WO2013049370A1

WO2013049370A1 - Systems for closure of openings in organs and tissue and related methods

Info

Publication number: WO2013049370A1
Application number: PCT/US2012/057596
Authority: WO
Inventors: Dawn BARDOT; Gwenyth FISCHER; Michael DAHL; Kiyoyuki Miyasaka; Daniel GRUENSTEIN
Original assignee: Regents Of The University Of Minnesota
Priority date: 2011-09-27
Filing date: 2012-09-27
Publication date: 2013-04-04

Abstract

A tissue access and closure device includes an introducer portion defining a lumen therein, the introducer configured for providing access to a bodily cavity. The device further includes a tubular element coupled to the introducer portion where the tubular element includes a lumen therein, and a spring closure device received on or within the tubular element. The spring closure device comprises a shape-memory material having a relaxed, contracted state and an expanded state.

Description

SYSTEMS FOR CLOSURE OF OPENINGS IN ORGANS AND

TISSUE AND RELATED METHODS

TECHNICAL FIELD Systems for closure of openings in bodily organs and tissues, and related methods.

BACKGROUND

The need to close openings in bodily organs and tissues arises in a variety of medical situations. Traumatic wounds, either external or internal, are a common example of the types of openings that may require tissue closure. Another example is closure of openings made in the intestinal wall, bodily organs, deep skin or fascial wounds. Yet another example of closure of opening involves the heart during heart valve replacement procedures associated with aortic stenosis.

Referring to the example of heart valve procedures, a number of different strategies have been used to repair or replace a defective heart valve. Surgical valve repair or replacement surgery has traditionally involved a gross thoracotomy, usually in the form of a median sternotomy. In this procedure, a saw or other cutting instrument is used to cut the sternum longitudinally and the two opposing halves of the anterior or ventral portion of the rib cage are spread apart. A large opening into the thoracic cavity is created, through which the surgeon may directly visualize and operate upon the heart and other thoracic contents. The patient must be placed on cardiopulmonary bypass for the duration of the surgery. While open-chest valve replacement surgery has the benefit of permitting the direct implantation of the replacement valve at its intended target site, patient recovery is slow, complications are frequent and medical expense is high.

Minimally invasive percutaneous valve replacement procedures have emerged as an alternative to open-chest surgery. Unlike open-heart procedures, percutaneous procedures are indirect and involve intravascular catheterization from a vessel, such as femoral, subclavian and the like, to the heart. Because the minimally invasive approach requires only a small incision, it allows for a faster recovery for the patient with less pain and the promise of less bodily trauma. This, in turn, reduces the medical costs and the overall disruption to the life of the patient.

The use of a minimally invasive approach, however, introduces new complexities to surgery. An inherent difficulty in the minimally invasive percutaneous approach, in particular the transfemoral retrograde approach, is the limited space that is available within the vasculature. Unlike open-heart surgery, the transfemoral retrograde approach offers a surgical field that is only as large as the diameter of a blood vessel. Consequently, the introduction of tools and prosthetic devices becomes a great deal more complicated. The device must be dimensioned and configured to permit the device to be introduced into the vasculature, maneuvered therethrough, and positioned at a desired implant location. A fairly new procedure, the transapical antegrade approach, is increasingly preferred for certain cases over the transfemoral approach. The apical area of the heart is generally the blunt rounded inferior extremity of the heart formed by the left and right ventricles. In normal healthy humans, the apical area generally lies behind the fifth left intercostal space from the mid-sternal line. The unique anatomical structure of the apical area permits the introduction of various surgical devices and tools into the heart without significant disruption of the natural mechanical and electrical heart function. Because transapical procedures allow direct access to the heart and great vessels through the apex, they are not limited by the size constraints which are presented by percutaneous surgical methods. While access to the heart through the femoral vessels in intravascular approaches are limited to the diameter of the vessel (approximately 8 mm), access to the heart through the apical area is significantly larger (approximately 25 mm). Thus, apical access to the heart permits greater flexibility with respect to the types of devices and surgical methods that may be performed in the heart and great vessels.

Typically, in the transapical approach a trocar or other sharp needle device is used to puncture the apex of the heart to create an opening. A catheter-mounted stented prosthetic valve and other instruments necessary for implanting the valve are introduced in to the left ventricular space via the apical opening. After surgery is completed, the apical opening must be closed. The fragility of the cardiac apex and improper closing is the most important cause of surgical bleeding and massive blood loss during a transapical procedure frequently leading to death in many patients. Purse string sutures, typically reinforced with Teflon, that are placed in the external surface layer of the myocardium have been the standard for closing the apical opening. However, the closing force is applied to a very thin layer of myocardium. Assuming the heart is already diseased and friable, when suturing the tissue with purse string sutures the amount of force used may be too great for the myocardium and may cause tears in the tissue. An alternative to the superficial purse string suture method of closure is desirable.

Thus, new systems and methods for closing the apex of the heart and other openings in bodily tissues and organs are needed to address the short coming of conventional devices and methods.

SUMMARY

Novel systems and methods for closing openings made in tissue, organs and the like, and for identifying access points in bodily organs and tissues.

In one or more embodiments, a closure device for closing openings made by perapically introduced medical devices is provided, for example, devices introduced through the apex. In one or more embodiments of the systems and method, hemostasis is achieved for openings in the left ventricle free wall of the heart. In one or more embodiments, minimally invasive, percutaneous access for device delivery via the cardiac apex and closure of the apex is provided. In one or more embodiments, systems methods to achieve hemostasis for large access punctures, allowing the introduction of approximately 32F devices, are provided. In one or more embodiments, a surgeon identifies the access point to the apex of the heart. In one or more embodiments, a non-invasive, catheter-delivered, magnet-guided navigation system allows a user to precisely locate the apex of the right or left ventricle. In one or more embodiments, fluoroscopy can be used location. The catheter is guided through a distal vein or artery, such as the femoral artery, and is delivered using conventional catheter guidance to the apex of the right or left ventricle. A second magnet placed on the outside of the patient's apical area identifies the location of the magnet and thus the ideal location for the minimally invasive puncture or small thoracotomy. The magnet may be a standard magnet or an electric magnet. Alternatively an acoustical signal or radioactive pellet may be used. Those of ordinary skill in the art will appreciate that the novel systems of the present invention may also be used with conventional methods of locating the apex of the heart.

In one or more embodiments, after access to the heart is identified a needle is used to puncture the myocardial free wall in the vicinity of the left ventricular apex to gain access to the lumen of the left ventricle. A guide wire is placed through the lumen of the needle. The needle is retracted leaving the guide wire in place. A dilator, known to those of skill in the art, is advanced along the guide wire, creating a larger bore route into the left ventricular lumen. The tissue access and closure device in accordance with the invention is then positioned over the dilator and the dilator removed. With large bore access created in the apex, a variety of surgical tools and prosthetic devices may then be introduced via this route into the left ventricle and adjacent structures.

The tissue access and closure device includes an introducer defining a lumen therein, a rigid helical-shaped tubular element including a sharp end and a spring closure device having a helical configuration and made of suitable shape-memory material or retractable, spring-like plastics. The introducer may be used as rotatable element for rotatably driving the spring closure device into a tissue opening or may optionally including a rotatable element knob on a proximal end thereof.

The spring closure device is operably coupled to the rotatable element. Initially the spring closure device is dilated to its elastically deformed, expanded state. It is then introduced into the lumen of the rigid, helical-shaped, tubular element, which has a diameter that is larger than the diameter of the spring closure device. The tubular element may be carried by and may be co- axially aligned with the introducer portion.

The tubular element is rotatably screwed into the opening in the heart to create a helical path in the tissue for the spring closure device to reside. It is then rotated in the opposite direction which causes it to retract back over the helical spring closure device, which in turn causes the spring closure device to be exposed and exit the tubular element. As the tubular element is retracted back, the spring closure device occupies the helical path in the access opening of the myocardium previously created by the tubular element and contacts the tissue. Any excess portion of the helical spring closure device that may extend outside the apical opening (as seen in FIG. 11) is removed by methods known to those of skill in the art, for example with a shearing tool. The introducer portion may then be removed.

As the introducer is removed the helical spring closure device exerts a concentric radial force on the apical opening as the spring closure device reverts from its elastically deformable, expanded shape to the remembered or contracted state, and closes the opening in the organ wall or vasculature, such as but not limited to a heart wall.

In one or more embodiments, the closure device includes a fluid delivery device having a series of small fluid injectors, ranging from 18 gauge to microscopic in size depending on the fluid being delivered. A fluid that causes bulking of the surrounding tissue and/or provokes an inflammatory response is delivered to the target site to be closed via the fluid delivery device. In one or more embodiments, the fluid causes the tissue to approximate. In one or more embodiments, an osmotically driven swelling response occurs, an inflammatory response occurs, a temporary extracellular response occurs, or a combination thereof. The fluid may cause the tissue surrounding the opening in the apex to bulk up, swell through osmosis, or by an inflammatory reaction that causes edema forcing the tissue to approximate. In another one or more embodiments of the invention high intensity focus ultrasound

(HIFU) is applied to the myocardium or other opening in a tissue to close the opening. The HIFU is in the 0.5 to 3MHz range and can be focused in a pattern to sweep across the opening and alternate the focal depth. The native collagen is denatured and cross-links to close the hole. In one or more embodiments of HIFU treatment, the opening may be filled or plugged with non-native or harvested, exogenous collagen. HIFU is then applied to denature both the local native collagen and the non-native collagen. The two types of collagen cross-link to form a plug, which closes the opening.

In one or more embodiments a blood sponge device forms a biodegradable plug for closing an opening in tissue such as an opening to a cardiac ventricle. The sponge device is placed in the opening and expands when it contacts blood, saline or other liquids, or heat. In one or more embodiments, the blood sponge is pre-shrunk with, for example, cold temperature, and is allows to expand as the pre-shrinking effect dissipates. After surgery when an opening is ready to be closed, the surgeon places the sponge device in unclotted blood, or saline allowing the sponge to commence the expansion process. As the sponge is expanding, it is placed in the opening thereby closing it. In one or more embodiments, the sponge is made from a biodegradable material, such as fibrin, cellular matrices, hydrogels and the like, that degrades over time as scar tissue forms around and through the sponge matrix permanently closing the opening. In one or more embodiments, the blood sponge can include native tissue and/or blood from the patient, for example, that is collected prior to placement of the blood sponge.

In one or more embodiments, spiral sutures may be used to close an opening. A pathway is created around the tissue opening 42, which can then be filled with a material or

structure, such as suture, bioabsorbable suture, or reinforced suture material, which applies forces to the tissues to close an opening. The forces close the tissue opening in multiple dimensions, in contrast to conventional techniques that attempt to close a three dimensional wound along a single plane. The pathway can be of a shape such as a helix or double helix that circumscribes the tissue opening and also covers its length. The pathway may include various patterns, such as rings or C-shape that are placed along the length of the tissue opening. The pathway can also have varying pitches, radii, or diameters along any dimension. The material or structure placed in the pathway provides the forces necessary to close the opening. In one embodiment a device can be used to form the pathways and then deliver the structure. In another embodiment the structure is designed to form its own pathway through the tissue.

One or more embodiments utilize guy-wires. A guy-wire, also known simply as a guy, is a tensioned cable designed to add stability to structures. One end of the cable is attached to the structure, and the other is anchored at a distance from the structure's base. They are often configured radially (equally spaced about the structure) in trios, quads (pairs of pairs) or other sets. This allows the tension of each guy-wire to offset the others. Pathways circumferentially surrounding the tissue opening and running radially outward therefrom can be formed. The guy- wires, which may be wires, sutures or reinforced sutures, springs, and the like, are then placed in the radial pathways. The guy- wires are anchored on one side of the wall or tissue and then tensioned using a second anchor that may be adjusted along the guy- wire thereby forming an adjustable anchor that may serve to block or otherwise plug the opening. The varying directions or diameters of the pathways aid in providing forces along directions that close the opening in multiple directions, such as radially, longitudinally or both. One or more embodiments include a monorail system and method for installing a prosthetic medical device in the heart and closing the access hole. The monorail system combines the retrograde and antegrade approaches to deliver and stabilize prosthetic device within the heart. A peripheral catheter including catch on the distal end thereof is introduced into the ventricle by the retrograde approach known to those of skill in the art. An access puncture is made in the apex of the heart. A second catheter or wire carries the prosthetic device thereon and includes closure such as a plug, sponge, cap or the like located proximal to the position of the prosthetic device. The catch on the retrograde/peripheral catheter catches or couples to the second catheter in the ventricular space. The prosthetic device can then be attached to the monorail system and maneuvered into position. The antegrade catheter is then pulled out through the femoral artery, for example, thus pulling the closure into the opening in the apex of the heart and closing the apex.

One or more embodiments, hemostasis is provided by applying a plug having a substantially central body portion and a plurality of spider-like legs extending therefrom. The plug is introduced into an access opening made in, for example, the apex of the heart. Upon deployment the spider legs expand radially and seat the central body portion against the inner wall of the apical opening. The substantially concave central body portion fills the opening and the blood flow in the heart contacts the concave body. The pulsating blood flow is transmitted through the central portion into the spider-like legs which in turn are compressed against the wall of the myocardium creating a secure hemostasis device. In one or more embodiments, the spider legs include contractable sutures which tighten upon deployment, creating

circumferential force around the body of the plug.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cut-away view of the heart detailing an illustrative embodiment of a surgical site in accordance with one or more embodiments.

FIG. 2 is a cutaway view of the heart illustrating a method of puncturing the apex of the heart with a needle to produce an access site to the ventricular space.

FIG. 3 depicts a guide wire being placed through the needle.

FIG. 4 depicts the needle removed with the guide wire remaining in situ. FIG. 5 illustrates the introduction of a dilator over the guide wire to increase the size of the access opening.

FIG. 6 illustrates the tissue access and closure device in accordance with one or more embodiments being introduced over the dilator.

FIG. 7 depicts the tissue access and closure device in position in the apical opening with the dilator removed creating an access path for the introduction of prosthetic medical devices and other surgical tools.

FIG. 8 depicts the spring closure device exiting the rigid, tubular element and being positioned in the apical opening.

FIG. 9 depicts the spring closure device in situ and closing the apical opening.

FIGS. 1 OA- IOC are perspective views of exemplary embodiments of spring closure devices.

FIG. 11 is a side view of a tissue access and closure device.

FIG. 12 depicts a fluid delivery device injecting fluid in an apical opening in accordance with one or more embodiments.

FIG. 13 depicts one or more embodiments in which high intensity focus ultrasound is applied to the myocardium to close the apical opening.

FIG. 14 depicts a biodegradable plug for closing tissue in accordance with one or more embodiments.

FIG. 15 illustrates spiral sutures in accordance with one or more embodiments.

FIG. 16 depicts guy- wires for closing the apical opening in accordance with one or more embodiments.

FIG. 17 illustrates the monorail system in accordance with one or more

embodiments. FIG. 18 depicts a plug having spider-like legs for closing a tissue opening in accordance with one or more embodiments.

FIG. 19 depicts a navigation system that locates the apex of the right or left ventricle in accordance with one or more embodiments.

DETAILED DESCRIPTION

The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the fluid manifold and fluidic control systems and methods may be practiced. These embodiments, which are also referred to herein as "examples," or "options" are described in enough detail to enable those skilled in the art to practice the present invention. The embodiments may be combined, other embodiments may be utilized or structural or logical changes may be made without departing from the scope of the invention. The following detailed description is, therefore, not to be taken in a limiting sense and the scope of the invention is defined by the appended claims and their legal equivalents.

In this document, the terms "a" or "an" are used to include one or more than

one, and the term "or" is used to refer to a nonexclusive "or" unless otherwise indicated. In addition, it is to be understood that the phraseology or terminology employed herein, and not otherwise defined, is for the purpose of description only and not of limitation.

The present document is directed towards improved systems, devices and methods of closing tissue. The specification describes systems, devices and method of closing tissue using the ventricular apex of the heart as an example. These specific uses of the invention, however, are for only illustrative purposes. Those of ordinary skill in the art will appreciate that closing an opening in the apex of the heart is after a transcatheter procedure is only one of many possible applications described herein may be used to close a wide variety of bodily tissues and openings.

Without limiting the variety of surgical procedures in which the present invention may be applied, the novel system and method is discussed as it may be used in heart valve replacement procedures. In an exemplary transcatheter procedure, a heart valve is replaced. Using the antegrade approach to access the left or right ventricular apex, the surgeon must first access the ventricular apex 38 via a mini-thoracotomy or a percutaneous incision in the chest. FIG. 1 is a cut away view of the heart 10, showing the left atrium 34, right atrium 18, left ventricle 26, and right ventricle 24. FIG. 1 also shows the four valves of the heart: tricuspid valve 20, pulmonary valve 16, aortic valve 30, and mitral valve 28. Other anatomical structures illustrated are the aorta 12, superior vena cava 14, inferior vena cava 22, apex 38, myocardium 40, pulmonary veins 32 and pulmonary artery 36. After accessing the heart 10 or other organs and/or bodily systems as discussed above and below via a mini-thoracotomy or percutaneously, the myocardium 38, or other organs or systems, is first punctured with a needle 50 or other suitable device to gain access inside the heart 10 as illustrated in FIG. 2. Referring to FIG. 2, the myocardium 40 is pierced at the left ventricular apex 38 by a hollow needle to gain access to the left ventricle 26, creating an opening 42 in the tissue. After the needle 50 is inserted to access the left ventricle 26, a guide wire 60 is introduced through a lumen in the needle 50 and into the desired physiological site as best seen in FIG. 3. The needle 50 is then removed from the surgical site leaving the guide wire 60 in position as best seen in FIG. 4. After the guide wire 60 is placed in the left ventricle 26, and the needle 50 removed, a dilator 62 is advanced along the guide wire 60 creating a larger access opening 42 into the left ventricular lumen as best seen in FIG. 5. Referring now to FIG. 6, after the dilator 62 is in place the tissue access and closure device 73 (referred to herein as tissue access and closure device and tissue closure device) is introduced over the dilator 62 and the dilator 62 removed. The tissue access and closure device 73 allows for the introduction of prosthetic repair devices and other surgical tools and accessories into organs or bodily systems such as the left ventricular and/or other internal heart space and will include appropriate means thereon to contact the outer surface of the heart wall to prevent blood loss during surgery.

In one or more embodiments, the tissue access and closure device may include and be integral with and/or separable from an introducer portion. Referring now to FIG. 7, the tissue closure device 73 comprises an introducer portion 72 defining a lumen therewithin, optional rotatable element 75 on a distal end thereof, a substantially rigid, or non-rigid, helical-shaped tubular element 74 defining a lumen merewithin and having a sharpened distal end 69, and a spring closure device 76 (as best seen in FIG. 8). Tubular element 76 may be operably coupled to rotatable element 75 or alternatively may be co-axially positioned over introducer portion as best seen in FIG. 6. Lumen of tubular element 74 is sized to receive spring closure device 76. Tubular element 74 may be a different size and shape than that of the spring closure device 76 but generally is helically-shaped and co-axially positioned on introducer portion 72. Tubular element 74 may be made from a rigid or non-rigid material so long as it is malleable. Tubular element 74 may be made from an elastically deformable, memory-shaped material. Alternatively, tubular element 74 may be made from plastic. Spring closure device 76 may have a generally helical shape and may be of varying pitch and diameter. Spring closure device 76 may be made from a memory-shaped material such as Nitinol but may also comprise metals, polymers, suture fibers, plastic or any other elastically deformable material that can revert to a remembered, initial shape. Depending on the use, the materials may be bioabsorbable. In one or more embodiments, spring closure device 76 has an expanded shape and a contracted state. Initially, the spring closure device 76 is dilated to its elastically deformed, expanded state and introduced into the lumen of the tubular element 74. The tubular element 74 is rotated into the apical opening where the sharpened, distal end 69 cuts a helical path into the tissue. After surgery, the tubular element 76 is retracted over the spring closure device 76 by rotating the rotatable element 75 or alternatively by otherwise manually rotating the tubular element 74 over the introducer in a counterclockwise direction. This exposes the spring closure device 76 and allows it to contact the wall of the access opening and the helical path previously created. Any excess portion of the spring closure device 76 that extends past the access opening is removed by methods for example with a shearing tool. After the spring closure device 76 is in position in the apical opening, the tissue closure device 73 and introducer portion 72 may then be removed from the apical opening. As seen in FIG. 9, as the tissue closure device 73 is removed from access opening, the spring closure device 76 exerts a concentric radial force on the opening as the shape-memory, plastic or other retractable material reverts from its elastically deformable, expanded shape to the remembered or contracted initial state thus closing the opening in the heart wall. If the spring closure device 73 comprises biodegradable and/or bioabsorbable material, it degrades over time.

FIGS. 10A through IOC depict exemplary embodiments of the tubular element 74 co- axially aligned with the introducer portion 72 having generally helical configurations as in FIGS. 10A and 10B or double-helix shapes as in FIG. IOC. FIG. 11 depicts an exemplary embodiment of the tubular element 74 showing the exit opening for the spring closure device.

In one or more embodiments, the spring closure device can be activated, for example the shape memory qualities and/or the super elastic qualities using a variety of activation measures, which can be passive or active. The activations include, but are not limited to, electrical currents, magnetic currents, heat, such as, but not limited to, body heat. The activations can be initiated and/or terminated using pre-determined values or over pre-determined ranges for the activation measures. The closure device can be used to close openings in a variety of organs or bodily tissue, including, but not limited to heart, lungs, bronchial tubes, thyroid gland, or the larynx, stomach, bladder, liver, kidneys, GI systems including intestines, and/or bowel. The structure distributes the force through a fuller thickness of the organ and/or tissue and provides a radial closure force through a thickness of an organ and/or tissue wall, which is significant for diseased organs, such as diseased hearts which have become friable.

FIG. 12 depicts another embodiment for closing a tissue opening 42 or other areas, such as intestinal wall, organs, traumatic wounds, deep skin or fascial wounds or any other type of injury which needs to have approximation. Examples include, but are not limited to heart, lungs, bronchial tubes, thyroid gland, or the larynx, stomach, bladder, liver, kidneys, GI systems including intestines, and/or bowel. In one or more embodiments, a fluid delivery device 120 includes a series of small needle-like fluid injectors 122 disposed on a distal end thereof, a cylindrical body portion 124, and plunger device 126. The fluid delivery device 120 can have a variety of shapes includes a ring, square, triangular shape, that is configured to surround the tissue opening. In one or more embodiments, the fluid delivery device 120 includes discreet injectors 122. In one or more embodiments, the injectors 122 can be used to topically apply fluid within the tissue opening and/or at an outer portion of the opening. In one or more embodiments, the injectors 122 are used to deliver fluids at various depths and/or circumferentially around a wound site or tissue/organ opening.

The fluids can be delivered in differing amounts depending on the location around or within the opening to be closed to ensure a proper and even closure of the opening. The device and/or method can further be used to close a channel or passageway through a patient. In one or more embodiments, the device and/or method can be used to temporarily close a channel or passageway through a patient so that treatment and/or or healing can occur without interference from fluids, such as bodily fluids.

Needle-like fluid injectors 122 may be from 18G to microscopic in size, and in one or more embodiments from 22-26G, depending on the fluid being delivered and the target site to which the fluid is being delivered. The cylindrical body portion 124 contains a fluid that is used to inject in the tissue around the tissue opening 42.

A fluid that causes bulking of the surrounding tissue, spasmodic reaction, and/or provokes an inflammatory response is delivered to the target site circumferentially around the opening and at variable depths to create radial pressure, which is less damaging to the tissue than

approximating tissue from one side. The fluid may cause the tissue surrounding the opening 42 to bulk up, swell through osmosis, or by an inflammatory reaction that causes edema forcing the tissue to approximate and/or close.

The injected fluid may be but not limited to a gas, or liquid, such as collagen, normal saline, hypotonic saline, sterile water, insect venom such as bee venom, or a substance with inflammatory properties such as capsaisin, or combinations thereof. The fluids will have one of the following properties, the ability to cause mechanical bulking around the hole putting pressure on the tissue and approximating it; the ability to cause surrounding cells to swell through osmosis, such as with hypotonic fluids, causing increased pressure on the tissue forcing it to approximate; or the ability to cause a temporary inflammatory reaction, causing edema and swelling in the area and forcing the tissues to approximate until closure is achieved.

FIG. 13 depicts one or more embodiments. A device that delivers high intensity focus ultrasound (HIFU) 130 is applied to the myocardium or other opemng in a tissue to close the opening. Examples of organs and/or tissue with which the device and method can be used include, but are not limited to heart, lungs, bronchial tubes, thyroid gland, or the larynx, stomach, bladder, liver, kidneys, GI systems including intestines, and/or bowel. In one or more

embodiments, the device and/or method can be used to temporarily close a channel or passageway through a patient so that treatment and/or or healing can occur without interference from fluids, such as bodily fluids. The device used to deliver the HIFU can include a catheter. The HIFU that is delivered by the device is in the 0.5 to 3MHz range and can be focused in a pattern to sweep across the opening and alternate the focal depth. The native collagen and/or exogenous collagen is denatured and cross-links by the focused HIFU to close the hole or channel. In another HIFU treatment, the opening may be filled or plugged with non-native or harvested, exogenous collagen. HIFU is then applied to denature both the local native collagen and the non native collagen. The two types of collagen cross-link to form a plug, which closes the opening.

Referring now to Fig. 14, one or more embodiments are illustrated. The device includes a blood sponge device forms a biodegradable plug for closing an opening in tissue such as an opening to a cardiac ventricle. Examples of organs and/or tissue with which the device and method can be used include, but are not limited to heart, lungs, bronchial tubes, thyroid gland, or the larynx, stomach, bladder, liver, kidneys, GI systems including intestines, and/or bowel. In one or more embodiments, the device and/or method can be used to temporarily close a channel or passageway through a patient so that treatment and/or or healing can occur without interference from fluids, such as bodily fluids.

The sponge device is placed in the opening and expands when it contacts blood, saline or other liquids, or heat. After surgery when an opening is ready to be closed, the surgeon places the sponge device in unclotted blood, or saline allowing the sponge to commence the expansion process. In one or more embodiments, one or more sponges are placed within the opening or channel, for example at different depths, or with different properties that affect closure rate. As the sponge is expanding, it is placed in the opening thereby closing it. The sponge is made from a biodegradable material, such as fibrin, cellular matrices, hydrogels and the like, that degrades over time as scar tissue forms around and through the sponge matrix permanently closing the opening.

FIG. 15 illustrates one or more embodiments utilizing spiral or helical sutures 150 to close a tissue opening. The spiral or helical sutures 150 can be used to close openings in a variety of organs or bodily tissue, including, but not limited to heart, lungs, bronchial tubes, thyroid gland, or the larynx, stomach, bladder, liver, kidneys, GI systems including intestines, and/or bowel. The structure distributes the force through a fuller thickness of the organ and/or tissue and provides a radial closure force through a thickness of an organ and/or tissue wall, which is significant for diseased organs, such as diseased hearts which have become friable.

A pathway is created around the tissue opening 42, which can then be filled with a material or structure, such as suture, bioabsorbable suture, or reinforced suture material, which applies forces to the tissues to close an opening. The forces close the tissue opening in multiple dimensions, in contrast to conventional techniques that attempt to close a three dimensional wound along a single plane. The pathway can be of a shape such as a helix or double helix that circumscribes the tissue opening and also covers its length. The pathway may include various patterns, such as rings or C-shape that are placed along the length of the tissue opening. The pathway can also have varying pitches, radii, or diameters along any dimension. The material or structure placed in the pathway provides the forces necessary to close the opening. In one embodiment a device can be used to form the pathways and then deliver the structure. In another embodiment the structure is designed to form its own pathway through the tissue.

In one or more embodiments, the spiral suture 150 can be activated, for example, with shape memory qualities and/or the super elastic qualities using a variety of activation measures, which can be passive or active. The activations include, but are not limited to, electrical currents, magnetic currents, heat, such as, but not limited to, body heat. The activations can be initiated and/or terminated using pre-deteraiined values or over pre-determined ranges for the activation measures.

FIG. 16 depicts another device utilizing guy- wires 160. A guy- wire, also known simply as a guy, is a tensioned cable designed to add stability to structures. One end of the cable is attached to the structure, and the other is anchored at a distance from the structure's base. They are often configured radially (equally spaced about the structure) in trios, quads (pairs of pairs) or other sets. This allows the tension of each guy- wire to offset the others. Pathways

circumferentially surrounding the tissue opening and running radially outward therefrom can be formed. The guy-wires, which may be wires, sutures or reinforced sutures, springs, and the like, are then placed in the radial pathways. The guy- wires are anchored on one side of the wall or tissue and then tensioned using a second anchor that may be adjusted along the guy- wire thereby forming an adjustable anchor that may serve to block or otherwise plug the opening.

The varying directions or diameters of the pathways aid in providing forces along directions that close the opening in multiple directions, such as radially, longitudinally or both. The adjustable anchor may also serve to block or plug the tissue opening 42 as well. In another embodiment the structure that the adjustable anchor is guided by could be that of like a zip tie and ratchet down the structure. It may also twist the structure thus closing the tissue opening 42.

FIG. 17 depicts another embodiment and includes a monorail system 170 and method for installing a prosthetic medical device in a variety of organs or bodily tissue, including, but not limited to heart, lungs, bronchial tubes, thyroid gland, or the larynx, stomach, bladder, liver, kidneys, GI systems including intestines, and/or bowel. In one or more embodiments, the method is for installing a prosthetic medical device in the heart and closing the access hole. The monorail system combines the retrograde and antegrade approaches to deliver and stabilize prosthetic device within the heart. A peripheral catheter including a catch element on the distal end thereof is introduced into the ventricle by the retrograde approach. An access puncture is made in the apex of the heart. A second catheter or wire carries the prosthetic device thereon and includes a closure element such as a plug, sponge, cap or the like located proximal to the position of the prosthetic device. The catch element on the retrograde/peripheral catheter catches or couples to the second catheter in the ventricular space. The prosthetic device can then be attached to the monorail system and maneuvered into position. The antegrade catheter is then pulled out through the femoral artery, for example, thus pulling the closure into the opening in the apex of the heart and closing the apex.

In one or more embodiments, the monorail system 170 is a peripheral catheter delivered system that connects to a needle delivered device which enters into a tissue space, such as a cardiac ventricle. The monorail attaches to the end of a catheter and clips or catches a wire or catheter that is placed through the chest wall into the ventricle. The monorail system then provides a guide through a space once attached to the outside wire, such as through any of the cardiac valves, patent foramen ovale, atrial septal defect, ventricular septal defect, or through the coronary arteries.

A prosthetic medical device such as a replacement valve, stent, valve repair system or closure device can then be attached to the monorail, and pulled through to the appropriate place without need to maneuver inside the ventricle or other living tissue space. Once the prosthetic medical device is in place, the monorail and the outside wire can be pulled out through the distal catheter placement site, such as the femoral artery. The end of the outside wire attaches to a closure device, such as a plug, sponge, cap, or suturing system, which pulls tight against the epicardial hole made by the outside delivery system, allowing for minimally invasive closure of the tissue hole.

FIG. 18 depicts one or more embodiments wherein hemostasis is provided by a delivery device including a plug 180. The plug includes a substantially concave central body portion 182 and a plurality of spider-like legs 184 extending therefrom. The spider-like legs made be of any number and may include barbs, hooks, needles or other seating or penetrating mechanisms on the tissue contacting end. The spider-like legs made be made from self-expandable memory shape material such as Nitinol. The plug is introduced into an access opening made in, for example, the apex of the heart. Upon deployment the spider legs expand radially and seat the central body portion against the inner wall of the apical opening. The substantially concave central body portion fills the opening and the blood flow 188 in the heart contacts the concave body. The pulsating blood flow is transmitted through the central portion into the spider-like legs which in turn are compressed against the wall of the myocardium creating a secure hemostasis device.

In one or more embodiments, the plug 180 provides hemostasis by applying a

perpendicular blockage and compressive force to the inner walls of a hole through an organ or tissue, such as a myocardium. The plug 180 is inserted in compressed form into a dilated hole. The plug 180 expands to fill the void with a topmost plunger face in contact with blood flow. As the heart beats the pulsating flow is transmitted through the plunger face into the legs and then feet of the plug 180. The feet drive further into the myocardium as the pressure pulses thus using the pressure to create a secure hemostasis device.

Referring now to FIG. 19, prior to piercing the ventricle apex 38 it may be necessary to precisely locate it for percutaneous procedures. In one or more embodiments, a surgeon identifies the access point to the apex of the heart. A non-invasive, catheter-delivered, magnet-guided navigation system allows a user to precisely locate the apex of the right or left ventricle. The tissue closure device can also be used to deliver the magnet, and/or apply the magnetic force. The catheter is guided through a distal vein or artery, such as the femoral artery, and is delivered using conventional catheter guidance to the apex of the right or left ventricle.

A second magnet placed on the outside of the patient's thorax identifies the location of the magnet and thus the ideal location for the minimally invasive puncture or small thoracotomy. The magnet may be a standard magnet or an electric magnet. Alternatively, an acoustical signal or radioactive pellet may be used. Those of ordinary skill in the art will appreciate that the novel systems may also be used with conventional methods of locating the apex of the heart. These methods are particularly useful for percutaneous approaches to identifying the apex. Alternatively, a marker may also be used to locate the apex of the ventricle. A marker may be placed at the tip of a catheter such that it can be maneuvered into the apex of the ventricular lumen via a retrograde approach. The marker is configured such that its location and angular orientation can be identified noninvasively. This can be accomplished in a variety of ways. In one embodiment the marker includes a radiopaque material that may be visualized by fluoroscopy. The marker may have an elongated or known geometrical shape to aid in assessing angular orientation via two-dimensional imaging modalities. In another example the imaging modality is ultrasound. The marker may be made of a material that is identifiable on an ultrasound image by using materials and/or surface configurations that vary notably in

echogenicity from surrounding tissue and structures. The marker may be configured to vary its echogenicity cyclically over time, appearing as a beacon on an ultrasound.

Alternatively, the marker may be magnetic. A magnet pole located and oriented in the lumen of the ventricle at the desired entry location (such as the apex) generates magnetic flux that may be used to attract and orient a tool containing a second magnet pole, defining a path for entry. The magnet in the lumen is, in one or more embodiments, a small permanent magnet, while the second magnet that approaches from the exterior may be a larger electromagnet. The degree of magnetic attraction may be sufficient to allow for guidance of the entry on tactile feedback alone.

In another embodiment the marker may be radioactive. The retrograde catheter may be tipped with a pellet of radioactive material with low radiation burden to the body such as

Technetium-99m. An instrument to detect the appropriate form of radiation, such as a Geiger counter, may be used to provide visual and auditory feedback indicating proximity and angular alignment with the radiation source.

In yet another embodiment the marker can emit an electromagnetic signal that may be used to determine information such as location, proximity, and angular alignment. Conversely, the marker can receive an electromagnetic reference signal that may be used to determine said information through signal processing techniques such as trilateration.

A surgical kit includes one or more of an introducer, a spring closure device, fluid delivery device, the uses and fuller descriptions of each are detailed above and/or shown in the drawings. The surgical kit can be provided with supplemental supplies such as bandages or dressings.

While the above description contains many specificities, various changes could be made without deviating from the spirit of the present invention. It is therefore desired that the present embodiment be construed as illustrative and not restrictive. Accordingly, the scope should be determined not by the embodiments illustrated, but by the appended claims and their legal equivalents.

Claims

What is claimed is:

1. A tissue access and closure device comprising: an introducer portion defining a lumen therein, the introducer configured for providing access to a bodily cavity; a tubular element coupled to said introducer portion, said tubular element including a lumen therein; and a spring closure device received on or within the tubular element.

2. The tissue access and closure device as recited in claim 1, wherein said spring closure device comprises a shape-memory material having a relaxed, contracted state and an expanded state.

3. The tissue access and closure device as recited in claim 2, wherein said spring closure device is received in said tubular element in the expanded state.

4. The tissue access and closure device as recited in claim 3, wherein said spring closure device reverts to said contracted state when released from said tubular element.

5. The tissue access and closure device as recited in any of claims 1 - 4, further comprising a plug for closing an opening associated with the bodily cavity.

6. The tissue access and closure device as recited in any of claims 1 - 5, wherein the spring closure device has a helical shape.

7. The tissue access and closure device as recited in any of claims 1 - 6, wherein the spring closure device has a double helical shape.

8. The tissue access and closure device as recited in any of claims 1 - 7, further comprising a fluid delivery device including fluid adapted to cause edema.

9. The tissue access and closure device as recited in claim 2, wherein the spring closure device comprises Nitinol.

10. A method of closing an opening in tissue, the method comprising:

introducing a tissue closure device into the opening, the tissue closure device including an introducer portion, a tubular element having a lumen therein and coupled to said introducer portion, a spring closure device received within the lumen of the tubular element;

driving the tubular element into the opening in the tissue and creating a helical path in a surface thereof;

retracting the tubular element from said opening whereby said spring closure device exits the tubular element and becomes positioned in said helical path;

allowing said spring closure device to revert to a contracted state to apply a predetermined concentric radial force on said tissue; and

closing said tissue opening.

11. The method as recited in claim 10, further comprising applying a magnetic force with the tissue closure device and locating a second magnet.

12. The method as recited in any of claims 10 - 11, further comprising delivering fluid with a fluid delivery device including fluid adapted to cause edema and close the opening.

13. The method as recited in any of claims 10 - 12, further comprising applying high intensity focused ultrasound and closing the opening.

14. The method as recited in any of claims 10 - 13, wherein introducing said tissue closure device into said opening is at a ventricular apical opening of a heart.

15. The method as recited in any of claims 10 - 13, wherein introducing said tissue closure device into said opening is at a bowel.

16. The method as recited in any of claims 10 - 13, wherein introducing said tissue closure device into said opening is at a GI system.

17. The method as recited in any of claims 10 - 16, wherein closing the tissue opening includes closing with a sponge.

18. The method as recited in any of claims 10 - 17, wherein closing the tissue opening includes closing with a plug.