US20050228407A1 - Suturing method and apparatus - Google Patents

Abstract

A suturing apparatus comprises an elongated body, at least one arms movable relative to the elongated body and at least one needle movable relative to the elongated body. The arm releasably holds an end portion of a length of suture. The arm has a sharp end portion adapted to pierce an inner surface of a wall of a biological structure and pass an end portion of the suture through the inner surface. The needle is adapted to pierce the inner surface of such biological structure at a location proximal to the location where the end portion of the suture was inserted. The needle captures an end portion of the suture from the arm and draws the end portion of the suture back through the inner surface. The end of the suture is then drawn out of the biological structure by removing the elongated body.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a divisional of U.S. application Ser. No. 09/882,821, filed Jun. 14, 2001, which claims the benefit of U.S. Provisional Application No. 60/211,763, filed Jun. 14, 2000, the entirety of both which are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates generally to medical devices, and more specifically to suturing devices and methods for applying suture to internal biological structures. The suturing devices and methods are well-suited for passing suture through the wall of a tubular biological structure from a location within the lumen or around the ostium for the purpose of closing the tubular biological structure. The suturing devices and methods are particularly well-suited for tubal sterilization.
• 2. Description of the Related Art
• Each year, many thousands of women undergo some form of tubal sterilization in the United States and around the world. Tubal sterilization involves the blocking or removal of a segment from each of the fallopian tubes to prevent the fertilization of ovulated eggs. The various surgical methods used to accomplish tubal sterilization include: the laparoscopy method, the abdominal method, and the vaginal method.
• In the laparoscopy method, one or two tiny incisions are made in the abdomen, in or near the navel. The laparoscope, a slim, lighted viewing tube, is inserted and a cauterizing instrument is passed through the laparoscope or through a second incision. The tubes are visualized so the surgeon can cauterize and seal each tube in turn.
• In the abdominal method, a 3 to 4 inch incision is made just above the pubic hairline. The fallopian tubes are cut, sealed, and a section of each tube is removed. The ends of the tubes may be sealed or tied into the surrounding tissue.
• In the vaginal method, the procedure is similar to the abdominal method. However, in this method the incision is made at the top of the vagina to avoid leaving a visible scar.
• Unfortunately, these tubal sterilization procedures are quite invasive and involve the formation of one or more incisions. Because the incisions leave scars and can be damaging to the surrounding tissue, a need exists for an improved method for accomplishing tubal sterilization in a less invasive manner.
• Hysterectomy is a common medical procedure in which the uterus is surgically removed from the body. Surgical removal of the uterus is widely accepted both by medical professionals and the public as an appropriate treatment for uterine cancer, and for various common non-cancerous uterine conditions that can produce often disabling levels of pain, discomfort, uterine bleeding, emotional distress, and related symptoms. A hysterectomy first requires cutting and tying the fallopian tubes to detach the uterus from the fallopian tubes. Accessing the fallopian tubes typically involves the formation of one or more incisions in the patient's skin as described above with respect to tubal sterilization procedures.
• There are two traditional methods for removing the uterus from the body. The first method involves removing the uterus through a cut in the lower abdomen. The second method involves removing the uterus through a cut in the top of the vagina. The top of vagina is then sutured shut. Because these traditional hysterectomy methods involve the formation of one or more large incisions in the patient's abdomen or vagina in order to remove the uterus, a less invasive method is desired.
• One less invasive method of hysterectomy has recently been developed and is known as laparoscopically-assisted vaginal hysterectomy (LAVH). In this procedure, a few small abdominal incisions are made which allow for the insertion of a laparoscope and specially designed instruments designed for detaching and removing the uterus. The procedure is referred to as “vaginal” because the uterus is then removed through the vagina. While this procedure has become quite popular with patients because of the shortened recovery time and reduced scarring, this method has been shown to have a higher complication rate than traditional vaginal or abdominal techniques. Therefore, an improved method for performing a hysterectomy is needed.
• Vasectomy is a medical procedure in which the vas deferentia are surgically interrupted so that the sperm can no longer enter the ejaculatory ducts and fertilization cannot take place. In a conventional vasectomy, the surgeon makes one or two small incisions in the scrotum to gain access to the vas deferens. One vas deferens is isolated, drawn through the incision, and clamped at two sites close to each other. The segment between the clamps is then removed. The surgeon seals either one or two of the cut ends with sutures, clips, or cauterization using an electric needle. The vas deferens is gently placed back into the scrotum and the procedure is then repeated on the other vas deferens.
• No-scalpel vasectomy (NSV) is a less invasive procedure in which the vas deferens are accessed without making any incisions in the scrotum. In this procedure, the surgeon makes only one tiny puncture in the scrotum using a special instrument. The instrument is then used to gently stretch the opening until the vas deferens can be pulled through it. The vas is then blocked using any of the same methods as conventional vasectomy.
• A wide variety of other surgical procedures may involve the application of suture to biological structures, such as, for example, soft tissue approximation and the treatment of bladder or uterine prolapse. These procedures typically require the formation of one or more large incisions through the patient's skin in order to access the target site. Once the target site is accessed, the application of suture to the biological structure is often cumbersome and time consuming due to the anatomy of the biological structure or the consistency of the tissue.
• Thus, there has been a long-felt need for new and improved devices and methods for applying suture to internal biological structures that are difficult to treat with existing suturing devices.
SUMMARY OF THE INVENTION
• The preferred embodiments of the present invention describe devices and methods for applying suture to internal biological structures. The suturing devices provide means for quickly and easily applying suture to areas of the body that are often difficult to access with existing suturing devices and methods. The suturing mechanism of these devices can be operated remotely from outside the body, thereby making it possible to perform a wide variety of surgical procedures in a minimally invasive or non-invasive manner.
• One aspect of the invention relates to a suturing device for closing an opening in a tubular biological structure having an inner surface, such as, for example, a fallopian tube, a common bile duct, or an arterial-venous fistula. One embodiment comprises a suturing device for applying a suture, comprising an elongated body, at least one arm having a suture mounting portion, and at least one needle having a distal end. The suture mounting portion of the arm releasably holds a portion of the suture. The arm is mounted to cause an end portion of the arm to move (i) away from the elongated body from a first position to a second position and (ii) towards the elongated body from the second position to the first position. The end portion of the arm is adapted to penetrate tissue as the arm moves away from the elongated body to the second portion while holding the portion of the suture during such movement. The needle is mounted to move relative to the elongated body, the distal end of the needle movable from a first position adjacent to the elongated body to a second position adjacent the suture mounting portion of the arm when the arm is in the second position. The distal end of the needle is adapted to capture the portion of the suture from the suture mounting portion of the arm and draws the portion of the suture toward the elongated body.
• The suturing device in one preferred embodiment is particularly adapted for closing a conical or funnel-shaped biological structure such as, for example, an ostium or an infundibulum where the uterine cavity narrows into the fallopian tube. However, this embodiment is not limited to such applications, and can be used for other biological structures as well. This embodiment is formed with one or more arms that extend distally and radially at an angle ideally positioned for insertion into the tissue of the funnel-shaped biological structure. This embodiment is also well suited for soft-tissue approximation procedures and can be used to facilitate various steps in a hysterectomy procedure, as described below.
• In another embodiment, the arms of the suturing device can be operated independently, thereby allowing each end portion of the suture length to be applied separately. This modification is ideally suited for closing a gap between a first body structure and a second body structure or for attaching tissue to an adjacent body structure, such as, in the treatment of bladder or uterine prolapse. This modification is also ideally suited for use in achieving male sterilization wherein the suturing device is used to loop suture around a vas deferens.
• In another embodiment, the suturing device is adapted for closing wounds or surgical incisions from the surface of the skin or other biological structure. This modification includes arms that extend beyond the distal end of the elongated body for insertion into the surface from an external location. The distal end of the elongated body is placed against the surface and the arms are extended distally to penetrate the tissue on both sides of the wound. The needles are deployed to capture and withdraw the suture ends from the tissue. After the suture ends have been withdrawn, they are tied together to close the wound.
• Another aspect of the present invention relates to a method of placing a suture. The method comprises positioning a distal portion of an elongated member adjacent a location to be sutured. At least one arm is deployed which releasably holds a portion of a suture. A sharp end portion of the arm penetrates tissue. A needle also penetrates tissue and is driven toward the suture portion. The suture portion is captured from the arm with the needle and drawn through the tissue and toward the elongated body.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of one embodiment of the suturing device of the present invention.
• FIG. 2 is a perspective view of a distal portion of the device ofFIG. 1.
• FIG. 3 is a perspective view of the distal portion of the device ofFIG. 1 with a pair of arms in the deployed position.
• FIG. 4 is a perspective view of an arm ofFIG. 3.
• FIG. 5 is a side view of the distal portion of the device ofFIG. 1 inserted in a tubular biological structure, with the tubular biological structure shown partially cut-away.
• FIG. 6 is a side view of the distal portion of the device ofFIG. 5 with a pair of arms opening.
• FIG. 7 is a side view of the distal portion of the device ofFIG. 5 with the arms piercing the walls of the tubular biological structure.
• FIG. 8 is a side view of the distal portion of the device ofFIG. 5 with a pair of needles engaging the arms.
• FIG. 9 is a side view of the distal portion of the device ofFIG. 5 with a suture placed in the walls of the tubular biological structure by the arms and needles of the distal portion of the device ofFIG. 1.
• FIG. 10 is a side view of the distal portion of the device ofFIG. 5, the suture ofFIG. 9 pulling the walls of the tubular biological structure together.
• FIG. 11 is a side view of the distal portion of the device ofFIG. 1, with a pair of needles engaging a pair of arms beyond the walls of a tubular biological structure shown partially cut-away.
• FIG. 12 is a side view of the distal portion of the device ofFIG. 1 with a pair of needles engaging a pair of arms in the walls surrounding a rupture or tear of a biological structure, shown partially cut-away.
• FIG. 13 is a partial cross-sectional view of a first suture placed in a tubular biological structure by the distal portion of the device ofFIG. 1 and a cutting device severing the tubular biological structure into a distal end and a proximal end.
• FIG. 14 is a partial cross-sectional view of the distal portion of the device ofFIG. 1 placing a second suture in a proximal end of a severed tubular biological structure.
• FIG. 15 is a partial cross-sectional view of a first suture in the distal end of the severed biological structure ofFIG. 14 and a second suture in a proximal end of the severed tubular biological structure.
• FIG. 16 is a partial cross-sectional view of a first securement in the first suture and a second securement in the second suture ofFIG. 15.
• FIG. 17 is a perspective view of a second preferred embodiment of the suturing device of the present invention.
• FIG. 18 is a side view of the distal portion of the device ofFIG. 17.
• FIGS. 19A-19D are partial cross-sectional views of the distal portion ofFIG. 17 as the arms and needles are deployed.
• FIGS. 20A-20F are side views of the distal portion of the device ofFIG. 17 as used to apply suture to an ostium, with the ostium shown partially cut-away.
• FIG. 21 is a perspective view of the distal portion of another embodiment of a suturing device, wherein the suturing mechanism comprises two arms and two needles per arm in a side-by-side configuration.
• FIG. 22 is a side view of the distal portion of another embodiment of a suturing device, wherein the suturing mechanism comprises two arms and two needles per arm in an inner-outer configuration.
• FIG. 23 is a side view of the distal portion of another embodiment of a suturing device, wherein the suturing mechanism comprises four arms and four needles.
• FIG. 24 is a side view of the distal portion of another embodiment of a suturing device, wherein the distal portion of the device is formed with a flat surface.
• FIG. 25A-25C are side views of the device ofFIG. 24 used to close an incision from an external location, with the incision shown partially cut-away.
• FIG. 26A is a perspective view of another embodiment of a suturing device, wherein the arms and needles of the suturing mechanism can be operated independently.
• FIG. 26B is a side view of the distal portion of the device ofFIG. 26A.
• FIG. 27A is a side view of the distal portion of the device ofFIG. 26A, shown attaching two biological structures.
• FIG. 27B is a cross-sectional view of the biological structures ofFIG. 27A attached together.
• FIG. 28A is a perspective view of another embodiment of a suturing device, wherein the arms and needles can be deployed asymmetrically.
• FIG. 28B is a side view of the distal portion of the device ofFIG. 28A.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• The application of suture to an internal biological structure can often be difficult due to the location of the target site in the body. Therefore, a suturing procedure often requires the formation of one or more large incisions through the patient's skin simply to access the target site. Because of the highly invasive nature of such procedures and other difficulties associated with suturing internal biological structures, there is an urgent need for improved suturing devices and methods that can be used in a less invasive manner. Various forms of improved suturing devices are disclosed in U.S. Pat. No. 5,860,990 to Nobles et al., and U.S. Pat. No. 6,117,144 to Nobles et al., both of which are incorporated herein by reference in their entirety.
• FIG. 1 illustrates asuturing device100 in accordance with one embodiment of the present invention. The apparatus includes, generally, ashaft102 for insertion into an internal biological structure, amain body104, atrigger actuator106 for actuating the suturing mechanism, and ahandle108 for gripping and manipulating the device. Theshaft102 is preferably flexible to allow it to bend when advanced through an internal biological structure, such as a body lumen. The length of theshaft102 may be modified to accommodate various suturing applications. Thetrigger106 is formed with afinger aperture110 to ensure secure engagement with the physician's hand. Alever112 is provided for controlling the deployment of the distal suturing components and is contained within ahorizontal slot114 and avertical slot118 on thehandle104. Thetrigger106 andlever112 are operatively connected to thedistal portion200 of thesuturing device100 and may be used to remotely manipulate the components of thedistal portion200.
• FIGS. 2 and 3 illustrate thedistal portion200 of thedevice100 in greater detail. Thedistal portion200 comprises asuture introducer head202, a pair ofarms204,204′, a pair ofarm apertures210,210′, a pair of curved or slanted upper arm guides282,282′, a pair of lower arm guides280,280′, a pair ofneedle apertures214,214′, a pair ofneedles216,216′, a pair of curved needle guides215,215′ and anactuating rod226. When thearms204,204′ are retracted into thearm apertures210,210′, the arms are recessed within theintroducer head202 so that the arms do not cause tissue damage upon insertion and retraction of thedistal portion200 from a biological structure.
• FIG. 3 illustrates thedistal portion200 of thedevice100 ofFIG. 1 with thearms204,204′ deployed outwardly from their recessed position. Such deployment is achieved by moving thelever actuator112 upwardly. InFIG. 3, theshaft102 is preferably a multi-lumen tube with acenter lumen224, twoneedle lumens220,222 and twoother lumens221,223. Theneedles216,216′ may be advanced from a recessed position within themain body104 to a distally extended position by squeezing thetrigger actuator106. When the twoneedles216,216′ are moved distally, the needle guides215,215′ (FIG. 2) guide theneedles216,216′ out of theneedle apertures214,214′ at an angle relative to the axis of theactuating rod226.
• FIG. 4 shows details of thearm204. Theother arm204′ (FIG. 3) is identical to thearm204 shown inFIG. 4. Thearm204 comprises asharp end208, aneedle receiving aperture218, asuture end support206, asuture support212, ahinge228, apin slot230 and ahinge receiving portion232. Thehinge receiving portion232 receives a hinge portion of theother arm204′. Except for the configuration of thearms204,204′, the structural components are similar to those shown and described in U.S. Pat. No. 6,117,144 and U.S. patent application Ser. No. 09/524,211, filed Mar. 13, 2000, both of which are incorporated herein by reference in their entirety. The distal end of the actuating rod226 (the end furthest from themain body104 ofFIG. 1) is attached to the hinge portions of thearms204,204′ via a pin (not shown). Actuation of theactuating rod226 controls the movement of thearms204,204′.
• Before operation, thearms204,204′ are pre-loaded with the ends of a suture, such as a polypropylene suture. Specifically, each end of a suture has a capture portion comprised of a loop, a sphere or a ferrule. In one embodiment, the loop, sphere or ferrule may be formed (e.g., by heat molding) with the same suture material as the length of suture. In another embodiment, the loop, sphere or ferrule may be a separate piece attached (e.g., molded, glued, etc.) onto each end of the length of suture. The loop, sphere or ferrule is loaded in each suture end support206 (FIG. 4) of thearms204,204′. Thesuture support212 receives a portion of the suture which adjoins the loop, sphere or ferrule. The remaining length of the suture is loaded into the distal end of theintroducer head202 and into one of thelumens221,223 shown inFIG. 3.
• When the lever actuator is moved upwardly, theactuating rod226 translates proximally. As theactuating rod226 translates proximally, theends208,208′ of thearms204,204′ come in contact with the curved, upper arm guides282,282′ and cause thearms204,204′ to deploy radially. In one embodiment, thearms204,204′ continue to deploy radially until thearms204,204′ are substantially parallel to each other and perpendicular to the axis of the main body, as shown inFIG. 3. In other embodiments, thearms204,204′ are considered fully deployed when they reach an acute or obtuse angle relative to each other. When thearms204,204′ are fully deployed, either parallel to each other or at an angle, the physician may squeeze thetrigger actuator106 to move theneedles216,216′ distally. In one embodiment, theneedles216,216′ may be moved distally at substantially the same time. In another embodiment, theneedles216,216′ are actuated separately so that oneneedle216 moves before theother needle216′.
• Theneedles216,216′ move distally at an angle or along a curved path until the tips of theneedles216,216′ engage the capture portion of the suture ends (e.g., loop, sphere or ferrule) lying within the suture end supports206,206′. Such engagement causes the suture capture portions to become attached to the ends of theneedles216,216′, respectively. The physician then returns the trigger actuator to its original position to cause theneedles216,216′, with the ends of the suture attached to the ends of theneedle216,216′, to retract proximally back into theintroducer head202 and theshaft102. The physician then moves the lever actuator such that theactuating rod226 translates distally. As theactuating rod226 translates distally, thearms204,204′ come in contact with the lower arm guides280,280′, which causes thearms204,204′ to return to their retracted position as shown inFIG. 2. The physician then removes thedistal portion200 from the patient. As tension is applied to the suture ends, the length of the suture in the distal end of thehead202 is pulled out of thedistal portion200.
• Thesuturing device100 ofFIG. 1 may be used to suture a variety of biological structures. In general, the physician inserts thedistal portion200 into a cavernous or tubular structure within a patient to place a suture through two tissue portions. Thedistal portion200 is then withdrawn from the patient to draw the two suture ends outside of the patient. The physician ties a knot with the suture ends, slides the knot down to the suture site, and cuts the lengths of suture that are unused. One preferred method involves use of thedevice100 to close a fallopian tube. Other methods may, for example, involve closing a common bile duct, or an arterial-venous fistula.
• In one application, shown inFIG. 5, the physician inserts thedistal portion200, preferably with a thin sheath (not shown) covering thedistal portion200, into a patient's vagina and into afallopian tube232. The sheath protects thedistal portion200 from a non-sterile environment, such as the vagina. Although theshaft102 can be inserted directly into the fallopian tube, it may be desirable to use a guidewire to guide the placement of thedistal portion200. After the guidewire is inserted into the fallopian tube, theshaft102 is advanced along the guidewire with the guidewire within a lumen extending through thedistal portion200. The physician positions the introducer head at a desired suture location within the fallopian tube. During insertion and positioning, thearms204,204′ are in a retracted position, with eacharm204,204′ holding one end (loop, sphere or ferrule) of a suture. The length of the suture between the end portions is stored within theintroducer head202 and/or theshaft102 and may extend outside the handle body (104 ofFIG. 1).
• Referring toFIG. 5, after thedistal portion200 is positioned at the desired location, the sheath is withdrawn to expose thearms204,204′. Thelever112 is then moved to actuate thearms204,204′.FIG. 6 illustrates thedistal portion200 with the pair ofarms204,204′ beginning to open radially outwardly.
• As shown inFIG. 7, as thearms204,204′ pivot outwardly, the sharp ends208,208′ of thearms204,204′ pierce the interior surface of thewalls230 of thefallopian tube232. Additionally, although thearms204,204′ are shown as being substantially planar with the sharp ends208,208′ pointed in the direction of the longitudinal axis of thearms204,204′, other configurations may be used. For example, in some situations, it may be desirable to orient the sharp ends208,208′ at an angle relative to the longitudinal axis of thearms204,204′ so that the sharp ends208,208′ will be pointed more or less perpendicular to the inner surface of thewalls230 when it contactssuch walls230.
• In one variation, thearms204,204′ are deployed until thearms204,204′ are parallel to each other as shown inFIG. 8. The length of thearms204,204′ and/or the diameter of theintroducer head202 are selected such that the needle receiving apertures of thearms204,204′ are well beyond the inner wall surface of thefallopian tube232 when the arms are fully extended radially outwardly in a deployed position. Preferably, thearms204,204′ penetrate approximately 1.0 mm into thewalls230 of thebiological structure232 on each side of thedistal portion200. However, the depth of penetration may be varied without departing from the spirit of the invention.
• As shown inFIG. 8, after the arms have been extended to pierce the fallopian tube, thetrigger106 is moved to advance theneedles216,216′ towards the needle receiving portions of the arms. As theneedles216,216′ are advanced, they pierce thewalls230 of thefallopian tube232 at a location proximal to the location where thearms204,204′ pierced thewalls230. Theneedles216,216′ continue to advance through tissue until they engage the capture portion (e.g., loops, spheres or ferrules) at the ends of the suture held by thearms204,204′, as described above.
• When theneedles216,216′ are withdrawn back into theintroducer head202, the ends of the suture are also drawn into thedistal portion200, as shown inFIG. 9. Thesuture234 thus passes through opposing sides of thewalls230 of thefallopian tube232 with the ends of the suture captured by theneedles216,216′. InFIG. 9, the physician has retracted both theneedles216,216′ and thearms204,204′. The physician removes thedistal portion200 from the patient, and the length ofsuture234 between the end portions is released from the distal end of theintroducer head202. Once thedistal portion200 is outside the patient, the physician detaches the ends of thesuture234 from thedistal portion200.
• FIG. 10 illustrates tension being applied to thesuture234 during withdrawal of thedistal portion200. Such tension pulls thewalls230 of thefallopian tube232 inwardly. Such pulling also causes thefallopian tube232 to constrict longitudinally. After thedistal portion200 is removed from the patient and the suture end portions detached therefrom, the physician forms a self-cinching knot, such as a clinch knot or a half hitch, with the suture end portions that extend outside of the patient and slides the knot down the fallopian tube to the suture site. The knots may be advanced to the suture site using, for example, any of the devices disclosed in co-pending U.S. application Ser. No. 09/571,759, filed May 15, 2000, which is incorporated herein by reference in its entirety. As the knot reaches the suture site, it will apply tension to the portion of the suture extending through thewalls230 and draws the walls together as well as longitudinally shorten the fallopian tube. Additional self-cinching knots may be pushed down on top of the first knot to lock the first knot in place, and the lengths of thesuture234 extending from the knot are cut by the physician. Thesuture234 is preferably made of a biocompatible material.
• Although the above-discussed procedure passed the suture through walls of the fallopian tube without penetrating the exterior surface of the fallopian tube, it will be understood that thesuturing device200 may also be configured to pass the suture completely through the walls so as to penetrate the exterior surface of the fallopian tube.FIG. 11 illustrates thedistal portion200 of thedevice100 ofFIG. 1 with both theneedles216,216′ and thearms204,204′ extending through exterior surface of thewalls250,252 of a tubularbiological structure251, such as a fallopian tube. Thearms204,204′ fold outwardly and puncture thewalls250,252 such that the capture portion of the suture is exterior to thetube251. As the unfolding arms engage the tissue to begin such penetration, the physician preferably pulls thedistal portion200 proximally to cause the pointed ends of the arms to be driven into the tissue and through thewalls250,252. Theneedles216,216′ pass through the tissue at a location proximal to thearms204,204′ and engage the capture portions of the suture that are within the suture end supports206,206′. The physician then withdraws theneedles216,216′ and the ends of thesuture234 into theintroducer head202, retracts thearms204,204′, and removes theintroducer head202 from the patient. The physician then secures thesuture234 with a securement, such as a knot, as described above with reference toFIGS. 9 and 10.
• FIG. 12 illustrates thedistal portion200 of thedevice100 ofFIG. 1 with theneedles216,216′ engaging thearms204,204′ in the walls of another type ofbiological structure240. InFIG. 12, thedistal portion200 is used to close asuture site242, such as an incision, rupture or tear, within thebiological structure240. For example, the rupture or tear can be an aneurysm. In operation, the physician inserts theintroducer head202 into acavity244 and deploys thearms204,204′. The physician manipulates thearms204,204′ to pierce the walls of thestructure240. The physician then moves theneedles216,216′ distally until they engage thearms204,204′ in the walls of thebiological structure240. The physician retracts theneedles216,216′ and the suture ends into theintroducer head202. The physician removes theintroducer head202 from the suture site and then removes the ends of the suture from theintroducer head202. The physician secures the suture with a securement such as a knot or clip. The physician then cuts the remaining, unused ends of the suture.
• FIGS. 13-16 illustrate a method of using thedevice100 ofFIG. 1 to suture a tubular structure, such as a fallopian tube, at proximal and distal locations that are spaced from each other. In reference toFIG. 13, the physician initially uses thedistal portion200 to place afirst suture234 in the tubular structure as described above with reference toFIG. 11. The physician removes theintroducer head202 from the tubular structure, pulls the suture ends taut, and secures thefirst suture234 with afirst knot270 or clip near the first suture site. The physician cuts and removes the remaining, unused ends of thesuture234.
• As illustrated inFIG. 13, the physician then inserts ashaft260 into the tubular biological structure. Preferably, theshaft260 is flexible or bendable such that the physician can insert and position theshaft260 at a desired location within the tubular structure. Acutter264 is attached to the distal end of theshaft260 by apivot pin262. In another embodiment, thecutter264 and theshaft260 are integrated as a single piece. In one embodiment, more than one cutter may be attached to theshaft260 by one or more pivot pins. In one embodiment, the cutter is a fan-shaped blade.
• During insertion of theshaft260 into the tubular biological structure, thecutter264 retracted. Once theshaft260 andcutter264 are positioned at a desired location near thefirst suture knot270, the physician deploys thecutter264. In one embodiment, thecutter264 may be attached to an actuating rod or a spring that is attached to a lever or actuating rod at the proximal end of theshaft260 outside of the tubular structure. The physician deploys thecutter264 by pushing or pulling the lever or actuating rod outside of the tubular biological structure.
• When thecutter264 is deployed, thecutter264 pierces the walls of the tubular biological structure. The physician rotates thecutter264 to completely sever the tubular structure and thereby create adistal end266 and aproximal end268. The physician then retracts thecutter264 and removes theshaft260.
• As shown inFIGS. 14-15, the physician then inserts thedistal portion200 of thedevice100 ofFIG. 1 (either thesame device100 loaded with another suture or another pre-loaded device100) into the tubular structure and advances theportion200 to a position near thesecond end268. In one embodiment, a flexible, hollow tube with an inflation lumen and an inflatable balloon is inserted over theshaft102. The physician causes the balloon to inflate and come in contact with the inner walls of thesecond end268 of the severed tubular biological structure. Thus, the inflated balloon supports thesecond end268 of the severed tubular biological structure as thedistal portion200 of thedevice100 is used to place asecond suture274.
• After thesuture274 has been passed through the tissue at theend268, the physician removes theintroducer head202 from the tubular structure, pulls the second suture ends taut, and secures thesecond suture274 with asecond knot272 or clip, as illustrated inFIGS. 15-16. The physician cuts and removes the remaining, unused ends of thesuture274.
• The order of the acts described above with reference toFIGS. 13-16 may be rearranged in other embodiments of the suture method. For example, in one embodiment, the physician places thefirst suture234 in the tubular biological structure, pulls thefirst suture234 taut, forms afirst securement270 with ends of thefirst suture234, cuts the remaining, unused ends of thefirst suture234, places thesecond suture274 but does not form a securement yet, inserts the flexible, hollow tube with the balloon, inflates the balloon for support, inserts thecutter264 to cut the tubular biological structure into afirst end266 and asecond end268, pulls thesecond suture274 taut, forms asecond securement272 with ends of thesecond suture274 and finally cuts the remaining, unused ends of thesecond suture274.
• It will also be appreciated that the suturing device described inFIGS. 1-4 may incorporate more or less than two arms and needles in order to close the fallopian tube or other biological structure. Suturing devices with multiple arms and needles are described below and in U.S. Pat. No. 6,117,144 and U.S. patent application Ser. No. 09/524,211, filed Mar. 13, 2000, referenced above. By providing more than two arms and two needles around the circumference of theshaft102, suture can be applied to more effectively close the body lumen.
• FIG. 17 illustrates asuturing device300 in accordance with a second preferred embodiment of the present invention. One preferred use of this embodiment is to close an infundibulum, particularly the conical or funnel-shaped cavity where the uterine cavity narrows into the fallopian tube. Other uses of this embodiment include soft tissue approximation in general surgical applications (such as laparoscopy), post-hysterectomy closure of a vagina (e.g., vaginal closure at the junction between the vagina and the uterus/cervix), treatment of prolapse by attachment of a bladder or uterus to an adjacent or distant body structure, closure of blood vessels, and closure of wounds or surgical incisions in the skin.
• Still referring toFIG. 17, thesuturing device300 includes, generally, anelongated shaft302 for insertion into an internal biological structure, amain body304, aplunger306 and ahandle308 for gripping the suturing device. Theplunger306 is located at the proximal end of themain body304 and is operatively connected to thedistal portion400 of thesuturing device300. Actuation of the plunger provides a means for remotely manipulating the suturing components, as described below. The suturing device includes a distalannular mechanism310 that can be turned to articulate or bend the distal end of the elongated shaft. Furthermore, the suturing device also includes a proximalannular mechanism312 that can be turned to rotate the entire elongated shaft. The articulation and rotation of the elongated shaft are advantageous for advancing the device through or around biological structures, and for placement of the device in difficult to reach locations.
• FIG. 18 illustrates thedistal portion400 of thesuturing device300 ofFIG. 17 in greater detail. Thedistal portion400 includes a conically-shapednose portion402, a pair ofarms404,404′, a pair ofarm apertures406,406′, a pair ofneedles416,416′ and a pair ofneedle apertures414,414′. Thenose portion402 is adapted for insertion into an ostium, infindibulum or similarly shaped structure and provides a means to enable access into narrow passageways or openings. The nose portion may also be used to place the suturing device in optimum position of contact within the surrounding tissue. Thearms404,404′ extend through thearm apertures406,406′ for penetrating the surrounding tissue in, for example, a conical or funnel-shaped biological structure such as an ostium. Theneedles416,416′ extend through theneedle apertures414,414′ for capturing the end portions of the suture from the arms and withdrawing them back toward the device. Anopening428 is provided near or on thenose portion402 to provide a location for the suture material to extend out of thedevice300, as shown inFIG. 20A below.
• FIGS. 19A-19D sequentially illustrate the movement of the arms and needles of the suturing device shown inFIGS. 17-18.FIG. 19A shows thearms404,404′ in the recessed position within theapertures406,406′ in thedistal portion400 of the suturing device. In the recessed position, the arms are fully contained within the suturing device and are configured in a substantially parallel arrangement. The proximal ends of the arms are coupled together by ahinge408. InFIG. 19B, the arms are shown partially advanced such that the distal end of each arm contacts aspreader mechanism412 thereby causing thearms404,404′ to separate. As the arms are extended farther, they are guided outward through thearm apertures406,406′. InFIG. 19C, thearms404,404′ are shown in the fully deployed position, such that each arm extends outward distally and radially away from the distal end of the device. InFIG. 19D, the suturing device is shown with theneedles416,416′ in the extended position, such that the distal end of the needles engage theneedle receiving portions418,418′ of thearms404,404′.
• A method of using the device ofFIG. 17 on a tapered or narrowing body structure, such as the opening of a fallopian tube, is illustrated sequentially inFIGS. 20A through 20F. The physician initially advances thedistal portion400 of the elongated shaft of the suturing device through the patient's body toward the desiredbody structure420, such as an ostium. The body structure may be accessed by various methods including: transcervically, transvaginally, percutaneously, laparoscopically, or through an incision in general open surgery. During the insertion of the suturing device, the elongated shaft may be articulated and rotated relative to the main body in order to steer the distal portion through the body structure.
• Once the physician places thedistal portion400 of the suturing device at the desired location within thebody structure420, the plunger306 (shown inFIG. 17) is rotated to advance thearms404,404′ out of thearm apertures406,406′ as shown inFIG. 20A. The plunger may be used to advance the arms through a variety of mechanisms. For example, the plunger may be coupled to a threaded screw in the main body and the arms may be coupled to a threaded nut. By rotating the plunger, the nut is advanced or retracted longitudinally along the length of the screw. Further mechanisms for operating the plunger are described in the above-referenced U.S. Pat. No. 6,117,144 and U.S. patent application Ser. No. 09/524,211, filed Mar. 13, 2000, the entirety of which are incorporated by reference. As the arms are advanced outward and become fully deployed, the distal portion of each arm penetrates the tissue of thebody structure420. As the arms penetrate the tissue, the end portions of thesuture422 are inserted into the tissue as shown inFIG. 20B.
• After the arms are fully deployed, the physician pushes the plunger distally relative to the main body to advance theneedles416,416′ through the needle apertures and out toward the needle receiving portion of each arm as shown inFIG. 20C. As each needle is advanced, it pierces the tissue of thebody structure420 at a location proximal to the location where the arm pierced the tissue. The needles continue to advance through the tissue until they engage thecapture portion424,424′ (e.g. loops, spheres or ferrules as described above) at the ends of the suture. The needles are then retracted by pulling the plunger proximally relative to the main body thereby removing the suture from the needle receiving portion of each arm and drawing the suture ends back toward the suturing device as shown inFIG. 20D. It should be noted that each suture end portion is inserted into the tissue by an arm along a first path and then retracted from the tissue by a needle along a second path. Therefore, the suture captures a portion of tissue denoted as426,426′ inFIG. 20D.
• After the suture has been applied through the tissue of the biological structure, the arms are retracted by rotation of the plunger in the other direction. The arms are retracted so that the suturing device can be removed from the biological structure without damaging the surrounding tissue. The physician removes the suturing device from thebiological structure420 with the capture portions of the suture ends still held by the needles as shown inFIG. 20E. If necessary, this procedure may be repeated to insert multiple sutures through the walls of the ostium. After the suture(s) are in place, the end portions of each suture are drawn together to create tension and pull the walls of the biological structure into contact with each other as shown inFIG. 20F. The suture ends are secured together with a securement, such as a knot, as described above and to close the biological structure.
• The second preferred embodiment described above inFIGS. 17 through 20F advantageously incorporates arms that penetrate the walls of a biological structure at an acute angle relative to theshaft302. When the arms are in their fully extended position, they form an angle relative to each other that is less than 180°, more preferably, about 90°. The “forward-firing” arms of the second preferred embodiment are particularly advantageous for penetrating ostium-shaped tissue structures. The angle of the arms enables the needles to penetrate deeply into tissue, thereby allowing the suture to grab more tissue and form a stronger connection. The angle also enables the arms to penetrate difficult to reach locations.
• FIGS. 21 through 23 show modifications of the second preferred embodiment of the suturing device whereby multiple sutures can be applied simultaneously.FIG. 21 illustrates thedistal portion500 of a suturing device having widenedarms504,504′ that are each formed with two suture end supports520,520′ and522,522′ in a side-by-side arrangement. Two pairs ofneedles516,518 and516′,518′ are provided, one pair of needles on each side. On each side, afirst needle516 cooperates with afirst end support520 and asecond needle518 cooperates with asecond end support522.Needles516 and516′ work together to apply a first suture and needles518 and518′ work together to apply a second suture. By advancing and retracting both sets of needles at the same time, this embodiment can be used to simultaneously apply two parallel sutures.
• FIG. 22 illustrates another modification of the second preferred embodiment in which multiple sutures can be applied simultaneously in a colinear arrangement. Thedistal portion600 of a suturing device in accordance with this embodiment includes a pair ofarms604,604′ that are each formed with two suture end supports620,622 and620′,622′. In this modification, the end supports on each arm are arranged such that one of the end supports is distal to the other along the length of the arm. Twoneedles616,618 and616′,618′ are provided on each side arranged in an inner-outer configuration. Thefirst needle616 advances into the outersuture end support620 and thesecond needle618 advances into the innersuture end support622.Needles616 and616′ work together to apply a first suture and needles618 and618′ work together to apply a second suture. By advancing and retracting both sets of needles at the same time, this embodiment can be used to simultaneously apply two colinear sutures. The colinear sutures are configured with one on top of the other such that a top suture extends into the tissue at locations proximal and distal to the bottom suture.
• FIG. 23 illustrates yet another modification to the second preferred embodiment of the suturing device whereby multiple sutures can be applied simultaneously. Thedistal portion700 of a suturing device in accordance with this modification comprises fourarms704,704′,704″,704′″ and fourneedles716,716′,716″,716′″ equally spaced about thedistal portion700 of the suturing device. This embodiment is designed for simultaneously applying two perpendicular sutures to a conical or funnel-shaped biological structure, such as an ostium. In further modifications, the suturing device can be formed with any even number of arms and needles, such as, for example, six or eight.
• FIG. 24 illustrates yet another embodiment of a suturing device of the present invention. Thedistal portion800 of this suturing device is formed with a flatdistal surface802 such that thearms804,804′ and needles816,816′ extend distally beyond the flatdistal surface802 of the elongated shaft when fully deployed. In this embodiment, the suture is provided to the arms through an opening in the distal end of the device. This embodiment may be advantageously used to apply suture to a substantially flat body structure from an external location and is particularly advantageous for closing wounds or surgical incisions.
• A method of using the device ofFIG. 24 for closing an incision in the skin or surface of another biological structure is illustrated sequentially inFIGS. 25A through 25C. As shown inFIG. 25A, the flatdistal surface802 of thesuturing device800 is placed against a substantially flat region oftissue820 such that the longitudinal axis of thedevice800 is substantially perpendicular to the plane of thetissue820. The plunger mechanism (not shown) is rotated to deploy thearms804,804′ thereby inserting the end portions of thesuture822 into thetissue820, one end portion on each side of the incision. The plunger mechanism is then advanced distally to extend theneedles816,816′ into thetissue820 and capture the end portions of thesuture822. By moving the plunger proximally, the needles are withdrawn thereby pulling the end portions of thesuture822 out of thetissue820 as shown inFIG. 25B. The end portions of thesuture822 are then pulled to close the incision as shown inFIG. 25C.
• It will be appreciated that for each of the embodiments described above, the arms and/or needles can be deployed simultaneously or sequentially.FIGS. 26A and 26B illustrate one embodiment which enables independent deployment of the arms. Thesuturing device900 includes, generally, anelongated shaft902 for insertion into an internal biological structure, amain body904, twoactuation mechanisms906,906′ and ahandle908 for gripping the suturing device. Theactuation mechanisms906,906′ are located at the proximal end of themain body904 and are operatively connected to thedistal portion1000 of thesuturing device900. In this modification, each of thearms1004,1004′ can be actuated independently through independent manipulation of theactuation mechanisms906,906′. In such applications, the first needle/arm pair1004,1016 would be actuated independently of the secondneedle arm pair1004′,1016′ (shown inFIG. 27A).
• The use of independently deployable arms allows for suturing across large gaps in tissue by first placing a first end of a suture in one area of tissue and then moving the device and placing a second end of the suture in a different area or tissue. In operation, one end of the suture is passed through tissue on one side of a cavity using the firstneedle arm pair1004,1016. The other end of the suture is passed through tissue using the second needle/arm pair1004′,1016′ on the other side of the cavity. This feature may also be advantageous for moving a body structure and attaching it to a new location such as in the treatment of bladder or uterine prolapse.
• Independent actuation of the arms can also be advantageously used to attach or suspend a first body structure to a second body structure. The body structures used in this method can be any implantable or biological structures, including bones, ligaments, muscle tissue and body organs. In operation, one end of a suture is looped around afirst body structure1050 for use as an anchor as illustrated inFIG. 27A. One of thearms1004′ is deployed on one side of thebody structure1050 and thecorresponding needle1016′ is deployed on the other side of the first body structure, such that thearm1004′, theneedle1016′ and the elongated body surround the body structure. One end portion of thesuture1022 is passed from thearm1004′ to theneedle1016′ to form a loop around the first body structure.
• The other end portion of the suture can then be threaded through a second body structure ortissue1020 that is adjacent to, or distanced from, the first body structure. A penetratingarm1004 penetrates thetissue1020, and a deployingneedle1016 is moved relative to thearm1004 to retrieve the suture end held in thearm1004. Alternatively, the second arm and needle can be used to loop a suture around a second body structure, as with the first arm and needle. The ends of thesuture1022 are then pulled tight to bring thebody structure1050 and thetissue1020 together as illustrated inFIG. 27B.
• It will be appreciated that thearms1004 and1004′ can be deployed in any preferred sequence, and thus,arm1004 can be used to penetrate tissue beforearm1004′ is used to loop a body structure. It will also be appreciated that thearms1004 and1004′ can be deployed simultaneously. In one embodiment of the device ofFIG. 27A, thearm1004′ that is positioned around the body structure has a blunt tip, while thearm1004 that penetrates tissue has a sharp tip.
• The embodiment ofFIG. 27A may also be used for suspending an organ from an adjacent or distant body structure, such as, for example, in the treatment of bladder or uterine prolapse. Organ suspension may be accomplished with this embodiment by penetrating an arm and firing an needle into an organ to place a first end of a suture, moving the suturing device to traverse a space, and then positioning a second arm and firing a second needle around a ligament to loop the second end of the suture around the ligament. By tightening the suture, the organ is suspended by using the ligament.
• The ability of the suturing device to loop suture around a body structure may also be advantageously applied to an improved method for performing male sterilization. The vas deferens are first accessed using either a conventional approach (through scrotal incisions) or through a tiny puncture (similar to the no-scalpel vasectomy approach). After accessing the vas deferens, one arm of the suturing device is then deployed on one side of the vas deferens and one needle is deployed on the other side. The needle picks up the suture to loop suture around the vas deferens. The suture is then pulled tight and tied off to block the lumen in the vas deferens thereby blocking the flow of sperm into the ejaculatory ducts.
• Other devices, including those described above, may also be used for looping suture around a body structure or for suspending a first body structure to a second body structure. For example, suturing devices may be used in which the arms are not moveable from within the elongated body to outside the elongated body. Rather, in these embodiments, the arm or arms may be fixed relative to the elongated body, and may simply be placed around the body structure to be suspended before the needles are deployed. Furthermore, once a first body structure is suspended to a second body structure, it will be appreciated that the distance between the two structures can be adjustable using an adjustment feature, such as a turnbuckle, that can be utilized to draw up an organ, or draw to an organ.
• It will also be appreciated that a suturing device with one or more fixed arms extending from the elongated body can be used in other applications as well. For example, this device can be used to place suture into tissue simply by manipulating the device such that the arm or arms punctures the desired tissue location. The needles then deploy in the manner described above to grab the suture ends mounted on the arms of the device.
• FIGS. 28A and 28B illustrate yet another embodiment of a suturing device of the present invention. The suturing device1100 includes, generally, anelongated shaft1102 for insertion into an internal biological structure, amain body1104, aplunger1106 and ahandle1108 for gripping the suturing device. Theplunger1106 is located at the proximal end of themain body1104 and is operatively connected to thedistal portion1200 of the suturing device1100. In this modification, thearms1204,1204′ are simultaneously deployed into an asymmetrical configuration using asingle plunger1106. This modification can be advantageously used to simultaneously penetrate different types of tissue that require different angles of entry or different tissue capture geometries. This modification can also be used for surrounding a body structure with a first arm/needle pair and applying suture through tissue with the other arm/needle pair. With this embodiment, theneedle1216,1216′ have trajectories that are preferably adjusted to find the proper placement in thearms1204,1204′. This embodiment can also be combined with independent arm actuation, as described above with reference toFIGS. 26A-27B, thereby providing independent arm actuation and asymmetric arm deployment in the same unit.
• In variations of the preferred embodiments described above, each of the suturing devices described above may be formed with a guidewire lumen extending lengthwise through the elongated body for slidably receiving a guidewire. Such a lumen preferably terminates at an opening located on the distal portion of the device. Such an opening may be similar to theopening428 shown inFIG. 18. The suturing device may be advanced over the guidewire to facilitate the placement of the device in the patient's body. In other variations, each of the suturing devices described above may be formed with an additional lumen for receiving an endoscope for viewing the target site within the body.
• In another aspect of the present invention, various devices and methods are provided for performing a hysterectomy. In a first preferred method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, the uterus is inverted through the cervix. The uterus is cut away from the cervix and is removed from the body. A suturing device as described above can then be used to apply suture to the cervix to close the distal portion of the vagina. For closure of the cervix, it may be preferable to use a suturing device with multiple arms and needles, for example, 6 or 8.
• In a second method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, the uterus is cut away from the cervix and is removed from the body. A suturing device as described above is then used to apply suture to the cervix to close the distal portion of the vagina.
• In a third preferred method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, a suturing device such as described is inserted into the cervical opening, and suture ends are placed loosely applied around the opening of the cervix in a purse-string arrangement. The uterus is cut around the cervix at a location distal to the placed sutures and is removed from the body. The ends of the sutures are then pulled together and tied to close the distal portion of the vagina.
• In a fourth preferred method for performing a hysterectomy, a suturing device is inserted into each fallopian tube as described above and suture is applied to each fallopian tube to close the lumen. A cutting tool is then inserted into each fallopian tube and each fallopian tube is severed thereby disconnecting the tubes from the uterus. After the fallopian tubes have been severed, suture is loosely applied around the cervical opening as described in the third method above. After the suture has been applied, the uterus is inverted through the cervix. The uterus is then cut at a location distal of the placed sutures and the uterus is removed from the body. The ends of the sutures are then pulled together and tied to close the distal portion of the vagina.
• While embodiments and applications of this invention have been shown and described, it will be apparent to those skilled in the art that various modifications are possible without departing from the scope of the invention. It is, therefore, to be understood that within the scope of the appended claims, this invention may be practiced otherwise than as specifically described.

Claims (24)

1. A method of placing a suture, comprising:

positioning a distal portion of an elongated member adjacent a location to be sutured;

deploying at least one arm which releasably holds a portion of a suture;

penetrating tissue with a sharp end portion of the arm;

penetrating tissue with a needle and driving the needle toward said suture portion; and

capturing the suture portion from the arm with the needle and drawing the suture portion through the tissue and toward the elongated body.

2. The method ofclaim 1, wherein penetrating tissue with a sharp end portion of the arm comprises penetrating an inner wall of a tubular biological structure.

3. The method ofclaim 2, wherein the tubular biological structure is a fallopian tube.

4. The method ofclaim 2, wherein the tubular biological structure is a common bile duct.

5. The method ofclaim 2, wherein the tubular biological structure is an arterial-venous fistula.

6. The method ofclaim 2, wherein penetrating tissue with a sharp end portion of the arm further comprises positioning the sharp end portion beyond an outer surface of the biological structure.

7. The method ofclaim 1, comprising deploying two arms which releasably hold end portions of a suture.

8. The method ofclaim 7, further comprising penetrating tissue with the two arms on opposite sides of an opening.

9. The method ofclaim 8, wherein the two arms penetrate tissue simultaneously.

10. The method ofclaim 8, wherein the two arms penetrate tissue sequentially.

11. The method ofclaim 8, comprising penetrating tissue with two needles and driving each needle toward the end portions of the suture held by each of the arms.

12. The method ofclaim 7, further comprising penetrating tissue with only one of the two arms.

13. The method ofclaim 12, comprising penetrating tissue with a first needle and driving the first needle toward the end portion of the suture held by the first arm, and driving a second needle toward the end portion of the suture held by the second arm without driving the second needle through tissue.

14. The method ofclaim 1, wherein deploying the at least one arm comprises moving the arm from within the elongated member to outside the elongated member.

15. The method ofclaim 11, wherein deploying the at least one arm comprises moving the end portion of the arm to a location distal to the elongated member.

16. A method of closing a tubular biological structure from within the tubular biological structure, the method comprising:

inserting a distal portion of an elongated member into the tubular biological structure;

deploying a pair of arms, each arm releasably holding an end portion of a suture;

penetrating an inner surface of the tubular biological structure with sharp end portions of the arms such that the arms position the suture portions beyond the inner surface of the tubular biological structure;

penetrating the inner surface of the tubular biological surface with a pair of needles;

capturing the suture portions from the arms with the needles and drawing the suture portions through the tissue and toward the elongated body; and

tying the suture to close the tubular biological structure.

17. The method ofclaim 16, wherein deploying the pair of arms comprises moving the arms from within the elongated member to outside the elongated member.

18. The method ofclaim 16, wherein the pair of arms when deployed are parallel to one another.

19. The method ofclaim 16, wherein the pair of arms when deployed form an acute angle relative to one another.

20. A method of suspending a biological structure, comprising:

positioning a distal portion of an elongated member adjacent the biological structure to be suspended;

positioning a first arm connected to the elongated member on one side of the biological structure, the first arm releasably holding an end portion of a suture;

penetrating tissue of an adjacent biological structure with a sharp end portion of a second arm, the second arm releasably holding an end portion of the suture;

driving a first needle toward the end portion of the suture in the first arm, the first needle moving on an opposite side of the biological structure such that when the first needle engages the first arm, the biological structure is surrounded by the first arm, the first needle and the elongated member;

driving a second needle toward the end portion of the suture in the second arm, wherein the second needle penetrates tissue to engage the second arm;

capturing the suture portions from the arms with the needles and drawing the suture portions with the needles toward the elongated member; and

tying the ends of the suture together to suspend the biological structure to the adjacent biological structure.

21. The method ofclaim 20, wherein the first arm and the second arm are moveable from a first position within the elongated member to a second position extended from the elongated member.

22. The method ofclaim 20, wherein positioning the first arm and driving the first needle occurs prior to penetrating tissue with the second arm.

23. The method ofclaim 20, wherein penetrating tissue with the second arm and driving the second needle occurs prior to positioning the first arm.

24. A method of blocking the vas deferens to achieve male sterilization, comprising:

accessing the vas deferens through the scrotum;

positioning a distal portion of an elongated member adjacent a vas deferens to be blocked;

deploying an arm connected to the elongated member on one side of the vas deferens, the first arm releasably holding an end portion of a suture;

deploying a needle toward the end portion of the suture in the first arm, the needle moving on an opposite side of the vas deferens such that when the needle engages the arm, the vas deferens is surrounded by the arm, the first needle and the elongated member;

capturing the suture portion from the arm with the needle and drawing the suture portion with the needle toward the elongated member;

tying the ends of the suture together to block the vas deferens; and

repeating the procedure on the other vas deferens.

Images