WO1996024291A1 - Systeme de fermeture de point de piqure - Google Patents

Systeme de fermeture de point de piqure Download PDF

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Publication number
WO1996024291A1
WO1996024291A1 PCT/US1995/001598 US9501598W WO9624291A1 WO 1996024291 A1 WO1996024291 A1 WO 1996024291A1 US 9501598 W US9501598 W US 9501598W WO 9624291 A1 WO9624291 A1 WO 9624291A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
body cavity
control member
expandable
sealing material
Prior art date
Application number
PCT/US1995/001598
Other languages
English (en)
Inventor
Christopher U. Cates
William D. Knopf
Douglass G. Whitney
Original Assignee
Cardiovascular Ventures, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Cardiovascular Ventures, Inc. filed Critical Cardiovascular Ventures, Inc.
Priority to AU19658/95A priority Critical patent/AU1965895A/en
Priority to PCT/US1995/001598 priority patent/WO1996024291A1/fr
Publication of WO1996024291A1 publication Critical patent/WO1996024291A1/fr

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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

Definitions

  • This invention relates generally to the stopping of bleeding from blood vessels through openings in the vessel wall and more particularly through surgically produced punctures for different medical procedures.
  • Certain medical procedures require the percutaneous puncturing of a blood vessel to gain access to the interior of the vascular system of the patient for the procedure to be conducted.
  • Procedures that commonly require such an percutaneous punctures are balloon angioplasty procedures, arteriography, venography, angiography and other diagnostic procedures that use blood vessel catheterization.
  • the percutaneous opening or puncture is made into a relatively large blood vessel such as a femoral artery.
  • One of the difficulties in these procedures is reclosure of the opening in the blood vessel wall after the procedure.
  • manual pressure and/or mechanical clamping pressure have been used to physically hold the opening closed until a blood clot formed with sufficient strength to keep the opening blocked until healing takes place.
  • several techniques have been used to insert a collagen plug in the tissue access passage to the blood vessel that promotes the formation of a coagulum at the vessel wall opening.
  • One such prior art technique simply inserts the collagen plug into the access passage in the tissue to the vessel wall puncture.
  • the difficulty with this procedure is that there is no practical way to positively limit the protrusion of the collagen into the interior of the blood vessel. This sometimes results in the collagen being inserted or subsequently expanding through the blood vessel wall opening into the vessel lumen and causing a blood clot to form in the interior of the blood vessel. This is undesirable because the clot and/or the protruding collagen can dislodge and move along the blood vessel to cause an embolus.
  • the clot formed at the interior end of the puncture site can serve to undesirably restrict the blood flow past the site (i.e. thrombosis).
  • Another technique is to insert a sealing plug through the opening in the blood vessel wall with a first orientation and then turned to an orientation such that it will not pass back out through the opening.
  • the sealing plug is manipulated by a lanyard which extends back out through the tissue access passage exteriorly of the patient's body to be manually held.
  • the collagen plug is then passed down over the lanyard while the sealing plug is manually held in the blood vessel wall opening. Enough seepage of blood around the sealing plug is present to form the clot at the blood vessel wall opening.
  • the sealing plug is left in position in the blood vessel wall and is made out of a material which is absorbable by the body over a several weeks or months period.
  • the problem with this technique is that the sealing plug may break loose before it is absorbed by the body and cause a blockage of the blood flow through the blood vessel.
  • the sealing plug may be a nidus for a blood clot to form and subsequently dislodge resulting in embolization.
  • Another potential problem in leaving a device inside the vessel wall is that the device, like any foreign body, may erode the wall of the vessel or promote extensive intravascular scaring both of which potentially will disrupt vessel architecture.
  • the tamponading means is selectively expandable to an expanded size and shape such that it will not pass back out through the blood vessel wall opening and its position in the blood vessel is controlled by a control member extending exteriorly of the patient for easy manipulation.
  • tamponading means is selectively collapsible to a collapsed condition small enough to pass back out through the installed collagen plug without interfering with the coagulum forming capability of the collagen plug.
  • the technique is simple to use and the location of the collagen plug is inherently accurately positioned at the blood vessel wall opening independently of variances in the patient's skin and tissue thickness at the puncture site and without premeasuring or adjustment of the applicator.
  • the method of the invention is directed to the sealing a percutaneous puncture through a blood vessel wall comprising the steps of inserting a collapsed expandable tamponading member attached to a control member into the blood vessel lumen through 3 the blood vessel wall puncture so that the control member extends out of the patient through the access passage to the skin surface; expanding the tamponading member to a size larger than the blood vessel wall puncture; pulling the expanded tamponading member back against the blood vessel wall opening using the control member to form a seal at the interior end of the blood vessel wall puncture; inserting a collagen plug into the access passage around the control member while the seal is maintained at the blood vessel wall puncture until the leading end of the collagen plug is located at the exterior end of the blood vessel wall puncture; then collapsing the tamponading member to the collapsed condition; and retracting the collapsed tamponading member back through the collagen plug.
  • the collagen plug has a preformed passage therethrough which slidably receives the control member to allow placement of the collagen plug along the control member.
  • the collagen serves to induce a coagulum that seals the outside end of the puncture in the blood vessel wall. After the collapsed tamponading member is pulled back through the collagen plug, the collagen plug self seals any opening through the plug left by the passage of the expandable member.
  • the collagen plug may be housed in a retractable barrel while the collagen plug is inserted into the access passage and the barrel then retracted from around the collagen plug while maintaining the collagen plug in a substantially fixed position in the access passage. The barrel may be retracted fully or partially from around the collagen plug before the expanded tamponading member is collapsed and withdrawn.
  • the method may also include visually indicating when the projecting end of the collagen plug is located at the exterior end of the blood vessel puncture.
  • the collagen plug may also be backed up while the collapsed tamponading member is withdrawn through the plug to insure that the plug remains in place.
  • the collagen plug may also be urged slightly toward the blood vessel wall puncture to compensate for any loss in volume of the collagen plug as it turns into a gelatinous mass.
  • the apparatus of the invention comprises a temporary sealing arrangement including an elongate flexible control portion small enough to pass through the blood vessel wall puncture with an expandable tamponading portion on the projecting end of the control portion collapsible to a condition smaller than the blood vessel wall puncture and expandable to a condition larger than the blood vessel wall puncture so that it will not easily pull back through the puncture.
  • An applicator is provided to install the collagen plug in the access passage through the skin and tissue of the patient down to the exterior end of the blood vessel wall. The applicator cooperates with the control portion of the temporary sealing arrangement to fixedly locate the applicator with respect to the exterior end of the blood vessel wall and facilitate the positioning of the collagen plug with respect to the exterior end of the blood vessel wall puncture.
  • the applicator includes a plug carrying assembly with a prescribed length used to insert the collagen plug.
  • the control portion of the sealing arrangement includes indicia spaced a prescribed locating distance from that side of the expanded tamponading portion facing the puncture to provide a visual indication that the leading end of the collagen plug is located at the exterior end of the blood vessel wall puncture.
  • the plug carrying assembly has an installation barrel defining a plug carrying chamber therein adapted to receive the collagen plug for installation in the access passage and a retraction arrangement is provided for selectively retracting the installation barrel from around the collagen plug while maintaining the plug at a substantially fixed position relative to the exterior end of the blood vessel wall puncture.
  • the applicator may have a tightening mechanism for pulling the expanded tamponading portion of the temporary sealing arrangement tighter against the blood vessel wall puncture as the installation barrel is withdrawn from around the collagen plug.
  • the applicator may also have an urging mechanism for urging the exterior end of the collagen plug toward the blood vessel wall with a slight force just sufficient to offset volume loss as the collagen plug softens to a gelatinous mass on contact with body fluids. This is especially true while the collapsed tamponading member is being withdrawn.
  • the expanded tamponading portion of the sealing arrangement may be an inflatable balloon with an inflation lumen through the control portion for use in selectively inflating the balloon to the expanded condition.
  • Fig. 1 is a perspective view of a first embodiment of the invention
  • Fig. 2 is an enlarged longitudinal cross-sectional view of the applicator
  • Fig. 3 is an enlarged longitudinal cross-sectional view of the expandable tamponading member
  • Fig.4 is an enlarged longitudinal cross-sectional view of the coupling arrangement on the end of the control member
  • Figs. 5-9 illustrate one embodiment of the method of the invention
  • Fig. 10 is an enlarged longitudinal cross-sectional view of another embodiment of the expandable tamponading member
  • Fig. 11 is a perspective view of a second embodiment of the invention.
  • Fig. 12 is an enlarged transverse cross-sectional view taken along line 12-12 in Fig.
  • Fig. 13 is an enlarged transverse cross-sectional view taken along line 13-13 in Fig.
  • Fig. 14 is an enlarged transverse cross-sectional view taken along line 14-14 in Fig.
  • Fig. 15 is an enlarged perspective view of the collagen plug used in that embodiment of the applicator seen in Figs. 11-14;
  • Fig. 16 is a perspective view of a third embodiment of the invention.
  • Fig. 17 is a longitudinal cross-sectional view of the collagen plug of the third embodiment of the invention.
  • Fig. 18 is a longitudinal cross-sectional view of another embodiment of the invention.
  • the blood vessel sealing system 10 is used to stop the bleeding from a percutaneous puncture BVP made in the wall BVW of a blood vessel BV as an incident to a medical procedure.
  • the blood vessel BV used is a femoral artery in the groin region with a relatively large vessel passage or lumen BVL to facilitate locating the blood vessel and permits a sufficiently large puncture to be made through the wall BVW thereof to carry out the procedure.
  • Medical procedures which are typically performed through such an puncture are angioplasty and other procedures which pass a catheter or other type probe into and along the blood vessel lumen BVL.
  • an initial percutaneous puncture with an appropriate needle is made from the patient's skin through the tissue and the blood vessel wall into the blood vessel lumen and a guide wire installed.
  • the needle is then removed leaving the guide wire in place and a tapered introducer guide sheath GS is installed over the guide wire to enlarge that portion of the puncture through the skin and tissue into an access passage AP while the blood vessel wall puncture BVP remains at about the original puncture size.
  • the guide sheath GS serves to keep the passage open and prevent further damage to the tissue and skin around the passage.
  • the guide sheath GS is removed after the procedure is completed. This sheath GS assists in the installation of the sealing system 10 as will become more apparent.
  • the sealing system 10 embodying the invention includes generally a temporary sealing assembly 11, a collagen plug 12 and an applicator 14.
  • the sealing assembly 11 is inserted into the blood vessel lumen BVL through the introducer guide sheath GS and then the sheath removed leaving the sealing assembly in place.
  • the sealing assembly 11 serves to temporarily seal the interior end of the puncture BVP in the blood vessel wall BVW while the collagen plug 12 is placed in the access passage AP to the exterior end of the puncture BVP.
  • the temporary sealing assembly 11 is removed through the collagen plug to insure that nothing protrudes into the blood vessel lumen BVL to cause problems later.
  • the applicator 14 serves to install the collagen plug 12 in the access passage AP around the temporary sealing assembly 11 so the collagen plug 12 can cause a coagulum to form at the exterior end of the blood vessel wall puncture BVP and stop the bleeding through the puncture.
  • the sealing assembly 11 includes an elongate flexible control member 20 on which is mounted an expandable tamponading member 21.
  • the control member 20 is designed for the projecting end 22 thereof to pass through the guide sheath GS in the access passage AP and then through the puncture BVP in the blood vessel wall BVW into the blood vessel lumen BVL while the opposite end 24 thereof remains exteriorly of the patient.
  • the projecting end 22 extends through the tamponading member 21 sufficiently for the control member 20 to still extend into the blood vessel lumen BVL after the tamponading member is removed from the patient so that the tamponading member 21 can be reinserted if necessary in the event of a failure.
  • the exterior end 24 of the member 20 is provided with a coupling 25 for connection to an expanding mechanism 26 for selectively expanding the tamponading member 21 from a collapsed condition as seen by solid lines in Fig. 1 closely adhering to the control member outside surface to an expanded condition as will become more apparent.
  • the tamponading member 21 may be mechanically, electrically, pneumatically or hydraulically expanded and collapsed without departing from the scope of the invention.
  • the particular expanded exterior configuration of the tamponading member 21 can be selected depending on the particular circumstances of use.
  • the configuration may be elongated in one direction and/or may have a flattened side facing the blood vessel wall puncture BVP after the tamponading member 21 is located in the blood vessel lumen BVL.
  • the criteria that is used to determine the particular size and configuration is the blood vessel condition at the puncture BVP and the cross-sectional size and shape of the blood vessel lumen BVL in the vicinity of the puncture BVP.
  • the largest cross-sectional dimension of the expanded tamponading member 21 must be small enough for the member 21 to be pulled back against the interior end of the puncture BVP without dragging or hanging up in the blood vessel lumen BVL. It has been found that an expanded dimension in one direction for the member 21 that is at least about 1.5 times larger than the puncture BVP is satisfactory to prevent the tamponading member 21 from being pulled back through the puncture BVP under typical conditions. That portion of the tamponading member 21 at the puncture BVP must be larger than the size of the puncture BVP to insure sealing when the tamponading member 21 is pulled back up against the interior end of the puncture BVP as will become more apparent. While different expanded sizes may be used, dimensions on the order of 0J50-0.200 inch (3.8-5J mm) should be successful under typical conditions where the puncture BVP is made with a 4 french puncture.
  • the particular tamponading member 21 illustrated in Fig. 3 is a small inflatable balloon which can be inflated to a size and configuration sufficiently larger than the blood vessel wall puncture BVP to prevent the expanded balloon member 21 from being pulled back through the puncture BVP while at the same time not hanging up in the blood vessel lumen BVL in its expanded condition.
  • the member 21 In the expanded condition, the member 21 has a puncture facing side that is substantially normal to the centerline of the control member 20.
  • the inflatable balloon member 21 may be made out of any suitable material such as latex. The balloon member 21 is inflated and deflated through the control member 20 as will become more apparent.
  • the control member 20 is a thin elongate member similar in size and flexibility to the guide wire used to originally install the sheath GS in the access passage AP.
  • the control member 20 is sufficiently long to extend from within the blood vessel lumen BVL out through the puncture BVP and the access passage AP exteriorly of the patient so that it can be manually manipulated and is also long enough that the guide sheath GS can be removed while manually holding the expanded tamponading member 21 in place over, the puncture BVP to maintain the seal.
  • the control member 20 defines an inflation lumen 28 therein seen in Figs. 3 and 4 that extends from and communicates with the interior of the balloon member 21 along the length of the member 20 and opens out through the coupling 25.
  • the balloon tamponading member 21 can be inflated and deflated through the lumen 28 from a position external to the patient.
  • the balloon member 21 is inflated by any convenient fluid inflation device such as the syringe 26 illustrated.
  • the syringe 26 or other inflation device will be of the same type as that already used in balloon angioplasty and has an extension 31 sized similarly to the control member equipped with a mating coupling 30 to be selectively connected to the coupling 25 on the end of the control member 20.
  • the inflation fluid under pressure from the syringe 26 flows along the inflation lumen 28 in the control member 20 into the balloon member 21 to inflate same.
  • the balloon member 21 can be maintained inflated by providing a check valve 29 on the exterior end 24 of the control member 20.
  • the check valve 29 may be incorporated in the coupling 25 or be a separate member as shown in the drawings at Fig.4.
  • the physician can insert a needle into the valve 29 to open it or if the valve is a separate member, the valve 29 can simply be removed from the coupling 25.
  • the outside diameter of the member 20 including the coupling 25 and the check valve 29 should be as small as possible in order to pass freely through the puncture BVP and to pass through the collagen plug 12 without significantly disturbing it. While different diameters may be used, diameters of 0.030-0.050 inch (.8-1.3 mm) are satisfactory.
  • the applicator 14 best seen in Figs. 1 and 2 includes a housing assembly 35 which mounts an introducer assembly 36 to house the collagen plug 12 while it is inserted into the access passage AP.
  • a retraction mechanism 38 withdraws the introducer assembly 36 from around the collagen plug 12 after it is inserted in the patient.
  • An interconnect assembly 39 interconnects the control member 20 and the applicator 14 to positively locate the tamponading member 21 with respect to the introducer assembly 36 is being withdrawn from around the collagen plug.
  • a locator mechanism 40 is provided on the housing assembly 35 to be adjusted for a secondary fixed point of reference as the introducer assembly 35 is being withdrawn from around the collagen plug by the retraction assembly 38.
  • the housing assembly 35 includes an elongate cylindrical body 45 with a hand grip 46 on one end thereof.
  • the body defines an introducer passage 48 seen in Fig. 2 centrally therethrough that receives the introducer assembly 36 therein.
  • a side slot 49 is defined through the wall of the body 45 and extends lengthwise of the body in alignment with the hand grip 46 for the manually engageable portion of the retraction mechamsm to extend for manipulation.
  • the introducer assembly 36 includes a thin wall insertion barrel 50 slidably mounted in the body 45 of the housing assembly 35.
  • the barrel has a projecting end 51 thereon that is inserted into the access passage AP and an opposite rear end.
  • the barrel 50 defines a collagen plug receiving passage therein and is provided with an inwardly directed flange 52 at the rear end thereof.
  • the barrel 50 has a length sufficient for the barrel to project from the body 45 far enough for the barrel to extend along the access passage AP to the wall of the blood vessel BV.
  • the barrel 50 is slidably mounted over a locator plunger 55 carried by the body 45 of the housing assembly 35 to maintain the collagen plug in place as the installation barrel 50 is being retracted.
  • the plunger 55 has an enlarged head 56 on the projecting end thereof which fills the cross-sectional space in the plug receiving passage under the flange 52 when the barrel is fully extended.
  • the smaller diameter support shaft 58 of the plunger 55 slidably extends through the opening in the flange 52 and is attached to the rear end of the body 45.
  • the projecting face of the head 56 is spaced from the projecting end of the barrel 50 a distance substantially equal to the length of the collagen plug 12 when the barrel 50 is fully extended from the body 45 with the flange 52 on the barrel 50 against the rear annular face of the head 56 to insure that the plug will be properly in position.
  • the retraction mechanism 38 is attached to the barrel 50 and projects through the slot 49 through the body 45.
  • the mechamsm 38 may be any convenient arrangement which can retract the barrel 50 into the body 45.
  • the mechanism 38 illustrated as an example includes a connector ring 60 attached to the rear side of the flange 52 on the barrel 50 to slide in the passage 48 with the barrel and a manually engagable actuator member 61 attached to the ring 60 and projecting out through the slot 49 to be manually engaged and pulled back toward the hand grip 46 pulling the banel 50 therewith.
  • the actuator member 61 is resiliently connected to the ring 60 so that it is urged away from the ring and is equipped with a ratchet pawl 62 that prevents the ring 60 and thus the barrel 50 from moving toward the trailing end of the body 45 until the actuator member 61 is pulled back toward the hand grip 46. This action pivots the actuator member 61 and the ratchet pawl 62 out of engagement with the wall of the body 45 to release the barrel 50 for retraction.
  • the applicator 14 has a prescribed overall length L j when the barrel 50 is extended. This length cooperates with the control member 20 to let the physician know when the projecting end 5 ⁇ t f of the banel 50 is located at the blood vessel wall BVW.
  • the control member 20 is marked with appropriate indicia 65 that will be exposed at the trailing end of the applicator 14 when the projecting end of the barrel and thus the collagen plug is located at the exterior end of the puncture BVP through the wall of the blood vessel.
  • the indicia 65 is shown is a safety band 66 spaced so that, as long as the safety band 66 is visible on the trailing end of the applicator 14, the leading end of the collagen plug 12 is located in the vicinity of the exterior end of the puncture BVP.
  • a warning band 68 is positioned inboard of the band 66 so that, if the band 68 is visible, the plug 12 is overinserted into the puncture BVP.
  • the interconnect assembly 39 is mounted on the housing assembly 35 and serves to grip the control member 20 on the sealing assembly 11 to interrelate the position of the applicator with the control member.
  • the interconnect assembly 39 has a one way gripping arrangement 70 with appropriate ratchet teeth that permit the arrangement 70 and tamponading member 21 to move toward each as the arrangement 70 slides along the control member 20 but prevents motion in the opposite direction.
  • a one way gripping arrangement 70 with appropriate ratchet teeth that permit the arrangement 70 and tamponading member 21 to move toward each as the arrangement 70 slides along the control member 20 but prevents motion in the opposite direction.
  • the interconnect assembly 39 also has a tightening arrangement 71 which slightly tightens the tamponading member 21 against the inside end of the puncture BVP while the barrel 50 is being withdrawn from around the collagen plug 12.
  • the tightening arrangement 71 is connected to the retraction mechanism 38 and the gripping arrangement 70 so that the gripping arrangement 70 is moved with the barrel 50 when the barrel initially moves.
  • the arrangement 71 releases the retraction mechanism 38 after the gripping anangement 70 has moved the control member 20 a prescribed short distance which insures that the puncture BVP remains closed but insufficient to pull any portion of the tamponading member 21 through the puncture BVP.
  • the tightening arrangement 70 includes an extension 75 on the connector 60 that projects rearwardly along the passage 48 to the rear end of the body 45.
  • the rearwardly projecting end of the extension 75 has a detent engaging cavity 76 therein.
  • the forwardly projecting portion of the gripping anangement 70 is connected to a resilient extension 78 with a detent 79 thereon that fits into the cavity 76 of the extension 75.
  • the natural resiliency of the extension 78 urges the detent 79 inwardly out of the cavity 76 to disconnect the extension 78 from the extension 75.
  • the passage 80 through the end of the body 45 keeps the detent 79 and cavity 76 forced together until the forwardly projecting end of the extension 78 moves into registration with a release cavity 81 in the body 45 opening into the passage 80. This releases the gripping arrangement 70 from the extension 75 on the tightening arrangement 70 and also holds the gripping arrangement 70 in a fixed position with respect to the body 45 while the extension 75 continues to move with the retraction of the banel 50
  • the locator mechanism 40 includes a locator pad 85 defining a central passage therethrough to the slidably fit over the banel 50.
  • a tubular member 86 is attached to the pad 85 and extends over the forward end of the body 45.
  • the member 86 is divided into rearwardly directed resilient strips 88 that are equipped with inwardly facing one way grippers that cooperate with complementary grippers 89 on the outside of the body 45.
  • the grippers are ananged to permit the locator mechamsm 40 to be moved out over the barrel 50 until the pad 85 is against the skin but prevents movement in the opposite direction. This provides a secondary method for locating the applicator 14 with respect to the blood vessel wall puncture BVP.
  • a compensator assembly 90 is provided. While different mechanisms may be used, the assembly 90 shown for purposes of illustration is mounted in the projecting end of the enlarged head 56 on the plunger 55 and is activated as an incident to the retraction of the banel 50 off of the collagen plug 12.
  • the assembly 90 includes a pusher plate 91 with a support tube 92 slidably extending into an annular passage in the head 56 and opening onto the end thereof.
  • the plate 91 is urged out of the head 56 by a spring 94 captured between the end of the tube 92 and the bottom of the passage.
  • the tube 92 has a limiting stop on it to limit the extension of the plate 91 away from the end of the head 56.
  • the amount of possible extension from the head 56 is selected to correspond to the plug volume lost as the plug softens.
  • the strength of the spring 94 is limited so that the plate 91 will not force the plug 12 through the puncture BVP.
  • the plate 91 is held in the retracted position until the barrel 50 releases the plug by the friction between the plug and the banel 50.
  • the temporary sealing assembly 11 is installed while the introducer guide sheath GS is still in position.
  • the temporary sealing assembly 11 is installed by threading the projecting end 22 thereof down through the guide sheath GS and into the blood vessel lumen BVL.
  • the control member 20 is threaded through the guide sheet GS until the collapsed tamponading member 21 passes NOT FURNISHED UPON FILING
  • the banel 50 does not have to be fully retracted before the procedure is completed, it typically is fully retracted as seen in Fig. 8 to leave the plug 12 in position in the access passage AP.
  • the applicator 14 is left in position while the tamponading member 21 is collapsed back to its original position and the control member 20 pulled to pull the tamponading member 21 back through the collagen plug 12 into the applicator 14.
  • Fig. 10 shows an alternate embodiment of the sealing assembly which has been designated as 111.
  • the sealing assembly 111 like the sealing assembly 11, has an elongate flexible control member 120 with an expandable tamponading member 121 mounted on the control member 120.
  • an injection lumen 132 is provided along the length of the control member 120 and exits the control member 120 adjacent the trailing end of the tamponading member 121 that faces the blood vessel wall puncture BVP.
  • the size of the discharge port 134 through which the injection lumen exits is selected to have a longitudinal length L j as seen in Fig. 10.
  • the length L is selected to be less than the thickness of the blood vessel wall BVW at the puncture BVP.
  • An appropriate injection port (not shown) to the injection lumen 132 is provided in the exterior end of the control member 120.
  • the second embodiment of the applicator is designated 114 and is illustrated in Figs. 11-15.
  • the basic difference between the applicator 114 and the applicator 14 is that the applicator 114 has an open section through which the control member on the temporary sealing assembly can be installed without feeding the control member axially through the collagen plug and applicator.
  • the applicator 114 like the applicator 14, includes a housing assembly 135, and introducer assembly 136, a retraction mechanism 138, an interconnect assembly 139, and a locator mechamsm 140. These assemblies and mechanisms operate similarly to the conesponding assemblies and mechanisms of the first embodiment of the invention.
  • the cylindrical body 145 defines a V-shaped cutout 147 therein down to the passage through which the control member on the temporary sealing assembly passes so that control member can be laid into the passage as it is being operated to install the collagen plug.
  • the insertion banel 150 of the introducer assembly 136 is slit at 141 along its length and the sidewall thereof is turned slightly inwardly so that the control member on the temporary sealing assembly can be pressed therethrough. This slit 141 is also defined through the inwardly directed flange 152.
  • the locator plunger 155 is provided with a V-shaped cutout 142 that extends from the central passage through which the control member passes to the exterior surface thereof.
  • the gripping arrangement 170 on the interconnect assembly 139 is provided with a V-shaped cutout 143 to allow the control member to be placed laterally into the passage up through the arrangement 170. It will be appreciated that the anangement 170 still is able to grip the control member during use as with the first embodiment of the invention.
  • the locator pad 185 and tubular member 186 have a V-shaped cutout 144 to allow the control member to pass through the center thereof.
  • the body 145 is provided with a closure 195 that closes the rear portion of the cutout through the body 145 to keep the control member in place once it is placed in the central passage running through the applicator.
  • the collagen plug 112 used with the second embodiment of the applicator is illustrated in Figs. 12 and 15 and includes a thin V-shaped cutout 196 which extends to the central passage through the plug 112 to receive the control member of the temporary sealing anangement. While the plug 112 may work with a single V-shaped cutout 196, it is illustrated with a wider opening section 198 adjacent the exterior surface thereof to facilitate placement of the control member therein. It will be noted that the cutout comes together just before the central passage through the plug 112 is reached so that, once the control member is snapped into the passage through the plug, it is retained therein.
  • Figs. 16 and 17 illustrate a third embodiment 210 of the invention which includes a collagen plug 212 and an applicator tube 214.
  • the collagen plug 212 is installed on the control member and the extension 31 to the syringe 26 as described with the first embodiment of the invention.
  • the applicator tube 214 is a cylindrical tube defining a central passage therethrough to just slidably receive the control member of the temporary sealing anangement. The physician simply slides the collagen plug 212 and the tube 214 onto the control member of the temporary sealing arrangement so that the leading end of the collagen plug 212 faces the access passage AP in the patient. The physician then uses the applicator tube 214 to push the collagen plug 212 down to the outside end of the puncture BVP.
  • the combined overall length of the collagen plug 212 and the applicator tube 214 conesponds to that of the first embodiment of the invention so that the physician can use the indicia 65 on the temporary sealing assembly to determine when the leading end of the collagen plug 212 is located in the vicinity of the outside end of the puncture BVP.
  • the collagen plug 212 is made so that an outside layer 215 thereon has a prescribed spring and softening rate so that the plug 212 will not soften prior to being fully inserted into the access passage AP.
  • the tapered leading end 216 on the collagen end 212 serves to keep the collagen plug centered in the access passage AP and open it up to receive the plug 212.
  • the higher strength at the trailing end of the collagen plug 212 permits the applicator tube 214 to push it into place before the plug softens.
  • Fig. 18 illustrates an alternate embodiment of the applicator which has been designated by the reference of 314.
  • the applicator 314 include an insertion banel 150 with the projecting end 351 thereon adapted to be inserted into the access passage AP in the patient.
  • the barrel 350 defines an internal passage therethrough adapted to slidably receive the collagen plug 12 therein.
  • a one-way check member 353 is mounted in the barrel 350 behind the plug 12 and has a face thereon abutting the plug 12 to maintain it lengthwise of the barrel 350 as will become more apparent.
  • the check member 353 defines a tamponading member receiving chamber 352 which opens onto the trailing end of the plug 12 and trailing end of the check member 353 is provided with a one-way gripping assembly 354 which grips the control member of the temporary sealing arrangement to allow the check member 353 to be moved along the control member toward the expanded tamponading member but prevents movement of the check member 353 in the opposite direction.
  • a locator plunger 355 extends into the banel 350 behind the check member 353 to maintain the check member 353 in position relative to the collagen plug 12 as the collagen plug 12 is being installed.
  • An appropriate drive flange 356 is provided on the trailing end of the plunger 355 projecting out of the banel 350 to be manually engaged.
  • the leading end of the plunger 355 is counterbored at 358 to receive the projecting portion of the check member 353 therein so that the leading end of the locating plunger abuts the back side of the check member 353.
  • the holding ring 359 is provided on the trailing end of the banel 350 so that the physician can hold both the flange 356 and the ring 359 to simultaneously push both the plunger 355 and the banel 350 into the access passage AP.
  • the banel 350 can be withdrawn from around the collagen plug 12 simply by pulling out on the plunger 356 and the member 353.
  • the check member 353 prevents the collagen plug 12 from being withdrawn with the banel 350.
  • the physician can hold the back side of the plug 12 while the collapsed tamponading member 21 is pulled through the plug 12 into the recess 352. Because the projecting end 22 on the control member 20 is smaller than the collapsed tamponading member 21, the rest of the control member can be pulled out of the plug 12 without damaging the plug.

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Abstract

La présente invention concerne un procédé et un appareil pour fermer un point de piqûre pratiqué dans des cavités du corps telles que des vaisseaux sanguins, à l'aide d'un élément extensible (21) placé dans la cavité du corps sur un élément de commande (20) qui ressort par le point de piqûre, et d'un applicateur qui insère une matière obturante préformée (12) à l'intérieur de la piqûre sur l'élément de commande, pour garder ce dernier ainsi que l'élément extensible centrés dans la piqûre et pour retirer l'élément extensible affaissé en le faisant passer à travers la matière obturante après fermeture du point de piqûre.
PCT/US1995/001598 1995-02-07 1995-02-07 Systeme de fermeture de point de piqure WO1996024291A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU19658/95A AU1965895A (en) 1995-02-07 1995-02-07 Puncture sealing system
PCT/US1995/001598 WO1996024291A1 (fr) 1995-02-07 1995-02-07 Systeme de fermeture de point de piqure

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1995/001598 WO1996024291A1 (fr) 1995-02-07 1995-02-07 Systeme de fermeture de point de piqure

Publications (1)

Publication Number Publication Date
WO1996024291A1 true WO1996024291A1 (fr) 1996-08-15

Family

ID=22248632

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/001598 WO1996024291A1 (fr) 1995-02-07 1995-02-07 Systeme de fermeture de point de piqure

Country Status (2)

Country Link
AU (1) AU1965895A (fr)
WO (1) WO1996024291A1 (fr)

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WO1998024374A1 (fr) * 1996-12-05 1998-06-11 Loma Linda University Medical Center Systeme de fermeture de plaie vasculaire
EP0858776A2 (fr) * 1997-02-14 1998-08-19 Tricardia, L.L.C. Appareil pour la délivrance d'un agent hémostatique avec capteur de pression intégré
US6004341A (en) * 1996-12-05 1999-12-21 Loma Linda University Medical Center Vascular wound closure device
EP0998324A4 (fr) * 1995-10-27 2000-05-10 Gary Gershony Appareil d'obturation vasculaire et procede associe
US6287322B1 (en) 1995-12-07 2001-09-11 Loma Linda University Medical Center Tissue opening locator and everter and method
US6524326B1 (en) 1995-12-07 2003-02-25 Loma Linda University Medical Center Tissue opening locator and everter and method
WO2003047434A1 (fr) * 2001-11-30 2003-06-12 Integrated Vascular Systems, Inc. Dispositif et procedes permettant d'obtenir une sensation tactile pendant la pose d'un systeme de fermeture
WO2010002918A1 (fr) 2008-06-30 2010-01-07 Cardiva Medical, Inc. Appareil et methodes de mise en place de materiaux hemostatiques pour l’obturation de vaisseaux sanguins
US7931628B2 (en) 2000-02-24 2011-04-26 Loma Linda University Medical Center Device for closing tissue openings
US8012167B2 (en) 2003-08-14 2011-09-06 Loma Linda University Medical Center Vascular wound closure device and method
US8088145B2 (en) 2005-10-05 2012-01-03 Loma Linda University Medical Center Vascular wound closure device and method
US8425552B2 (en) 2000-08-02 2013-04-23 Loma Linda University Medical Center Apparatus for closing vascular puncture
US8491628B2 (en) 2000-08-01 2013-07-23 Loma Linda University Medical Center Vascular wound closure device and method
US8690910B2 (en) 2000-12-07 2014-04-08 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US8858594B2 (en) 2008-12-22 2014-10-14 Abbott Laboratories Curved closure device
US8893947B2 (en) 2007-12-17 2014-11-25 Abbott Laboratories Clip applier and methods of use
US8905937B2 (en) 2009-02-26 2014-12-09 Integrated Vascular Systems, Inc. Methods and apparatus for locating a surface of a body lumen
US8911472B2 (en) 2005-12-13 2014-12-16 Cardiva Medical, Inc. Apparatus and methods for delivering hemostatic materials for blood vessel closure
US8920442B2 (en) 2005-08-24 2014-12-30 Abbott Vascular Inc. Vascular opening edge eversion methods and apparatuses
US8926656B2 (en) 2003-01-30 2015-01-06 Integated Vascular Systems, Inc. Clip applier and methods of use
US8926633B2 (en) 2005-06-24 2015-01-06 Abbott Laboratories Apparatus and method for delivering a closure element
US8956388B2 (en) 2000-01-05 2015-02-17 Integrated Vascular Systems, Inc. Integrated vascular device with puncture site closure component and sealant
US9050068B2 (en) 2005-07-01 2015-06-09 Abbott Laboratories Clip applier and methods of use
US9060769B2 (en) 2000-09-08 2015-06-23 Abbott Vascular Inc. Surgical stapler
US9089311B2 (en) 2009-01-09 2015-07-28 Abbott Vascular Inc. Vessel closure devices and methods
US9089674B2 (en) 2000-10-06 2015-07-28 Integrated Vascular Systems, Inc. Apparatus and methods for positioning a vascular sheath
US9149276B2 (en) 2011-03-21 2015-10-06 Abbott Cardiovascular Systems, Inc. Clip and deployment apparatus for tissue closure
US9173644B2 (en) 2009-01-09 2015-11-03 Abbott Vascular Inc. Closure devices, systems, and methods
US9241696B2 (en) 2008-10-30 2016-01-26 Abbott Vascular Inc. Closure device
US9271707B2 (en) 2003-01-30 2016-03-01 Integrated Vascular Systems, Inc. Clip applier and methods of use
US9282965B2 (en) 2008-05-16 2016-03-15 Abbott Laboratories Apparatus and methods for engaging tissue
US9295469B2 (en) 2002-06-04 2016-03-29 Abbott Vascular Inc. Blood vessel closure clip and delivery device
US9314230B2 (en) 2009-01-09 2016-04-19 Abbott Vascular Inc. Closure device with rapidly eroding anchor
US9320522B2 (en) 2000-12-07 2016-04-26 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US9332976B2 (en) 2011-11-30 2016-05-10 Abbott Cardiovascular Systems, Inc. Tissue closure device
US9364209B2 (en) 2012-12-21 2016-06-14 Abbott Cardiovascular Systems, Inc. Articulating suturing device
US9398914B2 (en) 2003-01-30 2016-07-26 Integrated Vascular Systems, Inc. Methods of use of a clip applier
US9414820B2 (en) 2009-01-09 2016-08-16 Abbott Vascular Inc. Closure devices, systems, and methods
US9414824B2 (en) 2009-01-16 2016-08-16 Abbott Vascular Inc. Closure devices, systems, and methods
US9456811B2 (en) 2005-08-24 2016-10-04 Abbott Vascular Inc. Vascular closure methods and apparatuses
US9486191B2 (en) 2009-01-09 2016-11-08 Abbott Vascular, Inc. Closure devices
US9498196B2 (en) 2002-02-21 2016-11-22 Integrated Vascular Systems, Inc. Sheath apparatus and methods for delivering a closure device
US9579091B2 (en) 2000-01-05 2017-02-28 Integrated Vascular Systems, Inc. Closure system and methods of use
US9585647B2 (en) 2009-08-26 2017-03-07 Abbott Laboratories Medical device for repairing a fistula
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US10111664B2 (en) 2000-01-05 2018-10-30 Integrated Vascular Systems, Inc. Closure system and methods of use

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US4890612A (en) * 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US5021059A (en) * 1990-05-07 1991-06-04 Kensey Nash Corporation Plug device with pulley for sealing punctures in tissue and methods of use
US5108421A (en) * 1990-10-01 1992-04-28 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient

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EP0998324A4 (fr) * 1995-10-27 2000-05-10 Gary Gershony Appareil d'obturation vasculaire et procede associe
EP0998324A1 (fr) * 1995-10-27 2000-05-10 Gary Gershony Appareil d'obturation vasculaire et procede associe
US6524326B1 (en) 1995-12-07 2003-02-25 Loma Linda University Medical Center Tissue opening locator and everter and method
US6287322B1 (en) 1995-12-07 2001-09-11 Loma Linda University Medical Center Tissue opening locator and everter and method
US6425901B1 (en) 1995-12-07 2002-07-30 Loma Linda University Medical Center Vascular wound closure system
US6004341A (en) * 1996-12-05 1999-12-21 Loma Linda University Medical Center Vascular wound closure device
WO1998024374A1 (fr) * 1996-12-05 1998-06-11 Loma Linda University Medical Center Systeme de fermeture de plaie vasculaire
EP0858776A3 (fr) * 1997-02-14 2000-01-12 Tricardia, L.L.C. Appareil pour la délivrance d'un agent hémostatique avec capteur de pression intégré
EP0858776A2 (fr) * 1997-02-14 1998-08-19 Tricardia, L.L.C. Appareil pour la délivrance d'un agent hémostatique avec capteur de pression intégré
US9579091B2 (en) 2000-01-05 2017-02-28 Integrated Vascular Systems, Inc. Closure system and methods of use
US10111664B2 (en) 2000-01-05 2018-10-30 Integrated Vascular Systems, Inc. Closure system and methods of use
US8956388B2 (en) 2000-01-05 2015-02-17 Integrated Vascular Systems, Inc. Integrated vascular device with puncture site closure component and sealant
US9050087B2 (en) 2000-01-05 2015-06-09 Integrated Vascular Systems, Inc. Integrated vascular device with puncture site closure component and sealant and methods of use
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US8491628B2 (en) 2000-08-01 2013-07-23 Loma Linda University Medical Center Vascular wound closure device and method
US9320505B2 (en) 2000-08-02 2016-04-26 Loma Linda University Apparatus for closing vascular puncture
US9101731B2 (en) 2000-08-02 2015-08-11 Loma Linda University Medical Center Vascular wound closure device and method
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