Suture anchor and approximating device

An elastically curved suture anchor is resiliently straightened and delivered into tissue by a needle. When the needle is withdrawn, resumption of the curvature provides leverage for anchor rotation as the attached suture is pulled to fasten the anchor within the tissue. A fin at the proximal end of the anchor further increases the rotational leverage and expedites anchor fastening. When two or more anchors with connecting suture are delivered in series on a needle, the tension of the suture helps to draw the anchors together and approximates the pierced tissue.

FIELD OF INVENTION

This invention relates to suture anchors and minimally invasive methods for delivering and fastening suture within tissue.

BACKGROUND

Suture anchors have been developed for anchoring sutures in endoscopic or arthroscopic surgery through single sided access. Most prior art suture anchors are delivered from a lumen of a needle or a tubular device. Prior art include U.S. Pat. No. 4,235,238 by H. Ogiu et al., issued on Nov. 25, 1980, U.S. Pat. No. 4,741,330 by J. Hayhurst, issued on May 3, 1988, U.S. Pat. No. 4,669,473 by W. Richards et al., issued on Jun. 2, 1987, U.S. Pat. No. 5,800,445 by K. Ratcliff et al., issued on Sep. 1, 1998; U.S. Pat. No. 5,041,129 by J. Hayhurst et al., issued on Aug. 20, 1991, U.S. Pat. No. 5,845,645 by P. Bonutti, issued on Dec. 8, 1998, U.S. Pat. RE36,974, reissued on Nov. 28, 2000, and U.S. Pat. No. 6,312,448 by P. Bonutti, issued on Nov. 6, 2001. Since the anchors reside within the lumen of the delivery device, the size of the needles or tubular members is correspondingly larger, making tissue penetration more difficult and traumatic.

Several prior art anchors reside outside and around a needle. For delivery, a push rod is used to push along one side of the suture anchor, sliding along the needle into the tissue. A suture connected at the opposite side of the push rod is used to pull the anchor as the anchor is being pushed by the push rod. A series of patents by P. Bonutti, U.S. Pat. No. 5,814,072, issued on Sep. 29, 1998, U.S. Pat. No. 5,948,002, issued on Sep. 7, 1999, U.S. Pat. No. 6,033,430, issued on Mar. 7, 2000 and U.S. patent application publication No. 2001/0002440, publication date: May 31, 2001, proposed the push and pull method to pivot the anchor within tissue. Pivoting of an anchor within tissue is classified as partial-thickness suture fastening. To facilitate instant pivoting, the suture is connected close to both distal and proximal ends of the anchor to provide favorable leverage for anchor rotation.FIG. 1depicts the prior art235, which has completed the rotation within tissue. The suture122is looped near or at both ends of the anchor235, as depicted in the prior art patents. For favorable leverage, the strands of suture122connected to the anchor235are widely spaced apart. As tension is applied to the suture122, the strands of suture122spread open, as indicated by the shaded area236, opening or pushing out the tissue130along the path of anchor235entry. Especially within soft tissue, the widely spaced sutures122wedge open the tissue directly above the anchor235. As a result, the pullout strength of the anchor235is likely to be low. The probable mode of failure is likely to be anchor235pullout, as depicted inFIG. 2, rather than suture122breakage. While the widely spaced suture122provides favorable leverage for rapid rotation, it appears to sacrifice the strength of tissue anchoring.

Another prior art suture anchor, U.S. Pat. No. 5,626,614 by C. Hart, issued on May 6, 1997, also resides outside and around a needle. Hart's invention is designed for fastening or proximating tissues separated by two distinct walls, such as the stomach and abdominal walls, using full-thickness fastening. Unfortunately, most tissue within the body adheres to adjacent tissue with no clear separation, space or cavity. Therefore, full-thickness anchor pivoting to fasten or proximate two tissues has limited use.

SUMMARY OF INVENTION

Organs and/or tissues, especially in urology, are virtually adhere to each other. This invention is capable of anchoring a suture in either partial- or full-tissue thickness fastening, without the cumbersome manipulations of the suture or delivery device as described in prior art. In addition, the suture anchor contains a platform designed to improve anchoring strength within tissue.

A curved anchor made with elastic material contains a lumen for the needle. A fin protrudes from one side and a platform covers the opposite side of the anchor. The fin is on the concave side and at the proximal end, while the platform is on the convex side of the curved anchor. A suture passes through an opening in the platform, loops around the concave side of the anchor, and exits through another opening in the platform. As a result, both strands of the suture can be pulled from the convex side of the anchor.

The suture anchor is resiliently straightened by a rigid needle inserted through the lumen of the anchor. The needle contains a widened portion or a step to prevent the anchor from sliding up the needle. The needle is used to deliver the anchor by puncturing into tissue. At a proper depth, the needle can then be withdrawn. The protruded fin is tapered for tissue insertion, but behaves as a tissue snagging barb, hooking onto the tissue and resisting pullout. As a result, the needle withdrawal strips the anchor off the needle, and at the same time deploys the anchor within the tissue at the proper depth.

The anchor resumes the elastic curvature within the tissue after withdrawal of the rigid needle. The fin at the proximal end of the concave curvature is laterally pressed into the adjacent tissue, while the central portion of the convex curvature connecting to the suture is pushed in the opposite direction further away from the fin. In essence, curvature resumption within tissue increases the distance between the fin and the openings for the suture, as the fin is pressed laterally into the tissue. When the strands of suture are pulled on the convex side of the anchor, the curved anchor begins to rotate within tissue from a vertical, or inserting position, to a horizontal, or fastening position. The platform is also repositioned from vertical to horizontal to greatly resist pullout during tissue fastening and repair.

Multiple anchors can be linked by a suture and delivered in series into tissue. When the suture is pulled, the anchors draw close to each other to shorten or approximate the pierced tissue.

REFERENCE NUMBER

DETAILED DESCRIPTION OF THE EMBODIMENTS

A curved anchor144is made with elastic material containing a longitudinal lumen or passage104, a fin134at or near the proximal end, and a relatively flat platform133on the convex side of the curvature with two openings123for a suture122, as shown inFIG. 3. Through the openings123on the platform133, the suture122is looped around the concave side of the curved anchor144for tension distribution.FIG. 4depicts a relatively rigid trocar or needle103inserted through the lumen104to resiliently straighten the elastic anchor144. The needle103is marked with measuring units, visible under endoscope, to indicate depth of needle103penetration into tissue. The distal portion of the needle103is sized and configured to fit into the lumen104of the anchor144. To prevent the anchor144from sliding up the needle103during tissue penetration, the cross-sectional diameter of the needle103is not uniform. A step165on the needle103, as shown inFIGS. 4 and 5, blocks the anchor144from sliding upward, over the needle103.FIG. 5depicts the proximal end of the resiliently straightened anchor144resting on the step165of the needle103, with the fin134protruding over or above the step165. In essence, the elastic suture anchor144has a curved position and a straightened position.

FIG. 6depicts a side view of the curved anchor144straightened by the rigid stepped needle103. The distal tips of the anchor144, platform133and fin134are tapered and/or beveled to accommodate tissue penetration. The proximal end of the fin134is designed to resist anchor144pull out during withdrawal of the stepped needle103.FIG. 7depicts the top view of the anchor144with an elliptical platform133tapered at both distal and proximal ends. The tapered distal end of the platform133is designed for tissue penetration spearheaded by the stepped needle103.FIG. 8depicts the bottom view with tapered distal ends of the anchor144and the fin134for ease of tissue penetration. The suture122passes through the openings123on the platform133and loops under the straightened anchor144to distribute tension of the suture122. Since the suture122is not tied to the anchor144, the suture122can slide freely, even after the anchor144is fastened within tissue. A sliding suture144can be useful, sometimes essential in tissue reattachment or other surgical manipulations.

The fin134serves as a reversed barb or a snag, favoring tissue penetration but resisting anchor144pullout. The anchor144is delivered by tissue piercing with the stepped needle103, as shown inFIG. 5. The depth of anchor144insertion is known by the measuring units on the stepped needle103, as shown inFIGS. 4 and 5. As the stepped needle103is withdrawn, the barb-like fin134catches, hooks or snags onto the surround tissue, allowing the anchor144to slide off the withdrawn stepped needle103. The anchor144remains in the tissue with the suture122attached. In essence, the anchor144is delivered in the tissue simply by inserting and withdrawing the stepped needle103.

Driven by suture122tension, the delivered anchor144is designed to rotate and fasten within tissue. After withdrawal of the stepped needle103, the anchor144resumes the curved configuration, laterally pressing the pointed proximal end of the fin134into the tissue. Three points curved anchor144: the suture openings123on top of the platform133, the fin134and the distal end of the anchor144, form a triangle. In essence, the lateral separation between the protruded fin134and the suture122connecting points or openings123increases with resumption of the anchor144curvature. The distance, W, between the suture openings123and the proximal end of the fin134, as shown inFIG. 9, provides initial rotational torque, when tension is applied to the suture122by the surgeon. The tapered proximal end of the platform133is shaped for lateral tissue penetration when the anchor144is pulled by the suture122. The curved arrow inFIG. 9indicates the rotational direction of the anchor144within the tissue from vertical to near horizontal, about 90°, as a direct response to suture122tension, shown as a straight arrow. The fin134guides, spearheads and/or prevents the anchor144from twisting during rotation or pivoting within tissue, repositioning the platform133from being parallel with the suture122, as shown inFIG. 5, to being near perpendicular with the suture122for maximum anchoring power. Anchor144rotation within the tissue may also be favored if L1is longer than L2, where L1is the distance between the proximal end of the anchor144to suture openings123, and L2is the distance between the distal end of the anchor144to suture openings123. However, depending on the size and shape of the platform133, if L1is significantly longer than L2, the anchor144may over rotate, beyond 90°. As a result, the suture122would no longer be perpendicular to the platform133, and the anchoring strength could possibly weaken.

Partial thickness suturing is common in open surgery, and rotation of the curved anchor144within the tissue allows the surgeon to obtain partial thickness suturing in endoscopic, arthroscopic or laparoscopic procedures. The curved suture anchor144is designed for: (1) elastically straightening with the stepped needle103, (2) tissue penetration with tapered distal portions, (3) dislodging with the barb-like fin134, (4) curvature resumption following needle103withdrawal, (5) rotation within the tissue driven by suture122tension, and (6) anchoring strength with the large platform133.

FIG. 10depicts penetration of the stepped needle103loaded with the suture anchor144into soft tissue130. A scale on the stepped needle103visible to the surgeon measures the depth of anchor144insertion. The fin134of the anchor144protrudes outwardly, catching the tissue130and preventing the anchor144from pulling out as the stepped needle103is withdrawn. In essence, withdrawal of the stepped needle103dislodges or strips off the anchor144, allowing the suture anchor144to remain at or near the intended depth of insertion.FIG. 11depicts resumption of the curved configuration of the anchor144after withdrawal of the stepped needle103. The curvature also provides compression on the fin134, embedding the fin134laterally into tissue130.FIG. 12depicts tension applied to the suture122to pull and rotate the anchor144from an insertion or vertical position to an anchoring or horizontal position. The initial lateral mobility is favored by (1) the curvature of the suture anchor144, and (2) protrusion of the fin134. During rotation, twisting of the anchor144along the longitudinal axis is prevented by the fin134and the platform133as both laterally penetrate into tissue130.FIG. 13depicts further tension applied to the suture122, orienting the platform133to nearly perpendicular to the suture122under tension. With the large surface area of the platform133pressing against the tissue130, the suture122is secured with good anchoring strength for surgical repair. The rotation of the anchor144within the tissue provides partial thickness suturing with endoscopic, arthroscopic or laparoscopic capability.

It is widely believed that most of the urinary incontinence in women is related to a descended position of the bladder127, the funneling of the bladder neck112and/or diminished posterior151urethral support. The dashed line ofFIG. 14indicates the normal position and the solid line depicts a descended position of the bladder127with its funnel-shaped bladder neck112.FIG. 15shows a failed lumen100closure and hypermobility under stress with the urethropelvic ligaments102pulling the lateral walls131of the poorly supported urethra101.FIG. 16shows the mid-sagittal view ofFIG. 15during stress, with urethropelvic ligaments pulling perpendicularly above and below the plane of the page.FIG. 16also indicates that the section of poorly supported posterior wall151withdraws from mucosal113coaptation, leading to urine117leakage.

Numerous existing surgical procedures are designed to treat urinary incontinence. The traditional surgical treatment for urinary incontinence is to add backboard support to the urethral posterior wall151, usually by repositioning the vagina114with sutures122.FIG. 17indicates the pre-surgical position of the vagina114with a dotted line, and that of the urethra101and bladder with dashed lines.FIG. 17also shows a large incision157required for repositioning and suturing both the vagina114and urethra101toward the abdominal wall. The post-surgical positions of the vagina114and backboard-supported urethra101are depicted with solid lines. The sutures122are knotted125to fascia or ligament on the abdominal wall.FIG. 18indicates a section of the backboard-supported posterior wall151. This significantly invasive procedure provides the backboard support needed for lumen150closure during stress with concurrent pulling of the urethropelvic ligaments102to prevent urine leakage, as shown inFIG. 19.

Through a much smaller incision157, the suture anchor144system can provide similar backboard support to the posterior wall151of the urethra101. A catheter154is introduced through the urethra101into the bladder127. The descended bladder127, depicted in dotted lines, is lifted by the pressure against the wall of the vagina144. Through the vagina114, the surgeon can also feel the catheter154within the urethra101to guide the needle/anchor103/144insertion lateral to the urethra101, as shown inFIG. 20, into the vaginal114wall. As the stepped needle103is withdrawn, the fin134hooks onto the vaginal114tissue, stripping the anchor144off the withdrawing needle103. The method of guiding the needle103with the surgeon's finger is currently being used with the Stamey needle, a prior art device, for repairing stress urinary incontinence. Unlike the Stamey needle, the needle/anchor103/144system does not require passing the suture122back and forth from the vagina114cavity to the abdominal wall. Furthermore, the suture122introduced by the Stamey needle is exposed within the vagina, which increases the risk of infection. The suture anchor144on the other hand, can be deployed within the vaginal114wall, as partial thickness suturing in open surgery. The suture anchor144can also be delivered and deployed in the vaginal114cavity, as full thickness suturing.FIG. 21depicts four suture anchors144fastened within the anterior vaginal114wall, providing backboard support to the posterior wall151of the urethra101. The sutures122from the anchors144are knotted to fascia or ligament, similar toFIG. 17, but requiring only a much smaller incision157. The orientation of the anchor144within tissue can be significant. For example, the anchors144deployed perpendicular to the urethra101, as depicted inFIG. 21, may provide a more firm backboard support than the anchors144deployed parallel to the urethra101.

To prevent twisting between the anchor144and needle103, the lumen104of the anchor144can be made non-round, elliptical for example, as shown inFIG. 22, with the stepped needle103sized and configured to fit the lumen104.FIG. 23shows an extended fin134sized and configured to fit into an indentation153on the stepped needle103. Similarly, an extended portion from the stepped needle103can fit into an indentation in the anchor144to prevent the anchor144from spinning on the stepped needle103.

FIG. 24depicts a patient with uterine161prolapse, a common problem in women. Uterine161prolapse is normally surgically treated with hysterectomy, removal of the uterus161, either through vaginal or abdominal incision. The following procedure is ideally used in conjunction with the ligament-tightening procedure described inFIGS. 80 and 81.FIG. 25depicts lifting and repositioning of the uterus161with a uterine tool163containing a blunt distal end171, a shaft172, a handle159and a lift160. The stepped needle103with the suture anchor144is then inserted through a small incision157, guided by an endoscope, into the repositioned uterus161. As the stepped needle103is withdrawn, the fin134hooks onto the uterine161tissue, dislodging the anchor144from the withdrawn needle103. The needle103and anchor144insertion procedure is repeated, and the sutures122are knotted125on the fascia or a ligament on the abdominal wall, as shown inFIG. 26, similar to the suture122tying for correcting urinary incontinence. Other supporting structures, such as the round ligament and broad ligament of the uterus, may also be suitable for fastening the suture122to and supporting the repositioned uterus161.

The suture anchor144can also be used in orthopaedic repairs.FIG. 27depicts penetration of the stepped needle103and anchor144through a torn ligament138into freshly decorticated cancellous bone118. The stepped needle103also contains a sleeve220, freely sliding over the stepped needle103. The position of the ligament138can be manipulated and maintained with grippers221on the distal end of the sleeve220, as the stepped needle103is withdrawn. During needle103withdrawal, the fin134acts as a barb, hooking onto the cancellous bone118, and stripping the anchor144off the withdrawing needle103.FIG. 28depicts curvature resumption of the suture anchor144within the porous cancellous bone118after having slid off the withdrawn stepped needle103.FIG. 29depicts tension applied to the suture122, pulling on the curved anchor144and driving the fin134further laterally. The platform133of the anchor144provides a large surface area to press against the bone118and resist pull out.FIG. 30depicts another anchor114delivered by the stepped needle103through the torn ligament138into the cancellous bone118. The stepped needle103is then withdrawn with the second anchor114also fastened within bone118.FIG. 31depicts suture knot125tying to fasten the torn ligament138onto the bone. In arthroscopic surgery, slip knots125are most frequently tied and delivered to the surgical site with a knot125pushing device. The fastened ligament138will eventually heal and reattach onto the cancellous bone118. In essence, the sutures122and anchors114are merely used to maintain the position of the torn ligament138; reattachment and healing occur naturally with the surgically inflicted bleeding bone118. Therefore, both the anchors144and sutures122can be made with biodegradable materials to prevent device migration with time.

The anchoring strength of the suture anchor144can be further improved. The anchor144reaches full anchoring strength as the anchor144forms almost a T-configuration or is perpendicular with the suture122, as shown inFIG. 13. With excessive tension on the suture122, the elastic anchor144may curve further, or even fold into a V-configuration. As a result, the anchoring strength would greatly decrease. To prevent the anchor144from excessive bending or folding, bend stops155can be added along both sides of the anchor144to increase rigidity and anchoring strength of the anchor144.FIG. 32depicts the bend stop155with a gap or V-groove156beneath the platform133. When the suture anchor144is in the curved configuration, the gap156is closed to resist further bending of the anchor144, as depicted inFIG. 32. As the elastic anchor144is resiliently straightened by the stepped needle103, the gap156is opened, as shown inFIG. 33.FIG. 34depicts the side view of the resiliently straightened anchor144, showing the open gap156of the bend stop155beneath the platform133.FIG. 35depicts the bottom or belly view of the resiliently straightened anchor144, showing the bilateral bend stops155and open gaps156. The bend stops155are designed and positioned to limit or resist excessive anchor144bending to maximize anchoring strength.

A straight and rigid anchor144with the fin134can also rotate within tissue by utilizing the tension applied to the suture122. As mentioned, the curvature of the anchor144, as shown inFIG. 9, increases the distance, W, to provide additional torque for lateral rotation. For a rigid anchor144, as shown inFIG. 36, a larger and more protruded fin134may adequately provide torque for the anchor144rotation within the tissue.FIG. 37depicts the side view of the rigid anchor144showing a distance, W1, measured from the proximal tip of the fin134to the suture opening123. The distance, W1, provides the initial rotational torque as tension is applied to the suture122by the surgeon. By elevating the suture openings123from a protrusion, a rigid anchor144, shown inFIG. 38with side view inFIG. 39, provides an even greater distance, W2, for greater initial rotational torque. The fin134can be made pointed or angled, as shown inFIGS. 36 to 39to facilitate lateral tissue penetration and anchor144rotation. Rotation of the anchor144within tissue is also favored when L1>L2, where L1is the distance between the proximal tip of the fin134and the suture openings123, and L2is the distance between the distal end of the anchor144and the suture openings123. The tapered proximal ends, as shown inFIGS. 36 and 38, also help to facilitate lateral insertion into tissue during anchors144rotation.

Several derivatives may provide adequate anchoring strength for the suture122.FIG. 40depicts a suture attachment164without threading through the platform133. For light duty suture122anchoring, the platform133may not be necessary.FIG. 41shows an anchor144with the fin134but without a platform.FIG. 42shows a curved anchor144without a fin. With a curvature built into the anchor144, it may be sufficient to provide initial torque to rotate the anchor144within tissue when tension is applied to the suture122.

The suture anchor144may also be used for full thickness anchoring.FIG. 43depicts a curved suture anchor144with a platform133on the concave side of the curvature. The fin134is made blunt to avoid damage to adjacent tissue. The anchor144is loaded onto the stepped needle103with a sleeve220capable of sliding over the stepped needle103, as shown inFIG. 44. The sleeve220is similar to that shown inFIG. 28for holding and manipulating tissue. For full thickness suture122anchoring, the sleeve220can also be used to push the anchor144off the stepped needle103and deploy the anchor144outside the tissue. The protruded fin134can provide an additional function, as a contact point for the sleeve220.FIG. 45depicts a cross section of a bulging L4-5 intervertebral disc100located between psoas major muscles188. Under fluoroscopic guidance or other means, the stepped needle103carrying the anchor144, as shown inFIG. 44, is delivered through a small posteriolateral incision, into the bulging annulus and nucleus pulposus128, as shown inFIG. 45. The advancement of the stepped needle103stops as the distal tip of the stepped needle103exits the disc100. The sliding sleeve220is used to push and expel the anchor144with the attached suture122out of the disc100. Especially with a radiopaque coating on the anchor144, it is possible to see the orientation of the anchor144. When tension is applied to the suture122, the platform133of the anchor144is likely to conform and press against the outer surface of the disc100, as shown inFIG. 46. Otherwise, the orientation of the anchor144can be corrected by advancing the distal tip of the sleeve220to manipulate the anchor144and pull on the suture122until the suture anchor144is properly positioned. Both the stepped needle103and sleeve220are withdrawn after proper deployment of the anchor144.

FIG. 47depicts a curved disc compressor111with two openings123for the suture122and a round or blunt annular compressing region119.FIG. 48depicts knot125tying and bulge compression of the fastened disc compressor111. The suture122is secured with full thickness anchoring by the anchor144and compressor111. The bulge is compressed and fastened to alleviate pain from nerve impingement.

Two suture anchors144with unique suture122arrangement between them can be loaded in series on a stepped needle103to be deployed within tissue. As the suture122is pulled by the surgeon, the anchors144draw close to each other, pulling in or approximating the inserted tissue.FIG. 49depicts portions of two anchors144connected by a suture122through holes123A,123B,123C,123D,123E,123F,123G then123H. Proximal ends of the suture122are threaded through a plunger109. The holes123B,123C,123F and123G are angled to facilitate sliding of the suture122after anchor144rotation. The suture122between the holes123D and123E forms a stationary loop beneath the proximal anchor144. As the suture122is being pulled and the plunger109is being pushed against the proximal anchor144, the strands of suture122will slide from123F to123G and from123C to123B. With the stationary loop beneath the proximal anchor144, the anchors144will draw close to each other to approximate, compress or plicate (fold) the inserted tissue. The distal and proximal suture anchors144with the suture122form an approximating device273designed for minimally invasive use.

Two resiliently straightened anchors144are loaded in series on a double-stepped165needle103, as indicated inFIG. 50. Similar toFIG. 49, the suture122is threaded through holes123A,123B,123C,123D,123E,123F,123G then123H. For clarification, the suture122from holes123A to123D is white and from holes123E to123H is black. Both white and black sutures122are slack to clarify points of origin. The distal end of the proximal anchor144is tapered for lateral tissue penetration. The lumen104of the distal anchor144is smaller than the lumen104of the proximal anchor144, each corresponding to the sizes of the distal and proximal steps165of the needle103. The distance between the steps165can be pre-set or fixed to deliver the anchors144.

As the fins134of the distal and proximal anchors144snag into tissue, the needle103is withdrawn to deposit both anchors144with the connecting suture122, as shown inFIG. 51. Both anchors144resume their curved configuration. In vertical or insertion position, the angled suture holes123B and123G of the distal anchor144are designed to resist suture122sliding and to favor pivoting of the distal anchor144, as shown inFIG. 52. The rotation of the distal anchor144creates tension on the suture122connecting holes123C to123D and123F to123E, as shown inFIGS. 49 and 53. The tension of the sutures122lifts the proximal anchor144by the loop beneath holes123D to123E, as shown inFIGS. 53 and 49. As a result, the proximal anchor144also rotates, laterally pressing the pointed distal end into the tissue, with the fin134behaving like a rudder to direct rotation.

The proximal anchor144can also be inserted by a sliding sleeve220, rather than by the stationary second step165of the needle103.FIG. 54shows a stepped needle103insertion to deliver the distal anchor144into the tissue130. As the tissue130is snagged by the fin134, partial withdrawal of the needle103deposits the distal anchor144within tissue130, as indicated inFIG. 55. The proximal anchor144is delivered by pushing the sleeve220and pulling the suture122, as shown inFIG. 56. Suture122pulling also initiates pivoting of the distal anchor144.FIG. 57shows complete insertion of the proximal anchor144into the tissue130. The needle103is then withdrawn to deposit the proximal anchor144, as shown inFIG. 58, to complete the installation of the approximating device273.

The approximating device273can be tightened and maintained under tension. A one-way suture lock239prevents backsliding during tying and allows further tightening of the suture122to fasten the approximating device273.FIG. 59depicts the composition of a suture lock239with a pair of sutures122passing through a hole240of a cone266into a loop267of an one-way grip237with individual grippers241, then threaded through a passage238at the proximal end of the grip237. The suture122passed through the loop267helps to direct the one-way grip237into the cone266. The passage238of the grip237provides a foundation for suture knot125tying. The loop267and passage238also keep the pair of sutures122apart to obtain maximum locking strength within the cone266. The cylindrical grippers241are arranged in angle, layers, sized and configured to fit within the cone266. Each layer of the grippers241are tapered, narrow at the top and widened at the base, biased against backsliding of the suture122but allowing further suture122tightening.FIG. 60shows the lock239assembly with the pair of sutures122fastened between the cone266and biased grippers241. The pair of sutures122is inserted into a plunger109. The plunger109is bilaterally tapered at the distal end, as shown inFIG. 60, for pushing against the proximal end of the one-way grip237without interfering with the pulling of the suture122to tighten the approximating device, as shown inFIG. 61. As an optional procedure, slipknots125can be tied then delivered by a knot pusher245onto the proximal end of the one-way grip237, as shown inFIG. 62.

Cutting the excess suture122beneath the tissue helps to conceal the entire approximating device273, which may be advantageous since exposure of the non-degradable suture122can promote infection. A suture122cutting device250contains an inner tube246and outer tube247.FIG. 63shows a channel open from the distal end of the inner tube246to a side window248of the suture cutter250.FIG. 64shows the outer tube247also containing a side window248. The inner tube246is tightly fitted inside the outer tube247with overlapping side windows248, as shown inFIG. 65, to form the suture cutter250. The suture cutter250is a relatively thin tubular device. The excess suture122is threaded through the distal opening and out the overlapping side windows248of the inner tube246and outer tube247, as shown inFIG. 66. By straightening and holding onto the proximal ends of the excess suture122, the cutter250can slide along the suture122into tissue through the entry punctured by needle103and anchors144.FIG. 67shows a mid-longitudinal view of the suture cutter250with sharp edges249at the side windows248. As the outer tube247slides against the inner tube246or vice versa, the sharp edges249behave like scissors, cutting the sutures122extending out of the side windows248, as shown inFIG. 68.FIG. 69shows a mid-longitudinal view of suture122cutting by sliding the outer247and inner tube246against each other.FIG. 70depicts suture122cutting with the device250after knot125tying. The cutter250is then withdrawn from tissue. As a result, all components are concealed within the tissue to complete the installation of the minimally invasive approximating device.

One of the most common causes of anal incontinence is scarring of the external sphincter from childbirth. The scarred tissue268of the external sphincter251can be revealed beneath adipose tissue272with retractors196opening a semi-circular incision between the vagina114and the rectum132, as shown inFIG. 71. Currently, the scarred sphincter251is cut, as shown inFIG. 72. Then the scarred tissue268is overlapped, sutured and knotted125to tighten around the internal sphincter252beneath, as indicated inFIG. 73. The tightness of the sphincteric repair is judged by the feel of the surgeon's finger. After surgical repair of the sphincter251, painful defecation is inevitable. Infection is also common.

Sphincter251repair can be minimally invasive using the approximating devices273. To guide the needle103into the proper location, radiopaque, echogenic or other tracing agents can be injected through a lumen269, as shown inFIG. 74, as the needle103advances into the body. Within the loosely packed adipose tissue272, the injected tracing agent is likely to diffuse quickly. However, within highly structured and relatively dense tissue, such as muscle, tendon, ligament or organ, diffusion of the tracing agent is limited, so it might be possible to indicate the shape of the tissue, an important criterion for verifying the target site for suture122anchoring.

The muscular external sphincter251encircles the rectum132beneath the adipose tissue272, as shown inFIGS. 71 and 75. With guidance, the needle103is laterally inserted between the vagina114and rectum132to bridge both sides of the loose external sphincter251. The needle103can be made with a slight curvature for puncturing through skin and adipose tissue272, then into both sides of the loose sphincter251. The anchors144can be inserted with the procedures similar toFIGS. 54 to 58, positioning the pair of anchors144into opposite sides of the loose sphincter251.FIG. 75depicts tightening of the external sphincter251by pulling the suture122and pushing the plunger109against the proximal end of the suture lock239at the same time, as shown inFIG. 61. As a result, the approximating device273restricts and narrows the circular external sphincter251by taking up the scarred268and loose tissue, as shown inFIG. 75. The sutures122can then be knotted125and cut beneath the skin, as shown inFIGS. 62,70and75. The suture122, anchors144and lock239can be made with biodegradable materials. Oozing from the sphincteric251muscle traumatized by insertions of needles103and suture anchors144can initiate permanent tissue adhesion, holding and keeping the sphincter251in the approximated position even after degradation of the suture122and the anchors144.

The tips of most surgical needles are designed to cut as well as puncture into tissue. On the other hand, for delivering the approximating device273along a slender tissue, a tip without cutting edges, similar to a sewing needle shown inFIG. 76, is preferred. The tip with non-cutting edges is more likely to advance within a tissue with longitudinally oriented fibers, especially accompany with rotation during advancement. The slender tissue can be a tendon or a ligament with collagen bundles270formed lengthwise along the tissue.FIG. 77depicts the needle103with non-cutting edges being advanced along a ligament138using rotational motion to drill and split a path between collagen bundles270. The needle103can also be made with flexible or shape memory material, such as nickel-titanium alloy, to conform within the tendon or ligament138. When the appropriate depth of the needle103is reached, both the distal and proximal anchors144can then be individually delivered with sleeves220. To guide the rotational needle103into tissue, radiopaque, echogenic or other tracing agents can also be injected through a lumen269, as shown inFIG. 78.

Uterine prolapse is commonly caused by sagging ligaments. The current treatment is hysterectomy.FIG. 79indicates a cross-sectional view of uterine161supports. The cardinal ligament253provides for lateral support, sacrouterine ligament254for posterior support and fascia255for anterior support to the uterus161.

Similar to the hysterectomy procedure through the vagina114under general anesthesia, the muscles and ligaments are relaxed. The uterus161is pulled down from the vagina114by a grasping device259to expose the cardinal253and sacrouterine254ligaments, as shown inFIG. 80, with ovaries256, fallopian tubes258and round ligaments257within the abdomen. Using various guiding and insertion techniques, the needle103is advanced along the ligament253or254to deliver the anchors144, as shown inFIG. 80. The sutures122are loaded with suture locks239and plungers109. The approximating devices273are then individually tightened by advancing the plungers109against the suture locks239, while the sutures122are being pulled to plicate and shorten the ligament253and/or254, as shown inFIG. 81. In essence, the ligament253and/or254is folded, crinkled or bunched together under the tension of the approximating devices273. As a result, the cervix271and the entire uterus161are lifted by the shortened cardinal253and/or sacrouterine254ligaments.

The shortened ligament can be permanently maintained to uphold the uterus161. As the ligament253and/or254are traumatized by insertions of needles103and anchors144, oozing from the traumatized tissue can initiate tissue adhesion to hold and keep the ligament253and/or254in the plicated position even after degradation of the suture122and the anchors144. The plicated ligament253and/or254also undergo tissue remodeling, including collagen crosslinking, which may also result in permanent shortening of the ligament253and/or254.

A modified procedure and a suture-gripping device are designed for fastening an anchor144within thin tissue.FIG. 82depicts partial insertion of the proximal anchor144of the approximating device273into a thin tissue130.FIG. 83shows a prior art suture-gripping device264, with jutted flaps265biting and resisting upward slippage of the suture122. The suture-gripping device264loaded on the suture122is followed by the plunger109, as indicated inFIG. 84. The needle103and sleeve220are then withdrawn from tissue130. Similar to the procedure depicted inFIG. 61, the sutures122are pulled, and the plunger109is pushed against the suture gripping device264to draw the proximal anchor144into the tissue130and tighten the approximating device273. Then, knots125are tied beneath the gripping device264to secure the sutures122, as shown inFIG. 85.

Accuracy of needle103insertion of the approximating device273can be improved with a guide185, as shown inFIG. 86. The guide185contains a track262for the needle103to slide along, an extendible arm260to align with the needle103, and a pointer261to indicate the target site. In addition, measuring units on the arm260indicate depth of needle103penetration.

As mentioned, the traditional surgical treatment for urinary incontinence is to provide backboard support to the urethral posterior wall151by pulling the vagina114forward with sutures122. The sutures122are then fastened onto the fascia or ligament in the abdominal wall, as indicated inFIGS. 17 and 18. The approximating device273can provide similar backboard support to the posterior wall151without any incision157.FIG. 87depicts the vagina114is dilated with a retractor196. The needle103is inserted through the anterior wall of the retracted vagina114, lateral to the bladder neck112, through the fascia255or ligament into adipose tissue272above the pubic symphysis115. The distal anchor144is then deployed within the adipose tissue272and the proximal anchor155within the vaginal114wall with the suture-gripping device264. The approximating device273is then tightened by pulling the suture122and pushing the plunger109. The tightness of the plication can be seen through the urethra101with an endoscope263. The suture122is then knotted125and cut, as shown inFIGS. 85 and 88.FIG. 88shows a minimally invasive approach to supporting the posterior-urethral wall151of the urethra101by pulling the vaginal114wall forward with approximating devices273. As mentioned, trauma from insertion of needles103and anchors144can lead to tissue adhesion, providing permanent posterior wall151support even after degradation of the suture122, anchor144and gripping device264.

It may also be possible to tighten the bladder neck112and restrict the sphincteric region of the urethra101without involving the ligament or fascia255in the abdominal wall. The needle103can be inserted lateral to the bladder neck112or the urethra101, into the retropubic space274, area between the pubic symphysis115and bladder/urethra127/101, to deliver the distal anchor144. The proximal anchors144are deployed as mentioned within the vaginal114wall. As the approximating devices273are tightened, the bladder neck112as well as the urethra101are sandwiched between the anterior152fascia and the vagina114, as shown inFIG. 89, to tighten the bladder neck112and treat sphincteric deficiency.

The most difficult step in installing the approximating device273is probably the guidance of the needle103safely and accurately into tissue. To maximize the benefit from the effort of needle103insertion, multiple pairs of approximating devices273can be loaded or passed along the needle103, as shown inFIG. 90. With only a single needle103insertion, the approximating strength is greatly enhanced with multiple devices273installed, as shown inFIG. 91.

The dynamics of anchor144pivoting or rotation responding to suture122tension is especially significant within thin tissue130. From observation within transparent gel wax, the initial movement of a crude prototype anchor144responding to suture122tension was in both pullout and lateral rotational directions. A similar result was obtained in meat. The suture122was not truly fastened until the prototype anchor144had rotated from the insertion position to fastening or perpendicular position. Before the fastened position was achieved, the suture122could be pulled with some resistance. The pivotal or rotational efficiency of the anchor144can probably be described by the pullout distance of the pulled suture122. In an experiment using pork and the crude prototype anchor144, the pullout distance was about one and half lengths of the prototype anchor144before the anchor144was secured. Within thin tissue, the anchor144would be pulled out before reaching the fastened position. With modifications to the crude prototype anchor144, rotational efficiency can be significantly improved.

The needle103can also contain an inner and outer sleeves220. The sleeves220are stacked over each other, and both sleeves220capable of sliding over the needle103, as shown inFIG. 92. The lumen104of the distal anchor144fits over the distal portion of the needle103, but too small to fit over the inner sleeve220. The slightly larger lumen104of the proximal anchor144fits over the inner sleeve220, but too small to fit over the outer sleeve220. In essence, the inner sleeve220supports the distal anchor144and the outer sleeve220supports the proximal anchor144, with both sleeves220and anchors144fit over the needle103. Spearheading by the needle103, the anchors144and sleeves220are punctured into tissue. Within a proper depth into the tissue, the inner sleeve220is held stationary while the needle103is partially withdrawn to disengage and deploy the distal anchor144. Similarly, the outer sleeve220is held stationary while the needle103is fully withdrawn to deploy the proximal anchor144.

The fin134can extend beyond the length of the body275and be made pointed to spearhead and expedite the rotation of the suture anchor144, as shown inFIG. 93. The side view of the pointed and extended fin134is more evident inFIG. 94. The sharpened fin134helps lateral penetration into tissue130. Extension of the fin134lengthens L1favors and expedites lateral rotation of the anchor144. Even though L1is significantly lengthened, the suture holes123are still at or near the center of the platform133to prevent excessive rotation after reaching the fastened position.

Anchor144rotation begins with lateral tissue130penetration of the fin134, followed by the proximal end of the body275, then the platform134of the anchor144. To ease tissue130penetration and expedite rotation, the proximal portion of the platform133is tapered and curved toward the fin134, as shown inFIGS. 93 and 94. As the anchor144rotates, the curved platform133follows the fin134and smoothly lodges into the tissue130. The tapered proximal end of the anchor144is supported by a shape-matching step165on the needle103, as shown inFIG. 94. The shape-matching contact between the anchor144and the step165also helps to minimize spinning of the anchor144around the delivering needle103.

Location of the elastic curvature of the anchor144can also affect the rotational efficiency. The curvature near the proximal end of the anchor144is more likely to have better rotational efficiency than the efficiency of the curvature situated near the distal end of the anchor144.

A wide range of materials can be used to fabricate the suture anchor144. Biocompatible polymers, such as polypropylene, polyethylene, poly-ether-ether-ketone, acetal resin, polysulfone and polycarbonate, are possible candidates. For biodegradable capability, the anchor144can be made with polylactate, polyglycolic, poly-lactide-co-glycolide, polycaprolactone, trimethylene carbonate or combinations of these materials. Many of these degradable polymers are in US FDA approved products. Other degradable polymers, such as polydioxanone, polyanhydride, trimethylene carbonate, poly-beta-hydroxybutyrate, polyhydroxyvalerate, poly-gama-ethyl-glutamate, poly-DTH-iminocarbonate, poly-bisphenol-A-iminocarbonate, poly-ortho-ester, polycyanoacrylate and polyphosphazene can also be used. Nickel-titanium alloy, spring-tempered stainless steel, titanium, stainless steel or other metallic material provides strength and durability.

The anchor144can also be coated with biocompatible polymers, such as polyurethane, polytetrafluoroethylene, silicon, ultra high molecular weight polyethylene or other material. For additional biological and surgical benefits, the anchor144can also be coated with lubricants, growth factors, nutrients, buffering agents, collagen, hydroxyapatite, analgesics, sealants, blood clotting agents, antibiotics, radiopaque or echogenic agents. All materials should be able to withstand sterilization by gamma, electron beam, autoclave, ETO, plasma or UV light to prevent infection.

The stepped needle103and sleeve220can be made with stainless steel, titanium, nickel titanium other metal or alloy. The stepped needle103and sleeve220can be coated with lubricant, blood clotting, radiopaque or echogenic agents. For hard-to-reach surgical sites, the stepped needle103can be made curved to gain accessibility for the surgeon. To accommodate the curvature of the stepped needle103, the sleeve220can also be made with elastic material, such as nickel titanium, polypropylene, polyethylene or other flexible material. The stepped needle103and sleeve220can also be coated with lubricant, antibiotic, radiopaque or echogenic agents.

The suture122can be permanent or biodegradable, braided or monofilament. The suture122can also be metallic for strength and durability.

In summary, the anchor144is designed for partial thickness or full thickness suture122anchoring and is delivered with the stepped needle103. Deployment of the anchor144can be as simple as inserting and withdrawing the stepped needle103in and from tissue. The sleeve220sliding over the stepped or a smooth needle103can be helpful in deploying the anchor144and manipulating tissue. The curvature of the anchor144promotes initial anchor144rotation within tissue when tension is applied to the suture122. The fin134is designed to (1) dislodge the anchor144, (2) enhance initial rotation of the anchor144, and (3) stabilize the anchor144during rotation. The platform133, especially fortified with bend stops155, is designed to increase the anchoring strength within tissue. When multiple anchors144are delivered in series into tissue, as the suture122is pulled, the anchors144draw close to each other to plicate or approximate the pierced tissue.

It is to be understood that the present invention is by no means limited to the particular constructions disclosed herein and/or shown in the drawings, but also includes any other modification, changes or equivalents within the scope of the claims. Many features have been listed with particular configurations, curvatures, options, and embodiments. Any one or more of the features described may be added to or combined with any of the other embodiments or other standard devices to create alternate combinations and embodiments.

It should be clear to one skilled in the art that the current embodiments, materials, constructions, methods, tissues or incision sites are not the only uses for which the invention may be used. It has been foreseen that the anchor144and the stepped needle103can be applied in other surgical and non-surgical purposes. Different materials, constructions, methods or designs for the anchor144, stepped needle103or the sleeve220can be substituted and used. Nothing in the preceding description should be taken to limit the scope of the present invention. The full scope of the invention is to be determined by the appended claims.