Abstract:
A surgical device includes a tubular member, a ring made of flexible material, a resilient membrane, and a pusher member. The ring is disposed in a collapsed insertion configuration inside the tubular member and has an expanded configuration surrounding or defining an aperture, the resilient membrane being connected to the ring along an entire circumference thereof so that the membrane is at least coextensive with the aperture, thereby closing or blocking the aperture. The membrane is also disposed in a folded configuration inside the tubular member. The pusher member extends into the tubular member from a proximal end thereof for ejecting the collapsed ring and the folded membrane from a distal end of the tubular member. The ring has internal spring forces or stresses tending to open the ring from the collapsed insertion configuration to the expanded configuration upon an ejection of the ring from the tubular member.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims the benefit of U.S. Provisional Patent Application No. 60/837,867 filed Aug. 15, 2007. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     This invention relates to medical procedures carried out without the formation of an incision in a skin surface of the patient.  
         [0003]     Such procedures are described in U.S. Pat. Nos. 5,297,536 and 5,458,131.  
         [0004]     As described in those patents, a method for use in intra-abdominal surgery comprises the steps of (a) inserting an incising instrument with an elongate shaft through a natural body opening into a natural body cavity of a patient, (b) manipulating the incising instrument from outside the patient to form a perforation in an internal wall of the natural internal body cavity, and (c) inserting a distal end of an elongate surgical instrument through the natural body opening, the natural body cavity and the perforation into an abdominal cavity of the patient upon formation of the perforation. Further steps of the method include (d) inserting a distal end of an endoscope into the abdominal cavity, (e) operating the surgical instrument to perform a surgical operation on an organ in the abdominal cavity, (f) viewing the surgical operation via the endoscope, (g) withdrawing the surgical instrument and the endoscope from the abdominal cavity upon completion of the surgical operation, and (h) closing the perforation.  
         [0005]     Visual feedback may be obtained as to position of a distal end of the incising instrument prior to the manipulating thereof to form the perforation. That visual feedback may be obtained via the endoscope or, alternatively, via radiographic or X-ray equipment.  
         [0006]     The abdominal cavity may be insulated prior to the insertion of the distal end of the endoscope into the abdominal cavity. Insufflation may be implemented via a Veress needle inserted through the abdominal wall or through another perforation in the internal wall of the natural body cavity. That other perforation is formed by the Veress needle itself. U.S. Pat. No. 5,209,721 discloses a Veress needle that utilizes ultrasound to detect the presence of an organ along an inner surface of the abdominal wall.  
         [0007]     A method in accordance with the disclosures of U.S. Pat. Nos. 5,297,536 and 5,458,131 comprises the steps of (i) inserting an endoscope through a natural body opening into a natural body cavity of a patient, (ii) inserting an endoscopic type incising instrument through the natural body opening into the natural body cavity, (iii) manipulating the incising instrument from outside the patient to form a perforation in an internal wall of the natural internal body cavity, (iv) moving a distal end of the endoscope through the perforation, (v) using the endoscope to visually inspect internal body tissues in an abdominal cavity of the patient, (vi) inserting a distal end of an elongate surgical instrument into the abdominal cavity of the patient, (vii) executing a surgical operation on the internal body tissues by manipulating the surgical instrument from outside the patient, (viii) upon completion of the surgical operation, withdrawing the surgical instrument and the endoscope from the abdominal cavity, (ix) closing the perforation, and (x) withdrawing the endoscope from the natural body cavity.  
         [0008]     The surgical procedures of U.S. Pat. Nos. 5,297,536 and 5,458,131 reduce trauma to the individual even more than laparoscopic procedures. Hospital convalescence stays are even shorter. There are some potential problems with the procedures, such as the difficulty in forming a fluid tight closure of the perforation formed in the wall of the hollow internal body organ.  
       OBJECTS OF THE INVENTION  
       [0009]     It is an object of the present invention to provide improvements on the afore-described surgical procedures.  
         [0010]     It is a more specific object of the present invention to provide a method for closing a perforation or opening in an organ wall, particularly where the organ wall is located in the abdominal cavity or other body space.  
         [0011]     A further object of the present invention is to provide a device and/or a surgical kit useful in performing the closure method.  
         [0012]     These and other objects of the present invention will be apparent from the drawings and detailed descriptions herein. While every object of the invention is believed to be attained in at least one embodiment of the invention, there is not necessarily any single embodiment that achieves all of the objects of the invention.  
       SUMMARY OF THE INVENTION  
       [0013]     A surgical closure kit in accordance with the present invention comprises a body member with an elastic membrane attached thereto, a tubular member, a pusher member, and an at least partially solid membrane deformation element engageable with the membrane and disposable together with the body member and the membrane in a patient for deforming the membrane from a relaxed configuration to an expanded configuration and for maintaining the membrane in the expanded configuration. The body member with the membrane is initially disposed (at the onset of a surgical closure procedure) in a collapsed or folded configuration inside the tubular member. The pusher member is insertable into the tubular member for ejecting the body member together with the membrane from the tubular member.  
         [0014]     Pursuant to further features of the present invention, the body member is a ring and the membrane is a sheet or film member connected at a periphery about an entire circumferential extent of the ring, an elongate tubular deployment member is provided for advancing the deformation element inside a patient to a surgical site, and the membrane deformation element is taken from a group consisting of a wire, a foam composition, a balloon, and liposuction material.  
         [0015]     A more specific embodiment of a surgical closure kit comprises, in accordance with the present invention, (a) a flexible ring with a membrane attached thereto about an entire circumferential extent of the ring, and (b) a tubular member. The ring and the membrane are disposed in a collapsed or folded configuration inside the tubular member. The ring has internal spring forces or stresses tending to open the ring from the collapsed or folded configuration to an expanded configuration upon an ejection of the ring and the membrane from the tubular member. The surgical closure kit further comprises (c) a pusher member insertable into the tubular member for ejecting the ring together with the membrane from the tubular member, and (d) a membrane deformation element engageable with the membrane for deforming the membrane from a relaxed configuration substantially coplanar with the expanded configuration of the ring to a mushroom-head configuration substantially displaced from a plane of the expanded configuration of the ring.  
         [0016]     Concomitantly, a surgical device in accordance with the present invention comprises (i) a tubular member, a ring made of flexible material, the ring being disposed in a collapsed insertion configuration inside the tubular member, the ring having an expanded configuration surrounding or defining an aperture, (ii) a resilient membrane connected to the ring along an entire circumference thereof so that the membrane is at least coextensive with the aperture, thereby closing or blocking the aperture, the membrane being disposed in a folded configuration inside the tubular member, and (iii) a pusher member extending into the tubular member from a proximal end thereof for ejecting the collapsed ring and the folded membrane from a distal end of the tubular member, the ring having internal spring forces or stresses tending to open the ring from the collapsed insertion configuration to the expanded configuration upon an ejection of the ring from the tubular member.  
         [0017]     The membrane deformation elements may be a wire, a foam composition, liposuction material, a balloon, etc.  
         [0018]     Pursuant to another feature of the present invention, the ring is provided with at least one pressure sensor for measuring mucosal pressure upon installation of the ring and expansion or deformation of the membrane. Also, the ring and/or the membrane may be provided with a growth factor taken from the group consisting of angiogenesis factors, mucosal implants, mucosal stimulation factors, gene therapy factors, and ox fascia.  
         [0019]     A surgical closure method in accordance with the present invention comprises (1) inserting a distal end of a tubular member into a patient, (2) thereafter ejecting from a distal end of the tubular member a flexible ring with a membrane attached thereto about an entire circumferential extent of the ring, (3) thereafter expanding or unfolding the ring from a collapsed or folded configuration to an expanded substantially planar configuration, (4) positioning the expanded ring against a wall of an internal organ of the patient about a hole in the organ wall so that the membrane covers the hole, and (5) pressing the membrane to deform the membrane from a relaxed configuration substantially coplanar with the expanded configuration of the ring to a mushroom-head configuration substantially displaced from a plane of the expanded configuration of the ring, thereby sandwiching, between the ring and the deformed membrane, a portion of the organ wall about the hole, closing and sealing the hole.  
         [0020]     The pressing of the membrane includes inserting a deformation element into the patient and placing the deformation element in contact with the membrane.  
         [0021]     The membrane deformation element may be a wire. In that case, the wire may be connected at a distal end to the ring. Pushing the wire at a proximal end thereof causes the wire to deform or bend upon encountering a resistance offered by the membrane. Continuous pushing of the wire causes the wire to curl in a tangled ball and push the membrane into a ballooned or mushroom configuration, with a rim of organ wall along the opening being sandwiched between the expanded membrane and the ring. The wire is preferably introduced into the patient through a catheter, so that bending of the wire occurs only at the membrane and not along an insertion path of the instrumentation.  
         [0022]     The membrane deformation element may alternatively take the form of a foam composition. The foam composition should not only be biocompatible, but also impervious to a low acid environment where the opening to be closed is in a gastric wall. In addition, the foam composition may be quick hardening, in which case injection pressure of the foam may be sufficient to expand the membrane and hold the membrane in the deformed bulbous or mushroom head shape. Alternatively, a balloon may be provided for temporarily deforming the membrane to facilitate a filling of the deformed membrane with the foam composition. In that event, upon expansion of the balloon to push against the membrane, the foam is ejected behind the expanded balloon, that is between the balloon and the membrane. The balloon is deflated as the foam is dispensed, so that the foam takes the place of the balloon.  
         [0023]     The membrane deformation element may be liposuction material. Preferably, the liposuction material is harvested from the patient prior to implantation of the ring and membrane.  
         [0024]     Where the ring is provided with at least one pressure sensor, the method further comprises operating the sensor to measure mucosal pressure upon installation of the expanded ring and expansion or deformation of the membrane. The pressure feedback is used to ensure that the gripping of the organ wall between the expanded membrane and the ring is sufficiently tight to seal the hole or opening in the organ wall, but not so tight as to cause tissue necrosis.  
         [0025]     As indicated above, the ring and/or the membrane may be provided with a growth factor taken from the group consisting of angiogenesis factors, mucosal implants, mucosal stimulation factors, gene therapy factors, and ox fascia. More generally, a surgical device may comprise an implantable body having at least one surface disposable in contact with internal tissues of a patient upon implantation of the body, at least part of the body being provided with a growth factor taken from the group consisting of angiogenesis factors, mucosal implants, mucosal stimulation factors, gene therapy factors, and ox fascia. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0026]      FIG. 1  is a top plan view of a surgical closure device in accordance with the present invention.  
         [0027]      FIG. 2  is a cross-sectional view, on a slightly larger scale, taken along line II-II in  FIG. 1 .  
         [0028]      FIG. 3  is a schematic longitudinal cross-sectional view, on a substantially enlarged scale, of a deployment tube carrying the device of  FIGS. 1 and 2  in a collapsed configuration.  
         [0029]      FIG. 4  is a schematic cross-sectional view of the surgical closure device of  FIGS. 1 and 2 , showing the device in a deformed and filled use configuration.  
         [0030]      FIG. 5  is a schematic side elevational view of a deployment tube for dispensing a membrane deformation agent against or into the surgical device of  FIGS. 1 and 2 .  
         [0031]      FIGS. 6A-6E  are schematic cross-sectional views of a stomach, showing successive steps in an endoscopic surgical closure procedure in accordance with the present invention.  
         [0032]      FIG. 7  is a schematic cross-sectional view, similar to  FIG. 4 , depicting a method of membrane deformation utilizable with the device of  FIGS. 1 and 2 .  
         [0033]      FIG. 8  is a schematic cross-sectional view, similar to  FIG. 7 , depicting a modified method of membrane deformation utilizable with the device of  FIGS. 1 and 2 .  
         [0034]      FIG. 9  is a schematic cross-sectional view, similar to  FIG. 7 , depicting another method of membrane deformation utilizable with the device of  FIGS. 1 and 2 .  
         [0035]      FIG. 10  is a schematic cross-sectional view, similar to  FIG. 2 , illustrating a modified embodiment of a surgical closure device in accordance with the present invention.  
         [0036]      FIG. 11  is a schematic cross-sectional view Similar to  FIGS. 7-9 , showing a step in the deployment and deformation of the device of  FIG. 9 . 
     
    
     DETAILED DESCRIPTION  
       [0037]     As shown in  FIGS. 1 and 2 , a surgical closure device  12  comprises a ring  14  made of flexible material and an elastic membrane  16  attached about its periphery to the ring along the entire circumferential extent thereof, thereby covering an aperture  17  defined by the ring. Membrane  16  is at least coextensive with aperture  17 , thereby closing or blocking the aperture. Both ring  14  and membrane  16  are made of a biocompatible polymeric material that is acid stable or impervious, thereby enabling implantation of the closure into the stomach for covering a gastric perforation formed, for instance, during a trans-organ or incisionless surgery as described in U.S. Pat. Nos. 5,297,536 and 5,458,131.  
         [0038]     Ring  14  and membrane  16  may be inserted into a hollow internal organ of a patient, such as the stomach, the vagina, the urinary bladder or the colon, by means of a tubular deployment member  18  as illustrated in  FIG. 3 . Deployment member  18  is made of a partially flexible material where closure device  12  is to be implanted, for example, in the stomach or colon. The flexibility of deployment member  18  enables that member to negotiate curves and bends along an insertion pathway such as the mouth and esophagus or the sigmoidal colon.  
         [0039]     During an insertion operation, closure device  12 , particularly including ring  14  and membrane  16 , is disposed in a collapsed insertion configuration inside tubular deployment member  18 , as depicted in  FIG. 3 . A pusher member  20  including a handle  22  and a pusher plate  24  is insertable into deployment member  18  for ejecting closure device  12  from the deployment member upon the attainment of a desired surgical site inside a patient.  
         [0040]      FIG. 4  illustrates closure device  12  in an expanded configuration closing an opening or perforation  26  in a wall  28  of an internal organ. More particularly, membrane  16  is deformed from a planar relaxed or neutral configuration shown in  FIG. 2  to a bulbous or mushroom-shaped clamping and plugging configuration shown in  FIG. 4 . Membrane  16  is deformed and held in the deformed configuration by a deformation agent or element  30 . Deformation agent or element  20  is inserted into the patient and ejected against membrane  16  via a deployment tube  32  operatively connected at a proximal end  34  to a supply  36  of the deformation agent ( FIG. 5 ). The deformation agent  30  is made of an at least partially solid material that remains inside the patient together with closure device  12  upon completion of a surgical closure procedure. Such a procedure is depicted in  FIGS. 6A-6E .  
         [0041]     As shown in  FIG. 6A , a patient&#39;s stomach ST has a perforation  38  formed, for instance, during intra-abdominal surgery conducted at least partially via perforation  38 . At the end of the intra-abdominal procedure, a distal end portion of tubular deployment member  18  is inserted into stomach ST via a biopsy or working channel  40  of an endoscope  42  in turn inserted into the stomach via the patient&#39;s esophagus ES. Pusher member  20  is shifted in the distal direction, towards perforation  38 , thereby ejecting closure device  12 , as shown in  FIG. 6B . Upon ejection from the distal end of tubular deployment member  18 , ring  14  expands automatically in response to internal spring forces to assume a circular configuration as shown in  FIGS. 1 and 2 .  
         [0042]     The expanded or unfolded closure device  12  is placed in contact with a wall  44  of stomach ST so that ring  14  surrounds perforation  38  and membrane  16  covers the perforation, as depicted in  FIG. 6C . If necessary, an endoscopic forceps (not shown) may be inserted via endoscope  42  either via working channel  40  or via a second biopsy or working channel (not shown) and manipulated to grasp the expanded closure device  12  and position it over perforation  38 .  
         [0043]     After the placement of closure device  12  over perforation  38 , a distal end portion (not separately labeled) of deployment tube  32  is inserted into the patient via endoscope  42 , as shown in  FIG. 6C . Deployment tube  32  and supply  36  is operated extracorporeally to eject deformation agent  34  against membrane  16 , thereby forcing the membrane to expand into the patient&#39;s abdominal cavity AC. The distal tip (not separately designated) may be inserted through ring  14  and into the expanded membrane  16 , as shown in  FIG. 6D , to facilitate a filling of the membrane  16 . The deformed membrane forms a bulbous pouch ( FIGS. 4, 6D ,  6 E) similar in shape to a mushroom head.  
         [0044]     Deformation agent  34  may particularly take the form of a foam composition  46 , as depicted in  FIG. 7 . The foam composition  46  should not only be biocompatible, but also impervious to a low acid environment inasmuch as closure device  12  will be subject to gastric juices. This same requirement applies to the materials of ring  14  and membrane  16 . This materials requirement will not necessarily pertain if closure device  12  is used to plug openings formed in other hollow internal organs such as the vagina or the urinary bladder.  
         [0045]     Foam composition  46  may be ejected from deployment tube  32  at such a rate that the force of the foam composition against membrane  16  is sufficient to distort the membrane. Preferably, foam composition  46  is quick hardening, so that membrane  16  is held in the expanded bulbous, enlarged or mushroom-head shape.  
         [0046]     In an alternative technique depicted in  FIG. 8 , a balloon  48  is used to expand and hold membrane  16  in an expanded configuration while foam composition  46  is injected via deployment tube  32  behind the expanded balloon  48 , that is, between the balloon and the membrane. During insertion into the patient via working channel  40  of endoscope  42 , balloon  48  is housed in a collapsed configuration inside a distal end portion of a tubular deployment member  50 . After closure device  12  has been positioned over perforation  38  and after an extension of the distal end portion of deployment member  50  from working channel  40  inside the patient&#39;s stomach, balloon  48  is ejected and partially inflated to push membrane  16  out of the plane of ring  14  and perforation  38  and into the patient&#39;s abdominal cavity AC. During this initial pushing against membrane  16 , the inflated balloon  48  is smaller in diameter than the diameter of perforation  38 , so that balloon  48  together with membrane  16  may pass through the perforation into the patient&#39;s abdominal cavity AC. Thereafter, balloon  48  is inflated further so that membrane  16  has a form significantly larger than perforation  38 , large enough to clamp and seal the edges or periphery (not separately designated) of perforation. As foam composition  46  is ejected from deployment tube  32  into a space between balloon  48  and membrane  16  and hardens, balloon  48  may be deflated and ultimately withdrawn through perforation  38  and out of the patient.  
         [0047]     In an alternative procedure, balloon  48  by itself may serve as a permanent deformation agent, not only deforming membrane  16  but also holding the membrane in the expanded or enlarged bulbous configuration. In that case, a neck  52  of balloon  48  is clamped, crimped, tied, sutured, glued, heat sealed, ultrasonically welded or otherwise closed to maintain balloon  48  in an inflated configuration larger in diameter than perforation  38 . To that end, a distal end portion of an ancillary instrument (not shown) may be inserted into the patient&#39;s stomach through a working channel of endoscope  42 , or separately alongside endoscope  42  or via a channel in a sheath encasing endoscope  42 . Again, in the case of gastric perforation  38 , the material of balloon  48  should not only be elastic and biocompatible, but also impervious to a low acid environment.  
         [0048]     The foam composition  46  of  FIG. 8  could be replaced by a liposuction material such as fragmented adipose tissue. In that case, the liposuction composition is preferably but not necessarily obtained from the same patient prior to the trans-organ surgery. Alternatively, the liposuction material may be obtained from a compatible human or animal donor.  
         [0049]     Deformation agent  34  may alternatively take the form of a wire element  54 , as depicted in  FIG. 9 . Wire  54  may be connected at a distal end to ring  14 . Pushing wire  54  from a proximal end thereof causes the wire to deform or bend upon encountering a resistance offered by membrane  16 . Continuous pushing of wire  54  causes the wire to curl in a tangled ball as shown in  FIG. 9  and push the membrane into an expanded, enlarged, ballooned or mushroomed configuration, with a rim of organ wall  44  along the perforation  38  being sandwiched between the expanded membrane  16  and ring  14 . Wire  54  is preferably introduced into the patient through deployment tube  32  such as a catheter, so that bending of the wire occurs only at the membrane  16  and not along an insertion path of the instrumentation.  
         [0050]     Ring  12  may be provided with at least one pressure sensor  56 , a wireless transmitter  58  and a battery  60 . Sensor  56  functions to measure mucosal pressure upon installation of the expanded ring  14  and expansion or deformation of membrane  16 . The pressure feedback is used by a surgeon or other medical practitioner to ensure that the gripping of the organ wall  44  between the expanded membrane  16  and the ring  14  is sufficiently tight to seal the perforation or opening  38  in organ wall, but not so tight as to cause tissue necrosis.  
         [0051]     As shown in  FIG. 10 , an alternative closure device  62  comprises a ring  64  of flexible material and two membranes  66  and  68  disposed on opposite sides or the same side of ring  62 . One membrane  66  may be substantially stiffer than then other membrane  68  so that disposition of a deformation agent or element  70  between membranes  66  and  68  during a closure procedure as described above causes deformation mostly of membrane  68  and not membrane  66 . In that case, membrane  66  functions more in the nature of a flexible disk (collapsed during insertion) rather than an elastic membrane. A deployment tube  72  for the insertion of deformation agent or element  70  between membranes  66  and  68  may be provided with a sharp distal tip  74  for piercing membrane  66 . Alternatively, membrane  66  and/or ring  62  may be provided with a valve (not shown) connectable with the deployment tube for receiving and passing the deformation agent or element  70 .  FIG. 11  shows in phantom lines  76 , a deformed configuration for membrane  66 .  
         [0052]     Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are profferred by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.