Suturing device and method

A suturing device and method of use involve inserting the device into a hole, positioning material around the hole into a notch of the device, passing a needle through a cavity in the device and the material positioned in the notch, and lining up an eye of the needle with a portal for passage of a suture. A suture is then passed through the eye of the needle and the needle is removed from the material (such as skin and fascia) with the suture. The suture is then removed and the process is repeated with another end of the suture at another location through the material, around the hole. When the suture is passed through the second point of penetration, the suture now extends both into and out of the material at different points around the hole and can be tied.

FIELD OF THE DISCLOSED TECHNOLOGY

The disclosed technology relates generally to surgical and mending devices and, more specifically, towards a device for suturing or closing an opening.

BACKGROUND OF THE DISCLOSED TECHNOLOGY

In standard surgical practice and, specifically in minimally invasive surgical procedures, incisions are made in the skin, subcutaneous fat, fascia, and muscle tissue. Using standard surgical techniques, instruments are introduced through these defects to perform surgery. These defects must be closed, usually with sutures, at the conclusion of a procedure, to prevent herniation and other complications at these sites.

Prior art methods used to close tissue defects (or, alternatively, which may be used to close any hole where one has ready/direct access only to one side thereof) usually involve the use of curved needles. Some of the technologies require placing a suture through the skin, then grasping the suture extending freely in the air under camera guidance. This task can be extremely difficult even in experienced hands. An additional drawback of the existing techniques is the excessive cost of usually disposable, specialized guide devices for each procedure which is unacceptable to hospitals and surgery centers. While sometimes the aforementioned guides or other tools may be employed to aid in the use thereof, one must rely solely on feeling one's way through a cavity, and/or looking in a camera, while at the same time, risking injury to bowels, blood vessels, or other intra-abdominal organs. This may lead to sepsis, hemorrhage, and even death. The current methods are cumbersome and require a significant learning curve for a practitioner to become proficient in the techniques.

There exists a need for a method and device which is easy to use, has a shorter learning curve than current techniques, and which reduces risk of internal injury to the patient. Still further, a reduction in the cost of surgery and, of course, the expense of errors, is needed in the art.

SUMMARY OF THE DISCLOSED TECHNOLOGY

It is therefore an object of the disclosed technology to provide a safe, low cost suturing method and device which is easy to use for suturing tissue defects. It is a further object to suture any other hole or portal, including those where direct access is available only to one side thereof. “Direct access” is defined as being able to touch an entire side of a work surface, as opposed to “indirect access” which requires first passing through the work surface.

In one embodiment of the disclosed technology, a suturing kit includes an elliptical cone having a base and an apex at opposite ends, as well as a needle. The base of the elliptical cone can or does form a unitary structure with an elongated handle, such that an acute, obtuse, or right angle is formed between the elongated handle and a side of the elliptical cone that is adjacent to the handle. A notch is cut into one side of the elliptical cone, extending partially between the base and the apex.

The elliptical cone can or does include at least one needle guide cavity extending in a straight path from a needle guide portal at the base of the cone and through the base of the cone. The needle guide cavity is then interrupted by the notch, but otherwise continues through the cone towards the apex. An exit portal is situated between the notch and the apex of the cone, and extends substantially perpendicular to, and joins with, the needle guide cavity, the cavity terminating, in some embodiments, before the apex. The needle included in the kit has an eye therein. The needle further can or does have a length that is longer than the needle guide cavity, such that the eye can align with the exit portal when the needle is inserted in the needle guide portal, such as when the needle is fully inserted therein.

The elliptical cone of the suturing kits, in embodiments of the disclosed technology, additionally includes at least one curved suture guide cavity. The suture guide cavity extends between a suture guide portal located substantially or exactly at the base of the elliptical cone, and at a point that is between the notch and the exit portal of the elliptical cone.

In a further embodiment of the disclosed technology, a suturing device includes a base and an apex, the base and the apex being located at opposite ends of the suturing device. A notch is cut (defined as “a break in an otherwise continuous structure, whether removed from the structure after production thereof, or produced without the lacking part”) into one side of the suturing device. The notch extends partially between the base and the apex. The suturing device further includes at least one needle guide cavity at the base, in this embodiment, extending in a straight path through the suturing device between the base and the notch, as well as between the notch and the apex. An exit portal is situated between the notch and the apex of the suturing device.

The device can or does have at least one curved suture guide cavity extending between a suture guide portal located substantially at the base and opening into the needle guide cavity, at a point between the notch and the exit portal of the suturing device.

In some embodiments, the suturing device can have a portion thereof in the shape of an elliptical cone, which, for purposes of this disclosure, can include a blunt apex at the tip of the device. The base of the elliptical cone can form a unitary structure with a handle, such that an acute, right, or obtuse angle is formed between the handle and a side of the elliptical cone adjacent to the handle. The needle guide cavity of the suturing device can terminate at a point before the apex. The suture guide portal may be located closer to the base than the apex of the suturing device, or, alternatively, the suture guide portal can be located at the base of the suturing device.

A method of suturing is also claimed. A first step includes inserting an apex of a suturing device into a pre-existing hole until material around the hole is positioned within a notch. The notch is cut into on one side of the suturing device between a base and the apex thereof, such that the base and the apex are located at opposite ends of the suturing device. A needle, with an eye, is inserted through a needle guide portal of the suturing device and is pushed through the material positioned within the notch (e.g., skin or other tissues) and continues until the eye of the needle aligns with an exit portal of the suturing device. The exit portal is, or can be, situated between the notch and the apex of the suturing device.

Still describing the current method, a first end of a first suture is then inserted through a suture guide portal of the suturing device and pushed through the eye of the needle, as well as through the exit portal. The needle is then at least partially extracted from the suturing device until the suture, still passing through the eye of the needle, passes back through the material at a point of the penetration, pulling the suture there-through. The suturing device is rotated with respect to the hole, such that insertion of the needle now can proceed at a second point of penetration of the material. Then, the process of inserting the needle and passing the suture (at a second end thereof) is repeated a second time, or as many times as needed to close the hole. The suture device can then be extracted from the hole. When the suture is passed through the second point of penetration, the suture now extends both into and out of the material at different points around the hole and can be tied.

The pre-existing hole can be a tissue defect, and the material around the hole can constitute bodily tissue. The method can first include a step of removing a trocar from a tissue defect before the first step of inserting the suturing device. The step of inserting an apex of a suturing device into a pre-existing hole can further include rotating and manipulating the device while maximizing an amount of tissue positioned in the notch. The suture guide portal can be located substantially at the base of the suturing device. Alternatively, the suture guide portal can be located at the base of the suturing device.

The step of at least partially extracting the needle can further include completely extracting the needle from the suturing device. The step of rotating the suturing device can further include rotating the device substantially 180 degrees. The suturing device can be elliptical, such that rotating the device substantially 180 degrees causes the tissue defect to stretch, such that first and second points of penetrating are spaced further apart than carrying out the method with a corresponding circular device. The step of extracting the suture device can further include a step of securing the ends of the suture and suturing the pre-existing hole. The first suture can be looped through a second suture, such that each end of the first and second sutures can be inserted through the suture guide portal after each step of inserting the needle and penetrating the material.

In an alternative embodiment of the technology disclosed, a method of suturing includes a first step of inserting a suturing device into a pre-existing hole, until material around the hole is positioned within a notch cut into one side of the suturing device. The notch is situated between a base and an apex, wherein the base and the apex are located at opposite ends of the suturing device. A needle having an eye is inserted though the suturing device. The inserted needle penetrates the material and is continually inserted until the eye of the needle aligns with an exit portal of the suturing device. The exit portal is situated between the notch and the apex of the suturing device. A first end of a suture is inserted through a suture guide portal of the suturing device, and is then pushed through the eye of the needle and through the exit portal. The needle is at least partially extracted from the suturing device until the suture, still passing through the eye of the needle, passes through the material at a point of the penetration. The steps of: penetrating the material at a second point on the material, inserting a second end of the suture through the suture guide portal, and at least partially extracting the needle until the suture passes through the material a second time, are carried out in this embodiment.

The suturing device can be substantially formed of an elliptical cone, with the exit portal at a tapered end thereof. The step of inserting a suturing device can further include inserting an apex of a suturing device into a pre-existing hole, and can further include a step of rotating and manipulating the device, so that a maximal amount of material is positioned in the notch.

The step of inserting a needle can include inserting a needle through a needle guide portal at the base of the suturing device, and the material penetrated can be the material positioned within the notch. The suture guide portal can be located substantially at the base of the suturing device. The step of at least partially extracting the needle can encompass completely extracting the needle from the suturing device, further include a step of rotating the suturing device with respect to the hole, and the step of rotating can encompass rotating the device substantially 180 degrees.

The suturing method can further include a subsequent step of extracting the suture device from the hole, and can further include a step of securing the ends of the suture, suturing the pre-existing hole, after the step of at least partially extracting the needle a second time is carried outs.

The term “substantially” is defined as “considered to be so by one having ordinary skill in the art of suturing,” and/or “at the side described or an adjacent side,” and/or “at least 90% of the term being modified by ‘substantially.’”

The terms “or” and “and/or” should be interpreted as being inclusive of one or both terms being joined thereby. For example, in the set {A, B}, the phrase “A or B” includes “A,” “B,” and “A and B.”

Embodiments of the disclosed technology comprise a safe and low cost suturing device and method that is also simple to use. The suturing device and method can be used for suturing tissue defects, or, for suturing and closing any other hole or portal where one has direct access only to one side thereof. The structure of the suturing device allows the device to be manipulated easily and accurately. Embodiments of the suturing device include a closed housing for an inserted needle, which prevents the needle's sharp tip from being freely situated in the abdominal cavity.

Embodiments of the disclosed technology will become clearer when reviewed in connection with the description of the figures herein below.

FIG. 1shows a side elevation view of a suturing device of embodiments of the disclosed technology. The suturing device of this embodiment is an elliptical cone80having a base10at a first end and an apex20at a second, opposite, end.FIG. 1shows a side86of the elliptical cone. The term “elliptical cone” is defined herein as a geometric cone with a notch cut into a part thereof. The elliptical cone may be elongated in one dimension, such that the base is in the shape of an oval. In an alternative embodiment, any elongated member may be used.

A notch40is cut into a front side82(the front side82is opposite the side84adjacent to the handle) of the elliptical cone80, the notch40also extending partially into adjacent and opposing sides86, and partially between the base10and the apex20of the elliptical cone. The term “cut into” is defined as “preformed” or “removed from the described mathematically defined structure” and defines a part of a device which is lacking from the otherwise described structure. The construction thereof need not actually be “cut” from the structure after it is produced, but rather can be produced with the lack of the portion described as being “cut into” such a shape. While the notch40is cut into the front side82in this embodiment, the notch40can be cut into any side of the elliptical cone80and still be in the scope of the disclosed technology.

The notch has a top surface42which defines a region of the elliptical cone between the base10and notch40. The notch has a bottom surface46which defines a region of the elliptical cone between the apex20and the notch40. A back surface44of the notch forms the back side thereof can be substantially parallel, in embodiments of the disclosed technology, to the adjacent side84opposite the notch of the cone region. A continuous plane or surface is formed between the apex20, base10(circumscribed also by back side84), and back surface44of the notch. Still further, the bottom surface46may for an acute or obtuse angle relative to the back surface44and/or the adjacent side84which helps ease removal of the device from the hole being sewn.

FIG. 2shows a cutaway view of the side elevation view of the suturing device shown inFIG. 1.FIG. 8shows a top and front side perspective view of a suturing device in an embodiment of the disclosed technology. Now discussingFIGS. 2 and 8simultaneously, a needle guide cavity24and a suture guide cavity34extend into the body of the elliptical cone80. In embodiments, the needle guide cavity24extends in a straight path from a needle guide portal22at the base10of the elliptical cone80, and through the body of the cone80. The needle guide cavity24is then interrupted by the notch40, after which it continues through a second needle guide portal25located on the bottom side46of the notch40, and continues through the cone80towards the apex20.

An exit portal26is situated on the front side82of the elliptical cone, between the notch40and the apex20of the cone80. The exit portal26may be on side of the device, including at the apex thereof. The exit portal26extends substantially perpendicular from the needle guide cavity24at a point between the second needle guide portal25and a point of termination of the needle guide cavity. The needle guide cavity24terminates, in some embodiments, at a point before the apex20.

The suture guide cavity34extends between a suture guide portal32located at the base10of the elliptical cone, and a point located between the notch40and the exit portal26of the elliptical cone80. The suture guide portal32can be located substantially at the base10, defined as located closer to the base10than the apex20of the suturing device, or, alternatively, the suture guide portal32may be located exactly at the base10of the suturing device. As shown inFIG. 2, the suture guide cavity34is curved and joins the needle guide cavity24at a point between the bottom side46of the notch40and the exit portal26. The suture guide cavity34joins with, and forms a unitary cavity with, the exit portal26via the needle guide cavity24.

FIG. 3shows a cutaway side elevation view of a suturing device with a needle60and a suture70each inserted therein, in an embodiment of the disclosed technology.FIG. 9shows a top and front side perspective view of a suturing device having a needle60and a suture70each inserted therein, in an embodiment of the disclosed technology. Now discussingFIGS. 3 and 9simultaneously, in embodiments of the disclosed technology, the eye62of the needle60aligns with the exit portal26when the needle is inserted into the needle guide portal22, past the notch40, and at least reaching the exit portal26. The needle60has an eye62and can or does have a length that is longer than the needle guide cavity24. In embodiments of the disclosed technology, the eye62aligns with the exit portal26when the needle60is completely inserted in the needle guide cavity24, such that the tip of the needle is in contact with the bottom of the needle guide cavity24. The needle60can be seen in the notch40when the needle60is inserted into the needle guide portal22and at least passes through the notch40. Still further, the needle guide cavity24and/or the needle guide portal22can have an oval or oblong shape, forcing the needle60to be oriented such that the eye62of the needle60faces the exit portal26when the needle is inserted in the cavity.

The term “suture” is defined herein as an elongated, flexible string, thread, sinew, strand, and so on. The suture70has a first end72and a second end74, and has a length that is longer than the length of the area between the suture guide portal32and the exit portal26. Upon insertion through the suture guide portal32, and upon being pushed through the curved suture guide cavity34, the first end72of the suture70passes through the eye62of the needle60aligned with the exit portal26, and exits through the exit portal26at substantially 90 degrees. A “double suture” can also be used with embodiments of the disclosed technology, having two strands which connect at a central area forming an “X” configuration. The method of use is otherwise the same, repeated with each of the four ends of such a suture.

FIG. 4shows a bottom plan view of a suturing device in an embodiment of the disclosed technology. The bottom surface of the unitary handle50is shown with the indentation54for finger placement that aids in gripping the device. The elliptical cone80portion is shown extending from the base and narrowing until terminating at the narrowest point shown, the apex20. The notch40is shown cut into the front side82of the cone80and in between the base10and the apex20of the cone80.

FIG. 5shows a top plan view of a suturing device, in an embodiment of the disclosed technology. In embodiments, the needle guide portal22and the suture guide portal32are situated linearly at the base10of the cone80. The base is an ellipse in embodiments of the disclosed technology. The elongated handle can extend in the same line from the base10as the needle and suture guide portals22and32discussed above. In further embodiments, the handle need not be used. Rather, the elongated portion of the device80is used without a handle portion50.

FIG. 6shows a back side elevation view of a suturing device in an embodiment of the disclosed technology.FIG. 10shows a top and back side perspective view of a suturing device in an embodiment of the disclosed technology. DiscussingFIGS. 6 and 10simultaneously, the back side84of the elliptical cone80adjacent to the elongated handle50extends downward from the base10, terminating at the apex20. The handle is shown extending from the point where it meets the elliptical cone forming the acute or 90 degree angle52, up to the tip of the handle50. In embodiments, the finger indentation54is situated between the tip of the handle50and the angle52formed, where the handle50meets the elliptical cone80. The notch40is partially cut into the side86of the elliptical cone between the front side82and the back side84, adjacent to the elongated handle.

FIG. 7shows a front side elevation view of a suturing device of an embodiment of the disclosed technology. In this figure, the notch40can be seen cut into the front side82of the elliptical cone portion80, in embodiments of the disclosed technology. The second needle guide portal25of the needle guide cavity24is located on the bottom surface46of the device, forming the notch40. The exit portal26, situated perpendicularly to the needle guide cavity24, is located at a point below the notch40, and before the termination of the needle guide cavity24. In another embodiment of the disclosed technology, the suture guide and needle guide cavities may be at any angle to each other and to the exterior of the suturing device as long as the cavities cross each other at some point.

FIG. 11shows a bottom and front side perspective view of a suturing device inserted into material, in an embodiment of the disclosed technology.FIG. 12shows a top and front side perspective view of a suturing device inserted into material, in an embodiment of the disclosed technology. Now discussingFIGS. 11 and 12simultaneously, the apex20of the suturing device is inserted into a preexisting hole in material90. The device is inserted into the hole until the material90surrounding the hole is positioned in the notch40. The base10, elongated handle50, and top portion of the elliptical cone80(extending between the base10and the notch40) remain visible above the material. The bottom portion of the cone80extending between the notch40and the apex20are visible from beneath the material.

FIG. 13shows a bottom and front side perspective view of a suturing device, with a needle inserted into material, in an embodiment of the disclosed technology. The needle60is inserted through the needle guide portal shown on the base10inFIG. 12. The needle60then passes through the needle guide cavity24, penetrates through the material90, and extends through the notch40. The needle60then continues passing into the second needle guide portal25and into the portion of the needle guide cavity24below the notch40, up to a point between the exit portal26and the apex20(both the second needle guide portal25and the needle guide cavity24not being visible inFIG. 13). The needle60is visible in the notch40beneath the material90.

The material90can include any kind of medium that can be sutured. The suturing device of the disclosed technology can be used with any material90where one has access only to one side. Additionally, the suturing device can be used with a material90having a pre-existing hole, in order to sew or otherwise close the hole by sewing/attaching the material90around the hole. In embodiments, the material90can include human tissue (such as human skin or fascia), fabric, synthetics, metals (e.g., screens), and so forth.

FIG. 14shows a bottom and front side perspective view of a suturing device, in an embodiment of the disclosed technology.FIG. 15shows a bottom and back side perspective view of a suturing device in an embodiment of the disclosed technology. DiscussingFIGS. 14 and 15simultaneously, an alternative embodiment of the suturing device is shown having a uniform bottom portion181. In this embodiment, an elongated handle150joins with a base110of a top portion of an elliptical cone180of the suturing device of the disclosed technology. The uniform bottom181joins with the cone top portion180on the back side184of the device, opposite the point where the notch40is located on the front side82of the device, in the embodiments ofFIGS. 1-13. The elliptical cone top portion180extends between the base110and a bottom surface (unnumbered). The bottom portion181extends between a point where the bottom portion181joins with the top portion180, and the apex120.

A needle guide portal122is located at the base110of the suturing device, and a suture guide portal is located substantially at the base of the suturing device, in embodiments of the disclosed technology. The suture guide portal can be located at the base110, or closer to the base110than the apex120of the suturing device. In embodiments, a first exit portal125and a second exit portal126are located on the front side182of the bottom portion181of the suturing device. The back side184of the elliptical cone portion180is adjacent to the elongated handle150.

FIG. 16shows a side elevation view of a suturing device inserted into tissue, in an embodiment of the disclosed technology. In another embodiment of the disclosed technology, the suturing device is inserted into a preexisting hole in material90ofFIGS. 11-13that is mammalian or other living tissue in the current embodiment. The apex20of the device is inserted through the subcutaneous fat92, fascia94, and muscle96layers of tissue, so that the layers of tissue are positioned in the notch40of the device. The portion of the device extending below the notch40to the apex20is visible below the subcutaneous fat92, fascia94, and muscle96layers of tissue. The handle50and top portion extending from the base10to the notch40are visible from above the tissue. In embodiments of the disclosed technology, the suturing device can be used to close a defect in human tissue, specifically a small incision made in a minimally invasive surgical procedure, where there is access only from the outside of the tissue defect.

FIG. 17shows a needle which can be used with the suturing device ofFIGS. 1-16 and 18, in an embodiment of the disclosed technology. The needle60has a sharp tip64and an eye62. The tip64of needle60can be inserted into the needle guide portal22ofFIG. 10and then passed through the needle guide cavity24ofFIG. 3. A suture70inserted into the suture guide cavity34passes through the eye62of the inserted needle60inFIG. 3, when the eye62is aligned with the exit portal26. The needle60, in embodiments, can be elliptical (having a flatter and/or more elongated front and back side and narrower left and right sides) matching that of an elliptical portal, such as that of the needle guide portal22. This ensures that the needle60enters the portal in only two orientations, with the eye62aligning with the exit portal26, allowing passage of a suture through the suture portal, eye of the needle, and exit portal.

FIG. 18Ashows a bottom and front side perspective view of a suturing device wrapped in insulation, in an embodiment of the disclosed technology. In embodiments of the disclosed technology, at least a portion of the elliptical cone80above the notch40of the suturing device is wrapped in insulation188which can be foam. The insulation188encloses the front side82of the elliptical cone80portion of the device from a point below the base10, substantially opposite the point where the elongated handle50joins with the elliptical cone80.

The insulation188additionally encloses the two sides86adjacent to the front side82from a point below the base10, substantially adjacent to where the handle50meets the elliptical cone80, to a point above the notch40, and above the exit portal26, in embodiments of the disclosed technology. The back side84is enclosed in insulation188from a point substantially where the handle50meets the elliptical cone80below the base10of the suturing device, to a point substantially at the apex20. In embodiments, the elongated handle50, the base10, the exit portal26, the notch40and the apex20remain visible.FIG. 18B-Cshows a cutaway perspective of an embodiment of the disclosed technology as described above.

FIG. 19shows a high level flow chart of a method of suturing a hole with a suturing device, in an embodiment of the disclosed technology. In a first step210, the suturing device is inserted into a pre-existing hole in material. The material is then positioned within a notch of the device in step220. In embodiments without a notch, the material is simply positioned below a needle cavity, so that a needle can be inserted into the material. This is further described in steps232and234, respectively, where a needle is inserted into a needle guide portal and then penetrated into the material. Where a notch (cutout into the body of the suturing device) is present, the material is positioned in the notch and the needle passes through the material, also in the notch.

Then, in step236, the eye of a needle is aligned with an exit portal of a suture. A suture, or other elongated thread used to sew, is inserted into another portal, such as that located at the top (base) of the suturing device, and extends through a cavity where exiting, at an exit portal, at a location of, or at a height of, an eye of the needle after the needle has passed through the material. This may be accomplished further by way of step238, inserting the suture into a suture guide portal (step242), and pushing the suture through the needle eye and an exit portal. Then, in step244, the needle is pulled out of the suturing device with the suture still passing through the eye of the needle. The needle and suture pass through the material, such that a first half of a stitch is made with the suture extending from the back side of the material (opposite side from a direction of entry of the suturing device). This completes a first pass of the sewing steps of box230.

After the first pass, another pass will be needed to complete the stitch. As such, in step250, the decision “yes” is made to another pass being needed. Step260is then carried out, and the suturing device is rotated transverse (or orthogonal) to the material. Then, a second end of the suture is inserted and the sewing steps in box230are repeated. After completing this second pass, the suture now passes through the material at two spaced-apart locations, with the ends of the suture both extending towards the direction in which the suturing device was inserted (such as outward from the body of a patient being sewn).

More passes can be used, or, alternatively, after decision box250, step270is carried out, and the ends of the suture are secured together, such as by tying. It should further be noted that a portal of the suturing device used for entry of the needle in this method may be elongated, so that a similarly shaped needle can enter only in a direction such that the eye of the needle is perpendicular to the direction of a suture.

Referring again toFIG. 19, the method of use will now be described with reference to the device shown inFIGS. 1-10, as well as such a device shown inserted into material, shown inFIGS. 11-12. In step210of embodiments of the method, the suturing device is inserted into a pre-existing hole in a material such as material90, shown inFIG. 11-13, or tissue, shown inFIG. 16. This may be accomplished by first inserting an apex20of the suturing device into a hole. Following the insertion, in step220, the material90is positioned within a notch40of the suturing device. The notch, as described above, such as with reference toFIG. 1, is cut into one side of the suturing device between the base10and the apex20thereof.

In the series of suturing steps230, the hole is sutured with the device and a needle60. In the first step of suturing, that is, in step232, the needle60is inserted into a needle guide portal22and into the needle guide cavity24. (The needle may be partially inserted into the needle guide portal before steps210and220). In step234, after insertion of the needle60into the needle guide portal22, the needle penetrates the material90in the notch. This can be seen inFIGS. 11 and 13,FIG. 11showing the device inserted into the material before the needle, andFIG. 13showing the needle passing through the material. The needle is inserted into the needle guide portal and can penetrate the material at an angle orthogonal to a plane passing substantially through the hole and the material. In step236, the needle then passes through the needle guide cavity24below the notch, and an eye of the needle62is aligned with an exit portal situated between the notch and the apex of the device, such as exit portal26shown inFIG. 13.

Still describing the current method, in step238, a first end of a suture72is inserted through a suture guide portal located substantially at the base20of the suturing device. The suture then passes through a suture guide cavity, such as suture guide cavity34, and is pushed through the eye of the needle52, as well as through the exit portal26in step242, exiting via the exit portal. The angle of the exit of an end72(or74, in a second pass) of the suture70can be 90 degrees from the angle of entry of the suture through the suture entry portal32. In step244, the needle60is then at least partially extracted with the suture from the needle guide portal22of the suturing device. In this step, the suture70, still passing through the eye of the needle, passes back through the material at a point of the needle penetration, pulling the suture there-through.

Following the completion of the series of steps230, a determination is made as to whether another pass of the needle and suture is needed in step250. If it is determined that another pass of the needle and suture are needed through the material, in step260, the suturing device is rotated transverse to the material with respect to the hole, such that another insertion of the needle now can proceed at a second point of penetration of the material. Then, the series of steps230are repeated at a second position of the material, and with a second end of the same suture used, or with an additional suture. If it is determined in step250that an additional pass in not needed, the suture device may then be extracted from the hole. Once the suture has passed through the second point of penetration, the suture extends both into and out of the material at different points around the hole and can be secured in step270of the methods.

Now discussingFIG. 19in view ofFIGS. 11-13 and 16, in embodiments, the pre-existing hole can be a tissue defect, and the material around the hole can constitute bodily tissue. In further embodiments, the method can additionally include a step of removing a trocar from a tissue defect before the step210of inserting the suturing device. The step210of inserting a suturing device into a pre-existing hole can further include rotating and manipulating the device, while maximizing an amount of tissue positioned in the notch, in embodiments of the disclosed technology. The step244of pulling a needle with suture out of needle guide portal can further include completely extracting the needle from the suturing device.

In embodiments, the step260of rotating the suturing device can further include rotating the device substantially 180 degrees. Additionally, the suturing device can be elliptical, such that rotating the device substantially 180 degrees causes the tissue defect to stretch, such that first and second points of penetrating are spaced further apart, as compared to carrying out the method with a corresponding circular device, in embodiments of the disclosed technology. The step270of securing the ends of the suture can first include a step of extracting the suturing device from the hole. In embodiments, the first suture can be looped through a second suture, such that each end of the first and second sutures can be inserted through the suture guide portal after each step232of inserting the needle and each step234of penetrating the material.

Combinations of any of the methods, systems, and devices described herein above are also contemplated and within the scope of the invention.