MX2008008346A - Systems and methods for closing a vessel wound - Google Patents

Abstract

Vessel wound closure systems and method for sealing a puncture wound in a target vessel, such as those puncture wounds that occur from interventional procedures. The vessel wound closure system comprises at least a biocomatible, visoelastic, self-sealing septum material injected onto the adventitia of the target vessel prior to performance of an interventional procedure. The prior injected septum material remains and seals the puncture wound of the target vessel even after various components associated with accessing the target vessel and the performance of the interventional procedure are removed from the target vessel and the puncture wound.

Description

SYSTEMS AND METHODS FOR CLOSING A VESSEL INJURY BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention relates in general to wound closure techniques of blood vessels. More particularly, the invention relates to systems and methods for sealing puncture wounds in a blood vessel such as those resulting from certain interventional procedures.

RELATED TECHNIQUE A large number of therapeutic and diagnostic procedures involve the percutaneous introduction of instrumentation into a blood vessel, for example, percutaneous transluminal coronary angioplasty (PTCA). Such procedures often involve access to a site destined through the femoral artery. Ideally, the closure and healing of the resultant vascular puncture wound successfully completes the procedure. Traditionally, the application of external pressure to the skin at the entry site of the instrumentation in the patient has been used to stop bleeding from the wound. A nurse or doctor, for example, applies pressure to the site of the wound until coagulation and tissue reconstruction occurs sufficiently to seal the perforation. In some situations, the external pressure is maintained for an hour or more, during which time the patient immobilizes uncomfortably. In this way patient comfort and doctor efficiency are affected where these external pressure techniques are used. Additionally, there is a risk of bruising while bleeding from the vessel occurs. This risk of hematoma continues until sufficient coagulation of the wound site occurs. In addition, external pressure devices, such as femoral compression systems, are often unsuitable for some patients, such as those with substantial amounts of subcutaneous adipose tissue, since the surface of the skin may be a considerable distance from the site of the skin. vasculature puncture. Wrong compression of the skin, and thus healing of the less effective wound, tends to occur as a result. The patent of E.U.A. No. 5,383,896 to Gershony, et al. describes a device that applies pressure to a puncture site internally for a limited period of time, after which the device is removed. The Gershony device includes an arrow with an expandable balloon and a guidewire tip at its distal end. The distal end of the device is inserted into a blood vessel through a sheath of the introducer that is typically used in percutaneous intervention procedures. The balloon is then inflated and removed until the balloon hemostatically couples the inner surface of the blood vessel, after which the sheath of the introducer is removed. A collar fixation on the arrow applies tension to the balloon for a medically sufficient time and from now on the balloon deflates and the entire device is removed from the body. The patent of E.U.A. No. 5,645,566 to Brenneman, et al. discloses a device that applies pressure to the outer wall of a perforated blood vessel from a distance using a balloon, a sheet and a foam pad. The pressure-applying device is located using a balloon in the vessel (similar to that of Gershony) and a radiopaque marker. The PCT application WO 98/11830, published on March 26, 1998, S. Barak, inventor, describes several embodiments of an apparatus for hemostasis. Among these is a device that places an anchor against an inner surface of an arterial wall and a balloon outside the wall. The balloon is inflated to press the wall of the artery, after which the anchor is removed. The balloon is held against the puncture until hemostasis is achieved. The anchor and the balloon are removed after hemostasis is achieved. Other arterial closure devices include bioabsorbable materials intended to remain in the body until they are absorbed as in the U.S. patent. related Nos. 5, 282,827 and 5,441, 517, which describes an anchor inserted in a vessel and urged against an inner wall of the vessel as a collagen plug externally deploys from the puncture site to expand and fill the tissue tract leading to the site of puncture. A filament fixes the plug to the anchor and moves the plug and anchor one relative to the other in a pulley-like manner to effect a seal at the puncture site. After settling, a tamping element can be used to push the plug against the external puncture site to seal it. The patent E.U.A. No. 5,662,681 describes an arterial closure device wherein an anchor and a plug are fixed to each other by means of a filament. The anchor is inserted into the vessel and urged against the inner wall of the vessel as the plug is pushed against the outer wall of the vessel at a puncture site. A separate locking means moves the plug and the anchor one relative to the other to hold the plug and the anchor in the sealing position at the puncture site. The patent of E.U.A. No. 5,391, 183 to Janzen, et al. describes a device that inserts the hemostatic material through a tissue channel and against the outer wall of the vessel around the puncture site. The patent of E.U.A. No. 5,690,674 for Diaz describes a biodegradable plug that has two substantially parallel discs joined at their centers by a waist. The plug is placed so that the distal disc is on the inner wall of the blood vessel, the proximal disc is on the outer wall, and the waist is in the wound of the vessel wall. Another known closure device includes the US patent. No. 5,741, 223 for Janzen, et al. This' 223 patent describes the placement of a plug to seal a puncture site.

The patent of E.U.A. No. 5,354,271 for Voda discloses suture threads with serrated ends, wherein the suture threads are deployed in a vessel and subsequently the jagged ends penetrate through the vessel wall and expand to prevent retraction thereof back into the vessel. the glass. The suture threads are then tied or otherwise secured through the puncture site. The patent of E.U.A. No. 5,324,306 discloses a mass of hemostatic material pushed against the outer wall of a vessel at a puncture site. Manual pressure is applied to ensure that the blood flow stops. The patent of E.U.A. No. 5,868,778 describes a balloon used in combination with a precoagulant injected at the puncture site in order to seal a puncture site of a vessel. The patent of E.U.A. 5,792,152 discloses a flexible needle with a suture fixed thereto which is deployed through a puncture site of a vessel. The flexible needle and suture are inserted into a vessel by means of an inlet lumen, which proceeds through a U-shaped return lumen, and exits the vessel through an exit lumen. Thereafter the suture is removed out of the vessel and tied or otherwise secured through the puncture site. The patent publication of E.U.A. No. 2004/0006352 describes an arterial closure device comprising an assembly wherein the closure arms, to which a suture is initially secured, are deployed within a vessel. Penetration elements including suture clips are subsequently deployed separately to engage or capture the sutures associated with a respective closure arm. The sutures are subsequently pulled by pulling the penetration element with the suture clasps out of the vessel, and subsequently tied or otherwise secured to close the puncture site. From here on the assembly is removed from the body. Current vessel closure devices in this manner tend to provide vessel wound closure devices and techniques after an intervention procedure has been performed. There is a need therefore for vessel wound closure systems and methods that apply a vessel wound closure device prior to performing an interventional procedure within the target vessel.

BRIEF DESCRIPTION OF THE INVENTION Various embodiments described herein comprise vessel wound closure systems and methods for closing a puncture wound in a target vessel. The vessel wound closure system generally comprises at least one biocompatible / biodegradable, self-sealing viscoelastic septum material placed on the outer covering of a target vessel prior to performing an interventional procedure within the target vessel. The septum material can be placed directly on the outer cover of the target vessel, or it can be placed inside a balloon comprised of natural or biodegradable polymeric materials of sufficient porosity that allows them a slow dispersion of the septum material therefrom to adhere to the cover external of the objective vessel. The septum material placed in the outer covering of the target vessel can further be preformed and comprise a hemostatic valve incorporated therein that closes and seals the vessel wound after an interventional procedure has been performed within the target vessel. In some embodiments of the vessel wound closure system, access to the target vessel is obtained by piercing or cutting through the skin, followed by an obtuse dissection to the outer covering, or outer wall of the target vessel. The septum material hereinafter is injected into the outer covering of the target vessel or into the balloon in proximity to the outer shell from the balloon. The septum material is filtered to adhere to the outer shell. An introducer is inserted into the target vessel through the septum material, through the introducer several instruments are passed to perform an intervention procedure. After finishing the intervention procedure, several instruments and the introducer or other components are removed and the septum material remains to seal the vessel wound. Alternatively, obtuse dissection of the outer covering of the target vessel may be omitted where the septum material is injected through a needle having aligned holes to place the septum material in the outer covering of the target vessel. An intervention procedure is then performed through an introducer that has been inserted through the septum material and into the target vessel. After completing the intervention procedure, various instruments associated with it and the introducer or other components are removed while the septum material remains and closes to seal the puncture wound of the target vessel. In other embodiments, the septum material is preformed and placed on the outer covering of the target vessel before performing an interventional procedure within the target vessel. An introducer is inserted through the preformed septum material and into the target vessel. Several instruments are passed through the introducer to perform the intervention procedure. After completing the intervention procedure, several instruments, the introducer, and other components are removed and the preformed septum material remains and closes to seal the puncture wound of the target vessel. The preformed septum material may further comprise a hemostatic valve incorporated therein through which the introducer or other components are placed to accommodate the performance of the intervention procedure. The above features and other features of the invention, including various novel details of the construction and combinations of parts, will now be described more particularly with reference to the accompanying drawings and claims. It will be understood that several exemplary embodiments of the invention described herein are shown by way of illustration only and not as a limitation thereof. The principles and features of this invention can be employed in various alternative embodiments without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects and advantages of the apparatus and methods of the present invention will be better understood with respect to the following description, appended claims, and accompanying drawings in which: Figure 1 schematically illustrates a biocompatible / biodegradable, viscoelastic septum material placed in the outer cover of the target vessel for closing a vessel wound according to the description herein. Figure 2 illustrates a needle and a guidewire penetrating the target vessel prior to performing an intervention procedure in accordance with the description herein. Figure 2a illustrates a stepped needle penetrating the target vessel before performing an intervention procedure in accordance with the description herein. Figure 3 illustrates the guide wire in place after removal of the needle of Figure 2 in accordance with the description herein.

Figures 3a and 3b illustrate various guide wire anchors in accordance with the description herein. Figure 4 illustrates an arrangement of the septum material in the outer cover of the target vessel in accordance with the description herein. Figures 4a-4c illustrate several different techniques for placing the septum material in the outer covering of the target vessel in accordance with the description herein. Figure 5 illustrates an insertion of an introducer over the guide wire, through the septum material, and into the target vessel in accordance with the description herein. Figure 6 illustrates the removal of the introducer, any instrument, and the guide wire as the septum material closes the vessel wound according to the description herein. Figure 7 illustrates a first needle and a guidewire that penetrates the target vessel prior to an intervention procedure in accordance with the description herein. Figure 8 illustrates the guidewire in place after removal of the first needle of Figure 7 in accordance with the description herein. Figure 9 illustrates an arrangement of the preformed septum material in the outer shell of a target vessel in accordance with the description herein.

Figure 10 illustrates the insertion of an introducer onto the guidewire, through the preformed septum material, and into the target vessel according to the description herein. Figure 11 illustrates the removal of the introducer, any instrument, and the guide wire as the septum material closes the vessel wound according to the description herein.

DETAILED DESCRIPTION OF THE INVENTION As used herein the proximal term, or variants thereof, should be understood as being close to an operator of medical personnel, and the term distal, or variant thereof, is understood as far from an operator of medical personnel. Figure 1 generally depicts a biocompatible / biodegradable, self-sealing, biocompatible septum material 100 placed on the outer cover (a) of a target vessel (V) to close a vessel wound (vw) after performing an intervention procedure in a target vessel (V) in accordance with the description herein. The septum material 100 is placed on the outer cover before performing an interventional procedure within the target vessel (V). Various systems and techniques can be used to place the septum material 100 in the outer cover (a) of the target vessel (V), as will be described in more detail below. The septum material 100 is a biocompatible / biodegradable, viscoelastic, self-sealing material and may be comprised of degradable polyesters, degradable PEG-esters (eg, lactones initiated with poly (ethylene glycol) such as caprolactone, glycolide and lactide, p-dioxanone. , and trimethylene carbonate, and copolymers thereof), degradable polyurethanes or functional polymers based on poly (vinylpyrrolidinone), for example. Of course, other biocompatible / biodegradable, viscoelastic, self-sealing materials known or subsequently developed can be used to understand the septum material 100 as long as it accommodates closure of the vessel wound as otherwise described herein. Figures 2-6 illustrate one embodiment of a vessel wound closure system and a method wherein the septum material 100 is placed on the outer cover (a) of the target vessel (V) prior to performing a procedure from intervention inside the target vessel (V). In particular, Figure 2 illustrates a tissue tract 110 created by drilling or cutting through the layers of the skin (epidermis 1, dermis 2 and subcutaneous 3), followed by an obtuse dissection to the outer covering (a) of the vessel. objective (V). In practice, a first needle 120 can be inserted through the tract of tissue 110 and into the target vessel (V) to locate the target vessel (V). Hereinafter, a guidewire 130 is inserted through the first needle 120 and into the target vessel (V). Next, as illustrated in FIG. 3, the first needle 120 is removed and the guide wire 130 remains in place within the target vessel (V). The guidewire 130 preferably comprises an expandable element, such as a balloon 131, or other anchor 132 (Figures 3a and 3b), which is held against an inner surface of the target vessel (V) during obtuse dissection. The anchor of the guide wire 132 may instead comprise a nitinol network 132a or a nitinol anchor 132b, for example, which is held against an inner surface of the target vessel (V) during obtuse dissection, as in FIGS. 3a and 3a. 3b, respectively. Figure 4 illustrates the disposition of the septum material 100 in the outer cover (a) of the target vessel (V). In particular, Figure 4 illustrates a second needle 140 inserted on the guide wire 130 so that a distal tip 141 of the second needle 140 abuts, but does not enter, the target vessel (V). The septum material 100 can then be indicated through the second needle 140 and in the outer cover (a) of the target vessel (V) through the holes 142 (see Figure 4 insert). After the disposition of the septum material 100, the second needle 140 is then removed and the introducer 150 inserted through the septum material 100 and into the target vessel (V) for performing the intervention procedure as further described with with respect to figures 5 and 6 shown below. Alternatively, the first needle 120 may instead be a stepped needle 120 as shown in FIG. 2a and the septum material 100 may be injected into the outer cover (a) of the target vessel (V) through the holes 1. 122 provided in a portion of the stepped needle 1 120. In practice, the target vessel can be located with the stepped or graduated needle 1 120 (FIG. 2a) instead of the configuration of the needle 120 and the guide wire 130 otherwise shown in Figures 2-6. Obtuse dissection may not be necessary where the stepped needle 120 places the target vessel (V) and supplies the septum material 100 to the outer shell (a) of the target vessel (V). The portion with small diameter at the distal end 1 121 of the stepped needle 1 120 assists in the insertion of the needle 1 120 into the target vessel (V). The distal tip with smaller diameter 1 121 measures or graduates, to a portion with a larger diameter 1 123 that supports the outer cover (a) of the target vessel (V) and resists entry thereto to the target vessel (V). Ideally, the larger diameter portion 123 of needle 1 120 includes holes 1 122 through which the septum material is supplied in the outer cover (a) of the target vessel (V). After the septum material is injected through the needle 1 120 and into the outer cover (a) of the target vessel (V) through the holes 1 122, the needle 120 is removed, leaving the septum material 100 instead. A guide wire 130 and the introducer 150 are inserted into and removed from the target vessel to accommodate the completion and termination of the intervention procedure as described otherwise above with respect to Figures 5 and 6, for example. Even alternatively, as shown in Figures 4a-4c, the disposition of the septum material 100 can occur through a catheter delivery tool 160, rather than through a needle as described above. The catheter delivery tool 160 comprises a balloon 161 or rigid teeth 162 that deploy from a distal end thereof. The catheter 160 is inserted over the previously inserted guide wire 130. The guide wire 130 can be inserted through a needle 120, for example, as described above with respect to Figures 2-3. The balloon 161 or teeth 162 deploy at the distal end of the catheter 160 to assist in dissecting the tissue further from the site of the vessel wound (vw) on the outer cover (a) of the target vessel (V). The septum material is then injected through catheter 150 and into the outer cover (a) of the target vessel (V) or into the balloon 161. The balloon 161 is preferably comprised of a natural material such as a bowel or a biodegradable polymer whose porosity allows the septum material 100 to slowly seep through and adhere to the outer shell (a) of the target vessel (V). Of course, said natural or biodegradable polymer balloon 161 may be used with various systems and methods described herein to help contain the septum material 100 when it is placed in the outer shell (a) of the target vessel (V). A mold 163 (Figure 4c) can further be provided at the distal end of the catheter 160 to help contain and form the septum material 100 when it is placed through the catheter to the site of the vessel wound (vw). After the septum material 100 is placed in the outer cover (a) of the target vessel (V), the catheter 160 is removed while the septum material 100, or balloon 161 containing the septum material 100, remains.

Even alternatively, the septum material 100 can be injected into the outer cover (a) of the target vessel (V) by means of a syringe (not shown) as can be easily appreciated by the expert, rather than through any other tool. supply of septum material in another manner described herein. Figure 5 illustrates an introducer 150 inserted on the guide wire 130 and into the target vessel (V) after the septum material 100 has been placed on the outer cover (a) and any septum material supply tool, is say, the first needle 120, the syringe, the second syringe 140 or another catheter 160, as the case may be, has been removed. A stent 155 may precede insertion of the introducer 150 in a conventional manner if desired, in order to assist insertion of the introducer 150 through the tissue tract 1 10, the septum material 100 and into the target vessel (V ). If it is used, the dilator 155 can be removed after the introducer 150 has penetrated into the target vessel (V). Once the introducer 150 is inserted, then several instruments can be inserted through it and an intervention procedure can be performed within the target vessel (V). After finishing the intervention procedure, as shown in Figure 6, several instruments, the introducer 150, and the guide wire 130 are removed from the target vessel (V) through the septum material 100, which remains in place in the outer cover (a) of the target vessel. Due to the viscoelasticity properties of the septum material 100, which ideally presents at least some deformation of 800-900%, the septum material 100 is easily recovered to close and seal the opening through which the introducer 150 and the wire guideline 130 were placed during the intervention procedure. Figures 7-11 illustrate another embodiment of a vessel wound closure system and the method wherein the septum material 100 is made and placed in the outer shell (a) of the target vessel (V) prior to performing the an intervention procedure within the target vessel (V), where similar numbers or reference characters are used to mention equal parts. The preformed septum material 100 may include a hemostatic valve 101 incorporated therein, through which the valve, introducer 150 or other instruments are passed through and into the target vessel (V) to perform an interventional procedure within of the objective vessel (V). After finishing the intervention procedure, the introducer 150 and the instruments are removed through the valve 101, which closes and seals the vessel wound (vw). In particular, Figure 7 illustrates a first needle 120 which locates the target vessel (V) as it penetrates through the skin and into the target vessel (V). A guidewire 130 is then inserted through the first needle 120 and into the target vessel (V). Hereinafter, as shown in Figure 8, the first needle 120 is removed, leaving only the guide wire 130 in place within the target vessel (V).

Figure 9 illustrates the disposition of the preformed septum material 100 in the outer cover (a) of the target vessel (V). In particular, Figure 9 illustrates a catheter 170 inserted over the guidewire 130 so that a distal end of the catheter 170 approaches, but does not enter, the target vessel (V). The preformed septum material 100 is then pushed through the catheter 170 and into the outer cover (a) of the target vessel (V) (see Figure 9). Preferably, a biocompatible / biodegradable bonding agent is applied to one or both distal surfaces of the preformed septum material 100 and the exposed outer cover surface to assist adhesion of the preformed septum material 100 to the outer cover (a) when it is placed therein from the catheter 170. Of course, the preformed septum material 100 may be contained within a balloon 161, as described above with respect to Figures 4a-4c, in which case the septum materials are slowly filtered out. of the balloon 161 and adhere to the outer cover. An impeller 171 can be provided through the catheter to assist in the disposition of the preformed septum material 100 in the outer shell. In any case, after the preformed septum material 100 is placed on the outer cover, the catheter 170 and the impeller 171, if used, are removed. Although the preformed septum material 100 can be penetrated to access the target vessel (V), it is preferred to provide the preformed septum material with a hemostatic valve 101, through which the introducer 150, guide wire 130 or other instruments can access to the objective vessel (V). Figure 10 illustrates an introducer 150 inserted over the guide wire 130 and into the target vessel (V) through the valve 101 of the preformed septum material 100 after the preformed septum material 100 has been placed in the outer shell (FIG. a) and catheter 170 has been removed. As in the above described embodiments, a stent 155 can precede insertion of the introducer 150 in a conventional manner, if desired, in order to assist insertion of the introducer 150 through the valve 101 and the septum material 100. , and in the target vessel (V). If used, the dilator 155 can be removed after the introducer 150 has penetrated the target vessel (V). Once the introducer 150 is inserted, then several instruments can be inserted through it and an intervention procedure within the target vessel (V) is performed. After finishing the intervention procedure, as shown in Figure 11, several instruments, the introducer 150, and the wire 130 are removed from the target vessel (V) through the valve 101 and the septum material 100, which remains in place on the outer cover (a) of the target vessel. Due to the valve 101 and the viscoelastic properties of the septum material 100, the access hole in the target vessel (V) is easily sealed and sealed. Several exemplary embodiments of the invention as described herein do not limit the different embodiments of the systems and methods of the invention. The materials described herein are not limited to the materials, designs or forms mentioned herein for illustrative purposes only, and may comprise several different materials, designs or shapes suitable for the systems and methods described herein, as will be appreciated by a expert. Although it has been shown and described what are considered preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail can easily be made without departing from the spirit or scope of the invention. It is therefore intended that the invention not be limited to the exact forms described and illustrated herein, but that they be constructed to cover all modifications within the scope of the appended claims.

Claims (1)

1. NOVELTY OF THE INVENTION CLAIMS 1. - A vessel wound closure system comprising: a self-sealing septum material placed on the outer covering of the target vessel and in a vessel wound prior to performing an intervention procedure on the target vessel. 2. - The vessel wound closure system according to claim 1, further characterized in that the material of the self-sealing septum is a biocompatible / biodegradable, viscoelastic material. 3. - The vessel wound closure system according to claim 2, further characterized in that the self-sealing septum material has at least 800-900% deformation properties that close and seal the access holes provided therein. to accommodate the completion of the intervention procedure. 4. - The vessel wound closure system according to claim 3, further characterized in that it comprises a balloon in which the self-sealing septum material is contained and from which the self-sealing septum material penetrates the internal septum cover. target vessel. 5. - The vessel wound closure system according to claim 4, further characterized in that the balloon is comprised of a natural membrane or a biodegradable polymer membrane of sufficient porosity to allow infiltration of the self-sealing septum material into the cover external of the objective vessel. 6. - The vessel wound closure system according to claim 5, further characterized in that the natural membrane is the intestine. 7. - The vessel wound closure system according to claim 3, further characterized in that the self-sealing septum material is preformed to accommodate the arrangement thereof in the outer covering of the target vessel in the wound of the vessel. 8. The vessel wound closure system according to claim 7, further characterized in that the preformed self-sealing septum material further comprises a hemostatic valve incorporated therein and allowing access thereto and closure of the same. the same. 9. The vessel wound closure system according to claim 1, further characterized in that it comprises: a first needle that penetrates through the layers of the skin and into a target vessel; a guidewire inserted through the first needle and into the target vessel; a second needle having holes through which the self-sealing septum material is placed on the outer cover; and an introducer inserted over the guide wire after the self-sealing septum arrangement, through which the introducer of the intervention procedure is performed. 10. - The vessel wound closure system according to claim 9, further characterized in that the guide wire further comprises an anchor or expandable element at a distal end; of the same one that leans against an inner surface of the target vessel when it is deployed. eleven . - The vessel wound closure system according to claim 10, further characterized in that the anchor is a nitinol net or basket. 12. - The vessel wound closure system according to claim 1 1, further characterized in that the expandable element is a balloon. 13. - The vessel wound closure system according to claim 1, further characterized in that it comprises: a stepped needle having a distal portion with small diameter and a portion with larger diameter proximal to it, the portion with greater diameter has orifices through which the self-sealing septum material is disposed in the outer cover of the target vessel. 14. - The vessel wound closure system according to claim 13, further characterized by comprising: the stepped needle that penetrates through the skin plates and penetrate the target vessel until the portion with larger diameter of the same leans against the target vessel; a guidewire inserted through the stepped needle and into the target vessel; and an introducer inserted over the guidewire and into the target vessel, through which the introducer of the intervention procedure is performed. 15. - The vessel wound closure system according to claim 1, further characterized in that it comprises: a first needle that penetrates through the layers of the skin and into the target vessel; a guidewire inserted through the first needle and into the target vessel; a catheter through which the self-sealing septum material is placed on the outer cover; and an introducer inserted on the guide wire after the self-sealing septum arrangement and the removal of the catheter, through the introducer the intervention procedure is performed. 16. - The vessel wound closure system according to claim 15, further characterized in that a distal end of the catheter further comprises a balloon. 17. - The vessel wound closure system according to claim 16, further characterized in that the balloon contains the self-sealing septum material and is placed thereon in the outer covering of the target vessel. 18. - The vessel wound closure system according to claim 16, further characterized in that the balloon is comprised of a natural or biodegradable polymer membrane of sufficient porosity to allow filtration of the self-sealing membrane thereof and on the cover external of the objective vessel. 19. - The vessel wound closure system according to claim 18, further characterized in that the natural membrane of the balloon is the intestine. 20. - The vessel wound closure system according to claim 15, further characterized in that the distal end of the catheter further comprises teeth. 21. - The vessel wound closure system according to claim 15, further characterized in that it comprises a containment mold of self-sealing septum material. 22. The vessel wound closure system according to claim 15, further characterized in that the guidewire further comprises an anchor or expandable element in a distal member thereof that bears against an inner surface of the target vessel when deployed. . 23. The vessel wound closure system according to claim 7, further characterized in that it comprises: a first needle penetrating through the layers of the skin and into the target vessel; a guidewire inserted through the first needle and into the target vessel; a catheter disposed on the guide wire and through which the pre-formed self-sealing septum material is placed on the outer covering of the target vessel; and an introducer inserted through the pre-formed self-sealing septum and into the target vessel, through the introducer, the intervention procedure is performed. 24. - The vessel wound closure system according to claim 23, further characterized in that it comprises an impeller provided through the catheter to assist in placing the pre-formed self-sealing septum material in the outer covering of the target vessel. 25. The vessel wound closure system according to claim 23, further characterized in that it comprises a bonding agent applied to one or both of the preformed self-sealing septum materials and the outer covering of the target vessel to secure the material of self-sealing septum preformed to the outer cover. 26. The vessel wound closure system according to claim 23, further characterized in that the preformed self-sealing septum material further comprises a hemostatic valve incorporated therein.