MXPA96004689A - Assembly to seal a puncture in a v - Google Patents

Abstract

This invention is a bio-absorbable assembly for sealing an incision or puncture in the patient's body that includes a first member (30) that is generally positioned along the wall of the blood vessel, duct, patient's body cavity and a gelatinous material. (52) which is injected into the incision or puncture around a filament (36) or clip (78) that is associated with the first member to seal the incision or puncture against the flow of fluids through the blood vessel, duct or opening of the patient and the method for the

Description

ASSEMBLY FOR SEALING A PUNCTURE IN A VESSEL BACKGROUND OF THE INVENTION This invention relates generally to medical devices and more particularly to hemostatic devices for closing various openings or incisions in a patient's body.

As will be appreciated by those skilled in the art, various surgical procedures can now be carried out intravascularly or intraluminally. For example, in the treatment of vascular diseases, such as atherosclerosis, it is common practice to invade the artery to insert an instrument or catheter, for example, a "balloon or other type of catheter to perform the procedure inside the artery. Procedures usually involve percutaneous puncture of the artery so that an introducer sheath can be inserted into the artery and from there the instrument or catheter itself can be inserted through the sheath to operative operation within the artery. problem with this type of procedure is that it is often difficult to stop the bleeding in the percutaneous puncture after the procedure has been completed and after the instrument (and any sheaths used with it) has been removed.

At present, the most common treatment for stopping such bleeding is by applying manual pressure on the puncture site by a trained physician or other appropriately trained medical personnel. Said manual pressure must be applied for a sufficiently long time for haemostasis to occur so that the opening is effectively closed preventing further bleeding. In the case of punctures within superficial femoral or femoral arteries, the pressure must be applied for forty-five minutes or more for hemostasis to occur. Not only is the application of manual pressure a waste of time of highly trained medical professionals, the procedure results in a substantial reduction, if not a virtual stop, of blood flow through the vessel. Since thrombosis is one of the side effects that can occur in the immediate period after the operation, any reduction in the flow blood, as caused by the application of manual pressure, is undesirable.

Simple applicator apparatuses have been presented in the patent literature for inserting a plug or absorbent member into the vagina. Said apparatuses basically comprise a tubular element adapted to be inserted inside the vagina and having a "« plug of absorbent material to push the plug out of the tubular element into the vagina.The plug may also include a spring thread attached thereto. Examples of such apparatus are shown in U.S. Patent Nos. 1,191,736 issued to Robertson and 1,794,221 issued to Washburn et al. 15 While these apparatuses are appropriate for their intended purposes, they do not exist. suggestion of its use, nor are they particularly suitable for insertion into an opening in the wall of a blood vessel or other bodily opening or duct to seal such an opening 20 U.S. Patent Nos. 4,744,364 and 4,852,568 issued to Kensey, present an insertion instrument and a closing or clamping device to seal a tissue opening that separates a portion of the body po of a living being from another portion, for example, a puncture in a blood vessel, duct or opening of a living being. Various Methods of use for that apparatus are also presented in those patents. The laying instrument of the Kensey invention basically comprises an elongated tubular body having an outlet at its distal end. The far end of the apparatus is arranged to be inserted through the opening or other opening. In the situation where the puncture is in an artery or other blood vessel, the exit of the tubular body is inserted through the puncture so that the distal end of the device is placed inside the blood vessel. A fastener is disposed within the tubular body and is oriented so as to be held in a compact configuration aligned or compressed within the tubular body before use. The tubular body also includes an ejector in the form of a plunger arranged to force the fastener out of the outlet into the body portion of the being generally adjacent to the opening, for example, within the interior of the blood vessel, after which the fastener is unfolded or expanded to form a contact surface with the grown tissue.

A retraction filament is secured to the fastener or closure to allow it to be pulled completely along or adjacent to the puncture after the tubular body of the apparatus has been removed so that the contact surface of the fastener or closure between in intimate contact or resting on the inner surface of the tissue along the puncture.

In accordance with one aspect of those presented in the Kinsey patents, the filament is held taut or secured in some other way and is placed adjacent the surface of the patient's skin to hold the fastener or closure in place at the puncture. Preferably, the fastener or closure and the associated filament are formed of a biodegradable material. When the fastener or closure is used to seal punctures or incisions in blood vessels it is constructed so that when it is open (ie, it is in its unwrapped or expanded state) and in position to seal the puncture, it does not appreciably block the puncture. blood flow through the blood vessel.

In U.S. Patent No. 4,890,612 issued to Kinsey, another closure apparatus is presented for sealing a puncture or incision formed percutaneously in tissue that separates two internal portions of the body from a living being and also various methods for using that apparatus are presented. The closure apparatus of this Kinsey invention is generally in the form of a fastener member, a filament and a sealing member. The fastening member is an elongate body, constructed as a tensioner and preferably formed of a biodegradable material, such as a thermoplastic polymer or polyglactide. The tensioner is molded on the distant end of the filament. The filament is also biodegradable and is preferably formed of polyglactide suture material. The flexibility of the filament allows the tensioner to rotate towards various orientations with respect to the suture and the sealing member. The sealing member basically comprises a cylindrical plug, preferably formed of a compressed foam or other material which is highly absorbent and which, when disposed inside the body, swells in excess of its compressed diameter.

The closure apparatus of this Kinsey patent is arranged to be used with an insertion instrument to place the closure apparatus within the puncture or incision to be sealed. The insertion instrument includes a tubular body in which the closure apparatus is positioned so that the fastening member is oriented with its longitudinal axis parallel to the longitudinal axis of the tubular body member. Thus disposed, the fastener member can compress a portion of the distal end of the sealing member. The filament extends rearwardly from the member fastened through or along the sealing member.

The insertion instrument of this Kinsey patent is inserted into the puncture or incision in the artery or any body tissue (for example, the liver, gallbladder, lung, heart, etc.) until its distant exit is in the desired position in the body of a patient. When this instrument is used to seal an artery, the exit of the insertion instrument is placed so that it is inside the artery. The insertion instrument is then operated to eject the fastener member from the tubular member. Once the fastener member is ejected, the instrument can be held in this position for a short period of time to allow the foam at the tip of the sealing member, i.e. the distal end portion of the closure apparatus, to swell. This action tilts the fastener member effectively. The insertion instrument can then be removed and the filament of the closure apparatus removed. This action pulls the sealing portion of the closure device back through the puncture or incision in the wall of the artery until the holding portion engages the inner surface of the artery wall to prevent further retraction. As the support member comes into contact with the arterial wall, can affect the compression of the far end portion of the sealing member. Moreover, the proximal end of the sealing member extends within the puncture or incision in the subcutaneous tissue to a point adjacent to the skin. These actions effectively seal the puncture or incision to the passage of blood through it.

The literature on patents also includes several different devices for sealing an opening in a blood vessel or other opening. PCT publication number WO 90/14796 discloses the use of an occluder member and an insulator member that are oriented through the wall of the blood vessel to seal the incision to blood flow therethrough. In U.S. Patent No. 5,108,421 issued to Fowler, a plug-like member is presented together with one or more methods of inserting the plug into an incision. Other means and techniques for closing a wound or other incision are presented in U.S. Patent No. 4,606,337 issued to Zimmermann et al. and in U.S. Patent No. 5,053,046 issued to Janese.

Despite all the relatively recent interest in this area, there is still a need for a simple and reliable means to effect the closure of an opening, such as those in the wall of a blood vessel, duct or opening, by placing a stopper in the opening with a gelatinous material or similar hemostatic material and a fastener or similar assembly without requiring the application of manual pressure to the incision over an extended period of time.

SUMMARY OF THE INVENTION From the foregoing, it is a general object of the present invention to provide an assembly that overcomes the disadvantages of the prior art.

Another object of the present invention is to provide a closure assembly that is effective to seal a puncture or other opening in a blood vessel, duct or opening without the need for the application of manual pressure to it and without resulting in a significant reduction in blood flow through the blood vessel.

Yet another object of the present invention is to provide an insertion instrument that is simple in construction and which can be reliably inserted into a blood vessel, duct or opening to place a fastener member or other closure therein to hemostatically seal temporarily puncture and then insert a different gelatinous or haemostatic material, such as a rubber fibrin type tissue into the incision to seal economically and simply incise.

Yet another object of the present invention is to provide a closure assembly that is fully absorbable in the patient's body within a relatively short period of time and which will allow the patient to wander shortly after insertion of the closure assembly.

These and other objects of the present invention are achieved by the proportion of a complete assembly to seal an opening in the wall of a blood vessel, duct or opening of a living being. The insert assembly includes an insertion instrument having a tubular body to receive the closure assembly within itself. The closure assembly is arranged to be issued from the tubular body. The tubular body is generally formed by an elongated tubular member having a portion positioned proximally and a portion positioned distally. The distally positioned portion has one end with an opening therein and which is arranged to be inserted through the opening in the vessel, duct, hollow or other coforal cavity.

The closure assembly of the present invention preferably generally includes a fastening member, a gelatinous material or the like that forms a sealing means and a filament. The fastener member includes a tissue contacting portion and is configured to pass through the opening in one direction, but refuses to pass therethrough in the opposite direction. The sealing means includes a gelatinous material, such as a fabric gum, which includes cyanoacrylate or fibrin material which is attached to the filament as the gelatinous material dries or cures. The filament is an elongated member that is preferably formed of a suture material having a length that is sufficient to connect between the fastener member and the sealing means while extending through the vessel wall, duct or opening.

The method of use of the present invention includes manipulating the insert carrier or assembly and the fastener member to initially locate the fastener member within the carrier adjacent the free or open end of the member. The open end of the insert assembly is inserted through an introducer sheath into the opening in the vessel, duct or opening of the patient and the fastener of the closure assembly is then expelled from the open end of the insert assembly. Thereafter the insertion assembly is operated to remove the tissue contacting portion of the fastener member to contact the tissue that is generally adjacent to the opening in the patient so that the contact portion with the tissue of the member fastener seals at least initially or temporarily the opening to the fluid flow of the vessel, duct or opening therethrough.

The insert assembly of the present invention also preferably includes a means for injecting a gelatinous material into the incision adjacent to the vessel, duct or opening and adjacent the filament to allow the insertion of the gelatinous material such as fibrin gum into the incision next to the bra. This portion of the insert assembly may include one or more plungers as part of an integral or separate syringe assembly to allow the gelatinous material to be injected into the incision once the fastener and the filament are positioned along the vessel, duct or opening. The use of a gelatinous material has the advantage that it functions as a gum of bioabsorbable tissue that comes in contact with the filament to retain the fastener and the filament along the vessel, duct or opening shortly after the gelatinous material is injected inside the incision or puncture. In this invention it is believed that the fastener member is primarily needed to provide a temporary seal of the puncture or incision, i.e., until the gelatinous material is ready or tanned. Therefore, the fastening member can be formed of a material that dissolves in a relatively short period of time and that is preferably equal to or less than the dissolution time of the absorbable fastening member disclosed in several of the Kinsey patents. In addition, the composition of the gelatinous material can be optimally varied next to the bed according to the needs of each patient. For example, the composition of the gelatinous material can be adjusted to tan faster or slower depending on the amount of anticoagulants received by the patient during the procedure. Similarly, the invention presented herein is considered to be significantly less complex and less expensive to manufacture than various other sealing devices that have been proposed above.

Brief Description of the Drawings Other objects and many of the advantages relating to this invention will be readily appreciated as they are better understood by reference to the following detailed description when considered in relation to the drawings appended hereto in which: Figure 1 is a view lateral elevational, partially in transverse, of a sealing apparatus constructed in accordance with the present invention for introducing a fastening member according to this invention into the body of a living being to seal an opening therein; Figure 2 is a top elevational view, partially transverse, showing the insert assembly and the introducer sheath of Figure 1 with the tubular body partially inserted into the introducer sheath; Figure 3 is an enlarged, partially transverse, lateral elevational view showing the insert assembly inserted into the introducer sheath and placed in the patient's vessel; Figure 4 is a side view, partially transverse, showing the introduction of the fastener member into the patient's vessel; Figure 5 is a side view, partially transverse, showing the fastener member drawn in contact with the distal outlet of the insert assembly; Figure 6 is a side view, partially transverse, showing the withdrawal of the insertion assembly at the puncture with the holding member in contact with the vessel wall; Figure 7 is a side view, partially transverse, showing the syringe assembly inserted into the partially removed insert assembly and the attached spring between the filament and the skin of the patient; Figure 8 is a side view, partially transverse, showing the injection of the gelatinous material into the puncture; Figure 9 is a side view, partially transverse, showing the preferred placement of the preferred specimen of the present invention; Figure 10 is a side view, partially transverse, of an alternative example of the present invention; Figure 11 is a side view, partially transverse, showing the syringe assembly of the exemplary embodiment of the present invention illustrated in Figure 10; Figure 12 is a side view, partially transverse, showing the plunger in the insert assembly of the exemplary illustrated in Figure 10 in its extended position; Figure 13 is a side view of an alternative example of the present invention similar to the example illustrated in Figures 10 through 12 wherein the gelatinous material is injected through a port that opens close to the distal end of the tubular member; Figure 14 is a side view, partially transverse, showing the syringe assembly of the exemplary embodiment of the present invention illustrated in Figure 13; Figure 15 is a side view, partially transverse, showing the gelatinous material in the insert assembly of the specimen illustrated in Figure 13 before removing the tubular core from the incision; Figure 16 is a side view, partially transverse, showing the syringe assembly of an alternative specimen of the present invention; Figure 17 is a side view, partially transverse, showing the syringe assembly of a specimen illustrated in Figure 16 placed in the puncture along the filament; Figure 18 is a side view, partially transverse, showing the syringe assembly of the specimen illustrated in Figure 16 with the gelatinous material injected into the incision; Figure 19 is a side view, partially transverse, showing an alternative example of the syringe assembly similar to the sample illustrated in Figure 16; Figure 20 is an elevated perspective view showing a clip of the exemplary illustrated in Figure 19; Y Figure 21 is a side view, partially transverse, showing the gelatinous material, the clip and the fastening member of the specimen illustrated in Figure 19 in the incision of the patient's body.

DETAILED DESCRIPTION OF THE PREFERRED FORMS OF THE PRESENT INVENTION Referring now in greater detail to the various figures of the drawings in which similar reference characters refer to similar parts, there is shown generally in 20 in Figure 1, an apparatus for the closing of an incision, duct or opening of a living being. The device 20 has particular utility when used in connection with intravascular procedures, such as the injection of angiographic dyes, angioplastic balloons and other types of recanalization of arterioscleorotic arteries, in situ valvulectomy, etc. However, it should be appreciated that the apparatus 20 can be used to haemostatically close a puncture or other opening in other types of vessels, ducts, openings or coforal cavities within the patient's body, as in several laparoscopic, arthroscopic or other procedures. Thus, it should be understood that while the description of the invention contained herein is described with respect to the closure of percutaneous punctures in blood vessels such as arteries, the apparatus 20 of the present invention has many other applications or uses. As used herein, the term "gelatinous" is intended to include a material having a wide viscosity range as a slightly viscous material, a slurry or paste.

Before describing the entire apparatus 20, a brief description of a typical and conventional intravascular surgical procedure, for example, the instrumentation of a catheter in an artery, using an incision or percutaneous puncture is offered to better appreciate the characteristics of the apparatus 20. In said procedure, a cannula such as the angiographic needles (not shown), is inserted percutaneously through the skin into the artery, such as the femoral artery 24 in the desired position for insertion of the instrument. The cannula needle is held in place and the flexible end of a mini guide wire (not shown) is then passed through the cannula into the artery at the desired depth (i.e., a longitudinal position along the same length). ). Once the mini guide wire is in place, the cannula needle is removed leaving the guide wire in position. A conventional introducer sheath 26 and an artery dilator (not shown) are then passed over the guide wire through puncture 28 and into artery 24. The guidewire and dilator are then removed leaving the sheath 26 in place. . The catheter (not illustrated) or other intravascular instrument is then inserted through the introducer sheath 26 and guided into the artery to the desired intravascular position, for example, the site of atherosclerotic occlusion. Once the intravascular procedure has been completed, the catheter or instrument is removed. Thereafter the sheath 26 can be removed and the surgeon or other trained professional has been required to apply manual pressure to the percutaneous puncture until haemostasis occurs. In many patients, this may require at least thirty minutes of manual pressure.

The apparatus 20 of the present invention generally performs the hemostatic closure of a type of percutaneous or distinct puncture, incision or opening in one artery, another duct coforal or opening without the need to apply manual pressure to it. Thus, once the catheter or other intravascular instrument has been removed but with the sheath 26 preferably left in place, the apparatus 20 of the present invention is inserted through the sheath 26 into the artery 24 and operated to eject a closure member or fastener 30 (to be described later) within the artery. The fastening member 30 is arranged to be pulled back generally adjacent to the wall of the blood vessel and adjacent the puncture 28 to at least temporarily seal the incision to the flow of blood therethrough. A gelatinous and / or hemostatic material can then be injected into the puncture and the introducer sheath and insert assembly then removed. The clamping member and the gelatinous material are then left in place to seal the puncture, incision or other opening to the flow of fluids therethrough. Due to its construction, the fastening member 30 and the gelatinous material, as described above, are preferably absorbed by the surrounding tissue in a relatively short period of time.

Referring now to Figures 1 through 9, further details of the preferred shape of the fastener member 30 will now be presented. The component or fastening member may comprise a strip of relatively thin and narrow material, such as a resorbable lactide / glycolide polymer sold by E.l. DuPont de Nemours, Inc., under the commercial description MEDISORB. The fastening member 30 is sufficiently rigid so that once in place within the artery it is resistant to deformations to prevent it from bending and thereby passing back through the incision or puncture through which it was introduced. first, however, it is sufficiently flexible or manageable to generally conform the shape of the interior of the artery so that it does not It hurts the artery tissue. The coforal portion of the fastening member 30 preferably includes at least one opening positioned in the middle section approximately of the fastening member 30 and through which a portion of the filament 36 extends.

The fastening member 30 can also be a unfoldable or expandable member which, being contracted or compressed, is compact enough to fit inside the tubular body 32, but when released from the tubular body 32 can be expanded or unfolded to an appropriate augmented configuration for closing the puncture 28 generally along the artery. Thus, the fastening member 30 may be generally formed of a hemostatic or elastic material that is preferably biodegradable or resorbable, so that it is absorbed into the patient's body after a relatively short period of time. A potentially effective material for an alternative form of fastener member 30 may be a hemostatic, porous, absorbable gelatin sold by Johnson & Johnson, Inc. under the name of GELFOAM.

The filament 36 preferably constitutes an elongated flexible thread, which may be formed of a long, more very thin biodegradable material, such as an absorbable suture, and which is preferably fixed or otherwise secured to the side or proximal surface of the fastening member 30. In addition, the filament 36 may preferably include a stop member 43 therein as shown in Figure 3. The obstacle brake 43 is a preferably metallic member that is fixedly attached to the filament 36 at a predetermined distance from the filament 36. fastener member 30. Although the filament 36 is described herein as a flexible and elongate member, it should be appreciated that a semi-rigid member or some other appropriate shape can also be provided. to use as a filament provided that the fastening member 30 is fixedly associated therewith and the gelatinous material can be attached or otherwise coupled with the filament to obstruct the flow of fluids through the incision, puncture or other opening.

In the preferred forms of the present invention, the filament 36 is preferably long and thin; and, therefore, the filament 36 does not interfere with the operation of the plunger 38 as the plunger 38 is actuated to eject the fastener member 30 out of the distal outlet 34 as described more fully forward. Moreover, the plunger 38 and / or portions of the filament 36 can be modified to accommodate the desired thickness and shape I > of the filament 36 as well as the route of the passage of the filament 36 through the tubular core 32. Therefore, as the fastening member 30 is expelled into the artery, the filament 36 slides through the tubular core 32 either along or through the plunger 38. The length of the filament 36 is sufficiently long so that a substantial portion of the filament 36 extends out of the proximal end of the apparatus 20 even after the fastening member 30 is properly positioned in the artery to allow the tubular core 32 to be removed from the incision without interfering with the tension application of the filament 36. The engagement of the filament 36 with the fastening member 30 can be effected in various ways to achieve any desired "mechanical advantage" to ensure that the fastener member 30 is securely retained on the filament 36 and for provide consistent performance of the fastening member 30 along the wall of the blood vessel adjacent to the incision.

As generally shown in the drawings, the gelatinous material 52 can be injected into the incision once the fastening member 30 is placed in the desired position, as it is adjacent to the vessel wall, opening or duct. In a preferred form of the present invention, the gelatinous material 52 may consist of a bioabsorbable and preferably hemostatic material such as a fibrin gum which may include two primary components. As an alternative, the gelatinous material 52 can be formed of a single component material such as the cyanoacrylate. The gelatinous material Also preferably it can be tanned in the patient's body and / or otherwise formed to react with the patient's coforal fluids to form a gelatin-like mass that adheres to the filament 36 to promote hemostasis in the incision or puncture. and securing the fastener member along the wall of the blood vessel.

The first preferred component of fibrin gum can be a fibrinogen material 54 that can be supplied in a solution or as a powder that must be reconstituted before use. The second preferred component of fibrin gum may be a thrombin 56 material that may also be provided to the physician in a solution or powder so that both components can be injected into the incision as described below. Due to the rapid rate of formation of fibrin clots with these components, they are preferably injected separately into the incision so that the fibrinogen and thrombin materials do not mix until they reach the desired position in the incision. One way to overcome the problems associated with the rapid formation of clots of these components is through the use of a double plunger syringe 33, an example of which is illustrated in Figures 8 and 12. This type of syringe assembly 33 may include a common or parallel outlet to ensure that components do not mix prematurely, potentially causing a clot to form in the delivery device before use. The use of fibrinogen materials and thrombin, 54 and 56 respectively, it is considered advantageous because thrombin 56 converts to fibrinogen 54 in fibrin by an enzymatic action at a rate that is determined by the concentration of thrombin. Therefore, the relative concentrations of the solutions of fibrin 54 and thrombin 56 can be varied to increase or decrease the rate of clot formation so that if equal concentrations of fibrinogen thrombin form a fibrin clot in a few seconds, a concentration More diluted thrombin can be used to form a fibrin clot in a few minutes.

In a fibrin sealant kit that is currently available from the Scottish National Blood Transfusion Service for use in clinical trials only, fibrinogen 54 is provided as a lyophilized friable solid material containing 225 mg of fibrinogen and approximately 50 factor units. VIL The solvent provided for the reconstitution of fibrinogen 54 consists of 20 mm Tris buffer with a pH of 7.5 and containing aprotinin at 3000 units of kali rein inactivator per millimeter. Thrombin 56 is provided as a friable lyophilized solid containing 1000 IU per bottle. The thrombin 56 is reconstituted with a calcium chloride solution containing about 40 mm of a calcium chloride.

At any relative concentration of fibrin 54 and thrombin 56 that is used, it is considered that the present invention is an improvement over any hemostatic apparatus currently proposed because the rate of clot formation can be adjusted by the physician as needed and according to the variety of factors that include the requirements of the individual patient.

The present invention describes the preferred form of the basic components of the present invention while the following describes the preferred form of the various apparatuses and methods for inserting the fastener member 30 and the gelatinous material 52 into their respective desired sites in the patient's body. to seal the incision, puncture or opening in the vessel, duct or wound. In the case where a single-component gelatinous material is used, the syringe assembly 33 can be a single-chamber syringe and the insertion technique can be modified accordingly.

A basic form of the present invention is shown in Figures 1 to 9. The apparatus 20 of this exemplary generally includes an insert assembly 31 which may consist of a simple delivery apparatus such as an elongated tubular core 32. The insert assembly may also include a plunger 38 associated therewith. The tubular body 32 and the combination of the tubular body 32 and the plunger 38 of the insertion assembly 31 serve as a relatively simple means of delivering the fastening member 30 to the desired site in the patient's body. The syringe assembly 33 preferably includes a pair of plungers 55 placed in a pair of separate chambers 57 although it is anticipated that separate syringes may be used to inject the materials into the incision. As will be described later completely, a variety of delivery means are considered satisfactory for the need to accurately deliver the sealing components of the present invention with the primary difference between the respective delivery means related to the complexity of the insert assembly 31 and the syringe assembly 33. Any combination of insertion assembly 31 and syringe assembly 33 that is chosen, it is important that the fastening member 30 and the gelatinous material 52 be positioned consistently and reliably in their desired positions in the incision, puncture or another opening and along the vessel, duct or wound of the patient because it is important that the gelatinous material is not injected into the blood vessel.

Figure 1 is illustrative of a basic form of the insert assembly 31 of the present invention. The insertion assembly 31 preferably includes a simple tubular body 32 having an outlet 34 at its distal end and a plunger 38 disposed in the tubular body 32. The tubular body 32 is an elongated tubular member which preferably has a relatively small outer diameter , for example, in the range of about 6 French to 14 French and is formed of a somewhat flexible material, such as a polyethylene or polyvinylchloride, to allow the tubular body 32 to be inserted through an introducer sheath 26 into the artery 24 or through the incision after the introducer sheath 26 has been removed. As shown in Figure 2, the length of the tubular core 32 is preferably sufficient to place the outlet 34 of the tubular core 32 adjacent to or slightly beyond the distal end of the introducer sheath 26 when the tubular body 32 is fully inserted therein.

The plunger 38 basically comprises a member similar to a cylindrical, elongated and simple tube, having a relatively flat distal end 39 therein. As with the tubular body 32, the plunger 38 is also formed of a relatively flexible material, such as polyethylene or polyvinylchloride, and has a size to be disposed within the interior of the tubular body 32. The outer diameter of the plunger 38 is slightly less than the inner diameter of the tubular body 32 to allow the plunger 38 to move manually along the longitudinal axis of the tubular body 32 and to push or force the fastening member 30 out of the distant end 34 while allows the filament 36 to pass between them. Thus, plunger 38 is arranged to move from a retracted position, as shown in Figure 2 to an extended position (Figure 3) wherein the distal end 39 of the plunger is adjacent to the distal exit 34 of the tubular body 32. When the plunger 38 moves to the extended position, the distal end 39 of the plunger 38 forces the clamped member 30 out of the exit 34 and inside the artery as described below.

The preferred operation of the present invention of the present invention is best understood by a sequential reference to Figures 1 through 9. The apparatus 20 can be initially inserted into the introducer sheath 26 so that the distal exit 34 of the tubular core 32 extends through the incision or puncture 28 and into the blood vessel, duct or opening of the patient as shown in 3. The apparatus 20 can then be fixed to the sheath 26 with the luer lock 48 of the tubular body 32. As shown in Figure 2, the proximal end of the tubular core 32 may be in the form of an annular projection flank 49 to serve as a handle to allow the user to take the insert assembly 31 with his fingers to execute the fastener member 30 as is described below.

Once the tubular body 32 and the sheath 26 are interconnected as shown in Figure 3, the user can then take and push the proximal end 50 of the plunger 38 with the thumb, while the flank 49 of the tubular body is taken. 32 between the fingers. This action slides the plunger 38 in the distal direction into the sheath 26, after which the distal end 39 of the plunger 38 comes into contact with the proximal portion of the fastening member 30 of the closure assembly. The continuous depression of the clamping member 30 towards the tubular core 32 forces the clamping member 32 towards the Distant outlet 34. At the point where the distal end 39 of the plunger 38 reaches the distal outlet 34 of the tubular body 32, an audible "signal" can be produced by almost any conventional means (not shown) to indicate that the plunger 38 has pushed to the holding member 30 out of the distant outlet 34 of the tubular body 32 and into the interior of the artery 24 as illustrated in Figure 4.

The distal exit 34 of the tubular body 32 may preferably include a plurality of curved, petal-like projections 51 that are equidistantly spaced around the periphery of the tubular body 32 to form a door capable of opening in a single direction or distant outlet 34 through wherein the holding member 30 is ejected when the insert assembly 31 is used. Once the fastening member 30 has been ejected past the distal exit 34 and into the artery 24, the user can allow the fastening member 30 to soften slightly to allow the fastening member 30 to remain suspended in the artery 24 during a few seconds. Next, the user can take the filament 36 to attract the fastening member 30 to make contact with the distal exit 34 of the tubular body 32 so that the fastening member 30 blocks the distal exit 34 of the tubular body 32 as shown in FIG. Figure 5. The user can then remove the sheath 26, the tubular core 32 and the fastening member 30 together until the fastening member 30 contacts the wall of the artery 24 adjacent to the puncture 28 as shown in Figure 6. Next, a tensioner such as a leaf or similar spring 62 can be used to apply a continuous pressure to the filament 36 to retain the fastening member 30 in the desired position adjacent to the wall of the artery 24. As shown in Figure 7, the spring 62 can be placed between the obstacle brake 43 and the patient's skin in a manner that the sleeve 26 and the tubular core 32 are movable in combination with respect to the fastening member and the filament 36 without altering the position of the fastening member 30. At this point in the procedure, it may be desired to remove the sheath 26 and the tubular member 30 slightly with respect to the fastening member 30 so that the distal exit 34 of the tubular member 32 is separated by a short distance from the fastening member 30 and withdraws into the incision slightly proximal of the wall of the blood vessel.

In this position, the holding member 30 temporarily seals the incision to the flow of blood through the artery. The plunger 38 can then be removed from the tubular body 32 and a syringe assembly 33 is then inserted into the tubular body 32 as illustrated in Figure 7. The syringe assembly 33 is preferably a conventional dual plunger syringe assembly. As shown in Figure 7, the syringe assembly 33 generally consists of a pair of plungers positioned side-by-side 55 that are movable in separate chambers 57 and open within a common outlet 59. The chambers 57 of the plunger assembly 33 they contain the reconstituted materials of fibrin and thrombin, 54 and 46, therein. As illustrated in Figure 7, the syringe assembly 33 is sized to extend along the length of the tubular body 32 so that the outlet 59 of the syringe assembly 33 extends slightly beyond the outlet 34 of the body. tubular 32 Once the syringe assembly 33 is properly positioned in the tubular body 32, the user can simultaneously press the pistons 55 of the syringe assembly 33 to eject the fibrin and trombin materials, 54 and 56, therefrom. As the fibrin and thrombin materials, 54 and 56, are ejected from their respective chambers 57, they are mixed with each other at the outlet 59 of the syringe assembly 33 as they enter the incision.

As shown in Figures 8 and 9, the fibrin and thrombin materials are expelled from the syringe assembly 33 into the distal portion of the incision and close to the fastening member 30 to form a mass of gelatinous material 52. The gelatinous material 52 it is placed in the incision proximate to the fastening member 30 and / or the wall of the blood vessel. As the fibrin and thrombin materials, 54 and 56, are expelled from the syringe assembly 33, it may be desired to remove the sheath 26 and the tubular core 32 gradually from the incision 28 to distribute the gelatinous material 52 along the length. of the incision. further, because the incision extends through the wall of the blood vessel and other percutaneous or subcutaneous tissues, the tissue along the incision has the tendency to retract or close as the syringe assembly is removed. The wall of the blood vessel is made of tissue similar to that of a muscle; and, therefore, the wall of the blood vessel retracts more quickly than the rest of the incision. Therefore, the contraction of the tissue layers and the position of the fastening member 30 adjacent to the blood vessel wall cooperate to prevent the fibrin and thrombin materials from entering the patient's blood vessel. Although the gradual removal of the sheath 26 and the tubular body 32 while the gelatinous material 52 is injected is desirable, it is not considered to be a requirement for the proper operation of the present specimen and will depend on a number of factors, including the relative concentrations of the fibrin and thrombin materials as well as the volume of gelatinous material 52 to be injected into the incision. It may also be desirable to leave the sheath 26 and the tubular body 32 in place in the incision 28 for a short period of time to allow the gelatinous material 52 begin to tan before the incision is disturbed by the removal of sheath 26 and tubular core 32 as described below in detail. Finally, when the user determines that an appropriate seal has been formed in the incision 28 and along the filament 36, the spring 62 can be released from the filament 36 and removed from the patient's skin. Then, the sheath 26 and the tubular body 32 can be completely removed from the incision and the portion of the filament 36 extending beyond the skin of the patient can be cut leaving the incision sealed by the gelatinous material 52, the clamping member 30. and the filament 36 as shown in Figure 9.

As the gelatinous material 52 cures and forms a clot in the incision, the gelatinous material 52 frictionally engages the filament 36 to ensure that the holding member 30 is held adjacent to the blood vessel wall. In addition, the clot formed by the gelatinous material 52 will absorb any bleeding from the surrounding tissue of the incision 28 and will absorb any blood that may escape from the holding member 30. During the next following weeks, the gelatinous material 52, the filament 36 and the member Bra 30 will be absorbed into the patient's tissue.

The fastening member 30 functions to ensure that no amount of the gelatinous material 52 enters the artery and also to ensure that the gelatinous material 52 has an opportunity to cure without substantial amounts of blood or other fluids that dilute fibrin and thrombin immediately. Because the gelatinous materials 52 are designed to form clots, it is very important that the gelatinous material is not injected or otherwise released into the patient's blood vessel. Ultrasound images of a study of a hemostatic apparatus having a fastening member 30 of the The type generally described herein illustrates that an initial step in the healing process involves the encapsulation of the fastening member 30 along the wall of the blood vessel. Therefore, it is considered that with the present invention, it may be possible to restrict the patient from forming another incision close to or in the anterior incision because the gelatinous material 52 can be formulated to be absorbed relatively quickly and the clot is considered not to be it would be adversely affected if it is drilled again before it is completely absorbed, to facilitate the patient's retraction, the fastening member 30 and / or the gelatinous material 52 can also be formulated to include a radio-opaque material thereon for assist the user in identifying the position of the previous incision 28.

Figures 10 to 12 are illustrative of yet another exemplary embodiment of the present invention wherein similar numbers have been added to similar members to illustrate the similarities between the respective specimens. In this example, the tubular member 32 includes one or more openings or ports 64 along the proximal end thereof and a hemostatic valve 65 at the proximal end thereof. As illustrated in Figure 10, the fastening member 30 is initially deployed in the manner described above with respect to the previous example and illustrated in Figures 1 through 7. The side port 64 of the tubular body 32 is in fluid communication with an outlet 66 which is located inside the tubular body 32 as best illustrated in Figure 11. Next, the plunger 38 is retracted in the tubular member 32 to a position that is close to the outlet 66 on the interior surface of the tubular member 32. tubular body 32. The user then connects syringe assembly 33 to side port 64 in the manner illustrated in Figure 11. If conventional single-chamber syringes are used, it is desirable to use multiple side ports so that the materials trombin and fibrin, 54 and 56, do not mix until they are injected into the incision 28. In the illustrated example, the double chamber syringe assembly 33 is connected to the lateral port, the thrombin and fibrin materials can be expelled from the syringe assembly 33 and into the interior of the tubular body 32. The user can allow the materials of thrombin and fibrin to be curing for a short period of time in the tubular body 32, if desired. Then, the plunger 38 of the tubular body 32 can be pressed and moved to the extended position as shown in Figure 12 to eject the gelatinous material 52 within the puncture adjacent the fastening member 30 and along the proximal side of the wall of the blood vessel.

As also illustrated in Figures 10 through 12, the fastening member 30 of the present exemplary embodiment may include an elongated head 68 extending inwardly from the blood vessel wall wherein the remaining portion of the fastening member 30 is positioned together. to the wall of the blood vessel. With this type of fastener member 0, the gelatinous material 52 can coagulate around the head 68 of the fastening member 30 to form a secure seal at the puncture. As with the fastener member of the previous specimen, the gelatinous material 52 also coagulates around the filament 36 to ensure that the fastening member 30 is securely retained adjacent the blood vessel wall.

Figures 13 to 15 are illustrative of another example of the present invention in which similar numbers have been added to similar members to illustrate the similarities between the respective specimens. In this example, the tubular body 32 is substantially similar to the tubular member 32 described above and illustrated in FIGS.

Figures 10 through 12. The tubular member 32 includes one or more side ports or openings 64 along the proximal end thereof and a hemostatic valve 65 at the proximal end of the member. As illustrated in Figure 13, the fastener member is initially deployed in the manner described above with respect to the previous example and illustrated in Figures 1 through 7. The side port 64 of the tubular core 32 is in fluid communication with a outlet 66 which is located inside the tubular body 32 as illustrated in Figure 13. Next, the plunger 38 is retracted and removed from the tubular member 32. The user then connects the syringe assembly 33 to the side port 64 in the shape illustrated in Figure 14 while the hemostatic valve 65 seals the proximal end of the tubular core 32. If conventional single-chamber syringes are to be used, it may be desirable to utilize multiple side ports so that the materials thrombin and fibrinogen, 54 and 56, do not mix until they are injected into the incision 28. In the illustrated example, the double chamber syringe assembly 33 includes the thrombin materials and reconstituted fibrin, 54 and 56, in it. Once the syringe assembly 33 is connected to the lateral port, the thrombin and fibrin materials can be expelled from the syringe assembly 33 and into the interior of the tubular body 32. The user can then allow the gelatinous material 52 to be cured during a short period of time in the tubular body 32 so that the gelatinous material 52 frictionally contacts the filament 36. Once the gelatinous material 52 has begun to tan, the tubular body 32 can be removed from the incision so that the gelatinous material 52 is positioned within the incision in contact with the filament 36 and adjacent the fastening member 30.

Figures 16 to 18 illustrate a further example of the present invention in which similar numbers have been added to similar members to illustrate the similarities between the respective copies. In this example, the fastening member 30 is positioned along the wall of the artery in the manner described both and illustrated in Figures 1 through 7. The sheath 26 and tubular body 32 are then removed from the puncture. to leave only the fastening member 30 and the filament 36 in the incision in the blood vessel. A spring 62, similar to the spring described above, may be placed on the filament 36 to hold the fastener member adjacent to the blood vessel wall and maintain a light and continuous pressure on the fastener member 30. Then a modified syringe assembly 70 (FIG. Figure 16) can be attached to the filament 36 in the manner illustrated in Figure 17. The syringe assembly 70 of this example preferably includes two separate chambers 72 and pistons. 74 therein and a common outlet 76. The distal end of the syringe assembly 70 is preferably lightly arranged and includes a U-shaped clip 78 therein. The clip 78 is designed to slide into contact or hold the filament 36 so that the syringe assembly 70 is movable in the direction toward the distal side along the filament 36 in the incision to the position illustrated in Figure 18 where the clip 78 comes into contact with the fastener member 30. The use of the clip on the distal end of the syringe assembly 70 ensures proper alignment between the outlet 76 of the syringe assembly 70 and the filament 36 so that the gelatinous material 52 and the filament 36 is secured as the gelatinous material is tanned. further, as shown in Figure 18, the outlet of the syringe assembly 70 is separated by a fixed distance from the clip 78 so that the syringe assembly 70 moves along the filament 36, the clip 78 will come into contact with the clamping member 30 to stop further movements distant from the syringe assembly 70. Once the clip 78 reaches the fastener member 30, outlet 76 will be spaced the desired distance from fastener member 30 and gelatinous material 52 can be expelled from syringe assembly 70 without injecting gelatinous material 52 into the patient's blood vessel.

An alternative form of the clip and syringe assembly described above and illustrated in Figures 16 through 18 is illustrated in Figures 19 through 21. As best illustrated in Figure 20, clip 78 is preferably formed as a member that is separate from the syringe assembly 70. In this alternative example, the clip 78 includes a relatively small semi-circular shaped distal end 80 and a larger semi-circular shaped proximal end 82 that is sized to enter contacting temporarily with the distal end of the syringe assembly 70. The proximal and distal ends, 80 and 82, are interconnected by a generally elongated shaft 84. It is contemplated that the clip 78 of this alternative specimen may be formed of a bioabsorbable material so that the gelatinous material 52 can be injected into the incision and allowed to tan around the clip 78. Therefore, once the gelatinous material 52 is initialized In this case, the syringe assembly 70 can be removed while the clip 78 remains in the incision. This exemplary may be further modified so that the distal end 80 of the clip 78 physically contacts the head 68 of the fastening member 30 with a precise fit or other type of fixed arrangement. Therefore, in this example, as the syringe assembly 70 is removed from the incision, the clip 78 is released from the distal end of the syringe assembly 70 and remains within the incision in contact with the fastening member 30. syringe assembly 70 of this specimen functions as a spacer to ensure that the distal end of syringe assembly 70 is spaced from fastener member 30. Clip 78 of this alternative specimen is particularly useful in situations where where it is desired to use radio opaque materials to identify the location of the posterior incision incision. For example, it is contemplated that the clip 78 is formed of a bioabsorbable material similar to that of the fastening member 30 and at least the body 84 thereof can easily include a radiopaque material formulated therein. The use of radio opaque material in clip 78 is particularly attractive because the Hi 78 is placed in the opening of the blood vessel wall and this is an area of interest to the doctor when the doctor is interested in carrying out reinsitions or other procedures. Yet another advantage of the peel-away clip type 78 relates to the respective sizes of the distal end 80 and the proximal end 82 of the clip 78. Because the proximal end 82 of the clip 78 is preferably larger than the distal end 80 of the clip 78 , the tissue will contract in the shape of a vessel along the length of the clip 78 to further assist in retaining the fastening member 30, the clip 78 and the gelatinous material 52 in the desired position within the incision as shown generally in Figure 21 as the gelatinous material begins to tan. As will be appreciated from the present, the syringe assemblies and introducer assemblies of the present invention and their methods of use allow the easy, effective and efficient sealing of an opening, such as a puncture or incision in organs, cavities or coforal tissue, be it a blood vessel, opening or duct or other opening formed in the patients' body. For example, the sealant assembly and its method of use may be used for the purpose of sealing transhepatic percutaneous punctures to prevent the risk of bile leakage into the peritoneum, by puncture in the liver after arthroscopic or laparoscopic procedures or even at length of the spine after spinal punctures. Moreover, closures, instruments and their method of use can also be used to seal percutaneous incisions in the lung or heart that can occur from a trauma or injury.

Claims (16)

1. ASSEMBLY FOR SEALING A PUNCTURE IN A VESSEL The claims are: 1. An assembly for sealing an incision in a patient's body where the incision extends from the patient's skin into a blood vessel, duct, opening or coforal cavity of the patient. patient, the assembly comprises; a first member formed of a bioabsorbable material and sized to be placed in the blood vessel, duct or opening of the patient; and a second member formed of a bioabsorbable and gelatinous material and said second member cooperatively seals the incision to the flow of fluids therethrough in combination with said first member.
2. 2. The assembly of claim 1 further including a third member extending between said first and second members.
3. 3. The assembly of claim 2 wherein said third member is a filament and said third member is frictionally in contact with at least one of said first member and second member.
4. 4. The assembly of claim 2 wherein said third member is a flexible filament.
5. 5. The assembly of claim 1 wherein said second member is formed of an injectable material that is injected into the incision in the patient's body.
6. 6. The assembly of claim 1 wherein said first member is operatively positioned in the blood vessel of a patient and said second member is operatively positioned in the incision and said third member extends between said first member and said second member so that said first member, said second member and said third member cooperatively seal the incision to the flow of blood from the blood vessel therethrough.
7. 7. The assembly of claim 6 wherein said second member is formed of a plurality of injectable materials that are mixed to seal the incision to the flow of fluids therethrough.
8. 8. The assembly of claim 7 wherein said materials include a thrombin-containing material therein.
9. 9. The assembly of claim 7 wherein said materials include a fibrinogen-containing material therein.
10. 10. An assembly for sealing an incision in the body of a patient wherein the incision extends from the patient's skin to a blood vessel, duct or patient opening, the assembly comprises; a first member formed of a bioabsorbable material and sized to be placed in the blood vessel, duct or opening of the patient; a second member formed of a bioabsorbable and gelatinous material and said second member cooperatively seals the incision to the flow of fluids therethrough < in combination with said first member; and an insert assembly including an elongated tubular member to facilitate the insertion of at least one of said first member and said second member.
11. 11. The assembly of claim 10 including a syringe assembly having a clip therein and said clip having a size for separating said syringe assembly from said first member in use.
12. 12. The assembly of claim 11 wherein said clip is bioabsorbable and has a size to contact said first member in use.
13. 13. A method for sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of a patient within a selected blood vessel of the patient, the method comprising; inserting a first member within the incision in a position generally adjacent to the wall of the blood vessel; and injecting a gelatinous material into the incision so that the gelatinous material is placed in the incision proximate the first member to seal the incision to the flow of blood passing through the blood vessel.
14. 14. The method of claim 13 further including the step of inserting a filament into the incision so that the filament is in frictional contact with the gelatinous material in the incision.
15. 15. The method of claim 13 further including the step of inserting a clip into the incision so that the clip is in frictional contact with the gelatinous material within the incision.
16. 16. An assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel, duct or opening or coforal cavity of the patient, the assembly comprising; a first member formed of a bioabsorbable material and of a size to be placed in the blood vessel, duct or opening of the patient; a second member formed of a bioabsorbable and injectable hemostasis promoter material and said second member is formed to cooperatively seal the incision to the flow of fluids therethrough in combination with said first member; and a third member extending close to said first member and having greater flexibility than said first member. ABSTRACT OF THE INVENTION This invention is a bio-absorbable assembly for sealing an incision or puncture in the patient's body that includes a first member (30) that is generally positioned along the wall of the blood vessel, duct, coforal cavity or opening of the patient and a gelatinous material (52) that is injected into the incision or puncture around a filament (36) or clip (78) that is associated with the first member to seal the incision or puncture against the flow of fluids to through the blood vessel, duct or opening of the patient and the method for it.