# Patent

## Title
Surgical instruments

## Abstract

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
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 & 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'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.

## Claims

1. A surgical instrument for addressing pelvic disorders comprising:
a handle having a width, height and depth, and said handle further having a proximal and distal end, and a longitudinal axis along its height, and
an elongate, slender, metal, curved rod emerging from the distal end of the handle, the rod having a proximal end portion permanently fixed to the handle, a curved axis, and a distal end portion having a distal tip, the elongate curved rod having at least a portion with a radius and a length along the curved axis between the distal tip of the rod and a point on the rod axis where the rod emerges from the handle, the length being between about 6 inches and about 12 inches;
the handle having a major anterior surface having a width and height, the major anterior surface being situated to face a surgeon with the rod extending generally toward the surgeon, a major posterior surface having a width and height, at least two minor side surfaces having a depth and height, the width of the handle being in a direction that is substantially perpendicular to the axis of the rod, the handle having 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 being less than the height of the handle,
said major anterior surface of the handle including an elongate channel extending across the width of the handle with an axis that extends substantially perpendicular to the longitudinal axis of the handle, and
said major anterior surface further including a plurality of tactile surfaces distal to the elongate channel, said plurality of tactile surfaces extending in a direction substantially perpendicular to the longitudinal axis of the handle.

2. A surgical instrument according to claim 1 wherein the rod is curved along a substantial portion of its axis with a radius of curvature that is between 4.5 and 5.5 inches, and the distal tip is substantially blunt.

3. A surgical instrument according to claim 1 wherein the length of the channel along the longitudinal axis of the handle is more than 0.5 inches and less than 1 inch.

4. A surgical instrument according to claim 1 wherein 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.

5. A surgical instrument according to claim 1, wherein the height to width ratio is greater than 3:1.

6. A surgical instrument according to claim 1 wherein the handle includes a flare at a proximal end portion, the posterior surface including a concave surface and the anterior surface including a convex surface.

7. A surgical instrument according to claim 1 wherein at least two thirds of the exterior surface of the elongate rod includes a surface treatment for enhancing grasping of the rod.

8. A surgical instrument according to claim 1 wherein the posterior surface has a plurality of tactile surfaces extending in a direction substantially perpendicular to the longitudinal axis of the handle.

9. A surgical instrument according to claim 1 wherein the handle includes polycarbonate.

10. A surgical instrument according to claim 1 wherein the tactile surfaces comprise protrusions.

11. A surgical instrument according to claim 1 wherein the anterior surface includes at least four tactile surfaces.

12. A surgical instrument according to claim 11 wherein the tactile surfaces comprise grooves.

13. A surgical instrument according to claim 1 wherein depth to width ratio of the handle is less than 1:2.