Source: http://www.google.com/patents/US5575759?dq=6031454
Timestamp: 2018-01-19 22:05:19
Document Index: 609381711

Matched Legal Cases: ['art 20', 'art 47', 'art 48', 'art 20', 'art 47', 'art 48', 'art 130', 'art 132', 'art 46', 'art 48', 'art 46', 'art 48']

Patent US5575759 - Methods of using inflatable retraction devices in laparoscopic surgery - Google Patents
Apparatus for retracting an organ to gain access to treat a tissue. The apparatus has a main envelope, a second envelope, a first inflation device and a second inflation device. The main envelope encloses a main chamber, and includes a window and a removable window. The second envelope covers substantially...http://www.google.com/patents/US5575759?utm_source=gb-gplus-sharePatent US5575759 - Methods of using inflatable retraction devices in laparoscopic surgery
Publication number US5575759 A
Application number US 08/457,396
Also published as CA2109803A1, CA2109803C, CA2110153A1, DE69213449D1, DE69213449T2, DE69225067D1, DE69225067T2, EP0586555A1, EP0586555B1, EP0586561A1, EP0586561B1, EP0804902A2, EP0804902A3, EP0804903A2, EP0804903A3, US5361752, US5402772, US5425357, US5454367, US5465711, US5531856, WO1992021293A1, WO1992021295A1
Publication number 08457396, 457396, US 5575759 A, US 5575759A, US-A-5575759, US5575759 A, US5575759A
Patent Citations (48), Non-Patent Citations (26), Referenced by (75), Classifications (31), Legal Events (7)
Methods of using inflatable retraction devices in laparoscopic surgery
US 5575759 A
Apparatus for retracting an organ to gain access to treat a tissue. The apparatus has a main envelope, a second envelope, a first inflation device and a second inflation device. The main envelope encloses a main chamber, and includes a window and a removable window. The second envelope covers substantially all the main envelope, except the window and the removable window. The second envelope and the main envelope enclose a second chamber outside the main chamber. The first inflation device passes a fluid into the main chamber to expand the main chamber and the second chamber from a compacted state to retract the organ. The second inflation device passes a fluid into the second chamber to further expand the second chamber to maintain the organ in its retracted state after fluid has been released from the main chamber.
1. A method for properitoneal hernia repair, the method comprising the steps of:
providing an inflatable retraction device in a compacted state, the inflatable retraction device including:
a main envelope enclosing a main chamber, the main envelope including a window and a removable window,
a second envelope covering substantially all the main envelope, except the window and the removable window, the second envelope and the main envelope enclosing a second chamber outside the main chamber,
an attachment point centered in the removable window, and
an insertion shaft passing through the main chamber, and having a distal end temporarily attached to the attachment point, the attachment point providing a distal tip for the inflatable retraction device;
making an incision through the abdominal wall at the umbilicus as far as the properitoneal layer;
inserting the distal tip of the inflatable retraction device into the incision;
using the inflatable retraction device to dissect the peritoneum from the properitoneal layer while advancing the inflatable retraction device inferiorly between the peritoneum and the properitoneal layer towards the hernia;
passing a fluid into the main chamber to expand the main chamber and the second chamber from the compacted state to dissect further the peritoneum from the properitoneal layer;
passing a fluid into the second chamber to further expand the second chamber;
releasing fluid from the main chamber; and
detaching the removable window from the main envelope.
2. The method of claim 1 additionally comprising the step of repairing the hernia using an instrument passed through the main chamber.
3. The method of claim 1, additionally comprising the step of detaching the insertion shaft from the removable window before the step of detaching the removable window.
the step of passing a fluid into the main chamber expands the main chamber to create a working space; and
after the step of detaching the removable window, the method additionally comprises the step of passing insufflation gas through the main chamber to insufflate the working space.
5. The method of claim 1, additionally comprising the step of driving a trocax through the window into the main chamber.
6. The method of claim 5, wherein the step of driving a trocar through the window includes the steps of:
pressing a probe on the abdominal wall above the window to cause a protrusion in the properitoneal layer;
observing the provision in the properitoneal layer through the window from inside the main chamber;
moving the probe until the provision is centered in the window; and
substituting the trocar for the probe.
7. The method of claim 1, wherein the step of using the inflatable retraction device to dissect the pefitoneum from the properitoneal layer is continued until the removable window is centered on the hernia, using the endoscope.
the step of providing a compacted inflatable retraction device provides an insertion shaft having an endoscope mounted therein, the endoscope providing observation through the distal tip of the inflatable retraction device; and
the step of using the inflatable retraction device to dissect the peritoneum from the properitoneal layer is continued until the hernia is seen using the endoscope.
9. The method of claim 1, wherein the step of using the inflatable retraction device to dissect the peritoneum from the properitoneal layer includes the steps of:
locating the hernia by feel through the abdominal wall; and
advancing the inflatable retraction device until the distal tip of the inflatable retraction device and the hernia are felt together through the abdominal wall.
10. A method for retracting an organ to gain access to treat a tissue, the method comprising the steps of:
a main envelope enclosing a main chamber, the main envelope including a window and a removable window, and
placing the inflatable retraction device in the compacted state adjacent the organ;
passing a fluid into the main chamber to expand the main chamber and the second chamber from the compacted state to retract the organ;
11. The method of claim 10, additionally comprising the step of treating the tissue using an instrument passed through the main chamber.
12. The method of claim 10, additionally comprising the step of driving a trocar through the window into the main chamber.
the inflatable retraction device is located inside a body wall; and
the step of driving a trocar through the window includes the steps of:
pressing a probe onto the body wall above the window to cause a provision in the body wall;
observing the provision in the body wall through the window from inside the main chamber;
14. The method of claim 10, wherein, in the step of placing the inflatable retraction device adjacent the organ, the inflatable retraction device is placed adjacent the organ using an insertion shaft.
15. The method of claim 14, additionally comprising the step of detaching the insertion shaft from the removable window before the step of detaching the removable window.
in the step of placing the inflatable retraction device adjacent the organ, the insertion shaft is manipulated until the organ is seen using the endoscope.
This is a divisional of application Ser. No. 08/134,573, filed Oct. 8, 1993, now U.S. Pat. No. 5,425,357, which is a continuation-in-part of application Ser. No. 07/794,590, filed Nov. 19, 1991, now U.S. Pat. No. 5,309,896, which is a continuation-in-part of application Ser. No. 07/706,781, filed May 29, 1991, now abandoned.
Laparoscopy dates back to the mm of the 20th Century. Early laparoscopic techniques were used primarily for diagnostic purposes to view the internal organs without the necessity of conventional surgery. Since the 1930s, laparoscopy has been used for sterilization and, more recently, for suturing of hemas. U.S. Pat. Nos. 4,919,152 and 4,944,443 are concerned with techniques for suturing hemas. Another recent innovation is the use of laparoscopic surgery for removing the gallbladder.
The parent application also describes using the two-chambered inflatable retraction device for properitoneal hernia repair. A hernia is the protrusion of part of a body part or structure through a defect in the wall of a surrounding structure. Most commonly, a hernia is the protrusion of part of abdominal contents, including bowel, through a tear or weakness in the abdominal wall, or through the inguinal canal into the scrotum.
The use of laparoscopic techniques to perform hernia repair is becoming increasingly common. In the conventional procedure for carrying out a hernia repair laparoscopically, an endoscope and instruments are introduced into the belly through one or more incisions in the abdominal wall, and are advanced through the belly to the site of the hernia. Then, working from inside the belly, a long incision is made in the peritoneum covering the site of the hernia. A small part of the pefitoneum is dissected from the properitoneal fat layer to provide access to the fat layer. This is conventionally done by blunt dissection. In this procedure, it is difficult to dissect the pefitoneum cleanly since patchy layers of properitoneal fat tend to adhere to the peritoneum.
In an alternative known extraperitoneal laparoscopic hernia repair procedure, an incision is made in the abdominal wall close to the site of the hernia. The incision is made through the abdominal wall as far as the properitoneal fat layer. The peritoneum is then blunt dissected from the properitoneal fat layer by passing a finger or a rigid probe through the incision and sweeping the finger or rigid probe under the pefitoneum. After the peritoneum is dissected from the properitoneal fat layer, the space between the peritoneum and the properitoneal fat layer is insufflated to provide a working space in which to apply the mesh patch to the properitoneal fascia. During the blunt dissection process, it is easy to puncture through the peritoneum, which can be quite thin. A puncture destroys the ability of the space between the peritoneum and the fascia to hold gas insufflation. Also, it is difficult to dissect the peritoneum cleanly since patchy layers of properitoneal fat tend to adhere to the peritoneum.
When the site of the hernia is reached, the chamber is fully expanded to create a working space at the site of the hernia. An endoscope can be inserted into the expanded chamber to obtain a visual conformation of the hernia defect. The inflatable retraction device is then withdrawn from the working space, and a trocar tube anchored by a small balloon is inserted into the incision. Insufflation gas is passed through the trocar tube to insufflate the tunnel and the working space. The hernia is then treated using instruments passed into the insufflated working space through the insufflated tunnel.
Experience with using the single-chambered balloon technique just described has shown that the peritoneum can sometimes rise up and obstruct access to the site of the hernia. This occurs if the pefitoneum is breached during the dissection process, and insufflation gas leaks into the abdominal cavity. This equalizes the pressure across the peritoneum, and the insufflation pressure no longer depresses the peritoneum away from the site of the hernia. It has also been found that blood accumulates in the tunnel leading to the site of the hernia, and contaminates the lens of the endoscope when the endoscope is passed through the tunnel. The endoscope must then be withdrawn from the tunnel, its lens cleaned, and another attempt to insert the endoscope made.
Accordingly, the invention provides an apparatus for retracting an organ to gain access to treat a tissue. The apparatus comprises a main envelope, a second envelope, a first inflation device and a second inflation device. The main envelope encloses a main chamber, and includes a window and a removable window. The second envelope covers substantially all the main envelope, except the window and the removable window. The second envelope and the main envelope enclose a second chamber outside the main chamber. The first inflation device passes a fluid into the main chamber to expand the main chamber and the second chamber from a compacted state to retract the organ. The second inflation device passes a fluid into the second chamber to further expand the second chamber to maintain the organ in its retracted state after fluid has been released from the main chamber.
The invention also provides a pressure control valve that allows fluid to pass in a first direction, and allows fluid to pass in a second direction, opposite to the first direction, only when fluid has a pressure in the second direction exceeding a predetermined limit. The valve comprises a valve body including a valve seat. The valve also comprises a one-way valve seating on the valve seat in the valve body. The one-way valve is oriented to allow fluid to pass in the first direction, and to prevent fluid from passing in the second direction. Finally, the valve comprises a compression spring disposed between the one-way valve and the valve body to apply a seating force between the one-way valve and the valve seat.
The invention also provides a method for properitoneal hernia repair. In the method, an inflatable retraction device is provided in a compacted state. The inflatable retraction device includes a main envelope enclosing a main chamber and including a window and a removable window; and a second envelope covering substantially all the main envelope, except the window and the removable window. The second envelope and the main envelope enclose a second chamber outside the main chamber. The device also includes an attachment point centered in the removable window, and an insertion shaft passing through the main chamber, and having a distal end temporarily attached to the attachment point. The attachment point provides a distal tip for inflatable retraction device.
Further, in the method, an incision is made through the abdominal wall at the umbilicus as far as the properitoneal layer, and the distal tip of the inflatable retraction device is inserted into the incision. The inflatable retraction device is then used to dissect the peritoneum from the properitoneal layer while advancing the inflatable retraction device inferiority between the peritoneum and the properitoneal layer towards the hernia. A fluid is passed into the main chamber to expand the main chamber and the second chamber from the compacted state and to dissect further the peritoneum from the properitoneal layer. A fluid is passed into the second chamber to further expand the second chamber. Fluid is then released from the main chamber, and the removable window is detached from the main envelope.
Finally, the invention provides a method for retracting an organ to gain access to treat a tissue. In the method, an inflatable retraction device is provided in a compacted state. The inflatable retraction device includes a main envelope enclosing a main chamber, and including a window and a removable window. The device also includes a second envelope covering substantially all the main envelope, except the window and the removable window. The second envelope and the main envelope enclose a second chamber outside the main chamber. The inflatable retraction device is placed in the compacted state adjacent the organ. A fluid is passed into the main chamber to expand the main chamber and the second chamber from the compacted state to retract the organ. A fluid is passed into the second chamber to further expand the second chamber. Fluid is released from the main chamber. And the removable window is detached from the main envelope.
FIG. 8B shows a fast alternative embodiment of a pressure control valve according to the invention with a fixed release pressure.
FIG. 8D shows a fast embodiment of a pressure control valve according to the invention with a variable release pressure.
FIG. 11D shows the inflatable retraction device after the main chamber has been expanded to retract the liver;
A top view, front elevation, bottom view, side elevation, and cross-sectional view of a version of the inflatable retraction device 10 according to the invention are shown in FIGS. 1A, 1B, 1C, 1D, and 1E, respectively. The shape of the inflatable retraction device shown in FIGS. 1A through 1E is optimized for bilateral hernia repair, as will be described in more detail below. It is intended that inflatable retraction devices with shapes specifically adapted for use in other procedures and in other parts of the body may be made by applying the principles to be set forth below.
Increasing the size of the second chamber 14 also increases the proportion of the surface of the main envelope 15 occupied by the second chamber 14. This, in turn, reduces the area of the main envelope 15 enclosing the main chamber 12 available to provide windows in which apertures can be pierced. However, by making the inflatable retraction devices of the present invention specific to an applications or a group of application, and by providing at least one large, removable window 18 (to be described below) in a predetermined, application-specific location in the main envelope, and by providing at least one smaller, piercable window 32 in a predetermined, application-specific location in the main envelope, the advantages of increasing the size of the second chamber can be obtained while providing excellent access to the tissue to be treated.
It should be noted that, unlike piercing an aperture in the main envelope 15 working from inside the main chamber 12, the apertures 30 and 34, which allow instruments to pass into the main chamber, are pierced working from outside the main chamber, as will be described in detail below. Piercing an aperture working from outside the main chamber involves a considerably reduced risk of the instrument used to pierce the apeme accidentally injuring the tissue being treated.
In the inflatable retraction device shown in FIGS. 1A through 1E for use in hernia repair procedures, in which the main retraction force is exerted between the top wall and the bottom wall, the baffles 40 disposed on the side wall 22 run substantially normally to the plane of the bottom wall 24 and the top wall 26. Other arrangements of the baffles on the side wall, for example, baffles running parallel to the top wall and the bottom wall, or baffles disposed at an angle to the plane of the top wall and the bottom wall, could be preferred in other applications.
In the inflatable retraction device 10 for used in bilateral hernia repair shown in FIGS. 1A through 1E, the bottom-wall baffles 42 on the bottom wall 24 preferably run concentrically, as shown in FIG. 1C, whereas the top-wall baffles 44 on the top wall 26 run radially, as shown in FIG. 1A. In other applications, it could be preferable for both bottom-wall baffles 42 and top-wall baffles 44 to be disposed concentrically, or to be disposed radially, or for the bottom-wall baffles 42 to run radially, and the top-wall baffles 44 to run concentrically, depending on the application.
During inflation of the second chamber 14 (FIG. 1E), provision must be made for the inflation fluid to pass from the side-wall part 20 of the second chamber 14, where the inflation fluid (gas, liquid, etc. ) enters the second chamber, to the bottom-wall part 47 and the top-wall part 48 of the second chamber. This was not a consideration in the inflatable retraction devices described in the parent application, because the preferred embodiment of the second chamber was not divided into a side-wall, bottom-wall, and top-wall portions.
A known way of making a provision for the inflation fluid to pass from the side-wall part 20 of the second chamber 14 to the bottom-wall part 47 and the top-wall part 48 of the second chamber is to weld a small part of the first envelope covered by the top-wall part of the second chamber to a small part of the main envelope covered by the side-wall part of the second chamber. A hole is pierced through the welded portion of the main envelope to connect the top-wall part of the second chamber to the side-wall part of the second chamber. A similar arrangement is used to connect the bottom-wall part of the second chamber to the side-wall part of the second chamber. With this arrangement, the parts of the main envelope that are welded together can pull apart when the second envelope is inflated. This produces a high level of stress localized at the welds, and, consequently, the welds are a potential rapture site for both the main chamber and the second chamber.
When the inflatable retraction device is in its collapsed state, the inflation fluid passages 140, 142, 144, and 146 are all aligned with one another. When the main chamber 12 of the Eatable retraction device is inflated, portions of the main envelope 15 move apart from one another. In particular, the part 130 moves apart form the part 132 as the top wall 26 and the side wall 22 move in the directions indicated by the arrows 148 and 150, respectively. The shape of the interconnection chamber 120 changes to accommodate this movement with little stress on the welds between the interconnection chamber and the main envelope.
When the second chamber 14 is inflated, inflation fluid passes from the side-wall part 46 of the second chamber to the top wall part 48 of the second chamber by passing through the interconnected inflation fluid passages 140 and 142 into the interconnection chamber. Inflation fluid then passes through the interconnected inflation fluid passages 144 and 146 into the top-wall part of the second chamber. Thus, provision is made for inflation fluid to pass from the side-wall part 46 of the second chamber to the top wall part 48 of the second chamber with litfie localized stress on the main and second envelopes.
To minimize the volume of the Eatable retraction device in its collapsed state, a new envelope material has been developed for the parts of the inflatable retraction device made of envelope material, i.e., the main envelope, the second envelope, the baffles, and the envelope halves of the interconnection chamber. When used with the localized stress reduction techniques described above, films of the new envelope material as thin as 2-3 mil (50-75 μm) are sufficiently strong to withstand the inflation pressures of both the main chamber and the second chamber.
The removable window 18 will now be described in more detail. The inflatable retraction devices described in the parent application provided plural piercable windows in the envelope of the main chamber. During the retraction process, the inflatable retraction device was manipulated to locate one of the windows adjacent to the tissue to be treated. Then, working from inside the main chamber, the surgeon used a sharp instrument to cut an aperture in the window adjacent to the tissue to gain access to treat the tissue. The process of cutting the aperture in the window could require a considerable time because the surgeon had to carry out the process carefully to ensure that the insmnnent cutting the aperture did not accidentally cut the tissue to be treated.
An alternative construction of the bond between the removable window and the side wall is shown in FIG. 6B. The removable window 18 is fabricated from two pieces of envelope material 180 and 182 attached to one another by a layer of a suitable adhesive 184. The preferred adhesive is an acrylic adhesive: silicone and urethane adhesives also work, but less well.
In the inflatable retraction device shown in FIGS. 1A through 1E for repair of bilateral hernias, the removable window 18 extends from the bottom wall 24 to the top wall 26 of the main chamber, and occupies about one third of the side wall 22 of the main chamber. The large size of the removable window 19 considerably reduces the retraction force that can be exerted by the second chamber in the retraction device 10 compared with the retraction force that can be exerted by the second chambers of the inflatable retraction devices 201 and 221 shown in FIGS. 7A and 7B. Accordingly, the inflatable retraction device shown in FIGS. 1A through 1E is preferably normally used in procedures in which the properitoneal space is insufflated. The pressure of the insufflation gas provides part of the retraction force, and thus assists the second chamber 14 to provide retraction, as will be described in more detail below.
Referring once more to FIGS. 1A through IF, the reliability of the main chamber 12 is increased by limiting the maximum inflation pressure in the main chamber during inflation of the second chamber. Inflation of the second chamber reduces the volume of the main chamber, and hence increases the pressure in the main chamber. Allowing the pressure in the main chamber to rise too far can lead to the main envelope rapturing.
The main chamber 12 and the second chamber 14 are expanded by inflation fluid passed through the inflation tube 50. The inflation robe is a coaxial arrangement of the inner inflatable tube 51 and the outer inflation robe 52. The port 56 mounted on the proximal end of the inflation robe 50 carries the pressure control valve 54 and the one-way valve 58. The port 56 also comes a flap valve 59 that seals the bore of the inner inflation robe 51, and also forms a gas-tight seal with insmmaents or the insertion shaft 62 passing through the flap valve into the main chamber 12.
The main chamber is expanded by inflation fluid passed through the pressure control valve 54 into the bore 55 of the inner inflation tube 51. The second chamber is expanded by inflation fluid passed through the one-way valve 58 into the lumen 53 between the outer inflation tube and the inner inflation robe.
(c) Pressure Control Valve-Alternative Embodiments
In FIG. 8F, the lower part of the valve body 220B includes the threaded portion 239, which is fitted with the threaded valve seat 237 on which the duckbill valve 228 seam. The release pressure of the valve is adjusted by rotating the threaded valve seat 237 in the threaded portion of the valve body 220B. This changes the axial position of the threaded valve seat, the duckbill valve 228, and the spring adaptor 230, which changes the force exerted by the compression spring.
The inflatable retraction device 10 shown in FIGS. 1A through 1E is packaged for use in a hernia repair procedure as shown in FIG. 9A. Packaging the inflatable retraction device in this way allows the inflatable retraction device to be inserted into an incision at the urnbilious; allows the packaged device to be used to dissect the peritoneum away from the properitoneal fat layer; allows the device to be correctly located in the lower abdominal region; and allows the surgeon to center the removable window 18 (FIG. 1A) on the site of the hernia by feel.
When the inflatable retraction device is packaged, the insertion shaft 62 is inserted through the port 56 on the inflation tube 50, through the bore 55 of the inflation tube, and through the main chamber to engage the distal end of the insertion shaft with the button 60, as shown in the longitudinal cross-sectional view of FIG. 9B. The envelope material portion 61 of the inflatable retraction device, i.e., the main envelope, second envelope, bees, etc, are then pulled proximafly, i.e., towards the port 56, and are wrapped around the distal part of the insertion shaft. The envelope material 61 wrapped around the insertion shaft 62 forms a distal extension of the inflation tube 50, and has substantially the same diameter as the inflation tube. Alternatively, the envelope material of the inflatable retraction device may be pulled back towards the port 56, and then folded in concertina folds on either side of the insertion shaft 62, as shown in the exploded lateral cross-sectional view of FIG. 9D.
The inflatable retraction device may additionally be packaged without the insertion shaft 62, as shown in the longitudinal cross sectional view of FIG. 9E. In this, the envelope material portion of the inflatable retraction device is rolled, or folded in concertinn folds such that it forms a distal extension of the inflation tube 50. The envelope material is packaged such that the button 60 in the center of the removable window is at the distal-most point of the package. The envelope material is retained in its rolled or folded state by the detachable sheath 64 held together by removable lacing 66, as described above, or by other suitable techniques.
Alternative constructions of the insertion shaft is shown in FIGS. 9F and 9G. In both alternative constructions, the insertion shaft consists of two concentric tubes, the attachment tube 240, which attaches to the button 60 in the center of the removable window 18 (FIG. 1E), and the release tube 242, which detaches the attachment tube 240 from the button when the surgeon wishes to withdraw the insertion shaft from the retraction device. In the arrangement shown in FIG. 9F, the attachment cube 240 fits over the outside of the button 60, and the release cube 242 runs inside the attachment tube. The release tube 242 may be solid; however, if the insertion shaft is to accommodate an endoscope for observing the location of the removable window during the insertion process, the release cube must be hollow. The surgeon squeezes the release button 244 towards the finger grips 246 to release the insertion shaft from the button 60.
In the arrangement shown in FIG. 9G, the attachment cube 240, fits inside the button 60, and the release cube 242 runs outside the attachment tube. The attachment tube 240 may be solid; however, if the insertion shaft is to accommodate an endoscope for observing the location of the removable window during the insertion process, the attachment tube must be hollow. The surgeon again squeezes the release button 244 towards the finger grips 246 to release the insertion shaft from the button 60.
A small incision I is made in the abdominal wall at the umbilicus. The incision is made through all the layers of the abdominal wall AW except the peritoneum P, as shown in FIG. 10A. The distal tip of the inflatable retraction device 300, which is the inflatable retraction device 10 shown in FIGS. 1A through 1E packaged as shown in FIG. 9A, is inserted into the incision until the button 60 at the distal tip of the package contacts the peritoneum P.
The distal tip of the package is then gently advanced slightly further to nudge the peritoneum P away from the properitoneal fat layer FL in the immediate vicinity of the incision I, as shown in FIG. 10B. The insertion shaft 62 extending the length of the packaged inflatable retraction device 301 to the button 60 in the center of the removable window 18 (not shown) makes the packaged inflatable retraction device rigid, and enables the packaged inflatable retraction device to be used as a blunt dissection tool to dissect to pefitoneum away from the properitoneal fat layer.
A source of inflation fluid (not shown) is applied to the pressure control valve 54 on the insertion port 56 on the inflation tube 50. The inflation fluid, which is preferably compressed air or carbon dioxide, flows into the pressure control valve 54, as indicated schematically by the arrow 307, and expands the main chamber of the inflatable retraction device 10 to its expanded state. As the main chamber expands, it gently dissects more of the pefitoneum P away from the properitoneal fat layer FL, as shown in FIG. 10E, creating a large working space WS around the site of the hernia H. During the expansion process, the insertion shaft 62 keeps the removable window 18 centered on the site of the hernia H, so that when the expansion process is complete, the site of the hernia is centered in the removable window.
When the second chamber is fully expanded, the inflation pressure in the main chamber is released, as indicated schematically by the arrow 313 in FIG. 10G. The second chamber in its expanded state maintains the retraction originally provided by the main chamber. The surgeon then operates the release button 244 on the insertion shaft 62 to detach the insertion shaft from the button 60. The surgeon then removes the insertion shaft from the inflation robe 50. An endoscope (not shown) is inserted into the inflation tube to cotfin the orientation of the removable window 18 relative to the site of the hernia H.
The endoscope is then reorientated to observe the top wall window 32 of the inflatable retraction device. A probe (not shown) is pressed into the skin S of the abdominal wall AW and is moved around near the location of the top wall window. The protrusion in the properitoneal fat layer caused by pressing the probe into the skin of the abdominal wall can be seen using the endoscope observing through the top wall window. The probe is moved until the provision is centered in the top wall window. The trocar (not shown) in the trocar tube TT is placed at the location of the probe, and is driven through the abdominal wall and through the top-wall window 32 to pierce the aperture 34 into the inflatable retraction device, as shown in FIG. 10H. The distal end of the trocar projects in to the main chamber.
In the method according to the invention just described, the embodiment of the inflatable retraction device shown in FIGS. 1A through 1E is left in place to maintain the working space while the hernia is being treated, and the hernia is treated working through the inflatable retraction device. The method according to the invention has a number of advantages over a properitoneal hernia repair procedure in which a single-chamber inflatable retraction device is used to dissect the peritoneum from the properitoneal layer to create the working space, is then withdrawn from the working space, and separation of the peritoneum from the properitoneal fat layer is maintained by insufflation of the working space alone. First, no insufflation, or a lower insufflation pressure, may be used in the method according to the invention. Second, even if insufflation is used, and the peritoneum is breached during the blunt dissection process, and insufflation gas enters the abdomen, resulting in a reduced pressure differential across the peritoneum, the inflatable retraction device keeps the peritoneum out of the working space, and prevents the peritoneum from rising up and obstructing access to the site of the hernia. Finally, the inflation robe 50 (or the trocar tube TT entering the main chamber through the top- or side-wall window) provides a clean and direct access route to the site of the hernia for the endoscope. On its way to the site of the hernia, the endoscope does not contact tissue that could deposit blood on the lens of the endoscope.
An intra-abdominal procedure according to the invention will now be described. As an example, a method of using an inflatable retraction device according to the invention to lift the liver to gain access to treat the gall bladder will now be described. In the method, an inflatable retraction device 401 shown in FIG. 11A is used. The inflatable retraction device is similar to that shown in FIG. 7A. However, the removable window 418 is on the center line defined by the inflation tube 450, and the device is about 50% larger (about 9"-10' (225-250 mm) in diameter). Additionally, the side-wall window 428 is located about 30 degrees to the left of the midline, and an additional window 431 is provided at about 90 degrees to the left of the midline. The additional window spans the side wall and the top wall of the main chamber. These windows are optimally located for the gall bladder procedure.
Prior to making the first incision, the abdominal wall AW may be lifted to provide additional working space by gas insufflation, or by one of the mechanical devices disclosed in U.S. patent application Ser. No. 07/706,781, of which application the parent of this application is a Continuation-in-Part, or by some other suitable mechanical retraction device. The insufflated state of the abdominal wall AW is indicated in FIG. 11B by the broken line A'.
When the inflatable retraction device 401 has reached its fully-expanded state, the position of the removable window 418 relative to the gall bladder GB, now exposed by lifting the liver L, is checked by viewing it through the endoscope E1 and/or an endoscope (not shown) inserted into the main chamber 412 via the inflation tube 450 and the port 56, or inserted into the insertion shaft 462. Preferably, the gall bladder should be centered in the removable window 418.
If the inflatable retraction device 401 is not correctly positioned, some inflation fluid may be bled off from the main chamber, and the insertion shaft 462 is used to manipulate the partially-inflated inflatable retraction device 401 to correct the positioning error while the position of the removable window 418 relative to the gall bladder GB is observed through the endoscope E1 or the endoscope (not shown) in the insertion shaft 462. After the positioning error is corrected, the main chamber is reexpanded.
Using the probing technique described above, trocars are centered on the side-wall window 428 and the side-top-wall window 43 1, and are driven into the main chamber through the abdominal wall AW and the respective window. The trocar is removed, leaving the trocar tube TT3 in place, as shown in FIG. 11F. The endoscope E1 is transferred to the trocar tube. Laparoscopic forceps F are then inserted into the inflation tube to engage the tab on the removable window 418. The laparoscopic forceps are then used to gently peel the removable window away from the side wall of the main chamber, as shown in FIG. 11F, and to remove the detached window material from the main chamber. Alternatively, the detached window material can be left in the main chamber. Removing the inflatable retraction device at the end of the procedure will then automatically remove the window material from the body. As a further alternative, detaching the removable window may result in the window material being only partially detached from the main envelope. The detached window material is then pulled out of the way to provide access to treat the hernia.
Although this application describes illustrative embodiments of the invention in detail, it is to be understood that the invention-is not limited to the precise embodiments described, and that various modifications may be practiced within the scope of the invention defined by the appended claims.
2 "Four Surgeons Describe Their Separate Techniques for Performing Laparoscopic Inguinal Hernia Repair", Laparoscopy News, Oct. 1991.
3 "Texas Team Routinely Performs Lymphadenectomy for Prostate Cancer Patients," Gen. Sug. News, p. 4, (1992, Feb.).
4 A. Guiarnieri, MD, et al., "A New Technique for Indirect Hernia Repair," 164 Am. J. Surgery, pp. 70-73 (1992 Jul.).
5 * A. Guiarnieri, MD, et al., A New Technique for Indirect Hernia Repair, 164 Am. J. Surgery, pp. 70 73 (1992 Jul.).
12 C. R. Nezhat, MD, et al., "Laparoscopic Radical Hysterectomy with Paraaortic and Pelvic Node Dissection," 166 Am. J. Obstet. Gynecol., pp. 864-865 (1992, No. 3). Laparoscopy in Focus, pp. 5-7, (1991, No. 1).
13 * C. R. Nezhat, MD, et al., Laparoscopic Radical Hysterectomy with Paraaortic and Pelvic Node Dissection, 166 Am. J. Obstet. Gynecol., pp. 864 865 (1992, No. 3). Laparoscopy in Focus, pp. 5 7, (1991, No. 1).
15 * Four Surgeons Describe Their Separate Techniques for Performing Laparoscopic Inguinal Hernia Repair , Laparoscopy News, Oct. 1991.
16 G. Ferzli, MD, FACS, et al., "Extraperitoneal Endoscopic Pelvic Lymph Node Dissection v. Lapaoscopic Lymph Node Dissection in the Staging of Prostatic & Bladder Carcinoma", 2 J. Laparoendoscopic Surg. pp. 219-222 (1992, No. 2).
17 * G. Ferzli, MD, FACS, et al., Extraperitoneal Endoscopic Pelvic Lymph Node Dissection v. Lapaoscopic Lymph Node Dissection in the Staging of Prostatic & Bladder Carcinoma , 2 J. Laparoendoscopic Surg. pp. 219 222 (1992, No. 2).
18 H. M. Delany, MD, et al., "Extent of Peritoneal Adhesions & Local Tissue Reaction in Response to Absorable vs. Nonabsorbable Mesh," 40 Contemporary Surgery, pp. 29-36 (1992 PRIL).
19 * H. M. Delany, MD, et al., Extent of Peritoneal Adhesions & Local Tissue Reaction in Response to Absorable vs. Nonabsorbable Mesh, 40 Contemporary Surgery, pp. 29 36 (1992 PRIL).
20 H. Ruckle, MD, et al., "Laparoscopic Pelvic Lymph Node Dissection: Assessment Intraoperative and Early Postoperative Complications," J. Endourology pp. 117-119, (1992, No. 2).
21 * H. Ruckle, MD, et al., Laparoscopic Pelvic Lymph Node Dissection: Assessment Intraoperative and Early Postoperative Complications, J. Endourology pp. 117 119, (1992, No. 2).
24 M. E. Arregui, MD, et al., "Laparoscopic Mesh Repair of Inguinal Hernia Using a Properitoneal Approach: A Preliminary Report," 2 Surg. Laparoscopy & Endoscopy, pp. 53-58 (1992, No. 1).
25 * M. E. Arregui, MD, et al., Laparoscopic Mesh Repair of Inguinal Hernia Using a Properitoneal Approach: A Preliminary Report, 2 Surg. Laparoscopy & Endoscopy, pp. 53 58 (1992, No. 1).
26 * Texas Team Routinely Performs Lymphadenectomy for Prostate Cancer Patients, Gen. Sug. News, p. 4, (1992, Feb.).
US6391060 * Oct 21, 1998 May 21, 2002 Sofradim Productions Prosthetic implant for obstructing an anatomical duct, and obstructing assembly comprising same
US7162309 Apr 7, 2003 Jan 9, 2007 Medtronic, Inc. Epicardial lead delivery system and method
US7294103 * Nov 12, 2004 Nov 13, 2007 Endoscopic Technologies, Inc. Retractor with inflatable blades
US7507209 Nov 14, 2005 Mar 24, 2009 Aragon Surgical, Inc. Method of establishing pneumoperitoneum
US7585281 Sep 10, 2002 Sep 8, 2009 Aragon Surgical, Inc. Vacuum-actuated tissue perforation device for establishing pneumoperitoneum
US8337412 * Nov 29, 2007 Dec 25, 2012 Terumo Cardiovascular Systems Corporation Integral fluid regulator for endoscopic vessel dissection/harvesting device
US8764646 * Apr 29, 2004 Jul 1, 2014 Umc Utrecht Holding B.V. Surgical expansion device
US20040049127 * Sep 10, 2002 Mar 11, 2004 Camran Nezhat Tissue perforation device and method
US20040199236 * Apr 7, 2003 Oct 7, 2004 Medtronic, Inc. Epicardial lead delivery system and method
US20050137460 * Nov 12, 2004 Jun 23, 2005 Bertolero Arthur A. Retractor with inflatable blades
US20050245960 * Apr 29, 2004 Nov 3, 2005 Grundeman Paul F Surgical expansion device
US20060079921 * Nov 14, 2005 Apr 13, 2006 Veresure, Inc. Method of establishing pneumoperitoneum
US20130218179 * Feb 19, 2013 Aug 22, 2013 Davol, Inc. (a C.R. Bard Company) Device especially useful for hernia repair surgeries and methods thereof
EP0956077A1 * Dec 27, 1996 Nov 17, 1999 Origin Medsystems, Inc. Method and inflatable chamber apparatus for separating layers of tissue
EP0956077A4 * Dec 27, 1996 Aug 26, 2009 Covidien Ag Method and inflatable chamber apparatus for separating layers of tissue
EP0983022A1 * May 5, 1998 Mar 8, 2000 General Surgical Innovations, Inc. Apparatus and method for developing an anatomic space for laparoscopic procedures
EP0983022A4 * May 5, 1998 Sep 19, 2001 Gen Surgical Innovations Inc Apparatus and method for developing an anatomic space for laparoscopic procedures
EP1648288A2 * Jul 2, 2004 Apr 26, 2006 Adrian Paz Virtual ports devices and method
EP1648288A4 * Jul 2, 2004 Sep 8, 2010 Ports Ltd Virtual Virtual ports devices and method
U.S. Classification 600/207, 606/192
International Classification A61B17/03, A61B17/00, A61B1/32, A61B17/32, A61B17/34, A61B19/00, A61B17/22, A61B19/02, A61B17/02, A61B17/30
Cooperative Classification A61B2090/306, A61B90/50, A61B17/3417, A61B17/0218, Y10T156/1003, A61B2017/00261, A61B17/22032, A61B2017/00535, A61B2017/00557, A61B2017/320048, A61B2017/306, A61B17/3462, A61B2017/3486, A61B17/0281
European Classification A61B19/26, A61B17/02E, A61B17/22E2, A61B17/02L, A61B17/34G
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MOLL, FREDERIC H.;WALLACE, DANIEL T.;SMITH, JEFFREY A.;AND OTHERS;SIGNING DATES FROM 19940906 TO 19941027;REEL/FRAME:024218/0514