Abstract:
The present invention discloses a system and method for providing sealable access to a viscus region or hollow organ and performing surgical procedures therein. The present invention is particularly useful in providing access to a patients heart without arresting the heart. The access system comprises a tissue stabilizer to provide a stable work area in a dynamic environment. A puncture device is inserted into the tissue stabilizer, which forms a puncture hole within the heart tissue. Thereafter, a sealing device, for example a sealing balloon, is inserted through the puncture hole and engages the interior tissue. A sealing cannula may then be advanced into and sealably engages the tissue.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    Presently, a variety of surgical procedures require the insertion of surgical devices into an arterial or venous vessel, a viscus region, or alternatively, into the heart of a patient. These procedures include diagnostic procedures, radiological procedures, coronary and peripheral angioplasties, thorascopic, laparoscopic, or endoscopic surgeries. Generally, these procedures require accessing the area of interest, forming an incision through the exterior wall of a body vessel or organ, and inserting an implement, commonly a trocar or other catheter-like surgical device, through the opening. Considerable care must be exercised during the insertion process to avoid introducing air into the viscus region, blood vessel, or heart. Furthermore, the quantity of blood loss through the incision should be limited.  
           [0002]    Commonly, cannula devices are used to avoid the risk of air embolism and limit blood loss through the incision, while providing access into the blood vessel or organ. Typically, an incision closing device, for example a purse string suture, is applied to the tissue surrounding the incision. Thereafter, the cannula is inserted into the incision and the incision closing device is used to sealably engage the cannula. The above disclosed insertion method may result in the unwanted application of pressure to the incision area and could result in damage to the tissue located within the blood vessel or body organ.  
           [0003]    Current cannula devices encounter additional problems in surgeries involving a beating heart. For example, there is an increased risk of damage to the beating heart during the insertion of the cannula. Generally, the heart is comprised of four chambers separated by artrio-ventricular valves. The insertion process disclosed above may result in compressive force being applied to the heart, thereby causing a disruption in normal circulatory function. Of equal concern is an increased risk of damaging the internal tissues and valves of the beating heart. Additionally, the internal pressure exerted during a cardiac cycle commonly results in chronic seepage or leakage at the incision-cannula interface.  
           [0004]    While excessive bleeding is common with a person having a normal blood-clotting response, this problem is magnified in persons utilizing anticoagulation medication. These medications are commonly prescribed to persons suffering from some forms of heart disease, for example, hypertension. As such, an interventional surgical procedure may be required should these medications fails to adequately address the patient&#39;s heart condition.  
           [0005]    Thus, there is a need for a cannula system for use on viscus regions and hollow organs of a body. Furthermore, the system would be capable of attaching to a beating heart or other vessel or organ and provide a stable working environment on a dynamic organ, while reducing the blood loss through and around the cannula.  
         BRIEF SUMMARY OF THE INVENTION  
         [0006]    The present invention solves the problem of gaining access to a viscus region or hollow organ of a patient while limiting excess blood loss through the access incision. Additionally, the present invention reduces or eliminates the likelihood of damage to the internal components of the organ during cannula insertion. The present invention is particularly well suited for procedures involving the heart. More particularly, the present invention permits access to the internal region of the heart without requiring the heart to be arrested. Additionally, the present invention permits remote cannulization of a hollow organ or viscus region.  
           [0007]    In one aspect, the present invention provides an access system comprising a tissue stabilizer capable of attachment to the viscus region or hollow organ, and a sealing cannula. A puncture device is inserted into the tissue stabilizer and forms a puncture hole in the tissue. Thereafter a sealing device is inserted into the tissue stabilizer and sealably engages the tissue around the puncture hole. A cutting trocar may then introduced into the puncture hole to enlarge the orifice to receive the sealing cannula. A sealing cannula is inserted into the orifice and a purse string suture is applied, thereby sealing the cannula/tissue interface.  
           [0008]    In another aspect of the present invention, a tissue stabilizer is disclosed herein. The tissue stabilizer comprises a central lumen in communication with a receiving flange and an attachment flange having a vacuum port positioned thereon. The vacuum port is in communication with a vacuum chamber located within the attachment flange. In an alternate embodiment a purse string template is positioned on the attachment flange.  
           [0009]    In yet another embodiment, the present invention discloses a sealing cannula having a device body in communication with a device lumen. The device body comprises a sealing washer and a guide member positioned within a receiving lumen, and a sealing member in communication with said receiving lumen and the device lumen.  
           [0010]    The present invention also discloses a method of providing access to a viscus region or hollow organ. Other objects and further features of the present invention will become apparent from the following description when read in conjunction with the attached drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    [0011]FIG. 1 a  is an operational flowchart of the various components of the sealing viscus access system;  
         [0012]    [0012]FIG. 1 b  is an alternate operational flowchart of various components of the sealing viscus access system;  
         [0013]    [0013]FIG. 2 a  is a cross sectional view of an embodiment of the tissue stabilizer of the present invention;  
         [0014]    [0014]FIG. 2 b  is a perspective view of an embodiment of the tissue stabilizer of the present invention;  
         [0015]    [0015]FIG. 3 is cross sectional view of the needle guide of the present invention;  
         [0016]    [0016]FIG. 4 is a cross sectional view of the tissue stabilizer of the present invention having a puncture device and a obturator positioned therein;  
         [0017]    [0017]FIG. 5 is a cross sectional view of the tissue stabilizer or the present invention having a removable dilator and a sealing device positioned therein;  
         [0018]    [0018]FIG. 6 is a cross sectional view of the cutting trocar or the present invention;  
         [0019]    [0019]FIG. 7 is a perspective view of the sealing cannula of the present invention;  
         [0020]    [0020]FIG. 8 a  is a cross sectional view of the sealing cannula of the present invention;  
         [0021]    [0021]FIG. 8 b  is an exploded view of the sealing cannula of the present invention;  
         [0022]    [0022]FIG. 9 a  is a side view of the tissue stabilizer of the present invention attached to tissue;  
         [0023]    [0023]FIG. 9 b  is a side view of the tissue stabilizer of the present invention attached to tissue and having a needle guide positioned therein;  
         [0024]    [0024]FIG. 9 c  is a side view of the tissue stabilizer of the present invention attached to tissue and having a needle guide positioned containing an obturator and a puncture device positioned therein;  
         [0025]    [0025]FIG. 9 d  is a side view of the tissue stabilizer of the present invention attached to tissue and having a needle guide positioned containing an obturator and a puncture device puncturing the tissue;  
         [0026]    [0026]FIG. 9 e  is a side view of the tissue stabilizer of the present invention attached to tissue and having a puncture device positioned therein;  
         [0027]    [0027]FIG. 9 f  is a side view of the tissue stabilizer of the present invention attached to tissue and having a removable dilator and a puncture device positioned therein;  
         [0028]    [0028]FIG. 9 g  is a side view of the tissue stabilizer of the present invention attached to tissue and having a removable dilator and a sealing device positioned therein;  
         [0029]    [0029]FIG. 9 h  is a side view of the tissue stabilizer of the present invention attached to tissue and having a sealing device positioned thereon;  
         [0030]    [0030]FIG. 9 i  is a side view of the tissue stabilizer of the present invention attached to tissue and having a sealing cannula containing a cutting trocar positioned thereon;  
         [0031]    [0031]FIG. 9 j  is a side view of the sealing cannula of the present invention having a cutting trocar and sealing device positioned thereon; and  
         [0032]    [0032]FIG. 9 k  is a side view of the sealable cannula of the present invention attached to tissue.  
         [0033]    [0033]FIG. 10 a  shows an alternate method of accessing a viscus region or hollow organ wherein a puncture device is inserted into tissue;  
         [0034]    [0034]FIG. 10 b  shows an alternate method of accessing a viscus region or hollow organ wherein a cutting trocar positioned within a sealing cannula is advanced on a puncture device is inserted into tissue;  
         [0035]    [0035]FIG. 10 a  shows an alternate method of accessing a viscus region or hollow organ wherein the cutting trocar positioned within a sealing cannula is engaging tissue; and  
         [0036]    [0036]FIG. 10 a  shows an alternate method of accessing a viscus region or hollow organ wherein the sealing cannula is sealably positioned on tissue. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0037]    Disclosed herein is a description of various illustrated embodiments of the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The section titles and overall organization of the present description are for the purpose of convenience only and are not intended to limit the present invention.  
         [0038]    The viscus access system of the present invention is generally used in surgical procedures to permit the introduction of surgical devices or implements while limiting patient blood loss. More specifically, the present invention is used to form an access point within a hollow organ or viscus body. For example, the present invention is particularly useful in providing sealed access to a heart without requiring the heart to be arrested. As those skilled in the art will appreciate, the present invention may be utilized as a system or, in the alternative, individual elements of the system may be utilized separately as desired. It is anticipated as being within the scope of the present invention to produce an access system capable of functionally attaching to a plurality of organs within a body.  
         [0039]    [0039]FIG. 1 a  shows an operational use flow chart of the viscus access system having a tissue stabilizer  10 , a needle guide  12 , a puncture device  14 , an obturator  16 , a removable dilator  18 , a deployable sealing device  20 , a cutting trocar  22 , and a sealing cannula  24 . For clarity the individual elements of the present invention will be presented individually. It should be understood the present invention may be utilized in various procedures to sealably access hollow organs within a body, and to provide a device for introducing various surgical implements therein. As such, the flow chart presented in FIG. 1 a  provides one embodiment of use, and is not intended to be limiting. For example, an alternate operational use flow chart is presented in FIG. 1 b.  As shown in FIG. 1 b,  the system may comprise a puncture device  14 , a cutting trocar  22 , and a sealing cannula  24   
         [0040]    [0040]FIGS. 2 a  and  2   b  show the tissue stabilizer  10  of the present invention having a central lumen  26  positioned between a receiving flange  28  and an attachment flange  30 . A vacuum port  32  is positioned on the attachment flange  30  and is in communication with a vacuum chamber  34  located within the attachment flange  30 . As shown in FIG. 2 a,  the present embodiment may further comprise vanes  36  located within the vacuum chamber  34  to prevent tissue from collapsing into the vacuum port  32 . The tissue stabilizer  10  may include a purse string template  38  located radially about the attachment flange  30 , thereby aiding the surgeon in applying a purse string suture or other wound closing mechanism to the area. FIG. 2 b  shows a perspective view of the tissue stabilizer  10  without having a purse string template  38  disposed thereon. As those skilled in the art will appreciate, the present invention may be manufactured from a plurality of materials including, without limitation, biologically compatible metal, plastics, or elastomers.  
         [0041]    [0041]FIG. 3 shows the needle guide  12  of the present invention having an insertion stop  40  attached to a guide body  42  defining a guide lumen  44  terminating in a receiving aperture  46  formed on the insertion stop  40 . The needle guide  12  may be inserted into and sealably engage the receiving flange  28  of the tissue stabilizer  10 . Those skilled in the art will appreciate the needle guide  12  may be manufactured from a plurality of materials including, for example, biologically compatible elastomers or polymers.  
         [0042]    [0042]FIG. 4 shows the puncture device  14  located within an obturator  16  sealably engaging the needle guide  12  positioned within the tissue stabilizer  10 . The puncture device  14  and obturator  16  puncture the tissue and enlarge the puncture site to permit the introduction of other devices. The puncture device  14  may comprise a plurality of tissue puncturing devices including, for example, a needle or a guidewire. The obturator  16  may be utilized to enlarge the puncture site formed in the tissue by the puncture device  14 . The obturator  16  may be manufactured from a plurality of materials, including, for example, biologically compatible metals, plastic or elastomers. In an alternate embodiment, the puncture site is created and enlarged with a single device, for example, a large bore needle.  
         [0043]    [0043]FIG. 5 shows a removable dilator  18  and sealing device  20  positioned within the central lumen  26  of the tissue stabilizer  10 . The removable dilator  18  may comprise a plurality of devices including, for example, a peel-away dilator. The sealing device  20  comprises a transfer lumen  48  proximally terminating in an inflation device  50  and distally terminating in a sealing balloon  52 . A plurality of inflation devices may be utilized to inflate the sealing balloon  52 , including, for example, a syringe containing a biologically inert fluid such as saline.  
         [0044]    [0044]FIG. 6 shows the cutting trocar  22  of the present invention having an elongated body  54  defining a device lumen  56  therein. The proximal portion of the device lumen  56  terminates in a insertion inlet  58  and the distal portion terminated in insertion outlet  60 . The distal portion of the cutting trocar  22  comprises a tissue cutting head  62 . At least one cutting member is positioned on the cutting head  62 . As shown in FIG. 6, the cutting head  62  of the present embodiment comprises three cutting members  64   a,    64   b,  and  64   c,  positioned radially thereon. The cutting trocar  22  of the present invention may be manufactured from a plurality of materials, including, for example, biologically compatible metals, plastics, or elastomers. In addition, the cutting trocar  22  of the present invention may be manufactured in a plurality of sizes to accommodate various hollow organs and viscus members of the body.  
         [0045]    [0045]FIG. 7 shows the exterior sealing cannula of the present invention. As shown in FIG. 7, the sealing cannula  24  comprises an upper cannula body  66  attached to a lower cannula body  68  having a device channel  70  connected thereto. A tissue-engaging channel  72  is located near the distal portion of the device channel  70 . The present invention may be manufactured from a plurality of materials or combinations of materials, including, elastomer, silicon, reinforced plastic, various plastic resins, and various metals. For example, the sealing components of the device may be manufactured from a flexible elastomer while the exterior structures may be manufactured from reinforced plastics.  
         [0046]    [0046]FIGS. 8 a  and  8   b  show the internal components of the sealing cannula  24 . As shown in FIG. 8 a,  the sealing cannula  24  comprises a cannula cap  74  having an access orifice  76  formed thereon positioned on the upper cannula body  66 . The cannula cap  74  may be attachable to the upper cannula body  66  in a variety of ways, including for example, in snap fit, screw relation, or adhesively joined. An o-ring  78  and sealing washer  80  defining a washer orifice  82  are positioned proximal the cannula cap  74 , and act as a sealing conduit between the cannula cap  74  and the guide member lumen  86  formed in the guide member  84 . The guide member  84  is attached to the upper cannula body  66  in screw-like fashion. In alternative embodiments, the guide member  84  may be attached to the upper cannula body  66  in slip-fit relation, snap-fit relation, or other manners known in the art. As shown in FIG. 8, the guide member lumen  86  is tapered. In another embodiment the walls of the guide member  84  forming the guide member lumen  86  maybe substantially parallel. FIG. 8 b  shows an exploded view of the sealing cannula  24 .  
         [0047]    The present invention further comprises a sealing member  88  located within the lower cannula body  68  and in communication with the guide member lumen  86  and the device channel  94 . The sealing member  88  prevents a backflow of blood or other material from entering the cannula. As shown, the sealing member  88  comprises a duckbill seal  90  having at least two sealing leafs  90   a  and  90   b  forming a sealing receiver  92 . In alternative embodiments, various sealing devices may be incorporated into the sealing cannula  24 , including, for example, sealing irises and flapper valve devices.  
         [0048]    Those skilled in the art will appreciate the degree of adaptability and servicability of the present invention. For example, the sealing cannula  24  may be easily adapted to sealably engage devices having various diameters. To adapt or service the device  24  the operator may remove one or all of following: the cannula cap  74 , the o-ring  78 , the sealing washer  80 , the guide member  84 , and the sealing member  88 . The operator may then install new components having a larger or small internal apertures and reassemble the device. For example, the operator may replace a sealing washer  80  with another sealing washer  80  having a smaller washer orifice  82 .  
         [0049]    The present invention also teaches a method of using the sealing viscus access system to provide sealed access to a viscus body or hollow organ during a surgical procedure. FIGS. 9 a - 9 K show one method of using the present invention to gain access to a viscus body, and should not be construed as limiting.  
         [0050]    To utilize the present invention the operator gains access to the viscus body or hollow organ. For example, in procedures involving the heart, one approach to the heart requires the patient be positioned for a left anterolateral thoracotomy. An incision is made in the patient&#39;s chest and the chest is entered through the bed of the respected fifth rib. The pericardium is incised posterior and parallel to the left phrenic nerve, such that the incision extends from the left pulmonary artery to the apex of the left ventricle. As shown in FIG. 9 a,  the tissue stabilizer  10  having a vacuum conduit in communication with the vacuum port  32  located thereon is positioned proximate the area of interest such that the attachment flange  30  of the tissue stabilizer  10  engages the tissue portion  96 . As shown in FIG. 9 b,  the needle guide  12  is positioned on and sealably engages the tissue stabilizer  10 . Thereafter, an external vacuum source (not shown) in communication with the vacuum conduit  98  is activated. The vacuum force is applied through the vacuum chamber  34  to the tissue portion  96 , resulting in the tissue stabilizer  10  attaching to the tissue portion  96 . In an alternate embodiment, a second independent vacuum source is in communication with the central lumen  26 , thereby increasing the vacuum force applied to the tissue portion  96 . As shown in FIG. 9 b,  a purse string suture  100  may then be applied to the tissue portion  96  through the suture template  38 .  
         [0051]    [0051]FIG. 9 c  shows an obturator  16  containing a puncture device  14  inserted through the receiving aperture  46  of the needle guide  12  and positioned within the central lumen  26  of the tissue stabilizer  10 . The distal portions of the puncture device  14  and obturator  16  are advanced to a position proximate the tissue portion  96 . Referencing FIG. 9 d,  the distal portion of the puncture device  14  is manually advanced through the central lumen  28  and punctures the tissue portion  96 , thereby entering the viscus region  102 . Thereafter, the distal portion of the obturator  16  is advanced into the viscus region, thereby enlarging the puncture hole. The needle guide  12  and obturator  16  may then be removed. FIG. 9 e  shows the puncture device  14  positioned within the tissue stabilizer  10 .  
         [0052]    Referencing FIG. 9 f,  a removable dilator  18  is positioned over the puncture device and advanced through the central lumen  26  of the tissue stabilizer  10 , entering the viscus region through the puncture hole. Thereafter the puncture device  14  is removed from the tissue stabilizer  10 .  
         [0053]    As shown in  9   g,  the deployable sealing device  20  is inserted into the removable dilator  18  and the sealing balloon  52  of the sealing device  20  is advanced through the removable dilator  18  entering the viscus region. As FIG. 9 g  shows, the inflation device  50  is actuated causing the sealing balloon  52  to inflate and sealably engage the tissue portion  96  within the viscus region. As shown in FIG. 9 h,  the removable dilator  18  may then be removed leaving the sealing device positioned within the tissue stabilizer  10 .  
         [0054]    As shown in FIG. 9 i,  the cutting trocar  22  has been inserted through the sealing cannula  24  such that the trocar insertion outlet  60  emerges from the device outlet  95  formed in the sealing cannula  24 . As shown in FIG. 9 i,  the sealing cannula  24  containing the cutting trocar  22  is advanced along the transfer lumen  48  of the sealing device  20 , and is progressed through the central lumen  26  of the tissue stabilizer  10 . FIG. 9 j  shows the blunt end  60  of the trocar engaging and displacing the balloon  52 . The cutting head  62 , which is disposed on the distal portion of the cutting trocar  22 , engages and advances through the tissue portion  96 , resulting in the tissue portion  96  engaging the tissue engaging channel  72  formed on the distal portion of the sealing cannula  24 . As shown in FIG. 9 j,  the vacuum force applied to the tissue stabilizer  10  is terminated and the purse string suture  100  is tightened about the tissue engaging channel  72  of the sealing cannula  24 . As shown in FIG. 9 k,  the cutting trocar  22  and sealing device  20  are removed from the sealing cannula  24 .  
         [0055]    An alternate method of accessing a viscus region or hollow organ is illustrated in FIGS. 10 a - 10   d.  In this alternate embodiment, the reference numerals  14 ,  22 ,  24 ,  62 ,  72 ,  95 ,  96 , and  100  have analogous meanings to the reference numerals identifying the features of the previous embodiment. As with the previous embodiment, access to the area of interest is gained in accordance with methods generally known in the art. As shown in FIG. 10 a,  a puncture closing mechanism, for example a purse string suture  100 , is applied to the tissue  96 . The distal portion of the puncture device  14  is advanced through the tissue  96 , thereby forming a puncture hole. The cutting trocar  22  is inserted through the sealing cannula  24  such that the trocar insertion outlet  62  emerges from the device outlet  95  formed in the sealing cannula  24 . As shown in FIG. 10 b,  the sealing cannula  24  containing the cutting trocar  22  is advanced along the puncture device  14 . As shown in FIG. 10 c,  the cutting head  62 , which is disposed on the distal portion of the cutting trocar  22 , engages and advances through the tissue portion  96 , resulting in the tissue portion  96  engaging the tissue engaging channel  72  formed on the distal portion of the sealing cannula  24 . FIG. 10 d  shows the purse string suture tightened around the tissue enagging channel  72 , after the cutting trocar  22  and puncture device  14  have been withdrawn.  
         [0056]    In closing it is understood that the embodiments of the invention disclosed herein are illustrative of the principles of the invention. Other modifications may be employed which are within the scope of the invention; thus, by way of example but not of limitation, alternative sealing devices, alternative cutting devices, and alternative sealing members included within the sealing cannula  24 . Accordingly, the present invention is not limited to that precisely as shown and described in the present invention.