CA2182478A1 - Percutaneous drug dosing closure system - Google Patents
Percutaneous drug dosing closure systemInfo
- Publication number
- CA2182478A1 CA2182478A1 CA002182478A CA2182478A CA2182478A1 CA 2182478 A1 CA2182478 A1 CA 2182478A1 CA 002182478 A CA002182478 A CA 002182478A CA 2182478 A CA2182478 A CA 2182478A CA 2182478 A1 CA2182478 A1 CA 2182478A1
- Authority
- CA
- Canada
- Prior art keywords
- active material
- biologically active
- sealing means
- anchoring means
- tract
- 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
- 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
- A61B2017/00646—Type of implements
- A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
-
- 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
- A61B2017/00646—Type of implements
- A61B2017/00659—Type of implements located only on one side of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00898—Material properties expandable upon contact with fluid
Abstract
A resorbable dispensing device (20, 20') for location in a percutaneous incision or puncture (22, 24) extending to an internally located penetratable or-ganic structure within the body of a liv-ing being to provide at least a first bio-logically active material (72) for uptake by the body. The percutaneous incision or puncture includes an opening (22) in the tissue forming penetratable struc-ture and a communicating tract (24) ex-tending from the opening. The dispens-ing device can be used as a hemostatic closure and basically comprises anchor-ing means (32, 32', 32'', 32'''), sealing means (30, 30'), and positioning means (34), e.g., a filament. The anchoring means (32, 32', 32'', 32''') is introduced through the opening (22) onto one side of the penetratable structure to engage a portion of the tissue adjacent the open-ing to hold the anchoring means in place.
The sealing means (30, 30') is arranged to be introduced into the tract (24) adja-cent the anchoring means and to be po-sitioned by the positioning means (34) on the other side of the tissue from the anchoring means to hold the entire device (20, 20') in position within the percutaneous incision or puncture (22, 24). The first biologically active material (72) is selected to have little or no significant clotting or anti-clotting effect on the blood of the being but has at least one significant physiological effect, e.g., therapeutic, diagnostic, or prophylactic, and is carried by at least one of the anchoring means (32, 32', 32'', 32''') and the sealing means (30, 30'). When used as a hemostatic closure the sealing means may carry a conventional blood clotting agent, e.g., tissue thromboplastin. If the anchoring means is located in a blood vessel it may carry a conventional non-thrombogenic material.
The sealing means (30, 30') is arranged to be introduced into the tract (24) adja-cent the anchoring means and to be po-sitioned by the positioning means (34) on the other side of the tissue from the anchoring means to hold the entire device (20, 20') in position within the percutaneous incision or puncture (22, 24). The first biologically active material (72) is selected to have little or no significant clotting or anti-clotting effect on the blood of the being but has at least one significant physiological effect, e.g., therapeutic, diagnostic, or prophylactic, and is carried by at least one of the anchoring means (32, 32', 32'', 32''') and the sealing means (30, 30'). When used as a hemostatic closure the sealing means may carry a conventional blood clotting agent, e.g., tissue thromboplastin. If the anchoring means is located in a blood vessel it may carry a conventional non-thrombogenic material.
Description
PERCUTANEOUS DRUG DOSING CLOSURE SYSTEM
SPECIFIt'~'rION
This invention relates generally to medical devices and methods o~ use, and more specifically to a system and methods of use for applying medicines, drugs or other biologically active materials percutaneou6 into the body of a living being for uptake thereof .
R~c 'I~-.KI 'UNU OF TT~ TNVENTION
In our cop~n~;n~ United States Patent Application Serial No.
07/846,322, filed on March 5, 1992, entitled T' - LdlCic Puncture Closure System and Method of Use, which is assigned to the same n~e as this invention and whose disclosure is incorporated by reference herein there is fl; P:c1 05r~ and claimed a system, a closure, and method of use ~or ~ torm;n;n~J the position of a blood vessel via a percutaneous ~U-,uLuL~: and for sealing the percutaneous ~u-1~;LuLe in the blood vessel. In particular, the system includes an i~.L~uduc~eL- sheath and associated positioning device, a hemostatic ~u1-~Lu-~ closure, and a deployment iII LL_ ~. The positioning device enables the introducer sheath to be positioned at a desired position within the vessel. The deployment ill=,LLI ~ includes a tubular carrier storing the closure. The carrier has a distally located free end to be extended via an il~L~vlu~ through the ~U--~;LuL~ and its associated tract.
The closure comprises an anchor in the form of a rA~9;orAT
rigid member, a sealing mel3ber in the form of compressed collagen plug, and a thin fil: L connecting the two in a pulley-like tlLLrl1~, -nt. The carrier ejects the anchor through the introducer and puncture and then draws it against the free end of the introducer. The inr LL1 L and i11LL.,duce:r are then withdrawn toge~h~r to pull the anchor against the tissue contiguous with the incision or ~U-IC~ LUL~ in the artery wall on the inner surface thereof. Further withdrawal draws the plug out of the carrier into the puncture tract, whereupon the plug moves with respect to the anchor into position adjacent the outside of artery wall to seal the puncture or ;nr;f~jon. A f~nP~inn;n~
device limits the force applied to the f;1; . The carrier' _ _ _ =
WO 95~20916 2 1 8 2 4 7 8 PCT/US9S/01211 also ; nrl~ a tamper which is used to mechanically deform the plug within the tract. Once positioned h ~ Lasis occurs rapidly, thereby locking the closure in place.
The system of that appliaation constitutes an; vv L
upon earlier systems of the same ~CsiqnD~ such as those of United States Letters Patent No . 4 , 74 4 , 3 64 ( Kensey), 4 , 8 52 , 568 ~Kensey), 4,890,612 (Kensey), 5,021,059 (Kensey et al.), 5,061,274 (Kensey), and 5,222,974 (Kensey et al.), whose disclosures are also inCOL~uL~lted by reference herein.
In another of our coppnrl i n~ United States Patent Applications, namely, Serial No. 08/012,816, filed on February 3, 1993, entitled A H - Latic Vessel Puncture Closure System Ut; 1; 7; n~ A Plug Located Within The Puncture Tract Spaced From The Vessel, And Method 0~ Use, which is ~ ign-~ to the same n~e as this invention and whose disclosure is incoL}JoL~ILed by reference herein there is disclosed and claimed a system, making use of a closure having a fipacer member located in the puncture tract interposed between the anchor and the sealing means but spaced from the opening in the wall of the blood vessel to ensure that if any portion of the sealing means should break off it will not enter into the blood vessel.
Notwithstanding the differences in the closures of all of the aforementioned patents and applications, all include portions which are arranged to be located within the interior of the a vessel duct or lumen, e.g., an artery, and portions which are to be located in the ~UII- LUL~2 tract, i.e., the p~s~ extending from the surface of the skin to the ~ulluLuL~: or inc; ~ n in the artery wall. In the later patents and patent applications the means located within the ~ULUL~ tract comprises sealing means, e.g., a h~ _Ltl~iC plug, which is coupled to the anchor means located in the artery via f; 1 ~r ' means.
Where the type of closure utilized makes use of a sealing means located in the ~ulluLuL~ tract h ~ Lasis in that tract may be expedited by in~ ;n~ a conv~nti~n~l clotting agent, e.g., tissue tllL , l~:tin in the sealing means, and t_is fact has been ri~ ~closed in several of the afo~ )n~3 patents.
LC:UVeI ~ when the closure is used to seal a perC~lt~n~ol-e WO95/20916 ~ 1 ~32~ 78 PCT/US95/01211 IJU~I~;LULC: in an artery the anchoring member, which is located within the interior of the artery, may be coated with a non-t~ material to prevent the formation of blood clots (as also .li Ccl~c~pd in some of the aru~ Lioned patents) . In U.S.
Patent No. 5,108,421 tFowler) there is disclosed a vessel plug which may include a clotting agent or a r~ i op~ P material .
NIP0 Publication No. W0 90/14796 (Van de Moer) ~ rlns~c an ocnl llcion element which contain6 agents to combat stenosis.
None of the aruLI Lioned prior art discloses or suggests the use of a percu~AnPoll~ly inserted blood vessel ~JU~IU~UL-a closure as a means of deliverinc some biologically active material have little or no Ai~n;f;c~n. clotting or anti-clotting effect on the blood of the being, but having at least one significant physiological effect, e.g., therapeutic, diagnostic, prophylactic .
Various skin-mounted or implantable devices have been fl; CClOEPd in the patent literature and some are _ u ially available for ~ pPncin~ one or more biologically active materials into the :body of a living being. For example, U.S.
Pat. No. 1,794,221 tWashburn et al.) ~i~rlospc an applicator for applying a --~ir;np-cnnt~;n;n~ pad in the vagina. The pad re-mains in place and i6 removed by an attached string. U. S . Pat.
No. 1,191,736 (Roberson) fl;crlncp- an applicator for a tampon containing a '; ~ . U . S . Patent No. 4, 356, 572 (Gll; 1 1 pm; n et al. ) discloses a biodegradable bone implant or p, u~ esis whose composition promotes bone growth but does not contain a separate drug. U.S. Pat. No. 4,606,337 (Z; I et al.) discloses a resorptive sheet material which promotes healing by providing a layer which is conductive to coagulation of blood using thL~ ' ~n and fibrinogen. It can include layers cnnt~;n~n7 active substances, i.e. antibiotics for gradual release. U.S.
Patent No. 4,774,091 (Yamahira) ~ rloEPF a solid bar-like or needle-like implantable sustained-release preparation consisting of an active ingredient and a biodegradable carrier.
While the afu~ ~ioned devices may be gener~lly suitable for their ;ntPnAP~ purposes, they appear to leave much to be desired from one or more of various st~n~lro~nts, e.g., ease o~
_ ,_ _ . _ . . _ . _ _ _ _ . _ _ . _ _ _ _ .
pl~ 1, Arrli:hil~tY to a wide variety of implant sites, simplicity of cu-.,,LLuu~ion. Thus, a need exists for a drug delivery system which can provide a biologically active material, e.g., a drug, ~ hQmiCAl, hormone, enzyme, antibody, percu~Anon~ y.
We have detQrmi nPd that the various closures of the aforementioned patents which have been i;cnloE;ed above and which are AcciqnPd to the same Acsi~nQe as this invention can serve as such drug delivery systems with very little modification thereof.
In particular, the closures of the aforementioned patents and patent applications can be readily modified to render them particularly suitable for tl;cpQnc;n~ any type of biologically active material, e.g., therapeutic, diagnostic, prophylactic, into the body of the being for uptake thereby.
OB;rECTS OF ~ ~ INVF NTION
Accordingly, it is a general object of this invention to provide dispensing devices and methods of use which ~ L~ -- the disadvantages of the prior art.
It is another object of this invention to provide a pQnc;n~ device for location in a paI~ Qollc in~-;cinn or ~u-l~LuL~: in a living being to rl;RpQnP:e a biolo~;rAlly active material therefrom for uptake by the being's body.
It is still another obj ect of this invention to provide a r~-cnrh~hle ~l;crDnc;nq device for location in a peL-;uLane-lus ;nricion or ~,u--~LuLa in a living being to ~I;Rr~nce a biologically active material therefrom for uptake by the being's body.
It is yet another object of this invention to provide a rQcnrhAhle closure for sealing a peL.:uLal~euus; nt~;cjnn or puncture in a living being and for tl; cr~snC; ng a biologically active material therefrom for uptake by the being's body.
It is yet another object of this invention to provide a p~-nc;ng device for location within a pe~ Q I: ;n,-;Rinn or ~u~;LuLa in a living being to ,1; CpQnce a biologically active material therefrom, and which device is simple in .-,..sLL..~Lion, easy to use, and low in cost.
WO 95/20916 2 1 8 2 4 7 8 PCT/rJ59~012~ ~
SlJr~lARY OF T~P~ INVENT~ON
These and other objects of this invention are achieved by providing a r~nrhAhle dispensing device and method of use in a preA~t~rmin~d situs in a percutaneous inri~jnn or ~Ull~_~UL~
extending to a blood vessel, duct, lumen, organ, or other penetratable organic ~LLU-.;LULC: within the body of a living being to provide at least a first biologically active material for uptake by some internal portion of the body to achieve a desired phy~inlo~cAl effect. The peL~ Juc inri~:io~ or ~UII- LUL~
includes an opening in the tissue forming said vessel, duct, lumen, organ, or other penetratable structure and a - icating tract extending from the opening.
The ~i~p-~nAin~ device comprises anchoring means, sealing means, and positioning means. The anchoring means is ~LL~11ged to be i..LLuluced through the opening onto one side of the tissue forming the vessel, duct, lumen, organ or other pe1~LL~L~ble structure to engage a portion of that tissue adjacent the opening to hold the anchoring means in place with respect to the tissue.
The sealing means is arranged to be i..LL-,-lu-.ed into the tract adjacent the anchoring means. The positioning means is coupled to the anchoring means and the sealing means and is operative to position the sealing means with respect to the anchoring means on the other side of the tissue from the anchoring means to hold the device in position.
The first hiolo~ Al ly active material is selected to have little or no sisnificAn~ clotting or anti-clotting effect on the blood of said being but having at least one significant phys iol ogica l ef f ect , e . g ., therapeuti c , diagnostic , prophylactic. The first biologically active material is carried into the percutaneous in~ inn or ~ulleLuLe by at least one of the anchoring means and the sealing means for release theLeLL and uptake by said portion of said body to achieve a desired physiological effect.
In accordance with one aspect of this invention the ~i ~p~nl:in~ device comprises a hemostatic closure, with the sealing means h~ tically sealing the puncture tract. In such an aLL~ nt the sealing means may carry or include therein ~
wogsnogl6 2 ~ ~24 7~ PCT/US95/01211 conventional blood clotting agent, e.g., tissue thL~ ctin~
to expedite hemostasis in the tract. If the closure i8 used with the anchoring means located in a blood vessel , e . g., an artery, the anchoring means may carry or include therein a conventional non-thl, ' , i r material .
The biologically active material can be of any desired formulation and can take any desired form, e.g., it may be a time release agent which i5 released from the device at a prQAI~t~rm;n~ time after the device is in place within the percutaneous inriciorl or puncture, or may be released from the device at a predet~min-~d rate immediately upon p1s~f within the percutaneous inricinn or ~u.,.;LuLa, or may be released from the device at a prerl~t~min~l rate a pr~ t~rmin~d time after the device is in place within the percutaneous incision or ~ull- ~ULa.
RRTFF nF!~rRTP'rION OF l'HF DRAWINGS
Other objects and many of the attendant advantage~ of this invention will readily be appreciated as the same becomes better understood by reference to the following ~lC.t:l; 1 ec~ description when considered in connection with the ~ ying drawings wherein:
Fig. 1 is a top plan view of a ~licp-~ncing closure device ~UIIDLLU. Led in accu~ ce with this invention shown with the sealing ~~ L in an, - ~6sed state;
Fig. 2 i6 a top plan view, like that of Fig. 1, but showing the sealing _ L in its essed state ready for deployment into a percutaneous inr;C;o~ or ~ulluLuLa by an in~LL, like tbat ~;~rlos~d in our aforementioned cop~-n~;
patent applicationS;
Fig. 3 is a side elevational view of the anchor L
of 11; crPnc; n~ closure device shown in Figs . 1 and 2;
Fig. 4 is a top plan view of the anchor ~ shown in Fig. 3;
Fig. 5 is an isometric view of an alternative anchor cul...LLu. Led in accuLdan~_e with this invention;
Fig. 6 is an enlarged side elevational view of the anrhor ~: t shown in Fig. 5;
~ Wo9s/20s16 21 824 78 r~l,ul~ - 1211 Fig. 7 i8 an illustration, partially in section, showing the closure tl;cpPnc;n~ device of Figs. 1 - 4 located within a percutaneous ;nn~c;nn or uul-~LuLe in an artery for ~;crPnc;n~ A
binlo~;ç~lly active material from the anchor -- L into the artery;
Fig. 8 is a side elevational view of another alternative anchor L cu..DLLu~;Led in accordance with this invention;
and Fig. 9 is an illustration, similar to Fig. 7, showing an alternative closure tl;cpPnc;n~ device located within a perC~lt~npollc incision or yu~cLuLa in an artery for ~;rrpncin~ a biologically active material from the sealing _ L into the punct~2 tract; and Pig. lO is an isometric view of an alternative anchor L .
D~ATTTn nTc~ K~ L~ OF ':~T~` ~y~ K~ D~ M~
Referring now in ~reater detail to the various figures of the drawings wherein like reference characters refer to like parts, there is shown at 20 a ~icpPnc;n~ device constructed in accordance with this invention for location within a perCuts~nPn--;nn;cinn or puncture extending from the skin to some p~ L~Ldble -LLu.;LuLa located within the body of a living being in or~er to provide a biologically active material into that incis~ ~n or puncture for uptake by the being~s body. The perC~It~nP~
incision or puncture includes an opening 22 (Figs. 7 and 9) in the penetratable ~LLu~LuLe, e.g., a blood vessel, duct, lumen, organ, or other pcs~LLcltable organic ~LLu~;Lu~e, and a ;~ating tract 24 or passageway extending from the opening 22 to the surface of the skin.
In the preferred ~ c shown herein in Figs. 7 and 9 the penetratable -LLu~;LuLe: comprises an artery 26. The opening 22 extends through the wall of the artery 80 that it is in ; c~tion with the interior lumen 2 8 thereof and is also in ; cation with the ~u-l.iLuL~ tract 24 .
The cu...LLu~;Lion of the r3;cpPnc;n~ device 20 and its various L parts will be described in cnnci~prable detail later.
5uffice it for now to state that in the preferred: '~';-... . . _ _ _ _ _ _ _ _ _ _ _ . .
W0 95120916 ;;~ i ~ 2 ~ 7 ~ PCTIIIS95/0l2ll shown herein the device 20 is in the form of a closure similarto the closures of the afol- Lioned patents and patent applications. Thus, the ~;CPDnC;nq closure includes a sealing portion (to be described later) for sealing the IJUI~U~UL~: tract from the egress of body fluids therefrom. To that end, and referring now to Figs. 1-4, it will be seen that the dispensing closure 20 has three basic ts, namely, a sealing member 30, an intraarterial anchor member 32, and a positioning member 34 .
The sealing member or plug 30 comprises a cylindrical member formed of a compressible, rDc~rh1h]e, ~oll~n foam, such as that sold by Colla-Tec, Inc. of Plainchnro~ NJ. and is arranged for sealing the puncture tract 24, and in some ~10~i c, e.g-, Fig. 9, for delivering a biologically active material into the puncture tract.
The anchor member 32 is an elongated, sti~f, low-profile, r-~cnrh~hle member which i8 arranged to be seated inside the pene-trated internal ~LUe~ULe against the tissue thereof contiguous with the opening through which it had been introduced to initially position the closure. The anchor member 32 is made of non-tllL -, ic r~corh~hle material, e.g., a r~cnrh~hle polymer similar to a r~corhs~hle suture, 8uch as a r~cnrhs~h~
lactide/glycolide polymer sold by MDr1 i corh Technologies International L. P. under the trade designation MR nJC-~DI~. The strip is sufficiently rigid such that once it is has been passed through the opening 22 in the penetratable structure, e.g., the ~rtery 26, 80 that it is in its desired position it is resistant to deformation to preclude it from bending to pass back through the ~ull- ~uLe opening through which it was first i~ u-luced.
The positioning member 34 preferably comprises a f l l . ', e.g., a r~cnrh~hle suture, which cnnnclctc the anchor member 32 and the sealing member 30 (collagen plug) via a pulley-like ~ILLCII, ' Accordingly, as shown clearly in Figs. 7 and 9 when the proximal end of the f ~ 1 a ~ 3 4, which extends out of the ~u..~u.-~ tract 24, i5 pulled in the proximal direction this action serves to move the plug member 30 toward the anchor 32 (which is ~n~in~ the interior surface of the artery cnntig~n11C
WO ~!;120916 2 1 8 2 4 78 PCT/US95/OIZII
.
with the opening 22) through the Iull~LuLe tract 24, close to but not into Pn~a~, L with the exterior of the artery wall. In fact the sealing means abuts a domed portion of the anchor which extends into the opening 22. This action keeps the sealing member away from the artery, where a portion could conceivably break off and flow distally, but within the ~u~-~;LuL~ tract 24 80 that it can hemostatically seal that tract from the passage of f luid thereout .
The plug 30 is arranged to be comp~essed from the larqe r configuration shown in Fig. 1 to the small diameter, elongated configuration shown in Fig. 2. In the configuration of Fig. 2 the diameter of the plug is very small, e.g., 1.32 mm, and therefor suitable for disposition within the deployment in,.LL L (not shown) for introducing it. That in~L~, L is disclosed in the afo.. Lioned patent app~ications Serial No~.
07/846,322, filed on March 3, 1992, and ~/012,816, filed on February 3, 1993. The plug 30 includes ~n annular recess 40 extending about its outer periphery adj acent its proximal end .
Three d~eLLUL~:S 42, 44, and 46 extend through the plug. In particular, the aperture 42 is located close to the recess 40 and diamet: cally through the centerline of the plug. The ap~L Lu~ ~=
46 is ~ocated close to the distal end of the plug and extends LLc.l.~va~ely through the plug on one side of the centerline. The ~el LuLe 44 is located between ap~L LuLes 42 and 44 and extends transversely through the plug on the other side of the centerline. These al~eL LuLe s serve as p~ y~ through which the filament 34 extends to connect the anchor member 32 to the plug member 30 and are spaced apart to preclude tearing of the plug.
The manner of --~nnPct; ~n of the plug member to the anchor member serves to couple the plug ~ t to the anchor L in an arrangement to effect the r ~ L of the plug ^nt toward the anchor L, once the anchor ~ L
is in its desired position in the E,e~ L~c.table internal body l,LLUULULe, e.g., ~-~ artery-, at the ~u-.~;LuLa or ;n~ n. In particular the ~c~.rl; n~ o ~ the plug ~ to the anchor WO95~20916 lO 2 ~ ~2~ 7~ PCTIUSgS/01211 -nt simulates a pulley to achieve a desired --~hAn;
advantage .
The anchor member 32 has a generally planar top surface 48 (Fig. 3), a radially contoured bottom surface 50 and a peripheral side surface 52. Each end of the me_ber 32 is roundQd. The side surface 52 of the anchor member 32 tapers inward slightly from its top surface 48 to its bottom surface 50 to facilitate the removal of the plug from the mold for making it. A homi~:rhorical dome-like projection 54 is located at the center of the top urface 48. The top surface of the dome 54 is slightly flatted.
A cylindrical opening 60 extends transversely across the member 32 under the domed projection 54. In particular the fili ~ 34 is threaded through the cylindrical opening 60 to connect the plug member 30 to the anchor member 32. In this regard the pulley-like connection between the anchor member and the plug member i8 effected by threading the fil~ ' 34 from a remote point in a chamber (not 6hown) in the proximal portion of the deployment ir. LLI ~ through the transverse ~lJeLLULè 42, down the plug to the aperture 4 6, through that ~pel LUL è to the opposite side of the plug and from there to the anchor member where it is threaded through the opening 60. From there the ~i 1 34 extends back to the plug where it enters into aperture 44, passes through the aperture to the opposite side of the plug, where it terminates in a loop 66 extending around the annular recess 40. The loop is secured by a knot 68.
As can be seen clearly in Figs. 3 and 4, the anchor 32 inrl~l~ol:: two chambers or Lecesses 70 in the top surface 48 of the anchor adjacent each rounded end thereof. Each of these lece&&es i8 arranged to receive any suitable bjo~o~icAlly active material 72 having at least one signi~icant physiological, e.g., therapeutic, diagnostic, prophylactic, effect on the being. A
third recess or chamber may be located in the flatted top of the domed portion 54 of the anchor 32' as shown in the ~ L of the anchor of Fig. 5. In any case, and as will be appreciated by those skilled in the art, the biologically active material 72 czln take any suitable form, e.g., it may be a solid, a: ~ essed powder or tablet, a particulate or powder, a liquid, or WO 95/20916 2 1 8 2 4 7 8 P~ s i211 mi~ LuPI -r- l ~ted 8pheres or pellets. In ac~uL~ ce with the t shown in Figs. l - 7 the biologically active material 72 is held within each chamber 70 by a respective cover 74 of a thin film, e . g ., the same material as that of the anchor, which is secured by heat or a solvent to the anchor member around the periphery of the associated recess.
In the: ir- ': of the anchor 32" shown in Fig. 8 the b;nlo7ic~11y active material 72 is dispersed tllLuu~l.uuL the material making up the anchor member, i.e., the anchor member is molded with the material 72 therein.
In Fig. lO there is shown an alternative anchor t 32~ constructed in accordance with this invention. That - -nt 32"' is similar to the -nts 32, 32 ' and 32"
de6cribed heretofore eYcept for the a~.y ical shape of its ends, the flatted sides 54' of the dome shaped portion 54, and the shape of the filament 34 receiving pi~ y or opening 60'.
In any case where the anchor material enclosing the biologica:~ sr active material 72 is ro~nrh~hle, the biologically active ma~ ~rial will be released upon the resorption of the anchor member with the b~ing's body for uptake thereby.
As should be appreciated by those skilled in the art pe~nr~;n~ upon the application desired the anchor member may be constructed and the biological material 72 chosen so that it will be released or gain egress from the anchor member immediately following the rla~ ~ of the dispensing closure device 20 within the percutaneous in~ ;oll or IJUlle~ULt: or may be arranged to be released or gain egress therefrom a pr~APtor~n;nDd time after location within the patient's body. In fact, the release of the material 72 may be A~ hPd at once or over some period of time, be it prc-~racted or short, and at a pLe~ LP-, ;n~cl or controlled rate, iLLe~.~e- Live of the time that the release begins. To achieve those ends the anchor member and/or t_e material 72 may be cû~.:.LLu~Led in various ways which will be n~yaLellL to those skilled in the art.
As should be appreciated from the foregoing when the tl;~p-~nc:;n~ closure device 20 is cu..~.LLu~;Led in accordance with the t~:~ch; n~c~ of Figs . 1 - 7 and is used so that the anchor _ _ _ _ _ . _ _ _ ~ 1 ~2~7~ ~
member 32 iæ located within an artery 26, a duct, or other fluid carrying lumen, once the biologically active material 72 is rele~sed from the anchor, it may be carried by the fluid flowing through that lumen to immediately adj acent tissue or to tissue at remote locations.
In Fig. 9 there is shown an alternative : ~; L of a p~nc;ng closure device constructed in accordance with this invention for ti~RpDncin~ a biologically active material directly into the ~UII-:LUL_ tract 24, and from there, if desired through the opening 22 in the tissue of the penetratable tiLLUU~UL~ into the structure itself, e. g., the artery . To achieve that end the fl~RpDn~:in~ closure device 20' sf Fig. 9 is similar in cu.-,,LLuuLion to the device 20 of Fig. 7 except that the sealing member or plug 30' includes the biologically active material 72.
In such a case the anchor member 32 ' need not contain the biologically active material 72 talthough it could contain the same or another biologically active material, if desired~. If no biologically active material is needed to be carried by the anchor member into the being's body the anchor member need not utilize any recesses 70. However, if desired the anchor can still make use of such rb- esses to hold a r~ i op~ material therein, such as lliCrlr~Co~ in the aforementioned application 07/846,322, to facilitate fluoroscopic pl~ L of the ~Rp~n~:;n g closure device 20. In fact, the recesses 70 in the anchor may be provided and left hollow, albeit covered with the covers 74, to create a pair of hollow spaces which may be readily visible using conventional imaging t~rhnirllDC.
The biologically active material 72 may be incorporated into the plug 30 in any suitable manner, e.g., as a coating on its surface(s), as microspheres or particulates el~LLc.~yed within the plug material , e . g ., as a collagen foam f ibrillar matrix of the coll~ n making up the plug and the biologically active material 72, or in any other suitable manner which will be apparent to those skilled in the art.
The tliRpDnRinrJ closure device 20 i5 used as follows: the physician inserts the delivery or deployment in.,LL, L (not æhown) containing the device 20 into a conventional introducer _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ~ WO 95/20916 2 ~ 8 2 4 7 8 PCT/llS9SJi)~211 sheath (not shown) extending into the patient's body to the situs of the structure to be penetrated and dosed with the biologically active material. In the case where the biologically active material i6 to be illLr~luced into a percutaneous incision or ~U-I. LuL-~ extending into a artery the dosing ~ce-luLe is as follows: the anchor member 32/32' is passed out Or the distal end of the introducer sheath in the manner disclosed in our afo~ Lioned applications so that it i5 deployed within the artery lumen. The deployment inaLL, L is then withdrawn from the introducer sheath until resistance is felt when the anchor member catches on the distal end thereof. Once this occurs (and F~lm; n~ that the anchor is in the correct orientation when it catches on the end of the i~LL-~-lu~eL sheath the deployment ina LL, L and the introducer sheath are then immediately withdrawn together. This withdrawing action causes the anchor member 32/32 ' to engage (catch) or2. the inner surface of the artery wall 26 contiguous with the puncture's opening 22. Con-tinued withdrawal of the illaLL L and illLL~-luc~r sheath cause~
the pulley-like configuration of the fil L 34 to pull the coll~ n plug 30/30' toward the anchor member 32/32', thereby depositing the plug in the ~u-~ LuLt tract 24 adjacent the exterior of the artery contiguous with the yul~;LuL~:. The plug 30/30' doea not engage the arterial wall but rather it contacts the flatted domed portion 54 of the anchor member 32/32 ' which extends from the interior of the artery into and somewhat through the opening 22 in the artery wall (See Figs. 7 and 9). This action prevents the plug 30/30' from being pulled into the artery's interior. The pulling on the f;l; L 34, to bring the sealing member or plug 30,30' into ~n~il-, L with the anchor's dome 54, also has the effect of deforming the plug 30/30' into a larger diameter body tc aid in holding it in place within the LUL~ tract 24 as shown in Figs. 7 and 9. IIol.:ov-aL, since the plug 30/30' is formed of ~c:ssed c~ g~n or other hydrophilic material it also expands automatica7 ly in the p~es~ e of blood within the ~u,.~.Lu-e tract 24 w~n deployed, thereby further contributing to the plug's enlargement. Further sti1l, the deployment il-aLL L includes a tamper (not ~how~
wo 9S/20916 2 1 ~ 2 4 7 ~ PCT/US9SJ01211 ~
which i5 mounted on the f i 1 i L 34 and which is slidable thereon .
The deployment of the ~'iiRp~nRin~ closure device 20 also effects the deployment of the tamper into the ~ul~uLuL~: tract 24 proximally of the plug 30/30'. The tamper is then uæed to gently compress and lock the collagen plug 30/30' on the suture filament 34 within the ~ulluLuL~3 tract 24, but outside of the artery. The closure 20 is now locked in place through the clotting of the atic coll il~on plug and by spring tension provided by spring means (not shown) and forming a portion of the deployment ~ystem located on the f ilament 3 4 .
Immediately after rl P.' - t the anchor 32 starts to absorb water and to break down by hydrolysis. The process of Qnt~r6~ tion of the anchor by the arterial wall also ~ 3f.
After approximately thirty days, only a small deposit of anchor material will remain. In fact, resorption of all, ~s will have ocuuLL~d after approximately sixty days.
When the ~iiRpDncing closure device 20 is CU~ L u~ed like the ~ t shown in Fig. 7 and i6 located within the percl~tAn~ollR incision or pul~uLuL~: as shown, upon the resorption of the anchor member 32/32'/32" itself or of the material 74 forming the chamber cover 74 the biologically active material 72 gains egress from the anchor and is picked up by the blood as shown gr~rh; ci~1 l y by the arrows designated with the reference nu~ber 80. The biologically active material is then taken up by the patient's body. When the tiiRp~nRin~ closure device 20 is ~u~.a~Lu~iLed like the I 'i- L shown in Fig. 9 and is located within the percutaneous i n--i Rinn or puncture as shown the biologically active material 72 in the sealing plug 30' gains egress from the sealing plug and is picked up by the blood or other fluid in the tissue contiguous with the ~UII~:LULt: tract 24 ns shown gr~rhir~lly by the arrows designated with the reference number 82. D~r~nAinq upon the composition of the material 72 some of it may flow through the opening 22 into the interior of the artery for uptake by a remote portion of the patient's body.
If desired a spacer member (not shown), like that ~liRC~or"d and claimed in our afuI~ ~ioned rop nrlin~ application S.ll_ _ _ _ _ _ _ ~ WO 95120916 2 l 8 2 4 7 8 1 ~1/. s~
08/012,816 may be utilized interposed between the anchor member 32 and the sealing or plug me~ber 30 to further space the plug member from the artery. The spacer member may, ir desired, be constructed, to include any type of biologically active material 72 therein. In such a case the spacer member will also serve to deliver that biological material into the ~JUl~;L.ULe~ tract 24 ~or uptake by the body.
Nithout further elaboration the foregoing will 80 fully illustrate our invention that others may, ~y applying current or future knowledge, adopt the same for use under various conditions o~ service.
SPECIFIt'~'rION
This invention relates generally to medical devices and methods o~ use, and more specifically to a system and methods of use for applying medicines, drugs or other biologically active materials percutaneou6 into the body of a living being for uptake thereof .
R~c 'I~-.KI 'UNU OF TT~ TNVENTION
In our cop~n~;n~ United States Patent Application Serial No.
07/846,322, filed on March 5, 1992, entitled T' - LdlCic Puncture Closure System and Method of Use, which is assigned to the same n~e as this invention and whose disclosure is incorporated by reference herein there is fl; P:c1 05r~ and claimed a system, a closure, and method of use ~or ~ torm;n;n~J the position of a blood vessel via a percutaneous ~U-,uLuL~: and for sealing the percutaneous ~u-1~;LuLe in the blood vessel. In particular, the system includes an i~.L~uduc~eL- sheath and associated positioning device, a hemostatic ~u1-~Lu-~ closure, and a deployment iII LL_ ~. The positioning device enables the introducer sheath to be positioned at a desired position within the vessel. The deployment ill=,LLI ~ includes a tubular carrier storing the closure. The carrier has a distally located free end to be extended via an il~L~vlu~ through the ~U--~;LuL~ and its associated tract.
The closure comprises an anchor in the form of a rA~9;orAT
rigid member, a sealing mel3ber in the form of compressed collagen plug, and a thin fil: L connecting the two in a pulley-like tlLLrl1~, -nt. The carrier ejects the anchor through the introducer and puncture and then draws it against the free end of the introducer. The inr LL1 L and i11LL.,duce:r are then withdrawn toge~h~r to pull the anchor against the tissue contiguous with the incision or ~U-IC~ LUL~ in the artery wall on the inner surface thereof. Further withdrawal draws the plug out of the carrier into the puncture tract, whereupon the plug moves with respect to the anchor into position adjacent the outside of artery wall to seal the puncture or ;nr;f~jon. A f~nP~inn;n~
device limits the force applied to the f;1; . The carrier' _ _ _ =
WO 95~20916 2 1 8 2 4 7 8 PCT/US9S/01211 also ; nrl~ a tamper which is used to mechanically deform the plug within the tract. Once positioned h ~ Lasis occurs rapidly, thereby locking the closure in place.
The system of that appliaation constitutes an; vv L
upon earlier systems of the same ~CsiqnD~ such as those of United States Letters Patent No . 4 , 74 4 , 3 64 ( Kensey), 4 , 8 52 , 568 ~Kensey), 4,890,612 (Kensey), 5,021,059 (Kensey et al.), 5,061,274 (Kensey), and 5,222,974 (Kensey et al.), whose disclosures are also inCOL~uL~lted by reference herein.
In another of our coppnrl i n~ United States Patent Applications, namely, Serial No. 08/012,816, filed on February 3, 1993, entitled A H - Latic Vessel Puncture Closure System Ut; 1; 7; n~ A Plug Located Within The Puncture Tract Spaced From The Vessel, And Method 0~ Use, which is ~ ign-~ to the same n~e as this invention and whose disclosure is incoL}JoL~ILed by reference herein there is disclosed and claimed a system, making use of a closure having a fipacer member located in the puncture tract interposed between the anchor and the sealing means but spaced from the opening in the wall of the blood vessel to ensure that if any portion of the sealing means should break off it will not enter into the blood vessel.
Notwithstanding the differences in the closures of all of the aforementioned patents and applications, all include portions which are arranged to be located within the interior of the a vessel duct or lumen, e.g., an artery, and portions which are to be located in the ~UII- LUL~2 tract, i.e., the p~s~ extending from the surface of the skin to the ~ulluLuL~: or inc; ~ n in the artery wall. In the later patents and patent applications the means located within the ~ULUL~ tract comprises sealing means, e.g., a h~ _Ltl~iC plug, which is coupled to the anchor means located in the artery via f; 1 ~r ' means.
Where the type of closure utilized makes use of a sealing means located in the ~ulluLuL~ tract h ~ Lasis in that tract may be expedited by in~ ;n~ a conv~nti~n~l clotting agent, e.g., tissue tllL , l~:tin in the sealing means, and t_is fact has been ri~ ~closed in several of the afo~ )n~3 patents.
LC:UVeI ~ when the closure is used to seal a perC~lt~n~ol-e WO95/20916 ~ 1 ~32~ 78 PCT/US95/01211 IJU~I~;LULC: in an artery the anchoring member, which is located within the interior of the artery, may be coated with a non-t~ material to prevent the formation of blood clots (as also .li Ccl~c~pd in some of the aru~ Lioned patents) . In U.S.
Patent No. 5,108,421 tFowler) there is disclosed a vessel plug which may include a clotting agent or a r~ i op~ P material .
NIP0 Publication No. W0 90/14796 (Van de Moer) ~ rlns~c an ocnl llcion element which contain6 agents to combat stenosis.
None of the aruLI Lioned prior art discloses or suggests the use of a percu~AnPoll~ly inserted blood vessel ~JU~IU~UL-a closure as a means of deliverinc some biologically active material have little or no Ai~n;f;c~n. clotting or anti-clotting effect on the blood of the being, but having at least one significant physiological effect, e.g., therapeutic, diagnostic, prophylactic .
Various skin-mounted or implantable devices have been fl; CClOEPd in the patent literature and some are _ u ially available for ~ pPncin~ one or more biologically active materials into the :body of a living being. For example, U.S.
Pat. No. 1,794,221 tWashburn et al.) ~i~rlospc an applicator for applying a --~ir;np-cnnt~;n;n~ pad in the vagina. The pad re-mains in place and i6 removed by an attached string. U. S . Pat.
No. 1,191,736 (Roberson) fl;crlncp- an applicator for a tampon containing a '; ~ . U . S . Patent No. 4, 356, 572 (Gll; 1 1 pm; n et al. ) discloses a biodegradable bone implant or p, u~ esis whose composition promotes bone growth but does not contain a separate drug. U.S. Pat. No. 4,606,337 (Z; I et al.) discloses a resorptive sheet material which promotes healing by providing a layer which is conductive to coagulation of blood using thL~ ' ~n and fibrinogen. It can include layers cnnt~;n~n7 active substances, i.e. antibiotics for gradual release. U.S.
Patent No. 4,774,091 (Yamahira) ~ rloEPF a solid bar-like or needle-like implantable sustained-release preparation consisting of an active ingredient and a biodegradable carrier.
While the afu~ ~ioned devices may be gener~lly suitable for their ;ntPnAP~ purposes, they appear to leave much to be desired from one or more of various st~n~lro~nts, e.g., ease o~
_ ,_ _ . _ . . _ . _ _ _ _ . _ _ . _ _ _ _ .
pl~ 1, Arrli:hil~tY to a wide variety of implant sites, simplicity of cu-.,,LLuu~ion. Thus, a need exists for a drug delivery system which can provide a biologically active material, e.g., a drug, ~ hQmiCAl, hormone, enzyme, antibody, percu~Anon~ y.
We have detQrmi nPd that the various closures of the aforementioned patents which have been i;cnloE;ed above and which are AcciqnPd to the same Acsi~nQe as this invention can serve as such drug delivery systems with very little modification thereof.
In particular, the closures of the aforementioned patents and patent applications can be readily modified to render them particularly suitable for tl;cpQnc;n~ any type of biologically active material, e.g., therapeutic, diagnostic, prophylactic, into the body of the being for uptake thereby.
OB;rECTS OF ~ ~ INVF NTION
Accordingly, it is a general object of this invention to provide dispensing devices and methods of use which ~ L~ -- the disadvantages of the prior art.
It is another object of this invention to provide a pQnc;n~ device for location in a paI~ Qollc in~-;cinn or ~u-l~LuL~: in a living being to rl;RpQnP:e a biolo~;rAlly active material therefrom for uptake by the being's body.
It is still another obj ect of this invention to provide a r~-cnrh~hle ~l;crDnc;nq device for location in a peL-;uLane-lus ;nricion or ~,u--~LuLa in a living being to ~I;Rr~nce a biologically active material therefrom for uptake by the being's body.
It is yet another object of this invention to provide a rQcnrhAhle closure for sealing a peL.:uLal~euus; nt~;cjnn or puncture in a living being and for tl; cr~snC; ng a biologically active material therefrom for uptake by the being's body.
It is yet another object of this invention to provide a p~-nc;ng device for location within a pe~ Q I: ;n,-;Rinn or ~u~;LuLa in a living being to ,1; CpQnce a biologically active material therefrom, and which device is simple in .-,..sLL..~Lion, easy to use, and low in cost.
WO 95/20916 2 1 8 2 4 7 8 PCT/rJ59~012~ ~
SlJr~lARY OF T~P~ INVENT~ON
These and other objects of this invention are achieved by providing a r~nrhAhle dispensing device and method of use in a preA~t~rmin~d situs in a percutaneous inri~jnn or ~Ull~_~UL~
extending to a blood vessel, duct, lumen, organ, or other penetratable organic ~LLU-.;LULC: within the body of a living being to provide at least a first biologically active material for uptake by some internal portion of the body to achieve a desired phy~inlo~cAl effect. The peL~ Juc inri~:io~ or ~UII- LUL~
includes an opening in the tissue forming said vessel, duct, lumen, organ, or other penetratable structure and a - icating tract extending from the opening.
The ~i~p-~nAin~ device comprises anchoring means, sealing means, and positioning means. The anchoring means is ~LL~11ged to be i..LLuluced through the opening onto one side of the tissue forming the vessel, duct, lumen, organ or other pe1~LL~L~ble structure to engage a portion of that tissue adjacent the opening to hold the anchoring means in place with respect to the tissue.
The sealing means is arranged to be i..LL-,-lu-.ed into the tract adjacent the anchoring means. The positioning means is coupled to the anchoring means and the sealing means and is operative to position the sealing means with respect to the anchoring means on the other side of the tissue from the anchoring means to hold the device in position.
The first hiolo~ Al ly active material is selected to have little or no sisnificAn~ clotting or anti-clotting effect on the blood of said being but having at least one significant phys iol ogica l ef f ect , e . g ., therapeuti c , diagnostic , prophylactic. The first biologically active material is carried into the percutaneous in~ inn or ~ulleLuLe by at least one of the anchoring means and the sealing means for release theLeLL and uptake by said portion of said body to achieve a desired physiological effect.
In accordance with one aspect of this invention the ~i ~p~nl:in~ device comprises a hemostatic closure, with the sealing means h~ tically sealing the puncture tract. In such an aLL~ nt the sealing means may carry or include therein ~
wogsnogl6 2 ~ ~24 7~ PCT/US95/01211 conventional blood clotting agent, e.g., tissue thL~ ctin~
to expedite hemostasis in the tract. If the closure i8 used with the anchoring means located in a blood vessel , e . g., an artery, the anchoring means may carry or include therein a conventional non-thl, ' , i r material .
The biologically active material can be of any desired formulation and can take any desired form, e.g., it may be a time release agent which i5 released from the device at a prQAI~t~rm;n~ time after the device is in place within the percutaneous inriciorl or puncture, or may be released from the device at a predet~min-~d rate immediately upon p1s~f within the percutaneous inricinn or ~u.,.;LuLa, or may be released from the device at a prerl~t~min~l rate a pr~ t~rmin~d time after the device is in place within the percutaneous incision or ~ull- ~ULa.
RRTFF nF!~rRTP'rION OF l'HF DRAWINGS
Other objects and many of the attendant advantage~ of this invention will readily be appreciated as the same becomes better understood by reference to the following ~lC.t:l; 1 ec~ description when considered in connection with the ~ ying drawings wherein:
Fig. 1 is a top plan view of a ~licp-~ncing closure device ~UIIDLLU. Led in accu~ ce with this invention shown with the sealing ~~ L in an, - ~6sed state;
Fig. 2 i6 a top plan view, like that of Fig. 1, but showing the sealing _ L in its essed state ready for deployment into a percutaneous inr;C;o~ or ~ulluLuLa by an in~LL, like tbat ~;~rlos~d in our aforementioned cop~-n~;
patent applicationS;
Fig. 3 is a side elevational view of the anchor L
of 11; crPnc; n~ closure device shown in Figs . 1 and 2;
Fig. 4 is a top plan view of the anchor ~ shown in Fig. 3;
Fig. 5 is an isometric view of an alternative anchor cul...LLu. Led in accuLdan~_e with this invention;
Fig. 6 is an enlarged side elevational view of the anrhor ~: t shown in Fig. 5;
~ Wo9s/20s16 21 824 78 r~l,ul~ - 1211 Fig. 7 i8 an illustration, partially in section, showing the closure tl;cpPnc;n~ device of Figs. 1 - 4 located within a percutaneous ;nn~c;nn or uul-~LuLe in an artery for ~;crPnc;n~ A
binlo~;ç~lly active material from the anchor -- L into the artery;
Fig. 8 is a side elevational view of another alternative anchor L cu..DLLu~;Led in accordance with this invention;
and Fig. 9 is an illustration, similar to Fig. 7, showing an alternative closure tl;cpPnc;n~ device located within a perC~lt~npollc incision or yu~cLuLa in an artery for ~;rrpncin~ a biologically active material from the sealing _ L into the punct~2 tract; and Pig. lO is an isometric view of an alternative anchor L .
D~ATTTn nTc~ K~ L~ OF ':~T~` ~y~ K~ D~ M~
Referring now in ~reater detail to the various figures of the drawings wherein like reference characters refer to like parts, there is shown at 20 a ~icpPnc;n~ device constructed in accordance with this invention for location within a perCuts~nPn--;nn;cinn or puncture extending from the skin to some p~ L~Ldble -LLu.;LuLa located within the body of a living being in or~er to provide a biologically active material into that incis~ ~n or puncture for uptake by the being~s body. The perC~It~nP~
incision or puncture includes an opening 22 (Figs. 7 and 9) in the penetratable ~LLu~LuLe, e.g., a blood vessel, duct, lumen, organ, or other pcs~LLcltable organic ~LLu~;Lu~e, and a ;~ating tract 24 or passageway extending from the opening 22 to the surface of the skin.
In the preferred ~ c shown herein in Figs. 7 and 9 the penetratable -LLu~;LuLe: comprises an artery 26. The opening 22 extends through the wall of the artery 80 that it is in ; c~tion with the interior lumen 2 8 thereof and is also in ; cation with the ~u-l.iLuL~ tract 24 .
The cu...LLu~;Lion of the r3;cpPnc;n~ device 20 and its various L parts will be described in cnnci~prable detail later.
5uffice it for now to state that in the preferred: '~';-... . . _ _ _ _ _ _ _ _ _ _ _ . .
W0 95120916 ;;~ i ~ 2 ~ 7 ~ PCTIIIS95/0l2ll shown herein the device 20 is in the form of a closure similarto the closures of the afol- Lioned patents and patent applications. Thus, the ~;CPDnC;nq closure includes a sealing portion (to be described later) for sealing the IJUI~U~UL~: tract from the egress of body fluids therefrom. To that end, and referring now to Figs. 1-4, it will be seen that the dispensing closure 20 has three basic ts, namely, a sealing member 30, an intraarterial anchor member 32, and a positioning member 34 .
The sealing member or plug 30 comprises a cylindrical member formed of a compressible, rDc~rh1h]e, ~oll~n foam, such as that sold by Colla-Tec, Inc. of Plainchnro~ NJ. and is arranged for sealing the puncture tract 24, and in some ~10~i c, e.g-, Fig. 9, for delivering a biologically active material into the puncture tract.
The anchor member 32 is an elongated, sti~f, low-profile, r-~cnrh~hle member which i8 arranged to be seated inside the pene-trated internal ~LUe~ULe against the tissue thereof contiguous with the opening through which it had been introduced to initially position the closure. The anchor member 32 is made of non-tllL -, ic r~corh~hle material, e.g., a r~cnrh~hle polymer similar to a r~corhs~hle suture, 8uch as a r~cnrhs~h~
lactide/glycolide polymer sold by MDr1 i corh Technologies International L. P. under the trade designation MR nJC-~DI~. The strip is sufficiently rigid such that once it is has been passed through the opening 22 in the penetratable structure, e.g., the ~rtery 26, 80 that it is in its desired position it is resistant to deformation to preclude it from bending to pass back through the ~ull- ~uLe opening through which it was first i~ u-luced.
The positioning member 34 preferably comprises a f l l . ', e.g., a r~cnrh~hle suture, which cnnnclctc the anchor member 32 and the sealing member 30 (collagen plug) via a pulley-like ~ILLCII, ' Accordingly, as shown clearly in Figs. 7 and 9 when the proximal end of the f ~ 1 a ~ 3 4, which extends out of the ~u..~u.-~ tract 24, i5 pulled in the proximal direction this action serves to move the plug member 30 toward the anchor 32 (which is ~n~in~ the interior surface of the artery cnntig~n11C
WO ~!;120916 2 1 8 2 4 78 PCT/US95/OIZII
.
with the opening 22) through the Iull~LuLe tract 24, close to but not into Pn~a~, L with the exterior of the artery wall. In fact the sealing means abuts a domed portion of the anchor which extends into the opening 22. This action keeps the sealing member away from the artery, where a portion could conceivably break off and flow distally, but within the ~u~-~;LuL~ tract 24 80 that it can hemostatically seal that tract from the passage of f luid thereout .
The plug 30 is arranged to be comp~essed from the larqe r configuration shown in Fig. 1 to the small diameter, elongated configuration shown in Fig. 2. In the configuration of Fig. 2 the diameter of the plug is very small, e.g., 1.32 mm, and therefor suitable for disposition within the deployment in,.LL L (not shown) for introducing it. That in~L~, L is disclosed in the afo.. Lioned patent app~ications Serial No~.
07/846,322, filed on March 3, 1992, and ~/012,816, filed on February 3, 1993. The plug 30 includes ~n annular recess 40 extending about its outer periphery adj acent its proximal end .
Three d~eLLUL~:S 42, 44, and 46 extend through the plug. In particular, the aperture 42 is located close to the recess 40 and diamet: cally through the centerline of the plug. The ap~L Lu~ ~=
46 is ~ocated close to the distal end of the plug and extends LLc.l.~va~ely through the plug on one side of the centerline. The ~el LuLe 44 is located between ap~L LuLes 42 and 44 and extends transversely through the plug on the other side of the centerline. These al~eL LuLe s serve as p~ y~ through which the filament 34 extends to connect the anchor member 32 to the plug member 30 and are spaced apart to preclude tearing of the plug.
The manner of --~nnPct; ~n of the plug member to the anchor member serves to couple the plug ~ t to the anchor L in an arrangement to effect the r ~ L of the plug ^nt toward the anchor L, once the anchor ~ L
is in its desired position in the E,e~ L~c.table internal body l,LLUULULe, e.g., ~-~ artery-, at the ~u-.~;LuLa or ;n~ n. In particular the ~c~.rl; n~ o ~ the plug ~ to the anchor WO95~20916 lO 2 ~ ~2~ 7~ PCTIUSgS/01211 -nt simulates a pulley to achieve a desired --~hAn;
advantage .
The anchor member 32 has a generally planar top surface 48 (Fig. 3), a radially contoured bottom surface 50 and a peripheral side surface 52. Each end of the me_ber 32 is roundQd. The side surface 52 of the anchor member 32 tapers inward slightly from its top surface 48 to its bottom surface 50 to facilitate the removal of the plug from the mold for making it. A homi~:rhorical dome-like projection 54 is located at the center of the top urface 48. The top surface of the dome 54 is slightly flatted.
A cylindrical opening 60 extends transversely across the member 32 under the domed projection 54. In particular the fili ~ 34 is threaded through the cylindrical opening 60 to connect the plug member 30 to the anchor member 32. In this regard the pulley-like connection between the anchor member and the plug member i8 effected by threading the fil~ ' 34 from a remote point in a chamber (not 6hown) in the proximal portion of the deployment ir. LLI ~ through the transverse ~lJeLLULè 42, down the plug to the aperture 4 6, through that ~pel LUL è to the opposite side of the plug and from there to the anchor member where it is threaded through the opening 60. From there the ~i 1 34 extends back to the plug where it enters into aperture 44, passes through the aperture to the opposite side of the plug, where it terminates in a loop 66 extending around the annular recess 40. The loop is secured by a knot 68.
As can be seen clearly in Figs. 3 and 4, the anchor 32 inrl~l~ol:: two chambers or Lecesses 70 in the top surface 48 of the anchor adjacent each rounded end thereof. Each of these lece&&es i8 arranged to receive any suitable bjo~o~icAlly active material 72 having at least one signi~icant physiological, e.g., therapeutic, diagnostic, prophylactic, effect on the being. A
third recess or chamber may be located in the flatted top of the domed portion 54 of the anchor 32' as shown in the ~ L of the anchor of Fig. 5. In any case, and as will be appreciated by those skilled in the art, the biologically active material 72 czln take any suitable form, e.g., it may be a solid, a: ~ essed powder or tablet, a particulate or powder, a liquid, or WO 95/20916 2 1 8 2 4 7 8 P~ s i211 mi~ LuPI -r- l ~ted 8pheres or pellets. In ac~uL~ ce with the t shown in Figs. l - 7 the biologically active material 72 is held within each chamber 70 by a respective cover 74 of a thin film, e . g ., the same material as that of the anchor, which is secured by heat or a solvent to the anchor member around the periphery of the associated recess.
In the: ir- ': of the anchor 32" shown in Fig. 8 the b;nlo7ic~11y active material 72 is dispersed tllLuu~l.uuL the material making up the anchor member, i.e., the anchor member is molded with the material 72 therein.
In Fig. lO there is shown an alternative anchor t 32~ constructed in accordance with this invention. That - -nt 32"' is similar to the -nts 32, 32 ' and 32"
de6cribed heretofore eYcept for the a~.y ical shape of its ends, the flatted sides 54' of the dome shaped portion 54, and the shape of the filament 34 receiving pi~ y or opening 60'.
In any case where the anchor material enclosing the biologica:~ sr active material 72 is ro~nrh~hle, the biologically active ma~ ~rial will be released upon the resorption of the anchor member with the b~ing's body for uptake thereby.
As should be appreciated by those skilled in the art pe~nr~;n~ upon the application desired the anchor member may be constructed and the biological material 72 chosen so that it will be released or gain egress from the anchor member immediately following the rla~ ~ of the dispensing closure device 20 within the percutaneous in~ ;oll or IJUlle~ULt: or may be arranged to be released or gain egress therefrom a pr~APtor~n;nDd time after location within the patient's body. In fact, the release of the material 72 may be A~ hPd at once or over some period of time, be it prc-~racted or short, and at a pLe~ LP-, ;n~cl or controlled rate, iLLe~.~e- Live of the time that the release begins. To achieve those ends the anchor member and/or t_e material 72 may be cû~.:.LLu~Led in various ways which will be n~yaLellL to those skilled in the art.
As should be appreciated from the foregoing when the tl;~p-~nc:;n~ closure device 20 is cu..~.LLu~;Led in accordance with the t~:~ch; n~c~ of Figs . 1 - 7 and is used so that the anchor _ _ _ _ _ . _ _ _ ~ 1 ~2~7~ ~
member 32 iæ located within an artery 26, a duct, or other fluid carrying lumen, once the biologically active material 72 is rele~sed from the anchor, it may be carried by the fluid flowing through that lumen to immediately adj acent tissue or to tissue at remote locations.
In Fig. 9 there is shown an alternative : ~; L of a p~nc;ng closure device constructed in accordance with this invention for ti~RpDncin~ a biologically active material directly into the ~UII-:LUL_ tract 24, and from there, if desired through the opening 22 in the tissue of the penetratable tiLLUU~UL~ into the structure itself, e. g., the artery . To achieve that end the fl~RpDn~:in~ closure device 20' sf Fig. 9 is similar in cu.-,,LLuuLion to the device 20 of Fig. 7 except that the sealing member or plug 30' includes the biologically active material 72.
In such a case the anchor member 32 ' need not contain the biologically active material 72 talthough it could contain the same or another biologically active material, if desired~. If no biologically active material is needed to be carried by the anchor member into the being's body the anchor member need not utilize any recesses 70. However, if desired the anchor can still make use of such rb- esses to hold a r~ i op~ material therein, such as lliCrlr~Co~ in the aforementioned application 07/846,322, to facilitate fluoroscopic pl~ L of the ~Rp~n~:;n g closure device 20. In fact, the recesses 70 in the anchor may be provided and left hollow, albeit covered with the covers 74, to create a pair of hollow spaces which may be readily visible using conventional imaging t~rhnirllDC.
The biologically active material 72 may be incorporated into the plug 30 in any suitable manner, e.g., as a coating on its surface(s), as microspheres or particulates el~LLc.~yed within the plug material , e . g ., as a collagen foam f ibrillar matrix of the coll~ n making up the plug and the biologically active material 72, or in any other suitable manner which will be apparent to those skilled in the art.
The tliRpDnRinrJ closure device 20 i5 used as follows: the physician inserts the delivery or deployment in.,LL, L (not æhown) containing the device 20 into a conventional introducer _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ~ WO 95/20916 2 ~ 8 2 4 7 8 PCT/llS9SJi)~211 sheath (not shown) extending into the patient's body to the situs of the structure to be penetrated and dosed with the biologically active material. In the case where the biologically active material i6 to be illLr~luced into a percutaneous incision or ~U-I. LuL-~ extending into a artery the dosing ~ce-luLe is as follows: the anchor member 32/32' is passed out Or the distal end of the introducer sheath in the manner disclosed in our afo~ Lioned applications so that it i5 deployed within the artery lumen. The deployment inaLL, L is then withdrawn from the introducer sheath until resistance is felt when the anchor member catches on the distal end thereof. Once this occurs (and F~lm; n~ that the anchor is in the correct orientation when it catches on the end of the i~LL-~-lu~eL sheath the deployment ina LL, L and the introducer sheath are then immediately withdrawn together. This withdrawing action causes the anchor member 32/32 ' to engage (catch) or2. the inner surface of the artery wall 26 contiguous with the puncture's opening 22. Con-tinued withdrawal of the illaLL L and illLL~-luc~r sheath cause~
the pulley-like configuration of the fil L 34 to pull the coll~ n plug 30/30' toward the anchor member 32/32', thereby depositing the plug in the ~u-~ LuLt tract 24 adjacent the exterior of the artery contiguous with the yul~;LuL~:. The plug 30/30' doea not engage the arterial wall but rather it contacts the flatted domed portion 54 of the anchor member 32/32 ' which extends from the interior of the artery into and somewhat through the opening 22 in the artery wall (See Figs. 7 and 9). This action prevents the plug 30/30' from being pulled into the artery's interior. The pulling on the f;l; L 34, to bring the sealing member or plug 30,30' into ~n~il-, L with the anchor's dome 54, also has the effect of deforming the plug 30/30' into a larger diameter body tc aid in holding it in place within the LUL~ tract 24 as shown in Figs. 7 and 9. IIol.:ov-aL, since the plug 30/30' is formed of ~c:ssed c~ g~n or other hydrophilic material it also expands automatica7 ly in the p~es~ e of blood within the ~u,.~.Lu-e tract 24 w~n deployed, thereby further contributing to the plug's enlargement. Further sti1l, the deployment il-aLL L includes a tamper (not ~how~
wo 9S/20916 2 1 ~ 2 4 7 ~ PCT/US9SJ01211 ~
which i5 mounted on the f i 1 i L 34 and which is slidable thereon .
The deployment of the ~'iiRp~nRin~ closure device 20 also effects the deployment of the tamper into the ~ul~uLuL~: tract 24 proximally of the plug 30/30'. The tamper is then uæed to gently compress and lock the collagen plug 30/30' on the suture filament 34 within the ~ulluLuL~3 tract 24, but outside of the artery. The closure 20 is now locked in place through the clotting of the atic coll il~on plug and by spring tension provided by spring means (not shown) and forming a portion of the deployment ~ystem located on the f ilament 3 4 .
Immediately after rl P.' - t the anchor 32 starts to absorb water and to break down by hydrolysis. The process of Qnt~r6~ tion of the anchor by the arterial wall also ~ 3f.
After approximately thirty days, only a small deposit of anchor material will remain. In fact, resorption of all, ~s will have ocuuLL~d after approximately sixty days.
When the ~iiRpDncing closure device 20 is CU~ L u~ed like the ~ t shown in Fig. 7 and i6 located within the percl~tAn~ollR incision or pul~uLuL~: as shown, upon the resorption of the anchor member 32/32'/32" itself or of the material 74 forming the chamber cover 74 the biologically active material 72 gains egress from the anchor and is picked up by the blood as shown gr~rh; ci~1 l y by the arrows designated with the reference nu~ber 80. The biologically active material is then taken up by the patient's body. When the tiiRp~nRin~ closure device 20 is ~u~.a~Lu~iLed like the I 'i- L shown in Fig. 9 and is located within the percutaneous i n--i Rinn or puncture as shown the biologically active material 72 in the sealing plug 30' gains egress from the sealing plug and is picked up by the blood or other fluid in the tissue contiguous with the ~UII~:LULt: tract 24 ns shown gr~rhir~lly by the arrows designated with the reference number 82. D~r~nAinq upon the composition of the material 72 some of it may flow through the opening 22 into the interior of the artery for uptake by a remote portion of the patient's body.
If desired a spacer member (not shown), like that ~liRC~or"d and claimed in our afuI~ ~ioned rop nrlin~ application S.ll_ _ _ _ _ _ _ ~ WO 95120916 2 l 8 2 4 7 8 1 ~1/. s~
08/012,816 may be utilized interposed between the anchor member 32 and the sealing or plug me~ber 30 to further space the plug member from the artery. The spacer member may, ir desired, be constructed, to include any type of biologically active material 72 therein. In such a case the spacer member will also serve to deliver that biological material into the ~JUl~;L.ULe~ tract 24 ~or uptake by the body.
Nithout further elaboration the foregoing will 80 fully illustrate our invention that others may, ~y applying current or future knowledge, adopt the same for use under various conditions o~ service.
Claims (24)
1. A resorbable dispensing device (20, 20') for location at a predetermined situs in a percutaneous incision or puncture (22, 24) extending to a blood vessel, duct, lumen, organ, or other penetratable organic structure within the body of a living being to provide at least a first biologically active material (72) at said situs for uptake by some internal portion of the body of said being to achieve a desired physiological effect, said percutaneous incision or puncture including an opening (22) in the tissue forming said vessel, duct, lumen, organ or other penetratable structure and a communicating tract (24) extending from said opening, characterized in that said device (30) comprises anchoring means (32, 32', 32", 32"'), sealing means 30, 30'), and positioning means (34), said anchoring means (32, 32', 32", 32"') being arranged to be introduced through said opening (22) onto one side of the tissue forming said vessel, duct, lumen, organ or other penetratable structure to engage a portion of said tissue adjacent said opening to hold said anchoring means in place with respect to said tissue, said sealing means (30, 30') being arranged to be introduced into said tract (24) adjacent said anchoring means (32, 32', 32", 32"'), said positioning means (34) being coupled to said anchoring means (32, 32', 32", 32"') and said sealing means (30, 30') and being operative to position said sealing means with respect to said anchoring means on the other side of said tissue from said anchoring means to hold said device in position, said first biologically active material (72) being selected to have little or no significant clotting or anti-clotting effect on the blood of said being but having at least one significant physiological effect, said first biologically active material being carried by at least one of said anchor means (32, 32', 32", 32"') and said sealing means (30) for release therefrom and uptake by said portion of said body to achieve a desired physiological effect.
2. The device (20, 20') of Claim 1 characterized in that said biologically active material (72) is selected so that said physiological effect is therapeutic.
3. The device (20, 20') of Claim 1 characterized in that said biologically active material (72) is selected so that said physiologic effect is diagnostic.
4. The device (20, 20') of Claim 1 characterized in that said biologically active material (72) is selected so that said physiological effect is prophylactic.
5. The device (20, 20') of Claim 1 characterized in that said biologically active material (72) is in time release form.
6. The device (20, 20') of Claim 5 characterized in that said biologically active material (72) is released from said device at a predetermined time after said device is in place.
7. The device (20, 20') of Claim 5 characterized in that said biologically active material (72) is released from said device at a predetermined rate.
8. The device (20, 20') of Claim 6 characterized in that said biologically active material (72) is released from said device at a predetermined rate.
9. The device (20, 20') of Claim 1 characterized in that said device comprises a closure wherein said sealing means (30, 30') hemostatically seals said puncture tract from the egress of fluid therefrom.
10. The device (20) of Claim 9 characterized in that said sealing means (30') carries a second biologically active material in the form of a conventional blood clotting agent.
11. The device (20, 20') of Claim 9 characterized in that said anchoring means (32, 32', 32'', 32''') comprises a second biologically active material (72 ) in the form of a non-thrombogenic material.
12. The device (20') of Claim 10 characterized in that said anchoring means (32') comprises a third biologically active material (72) in the form of a non-thrombogenic material.
13. A method of using a resorbable device (20, 20') including an anchoring means (32, 32', 32", 32"'), a sealing means (30, 30'), and a positioning means (34) to provide at least a first biologically active material (72) into a vessel, duct, lumen, organ, or penetratable structure within the body of a living being by inserting the device (20, 20') into a predetermined situs in a percutaneous incision or puncture (22, 24) in the body of a living being, said percutaneous incision or puncture including an opening (22) in the tissue forming a vessel, duct, lumen, organ, or structure, in the body of the being, and a tract (24) extending from said opening to the surface of the skin of the being, characterized in that said method comprises the steps of providing said first biologically active material (72) for transportation into said percutaneous incision or puncture by said device, said first biologically active material (72) being selected to have little or no significant clotting or anti-clotting effect on the blood of said being but having at least one significant physiological effect, introducing said anchor means (32, 32', 32", 32"') through said opening (22) into the interior of the vessel, duct, lumen, organ, or penetratable structure to engage a portion of the tissue thereof adjacent said opening, introducing said sealing means (30, 30') into said tract (24), coupling said positioning means (34) between said anchoring means and said sealing means and operating said positioning means to cause said sealing means to position said sealing means at a desired position with respect to said anchoring means and whereupon said sealing means engages tissue contiguous with said tract, said first biologically active material being released from said device for uptake by some internal portion of the body of said being after location at said situs.
14. The method of using the resorbable device (20, 20') as set forth in Claim 13 characterized in that said step of introducing said sealing means (30, 30') is carried out to hemostatically seal said tract (24) from the egress of liquid therefrom.
15. The method of using the resorbable device (20') as set forth in Claim 14 additionally characterized by providing said sealing means (30') with a second biologically active material in the form of a conventional blood clotting agent to be carried by said sealing means (30') into said tract (24).
16. The method of using the resorbable device (20, 20') as set forth in Claim 14 additionally characterized by providing said anchoring means (32, 32', 32", 32"') with a second biologically active material (72) in the form of a non-thrombogenic material to be carried by said anchoring means into said vessel, duct, lumen, organ, or penetratable structure.
17. The method of using the resorbable device (20, 20') as set forth in Claim 15 additionally characterized by providing said anchoring means (32, 32', 32", 32"') with a third biologically active material (72) in the form of a non-thrombogenic material to be carried by said anchoring means into said vessel, duct, lumen, organ, or penetratable structure.
18. The method of using a resorbable device (20,20'), as set forth in Claim 13 characterized by releasing said first biologically active material to provide a therapeutic effect.
19. The method of using a resorbable device (20,20'), as set forth in Claim 13 characterized by releasing said first biologically active material to provide a diagnostic effect.
20. The method of using a resorbable device (20,20'), as set forth in Claim 13 characterized by releasing said first biologically active material to provide a prophylactic effect.
21. The method of using a resorbable device (20,20'), as set forth in Claim 13 characterized by providing said first biologically active material in time release form.
22. The method of using a resorbable device (20,20'), as set forth in Claim 13 characterized by releasing said first biologically active material from said device at a predetermined time after said device is in place.
23. The method of using a resorbable device (20,20'), as set forth in Claim 13 characterized by releasing said first biologically active material from said device at a predetermined rate.
24. The method of using a resorbable device (20,20'), as set forth in Claim 22 characterized by releasing said first biologically active material from said device at a predetermined rate.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US19137694A | 1994-02-01 | 1994-02-01 | |
| US08/191,376 | 1994-02-01 | ||
| PCT/US1995/001211 WO1995020916A1 (en) | 1994-02-01 | 1995-01-31 | Percutaneous drug dosing closure system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2182478A1 true CA2182478A1 (en) | 1995-08-10 |
Family
ID=22705240
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002182478A Abandoned CA2182478A1 (en) | 1994-02-01 | 1995-01-31 | Percutaneous drug dosing closure system |
Country Status (4)
| Country | Link |
|---|---|
| JP (1) | JPH09508543A (en) |
| AU (1) | AU1609195A (en) |
| CA (1) | CA2182478A1 (en) |
| WO (1) | WO1995020916A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9055937B2 (en) | 2011-04-01 | 2015-06-16 | Edwards Lifesciences Corporation | Apical puncture access and closure system |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2326344A (en) * | 1997-06-18 | 1998-12-23 | John Overton Hudson | Filling means for repairing an intestinal diverticulum |
| US6306154B1 (en) | 1997-06-18 | 2001-10-23 | Bhk Holding | Hemostatic system for body cavities |
| US7070607B2 (en) | 1998-01-27 | 2006-07-04 | The Regents Of The University Of California | Bioabsorbable polymeric implants and a method of using the same to create occlusions |
| US5935145A (en) | 1998-02-13 | 1999-08-10 | Target Therapeutics, Inc. | Vaso-occlusive device with attached polymeric materials |
| US6706051B2 (en) | 1998-04-08 | 2004-03-16 | Bhk Holding, Ltd. | Hemostatic system for body cavities |
| US7018392B2 (en) | 1998-04-08 | 2006-03-28 | Arthrocare Corporation | Hemostatic system for body cavities |
| US7662161B2 (en) | 1999-09-13 | 2010-02-16 | Rex Medical, L.P | Vascular hole closure device |
| GB0011053D0 (en) | 2000-05-09 | 2000-06-28 | Hudson John O | Medical device and use thereof |
| US8105352B2 (en) | 2004-12-16 | 2012-01-31 | Radi Medical Systems Ab | Medical sealing device |
| US20080114395A1 (en) | 2005-01-14 | 2008-05-15 | Radi Medical Systems Ab | Closure Device |
| JP5225072B2 (en) | 2005-04-22 | 2013-07-03 | レックス メディカル リミテッド パートナーシップ | Left atrial appendage obturator |
| WO2009011751A1 (en) | 2007-07-13 | 2009-01-22 | Rex Medical, Lp | Vascular hole closure device |
| US9226738B2 (en) | 2008-02-15 | 2016-01-05 | Rex Medical, L.P. | Vascular hole closure delivery device |
| US8070772B2 (en) | 2008-02-15 | 2011-12-06 | Rex Medical, L.P. | Vascular hole closure device |
| US8491629B2 (en) | 2008-02-15 | 2013-07-23 | Rex Medical | Vascular hole closure delivery device |
| US11504105B2 (en) | 2019-01-25 | 2022-11-22 | Rex Medical L.P. | Vascular hole closure device |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4364392A (en) * | 1980-12-04 | 1982-12-21 | Wisconsin Alumni Research Foundation | Detachable balloon catheter |
| DE3214337C2 (en) * | 1982-04-19 | 1984-04-26 | Serapharm - Michael Stroetmann, 4400 Münster | Resorbable flat material for sealing and healing wounds and processes for their manufacture |
| NL8901350A (en) * | 1989-05-29 | 1990-12-17 | Wouter Matthijs Muijs Van De M | CLOSURE ASSEMBLY. |
| CA2078530A1 (en) * | 1991-09-23 | 1993-03-24 | Jay Erlebacher | Percutaneous arterial puncture seal device and insertion tool therefore |
| US5282827A (en) * | 1991-11-08 | 1994-02-01 | Kensey Nash Corporation | Hemostatic puncture closure system and method of use |
-
1995
- 1995-01-31 JP JP7520681A patent/JPH09508543A/en active Pending
- 1995-01-31 CA CA002182478A patent/CA2182478A1/en not_active Abandoned
- 1995-01-31 AU AU16091/95A patent/AU1609195A/en not_active Abandoned
- 1995-01-31 WO PCT/US1995/001211 patent/WO1995020916A1/en active Search and Examination
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9055937B2 (en) | 2011-04-01 | 2015-06-16 | Edwards Lifesciences Corporation | Apical puncture access and closure system |
Also Published As
| Publication number | Publication date |
|---|---|
| WO1995020916A1 (en) | 1995-08-10 |
| AU1609195A (en) | 1995-08-21 |
| JPH09508543A (en) | 1997-09-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |