Laparoscopic suture device with autoloading and suture capture

A suturing device provided. The suturing device may include at least a firing aperture, a drive mechanism and an autoloading mechanism. The firing aperture may include at least one needle rotatably disposed therein configured to engage a suture for deployment. The drive mechanism may be operatively coupled to the needle and configured to advance the needle from a retracted position to an extended position during engagement, and retract the needle from the extended position to the retracted position during disengagement. The autoloading mechanism may be operatively coupled to the drive mechanism and configured to slidably retrieve and position a suture to be deployed over the firing aperture during disengagement of the drive mechanism.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to medical fastening devices, and more particularly, relates to sutures and suturing devices for fastening tissue and/or prosthetic material.

BACKGROUND OF THE DISCLOSURE

The fastening of tissues has long been a need in the medical industry, and correspondingly, a finite number of fastening devices have been developed for different applications and uses. Among these devices are laparoscopic fastening devices or tackers which are often used with minimally invasive procedures such as laparoscopic repair of hernias, and the like. A typical laparoscopic procedure involves the insertion of thin, elongated instruments into relatively small incisions or access ports in the abdomen to access hernia defects in the abdominal wall from the inside. Moreover, the laparoscopic instruments are used to position a prosthetic mesh over the defect and fasten the prosthetic mesh against the inner abdominal wall using tacks, or the like.

Conventional laparoscopic tackers provide a relatively thin and elongated tubular member containing deployable tacks and having an end-firing mechanism positioned at the distal tip thereof. In particular, the end-firing mechanism is configured to deploy tacks directly from the tip of the elongated member in an axial manner, and thus, ideal application suggests positioning the elongated member perpendicularly against the tissue surface to be tacked. However, due to several factors, such as the relatively rigid and elongated nature of the laparoscopic tacker, the limited locations and number of access ports available, and the typical location of hernia defects, it is difficult to position the end of the laparoscopic device squarely against the inner wall of the abdomen. In practice, a surgeon using a laparoscopic tacker typically positions the tacker with one hand, sometimes even slightly bending the instrument, while using his other hand to press against the outer wall of the abdomen in order to achieve the best possible angle for installing the tacks.

Furthermore, due to the limited access to hernia defects and the minimally invasive nature of typical hernia repairs, laparoscopic tackers tend to use simple-action type mechanisms to deploy tacks, and correspondingly, employ tacks with basic means for fastening prosthetic mesh to the inner abdominal wall. More specifically, conventional tackers employ screw-type or simple push-type actions to install tacks with threads or barbs which help embed the tacks within abdominal tissue. Over time, especially in the case of metal, coil-like tacks, these tacks may cause irritation or pain to the patient, become dislodged from the abdominal wall, or cause other complications post-surgery. To address such drawbacks associated with metal tacks, absorbable tacks have been developed and employed. Absorbable tacks are designed to be eventually absorbed by the body, and thus, cause less irritation or pain to the patient over time. However, absorbable tacks also tend to provide holding or tensile strength that is less than optimal. In such cases, suturing the hernia defects or suturing prosthetic mesh to the abdominal wall may prove to be more effective. Even still, the relatively complex nature involved with suturing makes it difficult to use sutures on hernia defects via laparoscopic or otherwise minimally invasive procedures.

Accordingly, there is a need for minimally invasive or laparoscopic means of tissue fastening or installing sutures in tissue which substantially facilitates the installation process for the surgeon or user. There is also a need for a medical fastening device which provides a more effective and reliable means for closing tissue and/or fastening prosthetic mesh to tissue. Furthermore, there is a need for a medical fastening device which employs fasteners that reduce irritation, pain, and other complications to the patient without adversely affecting tissue holding strength.

SUMMARY OF THE DISCLOSURE

In accordance with one aspect of the disclosure, a suturing device is provided. The suturing device may include at least a firing aperture, a drive mechanism and an autoloading mechanism. The firing aperture may include at least one needle rotatably disposed therein configured to engage a suture for deployment. The drive mechanism may be operatively coupled to the needle and configured to advance the needle from a retracted position to an extended position during engagement, and retract the needle from the extended position to the retracted position during disengagement. The autoloading mechanism may be operatively coupled to the drive mechanism and configured to slidably retrieve and position a suture to be deployed over the firing aperture after a prior suture has been deployed.

In accordance with another aspect of the disclosure, a suturing device is provided. The suturing device may include at least an elongate member, a drive mechanism and an autoloading mechanism. The elongate member may extend between a working end and a control end, and include a track for receiving one or more deployable sutures therein. The working end may include a firing aperture disposed in communication with the track, and a distal needle and a proximal needle rotatably disposed therein. The drive mechanism may be disposed within the elongate member and configured to operatively couple the control end with each of the distal and proximal needles. The drive mechanism may be configured to advance each of the distal and proximal needles from a retracted position to an extended position during engagement, and retract each of the distal and proximal needles from the extended position to the retracted position during disengagement. The autoloading mechanism may be disposed along the elongate member and proximate the working end. The autoloading mechanism may be operatively coupled to the drive mechanism and configured to slidably retrieve and position one of the deployable sutures over the firing aperture for deployment after a prior suture has been deployed.

In accordance with yet another aspect of the disclosure, a tissue fastener is provided. The tissue fastener may include at least an elongated filament extending between a first end and a second end, a needle guide disposed on at least one of the first and second ends configured to be at least partially engaged by a needle during deployment, one or more retention elements disposed on the needle guide configured to resist retraction through at least one of a tissue and a prosthetic material, and one or more constriction elements disposed on the needle guide configured to at least partially constrict the needle guide against the needle during deployment.

These and other aspects and features of the disclosure will be better understood upon reading the following detailed description when taken into conjunction with the accompanying drawings.

DETAILED DESCRIPTION

Referring now to the drawings, and with specific reference toFIG. 1, a medical fastening or suturing device constructed in accordance with the teachings of the present disclosure is generally referred to by reference numeral20. The suturing device20, as will be described in further detail herein, may advantageously enable convenient yet effective means of providing fasteners within a surgical environment. The disclosed embodiments may additionally facilitate the installation of fasteners or sutures during minimally invasive surgical procedures, such as laparoscopic procedures, and the like. As used for laparoscopic treatment of a hernia, the embodiment ofFIG. 1, for example, may be employed to reach beneath sections of tissue, within or around the abdominal region, to fasten tissues of the abdominal wall or to fasten prosthetic mesh to the abdominal wall from the inside. Although the embodiments disclosed herein demonstrate tissue fastening as applied to laparoscopic applications, it will be understood that the present disclosure may be equally or similarly applied to other medical procedures.

As shown inFIG. 1, the suturing device20may generally include an elongate member22which extends between a control end24disposed at a proximal end thereof, and a working end26disposed at a distal end thereof. The control end24may generally include a grip28as well as a triggering mechanism30, or any other suitable means for receiving input or triggering actions from a user and converting the input or actions into a suturing action that is performed at the working end26of the suturing device20. The working end26may generally be configured with a firing aperture32, or a fastening interface disposed at a longitudinal side thereof, through which fasteners or sutures34may be deployed or installed in tissue and/or prosthetic material. Furthermore, one or more of the sutures34to be deployed may be provided along the elongate member22and distally advanced or fed toward the firing aperture32of the working end26, for example, along one or more guides or tracks36longitudinally disposed within the elongate member22.

As shown in more detail inFIGS. 2 and 3, the working end26of the suturing device20ofFIG. 1may at least partially enclose a first needle38and a second needle40, each of which may be substantially concealed within the firing aperture32of the working end26in a default or fully retracted position. More specifically, the first needle38may be rotatably and pivotally disposed about a first fixed axis42, and the second needle40may be rotatably and pivotally disposed about a second fixed axis44. Moreover, the first axis42may be axially offset but substantially parallel to the second axis44, for example, such that the first needle38is distally positioned relative to the suturing device20and the second needle40is proximally positioned relative to the suturing device20. In other alternative embodiments, each of the first and second needles38,40may be coaxially disposed about a common axis. In still further embodiments, a single needle or more than two needles may be disposed within the firing aperture32and comprise any one of a plurality of different arrangements.

Still referring toFIGS. 2 and 3, each of the first and second needles38,40may be configured to rotate in opposing directions between respective retracted and extended positions. For example, during advancement, the first or distal needle38may be configured to proximally rotate toward the elongate member22, while the second or proximal needle40may be configured to distally rotate away from the elongate member22. Conversely, during retraction, the first needle38may be configured to distally rotate away from the elongate member22, while the second needle40may be configured to proximally rotate toward the elongate member22. Moreover, each of the first and second needles38,40may be configured to advance and retract between respective retracted and extended positions simultaneously, or in substantially equal increments or at substantially equal rates of angular displacement. Each of the first and second needles38,40may further comprise a low-profile arcuate geometry which enables the needles38,40to be substantially concealed within the firing aperture32while in the fully retracted position, and have maximized reach during advancement. Furthermore, each arcuate needle38,40may be shaped and/or otherwise configured to rotate in a cammed fashion such that, it creates a progressively tighter pull as it travels through the tissue, and thus, creates a tighter fastening of the tissue.

In addition, each of the first and second needles38,40ofFIGS. 2 and 3may include one or more of needle hooks46, grooves, tines, recesses, canted surfaces, or any other suitable structure configured to enable engagement with a fastener or suture34, or one or more needle guides48thereof. As shown inFIGS. 2 and 3, for example, a hook46may be disposed on an outer edge of each of the first and second needles38,40and configured to engage with a needle guide48of a suture34as the respective needle38,40is retracted from the fully extended position. While the embodiments ofFIGS. 2 and 3may depict the needles38,40with retrograde-type hooks46configured to engage a suture34during retraction, it will be understood that other configurations may be equally or similarly employed, such as antegrade-type hooks configured to engage a suture34during advancement, or the like. In still further alternatives, one or more hooks may be disposed on an inner edge of each of the needles38,40.

Turning now toFIGS. 4-9, more detailed drawings of the first and second needles38,40are provided illustrating the relative rotational positions thereof as the needles38,40are advanced from fully retracted positions to fully extended positions. As shown, each of the first and second needles38,40may be operatively coupled to a drive mechanism50that is configured to advance the needles38,40from the retracted positions to the extended positions during an engagement of the drive mechanism50received via the control end24of the suturing device20, and conversely, to retract the needles38,40from the extended positions to the retracted positions during a disengagement of the drive mechanism50received via the control end24. Furthermore, the drive mechanism50may include a multi-bar linkage, such as a three-bar linkage, or the like, which operatively couples the control end24to each of the first and second needles38,40.

As shown inFIGS. 4-9, the drive mechanism50may include at least a first drive link52for driving the first needle38and a second drive link54for driving the second needle40, each of which may be slidably disposed within the elongate member22and in operative communication between the control end24and the working end26. The drive mechanism50may additionally include a first intermediate link56for driving the first needle38and a second intermediate link58for driving the second needle40, each of which may configured to pivotally couple the corresponding drive link52,54to the corresponding needle38,40. In other modifications, one or more links may be omitted or added to the drive mechanism50. As the needles38,40are opposedly arranged, the drive links52,54and the intermediate links56,58may be configured to be slidably and pivotally driven in substantially equal increments or rates of displacement, but in opposing directions relative to one another. For example, during advancement, the first drive link52of the first needle38may be slidably driven distally toward the working end26at substantially the same rate or in similar increments as the second drive link54of the second needle40being driven proximally away from the working end26.

In the fully retracted positions, as shown inFIGS. 4 and 5for example, each of the first and second needles38,40may be substantially concealed beneath the firing aperture32and within the working end26of the suturing device20so as to facilitate insertion thereof into minimal incisions or access ports, or the like. The first and second needles38,40may further include a low-profile geometry which enables the working end26of the suturing device20as well as the access ports to be generally smaller in size. During advancement or during engagement of the drive mechanism50, as shown inFIGS. 6 and 7for example, the first drive link52may drive or push the first intermediate link56toward the distal end of the firing aperture32thereby causing the first needle38to rotate about the first fixed axis42and upwardly extend from the distal end of the firing aperture32, while the second drive link54may drive or pull the second intermediate link58toward the proximal end of the firing aperture32thereby causing the second needle40to rotate about the second fixed axis44and upwardly extend from the proximal end of the firing aperture32. Moreover, the drive mechanism50may be configured to rotatably extend the needles38,40such that the reach of each needle38,40is maximally extended during advancement even with a low-profile geometry so as to sufficiently penetrate tissue and/or prosthetic material to be fastened or sutured.

The drive mechanism50may continue advancing each of the first and second needles38,40until the needles38,40respectively reach the fully extended positions, as shown for example inFIGS. 8 and 9. In particular, the drive mechanism50may be configured such that each of the first and second needles38,40extend until at least one or more of the hooks46thereof engage with a fastener or suture34for deployment. For example, positioning of the first and second needles38,40, the drive mechanism50, the firing aperture32, and the sutures34may be configured such that retrograde-type hooks46on the outer edges of the needles38,40are able to fully engage with one or more corresponding needle guides48of a given suture34. In other alternatives, each of the needles38,40may employ a retrograde-type hook disposed on the inner edge thereof, an antegrade-type hook disposed on the outer edge thereof, an antegrade-type hook disposed on the inner edge thereof, or any other suitable variation thereof, to which each of the drive mechanism50, the firing aperture32, and the like, may be modified to enable sufficient engagement with the corresponding needle guide48of a given suture34.

Once the first and second needles38,40respectively reach the fully extended positions thereof as shown for example inFIGS. 8 and 9, and once a suture34is fully engaged, the drive mechanism50may be released or disengaged, so as to retract the needles38,40and deploy the engaged suture34within tissue and/or prosthetic material to be fastened. Moreover, the needles38,40may be retracted toward the positions shown inFIGS. 4 and 5by substantially reversing the drive mechanism50. During retraction or during disengagement of the drive mechanism50, for example, the first drive link52may drive or pull the first intermediate link56toward the proximal end of the firing aperture32thereby causing the first needle38to rotate in reverse about the first fixed axis42and downwardly retract into the distal end of the firing aperture32. Correspondingly, the second drive link54may drive or push the second intermediate link58toward the distal end of the firing aperture32thereby causing the second needle40to rotate in reverse about the second fixed axis44and downwardly retract into the proximal end of the firing aperture32. Furthermore, each of the first and second needles38,40may be retracted until the needles38,40return to the fully retracted positions ofFIGS. 4 and 5and until a previously engaged suture34is completely deployed and released therefrom, at which point the needles38,40may be advanced again to engage with a new suture34for deployment.

While one possible implementation is provided in the drawings, other drive mechanisms and configurations therefor will be apparent to those skilled in the art without departing from the scope of the appended claims. For example, in other modifications, the suturing device20may employ more than two needles which, for instance, partially oppose one another, or alternatively, rotate in like manner and direction relative to one another. In alternative modifications, the needles38,40may be configured to be rotated sequentially rather than simultaneously relative to one another, and/or configured to be rotated at non-identical rates of angular displacement relative to one another. In additional modifications, the needles38,40may be configured to rotate about a common axis rather than axially offset. In further modifications, the suturing device20may provide a needle that is configured to rotate about an axis that is parallel, or otherwise generally not perpendicular, to the elongate member22. In still further modifications, the working end26of the suturing device20may be articulated, such as pivotable or otherwise movable, relative to the elongate member22about one or more axes.

Referring now toFIGS. 10-14, one exemplary triggering mechanism60that may be employed to operate the drive mechanism50ofFIGS. 2-9is provided. As shown, the triggering mechanism60may be disposed within a housing62provided at the control end24of the suturing device20and configured to interface with the first and second needles38,40via the elongate member22and the drive mechanism50disposed therein. Furthermore, one or more of the elongate member22and the drive mechanism50therein may be rotatably coupled to the housing62via a rotating collar64which may be used to adjust the radial position of the firing aperture32relative to the control end24. The housing62may further provide a grip66relative to which a trigger68of the triggering mechanism60may be pivotally anchored by an anchoring pin70and movable in one of two directions. For example, the trigger68may be configured to engage the drive mechanism50and advance the needles38,40when pulled toward the grip66, and disengage the drive mechanism50and retract the needles38,40when pushed away from the grip66. Correspondingly, as shown inFIG. 10, the trigger68may be provided with a proximal handle72for pulling the trigger68toward the grip66, as well as a distal handle74for pushing the trigger68away from the grip66.

Still referring toFIG. 10, the triggering mechanism60may further include a yoke76that is rigidly and axially coupled to the elongate member22and rotatably disposed within the housing62. The triggering mechanism60may additionally include a drive collar78that is axially movable relative to the yoke76and pivotally anchored to the trigger68via a lynch pin80. Furthermore, as shown inFIGS. 10-14, the interface between the drive collar78and the lynch pin80may be configured such that the drive collar78is pivotally anchored to the trigger68irrespective of the rotational position of the drive collar78relative to the trigger68and the housing62. The drive collar78may additionally be linked to the yoke76via a collar link82and a reversing lever84such that the rotational position of the drive collar78follows the rotational position of the yoke76. As shown inFIGS. 10-14, for example, the proximal end of the collar link82may be pivotally as well as radially coupled to the drive collar78, and the distal end of the collar link82may be pivotally and radially coupled to the yoke76.

The triggering mechanism60ofFIGS. 10-14may further provide means for translating a single action received by a user at the control end24of the suturing device20into two or more simultaneous but opposing actions effectuated at the working end26. For example, the distal end of the collar link82may be coupled to the yoke76via a reversing lever84, the substantial center of which may be pivotally anchored to the yoke76. In particular, a first end of the reversing lever84may be pivotally coupled to a first sliding block86that is rigidly coupled to the first drive link52but slidably movable relative to the yoke76. Correspondingly, a second end of the reversing lever84, opposite the first end, may be pivotally coupled to a second sliding block88that is rigidly coupled to the second drive link54but also slidably movable relative to the yoke76. In addition, the collar link82may be pivotally coupled proximate and biased to one of the first and second ends of the reversing lever84such that, for example, pushing the collar link82in a distal direction rotates the reversing lever84relative to the yoke76in a first direction, and pulling the collar link82in a proximal direction rotates the reversing lever84in a second direction opposite to the first direction.

As illustrated inFIGS. 13 and 14, for example, the collar link82may be coupled proximate to the second end of the reversing lever84which may further be coupled to the second sliding block88. In this particular arrangement, when the trigger68is moved toward the grip66as indicated by the arrow inFIG. 13, the drive collar78and the collar link82may be pulled toward the control end24of the suturing device20, thereby causing the reversing lever84to pivot in the manner shown and slidably urge the first sliding block86, as well as the first drive link52coupled thereto, in the distal direction while simultaneously urging the second sliding block88, as well as the second drive link54coupled thereto, in the proximal direction. Moving the trigger68in the manner shown inFIG. 13may thus cause the drive mechanism50to engage and actuate the first and second needles38,40. Conversely, when the trigger68is moved away from the grip66as indicated by the arrow inFIG. 14, the drive collar78and the collar link82may be pushed toward the working end26of the suturing device20, thereby causing the reversing lever84to pivot in the opposite direction and slidably urge the first sliding block86, as well as the first drive link52, in the proximal direction while simultaneously urging the second sliding block88, as well as the second drive link54, in the distal direction. Correspondingly, moving the trigger68in the manner shown inFIG. 14may cause the drive mechanism50to disengage and retract the first and second needles38,40.

Turning toFIGS. 15-27, the suturing device20may additionally include an autoloading mechanism90for successively feeding and automatically loading one of a plurality of sutures34into position relative to the firing aperture32for deployment. As shown inFIGS. 15 and 16, for example, a plurality of successively deployable sutures34, in the form of replaceable suture cartridges, suture ribbons, suture strings, or the like, may be removably inserted along guides or tracks36disposed within the elongate member22. The autoloading mechanism90may provide a pusher member92that is also slidably disposed along the tracks36and configured to successively or incrementally urge the sutures34toward the firing aperture32for deployment. As shown inFIGS. 17 and 18for example, the pusher member92may include at least one flexible pusher tab94extending therefrom that is biased so as to unidirectionally interface with one or more catches96that are disposed along one of the first and second drive links52,54of the drive mechanism50. Moreover, the pusher tab94and the catches96may be configured such that the pusher member92urges the sutures34toward the firing aperture32during engagement of the drive mechanism50or advancement of the needles38,40.

As shown in the particular arrangement ofFIGS. 17 and 18, for example, the pusher member92may be configured such that at least one pusher tab94engages with one of the catches96disposed on the first drive link52, and thereby moves the pusher member92in direct correspondence with the first drive link52. In this configuration, as shown inFIG. 17, the pusher member92may be urged to push the sutures34toward the firing aperture32while the first and second drive links52,54are being engaged and while the first and second needles38,40are being advanced. Furthermore, in this particular configuration, when the drive mechanism50is being disengaged and when the needles38,40are being retracted, as shown inFIG. 18, the catches96of the first drive link52may be free to return and move away from the working end26while the pusher member92remains stationary relative to the sutures34and the firing aperture32. Moreover, the pusher member92may include support members97as shown inFIG. 15configured to essentially wedge the pusher member92within the guides or tracks36of the elongate member22and provide the pusher member92at least some resistance against longitudinal movement therealong. The positioning of the catches96along the first drive link52may be spaced according to the distance allotted for each suture34. In addition, the number of catches96and the freedom of travel of the pusher member92may also be configured so as to sufficiently adapt to the changing length of the string of available sutures34which incrementally shortens after each deployment.

While the embodiments shown may disclose interactions between the pusher tab94and catches96provided on the first drive link52, the pusher tab94may alternatively interact with catches96disposed on the second drive link54or any combination of the first and second drive links52,54. In still further alternative embodiments, the pusher member92may be configured to interact with the drive mechanism50in other manners not shown, so long as the drive mechanism50is able to engage the pusher member92to timely and appropriately urge one or more sutures34toward the firing aperture32for deployment upon deployment of a prior suture34.

While the pusher member92and the catches96of the first drive link52ofFIGS. 15-18may aid in urging the string of sutures34toward the working end26for deployment, the extent to which the sutures34are pushed may be limited so as not to obstruct the firing aperture32through which the first and second needles38,40will need to extend in order to deploy a prior suture34. Accordingly, the autoloading mechanism90, as shown inFIGS. 19-27, may further include a shuttle98configured to retrieve the next suture34in line for deployment and position the suture34over the firing aperture32in alignment with the needles38,40upon full deployment and release of a prior suture34. As shown inFIG. 19, the shuttle98may be slidably disposed along the elongate member22and beneath the string of sutures34to be deployed. Moreover, the shuttle98may be movably disposed in communication between the working end26and the elongate member22such that the distance of travel of the shuttle98extends between at least the firing aperture32and the next suture34in line for deployment.

As shown inFIG. 20, the shuttle98may further include one or more suture pawls100for engaging with a suture34prior to deployment. More specifically, the suture pawls100may be configured such that the shuttle98is engaging when traveling in one direction but non-engaging when traveling in the opposite direction. In the embodiments ofFIGS. 19 and 20, for example, each of the suture pawls100may include a ramped edge102facing the proximal direction and a hooked edge104facing the opposite, distal direction. In addition, each of the suture pawls100may be formed of a partially flexible material and allowed to deflect within recesses106formed within the shuttle98. In such a way, the deflectable ramped edges102may enable the suture pawls100and the shuttle98to proximally travel from the firing aperture32to beneath the sutures34without substantial obstruction and without adversely affecting the position of the sutures34. Once the shuttle98is in the appropriate position beneath the next suture34in line for deployment, as shown inFIG. 19, the hooked edges104may be upright and in position to slidably engage with the suture34. As the shuttle98returns toward the working end26, the hooked edges104of the suture pawls100may distally slide the next suture34onto the firing aperture32. Moreover, the suture34may be positioned such that any needle guides48thereof are appropriately aligned with one or more corresponding needles38,40.

Turning toFIG. 21, the autoloading mechanism90may further interface with the drive mechanism50to at least cause the shuttle98ofFIGS. 19 and 20to move between the firing aperture32and the string of suture34. As shown, the autoloading mechanism90may include a shuttle pawl108that is generally disposed beneath the shuttle98and coupled to one of the first and second drive links52,54of the drive mechanism50. While other configurations are possible, in the particular embodiments shown, for example, the shuttle pawl108may be coupled to the first drive link52. Moreover, the shuttle pawl108may include a ramped edge110facing the distal direction that is configured such that the first drive link52and the shuttle pawl108are freely movable in the distal direction relative to the shuttle98without substantial obstruction or interference therewith, such as during advancement of the needles38,40. As illustrated, the shuttle pawl108may be formed of a flexible material that can be deflected within a recess112of the first drive link52. The shuttle pawl108may additionally include a hooked edge114facing the proximal direction that is configured such that the shuttle pawl108pulls the shuttle98with the first drive link52when the first drive link52moves in the proximal direction, such as during retraction of the needles38,40.

As shown more particularly inFIG. 22, during engagement of the drive mechanism50or during advancement of the first and second needles38,40, the first drive link52along with the shuttle pawl108may be distally pushed toward the working end26of the suturing device20in the manner shown. As the shuttle pawl108approaches the shuttle98, the ramped edge110thereof may enable the shuttle pawl108to deflect into the recess112of the first drive link52, and further, enable the shuttle pawl108to glide under the shuttle98without altering the position of the shuttle98relative to the sutures34. Each of the first drive link52and the shuttle pawl108may progress in such a way at least until the hooked edge114of the shuttle pawl108reaches and interfaces with the distal end of the shuttle98. Both the first drive link52and the shuttle pawl98may be sized and configured such that the hooked edge114interfaces with distal end of the shuttle98once the needles38,40are in the fully extended positions and ready to engage and deploy the prior suture34as shown inFIG. 21. Correspondingly, during disengagement of the drive mechanism50or during retraction of the needles38,40, the first drive link52along with the shuttle pawl108and the engaged shuttle98may be proximally pulled toward the string of sutures34so as to retrieve the next suture34in line for subsequent deployment.

Once the shuttle98is sufficiently pulled beneath the next suture34to be deployed, the shuttle pawl108may be configured to automatically release the shuttle98so as to enable the shuttle98to return to the working end26and send the retrieved suture34therewith to the appropriate position over the firing aperture32. As shown inFIG. 23, for example, the autoloading mechanism90may thus provide a declutch feature, such as a declutch pin116, or the like, configured to release the shuttle pawl108, or release the shuttle98from the first drive link52, once the shuttle98is appropriately positioned beneath the next suture34in line for deployment. For example, the declutch pin116may be coupled within the elongate member22and fixedly positioned relative to the shuttle pawl108such that, as the shuttle pawl108proximally passes thereby, the shuttle pawl108is caused to deflect within the recess112of the first drive link52and allow the shuttle98to return to the working end26. Furthermore, the shuttle pawl108may further provide a ramped interface118which proximally precedes the hooked edge114and is configured to sufficiently deflect and release the shuttle pawl108from the shuttle98at the appropriate moment, for instance, when the suture pawls100of the shuttle98are ready to engage with the next suture34in line for deployment.

Still referring toFIG. 23, once the shuttle pawl108is fully deflected, the shuttle98and the retrieved suture34may be sent to the firing aperture32by a bias mechanism120configured to continuously bias or urge the shuttle98toward the working end26. As shown, the bias mechanism120may employ a compression spring, or the like, that is longitudinally disposed within the elongate member22and configured to distally push the shuttle98away therefrom. In further modifications, the proximal end of the shuttle98may further provide a centering rod122longitudinally extending therefrom configured to interface with the compression spring of the bias mechanism120and maintain centering of the shuttle98relative to the elongate member22and the firing aperture32. Similarly, other bias mechanisms120may be employed to achieve comparable results so long as the biasing force applied upon the shuttle98in the distal direction does not exceed the force exerted thereon in the proximal direction by the shuttle pawl108and the first drive link52.

Turning now toFIGS. 24-26, one exemplary embodiment of the autoloading mechanism90is shown as it progressively retrieves the next suture34in line for deployment, and appropriately positions the suture34upon the firing aperture32. More specifically, as shown inFIG. 24, the shuttle98as well as the suture pawls100are proximally pulled toward the string of sutures34as the drive mechanism50is disengaged or as the needles38,40are retracted. As illustrated, the shuttle98is proximally pulled until at least the suture pawls100are in position to slidably engage respective sections of the suture34. For instance, each suture pawl100may be configured to engage an exterior of a needle guide48of the suture34, an interior of a needle guide48, or any other portion of the suture34that is suitable for carrying the suture34to the firing aperture32. Once released, the shuttle98and the suture pawls100, as well as the next suture34to be deployed, may be distally pushed toward the firing aperture32while leaving the remaining string of sutures34behind, as shown for instance inFIG. 25. Furthermore, as shown inFIG. 26, the shuttle98may continue carrying the suture34toward the firing aperture32until each of the needle guides48of the suture34is appropriately aligned to be engaged by the corresponding needle38,40.

In addition, as shown inFIG. 27, the autoloading mechanism90may also provide one or more release mechanisms124,126for completely deploying or releasing an engaged suture34from the first and second needles38,40during retraction thereof. For example, each release mechanism124,126may employ a blade or a cutting edge128that is longitudinally disposed within the firing aperture32and fixedly positioned proximate the retracted position of the corresponding needle38,40such that, as the needle38,40is retracted back into the firing aperture32and restored to its fully retracted position, the movement thereof relative to the cutting edge124causes the needle guide48of the suture34to be cut and released therefrom. In the particular embodiment ofFIG. 24, for instance, a first release mechanism124is fixedly disposed within the firing aperture32and proximate the first needle38, while the second release mechanism126is fixedly disposed within the firing aperture32and proximate the second needle40. Moreover, in each release mechanism124,126, the cutting edge128may be specifically positioned such that an engaged suture34is cut and completely released by the time the corresponding needle38,40returns to its retracted position. While only cutting edges128are shown, the release mechanisms124,126may alternatively employ hooks, pawls, ramped edges, or any suitable device capable of releasing the suture34from the needles38,40or hooks46thereof either by cutting or unlatching the suture34therefrom.

Referring now toFIGS. 28 and 29, one exemplary embodiment of a tissue fastener or suture34constructed in accordance with the teachings of the present disclosure is provided. As shown, the suture34may generally comprise an elongated filament130extending between a first end and a second end, and at least one needle guide48disposed at one or more of the first and second ends of the elongated filament130. The suture34may be unitarily formed of a material that is sufficiently flexible and compliant so as to be appropriately deployable by a suturing device20, while also providing sufficient resilience or rigidity to maintain closure between tissue and/or prosthetic material upon deployment. Additionally, the elongated filament130may be formed with one or more planar curves, such as the S-shaped curve shown, or the like, so as to provide for a more compact overall package and to increase the number of sutures34that can be made available for deployment, for example, along the elongated member22of a given suturing device20. Furthermore, the planar curves of the elongated filament130may be configured according to the anticipated geometry of the suture34once deployed and installed within tissue and/or prosthetic material.

Still referring to the sutures34ofFIGS. 28 and 29, each needle guide48may be sufficiently sized and configured to be engaged by, for example, one of the needles38,40of the suturing device20ofFIG. 1-27, or one the needle hooks46thereof, while also being sufficiently easily released from the needles38,40, for example, via any of the release mechanisms124,126provided inFIGS. 24-27. The needle guides48may further be shaped, for example, with a relatively tapered tip that is configured to facilitate advancement thereof through tissue and/or prosthetic material during deployment, as well as resist retraction thereof to promote a secure closure. For example, the needle guides48may be shaped in the substantial form of an oval, an ellipse, a circle, a semi-circle, a triangle, a polygon, or the like. As shown, each needle guide48may additionally include one or more retention elements132that are also configured to facilitate advancement thereof through sections of tissue and/or prosthetic material, and further aid in resisting retraction thereof once deployed. The retention elements132may be shaped in the form of a tine, a fin, a canted element, or any design sufficiently capable resisting retraction through tissue and/or prosthetic material.

Each of the needle guides48inFIGS. 28 and 29may further be provided with one or more constriction elements134configured to further secure an engagement between the needle guide48and a corresponding needle38,40or needle hook46thereof. More specifically, the constriction element134may be disposed within the needle guide48in a manner configured to at least partially bias or constrict the needle guide48against one of the needles38,40received therethrough. As shown inFIGS. 28 and 29, for example, the constriction element134may take the form of a tab, flap, or the like, that is disposed within the needle guide48and extending toward the tapered end of the needle guide48or extending toward any other the portion of the needle guide48that is anticipated to be engaged by a needle hook46. Moreover, the constriction elements134may be formed of a material that is sufficiently flexible and compliant so as to receive a needle38,40therethrough, but also formed of a material with sufficient resilience and rigidity so as to bias the needle guide48against the needle38,40and needle hook46.

Turning toFIGS. 30-32, one exemplary interaction between the suture34ofFIGS. 28 and 29and a given set of needles38,40and respective needle hooks46is provided. As shown, once the first and second needles38,40are advanced into the fully extended positions and received through the respective needle guides48, the constriction elements134are caused to bend, thereby pushing or exerting an outward force against the inner edge of the needles38,40. This outward pushing force exerted by the constriction element134may effectively exert a substantially equal and opposite inward force on the tapered end of the needle guide48, thereby biasing the needle guide48into the needle hook46of the respective needle38,40. Thus, the constriction elements134of the sutures34may provide an otherwise absent constricting force on a received needle38,40, which may further serve to secure an engagement between the needle hook46and the needle guide48of the suture34. While disclosed in the form of a tab or flap, the constriction elements134may be provided on the needle guides48in any one of variety of different forms, sizes and configurations. Alternatively, the constriction element134may be configured to substantially close the needle guide48except for one or more slots, apertures or other voids disposed toward the tapered end thereof in a manner which would effectively bias the needle guide48against a given needle hook46. In still further alternatives, the constriction element134may be completely closed but penetrable by a needle38,40in a manner which would effectively bias the needle guide48against the needle hook46.

As shown inFIGS. 33 and 34, another exemplary embodiment of a tissue fastener or suture34-1that may be used in association with a suturing device20is provided. Similar to the suture34ofFIGS. 28 and 29, the suture34-1shown may generally comprise an elongated filament130-1extending between a first end and a second end, and at least one needle guide48-1disposed at one or more of the first and second ends of the elongated filament130-1. The suture34-1may be formed of a material that is sufficiently flexible and compliant so as to be appropriately deployable by a suturing device20, while also providing sufficient resilience or rigidity to maintain closure between tissue and/or prosthetic material upon deployment. The elongated filament130-1of the suture34-1may further include a cross member136as well as filament guides138configured to stabilize the suture34-1as it is moved within the tracks36and along the elongate member22of a suturing device20. For example, the cross member136may aid in increasing the structural integrity laterally across the suture34-1and reduce binding, while the filament guides138may be sized and configured to interface with the tracks36of the elongate member22of a suturing device20so as to provide the suture34-1with additional lateral support and maintain proper alignment thereof. Furthermore, any one or more of the cross member136and the filament guides138may be configured with retention features configured to aid in resisting retraction thereof once deployed into tissue and/or prosthetic material.

As in previous embodiments, the needle guides48-1ofFIGS. 33 and 34may be sufficiently sized and configured to be engaged by a needle38,40of a suturing device20, or one of the needle hooks46thereof, while also being sufficiently thin or easily released from the needles38,40, for example, via any of the release mechanisms124,126provided inFIGS. 24-27. As shown, the needle guides48-1may be provided with a relatively tapered tip, as well as provided with one or more retention elements132-1, configured to facilitate advancement thereof through tissue and/or prosthetic material during deployment, and resist retraction thereof to promote a secure closure. Each of the needle guides48-1inFIGS. 33and34may be provided with constriction elements134-1which substantially conform to the shape of the needle guides48-1and serve to secure an engagement between the needle guide48-1and a corresponding needle38,40or needle hook46thereof. Specifically, each constriction element134-1may be configured to increase the integrity or lateral rigidity of each needle guide48-1when a needle38,40is not inserted therethrough, such as when the suture34-1is being moved along the tracks36of the elongate member22of a suturing device20, but also configured to effectively reduce the lateral rigidity of each needle guide48-1when a needle38,40is received therethrough, such as during advancement through tissue and/or prosthetic material. As shown inFIGS. 33 and 34, for example, the constriction elements134-1, when in the non-deflected state, may substantially fill the width of the needle guides48-1, and thereby provide lateral support thereacross. When in the deflected state, the constriction elements134-1may enable the needle guides48-1to substantially collapse and narrow so as to promote insertion or advancement thereof through a tissue, and the like. Furthermore, the constriction elements134-1may continue to provide lateral rigidity and support for the retention elements132-1once deployed and released into tissue and/or prosthetic material. For example, once the suture34-1is deployed and needle guides48-1are released, for instance cut, from the corresponding needles38,40, the constriction elements134-1may be configured to return to the non-deflected default state and thereby substantially prevent the retention elements132-1from collapsing and retracting from the tissue and/or prosthetic material.

As additionally shown inFIGS. 35 and 36, another exemplary embodiment of a tissue fastener or suture34-2that may be used in association with a suturing device20is provided. As in previous embodiments, the suture34-2may generally comprise an elongated filament130-2extending between a first end and a second end, and at least one needle guide48-2disposed at one or more of the first and second ends of the elongated filament130-2. The suture34-2may be formed of a material that is sufficiently flexible and compliant so as to be appropriately deployable by a suturing device20, while also providing sufficient resilience or rigidity to maintain closure between tissue and/or prosthetic material upon deployment. The elongated filament130-2of the suture34-2may further include a cross member136as well as filament guides138configured to stabilize the suture34-2as it is moved within the tracks36and along the elongate member22of a suturing device20. Additionally, any one or more of the cross member136and the filament guides138may be configured with retention features configured to aid in resisting retraction thereof once deployed into tissue and/or prosthetic material.

The needle guides48-2ofFIGS. 35 and 36may be sufficiently sized and configured to be engaged by a needle38,40of a suturing device20, or one of the needle hooks46thereof, while also being sufficiently thin or easily released from the needles38,40, for example, via any of the release mechanisms124,126provided inFIGS. 24-27. The needle guides48-2may be provided with a relatively tapered tip, as well as provided with one or more retention elements132-2, configured to facilitate advancement thereof through tissue and/or prosthetic material during deployment, and resist retraction thereof to promote a secure closure. Each of the needle guides48-2inFIGS. 35 and 36may be provided with constriction elements134-2configured to further secure an engagement between the needle guide48-2and a corresponding needle38,40or needle hook46thereof. Specifically, each constriction element134-2may be provided with a widened feature configured to increase the integrity or lateral rigidity of each needle guide48-2when a needle38,40is not inserted therethrough, such as when the suture34-2is being moved along the tracks36of the elongate member22of a suturing device20, but also configured to effectively reduce the lateral rigidity of each needle guide48-2when a needle38,40is received therethrough, such as during advancement through tissue and/or prosthetic material. As shown inFIGS. 35 and 36, for example, the widened feature of the constriction element134-2, when in the non-deflected state, may substantially abut the inner walls of the needle guide48-2, and thereby provide lateral support thereacross. When in the deflected state, the constriction element134-2may enable the needle guide48-2to substantially collapse and narrow so as to promote insertion or advancement thereof through a tissue, and the like. Furthermore, the constriction elements134-2may continue to provide lateral rigidity and support for the retention elements132-2once deployed and released into tissue and/or prosthetic material. For example, once the suture34-2is deployed and needle guides48-2are released, for instance cut, from the corresponding needles38,40, the constriction elements134-2may be configured to return to the non-deflected default state and thereby substantially prevent the retention elements132-2from collapsing and retracting from the tissue and/or prosthetic material.

In still further alternatives, another exemplary embodiment of a tissue fastener or suture34-3is provided inFIGS. 37 and 38. As in previous embodiments, the suture34-3may generally comprise an elongated filament130-3extending between a first end and a second end, and at least one needle guide48-3disposed at one or more of the first and second ends of the elongated filament130-3. The suture34-3may be formed of a material that is sufficiently flexible and compliant so as to be appropriately deployable by a suturing device20, while also providing sufficient resilience or rigidity to maintain closure between tissue and/or prosthetic material upon deployment. The elongated filament130-3of the suture34-3may further include a cross member136as well as filament guides138configured to stabilize the suture34-3as it is moved within the tracks36and along the elongate member22of a suturing device20. Additionally, any one or more of the cross member136and the filament guides138may be configured with retention features configured to aid in resisting retraction thereof once deployed into tissue and/or prosthetic material.

The needle guides48-3ofFIGS. 37 and 38may be sufficiently sized and configured to be engaged by a needle38,40of a suturing device20, or one of the needle hooks46thereof, while also being sufficiently thin or easily released from the needles38,40, for example, via any of the release mechanisms124,126provided inFIGS. 24-27. The needle guides48-3may be provided with a relatively tapered tip, as well as provided with one or more retention elements132-3, configured to facilitate advancement thereof through tissue and/or prosthetic material during deployment, and resist retraction thereof to promote a secure closure. Each of the needle guides48-3inFIGS. 37 and 38may be provided with constriction elements134-3configured to further secure an engagement between the needle guide48-3and a corresponding needle38,40or needle hook46thereof. Specifically, each constriction element134-3may be provided with a substantially webbed feature configured to increase the integrity or lateral rigidity of each needle guide48-3when a needle38,40is not inserted therethrough, such as when the suture34-3is being moved along the tracks36of the elongate member22of a suturing device20, but also configured to effectively reduce the lateral rigidity of each needle guide48-3when a needle38,40is received therethrough, such as during advancement through tissue and/or prosthetic material. As shown inFIGS. 37 and 38, for example, the webbed feature of the constriction element134-3, when in the non-deflected state, may provide rigidity and lateral support against the inner walls of the needle guide48-3. When the constriction element134-3is at least partially deflected state due to the insertion of a needle38,40, the needle guide48-3may be enabled to substantially collapse and narrow so as to promote insertion or advancement thereof through a tissue, and the like. Furthermore, the constriction elements134-3may continue to provide lateral rigidity and support for the retention elements132-3once deployed and released into tissue and/or prosthetic material. For example, once the suture34-3is deployed and needle guides48-3are released, for instance cut, from the corresponding needles38,40, the constriction elements134-3may be configured to return to the non-deflected default state and thereby substantially prevent the retention elements132-3from collapsing and retracting from the tissue and/or prosthetic material.

Referring now toFIGS. 39 and 40, another exemplary embodiment of a tissue fastener or suture34-4is provided. As in previous embodiments, the suture34-4may generally comprise an elongated filament130-4extending between a first end and a second end, and at least one needle guide48-4disposed at one or more of the first and second ends of the elongated filament130-4. The suture34-4may be formed of a material that is sufficiently flexible and compliant so as to be appropriately deployable by a suturing device20, while also providing sufficient resilience or rigidity to maintain closure between tissue and/or prosthetic material upon deployment. The elongated filament130-4of the suture34-4may further include a cross member136as well as filament guides138configured to stabilize the suture34-4as it is moved within the tracks36and along the elongate member22of a suturing device20. Additionally, any one or more of the cross member136and the filament guides138may be configured with retention features configured to aid in resisting retraction thereof once deployed into tissue and/or prosthetic material.

The needle guides48-4ofFIGS. 39 and 40may be sufficiently sized and configured to be engaged by a needle38,40of a suturing device20, or one of the needle hooks46thereof, while also being sufficiently thin or easily released from the needles38,40, for example, via any of the release mechanisms124,126provided inFIGS. 24-27. The needle guides48-4may be provided with a relatively tapered tip, as well as provided with one or more retention elements132-4, configured to facilitate advancement thereof through tissue and/or prosthetic material during deployment, and resist retraction thereof to promote a secure closure. Each of the needle guides48-4inFIGS. 39 and 40may be provided with constriction elements134-4configured to further secure an engagement between the needle guide48-4and a corresponding needle38,40or needle hook46thereof. As in the suture34-3ofFIGS. 37 and 38, the constriction elements134-4ofFIGS. 39 and 40may be provided with a webbed feature configured to increase the integrity or lateral rigidity of each needle guide48-4when a needle38,40is not inserted therethrough, such as when the suture34-4is being moved along the tracks36of the elongate member22of a suturing device20, but also configured to effectively reduce the lateral rigidity of each needle guide48-4when a needle38,40is received therethrough, such as during advancement through tissue and/or prosthetic material. Unlike the previous suture34-3, however, the constriction elements134-4of the suture34-4ofFIGS. 39 and 40may be arched or otherwise contrasted with the general plane of the suture34-4and biased to exert a lateral force against the inner walls of the needle guide48-4when in the non-deflected state. When the constriction element134-4is at least partially deflected due to the insertion of a needle38,40, the needle guide48-4may be enabled to substantially collapse and narrow so as to promote insertion or advancement thereof through a tissue, and the like. Furthermore, the constriction elements134-4may continue to provide lateral rigidity and support for the retention elements132-4once deployed and released into tissue and/or prosthetic material. For example, once the suture34-4is deployed and needle guides48-4are released, for instance cut, from the corresponding needles38,40, the constriction elements134-4may be configured to return to the non-deflected default state and thereby substantially prevent the retention elements132-4from collapsing and retracting from the tissue and/or prosthetic material.

Referring further toFIGS. 41 and 42, yet another exemplary embodiment of a tissue fastener or suture34-5is provided. Similar to previous embodiments, the suture34-5may generally comprise an elongated filament130-5extending between a first end and a second end, and at least one needle guide48-5disposed at one or more of the first and second ends of the elongated filament130-5. The suture34-5may be formed of a material that is sufficiently flexible and compliant so as to be appropriately deployable by a suturing device20, while also providing sufficient resilience or rigidity to maintain closure between tissue and/or prosthetic material upon deployment. The elongated filament130-5of the suture34-5may also include breakaway tabs140configured to help stabilize the suture34-5as it is moved within the tracks36and along the elongate member22of a suturing device20. As shown, each breakaway tab140may be coupled between a needle guide48-5and a corresponding section of the elongated filament130-5in the folded position, and configured to be detachable upon deployment. In particular, the breakaway tabs140may be sized and configured to provide, not only sufficient planar and lateral rigidity to the suture34-5prior to deployment, but also configured with sufficient detachability so as not to interfere with the deployment thereof. As better seen inFIG. 42, for example, each of the breakaway tabs140may incorporate attenuated features142, such as in the form of grooves, slits, perforations, or the like. Furthermore, the breakaway tabs140may be angled or otherwise positioned relative to the needle guides48-5in a way to help resist retraction thereof once deployed into tissue and/or prosthetic material.

The needle guides48-5ofFIGS. 41 and 42may be sufficiently sized and configured to be engaged by a needle38,40of a suturing device20, or one of the needle hooks46thereof, while also being sufficiently thin or easily released from the needles38,40, for example, via any of the release mechanisms124,126provided inFIGS. 24-27. The needle guides48-5may be provided with a relatively tapered tip, as well as provided with one or more retention elements132-5, configured to facilitate advancement thereof through tissue and/or prosthetic material during deployment, and resist retraction thereof to promote a secure closure. As shown, the edges of the needle guides48-5may additionally be beveled, rounded, or otherwise configured to further facilitate advancement thereof. In addition, each of the needle guides48-5inFIGS. 41 and 42may be provided with generally linear constriction elements134-5positioned to further secure an engagement between the needle guide48-5and a corresponding needle38,40or needle hook46thereof. Moreover, the constriction elements134-5may serve to increase the integrity or lateral rigidity of each needle guide48-5when a needle38,40is not inserted therethrough, such as when the suture34-5is being moved along the tracks36of the elongate member22of a suturing device20. Furthermore, the constriction elements134-5may continue to provide lateral rigidity and support for the retention elements132-5once deployed and released into tissue and/or prosthetic material. For example, once the suture34-5is deployed and needle guides48-5are released from the corresponding needles38,40, the constriction elements134-5may be configured to prevent the retention elements132-5from collapsing and retracting from the tissue and/or prosthetic material.

In addition, the suture34-5ofFIGS. 41 and 42may further include one or more nesting elements144, or extended features disposed along the elongated filament130-5, which may be sized and configured to detachably couple to a counterpart section of an adjacent suture34-5in a string of sutures34-5. As shown inFIG. 43, for example, each nesting element144may be configured to couple to the tip of the needle guide48-5of an adjacent suture34-5. Correspondingly, the tips of each needle guide48-5may be beveled, rounded, or otherwise sized and shaped to be mateably received within the nesting elements144of an adjacent suture34-5. In such a way, each suture34-5may include two sets of nesting elements144, such as forward-facing nesting elements144for coupling to the trailing needle guide48-5of a preceding suture34-5, and rearward-facing nesting elements144for coupling to the leading needle guide48-5of a subsequent suture34-5. Furthermore, the nesting elements144may be coupled to corresponding sections of adjacent sutures34-5using, for example, flexible bonding material or adhesives, friction fitments, attenuated connections, or any other suitable arrangement that is, not only capable of maintaining rigidity of the string of sutures34-5prior to deployment, but also capable of being easily detached so as not to interfere with deployment.

From the foregoing, it can be seen that the present disclosure sets forth a medical fastening or suturing device adapted to rapidly and reliably install fasteners or sutures to secure tissue and/or any applicable prosthetic material. The device not only greatly reduces the time required for fastening tissues, but also results in improved ease of use relative to other methods. Furthermore, through the unique combination of elements set forth in the present disclosure, the tissue fastening or suturing is more reliably retained with reduced irritation and other complications to the patient and without adversely affecting the integrity of the attachment and/or closure.