CROSS REFERENCE TO RELATED APPLICATIONSThe present application is a divisional of copending U.S. patent application Ser. No. 10/037,899, filed Oct. 22, 2001, the entire contents of which are specifically incorporated herein by reference.[0001]
BACKGROUNDThe present disclosure relates to an instrument and a method for closing a hole or puncture in a blood vessel. More particularly, this disclosure relates to a handle assembly for a surgical instrument.[0002]
When performing catheterization procedures, such an angiography or angioplasty, a catheter is generally introduced into the vascular system by first penetrating the skin, underlying muscle tissue and blood vessel with a sharpened hollow needle. Next, a guide wire is commonly inserted through the lumen of the hollow needle and is caused to enter the selected blood vessel. Subsequently, the needle is typically slid off the guide wire and a combination of a dilator and an introducer (or an introducer alone) are fed over the guide wire and pushed through the skin to enter the vessel. The guide wire can then be removed and the desired catheter to carry out the procedure is fed through the lumen of the introducer and advanced through the vascular system until the working end of the catheter is appropriately positioned. Following the conclusion of the catheterization procedure, the working catheter will be withdrawn and, subsequently, the dilator and/or introducer will also be removed from the wound.[0003]
At this point in the procedure, the vessel leakage must be controlled in order to stem the flow of blood through the puncture. Because it is common practice to administer a blood thinning agent to the patient prior to many of the catheterization procedures, stemming the blood flow can be troublesome. A common method of sealing the wound is to maintain external pressure over the vessel until the puncture naturally seals. This method of puncture closure typically takes about thirty minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated. In some anti-coagulated patients, the introducer is left in place for hours to allow the anti-coagulant to wear off. When human hand pressure is utilized, it can be uncomfortable for the patient and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags or clamps, have been employed, but these devices also require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure their effectiveness.[0004]
Suture securing instruments are being developed to assist in finalizing the suturing procedure, however some of these instruments leave behind crimped securing members with sharp edges, or require a separate step to be performed to cut the suture material after the securing member has been crimped.[0005]
SUMMARYThe above discussed and other drawbacks and deficiencies are overcome or alleviated by a surgical instrument, such as a crimping and cutting device, including a trigger member and a safety button, wherein the trigger member is not activatable until the safety button is depressed.[0006]
The above-discussed and other features and advantages of the present invention will be appreciated and understood by those skilled in the art from the following detailed description and drawings.[0007]
BRIEF DESCRIPTION OF THE DRAWINGSReferring to the FIGURES wherein like elements are numbered alike in the several FIGURES:[0008]
FIG. 1 shows an exploded perspective view of the cutting and crimping device;[0009]
FIG. 2 shows a side plan view of an exterior of the handle assembly for the cutting and crimping device of FIG. 1;[0010]
FIG. 3 shows an interior plan view of a side of the handle assembly for the cutting and crimping device of FIG. 1;[0011]
FIG. 4 shows a proximal plan view of a side of the handle assembly for the cutting and crimping device of FIG. 1;[0012]
FIG. 5 shows a proximal plan view of another side of the handle assembly for the cutting and crimping device of FIG. 1;[0013]
FIG. 6 shows a partial cross-sectional view of the side of FIG. 4;[0014]
FIG. 7 shows a partial cross-sectional view of the side of FIG. 5 taken along line[0015]7-7 of FIG. 3;
FIG. 8 shows a side plan view of the trigger of the handle assembly for the cutting and crimping device of FIG. 1;[0016]
FIG. 9 shows a top plan view of the trigger of FIG. 8;[0017]
FIG. 10 shows proximal perspective view of the trigger of FIG. 8;[0018]
FIG. 11 shows a distal perspective view of the trigger of FIG. 8;[0019]
FIG. 12 shows a perspective view of the safety button of the handle assembly for the cutting and crimping device of FIG. 1;[0020]
FIG. 13 shows a cross-sectional view of the safety button of FIG. 12;[0021]
FIG. 14 shows a perspective view of the adjustment screw of the handle assembly for the cutting and crimping device of FIG. 1;[0022]
FIG. 15 shows a cross-sectional view of the adjustment screw of FIG. 14;[0023]
FIG. 16 shows a side plan view of the hammer element for the cutting and crimping device of FIG. 1;[0024]
FIG. 17 shows a perspective view of the hammer element of FIG. 16;[0025]
FIG. 18 shows a perspective view of the tip for the cutting and crimping device of FIG. 1;[0026]
FIG. 19 shows another perspective view of the tip of FIG. 18;[0027]
FIG. 20 shows a distal plan view of the tip of FIG. 18;[0028]
FIG. 21 shows a cross-sectional interior view of the tip of FIG. 18;[0029]
FIG. 22 shows a side plan view of the central rod, hammer element, and tip of the cutting and crimping device of FIG. 1;[0030]
FIG. 23 shows a side plan view of the central rod, hammer element, tip, and tubular portion of the cutting and crimping device of FIG. 1;[0031]
FIG. 24 shows a perspective view of a ferrule for use in the cutting and crimping device of FIG. 1;[0032]
FIG. 25 shows a side cross-sectional view of the ferrule of FIG. 24;[0033]
FIG. 26 shows a partial side cross-sectional view of the cutting and crimping device of FIG. 1 in an initial stage of securing suture material;[0034]
FIG. 27 shows a partial side cross-sectional view of the cutting and crimping device of FIG. 1 in an advanced stage of securing suture material;[0035]
FIG. 28 shows a partial side cross-sectional view of the cutting and crimping device of FIG. 1 in a further advanced stage of securing suture material;[0036]
FIG. 29 shows a partial side cross-sectional view of the cutting and crimping device of FIG. 1 in a final stage of securing suture material;[0037]
FIG. 30 shows a perspective view of one embodiment of a suture loading assembly;[0038]
FIG. 31 shows a side cross-sectional view of the suture loading assembly of FIG. 30;[0039]
FIG. 32 shows a front plan view of the suture loading assembly of FIG. 30;[0040]
FIG. 33 shows a side perspective view of a cap for use in the suture loading assembly of FIG. 30;[0041]
FIG. 34 shows a side perspective view of a body for use in the suture loading assembly of FIG. 30;[0042]
FIG. 35 shows a side perspective view of another embodiment of a suture loading assembly;[0043]
FIG. 36 shows a top plan view of the suture loading assembly of FIG. 35;[0044]
FIG. 37 shows a front plan view of the suture loading assembly of FIG. 35;[0045]
FIG. 38 shows a side cross-sectional view of the suture loading assembly of FIG. 35 taken along line[0046]38-38 within FIG. 37;
FIG. 39 shows a side perspective view of a half of another embodiment of a suture loading assembly; and,[0047]
FIG. 40 shows a side perspective view of another half of the suture loading assembly of FIG. 39.[0048]
DETAILED DESCRIPTIONReferring to FIG. 1, a crimping and cutting[0049]device10 is shown for applying a ferrule around suture material after it has been applied to body tissue by a suturing apparatus, or by any other suturing procedure in which suture material is used, in order to secure the suture.
In general,[0050]device10 preferably includes ahandle assembly12. The handle assembly may include first andsecond sides14,16 and atrigger member18 with an associatedspring20 for the trigger return. Thehandle assembly12 further preferably includes asafety button22 which is centrally biased bysprings24,26 and which must be depressed before trigger actuation will be permitted. Also preferably within thehandle assembly12 is anadjustment screw28 which facilitates ferrule loading by the manufacturer. The adjustment screw is connected to aproximal end32 of acentral rod30, which extends from adistal end13 of thehandle assembly12. Ahammer element34 is connected to thedistal end36 of thecentral rod30. Surrounding thecentral rod30 is atubular portion38 which also extends from adistal end13 of thehandle assembly12. Atip40 is secured to the proximal end of thetubular portion38. Positioned within thetip40 is aferrule42.
An[0051]exterior54 ofside16 ofhandle assembly12 is shown in FIG. 2 and FIG. 3 shows an interior56 ofside16, similar to that shown in FIG. 1. Thehandle assembly12 includes adistal end13 from which thecentral rod30 andtubular portion38 extend. Theside16 includes anopening44 through which a portion of thesafety button22 extends, as will be further described. Theside16, as with theside14, preferably includes abody portion46 and a graspingportion48. Thebody portion46 houses thesafety button22 and theadjustment screw28 and includes the connections for thecentral rod30,tubular portion38, andtrigger18. The graspingportion48, on the hand, preferably includes an ergonomically shaped grip for an operator. The graspingportion48 includes anoutward surface50 and aninward surface52. Theinward surface52 faces an inner surface of thetrigger18.
As shown in FIGS. 4 and 5, the[0052]interior56 ofside16 is shown to includeprotrusions58 which mate with corresponding shaped recesses (not shown) within the interior ofside14 during manufacture. Alternatively, theprotrusions58 could be located onside14 with recesses withininterior56, or some of theprotrusions58 could be located on bothsides14 and16 with corresponding recesses oppositely positioned onsides14 and16. When assembled, anexterior60 of theside14 and theexterior54 ofside16 preferably combine to form a smooth outer surface of thehandle assembly12 for gripping by the operator.
Turning now to FIGS. 6 and 7, a cross-section of the[0053]sides14 and16 is shown. Specifically, a cross-section ofside16 taken along line7-7 within FIG. 3 is shown in FIG. 7. A cross-section ofside14 taken along the same location, that is, through theopening44 forsafety button22, is shown in FIG. 6. Theopening44 extends from theexterior54 ofside16 to theexterior60 ofside14. Thus, the safety button, as will be further described below, is accessible from eitherside14 or16 of thehandle assembly12.
Turning now to FIGS.[0054]8-11, thetrigger18 is shown to include aninner surface62 which, when assembled within thehandle assembly12, faces theinward surface52 of thesides14 and16.Outer surface64 is preferably smooth for grasping by an operator. Thetrigger18 may includespring receiving member66 for receiving a hook21 (as shown in FIG. 1) of thespring20. As shown, thespring receiving member66 is an opening, although other shapes, such as a hook shape would be within the scope of this invention. With thehook21 of thespring20 engaged within thespring receiving member66 of thetrigger18 and a securing member19 (FIG. 1) ofspring20 securing thespring20 to aprotrusion58 onside16, thetrigger18 must expand thespring20 when theinner surface62 of thetrigger18 is compressed towards theinward surface52 of thesides14,16. Thespring20 thus biases thetrigger18 in an “open” or “unsqueezed” configuration. That is, after thetrigger18 is squeezed, thespring20 will return thetrigger18 to its original position when pressure on thetrigger18 is removed.
The[0055]trigger18 further preferably includes apivot rod68 for pivotally securing thetrigger18 within thehandle assembly12, such as within opening70 withininterior56 ofside16, as shown in FIG. 3. Thus, when thetrigger18 is squeezed, it will pivot about the longitudinal axis ofpivot rod68 located within thesides14,16.
The[0056]trigger18 further preferably includes a hook-shaped safetybutton engaging member70 which includes aninner receiving pocket72 which either hovers above or rests upon thesafety button22 or is received within one of the grooves of thesafety button22, as will be further described with reference to FIGS.12-13.
Turning now to FIGS.[0057]12-13, thesafety button22 preferably includes a pair ofpins74,76. Each of thepins74,76 include anengageable end78,80, respectively, which protrude through theopenings44 of thesides14,16 and are accessible by the operator. Surrounding thepins74,76, respectively, are thesprings24,26. Thesprings24,26 are seated within pockets45 (FIGS. 6 and 7) of theopenings44. Thepockets45 have a slightly larger diameter than the exteriormost openings44 such that thesprings24,26 received therein abut against awall43 within thepockets45. Thesafety button22 further preferably includes three ribs, shown collectively asribs82. Theribs82 include afirst side rib84, asecond side rib86, and amiddle rib88. Afirst side gap90 is created between thefirst side rib84 and themiddle rib88 and asecond side gap92 is created between thesecond side rib86 and themiddle rib88.
When assembled within the[0058]handle assembly12, thesafety button22 is preferably centrally located, and spring biased to be centrally located, within thehandle assembly12 such that the safetybutton engaging member70 of thetrigger18 abuts with themiddle rib88 when an attempt to squeeze thetrigger18 is made. However, when theengageable end78 of thesafety button22 is depressed by an operator, thesafety button22 moves within thehandle assembly12 such that the safetybutton engaging member70 of thetrigger18 will fall into thegap90. Thus, thetrigger18 is now free to be squeezed by the operator. Likewise, when theengageable end80 of thesafety button22 is depressed by an operator, thesafety button22 moves within thehandle assembly12 such that the safetybutton engaging member70 of thetrigger18 will fall into thegap92 freeing thetrigger18 to be moved by the operator. While the accessibility of thesafety button22 from eitherside14 or16 of thehandle assembly12 provides ease of use to the operator, it is within the scope of this invention to have the safety button accessible from only oneside14 or16 of thehandle assembly12, which would thus require only one gap and only one pair of ribs in thesafety button22. Pressing thesafety button22 will preferably allow the safetybutton engaging member70 to be retained between two adjacent ribs, i.e.ribs84 and88 orribs88 and86, but with enough space within eithergap90 or92 to allow movement of the safetybutton engaging member70 during a squeeze of thetrigger18. The purpose of thesafety button22 is to prevent unintentional accidental firing of thedevice10. Thus, preferably thesafety button22 is self-centering due tosprings24,26. After depressing thesafety button22 and releasing thetrigger18 for movement, and after thetrigger18 is squeezed and released by the operator, thesafety button22 will preferably return to its center position, re-locking thetrigger18 from movement. Preferably, thedevice10 is a one-time use instrument such that aferrule42 cannot be reloaded within the device.
Turning now to FIGS. 14 and 15, and as additionally shown in FIG. 1, the[0059]adjustment screw28 is shown which facilitates ferrule loading by the manufacturer. Theadjustment screw28 preferably includes adistal end94 and aproximal end96. Thedistal end94 may include a bulbous orlarger diametered head98. Theproximal end96 may include a slottedportion100. Ashaft102 preferably connects thedistal end94 to theproximal end96. Extending within the adjustscrew28 is alongitudinal bore104 which extends along thelongitudinal axis106. Thebore104 may have a smallerinner diameter103 within thehead98 than within theshaft102. As demonstrated in FIG. 1, theadjustment screw28 is connected to aproximal end32 of thecentral rod30, which extends from adistal end13 of thehandle assembly12. Theadjustment screw28 is preferably completely contained within thehandle assembly12 and is not accessible by the operator. During assembly, theadjustment screw28 accepts thesection31, preferably threaded, of theproximal end32 of thecentral rod30 so that the length of thecentral rod30 may be properly adjusted with respect to thetubular portion38. The smallerinner diameter103 is also preferably threaded such that theinner diameter103 may be threaded to mate with threads onsection31 ofrod30. Turning theadjustment screw28 after loading theferrule42 shortens therod30 and allows thedistal end108 of thehammer element34 to retain theferrule42 in theferrule accepting opening142 in thetip40. That is, the proper length of thecentral rod30 with respect to thetubular portion38 helps ensure that theferrule42 is retained within the distal end of thedevice10. Also, the ability to correct the length of thecentral rod30 using theadjustment screw28 eliminates the need to require very tight tolerances during manufacture of thecentral rod30, thus easing the manufacturing process of thedevice10.
Turning now to FIGS.[0060]16-17, thehammer element34 is shown. Thehammer element34 includes adistal end108 and aproximal end110. Thedistal end108 includes thehammer head112. Thehammer head112 preferably includes afirst camming surface114 which engages with a camming surface on thetip40 as will be further described. Thefirst camming surface114 is located on afirst side126 of thehammer element34. Thefirst camming surface114 and thefirst side126 form an obtuse angle as shown. Located on thesecond side128 of thehammer element34 is aferrule engaging edge116. Anindent118 may separate theferrule engaging edge116 and anedge120. Alternatively edge120 may be removed and replaced with a smooth continuous edge, continuous withsecond side128. Thehammer element34 includes acentral portion122 of a selected width which is smaller in width than aproximal portion124. The smaller width of thecentral portion122 allows movement of thehammer head112 within thetip40. Each of thefirst side126 andsecond side128 may comprise a series of planar surfaces as shown in FIG. 17, withplanar sides130 connecting the first andsecond sides126,128. Thus, thehammer element34 preferably comprises a rectangular cross-section. As shown in FIG. 1, theproximal end110 of thehammer element34 is mounted to thedistal end36 of thecentral rod30.
Turning now to FIGS.[0061]18-21,tip40 is shown in detail.Tip40 has adistal end132 and aproximal end134. Thedistal end132 includes a hammerhead receiving portion136 which includes a second camming surface138 (shown in FIG. 21), which abuts with thefirst camming surface114 of thehammer head34 during retraction of the hammer element within thedevice10. Thesecond camming surface138 forms part of a wall of theopening140 of thetip40. Theopening140 preferably extends the length of thetip40 and has a rectangular cross section (as shown in FIG. 18) throughout most of thetip40 for receiving the rectangularly shapedhammer element34. Thedistal end132 of thetip40 further includes aferrule accepting opening142 which shares open space with theopening140. Thus, the opening at thedistal end132, as shown in FIGS. 19 and 20 is generally key-hole shaped. Proximal theferrule accepting opening142 is acutting edge144 formed on an inner wall of thetip40 for cutting the suture material as will be further described below. Adjacent thecutting edge144 is anaperture146 within thetip40. Theaperture146 allows the suture material to be threaded through theferrule42 from thedistal end132 and exit theaperture146. Thetip40 preferably includes aproximal portion148 having a reduced width. Awall150 is formed between theproximal portion148 and the hammerhead receiving portion136.
Turning now to FIG. 22, the[0062]distal end36 ofcentral rod30 is shown welded to theproximal end110 of thehammer element34 atarea152.Notch154 is shown within therod30. Then, thetip40 is installed upon thehammer element34. Turning to FIG. 23, thetubular portion38 is shown welded or otherwise secured to thetip40 at or aboutarea156. Thetubular portion38 overlaps theproximal portion148 of thetip40 and abuts thewall150, so that preferably a smooth continual surface is provided between thetubular portion38 and thetip40.Notch158 withintubular portion38 coincides withnotch154 in thecentral rod30. An anti-rotation feature is provided using the alignednotches154,158 during assembly by placing a pin, such as a square pin, into the notch area, thus preventing therod30 from rotating within thetubular portion38.Longitudinal axis106, which also runs throughadjustment screw28, extends generally through thecentral rod30 andtubular portion38.
FIGS. 24 and 25 show an[0063]exemplary ferrule42 for use within thedevice10, and more particularly for placement within theferrule accepting opening142 of thetip40. Theferrule42 includes abore168 which extends the length of theferrule42.Ferrule42 preferably comprises an ovalizedouter surface164. Theinner surface166 of theferrule42 will contact the suture material upon compression, as will be described below. Theferrule42 preferably comprises chamfered ends160 and162. The ends may be angled as shown byend160 or more preferably rounded as shown byend160. Theferrule42 is preferably manufactured without burrs of any sort. The material selected forferrule42 is preferably annealed titanium, but may be formed from another deformable biocompatible material, such as another non-bioabsorbable material. Alternatively, theferrule42 may be formed from a bioabsorbable polymer.
FIGS.[0064]26-29 describe how thehammer element34 andtip40 cooperate to compress theferrule42, secure the suture threads therein, and cut the suture thread ends. Theferrule42 is shown positioned within theferrule accepting opening142 and thesuture threads170 have been threaded through theferrule42 and exit theaperture146 of thetip40. FIG. 26 shows thehammer head112 positioned within thetip40 such that thefirst camming surface114 abuts thesecond camming surface138. In this initial position, theferrule engaging edge116 may abut theferrule42 and provide a slight compression of theferrule42 for retaining theferrule42 within theferrule accepting opening142. Turning now to FIG. 27, as thehammer element34 is drawn in the direction indicated byarrow172, thehammer head112 draws thefirst camming surface114 along thesecond camming surface138. In doing so, thehammer head112 is brought closer to theferrule42 such that theferrule engaging edge116 begins to crimp or compress theferrule142. Turning to FIG. 28, with thehammer element34 continually drawn in the direction indicated byarrow172, thefirst camming surface114 is no longer in contact with thesecond camming surface138, but thefirst side126 abuts the inner surface of theopening140 withintip40 such that theferrule engaging edge116 continues to crimp theferrule42. As shown in FIG. 29, after thehammer element34 has been moved in the direction indicated byarrow172 to completely crimp theferrule42, theferrule engaging edge116 moves towards the cuttingedge144 of thetip40 until thesuture threads170 are trapped between thehammer head112 and thecutting edge144. A small amount of pressure from thehammer head112 upon thecutting edge144 will release the ends of thesuture threads170 as shown. Thus, theferrule42 is crimped and the suture ends are cut in one step. Additionally, thehammer element34 does not contain the cutting edge, and therefore there is no risk of providing sharp edges to theferrule42 which will remain in the suture location.
FIGS.[0065]30-34 show one embodiment of asuture loading assembly174 for assisting an operator in threading thesuture threads170 through theferrule42 after a suturing operation and before a suture securing operation. Thesuture loading assembly174 preferably includes abody176 from which extends aflexible loop178, preferably made fromsuture material186 or wire, such as stainless steel wire, and acap180. Thebody176, as shown in FIG. 34, includes adistal end182 from which theloop178 exits, and aproximal end184. Thebody176 further preferably includes a bore188 (FIG. 31) containing thesuture material186 from which theloop178 is formed. As further shown in FIG. 31, thebody176 further preferably comprises astep190 for abutting with a stoppingsurface192 within thecap180. Additionally, thebody176 further includes an attachingmember194, which may have a clip-like shape as shown with a pair oflegs196,198. Thelegs196 and198 preferably define arounded receiving pocket200 for receiving thetubular portion38.
Because of the small size of the[0066]tubular portion38, and thus thebody176, thesuture loading assembly174 further preferably includes thecap180 for easy grasping and operating by an operator. Thecap180 includesopenings202 and204 for receiving thebody176 and attachingmember194. Thecap180 further preferably includessides206 which haveindents208 for ease in grasping.
The[0067]suture loading assembly174 is preferably pre-assembled upon thedevice10 by the manufacturer. During assembly, thesuture loading assembly174 is preferably secured to thetubular portion38 by inserting thetubular portion38 into theopening204 of thecap180 and snapping the attachingmember194 onto thetubular portion38. The loop178 (which may be much longer than what is shown) may then be pushed into theopening146 in thetip40 and threaded through theferrule42 which is preloaded within thetip40. Thus, a portion of theloop178 will remain extended through theferrule42 and out thedistal end132 of thetip40. Alternatively, theloop178 could be threaded through theferrule42 in the manner described and then the suture loading assembly could be secured to thetubular portion38.
When a suturing operation has been completed, and it is time to utilize the crimping and cutting[0068]device10 for securing the suture, the ends of thesuture material170 may be simply threaded through the large opening provided in theloop178. Then, the operator may grasp thecap180, such as atindents208, and then the operator may pull thesuture loading assembly174 in a proximal direction, towards thehandle assembly12. In doing so, theloop178, which is flexible and collapsible, will pull thesuture material170 through theferrule42 and out theopening146 in thetip40. Because thesuture material170 is likely to be wet and slippery following the suture operation, the ability to thread thesuture material170 through theferrule42 using thesuture loading assembly174 eliminates any tedious operational steps.
Turning now to FIGS.[0069]35-38, another embodiment of a suture loading assembly is shown. Thesuture loading assembly250 is similar in use to thesuture loading assembly174, but embodies a slightly different design. Thesuture loading assembly250 includes awire loop252 made ofwire253, abody254, and aplug256. During assembly, ends258 ofwire loop252 may be trimmed atlocation260 after installingplug256 so that thewire loop252 ends flush with aproximal end262 of thebody254. Thewire loop252 preferably includes a tapereddistal end264, awidest portion266, and across-over portion268 where thewire253 crosses over itself prior to running parallel into thebody254.
The[0070]body254 includes a taperednose section270 having adistal end272 and anopening274. Theopening274 receives thewire253 of thewire loop252. As shown in FIG. 38, theopening274 leads to alongitudinal bore276 having amain bore280 with a first inner diameter, distaltapered section278 having a smaller inner diameter than the first inner diameter, and aproximal bore282 having a second inner diameter slightly larger than the first inner diameter, such that a stoppingsurface284 is provided within thebore276. During assembly, theplug256 is inserted into theproximal end262 of thebody254 for retaining thewire loop252 within thebody254.
The[0071]body254 further preferably includes an integral attachingmember286 which includes a pair of clip-like legs288 separated by aslot290 having arounded end292 for receiving thetubular portion38. Eachleg288 further preferably includes anindented area294 for ease in grasping.
As with the[0072]suture loading assembly174, thesuture loading assembly250 is preferably pre-assembled upon thedevice10 by the manufacturer. During assembly, thesuture loading assembly250 is preferably secured to thetubular portion38 by inserting thetubular portion38 into theslot290 and snapping the attachingmember286 onto thetubular portion38 with thetubular portion38 residing in therounded end292 of theslot290. Thewire loop252, which is sufficiently flexible, may be pushed into theopening146 in thetip40 and threaded through theferrule42 which is preloaded within thetip40. Thus, a portion of thewire loop252 will remain extended through theferrule42 and out thedistal end132 of thetip40. Preferably, thewire loop252 is preformed such that upon its exit through theferrule42, it will begin to open up automatically thus creating a stable opening, as opposed to suture material in which the opening may have to be created by separating the thread used in theloop178 in thesuture loading assembly174. Alternatively, thewire loop252 could be threaded through theferrule42 in the manner described and then thesuture loading assembly250 could be secured to thetubular portion38. The ends ofsuture material170 may be threaded through the large opening provided in thewire loop252, and the operator may grasp theindented areas294 and pull thesuture loading assembly252 in a proximal direction, towards the handle assembly, for pulling thesuture material170 through theferrule42 as previously described with the operation of thesuture loading assembly174.
FIGS. 39 and 40 show an alternate embodiment of a[0073]suture loading assembly210, where halves of thesuture loading assembly210 are depicted in FIGS.39-40. Looking at the suture loading assembly from a distal location, i.e. from thefunnel212, FIG. 40 shows aleft half214 and FIG. 39 depicts aright half216. The twohalves214,216 preferably snap onto the distal end of thedevice10 for threading of theferrule42. Thesuture material170 may be threaded through afunnel212 created by a joining of the twohalves214,216. Then, thethreads170 would go directly into theferrule42 after being pushed into thefunnel212. After theferrule42 is threaded, thewings218,220 may be squeezed together to release thesuture loading assembly210 from the distal end of thedevice10. Thus, with thesuture material170 threaded through theferrule42, thedevice10 may be inserted near the suture location (the area where the body was closed by the suture material170) to secure theferrule42 upon thesuture material170.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.[0074]