CA2119027C - Hemostatic implant introducer - Google Patents

Abstract

A puncture seal device (32) for stemming the flow of blood from a punctured bloo d vessel (150) comprises an elongated outer sheath (40) affixed to a generally tubular housing (30) where the housing contains a manually actuable slide (48) which is affixed to a rigid tubular pusher member (48) coaxially disposed within the oute r sheath. Also contained within the outer sheath in longitudinal alignment with the pusher and distally thereof is a ring-shaped plug of a hemostatic material (44). The assembly thus far described may be fitted over a tubular introducer or the body of a cath eter (18) and then advanced therealong until the distal end of the outer sheath is proximate a bleeding blood vessel. By actuatin g the pusher member, the hemostatic plug surrounding the introducer or catheter is ejected from the distal end of the outer sheath (4 2) and held in abutting relationship to the bleeding blood vessel.

Description

2 1 ~ ~ 0 2 7 PCI/US92/07676 'i : E' t ~ i Background of the Invention This i,-~rentiGn relate~ generally to a surgical instrument for use in inb.~ s~
catheterization prl~cedures, and more particularly to a device for positioning al.e..lashtic agent ~ainst a puncture entry wound in a blood vessel to stem the flow of 10 blood therefrom f_'laAr;.g rer..ov..l of the ~U.etar and catheter introducer at the conclusion of the proc~lure.
When performing angiography or angioplasty proc~ures, following the Seldinger technique, the angiography ~tl-eter or angioplasty ~tl.~ter is generally intro~lucsd into the vascular system by first employing a shL ,~ ened hollow needle to 15 penetrate the skin, the underlying muscle tissue, and to enter the s ~ ' E ted blood vessel .
Next, a guidewire is cG,--monly inserted through the lumen of the hollow needle and made to enter the s e'~cted blood vessel. Following that, the needle is ~t~ i~,ped off the 9~ and a combinaffon of a dilator and an introducer (or an introducer done) are fed over the 9~ ~ 'a~ and pushed through the skin until first the dilator and next the 20 introdùcer enter the 591E~.~I blood vessel. The guidewire may next be re...o~/ed, and the selected catheter for C~ y out the proc~lure is ted through the lumen of theintroducer and adv_nced throu5~h the vascular system until the u~ki"y end of thecPU,Jtcr is ~prvp-;stely posiffoned. Depending upon the p~,cadure, a dye may be injected through the catheter or a balloon a;~ahJ6d. rclla~..g the conclusion of the 25 catl.~le.i ._t;Gn proc~ure, the working catheter will be withdrawn and, s~'s~uently, the combination dilator and introducer will also be sbipped out of the wound.
use it is cG---,..on pr~_tice to administer a blood thinning agent to the patient prior to many of the pn~c~ures, a problem exists in stemming the flow of blood through the puncture wound made in the vein or artery. Typically, it is necssss- ~ to 30 maintain pressure over the region for at least 30 minutes. Even more time is required ff the patient is h~e- Iansh~u- or c,. ItiCo9-3,~ 'Qd. When human hand pressure is utilized, it is sGr.,~-.vl,at wasteful of professiol)al time. Devices, such as pressure Land6yes, sand bags or clamps may be employed, but for these devices to work, the patient must be compliant and IllotiGrlsss for this ,vrvlanged period. Also, with obese pdtient~, 35 be~ u;e of the signfficant amount of tissue bQtv ~en the skin and the ,c.enet~ded vessel, good h~,o~tatic pressure ~te,lti.-.es cannot be obtained above the penetlat~l artery or vein. Thus, a need exists for a means for =~e' ~li-,~ her"GsI~s.

CA 02ll9027 l998-04-07 In U.S Patents 4,852,568, 4,890,612 and 5,061,274 to Kenneth Kensey, a device and method is described for sealing puncture or incision wounds created percutaneously during a surgical procedure. In accordance with the teachings of the Kensey patents, a collagen plug having an anchoring mechanism in the form of a filament or string attached, is passed through the introducer following removal of the working catheter and is allowed to enter the blood vessel to be sealed. The introducer is then removed from the body and the string is tensioned until the collagen plug affixed to its end abuts the surgically-created opening in the blood vessel proximate its interior wall. When the collagen material is exposed to body fluids, it swells to create a block for the wound in the vessel wall while the collagen itself acts as a blood clotting agent and accelerates hemostasis.
Problems exist with the approach set out in the aforereferenced Kensey patents. More particularly, any intraluminal deposition of a collagen can result in embolization, especially as the material begins to reabsorb.
Part~icles may break off and float downstream to the point where they may lodge in a smaller vessel, causing an infarct to occur. Not only that, but collagen material acts as a nidus for platelet aggregation which assists in blood clotting. Hence, the intraluminal deposition of a hemostatic agent can initiate a thrombosis at the site.
Patents 4,838,280 and 4,936,835 to John R. Haaga teach the idea of incorporating a hemostatic material as a 2a part of a needle biopsy device so that following the gathering of the tissue sample, a hemostatic plug can be left in the void in the tissue from which the sample had been excised.
The collagen plug that is left behind serves as a hemostatic agent for more rapidly stemming blood flow from the point of injection of the biopsy needle.
Applicants are also aware of a product produced by Datascope Inc. of Montvale, New Jersey, and sold under the trademark "VASOSEAL". That device comprises a kit including a guidewire, a needle clip, a skin dilator, an outer syringe barrel, an inner plunger, and two cylinders of compressed collagen material. In carrying out the blood vessel sealing procedure using the VASOSEAL apparatus, two operators are required. Before the original puncture needle is removed, a clip is placed on the shaft of the needle at the skin level to mark the distance down to the artery. The needle and clip are then placed up against a card having graduations printed thereon and one of a plurality of device lengths are selected.
When the catheterization procedure is completed, all devices are removed except for a guidewire. One operator is needed to maintain compression upstream while another operator works on the puncture site. A skin dilator is advanced over the guidewire into the tissue to the measured level. A syringe barrel is then advanced over the skin dilator to the same measured level. The dilator and the guidewire are then removed. Next, a plunger is loaded with one of the two plugs of collagen and this is inserted into the syringe barrel and advanced down into the wound. The plunger is removed and reloaded with a second collagen plug and this, too, is inserted down into the syringe barrel into the wound. The main operator now takes over the job of 10 applying a compression force over the area and holds the spot for several minutes. When no bleed-back or hematoma growth is seen, the operator removes the syringe and plunger.
It is accordingly a principal object of the present invention to provide an improved apparatus for effecting hemostasis in the course of a surgical procedure.
Summary of the Invention The invention provides a surgical instrument for delivering a hemostatic substance subcutaneously against a penetration site in a wall of a blood vessel in the course of a surgical procedure in which an incision is made 20 through the blood vessel and a tubular body is passed through said incision into said blood vessel, characterized by: (a) an outer tubular sheath member having a proximal end, a distal end and a lumen extending therebetween, the diameter of said lumen being of a predetermined size greater than that of said tubular body and adapted to allow said tubular body to pass coaxially therethrough; (b) a first annular mass of a hemostatic material, said mass having a proximal and a distal edge surface and initially being contained within said outer tubular sheath member proximate said distal end thereof and adapted to coaxially surround said tubular body; (c) an inner tubular member reciprocally movable relative to said outer tubular sheath member and within said lumen of said outer tubular sheath member, said inner tubular member being concentrically disposed relative to said outer tubular sheath member and having a wall thickness for engaging said proximal edge surface of said mass; and (d) means advancing said inner tubular member in engagement with said mass for exposing said mass exteriorly of said 10 lumen with said distal end against the exterior wall of said blood vessel at said penetration site.
The term "tubular member", as used in the context of this invention, is intended to broadly describe any one of a dilator, an introducer, a catheter or even a guidewire, even though it is recognized that a guidewire may not have a lumen .
The means for ejecting the hemostatic mass preferably in the inner tubular member that surrounds the inner tubular body and is contained within the lumen of the outer tubular sheath. A housing is affixed to the proximal end of the outer sheath and a slide, coupled to the pusher, is contained in the housing. In 20 one embodiment, a protruding thumb pad is provided for applying a moving force to the slide. In another, a rack and pinion mechanism is employed to move the pusher relative to the hemostatic mass. By advancing the pusher in the distal direction, its distal end engages the coaxial disposed hemostatic mass and is used to force it outward of the lumen of the tubular sheath member so that it will abut ,~ 64680-729 the penetration site in the wall of the blood vessel.
In a modified arrangement, the hemostatic mass is annular in shape and is housed within an outer tubular sheath proximate to the distal end of the sheath. The pusher is also tubular and has its distal end abutting the proximal end surface of the hemostatic mass within the outer sheath. The proximal end of the pusher extends beyond the proximal end of the outer sheath. In use, the instrument is threaded over the tubular member and its distal end is made to abut the exterior wall of the punctured blood vessel. To deploy the hemostatic mass, the pusher is held stationary while the outer sheath is pulled rearward, uncovering 10 the mass. Then, the entire instrument can be stripped back off of the tubular member. To avoid accidental, premature ejection of the hemostatic mass, a suitable locking arrangement is used to couple the pusher - 4a -A

WO 93/08740 PCI'/US92/07676 to the outer sheath to preverlt relative movement between these two parts until the lock is l~'s--~d.
In aeeordance with afurther modffled embodiment, the eoaxially disposed mass, as well as the tubular sheath, the tubular pusher and the housing SU,~JpGI ti. .9 the sheath 5 and pusher are longitudinally slit to allow the unit to be assembled onto the exterior of a tubular body from the side rather than using a eoaxial ~pproach.
The hen.o~latie mass may eol..p.ise a freeze-dried eollagen, a eellulose gel material, sueh as a GEUOAM~, a resorbable lactide/glycolide or other resGILable substanee whieh by virtue of its cl)em;~l properties or its lattiee eonstruetion fiJi)~;tiol)s 10 as a l.einGslatie agent. It is preforrned so as to m within the eonfines of the tubular sheath mer.lb~ in surrounding or eoaxial relationship to the first tubulam..an~l er, but when deployed out through the distal end of the tubular sheath rnemL,er, will expand when eontaeting bodyfluids to form a pred~ftel,-lined shape eonfiguration. The annular eollagen plug is preferably a eGr"posite whieh is preforrned to exhibit a distal, vessel 15 puneture-contaeting end that is highly l.e...Gst~tic and a pro~...al region that is highly self-expanding. When released from the eonfines of the puneture sealing device (PSD), it sweJls to bloek the wound and to maintain itself in position Brief DeseriDtion of the Drawinas A better understanding of the inv_ntiGri will be had by a reading of the f..llew,i..g 20 ddailed deseription of the preferred embodiment, espeeially when cons i~ ~l in eonjunction with the aCCGI . ~pu)yin9 drawings in which like numerals in the several views refer to eGu~sponJing parts.
Fgure 1 is a longitudinal eross-secffonal view illustraffng the eonstruction of a first preferred embodiment of a puneture sealing deviee;
Figure 2 is an enlarged, puffal view of the distal end portion of the puncture sealing deviee of Figure 1.;
Fgures 3A, 3B, 3C are enlarged, partial eross se~tional views of the distal end portion of the puncture sealing device having modified sheath configurations;
Figure 4 is a bottom view of the puncture sealing device of Figure 1, but modified in accGrdance with a second embodiment;
Figure 5 is a p~sp~ti~e view of a hel..Gslalic mass to be used with the embodiment of Figure 4;

21~ 2~
WO 93/08740 PCI/US92/0767f Figure 6 is a side s~ticinal view of the puncture sealing device in accGrdance with a third embodiment;
Figure 7 is a side sectional view of the puncture sealing device in accor~Jance with a fourth embodiment;
5Figures 8A, 8B and 8C are ~r-p~t;J~ views of the device of the pr~sent invention helpful in understandin~a the method of use thereof.
Figure 9 is an enlarged view of an altemative design for a puncture sealing device in nccordance with the ir.v_.,ti~n; and Figure 10 is an enlarged view of yet ~U.ar altemative design for a puncture 10sealing device in accordanca with the invention.
Detailed Deseription of the l~ ntiGn In describing the eons~uction and mode of operation of the present invention, it will be considered as being used in conn~tiGr, with the conduct of the Seldinger proo~lure for introdudng a catheter into the lumen of a blood vessel. It is to be 15 uderatood, h~v,-_~ar, that the invention may also be utilized in other surgical proceJures, such as bpar.sxF.~ or other endosc~pic proc~Jures, wherein a tubularworking instrument is routed through the lumen of a tube and where penetration of a blood vessel, such as a vein or a tery, is likely to be encountered. Having descriL.ed the pr~sellt invention in eom)~tiGn with the Seldinger p,oc6Jure, those skilled in the 20art will readily appredate howthe device and ,,.aUIGd may be employed in otherrelated proc~lures.
Referring now to Figure 1, there is shown a per~pective view of the puncture sealing device (PSD) in accGnJ&nea with a first embodiment of the pr~ao~ invention deployed on the converltiGnal apparatus used in introducing a working eatheter into the 25 lumen of a blood vessel, such as the f~-or~l artery. More particularly, as those skilled in the art appre~,iate, a hollow needle (not shown) having a sh&~,enacl distal end and graduated mc.ki..~s along its len~th is first pushed through the dermal layer and is made to enter the lumen of the l~mGrJ artery through a puncture wound cre~ted bythe needle in the wall of that artery. The depth of the artery can be n~sessed by noting 30 the ~-l~hillgs on the needle at the point where blood is first exiting the needle. Next, a g~id~.v: e, idenffled by numeral 10, is i..se,leJ through the hollow needle into the artery and adv~nced a pr~t6,..lined di~t~ce therein. The hollow needle is then st~i~Jped off the pru3ti.,-&1 end of the guidewire 10, and a dilator 12 may then slipped WO 93/08740 2 1 1 g O ~ 7 PCI/US92/07676 U.e~ c.,g in the disW direction until its hpered distal end 14 is made to enter the wound, enlarging it to the point where the distal end 16 of a tubular introducer 18 may also be made to enter the lumen of the s~e ~d blood vessel without crv~ti"g a tear.
The s~pe~ pJI~ ~Dns b~n the guidewire and the distal end of the dilator 5 and between the dilator and the distal end of the introducer, upon ent~ i. .9 the opening in the blood vessel creates a n.tic~hle tactile respGnse to the op~ator. For reasons which will LecG...e more apparerlt when the ..-~U-GJ of operdion is discussecl, instead of having graduated ~"~bi,.g~ on the puncture needle, the dilator 12 may have grAdua~l measu.~,..er,ts or ~--~kil-gs on the exterior thereof as identified by numeral 10 15 in Figure 1. When the distal end 14 of the dilator 12 enters the blood vessel, the tactile indicstion prov.d~ to the surgeon alerts him or her to glance at the portion of the dilator ~~x~-06~l above the skin to obtain a coarse estimate as to the distance beneath the skin at which the openinçl in the blood vessel is locsted.
Referring still to Figure 1 and the longitudinal cr~ss s~ 'icnal view of Figure 2, 15 the pr~xi..-al end 13 of the dilator 12 has a ~-01~8d plastic hub 20 affixed thereto, the hub having a tapared distal nose portion ~ U.ereon. A longitudinal bore 24 u.~tel.Js through the hub to allow the guidewire 10 to pass. Likewise, the ploxi",al end 17 of the tubular introducer 18 is secured within a socket formed in a molded plastic hub m~.,ber 26. The hub has a t~r~d bore 28 in its proxi"-al end for ~ecehri,.g the 20 hperad nose ~ of the dilator, thus allowing the two parts to be releasably locked or joined relative to one ~n.U.er. Those skilled in the art will also appreciate that other known locking mech~)isms can be i,.cG,~Gr~,ted on the PSD for r~'E---hly clamping that device to the tubular support (introducer, catheter, guidewire) which the PSD
surrounds. For example, the cGmmonly used Touhy Borst clamp may be configured 25 on the pruxi...al end 34 of the PSD whereby simple r~t~tiGn of a knob will lock or unlock the PSD to the tubular body 12 depending on the direction of rotation.
As can be seen from Figures 1 and 2, the 9~ ~e~r.e 10, dilator 12 and introducer 18 are coaxially ~"sFss~ relative to one anotl.er and extend through a housing ..-er.lber 30 which forms a part of the PSD indicated generally by numeral 32.
30 The housing 30 has a pro~i,.,al end 34 having an opening formed U.el~tl,rough for ~ecaiv;"g the tubular introducer 18. Also forrning a part of the housing is a distal end cap 36. The tubular sheath or barrel me,nber 40, like the dilator 12, is provided with graduated m~ki,~ys, as at 41, which perrnit the surgeon to insert the distal end of the 211~027 WO 93/08740 PCI'/US92/07676 sheath to a prer, .e~sured depth below the skin. As shown in Figure 2 the proxi" ,&l end 38 of a tubular sheath ."ember 40 is fitted into the end cap 36 and is adl,~sivGly bond~ or otllen~ 8 fixedly attached to the end cap 36. The inside diameter of the plastic sheath 40 is sized to provide a ~,reJete""ined clearance between it and the 5 outer surface of the introducer 18.
Contained within this dc~h~ space and proximate the distal end 42 of the sheath 40 are one or more pieces 44 of a suitable h~"o~tatic material which are preforrned to assume a coaxial disposition relative to the introducer 18 or other 'tubular " ,~rnbe. ~ as that term was earlier defined at page 5, supra. The material may be freeze-10 dried collagen, a cellulose gel, a reso,Lable polyglycolic acid comrG~iticn or anysuitable l~sG-Lable substance which, by virtue of its chemical cGm; osition or of its latUce construction, acts as a hemostaUc agent. The mass 44 partially or fully surrounds and fits snugly a~3ainst the outer diameter of the tubular introducer 18, within the confines of the sheath 40 where it remains generally isolated from conh_t with 15 blood and other body fluids unffl deployed. By virtue of being in a cG",pressed state untibd?FlDyeJ, it is pr~/_nt~l from prer"Pturely le&_ti"g with blood.
A longitudinal slot 46 is formed through the housing 30 allowing a thumb-opa.at~ slide r-~JnL,ly 48 to pass lhe,~l,rough. The slide ~sser"bly includes a thumb pad 50 which is ~.t~c~ed to a slide l"_..lber 52 contained within the housing 30.
20 The slide 52 includes a bore 54 through which the tubular introducer 18 may pass. The pr~,A...,~J end 56 of a generdly rigid tubular pusher 58 is affixed to the slide 52 and, thus, is movable therewith. The distal end 60 of the tubular pusher is n~ ted to~)~~&9a the pr~.u...~l edge surface of the coaxblly disposed l,e..,G~latic mass 44 when the slide is moved in the distal direction (to the right in Figure 2).
A locking pin is shown as pass;"y transversely through an aperture 62 across the slot 46 prevents inadverterit movement of the thumb slide assar"bly 48 and prer.,dture ejecffon of the llehlG~htic plug. Altemative locking ~,~nge",er,ts are also envisioned, including placing a downwudly extending bub or latch on the proA;" ,al end of thumb pad 50 which cooperdtes with the pro~i",al end 34 of housing 30 to prevent movement of the slide until the barb or latch is il It6l ItiGnally r~ - - ed. Those skilled in the art will r~cGy-.i~e that other ~safety~ devices can be used to prevent unintended deployment of the l~elllGaldtic material from the barrel or sheath 40.

WO 93/08740 2 ~ 1 ~ 0 2 7 PCI'/US92/07676 As is illustrated in Figures 2 and 3A, the distal end portion 42 ot the outer tubular sheath 40 may be rounded or bullet-shapecl and ap~,ni~,iately slX to more readily permit the coaxL plug(s) 44 (45) to be ejected out from the nose 42 of the sheath 40 upon actudion of the slide assembly 48 to which the tubular pusher 58 is 5 affixed. Figures 3B and 3C illustrate that the distw end ot the tubular sheath 40 may be blunt or bev~ ed and also that the l.er"o~staUc material, as at 44, may be preshaped into a desired configuraUon, with Figure 3B show:ng a somewhat mushr~Gm-shaped w Iwny6lll6l It and Figure 3C sl)c~ ~y a beveled shape. A beveled Up on the distal end of the outer tubuLr sheath assists in cutting its way through the skin and subdural 10 Ussue in ~>pruaching the punctured blood vessel.
~ t is wso possible to preform the he,nGstaUc mass in other forms, including, for example, as a helix or a woven or braided structure, the prime requirement being that it can be coaxLly dispos6-l about a tubular ",er"bar as previously expLned. Upon~os ~e to body fluids upon release thereof from the sheath, the mass will swell to 15 define a pr, '~tormined sh~pe, e.g., rounded, blunt, frusto-conical, bev~ ~: or mushr~.o,...
In the wlw~)ge~ t shown in Figures 1 and 2, the device for placing the plug of l.er"oA~tic ,n~ter;w against the exterior wall of a blood vessel at a point of puncture entry must be assembled onto the introducer and dilator before the ~sser,lbly is20 Un~:d~l onto the guidewire. In the ~.ar,yer"anl shown in Figure 4, the plug pla~",~"t instrument 32 is Jasiy"~1 so that H can be placed onto the body of atubulu ",er"ber at a time just prior to when the surgeon wishes to inject the I ,er, IGst~tic plug.
More particularly, Figure 4 is a bottom view of the instrument, i.e., the side thereof which is opposite to the thumb rest rner,lber 50. It can be seen that in the embodiment 25 of Fgure 4, a longitudinal slit 64 is formed through the walls of the tubular sheath 40, the tubular pusher 58, the housing 30 and the slide 52. Funl,e""Gre, as shown inFigure 5 the her"Gslatic mass 44 used ~nth the embodiment of Figure 4 is generally G~haped having a slot 66 formed through its wall and communicating with the central opening 68 thereof. By providing the slots 64 and 66 in the respe-ti~e pieces 30 ",e"tiGned, the device of Figure 4, loaded with one or more pieces of pr~shaped herllG~ldtic r"dte,ial 44, may be asser"bled onto a tubulu ".e".ber such as an introducer, a working catheter used with an endoscGpe or other similar device bymerely slipping it onto the tubular ~"~",ber from the side with the tubular mer"berfitting 2~U27 WO 93/08740 PCl-/US92/0767-into the respe.,tive slots 64 and 66. This may prove more advart~gsouc than an over-the-wire installation of the loaded PSD.
Referring now to Figure 6, there hs shown a further alternative embodiment of a PSD in accGrdence with the teachings of the pres~.lt invention. In this view, the 5 device is shown in longitudinal u~ss 6~tion but does not include the coaxial a,~ny~r..~nt of a guidewire, dilator and introducer as in the ~-~ger.,~l~ shown in Figures 1 and 2. It is to be und~DtoGd, however, that the device of Flgure 6 is intended to be assembled on to a tubular member, either using an endwise over-the-wire opproa~) or A side ~proLch as with the earlier described embodiment. The PSD
10 is indicated generally by numeral 70 and is seen to include a m~'~sd handle ...~ ber 72, preferably formed *om a medical-grade plastic. The handle 72 includes a longitudinal bore 74 in which is mted the prv,u,..eJ end of a tubular outer sheath or barrel me. . ~r 76. Contained within the lumen of the sheath 76 near its distal end 78 is a mass of l-~llo~t~tic material 80 which is preshaped so that it can assume a coaxial 15 relationship relative to a cylindrical tube or wire with which the PSD is to be used. Also ' F: s s ~ within the sheath or barrel 76 is a tubular pusher 82 which extends into and is slidingly r~a3hred within the bore 74 in the handle 72. Integrally molded with or ~U .~r~s 8 formed on the exterior surface of the tubular pusher 82 near its pro~,nal end is a gear rack 84 which is dimensioned to m within a key-way 86 extending radially 20 outward from the bore 74. Extending inwardly from the surface 88 of the molded handle 72 is a recess 90 having a generally circular profile. Fitting into the recess 90 and joumaled for rotation about a pin or axis 92 is a pinion gear 94 whose teetheng~e the rack 84.
It is apparent from Figure 6 that by rotating the pinion gear 94 about its axis 92, 25 the pusher ,..~ ber 82 can be effler adv- nc6d in the disW direction or r~ ted therefrom. In the view of Figure 6, the tubular pusher 82 is shown in its fully r~t~ ted position, its disW end 96 being slightly proxJ...~I of the pro~.,.al end edge of the mass of h6rllG~tdtic material 82. By simply rotating the pinion 94 in a counterclockwise direction (when viewed as in Figure 6), the pusher ...e..lber 82 will be advanced in the 30 distal direction and will force the h6r..G~t~lic mass 80 out from the disW end 78 of the outer sheath or barrel 76.
Figure 7 ' sclosss still an~U,Qr embodiment of the puncture sealing device of the pr~s~, n invention. That device is indicated generally by numeral 100 and it, too, is WO 93/08740 2 1 1 ~ 0 2 ~ PCI/US92/07676 pictured without being mounted on a tubular member, such as a ~l~ a~r.e, dilator, introducer, ~tl-~t~, etc. It includes a mol ~d plastic handle 102 su,uporti.,y an outer tubular sheath or barrel 104 which projects longitudinally outward from the distal end 106 of the handle. As with the other embodiments, there is ~i posecl near the distal end of the barrel 104, a mass of her"osl~tic material 108 which is preformed so as to be coaxially placeable about a tubular ".e,nber.
Slidably r~ived within the barrel 104 is a tubular pusher "~ernber 110, having its distal end 112 abutting or in closdy spaced relationship to the pr~.u,nal end of the her"ostatic mass 108. The pusher ",e",bar extends rearward into the handle 102 through a longitudinal bore 114 formed therein. nisposecl between the pl~".i",al end 116 of the tubular pusher 110 and an insert 118 fitted into the proxi" ,&l end 120 of the handle 102 is a cG"lpr~ssion spring 122. P,.j~ing radially outward from the exterior surfaoe of the pusher r"ernber 110 are first and secor,J stop ~ lbels~ 124 and 126.
These stop m~r~lb6l~ fit into a guideway 128 formed inwardly of the handle from the bore 114. At the distal end of the guideway 128 is a wall surface 130 which coope, -les with the stop 126 to end the distal ",over"e,lt of the tubular pusher 110.
An arcuab recess 132 is formed in the handle and fitted into that recess is a m~ plastic trigger 134 which is pivoted about a pin 136 to permit limited rot~iGn thereof.
The puncture sealing device 100 is in its cocked position when the spring 122 is co",press6d between the insert 118 and the prox;",al end 116 of the pusher, as illustrated. It is held in this position by the enga ~ori,erlt of a finger pr.,js~ticn 137 on the trigger with the stop 124. A cGmpre~sion spring 138 cooper~ti.,y between thehandle 102 and the trigger 134 resists cou,n~clochr/ise rotation of the trigger 134.
1 b/~ Jor, when the surgeon pulls back on the upwardly protruding end of the trigger 134, it cG",presses the spring 138 and rotates the finger 137 out of cGr,ta 1 with the stop 124, ~ n~a the spring 122 to move the tubular pusher 110 in the disW direction to thereby eject the mass of l,er"o~l~tic ~"dterial 108 out the distal end of the tubular sheath 104.
While each of the embodiments of the invention di~clos~J thus far expose the h61llG~latiC n,~te.ial by eje_tilly same out of the distal end of a tubular sheath or barrel by the action of a movable pusher ,ne",ber, the hemosl~tic r"~te,ial may also bee~l-osed by holding the tubular pusher sl~liGnc;r~ and rJt,~_ti,.g the outer barrel or 211~027 WO 93/08740 PCI'/US92/0767 sheath in a pro3~i..,al direction. In this regard, reference is made to Figure 9 which shows a top elevation view of a PSD device of the latter type. The device is indicated generally by numeral 158 and it is seen to include an outer sheath 160 having its proAi,.,al end 162 ~ALcl-ed to a hub 164. This hub is surrounded by a rotatable collar 5 166 having an integrally formed knob 168 II-er~ol- to fadlitate its rotdtiGn. The collar 166 includes a helical thread groove 170 in its outer surface with the knob being joumaled for rotation on the hub 164. The he"-.GDtatic mass is identified by numeral 172 in Flgure 9 and it is shown as being contained within the confines of the outer sheath 160 near its distal end 163. The disW end 163 is preferably slit so as to be 10 expansible, thereby allowing the instrument to be used with tubular supports of dHfering French ske. Also contained within the tubular sheath 160 is a tubular pusher 174having ~ lumen 176 coaxially aligned with a central bore 178 formed longitudinally through the hemostatic m~ 172. A wing-shap~l fin~~ery-i~ r-~.~bel 180 has a longitudinal bore 182 ~;-.9 through it of a size to loosely surround the O.D.- of the 15 tubular sheath 160. The finy~y~ .ner,lber 180 is dl~ched by means of a pin (not shown) which p~ses through the longitudinal slH 184 formed through the wall of the outer tubular sheath 160.
ng longitudinally from the pr~".al side of the finge.y.i~, menlber 180 is a narrow arm 186 which terminates in a radially extending finger 188. The finger 188 20 is ~.~g~J to ride in the helical groove or thread 170. It normally latches the fingary.i~s 180 and its attached pusher n.6r.1ber 174 relative to the knob 168 which is operatively coupled to the outer sleeve 160.
To deploythe hemostatic mass, the surgeon will first grip the finyeryl~ "ember 180 with his index finger and forefinger of one hand while at the same time rotating the 25 knob 166 in the direction ,~res~.tad by arrow 190. In doing so, the finger 188 will follow the helical groove 170 as the hub 164 moves in the direction of arrow 192. Once the finger 188 clears the helical groove 170, the surgeon may, by holding the finyeryl i~
stationary and r~ ti"g the knob 168 in the pr~xi..,al direction, withdraw the sheath 160 from its covering relation relative to the hemo-htic mass 172. The sheath may also 30 be formed with an uv_.ti,.g distal end which can be made to roll back proAi",ally to expose the h~hllG~lstic mass surrounding the coaxially disposed tubular "-en-ber.
Moreover, it is envisioned that once the mass of her..os.lat;c n.at6,i&1 has been approp,iately pG5itiGI ,ed relative to the puncture to be sealed by adv_nc;n g it within the W0 93/08740 ~ 7 PCI'/US92/07676 _1~

confines of its tubular sheath, it may be . ~ 2 S E ~ to blood and body fluids by providing a peel-away sheath not unlike the sheath a.--ny~---e-lt disclosed in the U.S. Patent 4,166,469 to littleford.
Flgure 10 is an enlarged view of yet uiotl.er implementation of the preferred 5 embodiment of the pr~ent invention. It, too, includes an outer tubular sheath 200 formed from a suitable medical çlrade phstic and which has a somewhat bullet-shaped distal end 202 and a pruxJ..~I end 204 which is suitably bonded to an inner tubular hub 206 so as to move with it. The inner hub 206 has a shoulder 208 cooperating with an annular recess fûrmed in a rotatable knob 210. The knob 210 includes external II .r~ads 10 212 cooperating with mating thread yl.OV65 formed into the inner cylindrical wall of an outer hub ...e~ ber 214.
Disposed within the lumen of the outer sheath 200 is a tubular pusher 216 which is coupled to the outer hub member 214 by means of pins as at 218 and 220.
Positi~neJ be~or.d the distal end ~2~ of the tubular pusher 216 is a tubular mass of 15 hemG~tatic material 224, preferably collagen. The diameter of the lumen 226 of the pusher ~--~-,bar 216 and of the hemostatic mass 224 allows the asser.~bly to fit over a fur~er structure, such as a guidewire, an introducer, or a catheter body, all aspreviously Jes~iL~. The distal end of the outer sheath 200 is taper~J to a reduced diameter and J~iy~ .ed to cooperate with the O.D. of the device with which the PSD is 20 Jesiy~ .eJ to cooperate. That is to say, the outer sheath 200 is adapted to eny~ ~e the O.D. of the device with which it is used at its distal end to thereby create a seal preventing the premature ingress of body fluids that might react with the collagen plug 224.
To fire the device of Figure 10, the user grips the outer hub 214 while r~t~ti..g 25 the knob 210 in the cou-ntn~,lG~is~ direction. As the knob 210 UIlSCl~Ji_ from outer hub 214, it r~ ~_t~ the inner hub 206 with it due to the engag~ . ~eut of the shoulder 208 with the annular recess of the knob 210. Hence, the inner hub 206 and the sheathatl~ol.ed to it are also ~ _tad in the pro~...al direction. The outer sheath may be slit so that the sheath may glide past the pins 218 and 220, but preferably, the sheath is 30 desiy..ed so that it will readily split as it is drawn over the pins. By so designing the outer sheath, it eliminates the risk of blood leakage through pr~'~ ....eJ slits, such as shown in the embodiment of Figure 9.

211~02~

wound and the PSD can be l~lloved, leaving the hen,ost~tic mass in place. That mass quickly reacts with blood and other body fluids to swell closed so as to act as an effective block to the leakage of blood of the puncture wound.
Referring next to Figures 8A through 8C, the mode of use of the PSD of Figure 1 of the prese.lt invention will be explained. The opar~t;Gn and use of the other embodiments shown in Figures 6, 7, 9 and 10 will also be readily u, Ideratood. Prior to the stage of the pr~lure r~pre~e lt~d by Figure 8A, a standard percutaneous technique of inserting an angioy,~h c needle into the 6e'~ hd blood vessel 150 has already been accG",plished and the guidewire 10 is shown as having been ins6lted10 through the needle (not shown) and gently adv~ced to a J~si,~l depth within the ves~el. rcu~ that, the percutaneous needle is carefully slipped off the guidewire at its pro~...d end while the g~id~v~ being held in place. At this point, the dilator 12 will have been i..s~t~ completely into the lumen of the introducer 14. Fo'l~v~!.lg that, and in accor.Jance with the embodiment of Figure 1, the dilator/;.lt.~,Jucer combination are insel ~eJ completely into the PSD indicated by numeral 32.
As is illustrated in Figures 8A through 8C, there is extending out from the hub 26 of the introducer 14 ~ flushing line 152, which is n~ pted to be coupled via a stopcock154, to a suitable liquid supply. At this point, the asse..lt~ly is inverted and flushed with hep&.i-.i~ed or ul~hep~i--ked saline solution so as to lemove b~"p~l air.
20 Once the purge of air has been completed, the stopcQck 154is closed.
The open tip of the dilator and the accor"p~)~. ,g introducer and PSD are now slipped onto the plo3~.",&1 end of the guidewire and fed over it to the point where the distal end of the dilator er,gages the blood vessel to be ern~red and a tactile l'~pGI ,se will be felt. The surgeon will by now have read the depth ".~hil-ys on either the percutaneous needle or the dilator and will make a mental note of same. Figure 8A is at a stage where the tip of the tubular introducer 18 penetrates through the skin layer 156. Byyl~Fily the introducer near its distal tip end and close to the skin surface and while using a rotary motion, the dilator 12 and introducer 18 are made to pass along the 9~ ~ ~e ~ and through the tissues so that they are each positioned within the lumen 30 of the blood vessel as illustrated. The introducer sheath may now be further advaoced to a desired positior, within the blood vessel.
Now, by yl ~F iny the PSD 32 near its distal ffp end 42 close to the skin surface and using a rotary moUon, the PSD is adv--nced dong the introducer in the distal 21~027 direction and through the skin layer 156 until the distal end of the PSD is tacitly determined to be up against the outside of the vessel wall at the puncture sight. The scale " ,c hil ~gs on the sheath can be used to measure off the distance previously noted when the dilator was first inserted helping to confirm the des;,~l placement of the distal 5 end of the sheath. See Figure 8B.
Holding the introducer sheath and the puncture seal device in place by installing a suture through the suture loop 37 on the handle 30 and through the patienrs skin or other ~ppr~,p,;~t~, means, the surgeon now withdraws the gu 'aw!.e and the dilator, v.' ,ereby a working catheter can now be inserted through the lumen of the introducer 10 and the catheterization proce~ure can be completed using ~landar J techniques.
Following the conclusion of the wth~t~i~Uon pr~Jure, the surgeon will again confirm that the position of the tip of the PSD 32 and lhel~lcre the yet unreleased h6mGal~tic material is up against the outside of the vessel wall at the puncture sight.
Once that has been done, all of the d3~rcas, e.g., the v/_. ki- -y wtl .~ter and g~ e v:. e, 15 are removed from the introducer 18 and the locking pin 62 or other ~safety- device is re~eased. The slide 52 is adv- n~d in the distal direcUon by ~ply;, .9 thumb pressure to the thumb pad 50 as the handle and dLched tubular sheath of the PSD are pulled back a corresponding amount. The he--.G~tic mass bocGm--s fully deployed by n~,.y the slide forward until the mass is ejected from the split disW end of the20 tubular sheath 40. While cGmpress;, ~y the tissue around the puncture sight at the tip end of the PSD and holding it in position, the introducer 18 is now ler,.oJed from the pro~".al end of the PSD. After a short delay, and while keeping the tissue cGI"pressed around the puncture site, the PSD sheath 40 is removed leaving the l.e...o~ tic seal 44 behind (Flgure 8C). Manual pressure is mainWned on the pùncture sight for 25 ~pprox....atelyfive minutes at which point it is relieved and an observation made as to v.heU.er the flow of blood has c6~
The above pn,cedure may be 4~propr;~tely modified when the PSD shown in the embodiment of Figure 4 is ernFlDyed. In particulu, the guidewire, dilator and introducer sheath may be made to enter the lumen of the blood vessel before the PSD
30 32 of Figure 4 is coupled onto the exterior surface of the tubulu introducer, given the fact that the longitudinal slots 64 and 66 in the device ~ and the coaxial her..oslnlic mass 44 allow the device to be slipped onto the introducer from the side rather than from the end. Those skilled in the ~rt will also appr~c.ala that the device of Figures 4 2 1~0,~7 WO 93/08740 PCI'/US92/0767 and 5 can be ass~..,bled onto the body of a w~ hi-,j3 catl,eter already fitted into the working lumen of an en 'os~Dpe and used to deposi~ a plug of he",Gslatic l"ate,ial against a bleeding blood vessel which may be obser~ed during the course of the en 'DSCOpiC proce~Jure.
While the embodiments illustrated in Figures 1, 4, 6, 7 and 9 are sized and configured to seal a puncture wound in a blood vessel ~' pos~ a relatively shortdistance beJow the skin surface, those skilled in the art will appreciate that the dil"~)~ ons of these devises may be c;hangGJ, especially the lengths of the outer tubular sheath and pusher so that the puncture seal device may be used v,~hen carrying out any number of surgical prùc~Jures. For example, during the course of a laparasaDpic ~ole~ stectomy, should a blood vessel ~id~ltally be nicked, the instrument of the present invention may be use,d to stem the flow of blood therefrom.
In particular, by providing an elongated sheath or barrel having a mass of her,-o~t~tic material near its distal e,nd and by providing a con~nbically 'i~oss~ probe, the15 instrument may be directed through a l~arus~pe orthrough one of the several trocars use,d in c~,~...y out the pr~o6dure to appn~ ch the t les J~r until the distal end of the PSD is j~ s ~ with it. When 4~pru,c, i~tely positioned, the slide m ecl ,&nism or other actuator for the tubular pusher can be activated to expose at least a portion of the coaxially located he.nG~htic material from the confines of the sheath while it is being 20 pr~s~ecJ against the exterior wall ot the bleeding vossel. After a few minutes, the slide ...~:h~)ism in the handle can be further ~tu~ted to totally release the mass from the distal end of the device.
It is also envisioned that the distal tip of the tubular sheath can be configured in a variety of ways. Specifically disclosed herein are tubular she~t h~ having rounded, 25 blunt and beveled ends. It is also contemplated that the distal end of the tubular sheath may have a V~l-apacl notch formed therein, which is particularly efficacious when it is Jesi-~l to have the Up end straddle the blood vessel as the sealing ,r~ce~lure is ~,e- h.. ~. SUII other shapes may permH a portion of the distal end of the outer tubular sheath to physically enter the puncture, serving to stabilize the distal end 30 of the instrument.
As an alternative to providing a suture loop 37 on the handle for facilitating the device being locked in place by p&ss;--g a suture through the skin and through this loop, it is dso feasible to prevent the instrument of the pr~sent invention from being As an alternative to providing a suture loop 37 on the handle for facilitating the device being locked in place by passing a suture through the skin and through this loop, it is also feasible to prevent the instrument of the present invention from being displaced during the course of a surgical procedure by providing a coarse, helical thread-like pattern on the exterior surface of the outer tubular sheath 40. When an instrument having this feature is effectively screwed into the skin and underlying tissue to the point where a tactile sensation indicates that its distal end abuts the blood vessel to be sealed, the increased friction afforded by the roughened surface inhibits the tendency for the instrument to slip out of the wound.

Claims (19)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A surgical instrument for delivering a hemostatic substance (44) subcutaneously against a penetration site in a wall of a blood vessel (150) in the course of a surgical procedure in which an incision is made through the blood vessel (150) and a tubular body (18) is passed through said incision into said blood vessel (150), characterized by:
(a) an outer tubular sheath member (40) having a proximal end (38), a distal end (42) and a lumen extending therebetween, the diameter of said lumen being of a predetermined size greater than that of said tubular body (18) and adapted to allow said tubular body (18) to pass coaxially therethrough;
(b) a first annular mass of a hemostatic material (44), said mass (44) having a proximal and a distal edge surface and initially being contained within said outer tubular sheath member (40) proximate said distal end thereof and adapted to coaxially surround said tubular body (18);
(c) an inner tubular member (58) reciprocally movable relative to said outer tubular sheath member (40) and within said lumen of said outer tubular sheath member (40), said inner tubular member (58) being concentrically disposed relative to said outer tubular sheath member (40) and having a wall thickness for engaging said proximal edge surface of said mass (44); and (d) means advancing said inner tubular member (58) in engagement with said mass (44) for exposing said mass (44) exteriorly of said lumen with said distal end (42) against the exterior wall of said blood vessel (150) at said penetration site.

2. The surgical instrument as in Claim 1 wherein said means for advancing comprises:
(a) a housing (30) affixed to said proximal end of said outer sheath member (40); and (b) a reciprocally movable slide (52) mounted in said housing (30) and operatively coupled to said inner tubular member (58) for imparting relative movement in the longitudinal direction of said inner tubular member (58) and said outer tubular sheath (40).

3. The surgical instrument as in Claim 2 wherein said housing (30) comprises:
(a) a generally cylindrical tube having a wall surface defining a longitudinal bore (54) with a longitudinal slot (46) formed through said wall surface into said bore (54);
(b) said slide (52) disposed in said bore (54); and (c) finger-engageable means (50) connected to said slide (52) and extending through said slot (46).

4. The surgical instrument as in Claim 1 wherein said means for advancing comprises:
(a) a tubular handle (72) affixed to said proximal end of said outer sheath member (76) having a wall surface defining a longitudinal bore (74) with an arcuate slot (90) formed through said wall surface and communicating with said bore (74);

(b) a gear rack (84) affixed to said inner tubular member (82); and (c) a manually rotatable gear (94) journaled in said arcuate slot (90) and engaging said rack (84) to effect relative longitudinal movement between said outer sheath member (76) and said inner tubular member (82).

5. The surgical instrument as in Claim 1 wherein said means for advancing comprises:
(a) a tubular handle (102) affixed to said proximal end of said outer sheath member (104) having a wall surface defining a longitudinal bore (114) for receiving at least a portion of said inner tubular member (110) therein, said handle (102) having an arcuate recess (132) formed through said wall surface and communicating with said bore (114);
(b) a stop member (124) affixed to said inner tubular member (110);
(c) spring means (122) disposed within said handle (102) and cooperating with said inner tubular member (110) for applying a distally directed force to said inner tubular member (110); and (d) trigger means (134) disposed on said handle (102) for selectively releasing said force to effect relative longitudinal movement between said outer sheath member (104) and said inner member (110).

6. The surgical instrument as in Claim 1 wherein said inner tubular member (58) is generally rigid.

7. The surgical instrument as in Claim 1 wherein said mass (44) is sized to prevent entry into said blood vessel through said penetration site.

8. The surgical instrument as in Claim 1 and further including a second mass (45) of hemostatic material initially adapted to surround said tubular body (18) adjacently positioned relative to said first mass (44).

9. The surgical instrument as in Claim 1 wherein said hemostatic material (44) is resorbable collagen.

10. The surgical instrument as in Claim 1 wherein said hemostatic material (44) is resorbable gelatin.

11. The surgical instrument as in Claim 1 wherein said hemostatic material (44) is a resorbable lactide/glycoside.

12. The surgical instrument as in Claim 2 wherein said outer tubular sheath member (40), said mass (44), said inner tubular member (58), said housing (30) and said slide (52) each include a longitudinal slot aligned with one another for receiving said tubular body (18) therein.

13. The instrument as in Claim 2 and further including a stop formed in said housing for limiting movement of said inner tubular member in the distal direction.

14. The instrument as in Claim 2 wherein said housing (30) further includes releasable locking means for preventing inadvertent deployment of said mass.

15. The instrument as in Claim 14 wherein said housing (30) further includes first and second finger grippable segments, the first being joined to said inner tubular member (58) and the second being joined to said outer tubular sheath member (40), and said releasable locking means comprises a pin extending between said first and second segments and a hole (62) extending through one of said first and second segments for selectively receiving said pin therethrough.

16. The surgical instrument as in Claim 1 wherein said means for advancing comprises:
(a) an inner tubular hub (206) affixed to said proximal end of said outer tubular sheath member (200);
(b) an outer tubular hub (214) secured to said inner tubular member (216) by a coupling (218, 220) passing radially through said outer tubular sheath member (200); and (c) a knob (210) rotatably supported on said inner tubular hub (206) and having screw threads (212) cooperating with said outer tubular hub (214) for imparting translational movement to said inner tubular hub (206) relative to said outer tubular hub (214) upon rotation of said knob (210) to thereby effect relative longitudinal movement between said outer tubular sheath member (200) and said inner tubular member (216).

17. The surgical instrument as in Claim 16 wherein said inner tubular hub (206) includes an annular flange cooperating with an annular shoulder formed on said knob (206).

18. The surgical instrument as in Claim 16 wherein said outer tubular hub (214) is coupled to said inner tubular member (216) by at least one pin (218, 220) extending radially through said outer tubular sheath member (200).

19. The surgical instrument as in Claim 1 wherein said means for advancing comprises:
(a) a cylindrical hub (164) affixed to said proximal end of said outer tubular sheath member (160);
(b) a knob (168) journaled for rotation about said cylindrical hub (164), said knob (168) including a helical groove (170) on a portion of an exterior surface thereof; and (c) a finger grip member (180) coupled to the inner tubular member (174) through a longitudinal slot (184) formed through a wall of said outer tubular sheath member (160), said finger grip member (180) further including a follower member (188) engaging said helical groove (170), so that rotation of said knob (168) allows said follower member (188) to clear said helical groove (170) and allows said knob (168) to be pulled longitudinally in a proximal direction while said finger grip member (180) is held stationary to effect relative longitudinal movement between the outer tubular sheath member (160) and said inner tubular member (174).