WO1992022252A1 - Sealing device for a blood vessel or the like - Google Patents

Sealing device for a blood vessel or the like

Info

Publication number
WO1992022252A1
WO1992022252A1 PCT/EP1992/001418 EP9201418W WO1992022252A1 WO 1992022252 A1 WO1992022252 A1 WO 1992022252A1 EP 9201418 W EP9201418 W EP 9201418W WO 1992022252 A1 WO1992022252 A1 WO 1992022252A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
holder
plug
blood
element
vessel
Prior art date
Application number
PCT/EP1992/001418
Other languages
French (fr)
Inventor
Jacobus Antonius Christiaan Deuss
Cornelis Hendrikus Anna Wittens
Original Assignee
Ashridge Ag
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

Links

Classifications

    • 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
    • A61B17/00491Surgical glue applicators
    • A61B2017/00495Surgical glue applicators for two-component glue
    • 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

Abstract

A device for sealing with a plug a surgically arranged or other non-natural opening in a wall of a liquid-containing organ, such as a blood vessel, gall bladder and the like, in a living organism, wherein an elongate, hollow, flexible holder (15) is used, having on the distal end a spreadable element (2) and on the proximal end an operating member in communication with the spreadable element for carrying the element from a straightened position to a spread position and vice-versa in order to block the opening, to place the plug against the spreaded element and to remove the collapsed element alongside the plug sealing off the opening.

Description

SEALING DEVICE FOR A BLOOD VESSEL OR THE LIKE

The invention relates to a device for sealing with a plug a puncture, incision or surgically arranged or other non-natural opening in a wall of a liquid-containing organ, such as a blood vessel, gall bladder and the like, in a living organism.

It occurs frequently in surgery that an opening must be made in a blood vessel or other organ in for instance a human body either surgically or by means of a puncture via the skin, which opening must afterward be re-closed. This causes particular problems in the case of blood vessels such as arteries because a digital pressure has to be applied to the opening over a long period before sufficient tissue is formed to close the hole in natural manner by clotting of the blood. Since use is often made of blood diluting means this clotting process is poor and bleeding is a regular occur¬ rence. It is sometimes even necessary to perform surgery. This results in a prolonged aftercare which is out of all proportion to the actual operation such as dottering or the like. It is known to seal the blood vessel and the above- lying tissue by .means of a plug of hemostatic and swellable material. The problem that occurs here is the precise placing of the plug in relation to the wall of the liquid vessel. It is namely inadmissible in the case of blood vessels for the plug material to enter the blood vessel, which can lead to blockages. If, however, the plug remains too far from the wall of the blood vessel after placing, blood loss will inevitably occur.

The invention has for its object to provide an auxi- liary device with which placing of the plug can take place in precise manner so that the opening can be closed effectively.

The device according to the invention is distinguished by an elongate, hollow, flexible holder on the free end of which a spreadable element is fixedly arranged and an opera- ting member communicating with the spreadable element for carrying the element from a straightened position to a spread position and vice-versa.

With the elongate holder and the spreadable element on the end thereof it is possible, making use of the flexibility of the holder, to place the free end with the spreadable element through the opening into the organ. After spreading the element by means of the operating member the holder can be retracted again, wherein the spread element remains hooked behind the opening against the inner wall of the organ, that is, the blood vessel. The surgeon can then arrange a plug of suitable material along the flexible holder and push it through until it comes up against the spread element of the device. The spread element is subsequently reset into the straightened position and pulled out of the opening. The plug of swellable material expands and closes the opening in the wall of the blood vessel or organ, since the side of the plug facing the organ is arranged precisely in position.

According to a first embodiment the element is fixed to the elongate hollow holder in the form of an inflatable balloon, wherein the operating member is a pump communicating with the balloon via the hollow holder. In this embodiment spreading of the element is effected by pumping up the bal¬ loon so that the outside of the balloon comes to lie against the inner wall of the organ after the holder has been pulled back. After placing of the plug the pressure can be released from the balloon and the balloon deflated so that it can be withdrawn easily along the plug out of the organ. Optionally a vacuum can be applied in the balloon in order to further simplify withdrawal. According to another embodiment of the invention the element is embodied as a number of strips lying in alignment with the elongate holder, the one ends of which are fixed to the outer end of the holder and the other ends to a common coupling piece, which coupling piece is embodied with a pulling member which is guided through the hollow holder.

The strips have a determined flexibility and stiffness so that in a released position they will extend in the line of the holder. In this situation the element strips and the holder can be inserted through the wall of the organ, where- after a pulling force is applied to the pulling member. This causes the strips to bend and therefore to spread so that the holder can be retracted again, wherein the outer sides of the strips come to lie against the inner wall of the organ. The plug can thus be accurately positioned against the strips, that is, against the wall of the organ.

By terminating the tensile force on the pulling member the strips will straighten again, whereafter the holder can be withdrawn with the element.

In a further embodiment of the invention the device for sealing the puncture or incision is formed by two parts, the first part being still the holder for guiding the spreadable element, and a second holder for bringing the plug in position.

According to a further development said holders are combined to a triple lumen catheter, the first lumen being connected to the spreadable element, the other two lumens being used for bringing the plug in position, said plug here being a two component glue.

Above mentioned and other features of the device according to the invention will be further elucidated herein- below with reference to a figure description of two embodi¬ ments. In the drawing: fig. 1 shows a longitudinal section of a blood vessel embedded in surrounding tissue, in which blood vessel a sheath is arranged for surgical purposes, wherein a device according to the invention is used in the form of a balloon, fig. 2, 3, 4, 5 and 6 show successive stages of the placing of the device according to the invention and the final sealing of the opening, fig. 7 and 8 show a section corresponding with fig. 1 and 2 of a blood vessel, wherein a holder embodied with strips is used as device for sealing the opening, fig. 9, 10 and 11 show a third embodiment of the sealing device according to the invention provided with a second holder for the plug, fig. 12 and 13 show a fourth embodiment, wherein the first and second holder are united to a triple lumen catheter.

The device as shown in fig. 1-6 consists of an elon- gate, flexible holder 1, on the free end of which is arranged a spreadable element in the form of a balloon 2. Only the outer end of the holder is shown in the figures, wherein it is assumed that the flexible holder 1 extends further than shown and is sufficiently long to reach the organ in the living organism from the outside. The other end of the holder is connected to a pressure pump 3, for instance bellows for manual operation, which is in communication with the hollow space in the holder 1 and therefore with the inside of bal¬ loon 2. Shown in fig. 1 is a so-called introducer sheath 4 which is introduced beforehand in the blood vessel V of tissue W for instance for guiding into the blood vessel surgical elements such as for example a dottering balloon. For this purpose a guide wire 5 can already have been trained through sheath 4 which can likewise be used for introducing the holder with balloon 2. This is not essential and the wire 5 may also be removed beforehand. The introduction of the balloon 2 with holder 1 through the sheath 4 is recommended due to the easy introduction thereof. When the holder 1 and balloon 2 have been introduced, the balloon 2 can be inflated by means of the pump 3, as shown in fig. 2. It is noted that the balloon here virtually closes the passage of the blood vessel V but with an appropriate dimensioning sufficient space can also be left for a normal blood flow. The sheath 4 is then retracted in the direction of arrow P2 and, after holder 1 has likewise been pulled back in the direction of arrow P2, the balloon will come to lie with the outer wall against the inner wall of blood vessel V, see fig. 3 and 4. A plug P can subsequently be arranged in the tissue W adjacent or around the holder 1, which plug is of suitable material, for instance material that is swellable on absorption of moisture and provided with clotting agents.

The plug P is guided inward into the tissue W until the underside 0 thereof comes up against the outside of the inflated balloon 2. This results in an accurate position of the plug P relative to the wall portion of blood vessel V so that no plug material P enters the blood vessel V.

By releasing the pressure out of the balloon 2 the latter will again assume the straightened position as shown in fig. 5 and the holder with the balloon can be retracted from the blood vessel V in the direction of the arrow P2. Finally, the plug P will fill up the opening caused by the holder 1 and the blood vessel V is thus completely closed.

Due to this procedure it is now possible to effective- ly close the opening in the blood vessel wall V without applying much pressure thereto. Blood loss is hereby preven¬ ted and eventual aftercare for bleeding can be avoided.

The figures 7 and 8 show a second embodiment of the device according to the invention, the holder 1 is provided here with a number of strips 7 which are connected at the top end 8 to the extremity of holder 1 and the bottom end 9 of which is coupled to a common coupling piece 10. The latter is connected to a pulling element 11 which is guided through the holder 1 and coupled outside the holder 1 to a pulling means, for instance an eye (not shown) .

By pulling the pulling element 11 in the direction of arrow P3 the coupling piece 10 is moved toward the end 8, whereby the strips 7 will bend in bulbous manner and be spread away from each other. With a sufficient curvature as according to the dashed line 12 the outside of the strips 7 will come up against the inner wall of the blood vessel V, whereafter the plug material P can be arranged against the strips 7. In the same manner as described above the position P is thus accurately determined and, after release of the pulling element 11, the holder 1 with the element strips 7, which have assumed the position according to fig. 7, can be withdrawn from the organ and tissue. The plug will subse¬ quently close up the opening caused by the holder 1 and assume the position in fig. 6. In the figures 9, 10 and 11 a third embodiment of the sealing device according to the invention is disclosed. In said figures the same reference numerals are used for the same parts of the device.

In said third embodiment the device consists of two holders. The first holder 1 is a thin shaft ballooncatheter, e.g. an embolectomy catheter with a shaftdiameter of max. 3 French and a length of approximately 40 cm. The plug holder 15 is a flexible hollow tubular device of which the distal part is loaded with a collageen plug of approximately 4 to 5 cm. The plug holder has a provision 16 to allow it to be hooked on the free exposed part 1* of the embolectomy catheter 1 during the procedure in a monorail fashion and to advance it over the shaft of the ballooncatheter. Said provision 16 on the plug holder 15 is a short tube with an internal diameter that accommodates the shaft 1 of the balloncatheter and has a slit 17 lengthwise. By pressing this part of the plug holder between thumb and indexfinger this small tube opens and the shaft of the ballooncatheter can be inserted in this space. Releasing the fingers closes this space around the shaft of the ballooncatheter whereupon the plug holder can ride in a monorail fashion over the shaft of the ballooncatheter. Inside the plug holder 16 is a stamp 18 inserted which reaches the plug P and which can be used to deliver the plug in place by keeping the stamp fixated and simultaneously withdrawing the hollow plug holder. Above device can be used as follows.

The introducersheath 4 of the clinical procedure is still in the bloodvessel. The ballooncatheter (e.g. a 3 French e bolectomycatheter) is advanced through the hemostatic valve of the introducersheath, and advanced untill it is out of the distal end and in the free bloodvessel. See fig. 1. Now the balloon is inflated and both the introducersheath and ballooncatheter are withdrawn until the inflated balloon reaches the hole in the vesselwall and closes this hole off. The introducersheath 4 is withdrawn another 10 cm to expose outside the body approximately 10 cm of balloonshaft 1. For this reason the ballooncathetershaft should be about 40 cm. This situation is shown in fig. 9. While the proximal part of the ballooncatheter is kept under pulling pressure to make sure that the balloon is closing off the hole in the vessel, the flexible plug holder 15 is hooked on the shaft of the ballooncatheter. This is shown in fig. 9 and fig. 10. The plug holder is now advanced over the shaft of the ballooncatheter in a monorailfashion until markers 19 on the plug holder 15 and the shaft 1 of the ballooncatheter corresponds. This means that the distal part of the plug holder has reached a position just above the bloodvessel.

This situation is shown in fig. 10. The balloon will now be deflated. While the stamp 18 is kept in position, the plugholder 15, together with the ballooncatheter 1 is withdrawn. This action releases the plug just above the bloodvessel. As the collageen plug is thrombogenic, it will provide for an immediate and effective closure of the hole in the bloodvessel. In the embodiment according to fig. 12 and 13 the two holders 1 and 15 for the speadable elements and plug positioning holder are united.

Here both holders are formed as a triple lumen catheter, one lumen of which is prolonged at the distal end over approximately 15 mm, whereas the distal end is connected to the inflatable balloon 2.

The outer diameter of the triple lumen catheter 20 is such that it is possible to introduce the catheter into the introducersheat 4, which was already positioned during surgical actions.

The lumen connected to the balloon can be connected to a syringe 21 so when pressing the syringe the balloon can be inflated.

The two other lumens are proximal connected to a double syringe, a so-called two component syringe filled with a two component fibrin glue, for instance tissue collagen.

The catheter can be used as follows. As soon as the catheter is brought in the blood vessel the balloon can be inflated. After removing the introducersheat from the blood vessel far out of the body, the catheter with the inflated balloon can be withdrawn also until the balloon will close off the puncture in the blood vessel. The openings of the double lumen are now approximately 15 mm above the wall of the blood vessel.

The two component glue can now be injected by means of the double syringe into the space just above the wall of the blood vessel. Due to the activated hardening elements in the fibrin glue, said glue will be hardened out, and will form a solid plug for sealing off the blood vessel. Prior to the final hardening of the glue the balloon is deflated and removed.

The invention is not limited to the above described embodiments. It will be apparent that with the device according to the invention no alien material remains behind in the organ or blood vessel so that no risk of blockage or damage in the organ will occur.

Claims

1. Device for sealing with a plug a surgically ar¬ ranged or other non-natural opening in a wall of a liquid- containing organ, such as a blood vessel, gall bladder and the like, in a living organism, characterized by an elongate, hollow, flexible holder, on the free end of which a spread¬ able element is fixedly arranged and an operating member connected to the spreadable element for carrying the element from a straightened position to a spread position and vir-i— versa.
2. Device as claimed in claim 1, characterized in that the element is arranged on the elongate hollow holder in the form of an inflatable balloon, wherein the operating member is a pump communicating with the balloon via the hollow holder.
3. Device as claimed in claim 2, characterized in that in the straightened position the diameter of the inflatable balloon is at least three times the outer diameter of the holder.
4. Device as claimed in claim 1, characterized in that the element is embodied in the form of at least two strips, wherein the one end of the strip is connected to the outer end of the holder and the other ends are mutually coupled, wherein the coupled ends are connected to a pulling member which is guided through the hollow holder.
5. Device as claimed in one of the previous claims, characterized in that a second holder is provided for introducing a plug just above the inflated or spreaded element.
6. Device as claimed in claim 5, characterized in that the second holder (15) is provided with a guide (16) cooperating with the first holder (1) of the spreadable element.
7. Device as claimed in claim 5, characterized in that both holders 1 and 15 respectively are united in a single holder provided with three lumen, one lumen of which is prolonged and connected to the spreadable element.
PCT/EP1992/001418 1991-06-18 1992-06-18 Sealing device for a blood vessel or the like WO1992022252A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
NL9101051 1991-06-18
NL9101051A NL9101051A (en) 1991-06-18 1991-06-18 Closure device for a blood vessel or the like.

Publications (1)

Publication Number Publication Date
WO1992022252A1 true true WO1992022252A1 (en) 1992-12-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (2)

Country Link
NL (1) NL9101051A (en)
WO (1) WO1992022252A1 (en)

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US5275616A (en) * 1990-10-01 1994-01-04 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5334216A (en) * 1992-12-10 1994-08-02 Howmedica Inc. Hemostatic plug
US5370660A (en) * 1993-11-01 1994-12-06 Cordis Corporation Apparatus and method for delivering a vessel plug into the body of a patient
US5383896A (en) * 1993-05-25 1995-01-24 Gershony; Gary Vascular sealing device
US5437631A (en) * 1990-09-21 1995-08-01 Datascope Investment Corp. Percutaneous introducer set and method for sealing puncture wounds
US5496332A (en) * 1994-10-20 1996-03-05 Cordis Corporation Wound closure apparatus and method for its use
EP0716833A2 (en) * 1994-12-14 1996-06-19 Global Therapeutics Inc. Method and apparatus for sealing a body site
EP0755226A1 (en) * 1995-02-10 1997-01-29 Sherwood Medical Company Assembly for sealing a puncture in a vessel
US5643318A (en) * 1994-03-31 1997-07-01 Boston Scientific Corporation Vascular plug with vessel locator
EP0774237A3 (en) * 1995-10-20 1997-07-30 United States Surgical Corp Apparatus and method for vascular hole closure
US5690674A (en) * 1996-07-02 1997-11-25 Cordis Corporation Wound closure with plug
EP0818178A2 (en) * 1996-07-09 1998-01-14 Cardiologics, L.L.C. Anchoring device for sealing percutaneous punctures in vessels
US5725551A (en) * 1993-07-26 1998-03-10 Myers; Gene Method and apparatus for arteriotomy closure
US5728122A (en) * 1994-01-18 1998-03-17 Datascope Investment Corp. Guide wire with releaseable barb anchor
US5810846A (en) * 1995-08-03 1998-09-22 United States Surgical Corporation Vascular hole closure
US5814065A (en) * 1996-02-09 1998-09-29 Cordis Corporation Suture delivery tool
WO1998040017A3 (en) * 1997-03-12 1998-10-22 Advanced Closure Systems Inc Vascular sealing device
US5941897A (en) * 1997-05-09 1999-08-24 Myers; Gene E. Energy activated fibrin plug
US6007613A (en) * 1994-11-03 1999-12-28 Fusion Medical Technologies, Inc. Bioadhesive; preparation procedure and device for the application of a bioadhesive; and hardeners for a bioadhesive
US6017359A (en) * 1993-05-25 2000-01-25 Vascular Solutions, Inc. Vascular sealing apparatus
US6033401A (en) * 1997-03-12 2000-03-07 Advanced Closure Systems, Inc. Vascular sealing device with microwave antenna
EP0998324A4 (en) * 1995-10-27 2000-05-10 Gary Gershony Vascular sealing apparatus and method
US6063061A (en) * 1996-08-27 2000-05-16 Fusion Medical Technologies, Inc. Fragmented polymeric compositions and methods for their use
US6066325A (en) * 1996-08-27 2000-05-23 Fusion Medical Technologies, Inc. Fragmented polymeric compositions and methods for their use
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US7074232B2 (en) 2000-09-01 2006-07-11 Medtronic Angiolink, Inc. Advanced wound site management systems and methods
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US7572274B2 (en) 2004-05-27 2009-08-11 Cardiva Medical, Inc. Self-tensioning vascular occlusion device and method for its use
US7622628B2 (en) 2005-05-04 2009-11-24 Innovasa Corporation Hemostatic wire guided bandage and method of use
US7691127B2 (en) 2005-12-13 2010-04-06 Cardiva Medical, Inc. Drug eluting vascular closure devices and methods
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US7993366B2 (en) 2004-05-27 2011-08-09 Cardiva Medical, Inc. Self-tensioning vascular occlusion device and method for its use
US8002742B2 (en) 2005-04-22 2011-08-23 Accessclosure, Inc. Apparatus and methods for sealing a puncture in tissue
US8128654B2 (en) 2003-06-04 2012-03-06 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US8323305B2 (en) 1997-02-11 2012-12-04 Cardiva Medical, Inc. Expansile device for use in blood vessels and tracts in the body and method
US8444671B2 (en) 2006-12-21 2013-05-21 Cardiva Medical, Inc. Hemostasis-enhancing device and method for its use
US8834864B2 (en) 2003-06-05 2014-09-16 Baxter International Inc. Methods for repairing and regenerating human dura mater
US8852230B2 (en) 2007-11-02 2014-10-07 Incept Llc Apparatus and methods for sealing a vascular puncture
US8911472B2 (en) 2005-12-13 2014-12-16 Cardiva Medical, Inc. Apparatus and methods for delivering hemostatic materials for blood vessel closure
US8940335B2 (en) 2010-06-01 2015-01-27 Baxter International Inc. Process for making dry and stable hemostatic compositions
US8951283B2 (en) 2004-11-05 2015-02-10 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
US8962025B2 (en) 2006-08-02 2015-02-24 Baxter International Inc. Rapidly acting dry sealant and methods for use and manufacture
US9005609B2 (en) 2003-08-07 2015-04-14 Ethicon, Inc. Hemostatic compositions containing sterile thrombin
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Cited By (94)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5437631A (en) * 1990-09-21 1995-08-01 Datascope Investment Corp. Percutaneous introducer set and method for sealing puncture wounds
US5275616A (en) * 1990-10-01 1994-01-04 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5716375A (en) * 1990-10-01 1998-02-10 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5478352A (en) * 1990-10-01 1995-12-26 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5449375A (en) * 1992-12-10 1995-09-12 Howmedica Inc. Method of making a hemostatic plug
US5334216A (en) * 1992-12-10 1994-08-02 Howmedica Inc. Hemostatic plug
US6017359A (en) * 1993-05-25 2000-01-25 Vascular Solutions, Inc. Vascular sealing apparatus
US5383896A (en) * 1993-05-25 1995-01-24 Gershony; Gary Vascular sealing device
US5957952A (en) * 1993-05-25 1999-09-28 Vascular Solutions, Inc. Vascular sealing device
US6296658B1 (en) 1993-05-25 2001-10-02 Vascular Solutions, Inc. Vascular sealing apparatus
US5725551A (en) * 1993-07-26 1998-03-10 Myers; Gene Method and apparatus for arteriotomy closure
US5370660A (en) * 1993-11-01 1994-12-06 Cordis Corporation Apparatus and method for delivering a vessel plug into the body of a patient
US5728122A (en) * 1994-01-18 1998-03-17 Datascope Investment Corp. Guide wire with releaseable barb anchor
US5871501A (en) * 1994-01-18 1999-02-16 Datascope Investment Corp. Guide wire with releasable barb anchor
US5643318A (en) * 1994-03-31 1997-07-01 Boston Scientific Corporation Vascular plug with vessel locator
US6302898B1 (en) 1994-06-24 2001-10-16 Advanced Closure Systems, Inc. Devices for sealing punctures in body vessels
US5496332A (en) * 1994-10-20 1996-03-05 Cordis Corporation Wound closure apparatus and method for its use
US6007613A (en) * 1994-11-03 1999-12-28 Fusion Medical Technologies, Inc. Bioadhesive; preparation procedure and device for the application of a bioadhesive; and hardeners for a bioadhesive
EP0716833A3 (en) * 1994-12-14 1997-01-29 Global Therapeutics Inc Method and apparatus for sealing a body site
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