Abstract:
A method and device for enabling direct visualization and access to a body organ without impeding or stopping the function of the organ is provided. The device includes a balloon catheter, having a balloon at or near its distal end, and a preferably funnel-shaped access member positioned around the catheter. In use, an incision is placed in a patient, and a path is cleared to the organ or tissue on which surgery is to be performed. The catheter is inserted into the organ and to or through the tissue requiring treatment. If the catheter moves through the tissue to be treated, the balloon is inflated to provide a seal preventing fluids from moving through the tissue. The access member is then advanced over the catheter to the tissue site, enabling the surgeon to directly see and access the tissue.

Description:
FIELD OF THE INVENTION 
     The present invention is in the field of surgical devices and methods for obtaining access to and visualizing a site where surgery or other treatment is needed. Specifically, the present invention contemplates a device and method for obtaining access to tissues within a body organ without impeding or stopping the function of that organ. 
     BACKGROUND OF THE INVENTION 
     In the field of surgery, two general methods of accessing a site within a patient&#39;s body are used. In open surgery, the patent is anesthetized, commonly with general anesthesia, and the surgeon then makes a relatively large incision in the patient. The location and size of the incision will, of course, depend on the organ or tissue to be treated, as well as the disease, injury, or other abnormality of such tissue. After the incision is made, the surgeon retracts the skin, muscle, fatty tissue, bones, or other tissue that lie between the incision and the treatment area or that otherwise hinder the surgeon&#39;s access to such area. The surgeon can then view the tissue to be treated, for example the heart, and can directly approach that tissue with surgical instruments. At this point, a surgeon may have to impede or stop the function of the organ or tissue to be treated. Most commonly, that step is necessary in order to prevent movement of the organ or tissue, or to prevent fluid flow into or out of the organ or tissue. Again using the heart as an example, open-heart surgery requires the surgeon to connect the patient&#39;s circulatory system to an external machine (a “heart-lung machine,” or in the surgeon&#39;s vernacular a “pump”), and to induce cardioplegia. With the patient&#39;s blood routed around the heart and the heart muscle itself stationary, the heart surgeon can then enter the heart and perform the necessary operation. 
     The principal advantage of such open procedures is the comparative ease of access to the organ or other tissue to be treated. The organ or other tissue is substantially exposed to operating theater conditions, providing ample light on and space around the tissue, and aid the surgeon in performing the procedure. A significant disadvantage, however, is the necessity of stopping the function of the organ or tissue. In such cases, the risks of ischemic or other damage or irritation to the organ resulting from discontinuing of the organ&#39;s function organ are substantially heightened. Additionally, there is the risk that the organ or tissue will not restart its function or will restart only partially. In heart surgery cases, for example, other risks such as the risk of emboli being introduced into the vascular system is also increased. Further, the damage to tissues that are retracted or proximate to the incision in such open surgical procedures, and their concomitant discomfort and relatively long healing term, are also disadvantages of open surgical procedures. 
     The second general method of performing internal surgery is via intravascular or percutaneous minimally-invasive procedures. Using non-invasive measures such as x-ray, ultrasound, or other techniques or procedures, it is frequently unnecessary to expose the internal tissues of patients in order to diagnose or treat medical problems. Once a disease, injury, or abnormality has been non-invasively detected, one or more small incisions are made through the patient&#39;s skin, either in the neighborhood of the problem to be treated or to gain access to a relatively large blood vessel, such as the femoral vein. Specially-developed thin and commonly flexible instruments can then be inserted into the patient through the incision, maneuvered into position and the tissues can be treated using such instruments. Some procedures may be performed by observing the motion of the instruments relative to the tissues under fluoroscopy. In other procedures, a flexible observation device or endoscope may be inserted through an incision, and a view of the tissues to be treated may be obtained through the endoscope. When the procedure is completed, the instruments are withdrawn and the small incision(s) are closed. 
     Again taking the heart as one example, in the case of minimally-invasive heart treatments, a catheter may be introduced into a blood vessel percutaneously. The catheter can then be advanced under fluoroscopic observation within the blood vessel toward and into the heart. At that point, medication may be administered, or instruments and/or implants may be advanced through the catheter and utilized within the heart. Alternatively, as indicated in U.S. Pat. No. 5,797,960, a small thoracic incision can be made, and a cannula inserted through the small incision and a substantial portion of the chest and into the heart. Minimal-diameter instruments or implants can be advanced through the cannula and into the interior of the heart for employment. 
     Such minimally-invasive techniques have several advantages. First, the organ or tissue to be treated need not be stopped or impeded in order to treat it using such procedures. Additionally, because smaller incisions are used and there is less need for retraction of tissues proximate to the incision, there is less overall trauma and scarring to the tissues involved. Thus, a significant portion of the risks associated with currently-known open surgical procedures is not present with minimally-invasive procedures. Nonetheless, there are several disadvantages to minimally-invasive procedures as well. The principal disadvantage is the lack of direct access to and visualization of the organ or tissue that requires treatment. Minimally-invasive procedures are generally not directly observable, due to the small profiles of cannulas, catheters, and incisions used in such procedures. Fluoroscopic techniques provide some indirect view of the treatment, but generally produce an image that is not very sharp or exact. Insertion of an endoscope can provide a somewhat sharper image, but such instruments have a limited field of vision and must provide light by which to see. Therefore, both the observation end and the light source must be focused relatively closely on a certain area of tissue, and may interfere with treatment of the tissue. 
     What is needed, therefore, is a device and method for minimally-invasive use in surgical procedures that allows direct access to and visualization of an organ or tissue needing treatment, but that does not require the stoppage or impedance of function of the organ or tissue. Such a device should incorporate the advantages of minimally-invasive surgery, in that it minimizes tissue trauma as well. The devices should be useful in one or more organs, but should particularly be useful in the heart, in which open surgeries necessitate stopping the heart, and in which minimally-invasive surgery may not adequately correct the problem. 
     SUMMARY OF THE INVENTION 
     The present invention contemplates an apparatus for accessing and visualizing tissue within a human heart cavity while said heart is beating, comprising a surgically sterile walled member having a perimeter wall, a distal portion and a proximal portion, with the wall member being positioned during open heart surgery within a cut opening in an outer heart wall. A substantially blood tight seal is formed between the walled member and the heart wall to prevent exsanguination therebetween. The distal portion of the walled member forms a substantially blood tight seal with an interior portion of the heart to prevent exsanguination therebetween, and the walled member and the seals providing an access to the interior of the heart within the walled member for direct surgical access to the interior heart tissue during open heart surgery while the heart is beating with blood flow through the heart and outside of said wall member. The distal and proximal portions of said perimeter wall may be substantially circular, and the walled member may be configured generally in the shape of a funnel. 
     In one embodiment, a tubular member is included having at least one lumen therethrough positioned within the walled member. The tubular member can include a balloon, such as a foam balloon that expands generally perpendicular to the tubular member to a greater degree than it expands generally parallel to the tubular member, at the distal end of the tubular member. 
     The perimeter wall may have at least one opening therethrough, which can include a port. The walled member can also include a seal member and/or at least one hook connected to said distal portion. The walled member can also be transparent. 
     In another embodiment, the invention contemplates an apparatus for accessing and visualizing a septum having a defect within a heart while said heart is beating, comprising a surgically sterile walled member having a perimeter wall including a distal portion and a proximal portion, with the walled member being positioned during open heart surgery within a cut opening in an outer heart wall with a substantially blood tight seal between the walled member and the heart wall to prevent exsanguination therebetween. The distal portion forms a substantially blood tight seal with a portion of the septum around the defect to prevent exsanguination therebetween, and the walled member and the seals provide an access to the interior of the heart within the walled member for direct surgical access to the septum and the defect during open heart surgery while the heart is beating with blood flow through the heart and outside of said walled member. Further, a catheter having at least one lumen therethrough can be positioned within the walled member. The catheter preferably includes a balloon, such as a foam balloon at the distal end of said tubular member. The catheter can be positioned through the defect and the balloon in its expanded state forms a substantially blood tight seal with the septum to prevent exsanguination therebetween. The distal portion and the balloon may press a portion of the septum therebetween to provide the seals. 
     The present invention also contemplates a method for accessing and visualizing tissue within a heart while it is beating, comprising the steps of providing a surgically sterile walled member having a perimeter wall including a distal portion and a proximal portion; positioning the walled member during open heart surgery within a cut opening in an outer heart wall with a substantially blood tight seal between the walled member and the heart wall to prevent exsanguination therebetween; and forming a substantially blood tight seal between the distal portion of the walled member and an interior portion of the heart to prevent exsanguination therebetween, thereby providing an access to the interior of the heart within the walled member for direct surgical access to the interior heart tissue during open heart surgery while the heart is beating with blood flow through the heart and outside of said wall member. The method may further include providing a tubular member having at least one lumen therethrough and a balloon at the distal end of the tubular member, with the tubular member being positioned within the walled member, and/or medically treating the interior portion of the heart to which access is provided, such as surgically repairing a defect in a septum. 
     In one embodiment, the method of the present invention includes inserting a tubular member having at least one lumen therethrough and a balloon at the distal end of the tubular member into the cut opening and through the defect, expanding the balloon, and forming a substantially blood tight seal between the balloon and the septum to prevent exsanguination therebetween. Additionally, the step of pressing the septum between the walled member and the balloon to form the substantially blood tight seals can be performed. 
     The device and method of the present invention provides the advantage of direct access to and visualization of internal tissues, particularly those inside a body organ, with a less-invasive approach than open surgery and with the advantage of avoiding the arrest of the tissue or organ to be operated on. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of one embodiment of the apparatus of the present invention. 
     FIG. 1A is a perspective view of another embodiment of the apparatus of the present invention. 
     FIG. 2 is a cut-away view of the embodiment of the invention depicted in FIG.  1 A. 
     FIG. 3 is an alternate embodiment of the device of FIG.  1 . 
     FIG. 4A is a cut-away view of a human heart, illustrating the use of the embodiment of the invention illustrated in FIG.  1 A. 
     FIG. 4B is a cut-away view of a human heart as in FIG. 4A, showing further the use of the embodiment of the invention illustrated in FIG.  1 A. 
     FIG. 4C is a cut-away view of a human heart as in FIG. 4A, further illustrating the use of the embodiment of the invention illustrated in FIG.  1 A. 
     FIG. 4D is a cut-away view of a human heart as in FIG. 4A, further depicting the use of the embodiment of the invention illustrated in FIG.  1 A. 
     FIG. 4E is a cut-away view of a human heart as in FIG. 4A, further depicting the use of the embodiment of the invention illustrated in FIG.  1 A. 
     FIG. 5 is a side view of the right atrium of the human heart, further depicting the use of the embodiment of the invention illustrated in FIG.  1 A. 
     FIG. 6A is a bottom view of an embodiment of the apparatus of the invention. 
     FIG. 6B is a cut-away view of the embodiment of the apparatus of the invention depicted in FIG.  6 A. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein, being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     Referring generally to FIGS. 1-3, there is shown an embodiment of the surgical accessing and visualizing device  20  of the present invention. Device  20  includes walled member  22 , having a perimeter wall  24  which includes a proximal portion  26  and a distal portion  28 . Proximal portion  26  defines a proximal opening  44 , and distal portion  28  defines a distal opening  48 . Walled member  22  is sized and configured to be placed through an outer organ wall, for example an outer heart wall, so that a surgeon can directly view and operate on an interior portion of the organ through the walled member. 
     In the illustrated embodiment, device  20  is generally funnel-shaped; that is, proximal portion  26  and proximal opening  44  are larger than distal portion  28  and distal opening  48 , respectively, and the inner dimension of device  20  narrows from proximal portion  26  toward distal portion  28 . The inside of device  20  is preferably completely open between proximal opening  44  and distal opening  48 . Device  20 , in cross section roughly parallel to openings  44  and  48  as illustrated in FIG. 1, is roughly circular throughout. Other configurations, such as oval, square, or a regular polygon, may also be provided. 
     Distal portion  28  is configured to form a substantially liquid-tight (e.g., blood-tight) seal with an interior portion of the organ on which the operation is to be performed (e.g., septum  70  of the heart  60  illustrated in FIGS.  4 A- 5 ). The part of distal portion  28  adjacent to distal opening  48  is preferably pressed against the interior portion to form the seal. Additionally, distal portion  28  may have a roughened surfaced to better grip and seal to the interior portion. Further, device  20  may be fitted with hooks or other fixation elements which allow it to be directly fixed to tissue. Hooks  51 , in this alternate embodiment, are attached to distal portion  46 , and may be adjacent to or within distal opening  48 . As illustrated in FIG. 3, device  20  may also include a seal member  54  fixed circumferentially around distal portion  28  of device  20 , and preferably directly adjacent to distal opening  48  of device  20 . Seal member  54  can be made of natural or synthetic rubber or other suitable ceiling material, and when device  20  is used as described below, prevents leakage of fluids, particularly liquids, into the interior of device  20  through distal opening  48 . 
     In an alternative embodiment, illustrated generally in FIG. 3, device  20  additionally includes a port  50 , which provides access to the interior of device  20 . Port  50  is tubular in the illustrated embodiment, and is preferably sized and configured for mating with standard medical or scientific tubing. Accordingly, port  50  may have a circular, oval, regularly polygonal, or other appropriate opening. Port  50  enables tubing to be connected to device  20 , so that suction may be provided, or so that liquids, gases, catheter-guided instruments, and the like may be introduced into device  20 . Port  50  may be integral with device  20 , or may be a separate piece fitted into an aperture in the side of device  20 . Port  50  may be placed in any position in device  20 . If port  50  is intended for introducing matter into device  20 , it may be advantageous to place port  50  at or near proximal portion  26  of device  20 . Conversely, if suction of fluids is desired, port  50  may be placed at or near the distal portion  28  of device  20 . 
     Additionally, in an alternate embodiment device  20  can include one or more apertures  52  in or adjacent to distal portion  28 . Apertures  52  can be used with suction or otherwise to drain fluids that accumulate inside device  20 . Also, apertures  52  may be used to allow carbon dioxide or other suitable gas from inside device  20  to diffuse into the area surrounding device  20  to prevent emboli or other dangerous or complicated medical situations. 
     Along with device  20 , a flexible and/or expandable member may be included, which is to be used in a sealing relationship with the distal portion  28  of device  20 . As used hereinafter, “flexible” is given a broad definition, and comprehends within its meaning the terms elastic, expandable and malleable. Referring generally to FIG. 2, there is shown an embodiment of the surgical accessing and visualizing device  20  of the present invention with a balloon catheter  30  placed within generally tubular visualization device  20 . 
     Balloon catheter  30 , in the illustrated embodiment, includes at least one lumen  32  through a substantial portion of the length of balloon catheter  30 . Balloon catheter  30  also includes a flexible and expandable balloon member  34  that may or may not communicate with lumen  32 . Balloon member  34 , in a particular embodiment, is placed at or near the distal end  35  of balloon catheter  30 . Balloon member  34  may be of any of a variety of constructions known in the art, such as a gas- or fluid-expandable balloon. Most preferably, balloon member  34  is a foam-filled balloon member having the rough shape of a circular disc (see FIGS. 4C and 4D) in its expanded state, and which contracts to a substantially smaller roughly circular disc (see FIG. 2) when suction is applied. Balloon catheter  30  may also include a radiopaque portion  35  to assist in its placement, as described below. 
     Balloon catheter  30 , in an alternate embodiment, includes an aperture  36  which communicates with lumen  32  of balloon catheter  30 . Lumen  32  and aperture  36  can be utilized to drain fluids from an anatomical site in which device  20  is being used. Alternately, lumen  32  and aperture  36  can be used to introduce gases, fluids, medicaments, or other agents into the anatomical site in which device  20  is being used. In an embodiment in which balloon catheter  30  includes aperture  36 , and further includes balloon member  34  which requires a fluid (liquid or gaseous) communication between balloon member  34  and a fluid source (not shown), balloon catheter  30  should include at least two lumens, one in fluid connection with aperture  36 , and one in fluid connection with balloon member  34 . 
     Surgical accessing and visualizing device  20  may be used in any surgical procedure in which it is desired to have direct access to an internal organ, or to an internal portion of an organ. Device  20  is placed through the tissue of an internal organ so that distal portion  46  and distal opening  48  are adjacent to or in contact with tissue to be surgically treated, while proximal portion  42  and proximal opening  44  remains outside the internal organ so that the surgeon can directly examine and perform the desired procedure on the desired tissue site. 
     Device  20  may be used with any hollow organ, among others, and especially with hollow organs having a relatively high volume of fluid within and/or fluid flow through the organ. Device  20  is especially useful in correcting certain diseases, injuries, malformations, or other defects of the heart, such as atrial septal defect, atrial septal aneurysm, patent foramen, and atrial myxoma. Visualizing device  20  can also be used to provide clearer visualization and access during electrophysical ablation of vascular and/or cardiac pathways, or during angioscopy procedures. 
     The general use of surgical access and visualizing device  20  is as follows with particular reference to repair of an atrial septal defect. Referring generally to FIGS. 4A-5, in which a schematic view from the top of a heart  60  is shown, heart  60  includes a right atrium  62  having a right atrium wall  64 , and a left atrium  66  having a left atrium wall  68 . Between right atrium  62  and left atrium  66 , there is a septum  70  which generally separates atria  62  and  66  into their respective separate chambers. As illustrated in FIGS. 4A-5, septum  70  is malformed in that it has an atrial septal defect  72 , which is an aperture through septum  70  that allows the abnormal flow of blood between atria  62  and  66  to occur. 
     To repair atrial septal defect  72  through use of accessing and visualizing device  20 , the patient is first anesthetized, and a mini-thoracotomy is made. It is believed that two modes of access to the heart are most preferable, those being (1) via a relatively small incision under the patient&#39;s breast, or (2) via a sternotomy. Other incision sites, however, may be used depending on the organ or problem to be treated, or on the surgeon&#39;s preference or experience. Once the incision is made, tissues are retracted as necessary in order to obtain a view of and access to the heart. 
     An incision is then made in an atrium wall, e.g., right atrium wall  64  in FIGS. 4A-4D. Through that incision, balloon catheter  30  is introduced into right atrium  62 . Stitching, such as a conventional purse-string suture  74 , may be placed around the incision and balloon catheter  30  so as to inhibit or minimize loss of blood therethrough. 
     Balloon catheter  30  is advanced through right atrium  62  and through atrial septal defect  72  and into left atrium  66 . This procedure may be performed under x-ray viewing, fluoroscopy, ultrasound, or other known ways of observing relative movement inside a closed bodily system. Balloon catheter  30  is advanced through atrial septal defect  72  to at least a position in which balloon member  34  is entirely clear of atrial septal defect  72 . Balloon member  34  is then expanded. Balloon member  34  should either be chosen to have a size and configuration after expansion to cover the entirety of atrial septal defect  72 , or should be variably expandable, and should be expanded at least to a size to completely cover atrial septal defect  72 . After expansion of balloon member  34 , balloon catheter  30  may be retracted so that balloon member  34  is in approximately fluid-tight contact with the portion of septum  70  surrounding the circumference of atrial septal defect  72 . 
     When the fluid-tight connection between balloon member  34  and septum  70  has been attained, device  20  is introduced over balloon catheter  30 . When distal portion  46  is in contact with or adjacent to right atrium wall  64 , purse-string sutures  74  are loosened. The incision surrounded by purse-string sutures  74  is then opened, distal portion  28  of device  20  is inserted through the incision, and purse-string sutures  74  are re-tightened around device  20 . Device  20  is advanced until distal portion  28  contacts septum  70  and such that distal opening  48  encircles atrial septal defect  72 , and a substantially blood-tight seal is formed between distal portion  28  and septum  70 . Device  20  may be pressed further against septum  70  to establish or improve the seal therebetween, and/or balloon member  34  of balloon catheter  30  may be further drawn toward septum  70  and distal portion  28  in order to ensure the best possible seals between balloon member  34  and septum  70 , and distal portion  46  and septum  70 . Alternatively, in the embodiment of device  20  including hooks  51  attached to distal portion  46 , as device  20  is advanced against septum  70 , hooks  51  penetrate such tissue, thereby fixing device  20  to such tissue. 
     After device  20  is in place, direct viewing of and surgical access to septum  70  is possible through openings  44  and  48  of device  20 . To repair atrial septal defect  72 , a patch  80  can be introduced into the interior of device  20 . Patch  80  may be introduced over balloon catheter  30 , or may be separately introduced into device  20  by the surgeon. Patch  80  preferably has a small hole or slit, which allows patch  80  to be introduced over balloon catheter  30  or placed around balloon catheter  30  in contact with septum  70 . After patch  80  is placed in contact with septum  70  so that it covers atrial septal defect  72 , patch  80  is attached to septum  70  (and if patch  80  includes a hole or slit therein, the hole or slit is closed by purse-string suturing or other manner), thereby repairing atrial septal defect  72 . The attachment can occur in a variety of ways, as for example by suturing, stapling, hooking, or implanting, or by other methods. Also, defect  72  may be stitched closed without a patch, as is known in the art. FIG. 4E depicts patch  80  being attached to septum  70  via sutures  82 . 
     When patch  80  is secured to septum  70 , balloon member  34  is deflated, and balloon catheter  30  and device  20  are removed, separately or simultaneously. Additional suturing or other closing or repair to patch  80  or septum  70  can be performed, if indicated. Purse-string sutures  74  are then tightened to close the incision through which access device  20  was inserted, and further sutures or other repair may be applied to atrium wall  64 . The main thoracotomy is then closed. 
     As noted above, the visualizing and access device  20  of the present invention is particularly useful in treating or repairing the interior tissues of the heart. Access to the heart from the left side (e.g., through the left atrium) can be performed using device  20  as well as access from the right side, as described above. Further, device  20  can be used in any hollow organ having inner tissues or surfaces needing surgery or other treatment. Use of balloon catheter  30  as described above is particularly preferred for visualizing and repairing an atrial septal defect, but may be unnecessary when device  20  is used to visualize and access solid or unperforated tissues. For example, device  20  could be inserted through atrial wall  64  and a seal formed between atrial wall  64  and device  20  as described above, and distal portion  28  of device  20  could be placed and/or pressed in contact with solid or unperforated tissue. The seal formed between distal portion  28  and such solid or unperforated tissue would be sufficient to prevent or minimize exsanguination, since no perforation or defect would allow fluid into device  20 . 
     Device  20  is preferably made of a sturdy plastic or metal, although other natural or synthetic materials could be used. Device  20  may be generally in the range of 3-5 centimeters in height (i.e., between proximal opening  44  and distal opening  48 ). The diameter of proximal opening  44  and distal opening  48  may be approximately 5-10 centimeters and 2-5 centimeters, respectively. Differing sizes of device  20 , both in height and in the diameters of openings  44  and  48 , are contemplated so that device  20  is well-suited to a patient&#39;s particular anatomy and problem to be corrected. For example, a child may require a device  20  which is smaller in height than a device  20  intended for an adult, and a patient having a smaller area of tissue to be visualized should receive a device  20  having a smaller distal opening  48 . 
     Balloon catheter  30 , as noted above, may be any of a number of known balloon catheters, or may be one specifically designed for use with device  20 . Specifically, a foam balloon catheter, in which the foam is in an expanded state without external force being applied to it, and may be contracted through the application of suction or vacuum, is preferred. Further, the balloon member  34  preferably expands and contracts substantially in a plane perpendicular to balloon catheter  30 . A balloon catheter that is currently preferred for use with device  20  is the foam balloon catheter manufactured by Bavona Corporation, model number 800-160, part number 800-165. 
     Flexible members other than balloon member  34  are also contemplated in the present invention, used either with or without a catheter. For example, a flexible member in the shape of a disc or shield may be deployed on the left atrial side of septum  70 . Such a flexible member may be held against septum  70  to cover defect  72  in any of a variety of ways, such as by suction, adhesive or piercing fixation, or by pressing or holding against septum  70  using an implement. Further, the flexible member can have any of a number of two-dimensional or three-dimensional configurations so long as it covers defect  72 , and can be made of any of a variety of materials, such as plastic, natural or synthetic rubber, nitinol or other shape-memory materials, or other appropriate substances. Introduction of the flexible member can occur in a number of ways, including direct placement or introduction via a catheter or other tubular member. 
     In another alternative embodiment of device  20  illustrated in FIGS. 6A and 6B, patch  80  may be removably attached to device  20 . Patch  80  may be attached to the inside or outside of distal portion  46  of tubular access member  40 , and patch  80  should cover distal opening  48 . Patch  80  may be attached to device  20  by adhesives or other known methods, and may include perforations to enable patch  80  to be easily detached from device  20 . In use, device  20  with attached patch  80  is placed in the organ, e.g., the heart, as described above. After access device  20  is in place, stitches may be placed through patch  80  and into septum  70  to close atrial septal defect  72 . Then patch  80  may be detached from tubular access member  40  by trimming with a scalpel or other appropriate cutting object, or by detaching at perforations if patch  80  is so equipped. Device  20  is then withdrawn and the surgery concluded, as described above. 
     While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.