WO2016065313A1

WO2016065313A1 - System and method for sealing access

Info

Publication number: WO2016065313A1
Application number: PCT/US2015/057205
Authority: WO
Inventors: Eric Scott BERENS
Original assignee: Buena Idea, Llc
Priority date: 2014-10-23
Filing date: 2015-10-23
Publication date: 2016-04-28

Abstract

An apparatus for sealing and healing a puncture site or hole in a wall of a tubular tissue structure or a wall of a body cavity, includes an introducer element having a sheath; and a sealing device including an intraluminal and an extraluminal disc for placement on the inside and the outside, respectively, of the tubular tissue structure or body cavity. The intraluminal and the extraluminal disc each include an outer ring of a bioabsorbable shape memory material supporting a bioabsorbable biologic membrane with characteristics that enhance healing. The intraluminal and the extraluminal disc each have a plan size dimension greater than the puncture or hole being sealed. A centering disc is provided between the intraluminal disc and the extraluminal disc, smaller than the puncture site or hole being sealed. A suture knot joins the intraluminal and the extraluminal disc, with the centering disc sandwiched therebetween.

Description

System and Method for Sealing Access The present invention relates to an apparatus and a method for achieving rapid hemostasis in repairing, e.g. patching, or sealing a puncture or hole in a tubular tissue structure or the wall of a body cavity. The invention will be described in connection with repair of a puncture hole in a wall of an artery, although other uses are contemplated.

The control of bleeding during and after surgery is important to the success of the procedure. The control of blood loss is of particular concern if the surgical procedure is performed directly upon or involves the patient's arteries and veins. Well over one million surgical procedures are performed annually which involve the insertion and removal of catheters into and from arteries and veins. Accordingly, these types of vasculature procedures represent a significant amount of surgery in which the control of bleeding is of particular concern.

Typically, the insertion of an access device, such as a catheter or sheath, creates a puncture through the vessel wall and upon removal the access device leaves a puncture opening through which blood may escape and leak into the surrounding tissues.

Therefore, unless the puncture site is closed clinical complications may result leading to increased hospital stays with the associated costs. To address this concern, medical personnel are required to provide constant and continuing care to a patient who has undergone a procedure involving an arterial or venous puncture to insure that post- operative bleeding is controlled.

Surgical bleeding concerns can be exacerbated by the administration of a blood thinning agent, such as heparin, to the patient during a catheterization procedure. Since the control of bleeding in anti-coagulated patients is much more difficult to control, stemming blood flow in these patients can be troublesome. A common method of healing the puncture to the vessel is to maintain external pressure over the vessel until the puncture seals by natural clot formation processes. This method of puncture closure typically takes about thirty to ninety minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated.

Furthermore, utilizing pressure, such as human hand pressure, to control bleeding suffers from several drawbacks regardless of whether the patient is hypertensive or anti- coagulated. In particular, when human hand pressure is utilized, it can be uncomfortable for the patient, can result in excessive restriction or interruption of blood flow, and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags, or clamps require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure the effectiveness of these techniques.

Other devices have been disclosed which plug or otherwise provide an obstruction in the area of the puncture. In current practice, submucosal tissue or another extracellular matrix-derived tissue is used to seal punctures in tubular tissue structures, such as blood vessels, or in the wall of a body cavity. The prior art method of placing the submucosal or extracellular matrix-derived tissue is described in U.S. Pat. No.

6,790,220, which is herein incorporated by reference, a simplified version of which is reproduced in Figures 1A- 1 D.

An introducer 10 with a sheath 1 1 carrying a ribbon or sheet 12 of extracellular matrix-derived tissue is inserted through the skin, the underlying muscle tissue, and through the blood vessel wall. Ribbon or sheet 12 includes a cuff 14 and an extended length 15. The cuff 14 is usually situated and secured directly above a hole 13 in the sheath 1 1, in which the extended length 15 is inserted. The outer diameter of the cuff 14 is greater than the outer diameter of the sheath 1 1. As is also shown in FIG. 1 A, pull-up tether 16 is woven through the extended length 15 and pull down tether 18 is woven into the cuff 14 and both tethers are exposed externally. The introducer 10 is inserted until the greater diameter of the cuff 14 prevents further insertion of the introducer 10. The cuff 14 is then released so that it is free to move relative to the sheath 1 1. The sheath 1 1 , is advanced as the cuff remains in position and the extended length is withdrawn from the interior of the sheath 1 1 through the hole 13.

When the procedure is completed, the entry to the artery will need to be closed. As shown in Figs. lB-1 D, the user pulls the tethers 16, 18 to bunch the ribbon or sheet 12 into a ball 15. When the sheath remains inserted, the ball 15 is held to the side of the puncture site by the sheath 1 1 . When the sheath is removed, the ball 15 moves into the puncture site, sealing the puncture site immediately. When the user determines that the patch completely seals the hole in the tubular structure, the tethers 16, 18 may then be cut and removed.

This patented method of sealing a hole in a tubular structure has an excellent safety profile, but can suffer from inconsistent tether compression of the device. If the user pulls too hard on the tether, the ribbon or sheet may be pulled out of position to seal the hole. At the same time, if the user does not pull hard enough on the tether, the ribbon or sheet will not be compressed sufficiently to effectively seal the hole. Even after the ribbon or sheet is compressed into a ball, by removing the sheath a space is created within the cuff. An incomplete mechanical closure of the hole may contribute to longer hold times being necessary to reach hemostasis. Some users advocate adding a "little" pull on the suture tether to further tighten the ball after removing the sheath, but it's success is very operator dependent and inconsistent.

Moreover, and significantly, the method and apparatus are described in the above mentioned U.S. Patent No. 6,790,220 cannot be used to seal holes greater than 8 French size (2.67 mm). Large sheath sizes can range from 10F (3.33 mm) to 24F (8mm) and these often cannot be closed without using open surgical technique to repair the artery. Thus, there exists a need for a method and apparatus for closing or sealing holes in internal tubular structures or the like greater than or equal to 3 mm diameter.

The present invention provides an apparatus and method for sealing punctured biologic tubular tissue structures, including arteries and veins, such as punctures which occur during diagnostic and interventional vascular and peripheral catheterizations, or for sealing a puncture in the wall of a body cavity. More specifically, the apparatus and method of the present invention employ a multilayer closure mechanism including a centering disc sandwiched between an intraluminal disc and an extraluminal disc to allow more consistent sealing of punctures in tubular tissue structures, such as blood vessels, or in the wall of a body cavity.

The present invention provides an apparatus including an introducer element including a sheath in the form of a hollow tube for accommodating a sealing device for delivery to a puncture site or hole. The sealing device is constructed of two discs, an intraluminal or internal disc and an extraluminal or external disc, one each for placement on the inside and the outside, respectively, of a biologic tubular structure such as an artery. The closure of the artery is based on a "sandwich" type mechanism, in which the artery wall will be compressed between the intraluminal disc and the extraluminal disc, a centering disc and an optional hemostatic agent layer. The internal or intraluminal disc is constructed of an outer thin ring formed of a shape memory material, preferably a bioabsorbable shape memory material ((such as polyglycolide (PGA), poly-ε- capro lactone (PLC) or poly-L-lactide (PPLA)) that acts as structural support for an absorbable biologic membrane (similar to an extracellular matrix - ECM) contained within it. The centering disc comprises a round disc that is smaller in plan than the intraluminal disc and the extraluminal disc and will ultimately be sandwiched between the intraluminal disc and the extraluminal disc at final deployment. The external or extraluminal disc may be constructed the same as the intraluminal disc or differently as determined by the requirement for hemostasis and stabilization.

The intraluminal disc and the extraluminal disc should be flexible enough to be constrained in an oval and folded shape, and, when deployed, assume their original round shape. The disc membranes should be sufficiently flexible in order to conform to the irregular margins of the hole (such as, in this application, the arteriotomy), whereby to create a hemostatic seal. The intraluminal disc and the extraluminal disc arc brought together at their centers. A small round disc is positioned at the center of the membranes (membrane stabilizer) in order to support suture used to compress the sandwiched material. Through the middle of the membranes, membrane stabilizers and the centering disc are holes for suture. As the device is deployed, a sliding suture knot will compress the intraluminal disc and the extraluminal disc together tightly, sandwiching the artery wall, centering disc and, optionally, coagulant material to further enhance hemostasis.

One of the unique key elements of this design is the use of a circular disc comprised of an outer ring and membrane center that is larger than the diameter of the artery hole created by the original working sheath. This ringed circular disc design may be used for both the internal and external discs that comprise the outermost layers of the sandwich. These discs are inserted into their respective positions by flexing them into oval shapes that will conform to the smaller internal diameter of the catheter. The intraluminal disc and the extraluminal disc may sit longitudinally or obliquely within their constraining sheath. A pushing rod will be used to sequentially deploy first the intraluminal disc and then the sandwich including the centering disc, optionally a coagulant agent and the extraluminal disc. The delivery catheter will either be the same size as the original procedural sheath (in that case the sealing device will be delivered over a wire) or it will be a catheter inserted through the original sheath. Alternatively, the sealing device will incorporate a delivery system with its own sheath that is the same outside diameter as the original working sheath. The device sheath of standard length and dimensions will replace the original sheath which may have variable dimensions. In this way the device sheath may be designed to assist in the delivery of the catheter that contains the closure elements.

The material qual ities of the shape memory outer ring of the intraluminal disc and the extraluminal disc are an essential component of this design. The material must be rigid enough to maintain a circular shape when deployed, giving strength and support to the closure, and maleable enough to assume an oval shape in order to load it into its delivery system. The diameter of the extraluminal disc, once deployed, must be larger than the sheath size in order to cover the arteriotomy with its membrane. The disc ring material must also be non-thrombogenic and constructed as thin as possible to conform to the arterial wall lumen but be stiff enough so that it could not be pulled out during deployment or pushed out by high intraarterial pressure. Preferably the intraluminal disc and the extraluminal disc are formed of a bioabsorbable shape memory material as above described.

To achieve seal ing when the sealing device is deployed, it is important to center the intraluminal disc over the artery hole. Centering is accomplished by using a third bioabsorbable middle disc ("centering disc") also pre ferably formed of a bioabsorbable material, that closely fits the diameter of the delivery catheter. The centering disc has central holes for sutures that are used to create a centering effect. At final deployment the centering disc will become part of the "sandwich" with the artery wall. The centering disc should be thin, flat and solid. It will serve three purposes: one to center the suture and in turn the intraluminal disc; secondly, to help close the hole and obtain faster hemostasis (control of bleeding) and thirdly; to prevent the next layer of coagulant material from entering the artery lumen.

The material qualities of the membrane are also important to this design. The membrane should be both thin and structurally durable as well as liquid impermeable. It also should be non-thrombogenic and preferably bioabsorbable absorbable with a timeframe range of 4-8 weeks to allow for arterial wall healing. Ideally it would provide a scaffolding to enhance healing into which new artery wall structures can grow naturally without scarring. It should also not become thromboembolic itself or allow thrombus to form on its surface and then later become thromboembolic. Extracellular matrices (ECMs) are available commercially, have been used in the intraarterial position and have been shown to have all of these qualities. Alternatively, other materials may be considered.

The fixation of the external supporting disc and the central membrane to the supporting rings form ing the intraluminal disc and the extraluminal discs may be accomplished with suture or biologically-compatible glue. The membrane material may be wrapped around the rings to create a double layer for added strength and provide certain mechanical advantages.

The relative absorption rates of the intraluminal d isc components are important to healing success and avoiding early or late thromboembolization, thrombosis, or pseudoaneurysm development. The five components of the intraluminal disc (supporting outer ring, membrane, membrane stabilizer and suture, or glue) need to be considered in these respects.

Positioning of the delivery catheter at the artery wall in order to deploy the intraluminal disc will require a bleed back mechanism. Using the delivery system sheath and dilator placed over a wire, a small side hole can be used as a bleed back indicator to signal when the delivery system is correctly positioned at the artery wall. First, the sheath will be inserted fully in the artery. Next, the dilator guide and wire will be removed. The delivery catheter can then be advanced through the sheath to its end, occluding it by its design. A side hole in the sheath will allow back bleeding from a more proximal hole or tubing near the external end of the sheath. As the operator pulls back on the entire delivery system, cessation of bleeding will indicate that the end of the sheath is near is at the artery wall and can immediately be deployed. The internal components can be advanced until the intraluminal disc is released within the artery lumen. Next, the intraluminal disc, acting as an occluding membrane and anchor due to the mechanical advantage of the ring design, controls initial bleeding as the combined sheath/catheter are withdrawn about 5 to 10 mm, allowing recoil of the arterial wall. Next the pusher rod is advanced to eject the external components, creating the multilayer hemostatic plug. Lastly, the suture is pulled, knot compressed and layers bound together.

Further features and advantages of the present invention will be seen from the following detailed description, taken in conjunction with the accompanying drawings, wherein like numerals depict like parts, and wherein:

Figs. 1 A-1D illustrate a prior art method and introduce elements for use in sealing access to a tubular tissue structure or body cavity;

Figs. 2A and 2B depict the sheath/int roducer apparatus of the present invention; Figs. 3A-3D illustrate the method and elements of the invention for use in sealing a tubular tissue structure or body cavity;

Fig. 4 illustrates a tubular tissue structure sealed in accordance with the present invention; and

Figs. 5A-5C are top-plan views of individual sealing elements in accordance with the present invention.

In the following description, and for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the various aspects of the invention. It will be understood, however, by those skil led in the relevant art, that the present invention may be practiced without these specific details. In other instances, known structures and devices are shown or discussed more generally in order to avoid obscuring the invention. In many cases, a description of the operation is sufficient to enable one to implement the various forms of the invention. It should be noted that there are many different and alternative configurations, devices and technologies to which the disclosed invention may be applied. The full scope of the invention is not limited to the examples that are described below.

In one aspect of the invention, the present invention is related to an apparatus and a method for repairing or sealing a puncture or hole in a tubular tissue structure, such as a blood vessel, or in the wall of a body cavity. The apparatus and method of the present invention can be used to repair or seal a puncture or hole in a tubular tissue structure, such as a blood vessel, or in the wall of a body cavity, that has been created intentionally or unintentionally such as during a surgical procedure or nonsurgically (e.g., during an accident) or an aneurysm or rupture. Punctures made intentionally include vascular punctures made in various types of vascular, endoscopic, or orthopaedic surgical procedures, or punctures made in any other type of surgical procedure, in coronary and in peripheral arteries and veins or in the wall of a body cavity. Such procedures include angiographic examination, angioplasty, laser angioplasty, valvuloplasty, atherectomy, stent deployment, rotablator treatment, aortic prosthesis implantation, intraortic balloon pump treatment, pacemaker implantation, any intracardiac procedure,

electrophysiological procedures, interventional radiology, and various other diagnostic, prophylactic, and therapeutic procedures such as dialysis and procedures relating to percutaneous extracorporeal circulation.

Referring now to the drawings, FIGs. 2A-2B, illustrate, in simplified form an introducer 100 exemplary of the type of introducer that may be used in accordance with the present invention. It is understood that the present invention is applicable to any type of introducer used to provide access to the lumen of a tubular tissue structure, such as a blood vessel, or to a body cavity. For example, the present invention is applicable to an introducer such as a cannula, a guide wire, an introducer adapted for dialysis, a trocar, or any other introducer used to access the lumen of a tubular tissue structure or a body cavity.

Typically, a catheter is introduced into the vascular system by first penetrating the skin, underlying muscle tissue, and the blood vessel with a needle, and a guide wire is inserted through the lumen of the needle and enters the blood vessel. Subsequently, the needle is stripped off the guide wire and working sheath is fed over the guide wire and pushed through the skin and through the vessel wall to enter the vessel. A standard working sheath also may comprise other standard elements such as a dilator and a sheath which extends axial ly over the dilator, a sheath cap disposed axially over a portion of the sheath, and a valve and valve cap connected to the sheath cap and to a side port tube, etc., the details of which have been omitted for the sake of clarity, but may be seen by reference to my co-pending U.S. Application Serial No. 13/405,91 1 , filed February 27, 2012, the contents of which are incorporated herein by reference. The guide wire can then be removed and a catheter is fed through the lumen of the working sheath and advanced through the vascular system until the working end of the catheter is positioned at a predetermined location. Alternatively, the guide wire may be left in place throughout the procedure and the working sheath removed before the guide wire is removed. At the end of the catheterization procedure, the catheter is withdrawn. The working sheath is also removed and the opening through which, for example, the working sheath is inserted must be sealed as quickly as possible once the procedure is completed.

The present invention may be employed, for example, to rapidly seal a puncture site in a blood vessel upon completion of a catheterization procedure. The introducer 100 illustrated in FIGs. 2A-2B is an exemplary embodiment and has a same diameter as the working sheath, a distal end 102 for insertion into a blood vessel and an user or proximal end 104.

Preferably the introducer 100 includes a bleed-back hole 106 adjacent its distal end and a bleed-back indicator 108 adjacent its proximal or user end which is used by the operator for positioning the introducer into the tubular tissue structure. The position of the introducer also could be visualized using, for example, ultrasound. The introducer 100 should have the same diameter as the working sheath.

In use, the original sheath is removed, leaving the guide wire in place. The introducer sheath is inserted, and the dilator and wire removed. The operator then pulls back the sheath until back bleeding stops, indicating that the intraluminal end of the sheath is near the arteriotomy. The bleed-back indicator 108 is oriented so that it is facing up, placing the bleed-back hole on a cephalad side of arteriotomy. This will give the first indication of crossing the artery wall as pull-back is performed.

Referring to Figs. 3A-3D, 4 and 5A-5C, the introducer 100 carries a closure or sealing assembly comprising intraluminal and extraluminal discs 1 10, 1 12, respectively, a centering disc 1 14, and optionally, a coagulant layer 1 16. Intraluminal disc 1 10 and extaluminal disc 1 12, preferably are circular in shape, and are formed of a shape memory material, preferably a bioabsorbable shape memory material such as polyg!ycolide (PGA), poly-E-caprolactone (PLC) or poly-L-lactide (PPLA). Intraluminal disc 1 10 and extaluminal disc 1 12 include a ring element 1 18 and a membrane element 120.

Membrane element 120 may be formed of the same or different bioabsorbable material as ring element 1 18, preferably a bioabsorbable material.

Intraluminal disc 1 10 and extraluminal disc 1 12 should have a diameter larger than the hole in the artery, while centering disc 1 14 should be smaller, and preferably have a diameter approximating that of the diameter of the hole in the artery. Ring 1 18 should have physical characteristics that allow flexible bending to oval shape to allow loading into delivering catheter. Ring 1 18 acts as a diaphragm, sealing the artery hole from the inside. The membrane should be thin, water impermeable, secured to the edges of the ring and flexible. It also should be non thrombogenic and strong. Centering disc 1 14 should be flat bioabsorbable disc - used as a centering device when internal disc 1 10 is deployed. Centering disc 1 14 keeps disc 1 10 centered over the artery hole, verifying that the membrane completely covers the defect hole and creating initial hemostasis during the first step of deployment. Intraluminal disc 1 10, extraluminal disc 1 12, centering disc 1 14 and optional coagulant disc 1 16 are tied together by suture material 122 which is threaded through holes in the discs 1 10, 1 12, 1 14 and 116.

To deploy the sealing assembly, the original sheath is removed with a wire, and introducer sheath 100 inserted in place thereof, and positioned at the anteriotomy using bleed-back indicator as discussed above. The sealing assembly comprising intraluminal and extraluminal discs 1 10, 1 12, centering disc 1 14 and optionally a coagulant disc 1 16 carrying a layer of coagulant substance (gel foam, collagen, or coagulant other) to enhance rapid hemostasis, is advanced in the introducer 100 using a pusher rod 120, to release the intraluminal disc 1 10 in the artery, whereupon the intraluminal disc assumes its original ring shape. The introducer 100 is then pulled back until the intraluminal disc 1 10 contacts the interior wall. Centering disc 1 14 and optional coagulant disc 1 16 also have holes through which the suture material may pass.

The introducer 100 is then pulled back to allow recoil of the artery wall, and the pusher rod 120 is advanced to release the centering disc 1 14, the optional coagulant disc 1 16 and the extraluminal disc 1 12 external to the arterial wall. The surgeon then pulls the suture 122 while advancing the pusher rod to secure a sliding knot 124 and pull the intraluminal disc and extraluminal disc together against the interior and exterior walls of the artery, wherein the centering disc 1 14 guides the closure assembly over the hole in the artery. The closure assembly plugs the hole or defect in the artery wall, and, typically being bioabsorbable, will slowly be absorbed into the body while the hole or defect heals. The characteristics of the membranes can minimize scarring, enhance healing and promote return of normal arterial wall architecture.

The apparatus may be sealed for use in sealing larger or smaller holes.

Various changes may be made in the above invention without departing from the spirit and scope thereof.

Claims

CLAIMS 1 claim:

1. An apparatus for sealing and healing a puncture site or hole in a wall of a tubular tissue structure or a wall of a body cavity in a patient, the apparatus comprising:

an introducer element having a sheath; and

a sealing device comprising an intraluminal disc and an extraluminal disc for placement respectively on the inside and the outside, respectively, of the tubular tissue structure or body cavity, wherein the intraluminal disc and the extraluminal disc each comprise an outer ring of a shape memory material supporting a biologic membrane wherein the intraluminal disc and the extraluminal disc have a plan size having a dimension greater than the puncture or hole being sealed,

a centering disc between the intraluminal disc and the extraluminal disc, said centering disc having a dimension smaller than the puncture site or hole being sealed; and

a suture knot joining the intraluminal disc and the extraluminal disc, with the centering disc sandwiched therebetween.

2. The apparatus of claim 1 , wherein the intraluminal disc and the extraluminal disc are formed of the same material, preferably a bioabsorbable material.

3. The apparatus of claim 1 or claim 2, wherein the suture knot comprises a sliding suture knot.

4. The apparatus of any of claims 1 -3, further comprising a coagulant agent sandwiched between the intraluminal disc and the extraluminal disc or coated on the intraluminal disc and/or the extraluminal disc and/or the centering disc.

5. The apparatus of any of claims 1-4, wherein the rings of the intraluminal disc and the extraluminal disc are formed of a bioabsorbable shape memory material (for example, from the group consisting of polyglycolide (PGA), poly-s-caprolactone (PLC) or poly-L-lactide (PPLA).

6. The apparatus of any of claims 1 -5, wherein the sheath includes a bleed-back hole adjacent its distal end and a bleed-back indicator hole adjacent its proximal end.

7. A method of sealing a puncture site or hole in a wall of a tubular tissue structure or a wall of a body cavity, said method comprising steps of:

inserting an introducer as claimed in claim 1 into the puncture site or hole, and advancing the intraluminal disc in the tubular tissue structure or body cavity; retracting the introducer until the intraluminal disc contacts an interior wall of the tubular tissue structure or body cavity;

advancing the centering disc and extraluminal disc and retracting the introducer; and

pulling the suture knot while advancing the pusher rod to secure, knot and pull the intraluminal disc and the extraluminal disc together against the interior and exterior walls of the tubular tissue structure or body cavity.

8. The method of claim 8, further comprising the step of withdrawing the introducer from the puncture site or hole.