WO1989011301A1 - Device for sealing percutaneous puncture in a vessel - Google Patents

Device for sealing percutaneous puncture in a vessel Download PDF

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Publication number
WO1989011301A1
WO1989011301A1 PCT/US1989/002016 US8902016W WO8911301A1 WO 1989011301 A1 WO1989011301 A1 WO 1989011301A1 US 8902016 W US8902016 W US 8902016W WO 8911301 A1 WO8911301 A1 WO 8911301A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
incision
plug means
sealing
expandable material
Prior art date
Application number
PCT/US1989/002016
Other languages
English (en)
French (fr)
Inventor
Kenneth Kensey
Original Assignee
Kensey Nash Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kensey Nash Corporation filed Critical Kensey Nash Corporation
Priority to DE68923617T priority Critical patent/DE68923617T2/de
Priority to HK98106491.4A priority patent/HK1007272B/en
Priority to EP89906881A priority patent/EP0422046B1/en
Publication of WO1989011301A1 publication Critical patent/WO1989011301A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30075—Properties of materials and coating materials swellable, e.g. when wetted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable

Definitions

  • This invention relates generally to medical devices and more particularly to devices for sealing percutaneously formed punctures or incisions.
  • Such procedures unavoid ⁇ ably present the problem of stopping the bleeding at the percutaneous puncture after the procedure has been completed and after the instrument (and any introducer sheaths used therewith) have been removed.
  • bleeding is stopped by the application of direct digital pressure over the puncture site by a trained physician or other suitably trained medical personnel.
  • direct pressure has to be applied for a sufficiently long time for hemostasis to occur so that the opening is effectively closed against further bleeding.
  • the pressure may have to be applied for as long as forty-five minutes for hemostasis to occur.
  • the plug also includes a thread or string attached to it to enable the plug to be retrieved from the vagina. Examples of such devices are shown in United States Patents Nos. 1,191,736 (Roberson) and 1,794,221 (Washburn et al.).
  • the patent literature also includes devices for closing an opening in a blood vessel using sutures, see United States Patent No. 4,587,909 (Gillis). Other means and techniques for closing a wound are disclosed in United States Patent No. 4,606,337 (Zimmermann et al.) .
  • None of the prior art teaches the use of simple means for effecting the closure of an opening, e.g., puncture, in the wall of a blood vessel, duct or lumen, by plugging the opening and without requiring sutures or the application of digital • pressure.
  • the device comprises a tubular body having an outlet at the distal end thereof and which is adapted to be inserted through the puncture or incision to expel a closure therefrom.
  • the closure comprises a first holding portion adapted to engage portions of the tissue adjacent the puncture or incision to hold the closure in place and a second sealing portion formed of an expandable material (e.g., a foam) which is adapted to extend through the puncture or incision and which expands automatically in response to the ambient surroundings when in the body of a living being to engage the tissue contiguous with the puncture or incision to seal it from the flow of a body fluid therethrough between the two body portions .
  • an expandable material e.g., a foam
  • Fig. 1 is a side elevational view partially in section showing a portion of one device constructed in accordance with this invention about to be inserted into- a conventional sheath extending through a percutaneous puncture into an artery ⁇ >
  • Fig. 2 is a side elevational view of the device 20 in place in the sheath;
  • Fig. 3 is a side elevational view of the device 20 during the expulsion of its puncture sealing closure into the artery;
  • Fig. 4 is a side elevational view of the artery showing the sealing closure in place to close off the percutaneous puncture;
  • Fig. 5 is a reduced plan view of the device 20 of the subject invention.
  • Fig. 6 is a side elevational view of the device shown in Fig. 1 but including an alternative embodiment of the closure;
  • Fig. 7 is a sectional view taken along line 7-7 of Fig. 6;
  • Fig. 8 is a side elevational view of the embodiment of the device shown in Fig. 6 during the expulsion of its puncture sealing closure into an artery;
  • Fig. 9 is a side elevational view similar to that of Fig. 8 but showing the puncture sealing device in place within the puncture in the artery;
  • Fig. 10 is a sectional view taken along line 10-10 of Fig. 9.
  • Fig. 11 is a sectional view through the body of the being showing the sealing of a percutaneous incision or puncture in the gall bladder and liver;
  • Fig. 12 is a sectional view through the body of the being showing the sealing of a wound in the lung and heart.
  • FIG. 1 an instrument for effecting the closure of a puncture or other opening in a blood vessel, duct or lumen in a living being.
  • the device 20 thus has particular utility when used in connection with intravascular procedures, such as angiographic dye injection, balloon angioplasty and other types of recanalization of atherosclerotic arteries, in-situ valvulectomy, etc.
  • intravascular procedures such as angiographic dye injection, balloon angioplasty and other types of recanalization of atherosclerotic arteries, in-situ valvulectomy, etc.
  • the device 20 can be used to he o- statically close a puncture or other opening in othe types of duct or lumens within the body.
  • the description of the invention as contained herein is directed to closing off percutaneous punctures in arteries, the device 20 has much more wide-spread applications.
  • a cannula of an instrument such as an angiographic needle (not shown) is inserted percutaneously through the skin into the artery, such as the femoral artery 24 at the situs for the instrument's insertion.
  • the needle cannula is held in place and the flexible end of a mini-guidewire (not shown) is then passed through the cannula into the artery to the desired depth (i.e., longitudinal position therealong).
  • the needle cannula is removed leaving the guidewire in place.
  • a conventional introducer sheath 26 and an arterial dilator (not shown) are then passed over the guidewire through the puncture 28 and into the artery 24.
  • the guidewire and then the dilator are removed leaving the sheath 26 in place.
  • the catheter (not shown) or other intravascular instrument (not shown) is then inserted through the introducer sheath 26 and threaded down the artery to the desired intravascular location, e.g., the situs of an atherosclerotic occlusion.
  • the intravascular procedure e.g., angioplasty
  • the catheter is removed. Thereafter the sheath is removed and the surgeon or other trained person applies digital pressure to the percutaneous puncture until hemostasis has occurred.
  • the device 20 effects the hemostatic closure of a percutaneous or other type of puncture, incision or opening in an artery or other body duct or lumen without necessitating the application of pressure thereto.
  • the device 20 of the subject invention is inserted through the sheath 26 into the artery 24 and operated to expel a closure member 30 (to be described later) into the artery.
  • the closure is arranged to be drawn back into the puncture 28 to seal it. .
  • the sheath is removed and the closure left in place. Due to its construction the closure is ultimately absorbed by the surrounding tissue.
  • the device 20 basically com ⁇ prises a tubular body 32 having an outlet 34 at its distal end, the heretofore identified closure member 30 having a retraction filament 36 connected thereto, and pusher means 38.
  • the tubular body is an elongate member preferably constructed of a sufficiently small outside diameter, e.g., 8 F (French), and somewhat flexible material, such as polyethylene or polyvinyl- chloride, to enable it to be inserted through the introducer sheath 26 into the artery 24, with the tubular body's outlet 34 within the artery distally of the puncture 28.
  • closure member 30 is an expandable member which, when contracted or compressed is sufficiently compact to fit within the interior of the tubular body 30, but when unconstrained by the tubular body it expands to an enlarged configuration (See Figs. 3 and 4) suitable for closing off the puncture 28 in the artery.
  • closure member 30 is formed of a resilient, hemostatic material, which is preferably biodegradable, so that it need not be removed after placement.
  • a porous hemostatic absorb- able gelatin sold by Johnson & Johnson, Inc. under the name Gelfoam.
  • the pusher means 38 basically comprises an elongated, cylindrical rod-like member, having a distal end 40.
  • the pusher is also formed of a relatively flexible material, such as poly ⁇ ethylene or polyvinylchloride and is disposed within the interior of tubular body 32.
  • the outside diameter of the pusher is slightly less than the inside diameter of the tubular body portion to enable the pusher to be manually moved (slid) down the longitudinal axis of the body portion 28, to push or force the closure 30 out of the outlet 34.
  • the pusher is arranged to be moved from a retracted position, like that shown in Fig. 2 to an extended position like that shown in Fig. 3 wherein its distal end 40 is located close to the outlet 34 of the body 32. When the pusher is moved to the extended position its distal end forces the closure member 30 out of the outlet 34.
  • the heretofore identifed retraction filament 36 consti ⁇ tutes an elongated thread, preferably formed of a long, yet very thin, biodegradable material, such as an absorbable suture, and is fixedly secured to the proximal side 42 of the closure member 30 at the middle thereof.
  • the thread 36 extends down the length of the tubular body 32 between it and the pusher 38 so that the proximal end of the thread is located outside the device 20.
  • the thread 36 being long and thin does not interfere with the operation of the pusher expelling the closure member 30 out of outlet 34. Thus, during the expulsion of the closure into the artery the thread 36 slides down the tubular member with the closure.
  • the thread 36 is sufficiently long that a substantial length extends outside of the proximal end of the device 20 even after the closure is in the artery.
  • the tubular body includes a collar 44 having a flanged projection 46 arranged to be grasped by the fingers of the user of the device 20.
  • the proximal end 48 of the pusher 38 includes an enlarged cap 50 arranged to be engaged by the user's thumb.
  • the closure member 30 when it is in its unconstrained state (such as when it is ejected into the artery) it assumes a configuration having an enlarged head portion 52 and an anchor portion 54.
  • the head portion is of generally disk-like shape of relatively large diameter, e.g., 6-9 mm, yet relatively thin, e.g., 1-2 mm.
  • the head portion includes the rear (proximal) surface 42 and a front (distal) surface 56.
  • the anchor portion 54 consists of a small diameter, e.g., 2-3 mm, hub-like projection from the proximal surface 42 at approximately the center thereof.
  • the distal end of the retraction thread 36 is fixedly secured to the anchor portion 54.
  • the resilient nature of the closure enables the enlarged head portion 52 to conform to the surface 58 of the interior of the artery 24 contiguous with the puncture 28 so that its proximal surface 42 intimately engages the artery surface 58 while the hub-like anchor portion 54 extends somewhat into the puncture 28 to hemostatically seal the puncture when the closure is pulled into place, as will be described hereinafter.
  • the head portion 52 of the closure is thin and conforms to the interior surface of the artery, it does not block off or otherwise impede the flow of blood through the artery.
  • the closure can be of any suitable shape and need not be of the disk-like shape shown herein, so long.as once it is puled into position at the situs of the puncture it serves to hemostatically seal that puncture without appreciably blocking the passageway.
  • the front (distal) face 56 of the closure 30, which is exposed to the flow of blood through the artery may be coated with a non-thrombogenic material. This feature serves to minimize the risk of thrombosis forming in the artery.
  • the thrombogenic material used can comprise a waxy coating, such as coconut oil, on the closure's front surface 56.
  • closure and its retraction filament are each preferably formed of an absorbable (e.g. , biodegradable) material.
  • an absorbable e.g. , biodegradable
  • the natural forming the closures of this invention may include conventional clotting agents, such as tissue throboplastin.
  • FIG. 6 there is shown an alternative embodiment of the closure utilized in a device 20 for sealing a percutaneous puncture or incision.
  • the alternative embodiment of the closure is designated by the reference numeral 100 and basically comprises three components, namely,- a holding member 106, a suture or filament 104, and a sealing member 102.
  • the holding member 106 is an elongated body constructed like a toggle and is preferably formed of a' biodegradable, thermoplastic polymer, such as polyglactide. This material will " degrade within the body within a short period of time, e.g., approximately 45 days.
  • the toggle is molded onto the distal end of the filament 104 which is slightly bulbous to hold the toggle in place thereon.
  • the filament is also preferably formed of polyglactide (e.g., it will degrade within the body in approximately 90 days).
  • the filament is quite flexible so that the toggle can pivot to various orientations with respect to it.
  • Disposed pro ixally behind the toggle 106 is the sealing member 102.
  • That member basically comprises a cylindrical plug preferably formed of a compressed foam which is highly absorbent and which, when disposed within the body, swells in excess of its compressed diameter, e.g., swells to twice its compressed diameter.
  • the plug is preferably formed of gelatin or collagen foam so that it also degrades quickly within the body, e.g., in approximately ten days or so.
  • the filament extends fully through the plug.
  • the closure 100 is located within the device 20 adjacent the outlet 34 of the tubular portion 32 thereof.
  • the foam plug or sealing portion 102 is located immediately adjacent the free end 40 of the plunger 38, with the toggle or holding portion 106 located at the distal end of the portion 102.
  • the toggle is oriented so that its longitudinal axis is parallel to the longitudinal axis of the device 20. When so disposed the toggle compresses a portion of the distal end of the plug portion.
  • the filament 104 extends backward from the toggle portion through the plug portion and through a central passageway in the plunger 38 to a point outside the device 20.
  • the closure is introduced into the artery, or into a puncture or incision in any body tissue, such as the liver (Fig. 11), gall bladder (Fig. 11), lung (Fig. 12), heart (Fig. 12), etc., until the insertion device's outlet 34 is in the desired position.
  • the outlet 34 of the device is positioned so that it is within the artery (See Fig. 8) and just slightly beyond the introducer sleeve 26. This placement is controlled by stops (not shown) on the device 20.
  • the plunger 38 is then operated as described earlier to expel the closure 100. Once the closure is expelled, the device 20 is held in this position for a short period of time, e.g., 15 to 60 seconds, to allow the foam at the tip of the closure, i.e., the distal end of portion 102, to swell. This action effectively tips the toggle.
  • the insertion device 20 is then removed in a similar manner as described earlier and the closure's filament 104 then retracted, that is, pulled in the direction of arrow 108 in Fig. 8.
  • This action pulls the closure's plug portion 102 back through the puncture or incision 28 in the artery wall until its toggle portion 106 engages the inner surface of the arterial wall to stop further retraction.
  • the toggle comes into engagement with the arterial wall, it effects the compression of the distal end portion 110 of the plug portion 102.
  • the proximal end portion of the plug 102 extends into the puncture or incision in the subcutaneous tissue 22A to a point closely adjacent the skin 22.
  • the engagement of the toggle with the inner surface of the artery wall can either be direct or indirect, the latter being through the interposed deformed distal end portion of the plug 102.
  • the toggle serves to act as a stop precluding the closure 100 from being pulled out of sealing engagement with the puncture or incision 28.
  • the closure 200 basically comprises a preformed foam plug having an enlarged distal end portion 106 (See Figs. 11 and 12) serving as the heretofore described holding member, a proxi ally located rod-like portion 102 (See Figs. 11 and 12) serving as the heretofore described sealing member and a retraction filament 104 secured thereto.
  • the closure 200 is preferably formed of a dense collagen foam with long collagen fiber reinforcement so that it has a high expansion ratio (wet-to-dry) and good mechanical wet strength.
  • the closure 200 like closures 30 and 100 is held within the tubular portion 32 of the insertion device 20 in a compressed state and with its holding portion 106 located immediately adjacent the outlet 34.
  • the device 20 is introduced into the artery in the manner as described heretofore.
  • the pusher member 38 then pushes the foam closure out of the outlet, whereupon the holding portion 106 swells upon contact with the blood in the artery.
  • the insertion device 20 is then removed so that the closure 200, now swollen, hangs up at the puncture or incision 28 within the arterial wall, i.e., the enlarged holding member portion 106 engages the inner surface of the arterial wall and the sealing portion 102 extends fully through the puncture or incision into the subcutaneous tissue 22A.
  • the retraction of the filament fully seats the closure in place so that the sealing portion extends fully through the puncture or incision in the artery wall and with its proximal end located within the subcutaneous tissue closely adjacent the skin.
  • the advantage of the preformed foam closure as just described over the toggle/plug closure 100 is that it is considerably simpler in construction, assembly and cost. As mentioned earlier, it is frequently desirable to be able to seal a puncture or incision in body organs or tissue other than blood vessels. For example, in cases where percutaneous transhepatic punctures are made into the gall bladder for purposes of introducing chemicals or mechanical instruments, there exists a very real risk of bile leakage into the peritoneum via the liver puncture site, thereby resulting in a dangerous possibility of peritonitis.
  • the closures 30, 100 and 200, as described heretofore, can be utilized to seal such percutaneous punctures or incisions to eliminate the risks of bile leakage. For example, as shown in Fig.
  • an insertion device 20 with a closure 100 or 200 disposed therein is introduced through the puncture or incision 28 in the right lobe of the liver and through the puncture or incision in the gall bladder so that the device's outlet 34 extends just beyond its introducer sheath 26.
  • the plunger 38 is then pressed to eject the closure so that the holding portion 106 thereof is located within the gall bladder and in engagement with the inner surface thereof, while the sealing portion 102 extends through the puncture or incision in the gall bladder and into the puncture or incision in the liver.
  • the closure 100/200 may be left in the incision or puncture 28 in the liver alone, if that makes best sense from a medical/surgical standpoint.
  • the subject invention is also useful for effecting the sealing of percutaneous incisions or punctures in the heart, such as could result from a wound.
  • a wound penetrating the left lung and left ventricle may be sealed by introducing the insertion device 20 with a closure 100/200 therein through the wound, through the puncture in the lung, and into the puncture in the left ventricle.
  • the closure 100/200 is then ejected so that its holding portion 106 is located within the left ventricle, while its sealing portion 102 extends through the puncture in the left ventricle wall and through the puncture in the left lung.
  • closure member 100/200 be configured so that its sealing portion 102 is of a substantial length to extend not only through the puncture in the left ventricle, but also the puncture in the lung and through the wound in the skin to some exterior point closely adjacent the skin.
  • the closure 100/200 acts as a tamponade.
  • the device and methods of this invention as we ' ll as the closure device mentioned in my copending United States Patent Application, can be puncture in any body tissue or organ to prevent the flow of fluid through that puncture or incision from one body portion to another.

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  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)
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PCT/US1989/002016 1988-05-16 1989-05-10 Device for sealing percutaneous puncture in a vessel WO1989011301A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE68923617T DE68923617T2 (de) 1988-05-16 1989-05-10 Vorrichtung zum abdichten einer perkutanen gefässpunktion.
HK98106491.4A HK1007272B (en) 1988-05-16 1989-05-10 Device for sealing percutaneous puncture in a vessel
EP89906881A EP0422046B1 (en) 1988-05-16 1989-05-10 Device for sealing percutaneous puncture in a vessel

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US194,641 1988-05-16
US07/194,641 US4890612A (en) 1987-02-17 1988-05-16 Device for sealing percutaneous puncture in a vessel

Publications (1)

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WO1989011301A1 true WO1989011301A1 (en) 1989-11-30

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PCT/US1989/002016 WO1989011301A1 (en) 1988-05-16 1989-05-10 Device for sealing percutaneous puncture in a vessel

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JPH0570469B2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) 1993-10-05
US4890612A (en) 1990-01-02
CA1322922C (en) 1993-10-12
JPH03505048A (ja) 1991-11-07
DE68923617D1 (de) 1995-08-31
EP0422046A4 (en) 1991-06-19
EP0422046B1 (en) 1995-07-26
EP0422046A1 (en) 1991-04-17
HK1007272A1 (en) 1999-04-09
ATE125434T1 (de) 1995-08-15
DE68923617T2 (de) 1996-02-01

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