HK1214747B - Device and method for delivering shape-memory staples - Google Patents

Abstract

Some embodiments relate to a device for delivering shape memory staples, the device comprising; a handle; and a delivery portion coupled to the handle, the delivery portion comprising retention walls for retaining the staples within the delivery portion in an elastically deformed configuration and further comprising release apertures for releasing the staples to adopt a deployed configuration based on their shape memory; wherein the release apertures extend in a slight spiral relative to a longitudinal axis of the delivery portion.

Description

Device and method for delivering shape memory staples

The present application is a divisional application of an invention patent application having an application date of 2010, 3-11, application No. 201080013104.6(PCT/AU2010/000282), entitled "device and method for delivering shape-memory staples".

Cross Reference to Related Applications

This application claims the benefit of U.S. provisional patent application serial No.61/162462, filed 3, 23, 2009 and the entire disclosure of which is incorporated by reference.

Technical Field

The described embodiments relate generally to methods and devices for delivering shape-memory staples. According to some embodiments, the delivered staples can be used to secure the graft to another body.

Background

In some types of surgical procedures, it can be advantageous to use staples to secure tissue or a graft to other tissue or grafts. Such staples can be used to hold tissues and/or grafts together while the body is recovering or undergoing treatment.

Not all medical staple applying devices are effective or optimal for every situation in which deployment of staples may be required or desired.

The described embodiments address or ameliorate one or more deficiencies or shortcomings associated with previous devices and/or methods for delivering shape-memory staples, or at least provide a useful alternative to such devices and/or methods.

Disclosure of Invention

Some embodiments relate to a device for delivering shape-memory staples, the device comprising:

a graspable portion including a first actuator;

a trigger actuator coupled to the handle;

a drive mechanism coupled to the trigger actuator and the handle;

a delivery portion coupled to the graspable portion, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration and a release aperture for releasing the staples into an in-use configuration based on shape memory of the staples, wherein the delivery portion is configured to extend one end of each staple out of the delivery portion in response to actuation of the first actuator; and

a nailing mechanism coupled to the graspable portion and configured to transmit a nailing impact to the feeding portion.

The stapling impact may cause the one end of each staple to protrude further while still remaining at least partially in the retention wall. The graspable portion may be coupled to the feeding portion via a shaft.

Some embodiments relate to a device for delivering shape-memory staples, the device comprising:

a handle; and

a delivery portion coupled to the handle, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration, the delivery portion further including release apertures for releasing the staples into an in-use configuration based on shape memory of the staples;

wherein the discharge aperture extends in a slight helical shape with respect to a longitudinal axis of the feeding portion.

Some embodiments relate to a device for delivering shape-memory staples, the device comprising:

a graspable portion including a first actuator;

a delivery portion coupled to the graspable portion, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration and a release aperture for releasing the staples into an in-use configuration based on shape memory of the staples, wherein the delivery portion is configured to extend one end of each staple out of the delivery portion in response to actuation of the first actuator; and

a dome-shaped portion at a distal end of the feeding portion and movable between a proximal position in which a baffle at an open end of the dome-shaped portion fits around a feeding tip of the feeding portion and a distal position in which the baffle is positioned distally relative to the feeding tip to allow the one end of each staple to protrude from the feeding tip.

Some embodiments relate to a device for delivering shape-memory staples, the device comprising:

a graspable portion;

a delivery portion coupled to the graspable portion, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration and a release aperture for releasing the staples into an in-use configuration based on shape memory of the staples, wherein the delivery portion is configured to extend one end of each staple out of the delivery portion in response to actuation of the first actuator; and

a head portion positioned at a tip of the delivery portion, the head portion being retractable in a proximal direction to splay the tip outwardly.

Some embodiments relate to a device for delivering shape-memory staples, the device comprising:

a handle formed as a pistol grip;

a trigger actuator coupled to the handle;

a drive mechanism coupled to the trigger actuator and the handle;

an delivery portion coupled to the drive mechanism, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration and a release aperture for releasing the staples into an in-use configuration based on shape memory of the staples, wherein the delivery portion is configured to extend one end of each staple out of the delivery portion in response to actuation of the trigger actuator.

Drawings

Embodiments are described in further detail below by way of example, and the detailed description should be read in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of a device for providing shape-memory staples;

FIG. 2A is an exploded perspective view of the device of FIG. 1 showing the proximal drive mechanism in greater detail;

FIG. 2B is an exploded perspective view of a portion of the actuation mechanism of the device of FIG. 1;

fig. 3 is an exploded perspective view of the device of fig. 1 showing the nailing mechanism in greater detail.

FIG. 4 is an exploded perspective view of the device of FIG. 1 showing the head retraction actuator and barrel in greater detail;

FIG. 5 is an exploded perspective view of the actuator clutch of the device showing the outer clutch sleeve and the feed sleeve in greater detail;

FIG. 6 is an exploded perspective view of the actuator clutch showing the inboard clutch sleeve and the expander rod in greater detail;

FIG. 7A is an exploded perspective view of the actuator clutch showing the core rod and drive clutch in greater detail;

FIG. 7B is a perspective partial cross-sectional view of the actuator clutch illustrating advancement of the core rod and the drive clutch;

FIG. 8A is a side cross-sectional view taken along the vertical centerline of the device of FIG. 1, showing the device in an unactuated state;

FIG. 8B is a plan view of the device shown in FIG. 8A in an unactuated state;

FIG. 8C is a cross-sectional view of the actuator clutch and feed portion taken along a vertical centerline similar to FIG. 8A;

FIG. 8D is a plan view of the actuator clutch and feed portion corresponding to FIG. 8C;

FIG. 9A is a side cross-sectional view taken along the vertical centerline of the device of FIG. 1, showing the device in a partially actuated state;

FIG. 9B is a plan view of the device shown in FIG. 9A in a partially actuated state;

FIG. 9C is a cross-sectional view of the actuator clutch and feed section taken along a vertical centerline similar to FIG. 9A, with the device shown in a partially actuated state;

FIG. 9D is a plan view of the actuator clutch and feed portion corresponding to the partially actuated state of FIG. 9C;

FIG. 10A is a side cross-sectional view taken along the vertical centerline of the device of FIG. 1, showing the device in a further actuated state;

FIG. 10B is a plan view of the device shown in FIG. 10A in a further actuated state;

FIG. 10C is a cross-sectional view of the actuator clutch and feed portion taken along a vertical centerline similar to FIG. 10A, showing the actuator clutch and feed portion in a further actuated state;

FIG. 10D is a plan view showing the actuator clutch and feed portion in a further actuated state;

FIG. 11A is a side cross-sectional view taken along the vertical centerline of the device of FIG. 1, showing the device in a still further actuated state;

FIG. 11B is a plan view of the device in a still further actuated state as shown in FIG. 11A;

FIG. 11C is a cross-sectional view of the actuator clutch and feed portion taken along a vertical centerline similar to FIG. 11A, showing the actuator clutch and feed portion in this yet further actuated state;

FIG. 11D is a plan view of the actuator clutch and feed portion in this yet further actuated state;

FIG. 12A is a side cross-sectional view of the actuator clutch and feed section taken along a plane angularly offset from the vertical centerline of the device, showing the actuator clutch and feed section in a final actuated state;

FIG. 12B is a plan view of the actuator clutch and feed portion shown in a final actuated state;

FIG. 13A is a perspective view, partially in section, of the delivery portion of the device of FIG. 1, showing the delivery portion in an unactuated state;

FIG. 13B is a perspective view, partially in section, of the delivery portion with the device in a partially actuated state;

FIG. 13C is a perspective view, partially in section, of the delivery portion with the device in a further actuated state;

FIG. 13D is a perspective view, partially in section, of the delivery portion with the device in a further partially actuated state;

FIG. 13E is a perspective view, partially in section, of the delivery portion of the device shown in a final actuated state;

FIG. 14A is a partial side cross-sectional view of the feeding portion shown when the device is in an unactuated state;

FIG. 14B is a partial side cross-sectional view of the feeding portion shown with the device in a partially actuated state;

FIG. 14C is a partial side cross-sectional view of the feeding portion when the device is in a further actuated state;

FIG. 14D is a partial side cross-sectional view of the feeding portion when the device is in yet a further actuated state;

14E, 14F and 14G illustrate the progressive sequence of staple release to use configuration, illustrating the feeding portion in partial side cross-section;

FIG. 15 is a partial plan view of the device providing a sleeve showing insertion and release holes for the staples.

The same reference numbers are used between figures to indicate the same elements, features or functions. The figures are not drawn to scale and should be considered exemplary for purposes of illustrating the features and functions of the described embodiments.

Detailed Description

The described embodiments relate generally to devices for delivering shape-memory staples 910 and staple delivery methods implemented using such devices. In some embodiments, staple feeding device 100 includes a stapling mechanism 190 for providing a stapling impact to cause the ends of staples 910 to protrude in a stabbing manner, thereby enabling staples 910 to penetrate into dense and/or hard matter around the staple feeding location.

In other embodiments, the release holes 554 for releasing the staples 910 from the delivery portion 140 extend in a slightly helical manner relative to the longitudinal axis of the delivery portion 140. In another embodiment, the device 100 includes a slightly spherical portion 660, the spherical portion 660 positioned at the delivery end of the device 100 and configured to retract axially into the delivery end to cause the substantially cylindrical sheath 550 around the delivery end to flare slightly outward.

In still other embodiments, the device 100 can include a dome-shaped cap 145 at its distal end that can be moved between a proximal position where a baffle 147 at an open end 148 of the dome portion 145 fits around the cylindrical delivery tip 142 to, for example, hold a graft in place, where the graft is a substantially tubular graft that fits around at least a portion of the shaft 130 of the device 100, and a distal position. In the distal position, the dome-shaped cover 145 does not overlie the tip portion 142 of the cylindrical end and allows one end of each staple 910 to protrude radially into the graft, ready for staple delivery to secure the graft to another body.

By way of non-limiting example, embodiments of the apparatus are shown and described in connection with fig. 1 to 15. As shown in fig. 1, the device 100 includes a graspable handle 110, the handle 110 having a palm grip 111, a ratchet tooth 112, a depressible trigger 150, and a finger grip portion 152. When the device 100 is held by a hand, the graspable handle 110 is shaped such that the palm grip 111 is received in the palm and/or thenar region of the hand, and the fingers extend around the trigger 150 and finger grip portion 152 to enable secure grasping and operation of the device 110. For example, the trigger 150 may be moved relative to the ratchet protrusions 113a, 113b, and 113c by grasping the third, fourth, and fifth fingers of the hand. Ratchet teeth 112 cooperate with angled trigger feet 155 at the bottom of trigger 150, which acts as a ratchet engagement portion, to impede outward movement of trigger 150 relative to the body portion of handle 110. The trigger foot 155 can be actuated to sequentially engage the ratchet tabs 113a, 113b, and 113c, with the ratchet tab 113a holding the trigger 150 in an unactuated state.

The trigger 150 may pivot relative to a finger grip portion 152 of the handle 110 about an axis defined by a trigger pivot pin 151, the trigger pivot pin 151 being received in a pin aperture 153 formed in the finger grip portion 152. The trigger 150 has a disengagement pawl 154 formed at an end opposite the trigger foot 155 for engaging a proximal drive mechanism 160 described below.

As shown in fig. 2A and 2B, the handle 110 further includes a movement limiting latch 115 positioned in a body of the handle 110 to limit inward movement of the trigger 150. One end of the spring 116 is disposed around the movement limiting latch 115 and is at least partially received within the body of the handle 110, and the spring 116 is disposed around a spring registration boss 117 formed on the inner surface of the trigger 150. The spring 116 serves to bias the trigger 115 outward so that the trigger foot 155 seats against the ratchet tooth protrusion 113a, 113b or 113 c. The handle 110 also houses a retention latch 118 to secure the proximal drive mechanism 160 to the handle 110.

Ratchet teeth 112 are preferably formed of flexible spring steel. Ratchet teeth 112 may be fastened to base 114 of handle 110 by base bolts 114a received at one end of ratchet teeth 112 through ratchet tooth holes 112 a. Ratchet tabs 113a, 113b, and 113c are formed at opposite ends of aperture 112a and ratchet teeth 112 are sufficiently flexible that trigger 150 can be moved outwardly past one or more of ratchet tabs 113a, 113b, and 113c (to reset trigger 150 after actuation) when ratchet teeth 112 are resiliently deflected downwardly away from the body of handle 110.

The handle 110 is coupled to an actuation portion 120, the actuation portion 120 including a proximal actuation portion 122 and a distal actuation portion 124. The shaft 130 is coupled to the distal actuating portion 124 to transmit the actuating motion and force to a delivery portion 140 disposed at the distal end of the device 100.

In the context of this description, using a positional reference, it is assumed that the device 110 is held in the manner of a pistol, the base 114 is oriented substantially downward and the "barrel" of the "pistol" extends substantially outward. The relative term "proximal" should be interpreted to indicate a direction or position that is close to or toward the palm of the hand when the hand is positioned about the handle 110 in the manner previously indicated. The term "distal" is used to indicate a direction or position opposite "proximal" that is substantially away from the handle 110 being grasped by the hand. These or other positional references are provided merely for ease of understanding and are not intended to limit the actual position or orientation of the device during use.

The proximal actuating portion 122 includes a proximal drive mechanism 160 and a stapling mechanism that can be actuated by a stapling actuator 180.

As shown in fig. 2A, the proximal drive mechanism 160 includes a proximal drive sleeve 162 coupled to and disposed against the top of the handle 110. Proximal drive sleeve 162 has a proximal end insert 164, which proximal end insert 164 is received through an open proximal end of sleeve 162. Insertion locator pin 211 is received through a correspondingly sized hole in proximal end insert 164 and a radial hole 214 formed in proximal drive sleeve 162. Insertion locator pin 211 remains partially received in radial bore 214 to secure proximal end insert 164 in place within sleeve 162. Drive spring 212 is also positioned within sleeve 162 such that one end of the spring is positioned against an internal boss on proximal end insert 164. The spring 212 is disposed partially around an extended boss of the proximal end 222 of the first clutch portion 220 that is also received within the proximal drive sleeve 162. The spring 212 serves to bias the first clutch portion 220 in the distal direction.

The proximal drive sleeve 162 partially houses a second clutch portion 230, the second clutch portion 230 having an additional slotted end 232, the end 232 being shaped to mate with the keyed end 226 of the first clutch portion 220. The second clutch portion 230 has a neck portion 234 positioned intermediate a first slotted end 232 and a second slotted end 236. Neck portion 234 is shaped to partially contact and engage disengagement pawl 154 of trigger 150 such that proximal actuation of trigger 150 (i.e., actuation by grasping a finger) causes distal movement of disengagement pawl 154 about neck portion 234 engaging second clutch portion 230, thereby moving second clutch portion 230 distally within drive sleeve 162.

Staple releasing actuator 165, which is typically formed as an extended lever and is indicated in the figures as "lever D", is coupled to first clutch portion 220 by a threaded coupling through a threaded bore 224 formed in first clutch portion 220. The torque applied to the staple releasing actuator 165 causes the first clutch portion 220 to rotate about the longitudinal axis of the device 100. This rotational movement of first clutch portion 220 induces a similar rotational movement of second clutch portion 230, which in turn causes a similar rotation of drive clutch 740 (described in more detail below), thereby moving a portion of feeding portion 140 relative to outer feeding sleeve 550 (as permitted by the positioning of release actuator limiting rod 812 within release actuator limiting channel 512, described below).

The proximal drive sleeve 162 has an enlarged distal end with a male threaded cylindrical wall 218 for threaded engagement with a cartridge housing 410 (fig. 4). Top screw 178 may be inserted through screw receiving aperture 418 in barrel housing 410 and into threaded aperture 168 formed in the distal end of proximal drive sleeve 162, thereby securing barrel housing 410 to proximal drive sleeve 162.

Spring 250 and positioning element 260 are received in the distal end of proximal drive sleeve 162 and the proximal end of cartridge housing 410 to receive and position second slotted end 236 relative to clutch head portion 742 of drive clutch 740.

The proximal drive sleeve 162 has a slot 216 formed toward the distal end of the sleeve 162 for receiving the strike transmission portion 188 of the anvil 186 therethrough. The strike transmission portion 188 is configured to project downwardly from within the substantially cylindrical nailing actuator housing 181 through the slot 216 to be received in the neck portion 234. The opposing jaw portions of the separation jaw 154 may be sized to fit around the reduced diameter portion of the neck portion 234 and at least partially receive the lower tip of the blow transmission portion 188. Thus, movement of either of the anvil 186 and the trigger 155 causes the second clutch portion 230 to move along its longitudinal axis.

As shown in fig. 3, the nailing mechanism 190 includes a nailing piston 185, and the nailing piston 185 is axially movable within a nailing actuator housing 181 (formed as a hollow cylinder) under the action of a nailing actuator spring 183 proximally positioned within the housing 181 to serve as a hammer acting on the anvil 186. The nailing actuator 180 formed as a rod and shown as "rod C" in the drawings may be coupled to the nailing piston 185 by means of a threaded engagement. The nailing actuator 180 extends radially through an L-shaped guide channel 182 formed in the housing 181. A portion of the guide passage 182 extends circumferentially to allow rotational movement of the nailing actuator 180 and nailing piston 185 within the housing 181. However, the housing 181 also defines a longitudinal section of the guide channel 182, thereby permitting the nailing actuator 180 to move longitudinally within the longitudinal section of the guide channel 182.

One end of the spring 183 is positioned against an end cap 187, the end cap 187 being secured to the proximal end of the housing 181, such as by a threaded engagement. The other end of the spring 183 acts on an inner cover 184 having a boss around which the end of the spring 183 fits. The inner cap 184 abuts the proximal end of the nailing piston 185 such that the nailing piston 185 is biased in a distal direction by the spring 183.

When the nailing actuator 180 is in the unactuated position, it is received within a circumferential portion of the guide channel 182 in which the portion of the nailing actuator housing 181 defining the guide channel 182 obstructs distal movement of the nailing actuator 180. To actuate (move) the nailing actuator 180 to the actuated position, a torque may be applied to the nailing actuator 180 to rotate the nailing actuator 180 toward the longitudinal section of the guide channel 182 such that the nailing piston 185 and nailing actuator 180 become free to move in the distal direction under the bias of the spring 183.

The nailing actuator housing 181 may be secured to the proximal drive sleeve 162 by receiving the proximal end screw 166 through a hole formed in a downwardly depending locating flange 312 formed on or attached to the housing 181. The threaded end of proximal end screw 166 may be received in the mating threaded proximal end of proximal end insert 164 to secure proximal end screw 166 in place and thus facilitate fixedly positioning housing 181 on or adjacent to proximal drive mechanism 160. The axes of motion of the mechanisms within the proximal drive mechanism 160 and the stapling mechanism 190 are substantially longitudinal and parallel.

As an additional means of securing housing 181 relative to proximal drive socket 162, distal end 314 of housing 181 is configured to mate with or receive a locating boss 322 disposed toward the distal end of proximal drive socket 162. The positioning boss 322 is fixed relative to the cylindrical barrel of the proximal drive sleeve 162 and is positioned slightly above the distal end of the slot 216.

Still referring to fig. 4, the head retraction actuator 170 and the cartridge housing 410 are described in more detail. The head retraction actuator 170 includes a stem 171, the stem 171 being received within a stem receiving channel 174 defined by a head portion of a rotation key 173. The ball 172 is received in a hole formed in the shaft of the rotary key 173 to secure the rod 171 in place relative to the channel 174. The rotation key 173 has a cam 175 on its inner end for engaging and moving the inner clutch sleeve 610 proximally by camming against a distal surface 611a of a proximal end flange 611 of the inner clutch sleeve 610 (fig. 6). The rotational key 173 is received within a registration barrel 176, which registration barrel 176 is received by threaded engagement with an actuator insertion port 414 formed in a side of the barrel housing 410. The registration barrel 176 has male threads 177, the male threads 177 for engaging corresponding female threads within the actuator insertion port 414.

The cartridge housing 410 includes a threaded proximal end 412, the proximal end 412 being sized to fit around the threaded cylindrical wall 218 of the proximal drive sleeve 162 and engage the cylindrical wall 218. The barrel housing 410 also includes an interior annular flange 420, and the positioning element 260 is seated within the interior annular flange 420. At its distal end, the cartridge housing 410 has a threaded distal end 416 with upper and lower registration bosses 422 extending distally from the distal end 416 to register and mate with registration recesses 522 formed at respective upper and lower locations on an outer annular flange 442 of the actuator clutch 440.

The retention cap 128 slides over the distal end of the actuator clutch 440 to retain the actuator 440 within the cartridge housing 440. The retention cap 128 has internal threads 426 to engage the threaded distal end 416 of the barrel housing 410 and has an inner annular flange 432 to engage and abut the distal surface of the outer annular flange 442 to thereby retain the actuator clutch 440 within the barrel housing 410. A distal opening in the retention cap 128 allows a distal portion of the actuator clutch 440 to extend therethrough along with the shaft 130.

The head retraction actuator 170, also shown as "rod B" in the figures, is able to rotate partially about the central axis of the rotation key 173, which is perpendicular to the longitudinal axis of the device 100. This rotation causes the slightly spherical expander head 660 within the feeding portion 140 to retract, thereby causing the feeding sleeve 550 to expand outward slightly proximal to the feeding tip 142.

It should be noted that the length of the shaft 130 is plotted very short in fig. 2A, 3, 4, 5, 6, 7A and 7B. This is done merely for ease of illustration and does not represent the actual length of the shaft 130. Rather, the relative lengths of the shafts 130 as shown in FIG. 1 are intended to more accurately reflect the desired configuration of the apparatus 100, although it should be noted that the figures are not drawn to scale.

Still referring to fig. 5 and 6, the actuator clutch 440 is shown and described in greater detail. The actuator clutch 440 includes an outer clutch sleeve 510 and an inner clutch sleeve 610. The outer clutch sleeve 510 surrounds a majority of the inner clutch sleeve 610 except for a proximal end flange 611, which proximal end flange 611 extends radially outward to an extent that it circumferentially coincides with an outer circumference of the outer clutch sleeve 510. The outer clutch sleeve 510 and the inner clutch sleeve 610 have radial holes 514 and 614 to receive the positioning cylinder 630 and radial screw holes 516 and 616 to allow insertion of a set screw 538 to secure the inner feed sleeve 820 to the inner rotatable component of the actuator clutch 440.

The substantially cylindrical wall of the outer clutch sleeve 510 defines a release actuator limiting passage 512 of substantially L-shaped configuration. The head of the release actuator limiting rod 812 is received in the release actuator limiting channel 512 such that the channel 512 limits relative movement between the outer clutch sleeve 510 and the limiting rod 812. The restraining bar 812 is coupled to internal components of the actuator clutch 440 and, as discussed below, may be indirectly coupled to the proximal drive mechanism 160 and plays an important role in avoiding premature actuation of the staple releasing actuator 165.

The outer clutch sleeve 510 has: an outer sleeve proximal opening 524 through which the proximal end of the inner clutch sleeve 610 is received; and an outer sleeve distal opening 526 through which a proximal portion of the shaft 130 extends. The distal end 542 of the outer clutch sleeve 510 has a plurality of circumferentially spaced fixation holes 537 for receiving fixation screws 536 to secure the feed sleeve 550 within the distal end 542 of the outer sleeve. The outer clutch sleeve 510 also defines an annular wall 546 toward the distal end 542, the spring 562 and the retaining ring 530 being disposed against the annular wall 546. Spring 562 serves to bias some of the internal components of actuator clutch 440 in a proximal direction. The spring 562 is positioned inside of the retaining ring 530. the retaining ring 530 has approximately the same inside diameter as the inside clutch sleeve 610.

The assembly of the shaft 130 is substantially coaxial with the inner and outer clutch sleeves 610, 510, the cartridge housing 410, and the proximal drive mechanism 160, but the nailing mechanism 190 is axially offset from them.

Distal actuating portion 124 includes head retraction actuator 170, barrel housing 410, actuator clutch 440, shaft 130, and delivery portion 140.

As shown in fig. 5, outer feed sleeve 550 has a proximal end that is received within outer sleeve distal opening 526 and is secured to outer sleeve distal end 542 by set screw 536. The outer feeding sleeve 550 has a number of release holes 554 at its distal end, these release holes 554 being formed as substantially longitudinally extending slots in the end of the outer feeding sleeve 550. The release holes 554 extend all the way to the distal tip of the outer delivery sleeve 550, thereby defining a plurality of fingers 552 arranged in an interrupted cylindrical configuration. The fingers 552 define a substantially angled inner profile at the distal opening of the outer delivery sleeve 550 to receivingly engage a corresponding angled outer surface 662 of the expander head 660. When the extender head 660 is retracted slightly in a proximal direction, the angled outer surface 662 engages and slides against the angled inner profile 558, which causes the fingers 552 to deflect slightly radially outward as the fingers 552 are formed of a resiliently deflectable material, thereby flaring the delivery tip 142 outward. This outward flaring can, for example, help to forcibly expand the vessel wall and can enable the staples to be released at radially enlarged locations, which can lead to improved medical staple application quality given the substantially circular shape memory of the staples.

The delivery sleeve 550 also defines insertion apertures 556 through which the deformed (i.e., relatively straightened) staples can be inserted for receipt within the staple receiving cavities 826. The insertion hole 556 may be formed as a notch substantially parallel to the release hole 556 but offset with respect to the release hole 556. The insertion hole 556 is generally shorter in length than the release hole 554 and is positioned near the proximal end of the release hole 554, but slightly proximal thereto.

The inner clutch sleeve 610 defines a release actuator limiting passage 612 to permit the release actuator limiting rod 812 to move in the proximal and distal directions, but not axially. When the limiter lever 812 is allowed to move rotationally within the limiter channel 512, the limiter lever 812 causes the inner clutch sleeve 610 to rotate with the limiter lever 812. This causes the expander rods 650 to rotate because the inner clutch sleeve 610 is rotatably coupled to the expander rods 650 by the positioning cylinder 630. Specifically, the extender rod 650 has its proximal end 652 received therein through a diametric through-hole 632 formed in the positioning barrel 630. The set screw 636 is axially positioned within the positioning barrel 630 to fix the spreader lever 650 relative to the positioning barrel 630.

As shown in fig. 6, the extender head 660 is positioned at the distal end of the extender rod 650 and has staple protruding notches 664 extending in a generally axial but outward direction on the outside of the extender head 660 to accommodate the protrusion of staples 910 from within the staple receiving cavity 826. The spreader head 660 also has a shoulder 668 against which the distal end of the inner feeding sleeve 820 abuts when the inner feeding sleeve 820 is moved to its distal most position. The angled outer surface 662 transitions from the shoulder 668 to a radially distal end of the extender head 660, the radially distal end of the extender head 660 being substantially coincident with the delivery tip 142.

The extender rod 650 includes a substantially hollow cylindrical wall 651 through which the core rod 710 passes and is capable of movement. The extender rod 650 is received within the inner feeding sleeve 820, which in turn receives the inner feeding sleeve 820 within the outer feeding sleeve 550. The core rod 710 has a rod proximal end 712 and a rod distal end 714. A distal end cap 145 is positioned at distal end 714. Distal end cap 145 may include a flexible medical grade plastic flap 147 extending proximally from a distal tip of distal end cap 145. It is desirable that the baffle 147 be sufficiently robust to retain the graft to the distal tip 142 in the unactuated position.

The proximal end 712 of the core pin 710 is received within a diametrically through bore 722 of the positioning cylinder 720. The core rod 710 is secured to the positioning cylinder 720 by a set screw 730 axially received within the positioning cylinder 720. The core rod 710 extends through the diametric throughbore 722 to be at least partially received within the central bore 743 of the drive clutch 740. Drive clutch 740 also has a transverse bore 744 for receiving positioning cylinder 720. The configuration is such that when the second clutch portion 230 is engaged with the clutch head portion 742, a rotational or axial force is applied to the second clutch portion 230, such as by either of the levers A, C and D, which is transmitted to the core rod 710 and the components housed within the inboard clutch sleeve 610.

Drive clutch 740 has a distal annular wall 746 that is arranged to interleave and abut a corresponding circumferentially spaced annular wall 840 to limit excessive distal movement of drive clutch 740 in response to second clutch portion 230 and permit clutch action for rotational transmission.

Referring now to fig. 8A-8D, the unactuated position of the device 100 is described. In the unactuated position, first and second clutch portions 220, 230, anvil 186, and drive clutch 740 are positioned in relatively proximal positions according to their limited freedom of movement within their respective housings. In this state, due to the position of the limiting rod 812 within the limiting channel 512, the outer clutch sleeve 510 and the inner clutch sleeve 610 are unable to rotate relative to each other and the limiting rod 812 is prevented from rotating relative to the outer clutch sleeve 510. Thus, the inner feeding sleeve 820 is prevented from rotating within the outer feeding sleeve 550.

In the unactuated state, the distal end cap 145 is in its proximal-most position, where the open end 148 of the dome-shaped flap 147 partially overlies the distal feeding tip 142, thereby impeding the staples 910 from accidentally protruding from the feeding tip 142 before being intentionally released.

When device 100 is in the unactuated state, it is desirable that staples 910 be inserted into staple receiving cavities 826 in their deformed (straightened) configuration.

Referring now to fig. 9A-9D, a first actuation state of the device 100 is described, which is one of a plurality of possible actuation states. The first actuation state is achieved by forcing levers 150 to move proximally, such as by grasping the fingers to bend them inwardly toward hand gripping handle 110, causing trigger feet 155 to move inwardly one ratchet position. The leverage of the trigger 150 about the trigger pivot pin 151 causes the disengagement pawl 154 to move distally. Which in turn pushes second clutch portion 230 in a distal direction, which in turn causes drive clutch 740 and stem 710 to move distally by an amount, such as a few millimeters.

Following the first actuation, distal annular wall 746 of drive clutch 740 is advanced adjacent proximal annular wall 840 to be rotatably engaged with proximal annular wall 840. Thus, the distal annular wall 746 effectively interleaves the interleaved fingers with the corresponding proximal annular wall 840 to transfer rotational force from the drive clutch 740 to the annular wall 840, which annular wall 840 is in turn rigidly coupled to the restraining rods 812 and the inner feed sleeve 820. In the first actuated state, the limiter bar 812 remains in its proximal-most position within the limiter channel 512. The purpose of the first actuation is to advance distal end cap 145 distally to allow staples 910 to subsequently protrude from distal delivery tip 142 and engage drive clutch 740 with annular wall 840 (acting as a clutch).

Referring now to fig. 10A to 10D, the second actuated state of the device 100 is described in more detail. In the second actuation state, the head retraction actuator 170 (lever B) is twisted so that the rod 171 is not substantially horizontal and parallel to the barrel housing 410, but is rotated 90 degrees counterclockwise (as viewed in fig. 10A) so that the rod 171 is positioned vertically. By rotating the lever 171 in this way, the rotation key 173 is rotated counterclockwise, which causes the cam 175 to engage the distal surface 611a of the proximal end flange 611, thereby displacing the inner clutch sleeve 610 in the proximal direction by an amount set according to the shape of the clutch 175. For example, the inner clutch sleeve 610 moves proximally by approximately 0.5mm under the action of the cam 175.

Retraction of the inner clutch sleeve 610 in the proximal direction displaces the expander rod 650 proximally the same amount while the core rod 710, outer delivery sleeve 550, and inner delivery sleeve 820 remain unmoved except for the slight expansion of the outer delivery sleeve 550 at the distal tip 142 as previously described. The angled outer surface 662 of the extender head 660 acts on the angled inner profile 558 of the fingers 552 thereby deflecting the fingers 552 outwardly such that the feeding portion 140 flares. This flaring of the distal tip 142 can be configured to result in an increase in diameter, for example, approaching 1 to 2 mm.

The second actuation step, achieved by actuation of head retraction actuator 170, need not achieve release of staples 910, but may be desirable to provide greater vessel wall expansion. This is believed to improve staple application quality.

Referring now to fig. 11A to 11D, the third and fourth actuation states will be described in more detail. In a third actuated state, the trigger 150 is depressed proximally by a further step such that the trigger foot 155 seats proximally of the ratchet tooth protrusion 113c, which causes the disengagement pawl 154 to further advance the second clutch portion 230 in a distal direction. This causes inner sleeve 820 to be pushed distally by drive clutch 740, thereby advancing staples 910 positioned in staple receiving cavities 826. When the staples 910 are received within the staple receiving cavities 826, the rugged or irregular inner cavity wall 822 partially defining the staple receiving cavities 826 serves to frictionally engage the staples 910 to facilitate advancement of the staples within their respective cavities. An additional or alternative advancement means is provided by an inwardly directed positioning groove 828 formed in the inner feeding sleeve 820 so as to coincide with the staple receiving cavity 826. The inward positioning grooves 828 are formed to allow each staple 910 to at least partially seat therein based on their shape memory, which is configured such that the staples assume a near circular in-use configuration. As the inner delivery sleeve 820 is advanced distally, the inner cavity wall 822 and/or the inward positioning grooves 828 help move the staples 910 such that one end of the staples 910 pass through the staple protruding notches 664 and extend slightly radially outward from the tip portion 142. This third actuated state allows the staples 910 to partially extend, e.g., causing the staples 910 to at least partially extend through the graft positioned around the delivery tip 142.

The inward positioning grooves 828 are formed as radially inwardly curved (concave) deformations in the inner feeding sleeve 820 adjacent the feeding sleeve distal end 824. The positioning grooves 828 provide axial engagement and proper orientation of the staples 910 such that when free, the ends of the staples 910 come together outside of the feeding portion 140 and away from the feeding portion 140 (as shown in fig. 13E and 14A). If the staples 910 are not properly oriented within receiving cavities 826, their ends may not be brought together in the proper position to achieve the desired stapling effect.

In the fourth actuated state, the nailing mechanism 190 is actuated to feed a nailing shot to the inside feeding sleeve 820 inside the feeding section 140. By applying a torque to the lever 180 to rotate the nailing piston 185 and the lever 180 to a position where the spring 183 biases the nailing portion 185 in the distal direction, thereby causing the nailing piston 185 to act as a hammer acting on the anvil 186, the anvil 186 transmits the power impact struck by the hammer to the second clutch portion 230 via the striking transmission portion 188 of the anvil 186; second clutch portion 230 thereby receives a power impulse in a distal direction that is transmitted to drive clutch 740 by abutting contact of second clutch portion 230 with drive clutch 740; the drive clutch 740 in turn transmits the power impact to an annular wall 840 coupled to the inner feeding sleeve 820, thus transmitting the nailing impact to the feeding portion 140.

The distally directed power impact transmitted from the stapling mechanism 190 is configured such that the protruding staple 910 protrudes further in a nearly poking manner. The purpose of this poking extension of the staples 910 is to enable the extended ends of the staples 910 to penetrate the relatively dense tissue or matter that may be formed on the vessel wall that is to be joined.

The feeding of the nailing strike in response to actuation of the nailing mechanism 190 is an optional step and may be omitted if desired. Further, according to some embodiments, the nailing mechanism 190 can provide more than one circumferential slot location for the bar 180. This enables more or less compression of the spring 183 in the proximal direction to provide more or less dynamic impact on the anvil 186 when the nailing mechanism 190 is actuated.

Referring also to fig. 12A and 12B, the fifth final actuation state is described in more detail. Because advancement of drive clutch 740 also advances annular wall 840 distally and, thus, advances limiting rod 812 relative to outer clutch sleeve 510, completion of the third actuation state enables the final actuation state (i.e., release of the staples) to be implemented. This is because distal movement of the limiter rod 812 relative to the outer clutch sleeve 510 and the limiter channel 512 positions the limiter rod 812 to slide laterally within the limiter channel 512. As shown in fig. 12A and 12B, this allows rotation of the inner feeding sleeve 820 within the outer feeding sleeve 550 such that the longitudinally extending staple receiving cavities coincide with the release holes 554, thereby releasing the staples 910 so that they adopt a circular in-use configuration according to their shape memory (920).

Because of the thinness of the wires used for staples 910, 920 and the strong shape memory induced in such staples, the ends of the staples are sharp enough and have sufficient force to pierce the tissue surrounding delivery tip 142 to come together. Although fig. 11A-11D, 12A-12D show distal feeding tip 142 being flared, this need not necessarily be the case. Regardless of whether the delivery tip 142 is deployed, actuation of the staple-releasing actuator 165 causes the staples 910 to be released through the release holes 554.

By applying torque to staple releasing actuator 165, for example by pressing it downward, inner feeding sleeve 820 is caused to rotate relative to outer feeding sleeve 550. This downward movement applied to staple releasing actuator 165 (lever D) causes rotation of first clutch portion 220, first clutch portion 220 transmitting the rotational movement to annular wall 840 via second clutch portion 230 and drive clutch 740. Because annular wall 840 is coupled to inner feeding sleeve 820, the downward moment applied to rods D causes longitudinally extending staple receiving cavities 826 to align with release holes 554, thereby ejecting outward and assuming their in-use configuration.

13A, 13B, 13C, 13D and 13E progressively illustrate an unactuated state, a first actuated state, a second actuated state, a third actuated state, and a fifth final actuated state. The illustration of the further extension resulting from the actuation of the nailing mechanism 190 is not shown as a different state independent of the state of fig. 13D, but fig. 13D can be considered to show the result of a combination of third and third actuation states as described above.

Similarly, fig. 14A to 14G illustrate the configuration of the feeding portion 140 during the progressive actuation state. 14A, 14B, 14C and 14D correspond to an unactuated state, a first actuated state, a second actuated state, and third and fourth actuated states, respectively. 14E, 14F, and 14G progressively illustrate a fifth actuated state in which release of the staples 910 from the release holes 554 is illustrated for embodiments of the device 100 in which the release holes 554 are formed with a slight spiral (i.e., angled slightly relative to the longitudinal axis as shown in FIG. 15).

For embodiments in which the release holes 554 are angled, the release holes 554 are configured such that when the distal ends of the staples 910 protrude from the delivery tip 142, only the proximal portions of the release holes 554 align with the underlying staple receiving cavities 826 during the initial stages of release. This enables the proximal end of each staple 910 to begin to curl outward from cavity 826 due to its shape memory. This initial protruding state of the proximal ends of the staples 910 at the beginning of the release phase is illustrated in FIG. 14E.

As can be seen from fig. 14F, as the inner feeding sleeve 820 is progressively more aligned with the release holes 554, more of the proximal end of each staple is released to assume its in-use configuration, although the staples 910 have not yet been fully released. As illustrated in fig. 14F, the proximal end of each staple 910 tends to curl upward such that once inner feeding sleeve 820 is further aligned with release hole 554, as illustrated in fig. 14G, the opposite ends of each staple 910 are allowed to come together in a clamping and piercing action, which is considered more effective for some staple application purposes than if there was no progressive release of the proximal end of each staple 910.

14A-14G illustrate the release of only one staple 910 into the in-use configuration, this is for purposes of simplifying the illustration only and should be understood as releasing multiple staples simultaneously from multiple different circumferentially spaced locations. Depending on which configuration may be suitable for a particular staple applying application, the device 100 can be configured with 4, 6, 8, 10, or 12 release holes 554 (and a corresponding number of insertion holes 556). Further, while in fig. 14A-14F, the staples 910 appear to be bent between the shoulders 668 and the delivery tip 142, such bending of the staples does not occur entirely in the manner illustrated. Conversely, if present, such a bend would be fairly smooth, rather than a sharp bend in the wire.

The angle of the relief holes relative to the longitudinal axis of the outer feeding sleeve 550 is relatively small, such as about 1 degree to about 7 degrees, for example. The angle may vary depending on the number of the release holes 554 provided in the feeding portion 140.

The wires used as staples 910, 920 may be, for example, nickel titanium alloy wires having a diameter of between about 0.1mm to about 0.5 mm. Some particular embodiments are configured to employ staples of about 0.3mm or about 0.33 mm.

The use of shape-memory staples described herein avoids the need for staples to be deformed to take the desired staple shape by being pressed against an anvil, thus eliminating the additional components and logistical difficulties associated with having an anvil at the staple feeding end of the staple.

Although the embodiments are described herein in particular detail, it should be understood that these embodiments are described by way of example, and are not to be construed as limiting with respect to equivalents or as limiting the scope of the invention.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

Parts list

100 staple

110 handle

111 palm grip

112 ratchet tooth

112a bolt hole

113a, b, c ratchet protrusions

114 base of handle

114a base bolt

115 movement limiting latch

116 biasing spring

117 spring registration boss

118 retention latch

120 actuating part

122 proximal actuating portion

124 distal actuating portion

128 retention cap

130 axle

140 feeding part

142 feeding tip

145 distal end cap

147 baffle plate

148 open end of the baffle

150 trigger

151 trigger pivot pin

152 finger grip portion

153 pinhole

154 separation claw

155 ratchet engagement portion/trigger foot

160 proximal drive mechanism

162 proximal drive sleeve

164 proximal end insert

165 Sewing needle release actuator (rod D)

166 proximal end screw

170 head retraction actuator (rod B)

171 rod

172 ball

173 rotating key

174 rod receiving channel

175 cam

176 registration cartridge

177 screw thread

178 Top screw

180 nailing actuator (Member C)

181 nailing actuator casing

182 guide channel

183 nailing actuator spring

184 inner cover

185 nailing piston/hammer

186 anvil

187 end cap

188 strike transmission portion

190 nailing mechanism

211 inserting positioning pin

212 drive spring

214 radial hole

216 slotted hole

218 threaded cylindrical wall

220 first clutch portion

222 Clutch proximal end

224 threaded hole

226 keyed end

230 second clutch portion

232 first strap end

234 neck portion

236 second slotted end

250 spring

260 positioning element

312 locating flange

314 distal end

322 positioning boss

410 tube housing

412 threaded proximal end

414 actuator insertion port

416 threaded distal end

418 screw receiving hole

420 inner annular flange

422 registration boss

426 internal thread

432 inner annular flange

440 actuator clutch

442 outer annular flange

510 outboard clutch sleeve

512 Release actuator restriction channel

514 holes for positioning cylinders

516 screw hole

522 registration groove

524 outer sleeve proximal opening

526 outer sleeve distal opening

530 positioning ring

536 set screw

537 fixation hole

536 set screw

542 outer sleeve distal end

546 annular wall

550 outside supply sleeve

552 finger

554 relief hole

556 insert hole

558 angled inside profile

562 spring

610 inside clutch sleeve

611 proximal end flange

611a distal surface of the proximal end flange

612 Release actuator restriction channel

614 for locating the bore of the cylinder

616 screw hole

618 inner sleeve distal end

630 positioning cylinder

632 through hole along diameter

636 fixed screw

650 expander rod

651 cylindrical wall

652 proximal end

660 expander head

662 angled outer surface

664 nail-riding protruding notch

668 shoulder

710 core rod

712 rod proximal end

714 rod distal end

720 positioning cylinder

722 through hole along diameter

730 fixed screw

740 drive clutch

742 clutch head portion

743 central hole

744 transverse hole

746 distal annular wall of drive clutch

812 releasing the actuator limit lever

820 inside feeding sleeve

822 inner cavity wall

824 feeding sleeve distal end

826 staple receiving chamber

828 inward positioning groove

840 annular wall (coupled to inner supply sleeve)

910 staple (deformed configuration)

920 staple (used configuration)

Claims (18)

1. A device for delivering shape-memory staples, the device comprising:

a handle; and

a delivery portion coupled to the handle, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration, the delivery portion further including release apertures for releasing the staples into an in-use configuration based on shape memory of the staples;

wherein the discharge aperture extends in a slight helical shape with respect to a longitudinal axis of the feeding portion.

2. The device of claim 1, wherein the release aperture is at an angle of 1 ° to 7 ° relative to the longitudinal axis.

3. The device of claim 1, wherein the release holes are configured to progressively align with retention cavities defined by the retention walls to allow the staples to be released through the release holes.

4. The device of claim 3, wherein the gradual alignment enables release of a proximal end of each of the staples to precede release of a distal end of the staple.

5. A device for delivering shape-memory staples, the device comprising:

a graspable portion including a first actuator;

a delivery portion coupled to the graspable portion, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration and a release aperture for releasing the staples into an in-use configuration based on shape memory of the staples, wherein the delivery portion is configured to extend one end of each staple out of the delivery portion in response to actuation of the first actuator; and

a domed portion at a distal end of the feeding portion and movable between a proximal position in which a baffle at an open end of the domed portion fits around a feeding tip of the feeding portion and a distal position in which the baffle is positioned distally relative to the feeding tip to allow the one end of each of the staples to protrude from the feeding tip.

6. The device of claim 5, wherein the baffles inhibit protrusion of the one ends of the staples when the dome-shaped portion is in the proximal position.

7. The apparatus of claim 5 or 6, wherein the baffle is formed of a flexible non-metallic material.

8. The device of claim 5 or 6, wherein the domed portion is coupled to a stem extending through a shaft, wherein axial movement of the stem causes movement of the domed portion between the proximal and distal positions.

9. The device of claim 5 or 6, wherein the first actuator is actuatable in a first actuation state to move the dome-shaped portion from the proximal position to the distal position.

10. The device of claim 9, wherein the first actuator is actuatable in a second actuation state to extend the one end of each of the staples.

11. The device of claim 10, wherein the device is configured to allow the second actuation state only after the first actuation state.

12. The device of claim 5 or 6, wherein the release holes are configured to progressively align with retention cavities defined by the retention walls to allow the staples to be released through the release holes.

13. The device of claim 12, wherein the gradual alignment enables release of a proximal end of each of the staples to precede release of a distal end of the staple.

14. A device for delivering shape-memory staples, the device comprising:

a graspable portion including a first actuator;

a delivery portion coupled to the graspable portion, the delivery portion including a retention wall for retaining the staples within the delivery portion in an elastically deformed configuration and a release aperture for releasing the staples into an in-use configuration based on shape memory of the staples, wherein the delivery portion is configured to extend one end of each staple out of the delivery portion in response to actuation of the first actuator; and

a head portion positioned at a tip of the delivery portion, the head portion being retractable in a proximal direction to splay the tip outwardly.

15. The device of claim 14, wherein the head portion is retractable in response to actuation of a fourth actuator.

16. The device of claim 14 or 15, wherein the tip of the delivery portion has an angled inside profile, the head portion engaging the inside profile to expand the tip when the head portion is retracted.

17. The device of claim 14 or 15, wherein the tip has a notch formed therein to interrupt a distal periphery of the tip, and wherein the material of the tip is elastically deformable.

18. The device of claim 14 or 15, wherein the tips are configured to allow the staples to protrude therefrom when the tips are splayed, whereby the staples delivered from the splayed tips are released at a radially increased position relative to when the tips are not splayed.