Urethral anastomosis device and method

Provided herein is a two-part coupling assembly for re-connecting a first hollow body part to a second body part and an instrument and method for emplacement. The coupling assembly comprises coupling parts having securement elements that are actuated by separate deployment mechanisms of the instrument and attach to the first and second body parts. The first and second coupling parts having interconnecting elements that couple the two-part assembly together and re-connect the first and second body parts.

TECHNICAL FIELD

This disclosure relates generally to the field of medical devices and, in particular, to devices and methods for reconnecting two hollow body parts such as a urethra to a bladder.

BACKGROUND

The prostate gland is a semen-producing organ located in the abdomen of males. Cancer of the prostate gland is an extremely common ailment among older American men. In fact, prostate cancer is the second-leading cause of cancer-related deaths and the most common cancer diagnosed in men. In 2010, an estimated 90,000 American men underwent radical prostatectomy, a surgery in which their prostate gland was removed. If past experience holds, nearly one-third of these men suffered complications, which at the least were painful and at most required further invasive surgery.

The most common complication, known as bladder-neck contracture, is caused by leakage of urine into the abdomen. During a radical prostatectomy, after the prostate is removed, it is necessary to re-attach the bladder (where the body stores urine) to the urethra (the passage carrying urine from the bladder to the penis). Unfortunately, the conventional hand-sewn five- to six-suture re-attachment (an anastomosis) often does not result in a leak-proof seal. Consequently, urine can leak from the bladder into the abdomen until the anastomosis is sealed, which can take up to five days. Such leakage causes scarring, which in turn leads to bladder-neck contractures. A patient suffering from such a contracture typically is unable to urinate and requires painful and expensive intervention.

In addition, with the robotic approach, the urethral vesicle anastamosis can be one of the most challenging components of the surgery. In the most-experienced hands, this can add thirty minutes to the operation, and in the hands of a novice, it can add one hour to the operation.

Accordingly, it can be seen that needs exist for improved ways to re-attach the urethra to the bladder. It is to this and other solutions that the embodiments of the present invention are primarily directed.

SUMMARY

We provide an instrument for re-connecting a first hollow body part to a second body part with a two-part coupling assembly, the two coupling parts each having securement elements. The instrument comprises a handle assembly, at least two elongate coaxial members longitudinally slidable with respect to each other, deployment mechanisms for deploying the securement elements of the coupling parts, and at least one release mechanism for releasing the two-part coupling assembly from the elongate members.

We also provide a two-part coupling assembly for re-connecting a first hollow body part to a second body part. The coupling assembly comprises coupling parts having securement elements that are actuated by separate deployment mechanisms and attach to the first and second body parts. The first and second coupling parts have interconnecting elements that couple the two-part assembly together and re-connect the first and second body parts.

We also provide a method of connecting a first hollow body part to a second hollow body part comprising inserting a first coupling into the first hollow body part and deploying the securement elements of the first coupling to secure the first coupling in place. Subsequently, the second coupling part is extended into the second hollow body part and the securement elements of the second coupling are deployed to secure the second coupling part in place. The second coupling is then retracted into an interconnecting relationship with the first coupling and the first and second coupling parts are released from the instrument.

DETAILED DESCRIPTION

The present disclosure generally relates to anastomosis systems and methods. In the depicted embodiments, the systems and methods relate to urethral anastomosis systems and methods. Persons of ordinary skill in the art will appreciate that the teachings herein can be readily adapted to other types of anastomosis systems and methods. Accordingly, as used herein, the terms such as urethra and bladder are not intended to be limiting of the embodiments of the present invention. Instead, it will be understood that the embodiments of the present invention relate generally to the field of medical devices and, in particular to devices and methods for reconnecting two hollow body parts or vessels, such as the urethra and the bladder, or two portions of any other body vessel. As used herein, the terms “proximal” and “distal” refer respectively to the directions closer to and further from the operator of the anastomosis device. For purposes of clarity, the distal portion of the device is inserted furthest into an anastomosis patient and the proximal portion of the device remains at least partly outside of the patient. Likewise, the term “lower” is generally used to refer to a portion of the device that is proximally located with respect to a corresponding portion of the device. The term “upper” is generally used to refer to a portion of the device that is distally located with respect to a corresponding portion of the device.

The anastomosis systems of the present disclosure generally include a coupling assembly for connecting and sealing the two body parts and a surgical implement for emplacing the coupling assembly. In typical embodiments, the couplings each include two rings, each ring with securement elements that attach to the respective body part and each ring with interconnecting elements that attach to each other. For example, in some of the depicted embodiments for urethral anastomosis, the couplings include two rings each made of a degradable/absorbable material and interconnected to form a leak-proof seal between the bladder and the urethra. The coupling assembly, which may also be referred to as a ring assembly herein, eliminates urine leakage, removing the cause of the most common post-operative complication, bladder-neck contracture. Also, the anastomosis is performed entirely within the urethra and thus there is no risk of damaging the neurovascular bundles that lie directly outside the urethra.

In addition, the surgical instrument of the anastomosis system can be used laparoscopically/robotically as well. Currently, a laparoscopic/robotic prostatectomy requires a hand-sewn urethral anastomosis that can take up to three hours and does not result in an immediate water-tight seal. There has been an enormous increase in robotic-assisted radical prostatectomies during the last five years. This surgical instrument can be used with the coupling assembly to form a seal between the bladder and the urethra in only approximately fifteen minutes (rather than three hours) and the resulting seal is leak-proof. This system and method also presents the potential to perform the procedure without a urethral catheter, which is normally left in place for seven to ten days. Finally, the system and method will only compromise about 4 mm of urethra, thereby maximizing “functional urethral length,” which is known to be one of the most important determinants of post-operative continence.

In the figures, in which like numerals indicate like elements throughout, there is shown an embodiment of an anastomosis system. The first embodiment of the anastomosis system is generally referred to by the numeral10.

Turning now to the drawings,FIG. 1shows an anastomosis system10, including a surgical instrument12and a ring coupling assembly14, according to a first exemplary embodiment of the present invention. The anastomosis system10is designed for connecting and sealing a bladder to a urethra, but can be adapted for connecting other hollow body parts.

Referring generally toFIGS. 2-5, the ring coupling assembly14includes a lower (or first or urethra) ring16and an upper (or second or bladder) ring18, each defining an internal coaxial lumen. The lower ring16has securement elements24that are pivotable on pivot pin23(seeFIG. 25) between a stored/retracted/delivery position in which they are recessed into the lower ring body and a deployed/extended position in which they extend outward from the lower ring body so that they engage and secure to the wall of the urethra or other hollow body part. The lower ring securement elements24have cam surfaces25(seeFIG. 25) on the inner facing surfaces that extend within the lumen of the lower ring16. Similarly, the upper ring18has securement elements26that are pivotable on pivot pin43(seeFIG. 31) between a stored/retracted/delivery position in which they are recessed into the upper ring body and a deployed/extended position in which they extend outward from the upper ring body so that they engage and secure to the wall of the bladder. The upper ring securement elements26have cam surfaces27(seeFIG. 30) on the inner facing surfaces that extend within the lumen of the upper ring18. In typical embodiments, the lower securement elements24pivot downward less than 90 degrees from the stored to the deployed position, and the upper securement elements26pivot upward less than 90 degrees from the stored to the deployed position, such that, in the deployed position, the securement elements are oriented towards each other in order to engage the walls of the urethra and the bladder to maintain a compression fit between the urethra and the bladder for good sealing.

As shown, the upper and lower rings18,16of the ring coupling assembly14define a central lumen that permits the passage of fluid therethrough. The ring assembly14has a generally circular cross-section; however, other shapes are possible, including octagonal or hexagonal cross-sectional shapes. In some embodiments for anastomosis of a bladder and urethra, the upper ring18may have an outer diameter of approximately 9.0 mm, an inner diameter defining a lumen of approximately 5.0 mm, and a height of approximately 8.0 mm and the lower ring16may have an outer diameter of approximately 9.0 mm, an inner diameter defining a lumen of approximately 6.0 mm, and a height of approximately 8.5 mm. However, larger or smaller dimensions are possible so long as the ring assembly (i) can be received within and securely engage to the hollow body parts being joined together by anastomosis and (ii) provides a lumen that permits the passage of fluid therethrough.

Referring specifically toFIGS. 3 and 4, the interconnector elements28and30of the rings16and18, respectively, can be provided by snap-fit connectors, screw-together connectors, or other conventional connector assemblies, whether detachable for decoupling or intended for one-time connection only. In typical embodiments, the snap- or press—fit connector elements28and30are provided by resiliently deflectable arms31with releasably interlocking catch surfaces (as depicted inFIGS. 35-38), detents, push-pin assemblies, or other types of connectors for coupling two parts together. Additional details of examples of the interconnecting (by interconnector elements28and30) of the rings16and18, and of their mounting to the surgical instrument12(by ring-mounting connectors20and22), are provided in the further description of the operation of the system10below.

Referring now toFIGS. 1,2,7,8,13A,14, and16, the surgical instrument12includes a handle assembly32, an intermediate applicator assembly40, and an inner applicator assembly64. The handle assembly32includes a hollow grip member34and a hollow elongate handle tube36extending distally from the grip member34, which together define an internal handle lumen37(seeFIG. 8). The grip member34includes a lock ring33with a lock button77and has inner screw threads35(see FIGS.8and39-42), as described in detail below. The handle tube36includes at least one ring-mounting connector38that mounts to the at least one ring-mounting connector20of the lower ring16(seeFIGS. 5 and 6). For example, in the depicted embodiment, the handle tube ring-mounting connector38is provided by two strip projections39extending from the distal end of the handle tube36and the lower ring ring-mounting connector20is provided by two recesses21adapted to releasably receive the projections with a friction fit (seeFIGS. 6 and 7). A detent can be included on either of the strip projections29or within the recess21to help hold the lower ring16on the handle tube36, so long as the axial force needed to overcome the detent forces and detach the parts does not interfere with intended detachment of the lower ring16during operation.

As shown inFIG. 1, portions of the handle assembly32, intermediate applicator assembly40, and inner applicator assembly64form coaxial elongate members when the anastomosis system10is assembled. At least a portion of the handle assembly32and intermediate applicator assembly40define lumens37,41forming passageways therethrough. As shown inFIGS. 2 and 8, the handle assembly32has a lumen37that is sized and shaped to receive at least a portion of the intermediate applicator assembly40. Additionally, the intermediate applicator assembly40has a lumen41(seeFIG. 2) that is sized and shaped to receive at least a portion of the inner applicator assembly64. Thus, when the respective members40,64are received within the appropriate lumens41,37, as the instrument12is assembled, the handle assembly32, intermediate applicator assembly40, and inner applicator assembly64provide coaxial arrangement of the members32,40and64.

As can best be seen in FIGS.,2,13A, and15, in the present embodiment, the intermediate applicator assembly40comprises two separate assemblies, an upper tube assembly42and a lower tube assembly44, that work together but can be detached for storage. Thus, the intermediate applicator assembly40includes a proximal rotary control60, a distal end48adapted to mount the upper ring18thereto and to deploy the lower urethra ring16securement elements24(i.e., a combination applicator and deployer), and a rotary-to-translating motion converter positioned between the proximal rotary control60and distal end48. In alternative embodiments, the intermediate applicator assembly40may be provided as a single assembly of parts not intended to be detachable after use.

Referring toFIGS. 2 and 9, the upper tube assembly42includes the distal end applicator/deployer (referred to as the lower ring securement element deployer48), a hollow upper tube46, and a proximal end52. As depicted inFIG. 13A, the lower tube assembly44includes a distal end55, a hollow lower tube56, and the proximal rotary control (e.g., knob)60. The hollow upper tube46and the hollow lower tube56are axially alignable and sized so that they are coaxially receivable through the lumen37of the handle assembly32and cooperatively define a lumen41therethrough. Referring now also toFIGS. 12 and 13, the proximal end52of the upper tube46includes an axial recess54and the distal end55of the lower tube56has a rotary bearing58that is received in the axial recess54(such as by a press-fit connection). The outer surface of the lower tube56has outer (male) screw threads57which cooperate with the rotary bearing58, to convert rotational motion of the rotary control knob60to axial movement of the upper tube46, as described below.

As seen best inFIGS. 14,15, and40-42, the handle assembly32comprises a handle grip member34that includes a portion of the lumen37and has inner (female) threads35. When assembled, the outer threads57of the lower tube56engage the inner threads35of the handle grip member34. During operation, when the knob60is rotated, the outer threads57of lower tube56engage the inner threads35of the handle grip member34to translate the lower tube56axially with respect to the handle assembly32(seeFIG. 14). However, the rotary bearing58does not transmit the rotation force to the upper tube46via the axial recess54. As a result, the upper tube translates axially, but does not rotate (seeFIG. 15). In an exemplary embodiment of a bladder-urethra anastomosis surgical instrument, the rotary bearing58may be a deep groove ball bearing having an outer diameter of 7.0 mm and an internal diameter of 3.0 mm (seeFIG. 13B). Alternatively, another known motion-converting mechanism can be used for converting the rotary and axial motion of the lower tube56to the desired axial motion of the upper tube46, such as known nut-and-screw mechanisms.

Referring toFIGS. 9-11, the distal end of the upper tube46comprises the lower ring securement element deployer48, which extends distally therefrom and is adapted to deploy the lower ring securement elements24upon the axial translation of the upper tube46with respect to the grip member34. The lower ring securement element deployer48defines a tapered surface extending from the upper tube46and forming cam surface47. The narrower portion of the tapered cam surface47of the lower ring securement element deployer48is oriented towards the proximal direction and the diameter of the wider portion of the tapered cam surface47is sized to be receivable within the lumen of the lower ring16, but wide enough to engage the cooperating cam surfaces25of the lower ring securement elements24. As shown, the cam surface47(seen best inFIG. 11) engages cooperating cam surfaces25of the lower ring securement elements24to pivot securement elements24towards the deployed position when the upper tube46is axially retracted with respect to the handle assembly32(as described in further detail with respect toFIGS. 24 and 25).

The lower ring securement element deployer48translates axially with respect to the handle portion34as the control knob60is rotated. As mentioned, the lower ring securement element deployer48is adapted to both mount thereto the upper bladder ring18and to deploy the lower urethra ring securement elements24, using cam surface27. The lower ring securement element deployer48and the upper ring18have cooperating ring-mounting connectors such that the upper ring18is releasably mounted to the deployer48. As best seen inFIGS. 10 and 11, the ring-mounting connectors of the lower ring securement element deployer48can be provided by angular slots50, for example, two circumferential slots each in communication with a respective axial slot, as depicted. Referring now toFIGS. 10 and 36, the ring-mounting connectors of the upper ring18may be provided with radially inward extending tabs53that slide within the angular slots of the deployer48. As such, the depicted cooperating ring-mounting connectors form a conventional bayonet fitting that is released by rotating the deployer48with respect to the upper ring18. Alternatively, other types of releasable ring-mounting connectors known in the art can be provided.

Referring now toFIGS. 39-42, the proximal end52of the upper tube assembly42of the intermediate applicator assembly40includes at least one lock element that engages with at least one lock element of the handle32. As shown, the lock element consists of two radial recesses51located within the proximal end52of the upper tube assembly42(seeFIGS. 9 and 12), and extending generally perpendicular to the longitudinal axis of the upper tube assembly42. The recesses51are adapted to engage two radially-movable lock buttons77in the rotary lock ring33of the handle32, when the device12is assembled. The buttons77include narrow inner portions77a, for engaging the radial recesses51, and generally wider outer portions77bthat are sized for manual operation by a user. In order to disengage the upper ring18, the buttons77are depressed inwardly towards the longitudinal axis of the device, such that the inner portions77aare slid into the recesses51, thereby engaging the lock ring33and the upper tube assembly42and hence, the intermediate applicator assembly40together so that they rotate together to release the upper ring18from the lower ring securement element deployer48.

Referring now toFIGS. 16-20, the inner applicator assembly64includes an elongate rod66, a proximal rotary control, such as a knob68, and a distal end having a deployer element72. These components can be provided as separate pieces assembled together. By way of example, the embodiment depicted herein, and shown best inFIG. 2, provides for the rod66and the deployer element72to be detachable. Alternatively, the rod66and deployer element72can be of unitary construction. During assembly, the elongate rod66is coaxially receivable within the lumen41of the tubes46and56of the intermediate applicator assembly40. In the depicted embodiment, the rotary control is provided by a knob68with outer screw threads70that mate with inner screw threads of knob60. In this way, rotating the knob68causes the elongate rod66to translate relative to the tubes46and56of the intermediate applicator assembly40(seeFIGS. 18-20). In other embodiments, the controls of the two applicator assemblies are interconnected by other conventional structures for producing translating relative motion.

Referring now toFIG. 17, the distal end of the rod66, which includes the upper ring securement element deployer72, is adapted to deploy the upper ring securement elements26upon the axial translation of the rod66. The upper ring securement element deployer72defines a tapered surface extending from the rod66and forming cam surface75. The narrower portion of the tapered cam surface75of the upper ring securement element deployer72is oriented towards the proximal direction and the diameter of the wider portion of the tapered cam surface75is sized to be receivable within the lumen of the upper ring18, but wide enough to engage the cam surfaces27of the upper ring securement elements26. As shown inFIGS. 30 and 31, the cam surface75engages cooperating cam surfaces27of the upper ring securement elements26to pivot the upper ring securement elements26towards the deployed position when the rod66is axially retracted with respect to the handle assembly34. The upper ring securement element deployer72can also include anti-rotation mounting features, such as axial channel74that receives an inwardly protruding element of the upper ring18, for preventing rotation between the deployer72and the upper ring18.

The operation of the instrument12and ring assembly14of the first example embodiment, as well as example anastomosis methods, are shown inFIGS. 21-43. As depicted inFIG. 21, the instrument12is inserted through the urethra (not shown) to position lower ring16within urethra neck by pushing grip member34of handle assembly32to advance the lower ring16coupled to the instrument12into the urethra neck. Once the lower ring16is aligned at a suitable position within the urethra neck, the knob60of intermediate applicator assembly40is rotated counter-clockwise, as shown inFIG. 22. Counter-clockwise rotation of the knob60causes the lower ring securement element deployer48defining cam surface47to axially retract in the proximal direction (i.e., translate axially with respect to the handle assembly32) through the lumen of the lower ring16. As the tapered portion of the lower ring securement element deployer48forming the cam surface47further advances through the lumen of the lower ring16in the proximal direction, the cam surface47engages cooperating cam surfaces25on the inner facing surface of the lower ring securement elements24(seeFIGS. 24-26). Engagement of the cam surface47with the cam surfaces25of the lower ring securement elements24displaces the lower securement elements24, thereby urging the securement elements24to pivot around a pivot pin23and extend outward towards the deployed position.

FIG. 23shows the arrangement of the anastomosis system10with the lower securement elements24in the deployed position with the upper securement elements26remaining in the retracted position.FIG. 24-26show in detail the lower ring16, with lower ring securement elements24in the retracted position (FIGS. 24 and 25) and deployed position (FIG. 26). Arrows inFIG. 25illustrate the direction of movement of the deployment of the lower securement elements24. The outward movement of the lower ring securement elements24to the deployed position causes the securement elements24to engage the urethra neck, such as by piercing the urethral wall tissue. The surgeon may compress the urethra tissue around the lower ring16to ensure that the securement elements24securely engage the urethra.

At this point in the procedure, the lower ring16mounted on the surgical instrument12securely engages the urethra neck by the lower ring securement elements24. To maintain engagement of the securement elements24with the urethra tissue, the surgeon may apply gentle pressure to the grip member34in the distal direction such that the lower ring securement elements24are pushed generally in the direction of the curvature of the securement elements24.

Turning now toFIG. 27, after the deployment of the lower securement elements24, the surgeon may press slightly forward (i.e., distally) on grip member34to maintain engagement of lower ring securement elements24and rotate the knob60of the intermediate applicator assembly40clockwise to cause the lower ring securement element deployer48to translate forward with respect to the handle assembly32(i.e., axially extend). InFIG. 27, arrow “A” illustrates the clockwise rotation of the knob60and arrow “B” illustrates the direction of movement of the axial extension of the lower ring securement element deployer48. Axial extension of the lower ring securement element deployer48carries the upper ring18forward and, if necessary, after manipulation of the angle or position of the surgical instrument12, into the bladder neck.FIG. 27shows the arrangement of the anastomosis system10after the knob60is rotated and the upper ring18is axially extended. The lower ring securement elements24remain in the deployed position and, in use, would be engaged with the urethra neck such as through continued application of gentle pressure on grip member34to maintain engagement of lower ring securement elements24.

As shown inFIG. 28, when the upper ring18is in a desired position within the bladder neck (not shown), the surgeon rotates the lock nut76on the proximal end31of the handle assembly32in a first angular direction, for example clockwise. Arrow “A” inFIGS. 28 and 32illustrates clockwise rotation of the lock nut76. The rotation of lock nut76restricts or prevents rotation of the intermediate applicator assembly40with respect to the handle assembly32. The surgeon then rotates the knob68counter-clockwise, as shown by arrow “B” inFIGS. 28 and 32, thereby causing the inner applicator assembly64to rotate and axially retract in the proximal direction with respect to the handle assembly32. As depicted inFIGS. 30 and 31, axial retraction of inner applicator assembly64urges the cam surface75of upper ring securement element deployer72into engagement with cooperating cam surfaces27of upper ring securement elements26. As the tapered portion of the upper ring securement element deployer72forming the cam surface75further advances through the lumen of the upper ring18in the proximal direction, the cam surface75engages cooperating cam surfaces27on the inner facing surface of the upper ring securement elements26. Engagement of the cam surface75with the cam surfaces27of the upper ring securement elements26displaces the upper ring securement elements26, thereby urging the securement elements26to pivot around a pivot pin43and extend outward towards the deployed position.

FIG. 28shows the arrangement of the anastomosis system10with the upper ring securement elements26in the deployed position.FIG. 29-31show in detail the operation of the upper ring18with upper ring securement elements26in the retracted position (FIGS. 29 and 30) and subsequently moved to a deployed position (FIG. 31). Arrows inFIG. 31illustrate the direction of movement of the deployment of the upper securement elements26. The outward movement of the upper ring securement elements26to the deployed position causes the securement elements26to engage the bladder neck, such as by piercing the bladder tissue. The surgeon may compress the bladder tissue around the upper ring18to ensure that the securement elements26securely engage the bladder.

Referring now toFIGS. 32-34, with the bladder neck securely engaged by the upper ring securement elements26of the upper ring18, the surgeon may rotate the lock nut76in a second angular direction, for example counter clockwise, to unlock the intermediate applicator assembly40. Arrow “A” inFIG. 32shows the counter clockwise rotation of the lock nut76. Then, as shown inFIG. 32, the surgeon rotates of the knob60of intermediate applicator assembly40counter-clockwise to cause the intermediate applicator assembly40to axially retract (i.e., translate backward) without rotating. Arrow “B” inFIG. 32shows the counter clockwise rotation of the knob60. Axial retraction of the intermediate applicator assembly40causes lower ring securement element deployer48to axially retract with respect to the handle assembly32through the lumen of lower ring16and to also retract the upper ring18mounted thereon. The operation of the instrument12to cause axial retraction of the upper ring18with respect to the handle assembly is the inversion of the operation to cause the axial extension of the upper ring18described above and shown inFIG. 27. Axial retraction of the upper ring18brings the upper ring18towards the lower ring16, thereby drawing the urethra neck and bladder neck closer together.

FIG. 33shows the arrangement of the anastomosis system10and, more specifically, the ring assembly14, after axial retraction of the intermediate applicator assembly40in the direction of arrow “C.” As shown, the upper ring18is adjacent the lower ring16. As shown inFIG. 34, further rotation of knob60causes the upper ring18to axially retract towards the lower ring16until interconnectors28and30engage to couple the upper and lower rings18,16together with a snap- or press-fit connection.FIGS. 35-38show in detail the axial retraction of upper ring18towards the lower ring16(FIGS. 35 and 36) and coupling of the upper and lower rings18,16to each other (FIGS. 37 and 38).

Referring now toFIG. 39, when the ring assembly14is in position and the upper and lower rings18,16are coupled together, the ring assembly14may be released from the surgical instrument12. To do this, the surgeon depresses locking button77inward into recess51of proximal end52of upper tube46of the intermediate applicator assembly40.FIGS. 40-42show the handle assembly32before (FIGS. 40 and 41) and after pressing locking button77(FIG. 42). Depression of the locking button77permits counter-clockwise rotation of the lock ring33with respect to the grip member34(as shown by the arrow inFIG. 39) which induces rotation of angular slots50of lower ring securement element deployer48out of engagement with cooperating elements on upper ring18. The surgeon may then release lower ring16from the friction fit with handle tube36by pulling grip member34proximally. Finally, as shown inFIG. 43, the surgical instrument12may be withdrawn from the urethra leaving the ring assembly14to hold the urethra and bladder in anastomosis. The ring assembly14may be removed after a period of healing or, alternatively, may be permitted to biodegrade in place.

The structure and deployment operation of an alternative embodiment of the device will now be described with respect toFIGS. 97-99c.FIGS. 97 and 98show the structure of an alternative embodiment of a ring assembly1714, whereFIG. 97depicts the upper ring assembly1718andFIG. 98depicts the lower ring assembly1716. The ring assembly1714comprises a lower ring assembly1716, having a lower ring1716L and a lower central ring1780, and an upper ring assembly1718, having an upper ring1718U and an upper central ring1782. The body of the upper ring1718U defines a plurality of guide structures1786, which extend through the circumferential wall of the upper ring1718. As shown, the guide structures1786comprise openings in the sidewall of the upper ring1718U that are sized and positioned to permit passage of securement elements1726therethrough, in a proximal and radial outward direction. The guide structures1786have angled deployer surfaces1775adapted to engage inner surfaces1727of the securement elements1726. When the upper central ring1782is mounted on the upper ring1718U, the securement elements1726extend through the lumen1719of upper ring1718and into the guide structures1786such that inner surfaces1727of the securement elements1726at least partially engage the angled deployer surfaces1775. This engagement occurs in both the undeployed position, as shown inFIG. 99A, and the deployed position, as shown inFIGS. 99B and99C.

The securement elements1726are formed of a resiliently flexible material and may be of unitary construction with the upper central ring1782. The securement elements1726are moveable between an undeployed position in which the securement elements1726are at least partially recessed in the upper ring1718U and a deployed position where the securement elements1726extend proximally and radially outward from the upper ring1718U so that they are able to engage and secure to the wall of the bladder. The securement elements1726are moveable between the retracted and deployed positions by flexing due to engagement with the angled deployer surfaces1775of the guide structures1786, as the upper central ring1782is moved in a proximal direction with respect to the upper ring1718U.FIG. 99Ashows the securement elements1726in the retracted position andFIG. 99Bshows the securement elements1726in the deployed position. The arrow “B” inFIG. 99Billustrates the direction of motion of the securement elements1726during deployment, as the upper central ring1782is moved proximally, in the direction of arrow “A,” with respect to the upper ring1718U. The upper ring securement elements1726may pivot towards the deployed position on living hinges (not shown), or through the use of an actual hinge element (not shown) or via the inherent flexibility of the upper central ring1782. Preferably, when in the deployed position, the securement elements1726have at least some sort of bias in the radial inward and proximal directions, to facilitate engagement and retainment of a vessel such as the bladder.

Alternatively, the securement elements1726may be physically locked or held in position. As shown inFIG. 97, the upper ring1718U comprises ring mounting elements1787extending distally from the upper ring1718U and defining locking elements1788. The ring mounting elements1787may be adapted to extend into the central opening of the upper central ring1782and engage an inner surface of the upper central ring1782such that the locking elements1788engage a corresponding structure in the inner surface of the upper central ring1782by snap-fit engagement after the upper central ring1782is moved in a proximal direction to fully deploy the securement elements1726. Thus, when the upper central ring1782is locked adjacent to the upper ring1718U, it is positioned distally of the upper ring1718U, further extending the central lumen1719of the upper ring1718U. As seen inFIG. 99B, this extension of the central lumen1719provides a path for fluid to flow through after the anastomosis device is deployed within a patient. The ring mounting elements1787may also engage and lock the upper central ring1782by friction fit or other means.

Turning now toFIG. 98, lower ring1716L is shown comprising a body that defines a central lumen1717. The central lumen1717of the lower ring1716L is adapted to receive the upper ring securement element deployer1772and a deployment shaft1773therethrough. The lower ring1716L is provided with a lower central ring1780having securement elements1724extending axially therefrom, in the undeployed position. The securement elements1724are preferably formed from a resiliently flexible material and may be of unitary construction with the lower central ring1780. The lower central ring1780may be mounted at the distal end of the lower ring1716L, and may be at least partially disposed with an inner circumference defined by the lower ring1716L. However, as one would appreciate from the embodiment shown inFIG. 91, the lower central ring1780may also be mounted on a proximal side of the lower ring1716L upon appropriate alteration of the mechanisms for deployment.

Like the upper ring1718U, the lower ring1716L may comprise ring mounting elements defining one or more locking elements (not shown) that engage and lock the lower central ring1780in contact with the lower ring1716L to hold securement elements1724in the deployed position. The locking elements may engage the lower central ring1780by snap-fit, friction fit or other means.

The body of the lower ring1716L contains a plurality of axial slots1785defined by a plurality of axially extending members1784located on the distal end of the lower ring1716L. The axial slots1785are sized and positioned to engage with and receive a portion of securement elements1724. In an undeployed position, the lower central ring1780is spaced distally from the lower ring1716L, such that the securement elements1724reside within the axial slots1785of the lower ring1716L.FIG. 99Ashows the securement elements1724extending into the axial slots1785of the lower ring1716L when the central ring1780is mounted on the lower ring1716L. The axial slots1785are provided with angled deployer surfaces1747that engage the curved inner surfaces1725of the securement elements1724during operation of the device1712.

Similar to the upper securement elements1726, the lower securement elements1724are moveable between an undeployed position where they are at least partially recessed into the lower ring body1716and a deployed/extended position in which the securement elements1724extend outward from the lower ring1716L so that the securement elements1724engage and secure to the wall of the urethra. The curved inner surface1725of the securement elements1724engages with the deployer surfaces1747of axial slots1785, thus urging and flexing the securement elements1724radially outward when the central ring1780is moved in a proximal direction with respect to the lower ring1716L. Additionally or alternatively, the lower ring securement elements1724may pivot towards the deployed position on living hinges1723. Arrow “C” inFIG. 99Billustrates the movement of the securement elements1724towards a deployed position. Preferably, when in the deployed position, the securement elements1724have at least some sort of bias in the radial inward and distal directions, to facilitate engagement and retainment of a vessel such as the urethra. Alternatively, the securement elements1724may be physically locked or held in position.

As shown inFIGS. 97 and 98, the upper and lower assemblies1718,1716also comprise interconnecting elements1730and1728, respectively, for coupling the rings together. The interconnecting elements1728and1730may be similar to the connector elements28and30of rings16and18. As shown, the upper interconnecting elements1730comprise an extending member with an engagement surface1731adapted to engage the lower interconnecting elements1728, which define an opening in the body of the lower ring1716, by snap fit connection.

FIGS. 94 and 95show a further alternative embodiment of a ring assembly1814comprising a lower ring assembly1816and upper ring assembly1818. The upper and lower ring assemblies1818,1816are structurally similar to ring assemblies1718and1716shown inFIGS. 97 and 98. For example, each ring assembly comprises a central ring1880,1882on which the lower and upper securement elements1824,1826are mounted and interconnecting elements1828,1830for coupling the ring assemblies together. The securement elements of upper and lower ring assemblies1818,1816may be deployed by similar mechanism and instrument as lower and upper ring assemblies1716,1718. However, the upper ring assembly1818differs from upper ring assembly1718ofFIG. 97in that the ring mounting elements1887define one or more resiliently flexible ring mounting elements1887and locking elements1888that engage and lock the outer surfaces of the upper central ring1882. Thus, when the upper central ring is locked in contact with the upper ring1818U, it is received within the lumen1819of the upper ring1818U. As shown, the locking elements1888engage the upper central ring1882through a snap-fit connection after the upper central ring1882is moved in a proximal direction to fully deploy the securement elements1826. The locking elements1888may also engage and lock the upper central ring1882by friction fit or other means.

Turning now toFIGS. 99A-99C, the deployment operation of a ring assembly1714will be discussed. During deployment of the ring assembly1714, the lower central ring1780is mounted distally with respect to the lower ring1716L. As shown inFIGS. 99A and 99B, the upper ring assembly1718is mounted on the distal end of surgical instrument1712, adjacent the upper ring securement element deployer1772, and distally of the deployment shaft1773with the upper central ring1782mounted on distal side of the upper ring1718.

As shown inFIGS. 99A and 99B, the securement elements1726of upper ring1718U are deployed by axial retraction of the upper ring securement element deployer1772with respect to the upper ring1718U, which carries with upper central ring1782proximally and urges inner surfaces1727of the securement elements1726against deployer surfaces1775of the guide structures1786of the upper ring1718U. InFIG. 99B, the direction of axial movement of the upper ring securement element deployer1772is shown by arrow “A” and the resulting deployment of the securement elements1726by radial extension is shown by arrow “B.”

As shown inFIGS. 99A and 99B, the securement elements1724of the lower ring assembly1716are deployed by axial movement of the lower central ring1780in a proximal direction with respect to the lower ring1716L. Axial movement of the lower central ring1780in the proximal direction with respect to the lower ring1716L can be achieved by mounting the lower ring1716L proximally with respect to the lower ring securement element deployer (not shown) with the distal surface of the central ring1780in engagement with the lower ring securement element deployer. With this arrangement, axial retraction of the lower ring securement element deployer with respect to the lower ring1716L urges the lower central ring1780to move proximally with respect to the lower ring1716L. The securement elements1724are moved towards the deployed position when the inner surfaces1725of the securement elements1724are urged against the deployer surface1747of the lower ring1716L. As shown, the securement elements1724are also curved and the curvature of the securement elements1724causes the piercing tips1789to follow an arced path, as indicated by arrow “C” inFIG. 99B, when the inner surfaces1725are urged against the deployer surfaces1747of the lower ring1716L.

Deployment of the upper and lower securement elements1726,1724, through operation of the device (as shown betweenFIGS. 99A and 99B) will preferably result in engagement of vessel tissue, such as engagement of the bladder neck with the upper securement elements1726and engagement of the urethra with the lower securement elements1724. Once the vessel tissue is engaged, the upper ring assembly1718and lower ring assembly1716are retracted towards each other until the interconnecting elements1728,1730engage each other, thereby retaining the upper and lower ring assemblies1716,1718together and securing the anastomosis of the vessels. The retracted upper and lower ring assemblies1716,1718are illustrated inFIG. 99C.

Referring generally toFIGS. 84 to 93and96, an alternate structure of a ring assembly114and its method of deployment will now be described. First, the structural details of the alternative embodiment of the ring assembly114and upper and lower rings118,116are depicted inFIGS. 85-93. As shown inFIG. 85, the upper ring118comprising a body that defines a central lumen119. The central lumen119is adapted to receive the upper ring securement element deployer172and a deployment shaft173therethrough. The upper ring118is provided with an upper central ring182having securement elements126extending axially therefrom, in the undeployed position, as shown inFIG. 85. The securement elements126are preferably formed from a resiliently flexible material and may be of unitary construction with the upper central ring182. The upper central ring182is mounted at the proximal end of the upper ring118, and may be mounted near ring mounting elements187.

The ring mounting elements187of the upper ring118may define one or more locking elements (not shown) that engage and lock the upper central ring182in contact with the upper ring118to hold securement elements126in the deployed position. As shown, the locking elements extend distally from the upper ring118into the central of the upper central ring182to engage an inner surface of the upper center ring182by snap-fit engagement after the upper central ring182is moved in a proximal direction to fully deploy the securement elements126. Thus, when the upper central ring182is locked adjacent to the upper ring118, it is positioned distally of the upper ring118, further extending the central lumen119of the upper ring118. As seen inFIG. 93, this extension of the central lumen119provides a path for fluid to flow through after the anastomosis device is deployed within a patient. The ring mounting elements187may also engage and lock the upper central ring182by friction fit or other means.

Referring now toFIG. 91, the body of the upper ring118defines a plurality of guide structures186, which extend through the circumferential wall of the upper ring118. As shown, the guide structures186comprise openings in the sidewall of the body of the upper ring118that are sized and positioned to permit passage of securement elements126therethrough, in a proximal and radially outward direction. As best seen inFIG. 91, the guide structures186have angled deployer surfaces175adapted to engage inner surfaces127of the securement elements126. When the central ring182is mounted on the upper ring118, the securement elements126extend through the lumen119of upper ring118and into the guide structures186such that inner surfaces127of the securement elements126engage the angled deployer surfaces175. This engagement occurs in both the undeployed position, as shown inFIG. 85, and the deployed position, as shown inFIGS. 91 and 92.

The securement elements126are formed of a resiliently flexible material and may be of unitary construction with the central ring182. The securement elements126are moveable between an undeployed position in which the securement elements126are at least partially recessed in the upper ring body118and a deployed position where the securement elements126extend proximally and radially outward from the upper ring body118so that they are able to engage and secure to the wall of the bladder. The securement elements126are moveable between the retracted and deployed positions by flexing due to engagement with the angled deployer surfaces175of the guide structures186, as the upper central ring182is moved in a proximal direction with respect to the upper ring118.FIG. 85shows the securement elements126in the retracted position andFIG. 86shows the securement elements126in the deployed position. The arrows inFIG. 85illustrate the direction of motion of the securement elements126during deployment. The upper ring securement elements126may pivot towards the deployed position on living hinges183, such as shown inFIG. 85, or through the use of an actual hinge element (not shown) or via the inherent flexibility of the securement elements126. Preferably, when in the deployed position, the securement elements126have at least some sort of bias in the radial inward and proximal directions, to facilitate engagement and retainment of a vessel such as the bladder. Alternatively, the securement elements126may be physically locked or held in position.

Turning toFIGS. 87-91, a lower ring116comprising a body that defines a central lumen117is shown. The central lumen117of the lower ring116is adapted to receive the upper ring securement element deployer172and a deployment shaft173therethrough. The lower ring116is provided with a lower central ring180(seeFIG. 91) having securement elements124extending axially therefrom, in the undeployed position, as shown inFIG. 87. The securement elements124are preferably formed from a resiliently flexible material and may be of unitary construction with the lower central ring180. The lower central ring180is mounted at the proximal end of the lower ring116, and may be at least partially disposed with an inner circumference defined by the lower ring116.

Like the upper ring118, the lower ring116may comprise ring mounting elements defining one or more locking elements (not shown) that engage and lock the lower central ring180in contact with the lower ring116to hold securement elements124in the deployed position. The locking elements may engage the lower central ring180by snap-fit, friction fit or other means.

The body of the lower ring116contains a plurality of axial slots185defined by a plurality of axially extending members184located on the proximal end of the lower ring116. The axial slots185are sized and positioned to engage with and receive a portion of securement elements124. In an undeployed position, the lower central ring180is spaced proximally from the lower ring116, such that the securement elements124reside within the axial slots185in the lower ring116.FIG. 91shows the securement elements124extending into the axial slots185of the lower ring116when the central ring180is mounted on the lower ring116. The axial slots185are provided with angled deployer surfaces147that engage the curved inner surfaces125of the securement elements124during operation of the device112.

Similar to the upper securement elements126, the lower securement elements124are moveable between an undeployed position where they are at least partially recessed into the lower ring body116and a deployed/extended position in which the securement elements124extend outward from the lower ring body116so that the securement elements124engage and secure to the wall of the urethra. The curved inner surface125of the securement elements124engages with the deployer surfaces147of axial slots185, thus flexing the securement elements124radially outward when the central ring180is moved in a distal direction with respect to the lower ring116. Additionally or alternatively, the lower ring securement elements124may pivot towards the deployed position on living hinges123. Arrow “A” shown inFIG. 88illustrate the movement of the securement elements124towards a deployed position. Preferably, when in the deployed position, the securement elements124have at least some sort of bias in the radially inward and distal directions, to facilitate engagement and retainment of a vessel such as the urethra. Alternatively, the securement elements126may be physically locked or held in position.

In the assembled anastomosis system shown best inFIGS. 85 and 91, the upper ring118and the lower ring116are mounted on the surgical instrument112with the upper ring securement element deployer172and deployment shaft173extending through the center of the upper and lower rings118,116. The upper ring118is positioned distally from the lower ring116. As best seen inFIG. 91, the upper central ring182is retained on the distal side of the upper ring118and, and the lower central ring180is retained within the proximal portion of the lower ring116. The upper ring securement element deployer172engages the distal surface of the upper central ring182of the upper ring118.

The method of delivering and implanting a ring assembly114similar to the ring assemblies shown inFIGS. 94,95and97-99cis now discussed.FIGS. 84 and 96, depict an alternative embodiment of a surgical instrument112, which includes a handle assembly132, grip member134, handle tube136, upper tube137, and the upper ring securement element deployer172. The handle assembly132comprises first and second knobs160,168. The first knob160operates to deploy the securement elements124of the lower ring116and the second knob168operates to deploy the securement elements126of the upper ring118. Arrows inFIG. 96illustrate the rotational motion of the knobs160and168. The surgical instrument112may comprise a rotary-translatory motion converter, such as the rotary bearing58of previously described surgical instrument12, that converts rotational motion of knobs160and/or168to axial motion of the deployer mechanisms in either or both the proximal and distal directions. Additionally, the handle assembly132includes a release switch133which, like locking ring33of the previously described surgical instrument12, operates to release the ring assembly114from the surgical instrument112after emplacement similar to the previously described embodiments. The handle tube136is preferably flexible, with a 360° range of motion, as indicated by arrows inFIG. 84. The flexibility assists in insertion of the surgical instrument112through the urethra and can accommodate the naturally curved pathways of the patient's anatomy.

As shown inFIG. 84, a ring assembly114comprising a lower ring116and upper ring118is mounted on the distal end of the surgical instrument112with the upper ring securement element deployer172passing through the lower and upper rings116,118, in the undeployed position. The upper ring118is mounted on the distal end of surgical instrument112(shown inFIGS. 84 and 96) with an upper central ring182mounted on the distal side of the upper ring118. The lower ring116is mounted on the surgical instrument112proximally with respect to upper ring118. The lower ring116is mounted on the surgical instrument112with a lower central ring180positioned on the proximal side of the lower ring116(best seen inFIG. 91). However, the surgical instrument112can be adapted to deliver and deploy lower rings having distally mounted lower central rings by altering the position and direction of movement of the deployer mechanism (see e.g.FIGS. 99A-99C). The upper ring118and lower ring116may be provided with interconnecting elements (not shown) similar to those described in previous embodiments for coupling the rings together, thereby joining vessel portions together in anastomosis.

Referring now toFIGS. 85 and 86, during operation the upper ring118is positioned within a cavity, such as the bladder. The securement elements126are deployed by axial retraction of the upper ring securement element deployer172in a proximal direction with respect to the upper ring118. The upper ring securement element deployer172may be axially retracted by rotating the knob168of surgical instrument112with respect to the handle assembly132, shown inFIG. 96. When the upper ring securement element deployer172axially retracts with respect to the upper ring118, the upper ring securement element deployer172urges the upper central ring182in a proximal direction with respect to the upper ring118. As the upper central ring182is moved in a proximal direction with respect to the upper ring118, the inner surfaces127of the securement elements126are urged towards engagement with the angled deployer surfaces175of the guide structures186of the upper ring118(similar to the operation of the embodiments described above with respect toFIGS. 97-98).

As shown inFIG. 86, engagement of the inner surfaces127of the securement elements126with the angled deployer surfaces175deploys the securement elements126by forcing the securement elements126to flex and deflect radially outward from the upper ring118, through the guide structures186of the upper ring118. As discussed above, ring mounting elements187may lock and secure the upper central ring182to hold the securement elements126in the deployed position. To engage the vessel tissue, the upper ring118is moved in a proximal direction such that the securement elements126engage and/or pierce the vessel, as a result of the radially outward and proximal extension of the securement elements126and their radial inward and proximal bias (see e.g.FIG. 89for engagement of the securement elements126with tissue).

After the upper ring118engages a vessel, such as the bladder neck, the lower ring116may be secured to an opposing vessel, such as the urethra neck, as follows. Turning now toFIG. 87, the lower ring116, with securement elements124in the retracted position, is positioned within the urethra neck. The securement elements124may be deployed by turning knob160with respect to the handle assembly132to axially extend the lower ring securement element deployer148, as shown inFIGS. 84 and 96. As best understood fromFIG. 91, when the lower ring securement element deployer148axially extends in a distal direction with respect to the lower ring116, the lower ring securement element deployer148urges the lower central ring180to move in a distal direction with respect to the lower ring116. Axial movement of the lower central ring180in a distal direction with respect to the lower ring116urges the securement elements124to move distally though the axial slots185until the inner surfaces125of the securement elements124engage the deployer surfaces147of the lower ring body116. Continued axial movement of the lower central ring180with respect to the lower ring116forces the securement elements124against the deployer surfaces147and urges the securement elements124to flex and/or deflect radially outward from the lower ring116.

As shown, the inner surfaces125of the securement elements124are curved. Due to the curvature of the securement elements124, the piercing tips189of the securement elements124follow an arched path in a generally radially outward direction with respect to the lower ring116. The length and angle of the path of the piercing tip189may depend on the curvature of the securement element124. As shown inFIG. 88, the securement elements124follow the path indicated by the arrow “A” when deployed to extend radially outward from the lower ring body116to engage the urethra.

FIG. 89shows an external view of the securement elements124,126of the lower and upper rings116,118after deployment and the engagement with the urethra and bladder tissue by piercing the vessel tissue. As shown, after engaging the respective vessels, the upper ring118is moved into proximity with the lower ring116, thereby drawing the bladder and urethra necks closer together.

An exemplary method of drawing the lower and upper rings together may include grasping knob168and shifting it proximally with respect to the grip member134. Upon proximal shifting, the knob168engages a separate mechanism in the surgical instrument112(not shown) that permits rotation of the knob168to rotate a threaded element (not shown) flexibly linked to the upper securement element deployer172, thereby allowing the upper securement element deployer172to be moved proximally and/or distally in relation to the lower ring116. Alternatively, further rotation of the first knob160(after deployment of the securement elements124,126, may retract the upper securement element deployer172, thereby drawing the upper ring118towards the lower ring116. Alternatively, a lever mechanism (not shown) may be included in the end of handle132and may be extended and used to move the upper securement element deployer172proximally and/or distally in relation to the lower ring116. In a further alternative method, the surgical instrument112can be provided with a third knob (not shown) on the proximal end of the handle assembly132that may be pulled proximally with respect the handle assembly132. Once the knob is proximally pulled, a portion of the knob can engage a threaded element (not shown) connected to the upper securement element deployer172such that, when the knob is rotated, it draws the upper securement element deployer172proximally and/or distally in relation to the lower ring116.

As shown inFIGS. 90 and 91, the lower and upper rings116,118are brought into contact and are coupled together, thereby forming an anastomosis of the bladder and urethra. AlthoughFIGS. 85-93do not show the upper and lower rings118,116comprising interconnecting elements, the rings can be provided with coupling mechanisms as described with respect to the previously discussed ring assembly14shown inFIG. 3, snap fit elements as shown inFIGS. 94,95, or grooves (not shown) provided on an inner luminal surface of the rings116and118that engage the respective upper and lower central rings182,180when the rings are moved to deploy the securement elements.

As shown inFIG. 92, the ring assembly114may be released from the surgical instrument112after the upper ring118and lower ring116are coupled together. The ring assembly114is released by depressing release switch133. As shown, release switch133comprises a safety type mechanism that prevents inadvertent triggering by requiring a two-step action, such as depression of the release switch133and urging the release switch133in a direction transverse to the handle assembly. In one example, release switch133may actuate a cam-type mechanism that releases the ring assembly114.

Referring now toFIG. 93, when the upper and lower rings118,116are coupled together with the securement elements126and124deployed, preferable, the vessel tissue is retained in place and allowed to heal. The upper securement elements126are oriented to extend in a radial outward and proximal direction from the upper ring118, thereby extending into the vessel tissue, such as a bladder neck, at an angle in a general direction towards the opposing vessel. Likewise, the lower securement elements124extend radially outward, and generally distally into an opposing vessel tissue, such as the urethra. The general direction that the securement elements126,124extend into the respective vessel parts is opposite to the direction of movement that would separate the opposing vessels, and separate the anastomosis. As a result, any tension on the vessel tissue in a direction away from the opposing vessel tissue, or vice versa, serves to further embed the securement elements126,124in the vessel tissue, thereby securing the anastomosis. After deployment and securement of the ring assembly, the surgical instrument112may be withdrawn from the urethra leaving the ring assembly114in place.

The preferred materials for the ring assembly14are now discussed. However, it will be understood that this discussion of materials can apply equally to all embodiments disclosed and contemplated herein. The ring assembly14is preferably formed of materials that are compatible with the environment (e.g. range of pH, variable constituents of urine and variable flow). The entirety of the ring assembly14may be formed from resorbable material(s) or at least a portion of the assembly may be formed from permanent material(s). Alternatively, one or more portions of the ring assembly14may be formed of resorbable material(s) while one or more other portions are formed from permanent material(s). In some embodiments, the securement elements24and26, in particular, are formed from resorbable material, whereas other portions are formed from permanent materials. In some examples, a ring assembly14can be formed with a resorbable element that connects two non-resorbable elements and breaks down to permit the ejection of the permanent elements in the urine stream. In other examples, portions of the ring assembly may be formed from mixtures of different resorbable materials and/or different permanent materials.

As used herein, “permanent materials” refers to materials that are not expected to undergo dramatic changes in strength or composition during the period of time that the ring assembly14is needed to allow healing of tissues and the establishment of a tissue-based channel for urine flow. Permanent materials include, but are not limited to, polymeric materials or metals. Examples of permanent polymeric materials include PEEK, polyethylene, polypropylene and others currently used in medical devices both in the United States and worldwide. Permanent metals include those used in surgery such as, but not limited to, stainless steel and titanium, both in a range of compositions and alloys.

As used herein, “resorbable materials” refers to materials that exhibit the ability to change over time, such as breaking down and eventually being eliminated from the body of the patient. Resorbable materials include, but are not limited to, bioabsorbable and biodegradable materials. Preferably, Resorbable materials may be used as elements of implantable devices where over a period of time the implant breaks up and is absorbed, shed, or ejected from the body.

Resorbable materials are well known in the literature. See, Principles of Tissue Engineering (Lanza and Vacanti, eds., Elsevier Academic Press 3d ed. 2007) (1997). Suitable resorbable materials include, but are not limited to, homopolymers and co-polymer blends from families including polylactic acid, polyglcolic acid, ε-caprolactone, and trimethylene carbonate. Other resorbable polymers may include polyphosphazenes, polydioxanones, polyanhydrides and polyurethane materials. Additionally, materials based on naturally occurring substances including, but not limited to polyhydroxyalkanoates, chitin and its derivatives, cellulose and certain other starches that can be fabricated to useful forms may be used. Additionally, suitable resorbable materials may comprise metals, such as magnesium, that can be broken down by the body when used as an implantable device.

Now, an exemplary embodiment of the ring assembly1914, depicted inFIGS. 100-101D, will be used to demonstrate an anastomosis and degradation of the ring assembly. It will be understood that, although the embodiment of the ring assembly1914is discussed, the degradation described herein will apply equally to all embodiments disclosed and contemplated herein. As mentioned above, when the ring assembly1914is formed from resorbable and/or biodegradable materials, it gradually degrades after implantation in the body. Preferably, the material is selected to degrade at a slower rate than the natural healing process, so as to allow healing of the anastomosis before degradation. For example, the ring assembly1914can be formed from a material that will (i) remain intact for approximately to six weeks after implantation before degradation and (ii) be completely resorbed or degraded after twelve weeks. Thus, the ring assembly1914can be removed or expelled from the patient's body without a follow-up surgical procedure when the ring assembly1914is no longer needed to hold the anastomosis.

In the interim, the ring assembly1914permits urine to flow from the bladder through a passageway1913defined by the lumens1917,1919of the coupling parts1916,1918. As shown inFIG. 100, when the upper ring1918and the lower ring1916are coupled together, lumens1917and1919define a passageway1913extending from the distal end of the upper ring1918through to the proximal end of lower ring1916. Thus, the passageway1913permits the flow of urine from the bladder into the urethra while the anastomosis is healing. Preferably, the ring assembly1914forms a leak-proof passageway, so as to reduce or eliminate the chance of leakage of urine into the abdominal cavity. The flow of urine through the ring assembly may operate to degrade the ring assembly and carry non-resorbed materials and portions of the ring assembly out of the body.

FIG. 100shows a ring assembly1914formed from a resorbable material immediately after emplacement, as the surgical instrument1912used to implant the ring assembly1914is removed, and prior to any degradation.FIGS. 101A to 101Ddepict the progression of the degradation of the ring assembly1914over time, as the anastomosis heals. As shown inFIG. 101A, after three weeks post-implantation, the ring assembly1914continues to hold the bladder neck and urethra neck together and permits urine to flow through the passageway1913. However, as seen by comparison toFIG. 100, a small amount of the material forming the ring assembly1914has degraded and been resorbed or carried away by urine flow.FIG. 101Bshows that, after six weeks post-implantation, the ring assembly1914continues to hold the bladder neck and urethra neck together, but the material comprising the ring assembly1914has further degraded. As seen inFIG. 101C, at approximately nine weeks post-implantation, the ring assembly1914has degraded substantially. After twelve weeks, the ring assembly1914has degraded completely, and the natural healing process has typically progressed sufficiently to permanently hold the bladder and urethra tissue together without the assistance of the ring assembly1914, hooks or other tissue fastening apparatus, as shown inFIG. 101D.

Details of several additional example embodiments of the ring assembly of the present invention are depicted and described inFIGS. 44-64B. Some of these ring assemblies, such as those described with respect toFIGS. 61-64B, can be adapted for use with the surgical instrument12of the first embodiment and/or with adapted versions thereof, with such adaptations being within the capabilities of one of ordinary skill in the art. It will be noted that the concepts described in the embodiments discussed above may be incorporated into the embodiments depicted and described inFIGS. 44-64B, and vice versa.

Referring now toFIGS. 61-64B, a further embodiment of a ring assembly1614comprising a collar1618is shown. The ring assembly could be used as an upper ring or lower ring, with similar positioning to the previously discussed upper and lower rings18,16. The ring assembly includes a central ring that is pivotally attached to securement elements1626, which are moveable between a stored/retracted/delivery position in which the securement elements1626are recessed into the upper collar1618and a deployed/extended position in which the securement elements1626extend outward from the collar1618so that they engage and secure to the surrounding tissue. Securement elements1626may be mounted on a central ring1682and moveable between the retracted and deployed positions by pivoting around the central ring1682which forms a common pivot point1643(as shown inFIG. 64A). Arrows “A” inFIGS. 62 and 64Aillustrate the movement of the securement elements1626towards a deployed position. Alternatively, the securement elements1626may be of unitary construction with the central ring1682and may be moveable between the retracted and deployed positions by pivoting on a flexible living hinge.

FIGS. 64A and 64B, show collar1618and securement elements1626in greater detail. The arrows “A” inFIG. 64Aillustrates the movement of the securement elements1626towards a deployed position. In this view, the securement elements1626are pivotably mounted to a central ring1682. The central ring1682is visible in cross-section only at pivot points1643, and is shown in phantom for illustration.

FIGS. 61-64Bshow the securement elements1626being guided outward by contact with surface1675of the collar1618when deployer1672is axially moved with respect to the collar1618. The securement elements1626are guided outward to effect piercing of tissue upon axial motion of central ring1682towards contact surface1675, which extends through a portion of the collar1675. The initial action of guiding the securement elements1626to an appropriate position may be aided by the inclusion of a guiding element or anvil1672that is part of the implant or insertion instrument. Additionally, the inclusion of notches (not shown) on the securement elements1626as shown inFIG. 63may act as locks to hold the securement elements1626in a preferred location with respect to the collar1618.

The securement elements1626may pivot outwardly and axially between 60 and 120 degrees from the stored to the deployed position, such that the securement elements are oriented to maintain a compression fit between the urethra and the bladder for good sealing.

FIG. 45shows a third exemplary embodiment of an anastomosis ring assembly214biodegradable clamp for anastomosis. As shown, the anastomosis ring assembly214comprises an upper clasp218and a lower clasp216, each generally having a ring or disk shape and having axially-facing surfaces with teeth. The upper clasp218also includes a ratchet mechanism280that extends axially from the upper clasp218and is sized and shaped to engage the inner ring surface of the lower clasp216. The ratchet mechanism may be of a length that accounts for variable tissue thickness. The ratchet mechanism280has resiliently deflectable ratcheting teeth on its outer surface that engage ratcheting teeth on the inner surface of the lower clasp216to tighten and hold the upper clasp218and lower clasp216together. The anastomosis ring assembly214maintains the bladder and urethra in compression during healing.

FIGS. 46-49show a fourth exemplary embodiment of an anastomosis device314comprising biodegradable pins318. As shown inFIGS. 46 and 47, the anastomosis device314is positioned by piercing the bladder and urethra walls with metal-tipped bio-degradable pins318using a first removable applicator380. As shown inFIG. 48, bio-degradable lower clasps316are attached to the bio-degradable pins318using a second removable applicator382. The bio-degradable lower clasps316secure the bio-degradable pins318in position. The lower clasps316may be threaded and engage a threaded outer surface of the bio-degradable pins318, or may be secured by press-fit, compression-fit, friction-fit, or the like. After the bio-degradable pins318are positioned piercing the bladder and urethra tissue, the metal tips may be removed as shown inFIG. 49. The anastomosis device314maintains the bladder and urethra in compression during healing.

FIGS. 50-51show a fifth exemplary embodiment of an anastomosis device414comprising biodegradable pins418. As shown inFIG. 50, needles on a lower applicator482are used to pierce the tissue of the urethra and bladder. The biodegradable pins418may be inserted into the pierced holes using an applicator480as shown inFIG. 51. The anastomosis device414maintains the bladder and urethra in compression during healing.

FIG. 52shows a sixth exemplary embodiment of an anastomosis ring assembly514. As shown, the anastomosis ring assembly514comprises an upper clasp518and a lower clasp516, each having axially-facing surfaces with teeth. The upper clasp518also has a structure defining a glue channel580with an inlet580aand outlet580b. The glue channel outlet580bis preferably positioned to align with the interface of the bladder neck and urethra neck when the anastomosis ring assembly514is emplaced.

The anastomosis ring assembly514is positioned by purse-stringing the bladder and fitting the bladder neck with the upper jaw518. A lower clasp516is attached to the upper jaw518and engages the urethra. The teeth of the axially-facing surfaces of the upper jaw518and lower clasp116securely engage with the tissue of the bladder and urethra, respectively.

Once properly positioned, a biocompatible liquid adhesive, such as glue, may be injected into the glue channel inlet580a. The liquid adhesive travels through the glue channel580and exits at the glue channel outlet580badjacent the bladder and urethra between the upper and lower clasps518,516. After tightening the upper and lower clasps518,516together and curing the liquid adhesive, the liquid adhesive securely adheres the bladder and urethra together. The upper and lower clasps518,516can then be removed leaving only the cured adhesive holding the anastomosis in place.

FIGS. 53 and 54show a seventh exemplary embodiment of an anastomosis ring assembly614. As shown, the anastomosis ring assembly614comprises an upper disk618and a lower clasp616. As shown, the upper disk618has securement members626extending from a lower surface and the lower disk616has openings sized and positioned to receive the securement members of upper disk618. The securement members626of the upper disk618may be barbed or hook-shaped.

The bladder and urethra are connected by being clamped between the upper disk618and lower disk616. The securement members626of the upper disk618pierce the tissue and insert into the openings of the lower clamp616to lock the upper disk618and lower clamp616together. The entire assembly may be formed from bio-degradable material.

FIGS. 55-58show an eighth exemplary embodiment of an anastomosis device714comprising biodegradable sutures718. As shown inFIGS. 55 and 56, the anastomosis device714is positioned by piercing the bladder and urethra walls with needles716using a first removable applicator780. As shown, the needles716are attached to trailing biodegradable sutures718which are barbed, but un-barbed sutures may also be used. As shown inFIG. 57, a second removable applicator782is used to advance the needles716and pull the bio-degradable sutures718through the tissue. The bio-degradable sutures718may have a preformed knot, bulb or other structure719on the end opposite the needle716to prevent the trailing end of the suture from continuing to advance through the bladder tissue. The combination of a knot or bulb on the trailing end and barbed sutures (where the barbs anchor into the tissue, thereby preventing the suture from pulling out of the tissue) or a second knot applied to the leading end of the suture secure the anastomosis.

FIG. 59shows a ninth exemplary embodiment of an anastomosis ring device814. As shown, the anastomosis ring device814comprises bio-degradable upper and lower disks818,816having lateral/radial outwardly-extending securement members880on their outer surfaces. The securement members880may be hooks, barbs, or any other shape so long as they have a pointed end capable of piercing the bladder and urethra. The upper and lower disks818,816are fixed to the bladder and urethra, respectively, by compressing the bladder and urethra onto the securement members880, which pierce and secure to the bladder and urethra walls. The disks are fixed and sealed together (e.g., by snap-fit connector elements) so that the bladder and urethra remain secured together.

FIG. 60shows a tenth exemplary embodiment of an anastomosis ring device914. As shown, the anastomosis ring device914is a ring that has a larger diameter than the cut end of the urethra915and is preferably resiliently deformable. The mouth of the urethra is formed into a funnel shape by pulling the urethra neck through the central opening and folding the urethra around the anastomosis ring device914. This funnel-shaped urethral mouth is then inserted into the bladder. The bladder neck is then purse-stringed to reduce the diameter of the bladder mouth around the funnel-shaped urethral mouth thereby preventing the funnel-shaped urethral mouth from pulling out of the bladder.

FIG. 44shows an eleventh exemplary embodiment of an anastomosis ring assembly1014that causes staged necrosis. As shown, the anastomosis ring assembly1014comprises an upper jaw1018and a lower clasp1016, each having axially-facing surfaces with mating teeth.

To position the anastomosis ring assembly1014, the bladder is purse-stringed and fitted with the upper jaw1018. A lower clasp is attached to the upper jaw1018and engages the urethra. The mating teeth of the axially-facing surfaces of the upper jaw1018and lower clasp1016pierce into the tissue of the bladder and urethra, respectively. As shown inFIG. 44, the lower clasp1016and the upper jaw1018are maintained in compression by retaining spring1018. However, other means of maintaining the lower clasp1016and the upper jaw1018in compression are possible, including but not limited to mating screw threads. Compression of the bladder and urethra tissue between the lower clasp1016and the upper jaw1018maintains the anastomosis for several days during healing. However, prolonged compression may lead to necrosis, so the upper jaw and lower clasp is preferably removed after a few days. A thread may be attached to ensure proper pull-out of the device.

Referring now toFIGS. 65-68B, a twelfth exemplary embodiment is shown. A ring1116defines acentral lumen and is provided with securement elements1124that are moveable between a stored/retracted position in which they are recessed into the ring body and a deployed/extended position in which they extend outwardly from the ring body so that they engage and secure to the wall of the bladder or urethra. As shown inFIG. 65, the securement elements1124are pivotably mounted on a central ring1180and comprise cooperating cam surfaces1125extending within the lumen of the ring1116. The securement elements1124may be moveable between the retracted and deployed positions by pivoting around the central ring1180which forms a common pivot point.

As shown inFIG. 66, the ring1116defines a central lumen1117that permits the passage of fluid and lower ring deployment mechanism1148therethrough. The ring1116is provided with a circumferential groove1184on its outer surface. Additionally, the body of the ring1116defines longitudinal slots1186. The groove1184is sized and shaped to receive the central ring1180and the longitudinal slots1186are adapted to receive the securement elements1124when the central ring1180is mounted in the groove1184. It should also be understood that the lower ring1116may have an inner circumferential groove on its inner circumferential surface (not shown) for retaining an appropriately sized version of the central ring within the inner diameter1116. The inner circumferential groove may replace the circumferential groove1184, while performing essentially the same function on the inner diameter of the lower ring1116.

FIGS. 67A and 67Bshow the central ring1180mounted in the groove1184of the ring1116and the securement elements1124in the undeployed position. As shown, the securement elements1124are received within corresponding longitudinal slots1186of the body of ring1116.FIGS. 68A and 68Bshow the securement elements1124in the deployed state radially extending from the body of the ring1116.

Similar to the previously described embodiments, the securement elements1124of this embodiment are adapted to be deployed by the lower ring securement element deployer1148. The lower ring securement element deployer1148extends from the tube1146and deploys the lower ring securement elements1124upon axial translation of the upper tube1146in the proximal direction (i.e., axial retraction) with respect to the ring1116. As illustrated by the cross-sectional views inFIGS. 67B and 68B, the lower ring securement element deployer1148defines a cam surface1147that engages cooperating cam surfaces1125of the lower ring securement elements1124to pivot securement elements1124towards the deployed position when the upper tube1146is axially retracted with respect to the handle assembly1132. In this embodiment, the lower ring securement element deployer1148may have circumferential ridges extending radially from the upper tube1146. As shown, the ridges define the cam surfaces1147that engage the cooperating cam surface1125of the lower ring securement elements1124.

Additionally, as mentioned with respect to the previously discussed embodiments, the lower ring securement element deployer1148may be adapted to mount an upper ring to its distal end. While the upper ring is not shown, the upper ring may also have a central lumen and upper ring securement elements may be pivotally mounted on a ring fitted into a circumferential groove on the outer surface. The upper ring securement element deployment mechanism of this embodiment may be similar to the upper ring securement element deployer72of the previously discussed embodiments.

As shown inFIG. 66, the ring1116has interconnector elements1128provided by resiliently deflectable arms. The interconnector elements1128are adapted to couple with corresponding interconnector elements on the upper ring and can be snap-fit connectors, screw-together connectors, or other conventional connector assemblies, whether detachable for decoupling or intended for one-time connection only. As with the previously discussed embodiments, the interconnector elements couple the ring1116when the ring is brought into proximity and urged towards an interconnecting relationship.

Referring now toFIGS. 69A-70B, a thirteenth embodiment of the upper and lower rings1218,1216with securement elements1226and1224connected to the upper and lower rings1218,1216by living hinges is shown. In this embodiment, the securement elements1224,1226are deployed by pivoting about the living hinge1222in the direction of the arrows inFIGS. 69B and 70B. As shown, the upper and lower ring1218,1216each have a unitary construction and may be injection molded.

In the undeployed position shown inFIGS. 69-70, the securement elements1224and1226reside within recesses in the body of the lower and upper rings1216,1218. The securement elements1224of the lower ring1216are adapted to be deployed by a lower ring securement element deployer (not shown) according to a mechanism similar to that of the first embodiment. Specifically, the lower ring securement element deployer extends through the central lumen of the lower ring and defines a cam surface that engages cooperating cam surfaces1229of the securement elements1224. Axial retraction of the lower ring securement element deployer against the lower ring securement elements1224urges the securement elements to pivot at the living hinges1222and radially extend.

The securement elements1226of the upper ring1218are also adapted to be deployed by an upper ring securement element deployer (not shown) according to a mechanism similar to that of the first embodiment. Specifically, the upper ring securement element deployer extends through the central lumen of the lower and upper rings1216,1218and defines a cam surface that engages cooperating cam surfaces1227of the upper ring securement elements1226. Axial retraction of the upper ring securement element deployer against the cooperating cam surfaces of the upper ring securement elements1226urges the securement elements to pivot at the living hinges1222and radially extend from the upper ring body1218.

As shown in69B, the cooperating cam surfaces1227of the upper ring securement elements1226may be provided with a notch or ridge to aid in engagement with the deployer cam surface (not shown). Alternatively, as shown inFIG. 71, the upper ring securement element1226may lack a ridge or notch such that cooperating cam surfaces1227smoothly extend from the inner wall of the upper ring1218.

Additionally, as shown inFIGS. 69A and 70A, the lower ring1216and upper ring1218are provided with interconnector elements1228and1230adapted to couple the upper ring1218and lower ring1216together. As with the previously discussed embodiments, the interconnector elements1230,1228couple the upper and lower ring1218,1216when the rings are brought into proximity and urged towards an interconnecting relationship. The upper ring1218defines a lumen1217and is provided with a slidable locking member1288. The locking member1288is mounted axially within the lumen1217of the upper ring1218and is movable though the lumen1217towards the lower ring1216when the upper and lower rings1218,1216are coupled together. The locking element1288engages a securement element1224of the lower ring1216when in the deployed position and restricts movement of the engaged securement elements1226towards the retracted position.

Referring now toFIGS. 72-74, a fourteenth embodiment of a coupling ring1315is shown. The coupling ring1315has rigid securement elements1324and a central lumen with a deployment mechanism1347extending therethrough. The body of the coupling ring1315defines openings1319adapted to receive the securement elements1324therethrough. As shown in the undeployed position, the securement elements1324are recessed within the body of the coupling ring1315with the tips positioned in alignment with the openings1319in the body of the coupling ring1315. A rotary deployment mechanism1347having tangentially extending teeth is also positioned in the lumen of the coupling ring1315. The teeth of the deployment mechanism1347engage the inward facing end of the securement elements1324.

The deployment mechanism1347is adapted to deploy the securement elements1324upon clock-wise rotation with respect to the coupling ring1315. The arrow “R” inFIGS. 72A and 72Billustrates the rotation of the deployment mechanism1347. Clockwise rotation of the deployment mechanism1347drives the securement elements1324at an angle through the openings1319in the body of the coupling ring1315, thereby extending the securement elements1324tangentially from the coupling ring1315. The angle of the securement elements1324may be selected to cause the tissue to be drawn towards the coupling ring1315when axial force is placed on the coupling ring1315.

FIGS. 72 and 73show the deployment mechanism that may be used in both the upper and lower rings of ring assembly. Accordingly, the coupling ring1315as shown inFIGS. 72-73is generic to the upper and lower coupling parts and lacks interconnecting elements. However, the generic coupling ring1315can be modified to include interconnecting elements to permit two corresponding coupling rings to couple together. For example,FIG. 74shows the lower ring and upper ring1316,1318with interlocking connector elements1328and1330. As shown, the securement elements1326of the upper ring1318extend at an angle, whereas the securement elements1324of the lower ring1316remain within the body.

FIGS. 75-81show a fifteenth embodiment of an anastomosis ring device. This embodiment includes a central ring1482having resiliently flexible securement elements1426extending axially from the central ring1482. The securement elements1426can bend and flex in a radial direction when a force is applied thereto, but are biased to return to the position of axially extending from the central ring1482as shown inFIG. 75. As shown, the securement elements1426are provided with a living hinge1443to further increase flexibility. However, the flexibility of the securement elements1426may be due solely to the flexibility of the material forming the securement elements1426rather than living hinge1443.

FIG. 76shows an example of an upper ring1418having a central lumen extending therethrough and interconnector elements1430adapted to couple to corresponding interconnecting elements of a lower ring (not shown). The upper ring1418has axial grooves1484and guide structures1486provided on the end opposite the interconnector elements1430. As shown inFIG. 77, the axial grooves1484and guide structures1486cooperate to receive there between and guide the securement elements1426during deployment.

As shown inFIGS. 78A and 78B, the central ring1482is mounted on an upper ring securement element deployer1472, which extends through the lumen of the upper ring1418. Axial retraction of the upper ring securement element deployer1472with respect to the upper ring1418draws the central ring1482proximally and the securement elements1426are received by the axial grooves1484and guide structures1486. As the upper ring securement element deployer1472is retracted further with respect to the upper ring1418, the securement elements1426are urged against the guide structures1486, which causes the securement elements1426to flex and deflect outwardly as shown inFIGS. 79A and 79B. As shown inFIGS. 80A and 80B, continued axial retraction of the upper ring securement element deployer1472pushes the central ring1482proximally and forces the securement elements1426to pass between the axial grooves1484and guide structures1486until the securement elements1426are positioned such that the axial grooves1484and guide structures1486no longer apply a force on the securement elements1426. As shown inFIGS. 81A and 81B, when the upper ring securement element deployer1472carries the central ring1482into engagement with the upper ring1418, the securement elements1426return to their unbiased configuration, thereby securing the upper ring1418to the vessel tissue.

While the deployment mechanism of the fifteenth embodiment is only illustrated by means of the upper ring1418, it can be adapted for use with a lower ring. Additionally, as with other embodiments, after deployment of the securement elements, the upper and lower ring can be brought into proximity and coupled together.

Referring now toFIGS. 82A and 82B, a sixteenth embodiment of an upper ring1518of an anastomosis ring assembly is shown. As shown, the upper ring1518has a unitary construction and may be injection molded. The upper ring1518has a central lumen, interconnecting elements1530, and securement elements1526that extend into the lumen. The securement elements1526are formed from a flexibly resilient material and are adapted to engage upper ring securement element deployer1572.

As shown, axial extension of the upper ring securement element deployer1572(as indicated by the arrow inFIG. 82B) through the lumen of the upper ring1518brings the cam surface1575of the upper ring securement element deployer1572into engagement with the securement elements1526. Further axial extension of the upper ring securement element deployer1572displaces the securement elements1526and causes the cam surface1575to urge the securement elements1526to project outward.

While the deployment mechanism of the sixteenth embodiment is only illustrated with respect to the upper ring1518, it can be adapted for use with a lower ring. Additionally, as with other embodiments, after deployment of the securement elements, the upper and lower ring can be bought into proximity and coupled together.

Turning now toFIGS. 83A-C, an example profile of securement elements for use with the various embodiments of the present invention are shown from top and side viewpoints and in cross-section. As shown, the securement element24is curved and has a ridge extending25along the curved outer surface. When mounted to a coupling ring and deployed, the ridge extends away from the coupling ring and the flat side faces the coupling body. The upper or lower securement element24as shown inFIGS. 83A-83Cmay used as upper and/or lower securement elements and may be adapted for use with any of the embodiments of coupling rings disclosed herein.

It will be noted that in some other embodiments, the mating screw threads can be reversed so that the operations described are performed by rotating the components in the opposite angular directions. In some other embodiments, the ring-mounting steps and the securement element-deploying steps can be performed by other components of the system. In some other embodiments, the securement elements can be spring-biased to their deployed positions and deployed by actuation of a release member.

It should be understood that, although this disclosure describes different embodiments separately, that one skilled in the art may combine the features different embodiments without departing from the anastomosis devices and system disclosed herein. For example, one skilled in the art may incorporate the securement elements and deployment mechanism of one embodiment in an upper ring (e.g., rigid pivotable hooks, etc.) while incorporating a different securement element and deployment mechanism (e.g., resilient flexible hooks, etc.) in the lower ring. Furthermore, it should be apparent to those skilled in the art that the tissue capture elements referred to as “upper” and lower” may be adapted for use interchangeably. In other words, a ring shown engaging the bladder or described as “upper” may be adapted to engage the urethra or used as a “lower” ring. Likewise, a ring shown engaging the urethra or described as “lower” may be adapted to engage the bladder or used as an “upper” ring.

Additionally, all US patents, applications, and published literature cited herein are incorporated by reference in their entireties.

It is to be understood that this invention is not limited to the specific devices, methods, conditions, or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only. Thus, the terminology is intended to be broadly construed and is not intended to be limiting of the claimed invention. For example, as used in the specification including the appended claims, the singular forms “a,” “an,” and “one” include the plural, the term “or” means “and/or,” and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. In addition, any methods described herein are not intended to be limited to the sequence of steps described but can be carried out in other sequences, unless expressly stated otherwise herein. And any dimensions shown the attached drawings are representative and not limiting of the invention, as larger or smaller dimension can be used as desired.

Although the present invention has been described above in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly to include other variants and embodiments of the invention which may be made by those skilled in the art without departing from the scope and range of equivalents of the invention.