CA2122041A1 - Plug device for sealing openings and method of use - Google Patents
Plug device for sealing openings and method of useInfo
- Publication number
- CA2122041A1 CA2122041A1 CA002122041A CA2122041A CA2122041A1 CA 2122041 A1 CA2122041 A1 CA 2122041A1 CA 002122041 A CA002122041 A CA 002122041A CA 2122041 A CA2122041 A CA 2122041A CA 2122041 A1 CA2122041 A1 CA 2122041A1
- Authority
- CA
- Canada
- Prior art keywords
- plug
- puncture
- incision
- filament
- instrument
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
An instrument (22) and methods of making and use for sealing a small opening, e.g., percutaneous incisions or punctures (28). The instrument (22) includes a tubular member (30) having a proximal portion (34) and a distal portion (32) with an open free end (36) for introduction into the incision or puncture (28). A plug (20) comprises a cord (50) and a thin filament (52), with the cord (50) being formed of a resorbable material and being folded in two to form an apex portion (64) and a pair of wing portions (66A, 68A) extending therefrom. The plug (20) is located within the tubular member (30) so that the apex portion (64) is disposed adjacent the free end. The plug (20) is then expelled partially from the tubular member (30) so that the apex portion (64) extends through the incision or puncture (28). The filament (52) is then drawn proximally to pull the apex portion (64) into engagement with the free end of the tubular member to expand the apex portion to form a head (68) having a tissue engagement surface.
Description
w~ g3/07~l3 ~ 1 2 2 0 ~ 1 PCT/US91/07924 PLUG DEVICE FOR SEA~ING
OPENINGS AND METHOD OF USE
Field of the Invention This invention relates generally to medical de~ices and methods of use, and more ~pecifically to devices and methods of use for sealing percutaneous openings or incisions in .the body of a living being.
Backaround Art In my United States patents 4,744,364 and 4,852,56~, assigned to the same assignee as this in~ention, there is dis-closed a device ~or s~aling an incision or punc~ure in tissue separating one portion o~ the body of a living being from another portion, e.g., a puncture in a blood vessel, duct or lumen, of a living being. Also disclosed are methods of use of that device. The device basically comprises an elongated tubular body having an outlet at its distal end. The distal end of the device is arranged to be inserted, such as percutaneously, through the puncture. In thP case where the puncture is an artery or other blood vessel, the outlet is inserted through the puncture so that ~t is located within the blood vessel's interior. An expandable closure is disposed within the device's tubu~ar body and is formed so that it is held in a compact or compresse~ configuration within the tubular body. The tubular body also includes ;an ejector in the form of a plunger-like member arranged to force the closure out of the outlet into the portion of the~ being's body contiguous wi~h the opening, e.g., withln the interior :of the blood vessel, whereupo~ the closure automatically expands~:to form an enlarged tissue engagement surface.
A retraction filament is ~ecured to the closure to enable it to be~pulled fully into the puncture after the device's tubular body has been withdrawn so that the ~ngagement surface of the closure intima~ely engages the inner surface of the tissue .
contiguous with the puncture.
In accordance with one aspect of the disclosure of those patents, the filament is held taut or otherwise secured and placed on the patientZs skin to hold the closure in position in the puncture. Pre~erably, the closure and filament are earh formed of some biod~gradable material to enable them to be left W~93/07~13 ~ ~2 ~ PCT/~S91/079~
' in place. When the closure is used for sealing punctures or incisions in blood vessels it is constructed so that when it is open (i.e., in its expanded ~tate) and in place ~eali~g the puncture it doesn't appreciably block the ~low ~f blood through the blood ve~sel. ^
In my co-pending United States patent application, Serial Num~er 1~4,641, filed on May 16, 19~8, entitled Device For Sealing Percutaneous Puncture In A Vessel, there is disclosed a device ~or sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being and a method of use of that de~ice. The devic basiçally comprises a closure or plug ~ormed of a material which when loc~ted within the puncture or inclsion expands automatic-ally to engage the tissue contiguous therewith to seal the puncture and incision ~rom the ~low o~ body fluid therethrough.
The clo~ure disclosed in that application basically comprises a holding member, a filament, and a sealing memberO The holding m~mber is an elongated body, constructed like a toggle, and preferably formed of a biodegradable, thermoplastic polymer, such as polyglactide. The toggle is molded onto the distal end of the ~ilam~nt. The filament is also biodegradable, and preferably formed of polygl~ctide suture. The filament, being flexible, enables the toggle ~o pivot to various orientations with respect to it. ~he sealing me~ er ba~ically compri~es a cylindrical plug, pre~erably formed of: ~ compressed foam, which is highly absorbent and~ which when dispo~ed within the body ~wells in exc~ss of its compressed diameter.
The closure is arranged to be used by an instrument to place it within the puncture ior inci~ion to be sealed. ~he ~nstrument includes a tubular member in which the closure is diæposed so ~hat the toggle i~ oriented with its longitudinal a~is parallel ~o ~he longitudinal~axis of the tubular me~ber.
When SQ dicposed the ~og~le compresses ~he portion o~ the distal end of the ~ealing member. The filament extends backward from the toggle thro~gh the sealing member.
The instrument is introduced into khe puncture or incision in the artery or any body tissue (e.g., the liver, gall bladder, lung, heart, etc.) un~il its ou~let is at the desired WO93/07813 ~ ~Z Q~ 1 PCT/US91/079 position. In the case of sealing an artery, the outlet of the instrument is positioned so that it i5 within the artery. The instrument is then operated to expel the closure member from the tubular member. Once ~he closure is expelled, the instrument is held in this position for a short period o~ time to a^llow the foam at the tip of the closure, that is the distal end portion o~
the closure, to swe1l. This action effecti~ely tilts the toggle.
The instrument may then be withdrawn and the closure' 5 filament retracted. This action pulls the closure's plug portion back through the puncture or incision i~ the artery wall until its toggle portion engages the inner surface of the artery wall to stop further retraction. As the toggle comes into engagement with the arterial wall, it ef~ects the compression of the distal end portion of the sealing member. Moreover, the proximal end portion of the ~ealing member ext~nds into the puncture or incision in the subcutaneous tissue to a point closely adj acent the skin. These actions effectively seal the puncture or incision from the passage of blood therethrough.
~ ther alternative embodiments of a plug or closure are also`disclosed in my aforementioned patent application~ Those alternati~e embodiments basica~lly comprise a preformed foam plug having an ~nlarged distal end portion serving as the holdi~g m~mber and a proximately :located, rod-like portion serving as a sealing member. A retraction filament is secured to the sealing m~mb~r. The ~lo~ure is~ pre~erably formed of a dense collagen foam! with: long collagen~fiber reinforcements, so that it has a high: expansion ratio~ ;(wet-to-dry) and good mechanical wet ctrength. : Those al~ernative cl:osur~s are also held within the instrument in a compr~ssed 'state, with the holding poxtion located adjacent the inst ~ ent' B outlet, and are inserted into the incision or puncture in the same manner as describ~d hereto~ore. Once the~closure is ejected out of the instrument, the holding portion of the~closure ~wells upon contact with blood in the artery. The closure, now ~wollen, hangs up at the puncture or incisiQn within the arterial wall, with the enlar~ed holding member portion engaging the inner surface of the i~terior wall and the sealing portion extending fully through the puncture or incision into the subcutaneous tissue. The filament is wog3/07~l3 2t ~ P~T/US91iO7924 ,.~..
retracted to fully seat the closure in place so that the sealing portion extends ~ully through the puncture or incision in the arterial wall and with its proximal end located within the subcutaneous tissue closely adjacent the skin.
While the foregoing closures are ge~erally s~itable ~or their 1~tended purposes, they still leave something to be desired from the standpoint of simplicity of construction and ease of use.
Qb~ec~s Of ~he Inven~ion Accordingly, it is a general object o~ this invention tu provide a device and methods of use which overcomes the disa~vantages of the prior art.
It is a further object of this invention t~ provide a devic~ and method of u~e for quickly, ea~ily, and effectively ~ealing a puncture or incision in tissue ~eparating one portion o~ the body of a-living being from another portion.
Summarv of The Invention These and other objects o~ this invention are achieved by providing a device and method of use ~or ~ealing a small incision or punct~re in tissue separating one por~io~ of the body o~ a living being ~rom another portion thereof to prevent the flow ~f bodily fluid from the one portion to the other portion through the incision or puncture. ~he device is arranged to be used with an instrument which:comprises a~ carrier in the form of a tubular me~ er. The:tubular member has a proxi~ally located portion and a dis ally located portion.: The latter i~clude~ an open fr~e end arranged to be introduced thr~ugh the inci~ion or puncture. Th~ proxi~ately locat~d portion of the t~bular member is arrang~d to be located~ou~ of the bo~dy of the being when the distally located portion is extended t~rough the incision or puncture.
The device basical1y compriæes~a:plug made up of a ~ord-like member and a thin ~ilament. The cord-like member comprises a resorbable material and is folded in ~wo ~o form an apex portion and a pair of wing portions extendi~g therefrom. The plug's filament is secured:to the apex portion~ The plug is arranged for loca~ion within the instrument's tubular carrier so that its apex portion is disposed adjacent the instrument's free WO93/07813 ~ J ~ e ~ f ~ PCT/US91/07924 , ~ i .
end, and with its wing portions and its ~ilament extending toward the proximally located portion of the instrument.
In accordance with one aspect of the method of this in~ention the plug means is arranged to be expelled partially from the tubular fr~e end of the carrier so that its ap2x portion extends through the incision or puncture. After that is accomplished the filament is drawn in the proximal direction to cause the apex portion to engage the free end o the carrier to cause the cord-like member to form an expanded head having a peripheral, tissue-engagement surface. The plug is then ~rawn back through the incision or puncture so that the peripheral tissue engagement surface intimately engages the tissue contiguous with the incision or puncture.
In accordance with another aspect of the method of this in~ention the filament is secured to the apex portion of the cord and comprises first and second portions. The first portion of the filament is introduced into the proximal end of the carrier means' tubular me~ber and drawn therethrough in a proxi-mal direction ~o pull the plug therein and through the tubular member until the apex portion of the plug is located immediately adj acent the open ree end of the tubular member; and with the second portion of the filament extending in a proximal direction from the plug and througb the proximal portion of the tubular member. Th first portion of the filament is then severed i D ediately ~djacent ~the apex of the plug, whereupon ~he i~stxument is ready for insertion in the puncture or incision to axpel the plug ther~rom~to seal ~hat incision or puncture.
.
~~rief Descri~tio~LC~ æ_~rawinas O~her ob~ect~ and ~a~y of he attendant advantages of this in~ention will readily be appreciated as the same becomes be~ter understood by referen e to the following detailed-d0scrip-tion wh~n con~idered:in connection with the accompanying drawings wh~rein~
Fig. l is a side~elevational view of the plug device of this invention;
Fig. 2 is a side elevational view, partially in section, showing an ini~ial step of inserting the plug device , wo g3/07813 2~ ~7~ ~4 PC~/US91/079~ -,,~.,, shown in Fig. 1 into a portion of an instrument in preparation for its use;
Fig. 3 is a side elevational view, partially in ~ection, similar to that of Fig. 1 and showing the final step readying the plug device and the instrument holding it for use to seal an incision or puncture.
Fig. 4 is a side elevational view, partially in sec-tion, ~howing the instrum~nt.ha~ing the plug device constructed in accordance with ~his invention therein being in~erted in~o a conventional sheath extending through a percutaneous incision or puncture into an artery to e~fect the sealing o~ that incision or punckure;
Fig. 5 is a side elevational view, partially in section; similar to Fig. 4 and showing an intermediate step in the process of sealing the incision or puncture;
Fig. 6 is a side elevational viewl partially in section, similar to Fig. 4 and showing a ~ubsequent intermediate step in the process of sealing the incision or puncture;
Fig. 7 is a side elevational view, partially in ~e~tion, similar to Fig. 4 and showing a further subsequent in~ermediate step in the process of ~ealing the incisîon or puncture;
Fig. 8 is a side elevational ~iew, partially in section, simi~ar ~o Fig. 4: and showing the final step in the proces~ of sealing the incision.or puncture.
D~ le~ Descri~tion Of Tha Prefe.~red Embodiment - R~erring now in greater ~etail o the ~arious figures .
of the drawings wherein like~-reference characters refer to like parts, a plug d~ice embodying the present invention is generally shown at ~ in Fig. l. The device 20 is arranged to be used to e~ect the ssaling of an incision or puncture or other small opening in any tissue separating two portions of the body of a living being to prevent liguid(s) or body fluid~s) to flow t~rough the incision or puncture. The devic 20 ~as partirular utility when used in connection with intravascular procedures, such as angiographic dye injection, balloon angioplasty and other types of recanalizing of athlosclerotic arteries, etc. However, it is to be understood that while the description of the 2 12 2 ~ 41 PCT/US~1/079~
preferred embodiment de~ice contained herein is directed to the clo~ing o~f of percutaneous lncisions or punctures in arteri0s, the deYice has much more wide-sprea~ applications. Thus, the sealing of a percutaneous incision or puncture in an artery shown herein is merely exemplary. ~
In order to use the device to seal the incision or puncture, the device is arranged to be located within an i~troducing instrument ~2 like that shown in Fig. 3 and which will be described in detail later.
Before describing the device 20 and the instrume~t 22 ~or inserting it to ~eal the incision or puncture, a brief description of a typical, conventional, intravascular surgical procedure, e.g., cathe~er instrumentation of an artery, utiliæi~g a percutaneous incision or punc~ure will be given to best appreciate the features of the invention. In such a procedure a cannula of an instrument, such as an angiographic needle (not shown), is inserted percutaneously through the skin into the artery, such as the femoral artery 24 a~ the situs for the instrument's 22 insertion (See Fig. 4). The needle cannula is held in place and the flexible end of a mini-guidewire (not shown) is then passed through the cannula into the artery to the desired depth ~i.e., longitudinal position therealong). Once the mini-guide wire is in place the needle cannula is removed, lea~ing the guidewire in place. ~ conventional introducing ~heath 26 and an arterial~ dilator (not .hown~ are the~ passed over the guidewire, through the puncture or incision 28 and into ghe artery 24.~ The~guidewire and~then the dilator are removed leavi~g the ~heath in:plaae~.~ The catheter (not s~own) or other intra~a~cular instrument ~(not ~hown) is then inserted through the introducer sheath 26 and threaded down the artery to the desired intravascular location, e.g., the situs of the athloscleroctic occlusion. Once the~intrava6cular:proaedure (e.g~, angiop1a~ty) has been complet~d, the catheter- ~s re~oved. Thereafter, the she~th is removed and the 6urgeon or other trained person applies digital pressure to the percutaneous puncture until hemostasis has occurred.
The device 20 effects the hemostatic closure of the percutaneous (or any other type of puncture, incision or opening) WOg3/07813 ~12Z~ PCT/US91/Q79~
~, in the artery or any other tissue separating two portions of the body without necessita~ing the application of pressure ther~to.
Thus, once the catheter or intra~ascular instrument has been removed, but with the introducer sheath 26 left in place, th~
instrument 22 holding the device 20 of the su~ject inv~ntion is inserted through the sh~ath, into the artery 24 and operated to expel the devic~ 20 into the artery 24.
. As can be ~een c}early in Fig. 1, the device 20 basically compri~es a closure or plug, whose details will be described lat~r, which is arranged to be drawn into the puncture or incision 28 to seal it. ~he introducer ~heath 26 is then removed and the closure or plug left in place. Due to its construction the closure or plug is ul~imately absorbed by the surrounding tissue.
Referring now to ~igs. 2 and 3, the details of instrument 22 will now be descr;.bed. As can be seen the instrument ~2 b~sically comprises ~ carrier in the form of a tubular body 30 ha~ing a distal end 32 and a proximal end 34.
The distal end 32 forms a free end of the instrument and comprises an open outlet 36. The tubular body is pr~ferably constructed of a sufficiently small outside diameter, e.g., 8F
(French) and somewha~ flexible material, such as polyethylene or polyvinyl chloride, to~ enable it ~o be inserted through the introducer heath 26 ints the ar~e ~ 24, with the tubular body's outlet 36 within the artery 24 di tally of the incision of punctur~ 28 ~s will be d~scribed later. ~ pusher member 38 is dispos~d within the tubular me~ber 30. The pusher basically comprises an elongated, cylindrical rod-like mem~er, having a free or distal end~ 40 and a proximal end 42. A central passagew~y-44 extends through the pusher. Preferably the pusher -i~ also fsrmed of a relatively flexible material~ such as polyethylene or polyvinyl chloride, and is disposed within the interior of the tubular body as ~hown in Fig. 3 when the instrum~nt is ready for use. The outside diameter of the pusher is slightly less than the inside diameter of the tubular body to enable the pusher to be manually moved, tha~ is slid, down the longitudinal axis of the tubular body, to push or force the closure 20 out of the outlet 36 t as will be described later.
WO~3/G78l3 2 i 2 2 0 41 . PCT/US~l/079~
g ., The proximal end o~ the tubular member 30 includes a ~lange 46 and the proximal end 42 of the pusher 38 includes a similax flange forming a cap 48. The flanges 46 and 48 f orm portions to be gripped or en~aged by the operator's fingers to enable the pusher to be moved (pushed) longitudinally d-own the tubular member to expel the closure 20, as will be described later.
~ eferring again to Fig. 1 it can be readily seen that the closure or plug 20 basically comprises a cord 50 and ~
~ilam~nt 52. In accordance with one aspect of the preferred embodiment of the invention, th~ cord comprises a stranded yarn of plural fibers 50A of collagen or some other absorbable material. In particular one exemplary yarn consists of fi~e strands 50A of .032 inch (.81 mm) fibers which are twisted together. The filament 52 is secured to the cord 50 by wrapping it about the midsection 54 o~ the cord and knotting it thereat.
This action forms a pair of filament sections, namely, 56 and 58, with section 56 forming a distally extending section with portion 58 forming a proximately extending portion.
As can be seen clearly in Fig. 2 the plug 20 i~
arranged to be inserted: into the tubular member 30 of the instrument 22 as follows: the distally extending filam~n~
portion 5~ is inserted through the open proximal end of the tubular member 30 and extended~therethrough until its ~`ree end 6~
~xtends out of the outlet 36 of the ~ubular member. The distally axtending filament por~ion 56 is then pulled in the distal ~iraction, likei~æhown by arrow ~2, whereupon the cord 50 of the `closure 20 enters into the open proximal end of the tubular me ~ er. This action~ca~ses the oord to fold in h~lf form a leading or apex porti~n 64`and a pair oP trailing, i.e., proximately ex~ending, wing~portions 66A and 66B. The distally extending ~ilament portion 56 is then continued to be pulled in the proximal direction, thereby drawing the folded plug 20 down the tubular member 3~ until its apex 64 is immediately adjacent the open end 3~ of the tubular member 30. When the plug is in this position (shown in Fig. 3) the proximally extending filament portion 58 extends in the proximal direction from the folded cord 50 through the tube 3 0 and out its open proximal end . The 3 ~ 2~4~ PCT/VS91/0~924 pu~her member 38 is then inserted within the tubular member 30.
In particular, the free end of the proximally extending filament portion 58 ls introduced into the distally located opening in the central passageway 44 of the pusher and threaded down the central passageway until it extends out of the opening at the flange or head 48 of the pusher. The pusher is then introduced into the proximately located opening in the tubular member and slid down t~e interior thereof in the distal direction until its 40 free end is located immediately adjacent the wings 66A and 66B of the p'lug 20. The distally extending~filament portion 56 is then cut off or severed from the apex 36 of the cord immediately adjacent the a~ex. Once this latter action has been achieved the instrument 22 is ready for use.
Operation of the instrument 20 is best understood by reference to Figs. 4-8 and is as follows: the instrument 20 is inserted within the introducer sleeve 26 so that the free end 3Z
of the tubular member~30 extends through the puncture or incision 28 like that shown in Fig. 4. The user then engages and pushes on the cap 48 of the pusher with his/her thumb while grasping the flange 46 of the tubular member between his/her fingers. This action slides the pusher in ~the distal direction within the tubular member 30 so that its free end 40 engages the end of the wing'portions 66A and 66B of~ the plug to force the apex portion 64 of the plug out of the open free~end 36 of the tubular member as shown, in'Fig. 5. The plug is left in this position for a few mi~utes, whereupon the~portion extending into the artery expands slightly~ in the~ presence of the liquid, e.g., blood, etc., within the artery, as shown in Fig. 6.
i~ The proxi,mally extend,ing filament portion 58 is then pulled in the proximal~ direction. This actio~ causes the enlarged portion of~ the cord's ~apex to ~engage the free edge of the~opening 36 of the tubular~member 30 thereby ~urther radially expanding and flattening that~ portion to form an enlarged or ~mushro shaped head 68., After the head 68 of the plug 20 has been expanded to its maximum diamet2r ~he~introducer sleeve 26 is removed from the puncture or incision 28 ~and the instrument 22 is then withdrawn as shown in Fig. 8~ This retraction action (i.e., the removal of WO93/07813 212~0 41 PcTrusg1/o79~
the instrument from within the puncture or incision 28) causes the peripheral edge portions 70 on the underside of the enlarged head 68 of the plug to be ~rawn into close or intimate engage~ent with the tissue contiguous with the incision or puncture 28 to thereby seal that incision or puncture.
As can be seen in Fig. 8 with the closure in position the head 68 does not take up a substantial portion of the interior of the artery and thus does not block off or otherwise impede the flow of blood therethrough.
When the closure 20 of the subjec~ invention is used to hemostatically ~eal a puncture or incision in an artery or other vessel, in order to minimize the risk of thrombosis the head of the closure which is exposed to the flow of blood through the artery may be coated with a non-thrombogenic material. Such a material can comprise a waxy coating, such as coconut oilt etc.
As mentioned earlier the cord 50 is ~ormed of a resorbable, e.g., biodegradable, m~terial. In accordance with the preferred embodiment of the invention, the filament 52 is also resorbable, and is preferably a suture of 3-0 size. These features enable the cord and filament to be left in place af~er hemostasis has occurred, ~ince both will be absorbed by body's tissues thereafter.~ Accordingly, the plug does not have to be removed after having served its purpose.
Moreover, when the plug of the instant invention is used for sealing punctures or ~incisions in arteries a conven-tional clotting agent, such as tissue thromboplastin may be provided in the closure to accelerate h~mostasis.
While the plug's cord has been de cribed as comprising a ~tr~nded yarn of plur~l fibers 6uch a const~uction is merely exemplary of variou~:types o~ cons~ructions~ ~hus, the alcord"
may merely consist of a strip or bar of some resorbable material which is sufficiently flexible to fold ov~r and form the hereto-fore described apex and wing portions.
As ~hould be apprecia~ed from the foregoing the plug dev.ice of the subject inYention and its method o~ use enables the ready, effective and efficient sealing of punctures or incisions in body organs or tissue, be they blood vessels, other lumens, ducts, etc. For example, the device and its me-thod of use can be WO93/07813 2 1 2 2 0 ~ 1 PCT/US91/07924 :
used fox the purpose of sealing percutaneou~ tran~hepati~ punc-tures to preclude the risk of bile leakage in~o the peritoneum, via the liver puncture site. Moreover, the ~e~ice and ~ethod of use can be used for sealing percutaneous incisions in the lung or heart, such as could result from a wound. ~
Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future ~nowledge, adopt the same for use under ~arious conditions of service.
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OPENINGS AND METHOD OF USE
Field of the Invention This invention relates generally to medical de~ices and methods of use, and more ~pecifically to devices and methods of use for sealing percutaneous openings or incisions in .the body of a living being.
Backaround Art In my United States patents 4,744,364 and 4,852,56~, assigned to the same assignee as this in~ention, there is dis-closed a device ~or s~aling an incision or punc~ure in tissue separating one portion o~ the body of a living being from another portion, e.g., a puncture in a blood vessel, duct or lumen, of a living being. Also disclosed are methods of use of that device. The device basically comprises an elongated tubular body having an outlet at its distal end. The distal end of the device is arranged to be inserted, such as percutaneously, through the puncture. In thP case where the puncture is an artery or other blood vessel, the outlet is inserted through the puncture so that ~t is located within the blood vessel's interior. An expandable closure is disposed within the device's tubu~ar body and is formed so that it is held in a compact or compresse~ configuration within the tubular body. The tubular body also includes ;an ejector in the form of a plunger-like member arranged to force the closure out of the outlet into the portion of the~ being's body contiguous wi~h the opening, e.g., withln the interior :of the blood vessel, whereupo~ the closure automatically expands~:to form an enlarged tissue engagement surface.
A retraction filament is ~ecured to the closure to enable it to be~pulled fully into the puncture after the device's tubular body has been withdrawn so that the ~ngagement surface of the closure intima~ely engages the inner surface of the tissue .
contiguous with the puncture.
In accordance with one aspect of the disclosure of those patents, the filament is held taut or otherwise secured and placed on the patientZs skin to hold the closure in position in the puncture. Pre~erably, the closure and filament are earh formed of some biod~gradable material to enable them to be left W~93/07~13 ~ ~2 ~ PCT/~S91/079~
' in place. When the closure is used for sealing punctures or incisions in blood vessels it is constructed so that when it is open (i.e., in its expanded ~tate) and in place ~eali~g the puncture it doesn't appreciably block the ~low ~f blood through the blood ve~sel. ^
In my co-pending United States patent application, Serial Num~er 1~4,641, filed on May 16, 19~8, entitled Device For Sealing Percutaneous Puncture In A Vessel, there is disclosed a device ~or sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being and a method of use of that de~ice. The devic basiçally comprises a closure or plug ~ormed of a material which when loc~ted within the puncture or inclsion expands automatic-ally to engage the tissue contiguous therewith to seal the puncture and incision ~rom the ~low o~ body fluid therethrough.
The clo~ure disclosed in that application basically comprises a holding member, a filament, and a sealing memberO The holding m~mber is an elongated body, constructed like a toggle, and preferably formed of a biodegradable, thermoplastic polymer, such as polyglactide. The toggle is molded onto the distal end of the ~ilam~nt. The filament is also biodegradable, and preferably formed of polygl~ctide suture. The filament, being flexible, enables the toggle ~o pivot to various orientations with respect to it. ~he sealing me~ er ba~ically compri~es a cylindrical plug, pre~erably formed of: ~ compressed foam, which is highly absorbent and~ which when dispo~ed within the body ~wells in exc~ss of its compressed diameter.
The closure is arranged to be used by an instrument to place it within the puncture ior inci~ion to be sealed. ~he ~nstrument includes a tubular member in which the closure is diæposed so ~hat the toggle i~ oriented with its longitudinal a~is parallel ~o ~he longitudinal~axis of the tubular me~ber.
When SQ dicposed the ~og~le compresses ~he portion o~ the distal end of the ~ealing member. The filament extends backward from the toggle thro~gh the sealing member.
The instrument is introduced into khe puncture or incision in the artery or any body tissue (e.g., the liver, gall bladder, lung, heart, etc.) un~il its ou~let is at the desired WO93/07813 ~ ~Z Q~ 1 PCT/US91/079 position. In the case of sealing an artery, the outlet of the instrument is positioned so that it i5 within the artery. The instrument is then operated to expel the closure member from the tubular member. Once ~he closure is expelled, the instrument is held in this position for a short period o~ time to a^llow the foam at the tip of the closure, that is the distal end portion o~
the closure, to swe1l. This action effecti~ely tilts the toggle.
The instrument may then be withdrawn and the closure' 5 filament retracted. This action pulls the closure's plug portion back through the puncture or incision i~ the artery wall until its toggle portion engages the inner surface of the artery wall to stop further retraction. As the toggle comes into engagement with the arterial wall, it ef~ects the compression of the distal end portion of the sealing member. Moreover, the proximal end portion of the ~ealing member ext~nds into the puncture or incision in the subcutaneous tissue to a point closely adj acent the skin. These actions effectively seal the puncture or incision from the passage of blood therethrough.
~ ther alternative embodiments of a plug or closure are also`disclosed in my aforementioned patent application~ Those alternati~e embodiments basica~lly comprise a preformed foam plug having an ~nlarged distal end portion serving as the holdi~g m~mber and a proximately :located, rod-like portion serving as a sealing member. A retraction filament is secured to the sealing m~mb~r. The ~lo~ure is~ pre~erably formed of a dense collagen foam! with: long collagen~fiber reinforcements, so that it has a high: expansion ratio~ ;(wet-to-dry) and good mechanical wet ctrength. : Those al~ernative cl:osur~s are also held within the instrument in a compr~ssed 'state, with the holding poxtion located adjacent the inst ~ ent' B outlet, and are inserted into the incision or puncture in the same manner as describ~d hereto~ore. Once the~closure is ejected out of the instrument, the holding portion of the~closure ~wells upon contact with blood in the artery. The closure, now ~wollen, hangs up at the puncture or incisiQn within the arterial wall, with the enlar~ed holding member portion engaging the inner surface of the i~terior wall and the sealing portion extending fully through the puncture or incision into the subcutaneous tissue. The filament is wog3/07~l3 2t ~ P~T/US91iO7924 ,.~..
retracted to fully seat the closure in place so that the sealing portion extends ~ully through the puncture or incision in the arterial wall and with its proximal end located within the subcutaneous tissue closely adjacent the skin.
While the foregoing closures are ge~erally s~itable ~or their 1~tended purposes, they still leave something to be desired from the standpoint of simplicity of construction and ease of use.
Qb~ec~s Of ~he Inven~ion Accordingly, it is a general object o~ this invention tu provide a device and methods of use which overcomes the disa~vantages of the prior art.
It is a further object of this invention t~ provide a devic~ and method of u~e for quickly, ea~ily, and effectively ~ealing a puncture or incision in tissue ~eparating one portion o~ the body of a-living being from another portion.
Summarv of The Invention These and other objects o~ this invention are achieved by providing a device and method of use ~or ~ealing a small incision or punct~re in tissue separating one por~io~ of the body o~ a living being ~rom another portion thereof to prevent the flow ~f bodily fluid from the one portion to the other portion through the incision or puncture. ~he device is arranged to be used with an instrument which:comprises a~ carrier in the form of a tubular me~ er. The:tubular member has a proxi~ally located portion and a dis ally located portion.: The latter i~clude~ an open fr~e end arranged to be introduced thr~ugh the inci~ion or puncture. Th~ proxi~ately locat~d portion of the t~bular member is arrang~d to be located~ou~ of the bo~dy of the being when the distally located portion is extended t~rough the incision or puncture.
The device basical1y compriæes~a:plug made up of a ~ord-like member and a thin ~ilament. The cord-like member comprises a resorbable material and is folded in ~wo ~o form an apex portion and a pair of wing portions extendi~g therefrom. The plug's filament is secured:to the apex portion~ The plug is arranged for loca~ion within the instrument's tubular carrier so that its apex portion is disposed adjacent the instrument's free WO93/07813 ~ J ~ e ~ f ~ PCT/US91/07924 , ~ i .
end, and with its wing portions and its ~ilament extending toward the proximally located portion of the instrument.
In accordance with one aspect of the method of this in~ention the plug means is arranged to be expelled partially from the tubular fr~e end of the carrier so that its ap2x portion extends through the incision or puncture. After that is accomplished the filament is drawn in the proximal direction to cause the apex portion to engage the free end o the carrier to cause the cord-like member to form an expanded head having a peripheral, tissue-engagement surface. The plug is then ~rawn back through the incision or puncture so that the peripheral tissue engagement surface intimately engages the tissue contiguous with the incision or puncture.
In accordance with another aspect of the method of this in~ention the filament is secured to the apex portion of the cord and comprises first and second portions. The first portion of the filament is introduced into the proximal end of the carrier means' tubular me~ber and drawn therethrough in a proxi-mal direction ~o pull the plug therein and through the tubular member until the apex portion of the plug is located immediately adj acent the open ree end of the tubular member; and with the second portion of the filament extending in a proximal direction from the plug and througb the proximal portion of the tubular member. Th first portion of the filament is then severed i D ediately ~djacent ~the apex of the plug, whereupon ~he i~stxument is ready for insertion in the puncture or incision to axpel the plug ther~rom~to seal ~hat incision or puncture.
.
~~rief Descri~tio~LC~ æ_~rawinas O~her ob~ect~ and ~a~y of he attendant advantages of this in~ention will readily be appreciated as the same becomes be~ter understood by referen e to the following detailed-d0scrip-tion wh~n con~idered:in connection with the accompanying drawings wh~rein~
Fig. l is a side~elevational view of the plug device of this invention;
Fig. 2 is a side elevational view, partially in section, showing an ini~ial step of inserting the plug device , wo g3/07813 2~ ~7~ ~4 PC~/US91/079~ -,,~.,, shown in Fig. 1 into a portion of an instrument in preparation for its use;
Fig. 3 is a side elevational view, partially in ~ection, similar to that of Fig. 1 and showing the final step readying the plug device and the instrument holding it for use to seal an incision or puncture.
Fig. 4 is a side elevational view, partially in sec-tion, ~howing the instrum~nt.ha~ing the plug device constructed in accordance with ~his invention therein being in~erted in~o a conventional sheath extending through a percutaneous incision or puncture into an artery to e~fect the sealing o~ that incision or punckure;
Fig. 5 is a side elevational view, partially in section; similar to Fig. 4 and showing an intermediate step in the process of sealing the incision or puncture;
Fig. 6 is a side elevational viewl partially in section, similar to Fig. 4 and showing a ~ubsequent intermediate step in the process of sealing the incision or puncture;
Fig. 7 is a side elevational view, partially in ~e~tion, similar to Fig. 4 and showing a further subsequent in~ermediate step in the process of ~ealing the incisîon or puncture;
Fig. 8 is a side elevational ~iew, partially in section, simi~ar ~o Fig. 4: and showing the final step in the proces~ of sealing the incision.or puncture.
D~ le~ Descri~tion Of Tha Prefe.~red Embodiment - R~erring now in greater ~etail o the ~arious figures .
of the drawings wherein like~-reference characters refer to like parts, a plug d~ice embodying the present invention is generally shown at ~ in Fig. l. The device 20 is arranged to be used to e~ect the ssaling of an incision or puncture or other small opening in any tissue separating two portions of the body of a living being to prevent liguid(s) or body fluid~s) to flow t~rough the incision or puncture. The devic 20 ~as partirular utility when used in connection with intravascular procedures, such as angiographic dye injection, balloon angioplasty and other types of recanalizing of athlosclerotic arteries, etc. However, it is to be understood that while the description of the 2 12 2 ~ 41 PCT/US~1/079~
preferred embodiment de~ice contained herein is directed to the clo~ing o~f of percutaneous lncisions or punctures in arteri0s, the deYice has much more wide-sprea~ applications. Thus, the sealing of a percutaneous incision or puncture in an artery shown herein is merely exemplary. ~
In order to use the device to seal the incision or puncture, the device is arranged to be located within an i~troducing instrument ~2 like that shown in Fig. 3 and which will be described in detail later.
Before describing the device 20 and the instrume~t 22 ~or inserting it to ~eal the incision or puncture, a brief description of a typical, conventional, intravascular surgical procedure, e.g., cathe~er instrumentation of an artery, utiliæi~g a percutaneous incision or punc~ure will be given to best appreciate the features of the invention. In such a procedure a cannula of an instrument, such as an angiographic needle (not shown), is inserted percutaneously through the skin into the artery, such as the femoral artery 24 a~ the situs for the instrument's 22 insertion (See Fig. 4). The needle cannula is held in place and the flexible end of a mini-guidewire (not shown) is then passed through the cannula into the artery to the desired depth ~i.e., longitudinal position therealong). Once the mini-guide wire is in place the needle cannula is removed, lea~ing the guidewire in place. ~ conventional introducing ~heath 26 and an arterial~ dilator (not .hown~ are the~ passed over the guidewire, through the puncture or incision 28 and into ghe artery 24.~ The~guidewire and~then the dilator are removed leavi~g the ~heath in:plaae~.~ The catheter (not s~own) or other intra~a~cular instrument ~(not ~hown) is then inserted through the introducer sheath 26 and threaded down the artery to the desired intravascular location, e.g., the situs of the athloscleroctic occlusion. Once the~intrava6cular:proaedure (e.g~, angiop1a~ty) has been complet~d, the catheter- ~s re~oved. Thereafter, the she~th is removed and the 6urgeon or other trained person applies digital pressure to the percutaneous puncture until hemostasis has occurred.
The device 20 effects the hemostatic closure of the percutaneous (or any other type of puncture, incision or opening) WOg3/07813 ~12Z~ PCT/US91/Q79~
~, in the artery or any other tissue separating two portions of the body without necessita~ing the application of pressure ther~to.
Thus, once the catheter or intra~ascular instrument has been removed, but with the introducer sheath 26 left in place, th~
instrument 22 holding the device 20 of the su~ject inv~ntion is inserted through the sh~ath, into the artery 24 and operated to expel the devic~ 20 into the artery 24.
. As can be ~een c}early in Fig. 1, the device 20 basically compri~es a closure or plug, whose details will be described lat~r, which is arranged to be drawn into the puncture or incision 28 to seal it. ~he introducer ~heath 26 is then removed and the closure or plug left in place. Due to its construction the closure or plug is ul~imately absorbed by the surrounding tissue.
Referring now to ~igs. 2 and 3, the details of instrument 22 will now be descr;.bed. As can be seen the instrument ~2 b~sically comprises ~ carrier in the form of a tubular body 30 ha~ing a distal end 32 and a proximal end 34.
The distal end 32 forms a free end of the instrument and comprises an open outlet 36. The tubular body is pr~ferably constructed of a sufficiently small outside diameter, e.g., 8F
(French) and somewha~ flexible material, such as polyethylene or polyvinyl chloride, to~ enable it ~o be inserted through the introducer heath 26 ints the ar~e ~ 24, with the tubular body's outlet 36 within the artery 24 di tally of the incision of punctur~ 28 ~s will be d~scribed later. ~ pusher member 38 is dispos~d within the tubular me~ber 30. The pusher basically comprises an elongated, cylindrical rod-like mem~er, having a free or distal end~ 40 and a proximal end 42. A central passagew~y-44 extends through the pusher. Preferably the pusher -i~ also fsrmed of a relatively flexible material~ such as polyethylene or polyvinyl chloride, and is disposed within the interior of the tubular body as ~hown in Fig. 3 when the instrum~nt is ready for use. The outside diameter of the pusher is slightly less than the inside diameter of the tubular body to enable the pusher to be manually moved, tha~ is slid, down the longitudinal axis of the tubular body, to push or force the closure 20 out of the outlet 36 t as will be described later.
WO~3/G78l3 2 i 2 2 0 41 . PCT/US~l/079~
g ., The proximal end o~ the tubular member 30 includes a ~lange 46 and the proximal end 42 of the pusher 38 includes a similax flange forming a cap 48. The flanges 46 and 48 f orm portions to be gripped or en~aged by the operator's fingers to enable the pusher to be moved (pushed) longitudinally d-own the tubular member to expel the closure 20, as will be described later.
~ eferring again to Fig. 1 it can be readily seen that the closure or plug 20 basically comprises a cord 50 and ~
~ilam~nt 52. In accordance with one aspect of the preferred embodiment of the invention, th~ cord comprises a stranded yarn of plural fibers 50A of collagen or some other absorbable material. In particular one exemplary yarn consists of fi~e strands 50A of .032 inch (.81 mm) fibers which are twisted together. The filament 52 is secured to the cord 50 by wrapping it about the midsection 54 o~ the cord and knotting it thereat.
This action forms a pair of filament sections, namely, 56 and 58, with section 56 forming a distally extending section with portion 58 forming a proximately extending portion.
As can be seen clearly in Fig. 2 the plug 20 i~
arranged to be inserted: into the tubular member 30 of the instrument 22 as follows: the distally extending filam~n~
portion 5~ is inserted through the open proximal end of the tubular member 30 and extended~therethrough until its ~`ree end 6~
~xtends out of the outlet 36 of the ~ubular member. The distally axtending filament por~ion 56 is then pulled in the distal ~iraction, likei~æhown by arrow ~2, whereupon the cord 50 of the `closure 20 enters into the open proximal end of the tubular me ~ er. This action~ca~ses the oord to fold in h~lf form a leading or apex porti~n 64`and a pair oP trailing, i.e., proximately ex~ending, wing~portions 66A and 66B. The distally extending ~ilament portion 56 is then continued to be pulled in the proximal direction, thereby drawing the folded plug 20 down the tubular member 3~ until its apex 64 is immediately adjacent the open end 3~ of the tubular member 30. When the plug is in this position (shown in Fig. 3) the proximally extending filament portion 58 extends in the proximal direction from the folded cord 50 through the tube 3 0 and out its open proximal end . The 3 ~ 2~4~ PCT/VS91/0~924 pu~her member 38 is then inserted within the tubular member 30.
In particular, the free end of the proximally extending filament portion 58 ls introduced into the distally located opening in the central passageway 44 of the pusher and threaded down the central passageway until it extends out of the opening at the flange or head 48 of the pusher. The pusher is then introduced into the proximately located opening in the tubular member and slid down t~e interior thereof in the distal direction until its 40 free end is located immediately adjacent the wings 66A and 66B of the p'lug 20. The distally extending~filament portion 56 is then cut off or severed from the apex 36 of the cord immediately adjacent the a~ex. Once this latter action has been achieved the instrument 22 is ready for use.
Operation of the instrument 20 is best understood by reference to Figs. 4-8 and is as follows: the instrument 20 is inserted within the introducer sleeve 26 so that the free end 3Z
of the tubular member~30 extends through the puncture or incision 28 like that shown in Fig. 4. The user then engages and pushes on the cap 48 of the pusher with his/her thumb while grasping the flange 46 of the tubular member between his/her fingers. This action slides the pusher in ~the distal direction within the tubular member 30 so that its free end 40 engages the end of the wing'portions 66A and 66B of~ the plug to force the apex portion 64 of the plug out of the open free~end 36 of the tubular member as shown, in'Fig. 5. The plug is left in this position for a few mi~utes, whereupon the~portion extending into the artery expands slightly~ in the~ presence of the liquid, e.g., blood, etc., within the artery, as shown in Fig. 6.
i~ The proxi,mally extend,ing filament portion 58 is then pulled in the proximal~ direction. This actio~ causes the enlarged portion of~ the cord's ~apex to ~engage the free edge of the~opening 36 of the tubular~member 30 thereby ~urther radially expanding and flattening that~ portion to form an enlarged or ~mushro shaped head 68., After the head 68 of the plug 20 has been expanded to its maximum diamet2r ~he~introducer sleeve 26 is removed from the puncture or incision 28 ~and the instrument 22 is then withdrawn as shown in Fig. 8~ This retraction action (i.e., the removal of WO93/07813 212~0 41 PcTrusg1/o79~
the instrument from within the puncture or incision 28) causes the peripheral edge portions 70 on the underside of the enlarged head 68 of the plug to be ~rawn into close or intimate engage~ent with the tissue contiguous with the incision or puncture 28 to thereby seal that incision or puncture.
As can be seen in Fig. 8 with the closure in position the head 68 does not take up a substantial portion of the interior of the artery and thus does not block off or otherwise impede the flow of blood therethrough.
When the closure 20 of the subjec~ invention is used to hemostatically ~eal a puncture or incision in an artery or other vessel, in order to minimize the risk of thrombosis the head of the closure which is exposed to the flow of blood through the artery may be coated with a non-thrombogenic material. Such a material can comprise a waxy coating, such as coconut oilt etc.
As mentioned earlier the cord 50 is ~ormed of a resorbable, e.g., biodegradable, m~terial. In accordance with the preferred embodiment of the invention, the filament 52 is also resorbable, and is preferably a suture of 3-0 size. These features enable the cord and filament to be left in place af~er hemostasis has occurred, ~ince both will be absorbed by body's tissues thereafter.~ Accordingly, the plug does not have to be removed after having served its purpose.
Moreover, when the plug of the instant invention is used for sealing punctures or ~incisions in arteries a conven-tional clotting agent, such as tissue thromboplastin may be provided in the closure to accelerate h~mostasis.
While the plug's cord has been de cribed as comprising a ~tr~nded yarn of plur~l fibers 6uch a const~uction is merely exemplary of variou~:types o~ cons~ructions~ ~hus, the alcord"
may merely consist of a strip or bar of some resorbable material which is sufficiently flexible to fold ov~r and form the hereto-fore described apex and wing portions.
As ~hould be apprecia~ed from the foregoing the plug dev.ice of the subject inYention and its method o~ use enables the ready, effective and efficient sealing of punctures or incisions in body organs or tissue, be they blood vessels, other lumens, ducts, etc. For example, the device and its me-thod of use can be WO93/07813 2 1 2 2 0 ~ 1 PCT/US91/07924 :
used fox the purpose of sealing percutaneou~ tran~hepati~ punc-tures to preclude the risk of bile leakage in~o the peritoneum, via the liver puncture site. Moreover, the ~e~ice and ~ethod of use can be used for sealing percutaneous incisions in the lung or heart, such as could result from a wound. ~
Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future ~nowledge, adopt the same for use under ~arious conditions of service.
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Claims (34)
1. An instrument for sealing a small incision or puncture in tissue separating one portion of the body of a living being from another portion thereof to prevent the flow of bodily fluid from said one portion to said other portion through said incision or puncture, said instrument comprising plug means and carrier means, said carrier means comprising tubular means having a proximally located portion and a distally located portion, said distally located portion having an open free end arranged to be introduced through said incision or puncture, said proximately located portion being arranged to be located out of the body of said being when said distally located portion is extended through said incision or puncture, said plug means comprising strip means and thin filament means, said strip means being formed of a resorbable material and being folded in two to form an apex portion and a pair of wing portions extending therefrom, said filament means being secured to said apex portion, said plug means being arranged for location within said tubular means so that said apex portion is disposed adjacent said free end and with said wing portions and a portion of said filament means extending toward said proximal portion, said plug means being arranged to be expelled partially from said free end of said tubular means so that said apex portion extends through said incision or puncture, said portion of said filament means being arranged to be drawn in the proximal direction to cause said apex portion of said strip means to engage the free end of said tubular means to form an expanded head having a tissue engagement surface, said plug means then being arranged to be positioned so that said tissue engagement surface intimately engages the tissue contiguous with said incision or puncture.
2. The instrument of Claim 1 wherein said strip means comprises a stranded yarn composed of plural fibers.
3. The instrument of Claim 2 wherein said fibers are twisted together.
4. The instrument of Claim 1 wherein said strip means comprises collagen.
5. The instrument of Claim 2 wherein said fibers comprise collagen.
6. The instrument of Claim 2 wherein said fibers are approximately .032 inch (.81 mm) in diameter.
7. The instrument of Claim 3 wherein said fibers are approximately .032 inch (.81 mm) in diameter.
8. The instrument of Claim 7 wherein said fibers comprise collagen.
9. The instrument of Claim 1 wherein said filament means comprises a resorbable material.
10. The instrument of Claim 9 wherein said filament means comprises a monofilament suture of 3-0 size.
11. The instrument of Claim 7 wherein said filament means comprises a resorbable material.
12. The instrument of Claim 11 wherein said filament means comprises a monofilament suture of 3-0 size.
13. The instrument of Claim 1 wherein said carrier means additionally comprises pusher means to eject said plug means from said free end of said tubular means.
14. A plug for sealing a small incision or puncture in tissue separating one portion of the body of a living being from another portion thereof to prevent the flow of bodily fluid from said one portion to said other portion through said incision or puncture, said plug being arranged to be inserted into said incision or puncture by an instrument comprising carrier means, said carrier means comprising tubular means having a proximally located portion and a distally located portion, said distally located portion having an open free end arranged to be introduced through said incision or puncture, said proximately located portion being arranged to be located out of the body of said being when said distally located portion is extended through said incision or puncture, said plug comprising strip means and thin filament means, said strip means comprising a resorbable material and being folded in two to form an apex portion and a pair of wing portions extending therefrom, said filament means being secured to said apex portion, said plug being arranged for location within said tubular means so that said apex portion is disposed adjacent said free end and with said wing portions and a portion of said filament means extending toward said proximal portion, said plug being arranged to be expelled partially from said free end of said tubular means so that said apex portion extends through said incision or puncture, said portion of said filament means being arranged to be drawn in the proximal direction to cause said apex portion of said plug to engage the free end of said tubular means to form an expanded head having a tissue engagement surface, said plug then being arranged to be positioned so that said tissue engagement surface intimately engages the tissue contiguous with said incision or puncture.
15. The plug of Claim 14 wherein said strip means comprises plural fibers.
16. The plug of Claim 15 wherein said fibers are twisted together.
17. The plug of Claim 14 wherein said strip means comprises plural fibers which are twisted together.
18. The plug of Claim 15 wherein said fibers are approximately .032 inch (.81 mm) in diameter.
19. The plug of Claim 15 wherein said fibers comprise collagen.
20. The plug of Claim 14 wherein said filament means comprises a resorbable material.
21. The plug of Claim 20 wherein said filament means comprises a monofilament suture of 3-0 size.
22. The plug of Claim 18 wherein said filament means comprises a resorbable material.
23. The plug of Claim 22 wherein said filament means comprises a monofilament suture of 3-0 size.
24. A method of preparing an instrument for sealing a small incision or puncture in tissue separating one portion of the body of a living being from another portion thereof to prevent the flow of bodily fluid from said one portion to said other portion through said incision or puncture, said instrument comprising carrier means and plug means, said carrier means comprising a tubular member having a proximally located portion and a distally located portion, said distally located portion having an open free end arranged to be introduced through said incision or puncture, said proximately located portion being arranged to be located out of the body of said being when said distally located portion is extended through said incision or puncture, said plug means comprising strips means and thin filament means, said strip means being folded in two to form an apex portion and a pair of wing portions extending therefrom, said filament means being secured to said apex portion of said strip means and comprising a first and a second portion, said method comprising introducing said first portion of said filament means into said proximal end of said tubular member and drawing it therethrough in a proximal direction to pull said plug means therein and through said tubular member until the apex portion of said plug means is located immediately adjacent said open free end of said tubular members with said second portion of said filament means extending in a proximal direction from said plug means and through said proximal portion of said tubular member, and then severing said first portion of said filament means immediately adjacent said apex of said plug means.
25. The method of Claim 24 wherein said instrument additionally comprises a pusher member having a free end, said method additionally comprising the step of placing said pusher within said tubular member so that said free end of said pusher member is located immediately adjacent said plug means.
26. The method of Claim 25 wherein said pusher member includes a passageway therethrough and wherein said method additionally comprises extending said second portion of said filament means through said passageway in said pusher member.
27. The method of Claim 24 wherein said strip means is foldable and wherein said method additionally comprises folding said strip means as said plug means is pulled into said tubular member.
28. The method of Claim 26 wherein said strip means is foldable and wherein said method additionally comprises folding said strip means as said plug means is pulled into said tubular member.
29. A method of using an instrument to seal a small incision or puncture in tissue separating one portion of the body of a living being from another portion thereof to prevent the flow of bodily fluid from said one portion to said other portion through said incision or puncture, said instrument comprising carrier means, plug means and pusher means, said carrier means comprising a tubular member having a proximally located portion and a distally located portion, said distally located portion having an open free end arranged to be introduced through said incision or puncture, said proximately located portion being arranged to be located out of the body of said being when said distally located portion is extended through said incision or puncture, said pusher means having a free end portion, said plug means comprising strip means and thin filament means, said strip means being folded in two to form an apex portion and a pair of wing portions extending therefrom, said filament being secured to said apex portion of said strip and comprising a first portion and a second portion, said method comprising introducing said first portion of said filament into said proximal end of said tubular member and drawing it therethrough in a proximal direction to pull said plug means therein and through said tubular member until said apex portion of said plug means is located immediately adjacent said open free end of said tubular member, with said second portion of said filament means extending in a proximal direction from said plug means and through said proximal portion of said tubular member, severing said first portion of said filament means immediately adjacent said apex of said plug means, said pusher means being within said tubular member so that a free end portion of said pusher means is located adjacent said plug means, introducing said open free end of said distal portion of said tubular member within said incision or puncture, causing said pusher means to expel said plus means partially from said free end of tubular member so that said apex portion of said plug means extends through said incision or puncture, drawing on said second portion of said filament means in the proximal direction to cause said apex portion of said plug means to engage the free end of said tubular member to form an enlarged head having a tissue engagement surface, and drawing said plug means in the proximal direction so that said tissue engagement surface of said plug means intimately engages the tissue contiguous with said incision or puncture.
30. The method of Claim 29 wherein said instrument additionally comprises the step of allowing said apex portion of said strip means which is extended through said incision or puncture to automatically expand somewhat in the presence of body liquid located at the situs of said incision or puncture and after said apex portion has expanded somewhat then drawing on said second portion of said filament means in the proximal direction to form said enlarged head.
31. The method of Claim 29 wherein said plug means comprises at least one resorbable material, and wherein said method additionally comprises leaving said plug means within said incision or puncture until it is absorbed by the body of said being.
32. The method of Claim 30 wherein said plug means comprises at least one resorbable material, and wherein said method additionally comprises leaving said plug means within said incision or puncture until it is absorbed by the body of said being.
33. The method of Claim 29 wherein said tissue engagement surface of said plug means is brought into intimate engagement with the tissue contiguous with said incision or puncture by the withdrawal of said instrument from within said incision or puncture.
34. The method of Claim 30 wherein said tissue engagement surface of said plug means is brought into intimate engagement with the tissue contiguous with said incision or puncture by the withdrawal of said instrument from within said incision or puncture.
Priority Applications (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/445,315 US5061274A (en) | 1989-12-04 | 1989-12-04 | Plug device for sealing openings and method of use |
| JP4505161A JP2528602B2 (en) | 1989-12-04 | 1991-10-25 | Plug device for sealing the opening |
| EP92904902A EP0609212A4 (en) | 1989-12-04 | 1991-10-25 | Plug device for sealing openings and method of use. |
| CA002122041A CA2122041A1 (en) | 1989-12-04 | 1991-10-25 | Plug device for sealing openings and method of use |
| PCT/US1991/007924 WO1993007813A1 (en) | 1989-12-04 | 1991-10-25 | Plug device for sealing openings and method of use |
| US07/783,645 US5192302A (en) | 1989-12-04 | 1991-10-28 | Plug devices for sealing punctures and methods of use |
| EP92924146A EP0619718B1 (en) | 1991-10-25 | 1992-10-27 | Plug devices for sealing punctures |
| PCT/US1992/009249 WO1993008743A1 (en) | 1991-10-25 | 1992-10-27 | Plug devices for sealing punctures and methods of use |
| JP5508571A JPH07503381A (en) | 1991-10-25 | 1992-10-27 | Plug device for sealing puncture wounds and method of use thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/445,315 US5061274A (en) | 1989-12-04 | 1989-12-04 | Plug device for sealing openings and method of use |
| CA002122041A CA2122041A1 (en) | 1989-12-04 | 1991-10-25 | Plug device for sealing openings and method of use |
| US07/783,645 US5192302A (en) | 1989-12-04 | 1991-10-28 | Plug devices for sealing punctures and methods of use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2122041A1 true CA2122041A1 (en) | 1993-04-29 |
Family
ID=27169751
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002122041A Abandoned CA2122041A1 (en) | 1989-12-04 | 1991-10-25 | Plug device for sealing openings and method of use |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5192302A (en) |
| EP (1) | EP0609212A4 (en) |
| JP (1) | JP2528602B2 (en) |
| CA (1) | CA2122041A1 (en) |
| WO (1) | WO1993007813A1 (en) |
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- 1991-10-25 EP EP92904902A patent/EP0609212A4/en not_active Ceased
- 1991-10-25 WO PCT/US1991/007924 patent/WO1993007813A1/en not_active Application Discontinuation
- 1991-10-25 CA CA002122041A patent/CA2122041A1/en not_active Abandoned
- 1991-10-25 JP JP4505161A patent/JP2528602B2/en not_active Expired - Lifetime
- 1991-10-28 US US07/783,645 patent/US5192302A/en not_active Expired - Fee Related
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| WO2010085449A1 (en) * | 2009-01-23 | 2010-07-29 | Cook Incorporated | Vessel puncture closure device |
Also Published As
| Publication number | Publication date |
|---|---|
| WO1993007813A1 (en) | 1993-04-29 |
| EP0609212A4 (en) | 1995-04-19 |
| JP2528602B2 (en) | 1996-08-28 |
| US5192302A (en) | 1993-03-09 |
| EP0609212A1 (en) | 1994-08-10 |
| JPH07501715A (en) | 1995-02-23 |
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| MXPA96004689A (en) | Assembly to seal a puncture in a v |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |