of the handle inFIGS. 8 through 14are 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 toFIGS. 1–7, there is shown a preferred embodiment of surgical instrument10according to the present invention. The surgical instrument10comprises a handle12having a width W, height H and depth D, and an elongate, slender, metal, curved rod14. The rod14emerges from the handle12, and has a proximal end portion permanently fixed within the handle12. By slender, it is meant for example, for the embodiments of the present invention with a circular cross sectional shape (e.g. seeFIG. 16), the major portion of the rod14along its length has a diameter less than about 4 mm, more preferably about 3.2 mm. The handle12is preferably rigidly or permanently affixed to the rod14.

The rod14preferably has a curved axis, and a distal end portion16. The distal end portion16preferably has a substantially blunt distal tip17. As used herein, when it is said that the rod14is curved or has a curved axis, it is understood that the entire rod14need not be curved. Indeed, the rod preferably has at least some straight portions (e.g. preferably the portion within the handle12, and optionally portions of the distal end portion16). 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.

inFIGS. 1–7, the distal end portion16of the instrument10includes a reduced diameter portion7and a frustoconical portion between the reduced diameter portion7and the rest of the rod14. The distal end portion16optionally has structure for associating the instrument10with another surgical article (e.g. a connector, dilator, sling assembly, sling or suture). Optionally, the distal end portion16may incorporate specially designed surfaces for cooperating with complementary surfaces on another surgical article, such as the structures described in U.S. Pat. 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. Pat. Application Publication No. 2002/0151762, published Oct. 17, 2002 or U.S. Pat. Application Publication No. 2002/0147382 published Oct. 10, 2002.

FIGS. 15 and 15Ashow an alternative embodiment of surgical instrument100in accordance with the present invention. In this embodiment, the instrument100includes an eyelet E in its distal portion with a distal tip107. 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 toFIG. 3, the rod14of the instrument10preferably has at least a portion with a radius R and a length L along the curved axis between distal tip17of the rod14and a point on the rod axis where the rod emerges from the handle (seeFIG. 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 rod14need not be continuously curved or situated along the same radius R. Preferably, the portion of the rod14within the handle12and the distal portion16are not curved along the same radius R, and instead, these portions are preferably substantially straight.

The handle12has a major anterior surface64that is best seen inFIG. 4. The major anterior surface64has width W and height H. The height H of the handle12is preferably between about 3.25 inches and about 4.75 inches. Referring toFIG. 1, the major anterior surface is situated to face a surgeon with the rod14extending toward the surgeon.

The handle12also has a major posterior surface42that is best seen inFIG. 5that also has a width W and height H. Notably, the width W of the handle12is in a direction that is substantially perpendicular to the axis of the rod14(seeFIG. 4). The major posterior surface42of 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 inFIG. 5). The depression is preferably substantially concave, but could alternatively be convex.

Referring toFIGS. 2,3and6, the handle12also has minor side surfaces having a depth D and height H. The depth D of the handle12is less than the height H of the handle12.

The handle12preferably has a height H that is more than forty percent of the length L of the rod14and less than eighty percent of the length L of the rod14.

The rod14may be rigid or malleable. Preferably, the rod14is 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, 316l, 17–4, 302, 303 and 304.

The handle12has a longitudinal axis A along its height H. The handle12preferably includes an elongate channel32extending across the width W of the handle12. The channel32has an axis that extends substantially perpendicular to the longitudinal axis A of the handle12. The height (length) of the channel32along the longitudinal axis A of the handle12is more than 0.5 inches and less than 1 inch, more preferably the length is about 0.9 inches. The depth of the channel32is preferably between 25% and 100% of the depth of the handle12.

The rod14preferably comprises stainless steel and at least one material comprising the polymeric handle12has a density less than stainless steel.

The height H to width W ratio of the handle12is preferably greater than 3:1, and the depth D to width W ratio is preferably less than 1:2.

Referring toFIGS. 1 and 4, the anterior surface64preferably has a plurality of tactile surfaces22,24,26and28extending in a direction substantially perpendicular to the longitudinal axis A of the handle12. Preferably, there are at least four tactile surfaces22,24,26and28. The handle12has proximal and distal ends and the rod14emerges from the distal end of the handle. The tactile surfaces22,24,26and28are preferably located distal to the elongate channel32. In a preferred embodiment, they are located on the bottom (distal) two thirds of the handle12. The tactile surfaces may extend above the major anterior surface64, or below the major anterior surface. They may comprise slits, slots, bumps, protrusions, ridges, ribs, grooves or the like.

The handle12preferably includes a flare34at a proximal end portion. In this embodiment, the posterior surface42preferably includes a substantially concave surface and the anterior surface64includes a substantially convex surface adjacent the proximal end portion of the handle12.

The surgical instrument10may have a portion of the exterior surface of the rod14polished and a portion treated. In the embodiment shown inFIG. 3, at least two thirds of the exposed, exterior surface of the elongate rod14preferably includes a surface treatment for enhancing grasping of the rod14. 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 rod14nearest the handle12is treated to increase its coefficient of friction and the portion or portions of the rod14remote from the handle12are polished. The portion of the rod14treated may include a predetermined pattern or selected areas or zones. The portion of the exposed rod14that is treated is preferably between about 5% and 98% of the length of the exposed rod14, more preferably, it is between about 50% and 95%. In the embodiment depicted inFIG. 3, it is about 66%.

Rather than grasping the handle12, which may isolate tactile sensation, the surface treatment allows grasping of a surface which allows for better tactile sensation for the physician passing the rod14through anatomical structures. Portions or patterns may be treated on the rod14to provide the necessary handling or visual characteristics. Specifically, when using cystoscopy to look for surgical trauma caused by the rod14to the bladder, by having only a portion of the rod14treated creates an altered light diffraction pattern so the otherwise reflective surface of the rod14may 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) end16of the rod14is free of surface texturing and has a substantially smooth surface. The trailing end of the rod (the portion emerging from handle12) has surface texturing extending a sufficient length to enhance handling of the instrument10. 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 toFIG. 5, the posterior surface42has a plurality of tactile surfaces (e.g. protrusions or slots)41,43,45,47,49,51,53,55,57and59extending in a direction substantially perpendicular to the longitudinal axis A of the handle12. Preferably, the posterior surface has at least five tactile surfaces, and more preferably at least ten tactile surfaces.

The materials of the handle12can 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 surfaces42and64may be constructed in a plurality of different fashions. Molding, casting and machining processes may be utilized. The surfaces42and64may comprise a monolithic, unitary or composite injection molded components.

The surgical instrument10may be constructed using a two-part molding process. The rod14is placed in a first base handle mold. A first polymer is injected molded to form a portion of the handle12(e.g. including the periphery of the minor side portions). One or more slots on the portion of the rod14designed to be within the handle12can help facilitate proper molding between the materials of the handle12and the rod14.

The first base handle mold can form, for example, the portion of the handle12that does not include the tactile surfaces22,24,26,28,41,43,45,47,49,53,55,57and59. The first polymeric material can comprise any suitable polymer such as a copolymer of acrylonitrile, butadiene and styrene (ABS). One suitable material is Bayer'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 surfaces22,24,26,28,41,43,45,47,49,53,55,57and59on 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 handle12, connecting the major anterior and posterior surfaces.

Referring now toFIGS. 15 and 15A, the surgical instrument100includes an indicator arm111which may be sized, shaped and situated to provide information on the path of the distal end of the rod114. Optionally, the indicator arm111may be deployable (movable) relative to the rest of the handle. Also optionally, as shown with the dashed lines inFIG. 15, the handle112may include a groove for receiving the arm111. In this embodiment, the surface texturing S′ runs about 50% of the length of the rod114.

FIGS. 8 through 14show 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 instruments10and100are 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 handles12and112are 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.