US20080161849A1 - Blood vessel sealing system - Google Patents

Blood vessel sealing system Download PDF

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Publication number
US20080161849A1
US20080161849A1 US12/002,425 US242507A US2008161849A1 US 20080161849 A1 US20080161849 A1 US 20080161849A1 US 242507 A US242507 A US 242507A US 2008161849 A1 US2008161849 A1 US 2008161849A1
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United States
Prior art keywords
puncture
sealing material
control member
body cavity
introducer
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
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US12/002,425
Inventor
Christopher U. Cates
William D. Knopf
Douglass G. Whitney
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
St Jude Medical LLC
Original Assignee
Cates Christopher U
Knopf William D
Whitney Douglass G
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Filing date
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=31720427&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20080161849(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US07/817,587 external-priority patent/US6056768A/en
Application filed by Cates Christopher U, Knopf William D, Whitney Douglass G filed Critical Cates Christopher U
Priority to US12/002,425 priority Critical patent/US20080161849A1/en
Publication of US20080161849A1 publication Critical patent/US20080161849A1/en
Assigned to SEALING SOLUTIONS, INC. reassignment SEALING SOLUTIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CCH ASSOCIATES, LLC
Assigned to ST. JUDE MEDICAL, INC. reassignment ST. JUDE MEDICAL, INC. CONDITIONAL ASSIGNMENT (SEE DOCUMENT FOR DETAILS). Assignors: SEALING SOLUTIONS, INC.
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00637Implements 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 for sealing trocar wounds through abdominal wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00646Type of implements
    • A61B2017/00654Type of implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00646Type of implements
    • A61B2017/00659Type of implements located only on one side of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00672Locating means therefor, e.g. bleed back lumen

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 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. 11 ;
  • FIG. 13 is an enlarged transverse cross-sectional view taken along line 13 - 13 in FIG. 11 ;
  • FIG. 14 is an enlarged transverse cross-sectional view taken along line 14 - 14 in FIG. 11 ;
  • 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 0.1500.200 inch (3.8-5.1 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 (0.8-1.3 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 mechanism 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 mechanism 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 barrel 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 1 when the barrel 50 is extended. This length cooperates with the control member 20 to let the physician know when the projecting end 51 of the barrel 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.
  • the applicator 14 is on the control member 20 , it can only be slipped toward the tamponading member 21 . This serves to hold the housing assembly 35 substantially fixed with respect the control member and thus the tamponading member 21 while the barrel 50 is being retracted.
  • 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 arrangement 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 arrangement 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 .
  • the locator mechanism 40 includes a locator pad 85 defining a central passage therethrough to the slidably fit over the barrel 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 arranged to permit the locator mechanism 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 barrel 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 barrel 50 .
  • FIGS. 5-9 The method of sealing a blood vessel using the first embodiment of the invention is illustrated in FIGS. 5-9 .
  • 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 into the blood vessel lumen BVL as seen in FIG. 5 .
  • the tamponading member 21 is expanded to its expanded condition with the syringe 26 and the guide sheath GS is removed.
  • the physician physically pulls back on the control member 20 so that the expanded tamponading member 21 is pulled back up against the inside end of the puncture BVP through the blood vessel wall.
  • the tamponading member 21 is illustrated in the sealing position in FIG. 6 .
  • the applicator 14 with the collagen plug 12 therein is inserted over the exterior end 24 of the control member 20 so that the applicator and collagen plug is slipped toward the patient's skin. It will be appreciated that the physician holds the control member 20 to maintain the pressure of the tamponading member 21 against the inside end of puncture BVP at all times. After the applicator and collagen plug are inserted over the control member 20 as seen in FIG. 6 , the physician carefully slides the applicator 14 along the control member 20 so that the insertion barrel 50 on the introducer assembly 36 passes into the access passage AP through the skin and tissue.
  • the physician continues to push the applicator 14 toward the patient while holding the control member 20 to keep the tamponading member 21 in place until the safety band 66 of the indicia 65 on the control member 20 becomes visible at the trailing end of the applicator 14 .
  • the projecting end 51 of the barrel 50 is located in the vicinity of the outside end of the puncture BVP through the blood vessel wall BVW as seen in FIG. 7 .
  • the collagen plug carried in the end of the barrel 50 is positively located with respect to the blood vessel wall puncture BVP.
  • the physician slides the locator mechanism 40 out along the body 45 until the locator pad 85 lies at the skin surface SS. This serves to stabilize the applicator 14 and also to act as a secondary reference to locate the applicator 14 with respect to the outside end of the blood vessel wall puncture BVP as is also shown in FIG. 7 .
  • the barrel 50 is now ready to be withdrawn from around the collagen plug 12 since the housing assembly 35 is fixed relative to the control member 20 .
  • the housing 35 remains stationary while the physician pulls the actuator member 61 back toward the hand grip 46 .
  • the barrel 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 body fluids contact the plug 12 , it starts to soften and any seepage of blood through the blood vessel puncture BVP serves to start the formation of a coagulum at the exterior end of the puncture BVP.
  • 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 .
  • the projecting end of the control member 20 can be pulled out through the collagen plug 12 to complete the procedure and leave the collagen plug 12 in place forming the coagulum CAM as seen in FIG. 9 .
  • 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 1 as seen in FIG. 10 .
  • the length L 1 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 physician can monitor the flow of the protectable fluid along the blood vessel lumen BVL with appropriate equipment such as fluoroscopy.
  • the physician continues to pull the tamponading member 121 toward the wall BVW until the flow of the detectable fluid along the lumen BVL is stopped. This ensures that the tamponading member 121 does not hang up on occlusions or plaque within the blood vessel lumen and not seat good against the blood against the blood vessel wall BVW.
  • 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 mechanism 140 . These assemblies and mechanisms operate similarly to the corresponding 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 barrel 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 arrangement 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 arrangement. 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 arrangement. 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 corresponds 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 barrel 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 barrel 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 barrel 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 barrel 350 so that the physician can hold both the flange 356 and the ring 359 to simultaneously push both the plunger 355 and the barrel 350 into the access passage AP.
  • the barrel 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 barrel 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.

Abstract

A method of and apparatus for sealing access openings into blood vessels using an expandable member in the blood vessel on a control member that extends out through the access opening and an applicator which inserts a preformed sealing material into the access opening over the control member to keep the control member and expandable member centered in the access opening and withdrawing the collapsed expandable member back through the sealing material after the access opening is sealed.

Description

    BACKGROUND OF THE INVENTION
  • 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. Typically 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, however, is reclosure of the opening in the blood vessel wall after the procedure. In the past, 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. More recently, 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. Also, 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.
  • SUMMARY OF THE INVENTION
  • These and other problems and disadvantages associated with the prior art are overcome by the invention disclosed herein by providing a technique for implanting a collagen plug in the tissue access passage to the percutaneous puncture or opening in a blood vessel which insures that the end of the plug does not extrude through the blood vessel wall opening into the blood vessel lumen. A tamponading means located inside the blood vessel lumen during installation of the collagen plug serves to positively prevent the collagen plug from being inadvertently pushed through the blood vessel wall opening as it is installed but which is removed after installation of the collagen plug so that no protrusion or other dislodgable material is left in the interior of the blood vessel after the procedure is completed. 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. For removal, however, 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 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.
  • These and other features and advantages of the invention will become more clearly understood upon consideration of the following detailed description and accompanying drawings wherein like characters of reference designate corresponding parts throughout the several views and in which:
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • 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. 11;
  • FIG. 13 is an enlarged transverse cross-sectional view taken along line 13-13 in FIG. 11;
  • FIG. 14 is an enlarged transverse cross-sectional view taken along line 14-14 in FIG. 11;
  • 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; and,
  • FIG. 17 is a longitudinal cross-sectional view of the collagen plug of the third embodiment of the invention; and
  • FIG. 18 is a longitudinal cross-sectional view of another embodiment of the invention.
  • These figures and the following detailed description disclose specific embodiments of the invention, however, it is to be understood that the inventive concept is not limited thereto since it may be embodied in other forms.
  • DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
  • 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. Typically, 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. When such a procedure is performed, 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.
  • Referring to FIG. 1, it will be seen that 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. After the collagen plug 12 is installed, 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.
  • It will be appreciated that 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 0.1500.200 inch (3.8-5.1 mm) should be successful under typical conditions where the puncture BVP is made with a 4 french puncture.
  • Without limiting the scope of the invention, 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. 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. To permit the balloon member 21 to be inflated, 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. Thus, 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. Typically, 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.
  • In those instances where it is necessary to remove the inflation device 26 after the balloon member 21 is inflated to the expanded condition to complete the insertion of the collagen plug into the access passage AP, 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. To deflate the balloon member 21 after the procedure is complete, 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 (0.8-1.3 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 mechanism 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. Thus, as the barrel 50 is pulled back along the plunger 55, the head 56 of the plunger holds the collagen plug in a fixed position with respect to the housing assembly 35 as will become more apparent. 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 mechanism 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 barrel 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 L1 when the barrel 50 is extended. This length cooperates with the control member 20 to let the physician know when the projecting end 51 of the barrel 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. Any appropriate indicia may be used, however, for purposes of illustration, 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. To prevent overinsertion of the collagen plug 12 into the puncture, 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. Thus, once the applicator 14 is on the control member 20, it can only be slipped toward the tamponading member 21. This serves to hold the housing assembly 35 substantially fixed with respect the control member and thus the tamponading member 21 while the barrel 50 is being retracted.
  • 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, however, releases the retraction mechanism 38 after the gripping arrangement 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 arrangement 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 barrel 50.
  • The locator mechanism 40 includes a locator pad 85 defining a central passage therethrough to the slidably fit over the barrel 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 arranged to permit the locator mechanism 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.
  • To compensate for any loss of volume in the collagen plug 12 as it becomes a gelatinous mass, 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 barrel 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 barrel 50.
  • Method of Use
  • The method of sealing a blood vessel using the first embodiment of the invention is illustrated in FIGS. 5-9. As seen in FIG. 5, 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 into the blood vessel lumen BVL as seen in FIG. 5. Thereafter, the tamponading member 21 is expanded to its expanded condition with the syringe 26 and the guide sheath GS is removed. The physician physically pulls back on the control member 20 so that the expanded tamponading member 21 is pulled back up against the inside end of the puncture BVP through the blood vessel wall. The tamponading member 21 is illustrated in the sealing position in FIG. 6.
  • After the tamponading member 21 is pulled up against the inside end of the puncture BVP, the applicator 14 with the collagen plug 12 therein is inserted over the exterior end 24 of the control member 20 so that the applicator and collagen plug is slipped toward the patient's skin. It will be appreciated that the physician holds the control member 20 to maintain the pressure of the tamponading member 21 against the inside end of puncture BVP at all times. After the applicator and collagen plug are inserted over the control member 20 as seen in FIG. 6, the physician carefully slides the applicator 14 along the control member 20 so that the insertion barrel 50 on the introducer assembly 36 passes into the access passage AP through the skin and tissue. The physician continues to push the applicator 14 toward the patient while holding the control member 20 to keep the tamponading member 21 in place until the safety band 66 of the indicia 65 on the control member 20 becomes visible at the trailing end of the applicator 14. At this time, the projecting end 51 of the barrel 50 is located in the vicinity of the outside end of the puncture BVP through the blood vessel wall BVW as seen in FIG. 7.
  • Since the one way gripping arrangement 70 of the interconnect assembly 39 prevents the applicator 14 from being moved back up the control member 20, the collagen plug carried in the end of the barrel 50 is positively located with respect to the blood vessel wall puncture BVP. The physician then slides the locator mechanism 40 out along the body 45 until the locator pad 85 lies at the skin surface SS. This serves to stabilize the applicator 14 and also to act as a secondary reference to locate the applicator 14 with respect to the outside end of the blood vessel wall puncture BVP as is also shown in FIG. 7. The barrel 50 is now ready to be withdrawn from around the collagen plug 12 since the housing assembly 35 is fixed relative to the control member 20. The housing 35 remains stationary while the physician pulls the actuator member 61 back toward the hand grip 46. This serves to retract the barrel 50 while leaving the housing assembly 35 in place so that the locator plunger 55 holds the collagen plug 12 in place. Although the barrel 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. As soon as the body fluids contact the plug 12, it starts to soften and any seepage of blood through the blood vessel puncture BVP serves to start the formation of a coagulum at the exterior end of the puncture BVP. Typically, 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. By having a projecting end 22 on the control member 20 long enough to still reach into the blood vessel lumen BVL with the tamponading member 21 within the applicator 14, contact is not lost with the blood vessel lumen if something causes the collagen plug 12 not to properly seal. This will facilitate re-access to the blood vessel lumen BVL. After the physician checks to see if the seal has been affected, the projecting end of the control member 20 can be pulled out through the collagen plug 12 to complete the procedure and leave the collagen plug 12 in place forming the coagulum CAM as seen in FIG. 9.
  • Alternate Embodiment of Sealing Assembly
  • 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. In addition to the inflation lumen 128 which is provided through 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 L1 as seen in FIG. 10. The length L1 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.
  • This allows the physician to inject a detectable fluid through the injection lumen 132 and out the port 134 as the expanded tamponading member 121 is pulled back toward the puncture BVP. The physician can monitor the flow of the protectable fluid along the blood vessel lumen BVL with appropriate equipment such as fluoroscopy. The physician continues to pull the tamponading member 121 toward the wall BVW until the flow of the detectable fluid along the lumen BVL is stopped. This ensures that the tamponading member 121 does not hang up on occlusions or plaque within the blood vessel lumen and not seat good against the blood against the blood vessel wall BVW.
  • Second Embodiment of Applicator
  • 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 mechanism 140. These assemblies and mechanisms operate similarly to the corresponding 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 barrel 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. Similarly, 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 arrangement 170 still is able to grip the control member during use as with the first embodiment of the invention. Likewise, 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 arrangement. 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.
  • Third Embodiment of the Invention
  • 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 arrangement. 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 corresponds 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.
  • Fourth Embodiment of the Applicator
  • FIG. 18 illustrates an alternate embodiment of the applicator which has been designated by the reference of 314. The applicator 314 include an insertion barrel 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 barrel 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 barrel 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 barrel 350 so that the physician can hold both the flange 356 and the ring 359 to simultaneously push both the plunger 355 and the barrel 350 into the access passage AP. As soon as the leading end of the collagen plug 112 is located in the vicinity of the outside end of the puncture BVP, the barrel 350 can be withdrawn from around the collagen plug 12 simply by pulling out on the plunger 356 and the member 353. This is because the check member 353 prevents the collagen plug 12 from being withdrawn with the barrel 350. After the collagen plug 12 is installed and the temporary sealing assembly is ready to be withdrawn, 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.

Claims (34)

1-10. (canceled)
11. A system for depositing a sealing material for sealing a puncture in a body cavity wall of a body cavity of a patient comprising:
a temporary sealing assembly comprising:
an elongate control member having a length greater than the length of the puncture to be sealed and a cross-sectional area smaller than that of the puncture to be sealed so that the control member passes through the puncture; and
an expandable member mounted on said elongate control member at a first prescribed axial position so that a portion of the control member extends exteriorly of the patient when said expandable member is located within the body cavity, the expandable member having a collapsed cross-sectional size smaller than that of the puncture and an expanded cross-sectional size larger than that of the puncture to prevent passage of the expanded expandable member through the puncture so that the elongate control member can be used to pull the expanded expandable member in the body cavity up against that end of the puncture opening into the body cavity; and
an applicator comprising:
an introducer member defining a sealing material chamber therein and a projecting end thereon, the sealing material chamber opening onto the projecting end of the introducer member,
a plunger slidably mounted within the introducer member, the plunger movable between an initial position in which a sealing material is housed within said sealing material chamber and a withdrawn position in which the introducer member is withdrawn from around the sealing material while the sealing material is held in position by the plunger, the plunger defining a central passage therethrough sized to allow the control member to slide therethrough, and
an interconnect structure connected to the elongate control member and positioned so as to fix the plunger at an axial position with respect to the elongate control member so that the position of the sealing material with respect to the puncture is maintained as the introducer member is withdrawn from around the sealing material.
12. The system of claim 11, wherein the interconnect structure is a ridge located around the control member of thickness sufficient to fix the position of the plunger but to allow the introducer member to be withdrawn over the interconnect structure.
13. The system of claim 11, wherein the interconnect structure permits withdrawal of the control member through the sealing material and through the puncture after the expandable member is collapsed.
14. The system of claim 11, wherein the sealing material is a preformed member having a preformed cylindrical passage through which the elongate control member passes.
15. The system of claim 11, wherein the sealing material is a flexible material that is wrapped around the elongate control member before the sealing material is inserted into the puncture.
16. The system of claim 11, wherein the puncture is in the wall of a blood vessel.
17. The device of claim 11, wherein the system further comprises an indicia for deploying the sealing material in the puncture and outside the body cavity.
18. The device of claim 11, wherein the system further comprises a locking mechanism used for deploying the sealing material in the puncture and outside the body cavity.
19. A device for sealing a puncture in a body cavity wall of a body cavity of a patient comprising:
a control member having a length greater than the length of the puncture to be sealed and a cross-sectional area smaller than that of the puncture to be sealed so that the control member can be inserted into the puncture; and
an expandable member fixed to the control member at a first axial position so that a portion of the control member extends exteriorly of the patient when said expandable member is located within the body cavity, the expandable member having a collapsed configuration that fits through the puncture and an expanded configuration that prevents passage of the expanded expandable member through the puncture so that the elongate control member can be used to pull the expanded expandable member in the body cavity up against that end of the puncture opening into the body cavity; and
an introducer member mounted on the control member, the introducer member having a proximal end and a distal end, the distal end comprising a sealing material mounted on the control member.
20. The device of claim 19, wherein the sealing material is wrapped around the control member.
21. The device of claim 19, wherein the sealing material is fixed to the control member so as to remain axially fixed in place while the introducer member is withdrawn from the puncture.
22. The device of claim 19, wherein the sealing material is withdrawn from the puncture with the control member after hemostasis begins.
23. The device of claim 19, wherein the introducer member is operable to deploy the sealing material in the puncture adjacent to the body cavity wall.
24. The device of claim 19, wherein the puncture is in the wall of a blood vessel.
25. The device of claim 19, wherein the device further comprises an indicia for deploying the sealing material in the puncture and outside the body cavity.
26. The device of claim 19, wherein the device further comprises a locking mechanism used for deploying the sealing material in the puncture and outside the body cavity.
27. A method of sealing a puncture in a cavity wall of a body cavity of a patient comprising the steps of:
inserting an expandable member attached to a control member into the body cavity through the puncture while the expandable member is in a collapsed condition with a cross-sectional area smaller than the cross-sectional area of the passage so that the control member extends out of the body cavity and the puncture exteriorly of the patient;
expanding the expandable member to an expanded condition having a cross-sectional area greater than the cross-sectional area of the puncture;
pulling the expandable member back against the puncture in the cavity wall using the control member so as to close the puncture in the cavity wall;
inserting an introducer member into the puncture until the distal end of the introducer member reaches the distal end of the puncture, the introducer member comprising a plunger and a sealing material; and
withdrawing the introducer member from the puncture while the plunger and the sealing material remain at the distal end of the puncture.
28. The method of claim 27, further comprising the steps of:
collapsing the expandable member to a collapsed condition having a cross-sectional area smaller than the cross-sectional area of the puncture;
withdrawing the control member and the collapsed expandable member from the body cavity.
29. The method of claim 27, further comprising the steps of:
collapsing the expandable member to a collapsed condition having a cross-sectional area smaller than the cross-sectional area of the puncture;
withdrawing the control member and the collapsed expandable member through the sealing material in the puncture.
30. The method of claim 27, wherein the sealing material is a preformed cylindrical member with a cylindrical passage along the length of the preformed cylindrical member.
31. The method of claim 27, wherein the sealing material is a preformed cylindrical member with an opening along its length so that the preformed cylindrical member can be placed on the control member passing through the plunger and the introducer member.
32. The device of claim 27, wherein the puncture is in the wall of a blood vessel.
33. The device of claim 27, wherein the step of inserting the introducer member into the puncture until the distal end of the introducer member reaches the distal end of the puncture further comprises reading an indicia indicating the sealing material is positioned in the puncture and outside the body cavity.
34. The device of claim 27, wherein the step of inserting the introducer member into the puncture until the distal end of the introducer member reaches the distal end of the puncture further comprises engaging a locking mechanism so that the sealing material is positioned in the puncture and outside the body cavity.
35. A method for sealing a puncture in a cavity wall of a body cavity of a patient comprising the steps of:
inserting a device into the puncture, the device comprising
an expandable member attached to a control member with a distal end of the control member and the expandable member extending into the body cavity through the puncture while the expandable member is in a collapsed condition so that a proximal end of the control member extends out of the body cavity and the puncture exteriorly of the patient; and
an introducer member extending into the puncture until a distal end of the introducer member reaches a distal end of the puncture, the distal end of the introducer member comprising a sealing material;
expanding the expandable member to an expanded condition that prevents passage of the expandable member through the puncture; and
pulling the expandable member back against the puncture in the cavity wall using the control member so as to position the control member and the distal end of the introducer member.
36. The method of claim 35, further comprising the step of withdrawing the introducer member from the puncture while the sealing material remains at the distal end of the puncture.
37. The method of claim 35, further comprising the step of withdrawing the introducer member from the puncture while the sealing material remains fixed to the control member at the distal end of the puncture.
38. The method of claim 35, further comprising the steps of collapsing the expandable member and withdrawing the control member with the sealing material after hemostasis begins.
39. The method of claim 35, wherein the sealing material comprises an opening along its length allowing the sealing material to be wrapped around the control member.
40. The method of claim 35, further comprising the steps of:
deploying the sealing material at the distal end of the puncture;
collapsing the expandable member to a collapsed condition; and
withdrawing the control member and the collapsed expandable member through the sealing material in the puncture.
41. The method of claim 35, wherein the puncture is in the wall of a blood vessel.
42. The method of claim 35, further comprising the step of reading an indicia indicating the sealing material is positioned in the puncture and outside the body cavity.
43. The method of claim 35, further comprising the step of engaging a locking mechanism so that the sealing material is positioned in the puncture and outside the body cavity.
US12/002,425 1992-01-07 2007-12-17 Blood vessel sealing system Abandoned US20080161849A1 (en)

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US07/817,587 US6056768A (en) 1992-01-07 1992-01-07 Blood vessel sealing system
US08/383,256 US6162240A (en) 1992-01-07 1995-02-03 Blood vessel sealing system
US09/656,643 US6699261B1 (en) 1992-01-07 2000-09-07 Blood vessel sealing system
US10/791,196 US7331981B2 (en) 1992-01-07 2004-03-02 Blood vessel sealing system
US12/002,425 US20080161849A1 (en) 1992-01-07 2007-12-17 Blood vessel sealing system

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Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080097521A1 (en) * 2004-11-05 2008-04-24 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US20100152748A1 (en) * 2008-12-12 2010-06-17 E-Pacing, Inc. Devices, Systems, and Methods Providing Body Lumen Access
US20110137338A1 (en) * 2009-12-08 2011-06-09 Victor Matthew Phillips Hemostatic Device and Its Methods of Use
US20110166595A1 (en) * 2010-01-06 2011-07-07 St. Jude Medical, Inc. Method and system for sealing percutaneous punctures
US8382798B2 (en) 2006-09-13 2013-02-26 Accessclosure, Inc. Apparatus for sealing a vascular puncture
US8506592B2 (en) 2008-08-26 2013-08-13 St. Jude Medical, Inc. Method and system for sealing percutaneous punctures
US8721680B2 (en) 2012-03-23 2014-05-13 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US8845682B2 (en) 2009-10-13 2014-09-30 E-Pacing, Inc. Vasculature closure devices and methods
US8876862B2 (en) 2011-04-14 2014-11-04 Phillips Medical Llc Hemostatic device and its methods of use
US9468428B2 (en) 2012-06-13 2016-10-18 Phillips Medical Llc Hemostatic device and its methods of use
US9642604B2 (en) 2012-04-12 2017-05-09 Phillips Medical Llc Hemostatic system and its methods of use
US9713462B2 (en) 2008-11-12 2017-07-25 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9724081B2 (en) 2013-06-04 2017-08-08 Phillips Medical Llc Hemostatic system and its methods of use
US9757105B2 (en) 2012-03-23 2017-09-12 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9839416B2 (en) 2013-07-12 2017-12-12 Phillips Medical, LLC Hemostatic device and its methods of use
US9993236B2 (en) 2009-12-08 2018-06-12 Phillips Medical, LLC Hemostatic device and its methods of use
US10085731B2 (en) 2013-07-15 2018-10-02 E-Pacing, Inc. Vasculature closure devices and methods
US10085730B2 (en) 2013-07-12 2018-10-02 Phillips Medical, LLC Hemostatic device and its methods of use
USD843573S1 (en) 2015-11-13 2019-03-19 Access Closure, Inc. Vascular closure apparatus
USD847988S1 (en) 2015-11-13 2019-05-07 Access Closure, Inc. Handle grip
US10456123B2 (en) 2014-11-14 2019-10-29 Access Closure, Inc. Apparatus and method for sealing a vascular puncture
USD865166S1 (en) 2015-11-13 2019-10-29 Access Closure, Inc. Sheath adapter

Families Citing this family (68)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6071300A (en) * 1995-09-15 2000-06-06 Sub-Q Inc. Apparatus and method for percutaneous sealing of blood vessel punctures
US6287322B1 (en) * 1995-12-07 2001-09-11 Loma Linda University Medical Center Tissue opening locator and everter and method
US6605294B2 (en) * 1998-08-14 2003-08-12 Incept Llc Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels
US6623509B2 (en) 2000-12-14 2003-09-23 Core Medical, Inc. Apparatus and methods for sealing vascular punctures
US6846319B2 (en) * 2000-12-14 2005-01-25 Core Medical, Inc. Devices for sealing openings through tissue and apparatus and methods for delivering them
US6896692B2 (en) 2000-12-14 2005-05-24 Ensure Medical, Inc. Plug with collet and apparatus and method for delivering such plugs
US8083768B2 (en) * 2000-12-14 2011-12-27 Ensure Medical, Inc. Vascular plug having composite construction
US6890343B2 (en) * 2000-12-14 2005-05-10 Ensure Medical, Inc. Plug with detachable guidewire element and methods for use
CN1306910C (en) * 2002-06-14 2007-03-28 洛马林达大学医学中心 Vascular wound closure device and method
US8709038B2 (en) * 2002-12-20 2014-04-29 Boston Scientific Scimed, Inc. Puncture hole sealing device
WO2005016152A2 (en) 2003-08-14 2005-02-24 Loma Linda University Medical Center Vascular wound closure device
US8852229B2 (en) * 2003-10-17 2014-10-07 Cordis Corporation Locator and closure device and method of use
US7361183B2 (en) 2003-10-17 2008-04-22 Ensure Medical, Inc. Locator and delivery device and method of use
TW200613022A (en) * 2004-09-15 2006-05-01 Light Sciences Corp Surgical sheath with instrument fixation structures
US8262693B2 (en) * 2004-11-05 2012-09-11 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US20060116635A1 (en) * 2004-11-29 2006-06-01 Med Enclosure L.L.C. Arterial closure device
US8088144B2 (en) * 2005-05-04 2012-01-03 Ensure Medical, Inc. Locator and closure device and method of use
US8926654B2 (en) 2005-05-04 2015-01-06 Cordis Corporation Locator and closure device and method of use
US8088145B2 (en) * 2005-10-05 2012-01-03 Loma Linda University Medical Center Vascular wound closure device and method
US11871916B2 (en) * 2005-12-13 2024-01-16 Cardiva Medical, Inc. Vascular closure devices and methods providing hemostatic enhancement
US8911472B2 (en) 2005-12-13 2014-12-16 Cardiva Medical, Inc. Apparatus and methods for delivering hemostatic materials for blood vessel closure
US9179897B2 (en) 2005-12-13 2015-11-10 Cardiva Medical, Inc. Vascular closure devices and methods providing hemostatic enhancement
US7691127B2 (en) * 2005-12-13 2010-04-06 Cardiva Medical, Inc. Drug eluting vascular closure devices and methods
US20100168767A1 (en) * 2008-06-30 2010-07-01 Cardiva Medical, Inc. Apparatus and methods for delivering hemostatic materials for blood vessel closure
US8795709B2 (en) 2006-03-29 2014-08-05 Incept Llc Superabsorbent, freeze dried hydrogels for medical applications
US7789893B2 (en) * 2006-09-12 2010-09-07 Boston Scientific Scimed, Inc. Method and apparatus for promoting hemostasis of a blood vessel puncture
US8568445B2 (en) 2007-08-21 2013-10-29 St. Jude Medical Puerto Rico Llc Extra-vascular sealing device and method
US8333787B2 (en) 2007-12-31 2012-12-18 St. Jude Medical Puerto Rico Llc Vascular closure device having a flowable sealing material
EP2209426A4 (en) * 2007-11-02 2015-04-22 Incept Llc Apparatus and methods for sealing a vascular puncture
US8840640B2 (en) * 2007-12-31 2014-09-23 St. Jude Medical Puerto Rico Llc Vascular closure device having an improved plug
US8241324B2 (en) * 2008-03-03 2012-08-14 Eilaz Babaev Ultrasonic vascular closure device
JP5547712B2 (en) * 2008-04-04 2014-07-16 クラシール,インコーポレイティド Implantable fistula closure device
US8029533B2 (en) 2008-04-04 2011-10-04 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9364206B2 (en) 2008-04-04 2016-06-14 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US8409228B2 (en) * 2008-06-06 2013-04-02 Duane D. Blatter Tissue management methods, apparatus, and systems
CA2735748C (en) 2008-09-04 2017-08-29 Curaseal Inc. Inflatable devices for enteric fistula treatment
US9179901B2 (en) * 2009-01-29 2015-11-10 Vital Access Corporation Vascular access ports and related methods
EP2391413A4 (en) 2009-01-29 2015-04-01 Vital Access Corp Vascular access ports and related methods
US11197952B2 (en) 2009-01-29 2021-12-14 Advent Access Pte. Ltd. Vascular access ports and related methods
AU2016253582B2 (en) * 2009-02-20 2018-11-08 Covidien Lp Methods and devices for venous occlusion for the treatment of venous insufficiency
US8317824B2 (en) * 2009-02-20 2012-11-27 Boston Scientific Scimed, Inc. Tissue puncture closure device
KR101781653B1 (en) 2009-02-20 2017-09-25 코비디엔 엘피 Methods and devices for venous occlusion for the treatment of venous insufficiency
US9913634B2 (en) * 2009-02-20 2018-03-13 Boston Scientific Scimed, Inc. Locking element for vascular closure device
US20100217309A1 (en) * 2009-02-20 2010-08-26 Boston Scientific Scimed, Inc. Plug for arteriotomy closure and method of use
US10143455B2 (en) 2011-07-20 2018-12-04 Covidien LLP Enhanced ultrasound visualization of intravascular devices
US8292918B2 (en) 2009-02-20 2012-10-23 Boston Scientific Scimed, Inc. Composite plug for arteriotomy closure and method of use
US8529598B2 (en) 2009-02-20 2013-09-10 Boston Scientific Scimed, Inc. Tissue puncture closure device
US8375553B2 (en) 2009-02-20 2013-02-19 Boston Scientific Scimed, Inc. Locking element for vascular closure device
US8052914B2 (en) * 2009-02-20 2011-11-08 Boston Scientific Scimed, Inc. Modified plug for arteriotomy closure
AU2010246115A1 (en) 2009-05-04 2011-12-08 Incept. Llc Biomaterials for track and puncture closure
US20110087274A1 (en) * 2009-10-08 2011-04-14 Tyco Healtcare Group LP, New Haven, Ct Wound Closure Device
US20110087273A1 (en) * 2009-10-08 2011-04-14 Tyco Healthcare Group Lp Wound Closure Device
US9833225B2 (en) * 2009-10-08 2017-12-05 Covidien Lp Wound closure device
US8617206B2 (en) * 2009-10-08 2013-12-31 Covidien Lp Wound closure device
US8858592B2 (en) * 2009-11-24 2014-10-14 Covidien Lp Wound plugs
EP2533698B1 (en) 2010-02-11 2018-03-28 Boston Scientific Scimed, Inc. Automatic vascular closure deployment devices
US8597340B2 (en) 2010-09-17 2013-12-03 Boston Scientific Scimed, Inc. Torque mechanism actuated bioabsorbable vascular closure device
US8758402B2 (en) 2010-12-17 2014-06-24 Boston Scientific Scimed, Inc. Tissue puncture closure device
CA2824964C (en) 2011-01-19 2019-01-08 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9820728B2 (en) 2011-01-19 2017-11-21 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US9402606B2 (en) * 2011-03-23 2016-08-02 St. Jude Medical Puerto Rico Llc Snap-on vascular closure device and methods
US9386968B2 (en) 2011-05-11 2016-07-12 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
WO2012158662A1 (en) * 2011-05-16 2012-11-22 St. Jude Medical Puerto Rico Llc Filled balloon arteriotomy locator for vascular closure devices and methods
JP6122424B2 (en) 2011-06-16 2017-04-26 キュラシール インコーポレイテッド Device for fistula treatment and related method
WO2012174468A1 (en) 2011-06-17 2012-12-20 Curaseal Inc. Fistula treatment devices and methods
WO2012178133A1 (en) * 2011-06-24 2012-12-27 Accessclosure, Inc. Transapical closure devices and methods for use
WO2014107179A1 (en) * 2013-01-04 2014-07-10 St. Jude Medical Puerto Rico Llc Vascular closure device with improved side loading
US9877711B2 (en) 2013-09-05 2018-01-30 Cook Medical Technologies Llc Expandable vascular closure plug

Citations (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1432482A (en) * 1920-08-16 1922-10-17 James A Merriam Fastener
US1563881A (en) * 1925-01-26 1925-12-01 R F Simmons Company Catch
US2647294A (en) * 1949-09-23 1953-08-04 Frank L Davis Releasable fastener
US3223083A (en) * 1960-09-09 1965-12-14 President And Directors Of Geo Method for adhesively securing together skin and other soft tissue and bone
US4645491A (en) * 1984-03-09 1987-02-24 David Evans Surgical needle
US4645488A (en) * 1982-08-12 1987-02-24 Board Of Trustees Of The University Of Alabama Syringe for extrusion of wetted, particulate material
US4660580A (en) * 1983-01-19 1987-04-28 Wella Aktiengesellschaft Process for the permanent shaping of the regrowth of hair and composition therefore
US4744384A (en) * 1986-07-18 1988-05-17 Fujitsu Limited Automatic gas distributing device controlled by a direct application of high gas pressure of a source for supplying a pipe with gas from an alternative gas source
US4790819A (en) * 1987-08-24 1988-12-13 American Cyanamid Company Fibrin clot delivery device and method
US4852568A (en) * 1987-02-17 1989-08-01 Kensey Nash Corporation Method and apparatus for sealing an opening in tissue of a living being
US4871094A (en) * 1986-12-31 1989-10-03 Alcon Laboratories, Inc. Means and method for dispensing substances
US4874366A (en) * 1984-12-03 1989-10-17 Baxter Internatiional Inc. Housing enabling passive mixing of a beneficial agent with a diluent
US4890612A (en) * 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US4909251A (en) * 1988-05-31 1990-03-20 Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte Tissue adhesive
US4929246A (en) * 1988-10-27 1990-05-29 C. R. Bard, Inc. Method for closing and sealing an artery after removing a catheter
US5021059A (en) * 1990-05-07 1991-06-04 Kensey Nash Corporation Plug device with pulley for sealing punctures in tissue and methods of use
US5053046A (en) * 1988-08-22 1991-10-01 Woodrow W. Janese Dural sealing needle and method of use
US5061274A (en) * 1989-12-04 1991-10-29 Kensey Nash Corporation Plug device for sealing openings and method 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
US5129882A (en) * 1990-12-27 1992-07-14 Novoste Corporation Wound clotting device and method of using same
US5141515A (en) * 1990-10-11 1992-08-25 Eberbach Mark A Apparatus and methods for repairing hernias
US5147318A (en) * 1991-03-04 1992-09-15 Board Of Regents, The University Of Texas System Valved arterial catheter
US5192300A (en) * 1990-10-01 1993-03-09 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5239982A (en) * 1991-06-07 1993-08-31 Baxter International Inc. Catheter depth gauge and method of use
US5290310A (en) * 1991-10-30 1994-03-01 Howmedica, Inc. Hemostatic implant introducer
US5320639A (en) * 1993-03-12 1994-06-14 Meadox Medicals, Inc. Vascular plug delivery system
US5363899A (en) * 1990-10-15 1994-11-15 Nippondenso Co., Ltd. Method of discriminating quality of die-cast article and die-casting process using same
US5370660A (en) * 1993-11-01 1994-12-06 Cordis Corporation Apparatus and method for delivering a vessel plug into the body of a patient
US5391183A (en) * 1990-09-21 1995-02-21 Datascope Investment Corp Device and method sealing puncture wounds
US5419765A (en) * 1990-12-27 1995-05-30 Novoste Corporation Wound treating device and method for treating wounds
US5810810A (en) * 1992-04-23 1998-09-22 Scimed Life Systems, Inc. Apparatus and method for sealing vascular punctures

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4660560A (en) * 1985-05-30 1987-04-28 The Beth Israel Hospital Association Method for treating obstructive prostatism
US4744364A (en) 1987-02-17 1988-05-17 Intravascular Surgical Instruments, Inc. Device for sealing percutaneous puncture in a vessel
US4874368A (en) 1988-07-25 1989-10-17 Micromedics, Inc. Fibrin glue delivery system
US5147316A (en) 1990-11-19 1992-09-15 Castillenti Thomas A Laparoscopic trocar with self-locking port sleeve
CA2103728A1 (en) 1991-02-11 1992-08-12 Barry L. Bowyer Biologically derived medical adhesive and its uses
US5383899A (en) 1993-09-28 1995-01-24 Hammerslag; Julius G. Method of using a surface opening adhesive sealer

Patent Citations (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1432482A (en) * 1920-08-16 1922-10-17 James A Merriam Fastener
US1563881A (en) * 1925-01-26 1925-12-01 R F Simmons Company Catch
US2647294A (en) * 1949-09-23 1953-08-04 Frank L Davis Releasable fastener
US3223083A (en) * 1960-09-09 1965-12-14 President And Directors Of Geo Method for adhesively securing together skin and other soft tissue and bone
US4645488A (en) * 1982-08-12 1987-02-24 Board Of Trustees Of The University Of Alabama Syringe for extrusion of wetted, particulate material
US4660580A (en) * 1983-01-19 1987-04-28 Wella Aktiengesellschaft Process for the permanent shaping of the regrowth of hair and composition therefore
US4645491A (en) * 1984-03-09 1987-02-24 David Evans Surgical needle
US4874366A (en) * 1984-12-03 1989-10-17 Baxter Internatiional Inc. Housing enabling passive mixing of a beneficial agent with a diluent
US4744384A (en) * 1986-07-18 1988-05-17 Fujitsu Limited Automatic gas distributing device controlled by a direct application of high gas pressure of a source for supplying a pipe with gas from an alternative gas source
US4871094A (en) * 1986-12-31 1989-10-03 Alcon Laboratories, Inc. Means and method for dispensing substances
US4852568A (en) * 1987-02-17 1989-08-01 Kensey Nash Corporation Method and apparatus for sealing an opening in tissue of a living being
US4890612A (en) * 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US4790819A (en) * 1987-08-24 1988-12-13 American Cyanamid Company Fibrin clot delivery device and method
US4909251A (en) * 1988-05-31 1990-03-20 Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte Tissue adhesive
US5053046A (en) * 1988-08-22 1991-10-01 Woodrow W. Janese Dural sealing needle and method of use
US4929246A (en) * 1988-10-27 1990-05-29 C. R. Bard, Inc. Method for closing and sealing an artery after removing a catheter
US5061274A (en) * 1989-12-04 1991-10-29 Kensey Nash Corporation Plug device for sealing openings and method of use
US5021059A (en) * 1990-05-07 1991-06-04 Kensey Nash Corporation Plug device with pulley for sealing punctures in tissue and methods of use
US5391183A (en) * 1990-09-21 1995-02-21 Datascope Investment Corp Device and method sealing puncture wounds
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
US5192300A (en) * 1990-10-01 1993-03-09 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5141515A (en) * 1990-10-11 1992-08-25 Eberbach Mark A Apparatus and methods for repairing hernias
US5363899A (en) * 1990-10-15 1994-11-15 Nippondenso Co., Ltd. Method of discriminating quality of die-cast article and die-casting process using same
US5129882A (en) * 1990-12-27 1992-07-14 Novoste Corporation Wound clotting device and method of using same
US5419765A (en) * 1990-12-27 1995-05-30 Novoste Corporation Wound treating device and method for treating wounds
US5147318A (en) * 1991-03-04 1992-09-15 Board Of Regents, The University Of Texas System Valved arterial catheter
US5239982A (en) * 1991-06-07 1993-08-31 Baxter International Inc. Catheter depth gauge and method of use
US5290310A (en) * 1991-10-30 1994-03-01 Howmedica, Inc. Hemostatic implant introducer
US5810810A (en) * 1992-04-23 1998-09-22 Scimed Life Systems, Inc. Apparatus and method for sealing vascular punctures
US5320639A (en) * 1993-03-12 1994-06-14 Meadox Medicals, Inc. Vascular plug delivery system
US5370660A (en) * 1993-11-01 1994-12-06 Cordis Corporation Apparatus and method for delivering a vessel plug into the body of a patient

Cited By (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8951283B2 (en) 2004-11-05 2015-02-10 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US10149670B2 (en) 2004-11-05 2018-12-11 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US20080097521A1 (en) * 2004-11-05 2008-04-24 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9039735B2 (en) 2004-11-05 2015-05-26 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US10213191B2 (en) 2006-09-13 2019-02-26 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US8382798B2 (en) 2006-09-13 2013-02-26 Accessclosure, Inc. Apparatus for sealing a vascular puncture
US8382797B2 (en) 2006-09-13 2013-02-26 Accessclosure, Inc. Methods for sealing a vascular puncture
US8506592B2 (en) 2008-08-26 2013-08-13 St. Jude Medical, Inc. Method and system for sealing percutaneous punctures
US8845683B2 (en) 2008-08-26 2014-09-30 St. Jude Medical, Inc. Method and system for sealing percutaneous punctures
US10806438B2 (en) 2008-11-12 2020-10-20 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US11707266B2 (en) 2008-11-12 2023-07-25 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US9713462B2 (en) 2008-11-12 2017-07-25 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US20100152748A1 (en) * 2008-12-12 2010-06-17 E-Pacing, Inc. Devices, Systems, and Methods Providing Body Lumen Access
US8845682B2 (en) 2009-10-13 2014-09-30 E-Pacing, Inc. Vasculature closure devices and methods
US9179900B2 (en) 2009-12-08 2015-11-10 Phillips Medical Llc Hemostatic device and its methods of use
US9993236B2 (en) 2009-12-08 2018-06-12 Phillips Medical, LLC Hemostatic device and its methods of use
US10765415B2 (en) 2009-12-08 2020-09-08 Phillips Medical, LLC Hemostatic device and its methods of use
US20110137338A1 (en) * 2009-12-08 2011-06-09 Victor Matthew Phillips Hemostatic Device and Its Methods of Use
US8926655B2 (en) * 2010-01-06 2015-01-06 St. Jude Medical, Inc. Method and system for sealing percutaneous punctures
US20110166595A1 (en) * 2010-01-06 2011-07-07 St. Jude Medical, Inc. Method and system for sealing percutaneous punctures
US8876862B2 (en) 2011-04-14 2014-11-04 Phillips Medical Llc Hemostatic device and its methods of use
US10245012B2 (en) 2012-03-23 2019-04-02 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US10499893B2 (en) 2012-03-23 2019-12-10 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US11272911B2 (en) 2012-03-23 2022-03-15 Access Closure, Inc. Apparatus and method for sealing a vascular puncture
US8721680B2 (en) 2012-03-23 2014-05-13 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9757105B2 (en) 2012-03-23 2017-09-12 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US9642604B2 (en) 2012-04-12 2017-05-09 Phillips Medical Llc Hemostatic system and its methods of use
US9468428B2 (en) 2012-06-13 2016-10-18 Phillips Medical Llc Hemostatic device and its methods of use
US9724081B2 (en) 2013-06-04 2017-08-08 Phillips Medical Llc Hemostatic system and its methods of use
US9839416B2 (en) 2013-07-12 2017-12-12 Phillips Medical, LLC Hemostatic device and its methods of use
US10085730B2 (en) 2013-07-12 2018-10-02 Phillips Medical, LLC Hemostatic device and its methods of use
US10722226B2 (en) 2013-07-12 2020-07-28 Phillips Medical, LLC Hemostatic device and its methods of use
US10772615B2 (en) 2013-07-12 2020-09-15 Phillips Medical, LLC Hemostatic device and its methods of use
US10085731B2 (en) 2013-07-15 2018-10-02 E-Pacing, Inc. Vasculature closure devices and methods
US11832804B2 (en) 2014-11-14 2023-12-05 Access Closure, Inc. Apparatus and method for sealing a vascular puncture
US10456123B2 (en) 2014-11-14 2019-10-29 Access Closure, Inc. Apparatus and method for sealing a vascular puncture
USD843573S1 (en) 2015-11-13 2019-03-19 Access Closure, Inc. Vascular closure apparatus
USD865166S1 (en) 2015-11-13 2019-10-29 Access Closure, Inc. Sheath adapter
USD847988S1 (en) 2015-11-13 2019-05-07 Access Closure, Inc. Handle grip

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