Source: http://www.google.com/patents/US5925058?dq=5893120
Timestamp: 2015-07-31 08:48:18
Document Index: 205449580

Matched Legal Cases: ['art 15', 'art 15', 'art 939', 'art 941', 'art 939', 'art 941', 'arts 939']

Patent US5925058 - Method and inflatable chamber apparatus for separating layers of tissue - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsAn apparatus for tissue dissection and instrument anchoring, including a dissection balloon having a viewing window (preferably a rigid, transparent window) at its distal end, or including an anchoring or dissection balloon having nonuniform elasticity selected to achieve desired inflated shape and pressure...http://www.google.com/patents/US5925058?utm_source=gb-gplus-sharePatent US5925058 - Method and inflatable chamber apparatus for separating layers of tissueAdvanced Patent SearchPublication numberUS5925058 APublication typeGrantApplication numberUS 08/878,293Publication dateJul 20, 1999Filing dateJun 18, 1997Priority dateMay 29, 1991Fee statusPaidAlso published asUS5728119, WO1997013464A2, WO1997013464A3Publication number08878293, 878293, US 5925058 A, US 5925058A, US-A-5925058, US5925058 A, US5925058AInventorsJeffrey A. Smith, Daniel T. Wallace, Edwin J. Hlavka, Charles Gresl, John P. Lunsford, Albert K. ChinOriginal AssigneeOrigin Medsystems, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (87), Non-Patent Citations (15), Referenced by (28), Classifications (44), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetMethod and inflatable chamber apparatus for separating layers of tissue
US 5925058 AAbstract
An apparatus for tissue dissection and instrument anchoring, including a dissection balloon having a viewing window (preferably a rigid, transparent window) at its distal end, or including an anchoring or dissection balloon having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics, and methods for using such apparatus. The window, which can be a lens (such as a wide angle lens), is transparent and either rigid or non-rigid but sufficiently strong to retain a desired optical shape while (and after) being pushed against tissue layers by a rigid instrument deployed within the balloon. In preferred embodiments, the balloon is a long-necked dissection balloon deployed through a cannula. In other embodiments, the invention is a dissection balloon having a viewing window at its distal end, or an anchoring or dissection balloon having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics, for use in an apparatus for tissue dissection, tissue retraction, and instrument anchoring. In other embodiments, the invention is a dissection balloon assembly including a long-necked dissection balloon having a viewing window at its distal end, and a housing to which the dissection balloon's mouth is attached. In accordance with the method of the invention, the distal end of a long-necked dissection balloon (deployed through a cannula) is inserted between tissue layers and inflated to dissect the tissue layers. The dissection balloon has a window at its distal end, or nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics, or both such a window and such nonuniform elasticity.
1. A dissection balloon, including:a mouth portion; a distal portion shaped so that inflation of the dissection balloon when the distal portion is between two tissue layers dissects said tissue layers; a neck portion between the mouth portion and the distal portion; and a substantially transparent viewing window provided at the distal portion, wherein the distal portion defines an opening, and the viewing window is attached to the distal portion of the dissection balloon over the opening, the viewing window has a grooved side wall, and the grooved side wall is glued to the distal portion of the dissection balloon. 2. The balloon of claim 1, also including a housing attached to the mouth portion of the dissection balloon, said housing including a port means through which inflating fluid can be supplied to the dissection balloon.
3. The balloon of claim 1, also including a housing attached to the mouth portion of the dissection balloon, said housing including a valve means through which inflating fluid can be supplied to the dissection balloon.
4. The balloon of claim 1, wherein the viewing window is made of rigid material.
5. The balloon of claim 1, wherein the viewing window is a lens.
6. The balloon of claim 5, wherein the viewing window is a wide angle lens.
7. A balloon, including:a mouth portion; and a remaining portion having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics when the remaining portion is inserted between two tissue layers, to dissect said tissue layers or anchor an object connected to the balloon to said tissue layers, wherein the remaining portion comprises a first sheet having a first elasticity, and a second sheet having a second elasticity bonded to the first sheet, and wherein the second elasticity is substantially less than the first elasticity. 8. A dissection balloon, including:a mouth portion; and a remaining portion having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics when the remaining portion is inserted between two tissue layers, to dissect said tissue layers or anchor an object connected to the balloon to said tissue layers, wherein the remaining portion is shaped so that inflation of the dissection balloon when the remaining portion is between the two tissue layers dissects said tissue layers, and wherein the dissection balloon comprises: a first sheet having a first elasticity and neck portion; and a second sheet having a second elasticity bonded to the first sheet, wherein the second elasticity is substantially less than the first elasticity, and the second sheet is bonded to the first sheet so that the second sheet reinforces the neck portion. 9. A dissection balloon, including:a mouth portion; and a remaining portion having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics when the remaining portion is inserted between two tissue layers, to dissect said tissue layers or anchor an object connected to the balloon to said tissue layers, wherein the remaining portion comprises:a first sheet and a second sheet, the first sheet and the second sheet have substantially the same size and shape, and the first sheet has a neck portion; and a third sheet bonded to the first sheet so as to reinforce the neck portion. 10. A dissection balloon, including:a mouth portion; and a remaining portion having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics when the remaining portion is inserted between two tissue layers, to dissect said tissue layers or anchor an object connected to the balloon to said tissue layers, wherein the remaining portion comprises:a first sheet; a second sheet bonded to the first sheet; and a third sheet bonded to a central portion of the second sheet, wherein the first sheet and the second sheet have substantially identical size, shape, and elasticity, and the third sheet has an elasticity substantially less than the elasticity of the second sheet. 11. The balloon of claim 10, wherein the remaining portion also comprises a fourth sheet bonded to a central portion of the first sheet, wherein the fourth sheet has an elasticity substantially less than that the elasticity of the first sheet.
12. A dissection balloon, including:a mouth portion; and a remaining portion having nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics when the remaining portion is inserted between two tissue layers, to dissect said tissue layers or anchor an object connected to the balloon to said tissue layers, wherein the remaining portion comprises:a first sheet; and a second sheet bonded to the first sheet, wherein the first sheet and the second sheet have substantially identical size and shape, the second sheet has lateral end portions and a central portion between the lateral end portions, the first sheet and the lateral end portions of the second sheet have substantially identical elasticity, and the central portion of the second sheet has an elasticity substantially less than the elasticity of the first sheet. 13. The balloon of claim 12, wherein the lateral end portion and the central portion are portions of a single piece of material, but said material has greater thickness at the central portion than at the lateral end portions.
This is a divisional of application Ser. No. 08/542,666, filed Oct. 13, 1995, now U.S. Pat. No. 5,728,119, which is a continuation-in-part (C.I.P.) of U.S. application Ser. No. 08/405,284, filed Mar. 16, 1995, of inventors Jeffrey A. Smith, Albert K. Chin, and Frederic H. Moll, now U.S. Pat No. 5,632,761, which is a C.I.P. of Ser. No. 08/365,096, filed Dec. 28, 1994, of inventors Albert K. Chin and Todd Thompson, now abandoned which is a C.I.P of Ser. No. 08/319,552, filed Oct. 7, 1994 of inventors Albert K. Chin, Jeffrey A. Smith, John P. Lunsford and Frederic H. Moll, now abandoned which is a C.I.P. of Ser. No. 08/282,287, filed Jul. 29, 1994 of inventors Frederic H. Moll, Jeffrey A. Smith, John P. Lunsford and Albert K. Chin, now U.S. Pat. No. 5,704,372, which is a C.I.P. of Ser. No. 911,714, filed Jul. 10, 1992, of inventors Albert K. Chin and John P. Lunsford, which is a C.I.P. of Ser. No. 794,590, filed Nov. 19, 1991, now issued as U.S. Pat. No. 5,309,896, of inventors Frederic H. Moll, Charles Gresl, Jr., Albert K. Chin, and Philip K. Hopper, which is a C.I.P. of Ser. No. 706,781, filed May 29, 1991, now abandoned, of inventors Frederic H. Moll, Albert K. Chin, Diane E. Caramore, and Frank T. Watkins III. The specifications of the above-referenced applications, which are commonly owned with present application, are incorporated by reference into the specification of the present application.
The abdominal wall includes various layers of tissue. The peritoneum (P) is the innermost layer. Overlying the peritoneum are several layers of tissue, including the properitoneal fat layer (FL) and the properitoneal fascia (F). The properitoneal fascia is the layer to which a mesh patch is preferably attached in hernia repair. The properitoneal fat layer separates the peritoneum from the properitoneal fascia. The properitoneal fat layer is relatively weak, which enables the peritoneum to be separated relatively easily from the fascia
An inguinal hernia occurs when the contents of the abdominal cavity break through the abdominal wall. As described above, a hernia is repaired by attaching a piece of mesh to the abdominal wall. To prevent the mesh from causing trauma to the bowel, either through irritation of the bowel by the rough surface of the mesh, or by adhesion of the bowel to the mesh, it is preferred to attach the mesh to the properitoneal fascia With the mesh attached to the fascia, the peritoneum covers the mesh and isolates the bowel from the mesh.
Laparoscopic techniques to perform hernia repair are being used increasingly frequently. 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 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. Part of the peritoneum is dissected from the properitoneal fat layer to provide access to the fat layer. This is conventionally done by blunt dissection, such as by sweeping a rigid probe under the peritoneum. In this procedure, it is difficult to dissect the peritoneum cleanly since patchy layers of properitoneal fat tend to adhere to the peritoneum.
In an alternative known laparoscopic hernia repair procedure, the belly is insufflated. 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 peritoneum. 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 is quite thin. Additionally, after initial dissection of the properitoneal space, known surgical procedures require introduction of various instruments in the space to conduct the surgery. These instruments can cause inadvertent puncture of the peritoneum wall after the initial dissection. A puncture destroys the ability of the space between the peritoneum and the fascia to hold gas insufflation; pressurized gas can travel through a puncture in the peritoneum to allow the fluid to migrate to the abdominal cavity and degrade the pressure differential maintaining the properitoneal cavity. Also, it is difficult to dissect the peritoneum cleanly since patchy layers of properitoneal fat tend to adhere to the peritoneum. Clearing difficult adhesions can sometimes result in a breach of the peritoneum itself.
U.S. Pat. No. 5,309,896 (of which this application is a C.I.P.), discloses a laparoscopic hernia repair technique that enables a mesh patch to be attached to the properitoneal fascia without breaching the peritoneum. An incision is made through the abdominal wall as far as the properitoneal fat layer. A multi-chambered inflatable retraction device is pushed through the incision into contact with the peritoneum, and is used to separate the peritoneum from the overlying tissue layer. The main end chamber of the inflatable retraction device is then inflated to elongate the inflatable retraction device towards the site of the hernia As it inflates, the inflatable retraction device gently separates more of the peritoneum from the overlying tissue layer. Once the main chamber of the inflatable retraction device is fully inflated, a second inflatable chamber is inflated. The second inflatable chamber enables the inflatable retraction device to continue to separate the peritoneum from the other tissue layers after the main inflatable chamber has been deflated.
One or more apertures are then cut in the envelope of the main inflatable chamber to provide access to the site of the hernia for instruments passed into the nain chamber. With such an arrangement, instruments pass through the main chamber while the main chamber remains between the peritoneum and the overlying layers. In this way, a patch can be attached to the properitoneal fascia without breaching the peritoneum.
In a method disclosed in U.S. Ser. No. 07/911,714 for using the two-component apparatus, the introducing device pushes the main envelope in a collapsed state through an incision through the second layer of tissue to place the main envelope between the first and second layers of tissue. The main envelope is then inflated to gently separate the first and second tissue layers. An endoscope may be passed through the bore of the introducing device into sthe main chamber to observe the extent of separation of the layers of tissue. The main envelope is then returned to a collapsed state, and the main envelope and introducing device are removed through the incision. Next, the insufflating device is inserted into the incision so that its distal end projects into the working space between the two layers of tissue, and the toroidal inflatable chamber is inflated. The anchor flange is slid distally along the insufflating device to compress the second layer of tissue between it and the expanded toroidal inflatable chamber, and thus to form a gas-tight seal. Insufflating gas is then passed through the insufflating device into the working space to maintain the separation of the first layer of tissue from the second. An endoscope may be passed through the bore of the insufflating device into the working space to observe within the working space.
A two-component apparatus (of the type disclosed in referenced U.S. Ser. No. 07/911,714) for separating tissue layers and insufflating the space between the separated layers is shown in FIGS. 1A-1C and 2A-2B. FIG. 1A shows a partially cut-away view of separation component 1 of the apparatus. In separation component 1, introducer tube 3 is a rigid tube having a bore with a circular cross section that can accommodate an endoscope.
Main envelope 12 defmes a main inflatable chamber 13. Main envelope 12 is fitted to distal end 15 of introducer tube 3. Main envelope 12 is shown in a collapsed state in FIGS. 1B and 1C. Dotted line 12X indicates the extent of main envelope 12 with chamber 13 in its expanded state. It should be noted that although the main envelope 12 is illustrated as generally spherical, it can be formed as oblong, "hockey puck" or disc shaped, kidney bean shaped or in other shapes as suited for the particular dissection contemplated.
The first part of a method (described in U.S. Ser. No. 07/911,714) using separation component 1 of the two-component apparatus of FIGS. 1A-1C and 2A-2B to separate a first layer of tissue from a second layer of tissue will next be described with reference to FIGS. 3A-3E (the entire method, for repairing a hernia, will be described with reference to FIGS. 3A-3I).
FIGS. 3A-3I show a longitudinal cross section of the lower abdomen. As indicated by FIG. 3A, an incision about 12-15 mm. long is made in the abdominal wall (AW), and is carried through the abdominal wall as far as, and including, the properitoneal fat layer (FL). Distal end 15 of introducer tube 3 of separation component 1 is then inserted into the incision to bring the distal end into contact with the peritoneum (P). Additional gentle pressure detaches the part of the peritoneum in the immediate vicinity of the incision from the overlying layer, as shown in FIG. 3B. FIG. 3B shows the peritoneum (P) detached from the properitoneal fat layer (FL). The deflated main envelope cannot be seen in FIG. 3B because it is inverted within the bore of introducer tube 3.
The inflation fluid progressively expands the main envelope 12, and hence the main inflatable chamber 13 defmed by the main envelope, into an expanded state (as shown in FIG. 3C). The main envelope expands between the peritoneum and the properitoneal fascia, and gently and progressively detaches an increasing area of the peritoneum from the overlying layer as it expands. When the main envelope is in its expanded state, the main inflatable chamber is preferably about 4"-6" (100-150 mm) in diameter.
Insufflation component 21 (shown in FIGS. 2A and 2B) of the two-component apparatus of FIGS. 1A-1C and 2A-2B will next be described. Insufflation component 21 comprises inner tube 35 and outer tube 37 mounted coaxially, with the outer tube covering the inner tube over most of the length of the inner tube. The inner tube is similar to the introducer tube 3 (FIG. 1A), and is a rigid tube having a bore with a circular cross section that can accommodate a 10 mm endoscope.
The use of insufflation component 21 in the second part of the method of FIGS. 3A-3I using the two-component apparatus of FIGS. 1A-1C and 2A-2B will next be described. It is preferred to use separation component 1 in conjunction with the first part of the method (described with referenced to FIGS. 3A-3E) and for dissecting the first and second tissue layers, but the second part of the method (using insufflation component 21) may be used in following any other dissection operation including manual dissection with an endoscope, graspers, operating scope or any blunt instrument which may be used to dissect the tissue layers by sweeping the area between the layers.
As part of the hernia repair procedure, additional gas-tight trocar sheaths are inserted through the abdominal wall into the working space, as shown in FIG. 3I. An endoscope (not shown) can be passed into the working space through the bore of inner tube 35, or through one of the additional trocar sleeves for observation. If the properitoneal fat layer remains attached to the properitoneal fascia, it is scraped off the fascia around the site of the hernia so that the patch can be attached directly to the fascia
A patch, preferably a Dacron� or Teflon� mesh, shown gripped by grippers, is passed through the sleeve of one trocar into the working space. Using the grippers, the patch is manipulated to place it in contact with the properitoneal fascia over the site of the hernia The patch is attached to the properitoneal fascia by staples inserted using a stapler passed through the trocar sleeve into the working space. Sutures can alternatively be used to attach the patch to the properitoneal fascia.
One-component apparatus 121 (one of the one-component apparatus embodiments disclosed in U.S. Ser. No. 07/911,714) is shown in FIG. 4A. Apparatus 121 is similar to insufflation device 21 of FIGS. 2A-2B, and components of apparatus 121 corresponding to those of device 21 are identified by the same reference numbers as in FIGS. 2A-2B with "100" added thereto. Apparatus 121 comprises tube assembly 160, including an inner tube 135 coaxially mounted inside an outer tube 137. Outer tube 137 covers inner tube 135 over most of the length of the inner tube. The inner tube is a rigid tube having a bore with a circular cross section that can accommodate an endoscope (not shown).
The apparatus of FIGS. 4A-4C also includes main envelope 112 detachably attached to the bore of inner tube 135. The main envelope defines main inflatable chamber 113. Main envelope 112 is preferably formed of an elastomeric material such as latex, silicone rubber, or polyurethane (but can also be formed from a thin, inelastic material such as Mylar�, polyethylene, nylon, etc.). If an inelastic material is used for envelope 112, it should be suitably packaged to fit inside the bore of the inner tube when in its collapsed state.
FIG. 5A shows a one-component apparatus (which is a variation on the apparatus of FIGS. 4A-4C) having an elongated main envelope 112A. As shown in FIG. 5A (and described in referenced U.S. application Ser. No. 07/911,714), tube assembly 160A includes inner tube 135A mounted coaxially inside outer tube 137A, with the proximal and distal ends of the tubes interconnected. Space 151A between the inner tube and the outer tube communicates with the toroidal inflatable chamber through a radial passage in the wall of the outer tube. The space between the inner tube and the outer tube also communicates with the toroidal chamber inflation valve 153A. The bore of the inner tube 135A communicates with the port 125A, fitted with the insufflation valve 185. The port 125A is also fitted with a flapper valve 132A, including the flapper valve seat 134A, which maintains gas pressure when the apparatus is used for insufflation. Flapper valve seat 134A also provides a gas-tight seal around any instrument, such as endoscope E, passed through the flapper valve.
When inflation fluid is passed into main inflatable chamber 113A through valve 131A, distal end 177 of main envelope 112A is ejected from inner tube 135A. The inflation fluid then progressively expands the main envelope 112A, and hence main inflatable chamber 113A defined by the main envelope, into an expanded state as shown in FIG. SA. The part of the main envelope inside the inner tube is subject to the same inflation pressure as the distal end 177 of the main envelope, but is constrained by the inner tube and so does not inflate.
The toroidal inflatable chamber and anchor flange 155A of the embodiment of FIGS. 5A-5D are the same as in the embodiment of FIGS. 4A-4C, and will not be described again.
Such a method (described in U.S. Ser. No. 07/911,714) of using either the apparatus of FIGS. 4A-4C or that of FIGS. 5A-5D to separate a first layer of tissue from a second layer of tissue will next be described with reference to FIGS. 6A-6H. For specificity, FIGS. 6A-6H will be described with reference to separation of the peritoneum from the properitoneal fascia in the course of repairing a hernia using the apparatus of FIGS. 4A-4C.
FIGS. 6A-6H show a longitudinal cross section of the lower abdomen. Incision I about 12-15 mm. long is made in the abdominal wall, and carried through the abdominal wall as far as, and including the properitoneal fat layer as shown in FIG. 6A. Distal end 115 of tube assembly 160 of apparatus 121 is then inserted into the incision to bring the distal end into contact with the peritoneum. Additional gentle pressure detaches the part of the peritoneum in the immediate vicinity of the incision from the overlying layer, as shown in FIG. 6B. FIG. 6B shows the peritoneum detached from the properitoneal fat layer. The main envelope cannot be seen in FIGS. 6A and 6B because it is inverted within the bore of the tube assembly.
The inflation fluid progressively expands main envelope 112, and hence main inflatable chamber 113 defmed by the main envelope, into an expanded state as shown in FIG. 6C. The main envelope expands between the peritoneum and the properitoneal fat layer, and gently and progressively detaches an increasing area of the peritoneun from the overlying layer as it expands. When the main envelope is in its expanded state, the main inflatable chamber is preferably about 4"-6" (100-150 mm) in diameter.
When a sufficient area of the peritoneum is detached, the supply of inflation fluid is turned off. The inflation fluid is then vented from main inflatable chamber 113, and the main envelope progressively returns to its collapsed state. The peritoneum remains detached from the overlying layer, however, as shown in FIG. 6D. The main envelope is then removed from the bore of tube assembly 160. The different methods of removing the main envelope from the bore of the tube assembly for the different forms of the one-component apparatus (that of FIGS. 4A-4C and that of FIGS. 5A-5D) are described above.
As part of a hernia repair procedure, additional gas-tight trocar sleeves (not shown) are inserted through the abdominal wall into the working space. The same procedure described above in connection with FIG. 3I is used to attach a mesh patch to the properitoneal fascia over the site of the hernia The process can be observed using an endoscope passed through the bore of tube assembly 160, or through one of the additional trocar sleeves.
Such second embodiment of a one-component apparatus is shown in FIGS. 7A-7B and 8A-8B. In this embodiment, a substantially toroidal shape of the main chamber avoids the need to detach and remove the main envelope at the end of the separation process, and the toroidal main chamber provides both the separating function of the main chamber and the sealing function of the toroidal chamber of the embodiment of FIGS. 4A-4C.
FIG. 7A shows main envelope 212 in its expanded state. To reach this state, a source of inflation gas is connected to valve 231 and the gas flows into the main inflatable chamber through the bore of outer tube 237. The pressure acting on surface 238 of the main envelope 212 causes the main envelope to assume the toroidal shape shown in FIG. 7A to define toroidal main chamber 213, with surface 234 defining the "hole" or "bore" through the toroidal main envelope. FIGS. 7A and 7B show the correspondence between the surfaces 234 and 238 of the main envelope when the main envelope is in a collapsed state (FIG. 7B) and in an expanded state (FIG. 7A).
FIG. 8B shows an endoscope E passed through first flapper valve 202, first port 226, the bore of inner tube 235, and bore 234 of main envelope 212. The distal part of the endoscope emerges from the bore of the main 212, and can be advanced beyond the main inflatable chamber 213 to observe tissue such as the site of the hernia more closely. The endoscope is inserted through the first port, the inner tube, and the bore of the main envelope during insufflation using the apparatus. Instruments other than endoscopes can also be passed to the site of-the hernia through the first flapper valve, the first port, the inner tube, and the bore of the main envelope if desired.
In a method described in U.S. Ser. No. 07/911,714 of using the embodiment of FIGS. 7A, 7B, 8A, and 8B to separate a first layer of tissue from a second layer of tissue, the outer elongated tube pushes the main envelope in a collapsed state through an incision through the second layer of tissue to place the main envelope between the first layer of tissue and the second layer of tissue. The main envelope is then inflated to gently separate the first layer of tissue from the second layer of tissue, and to create working a space between the layers of tissue. An endoscope may be passed through the outer elongated tube into the main chamber to observe the extent of separation of the layers of tissue. The anchor flange is slid distally along the introducing device tube to compress the second layer of tissue between it and the main inflatable chamber, to form a gas-tight seal. Insufflating gas is then passed through the bore of the inner elongated tube and the bore of the main envelope into the working space to maintain the separation of the first layer of tissue from the second. An endoscope may be passed through the bore of the inner elongated tube and the bore of the main envelope into the working space to observe within the working space.
More specifically, in performing this method, an incision about 12-15 mm long is made in the abdominal wall, and carried through the abdominal wall as far as, and including, the properitoneal fat layer. The distal end of tube assembly 260 is then inserted into the incision into contact with the peritoneum. Additional gentle pressure detaches the part of the peritoneum in the immediate vicinity of the incision from the overlying layer (at this time, main envelope 212 is inverted within the bore of the tube assembly). A source of inflation fluid is then connected to valve 231. A gas, preferably air, is the preferred inflation fluid, but other gases, such a carbon dioxide can be used. A liquid such as saline solution can be used, but a gas is preferred to a liquid because liquids change the optical properties of any endoscope inserted into the inflatable chamber. The flow of inflation fluid is turned on, which ejects the main envelope 212 from the bore of tube assembly 260.
The inflation fluid progressively expands main envelope 212, and hence main inflatable chamber 213 defined by the main envelope, into an expanded state. The main envelope expands between the peritoneum and the properitoneal fat layer, and gently and progressively separates an increasing area of the peritoneum from the overlying layer as it expands. When the main envelope is in its expanded state, the main inflatable chamber is preferably about 4"-6" (100-150 mm) in diameter.
In another method described in U.S. Ser. No. 07/911,714, access is provided through the abdominal wall from near the umbilicus to repair a hernia This method will be described with reference to FIGS. 9A-9I. This method is often preferable to the hernia repair methods described above in which the incision is placed close to the site of the hernia, since in practice, it is preferred to make the incision at or near the umbilicus because the boundary between the peritoneum and the properitoneal fat layer can be more directly accessed near the umbilicus. The midline location of the umbilicus is devoid of muscle layers that would otherwise need to be traversed to reach the properitoneal fat layer.
In the method of FIGS. 9A-9I, the main envelope is partially expanded, collapsed, and advanced toward the site of the hernia This sequence is repeated to progressively separate the peritoneum from the overlying layer and form the tunnel from the umbilicus to the site of the hernia. Then, at or near the site of the hernia, the main envelope is fully expanded to provide the working space at the site of the hernia The working space is then insufflated to maintain the separation of the peritoneum from the overlying layer. The method of FIGS. 9A-9I can be practiced using any of the two-component or one-component apparatuses described above. For specificity, the method will be described with reference to a two-component apparatus.
An incision about 12-15 mm long is made in the abdominal wall AW, and is carried through the abdominal wall as far as, and including, the properitoneal fat layer FL. The incision is made at the umbilicus U, as shown in FIG. 9A.
When main envelope 12 expanded such that the main inflatable chamber 13 is about one-fourth of its fully-expanded diameter, i.e., about 1.0"-1.5" (25-37 mm) in diameter, the supply of inflation fluid is turned off. Valve 11 is then operated to vent inflation fluid from the main inflatable chamber 13. The main envelope progressively returns to its collapsed state, as shown in FIG. 9D. The peritoneum portion DP that was separated by the main inflatable chamber remains detached from the overlying layer, as shown. Alternatively, the main envelope can be inflated to a fully-expanded state.
Once distal part 15 of the introducer tube has been positioned, the separation component 1 is clamped in position, or is gripped, and inflation fluid is once more passed through the valve 11 and the bore of introducer tube 3 into main inflatable chamber 13. The main envelope 12 expands once more, increasing the extent of the detached part of the peritoneum towards the groin, as shown in FIG. 9F. The increased extent of the detached part of the peritoneum is indicated by line DP' in FIG. 9F. The extent of the detached part of the peritoneum is increased in the direction from the umbilicus to the groin, but not in the direction transverse to this direction. Endoscope E is used to observe the extent of the separation.
The process of collapsing the main envelope 12, advancing the distal part 15 of the introducer tube to the limit of the detached part DP' of the peritoneum in the direction of the groin, holding the introducer tube in position, and partially re-inflating main envelope 12, is repeated until the detached part of the peritoneum includes the peritoneum over the site of the hernia This process provides a tunnel T between the incision at the umbilicus and the site of the hernia (as shown in FIGS. 9G, 9H, and 9I).
When the main envelope is in the vicinity of the site of the hernia H, main envelope 12 is filly inflated to form a working space WS including the site of the hernia This is shown in FIG. 9G.
In preferred embodiments, the balloon is a long-necked balloon deployed through a cannula The balloon has an open distal end, and a rigid, transparent window (made of polished, clear polycarbonate or acrylic material or the like) is glued over its open distal end. When the distal end of the balloon has been inserted between tissue layers, an endoscope extending through the cannula within the balloon can view the tissue layers through the window (whether or not the balloon is inflated).
Other embodiments of the invention are methods for using an apparatus for tissue dissection and instrument anchoring, said apparatus including a long-necked dissection balloon deployed through a cannula. The dissection balloon has a window at its distal end, or nonuniform elasticity selected to achieve desired inflated shape and pressure characteristics, or both such a window and such nonuniform elasticity. The distal end of the dissection balloon is inserted between tissue layers and inflated to dissect the tissue layers. In some embodiments, after dissection using the dissection balloon, the dissection balloon is deflated and withdrawn through the cannula before a medical operation is performed in a working space between the dissected tissue layers. In other embodiments, after dissection using the dissection balloon, the dissection balloon is deflated but retained in the patient during performance of a medical operation. In other embodiments, where the dissection balloon has lobes or other portions shaped so that instruments can be positioned between them, the dissection balloon remains inflated in the patient after the tissue layers have been dissected, instruments are then positioned between the dissected tissue layers without being obstructed by the inflated dissection balloon (e.g., between lobes or other separated portions thereof), and the instruments are manipulated to perform a medical operation.
FIG. 1A-1C and 2A-2B show a two-component apparatus for separating tissue layers and insufflating the space between the separated layers, where:
FIGS. 3A-31 are longitudinal cross sections of the abdomen illustrating a method of using a two-component apparatus to separate the peritoneum from the overlying layer, where:
FIG. 3H shows the working space between the peritoneum and the overlying layer insufflated with a gas passed through the bore of the insufflation component;
FIGS. 4A-4C show an embodiment of a first one-component apparatus for tissue dissection and instrument anchoring, where:
FIG. 4B shows details of the area marked "A" at the distal end of the tube assembly in FIG. 4A; and
FIGS. 5A-5D show an alternative one-component apparatus for tissue dissection and instrument anchoring, where:
FIGS. 6A-6H are longitudinal cross sections of the abdomen illustrating a method of using a one-component apparatus to separate the peritoneum from the overlying layer, wherein:
FIGS. 9A-91 show an alternative method of using either a one-component or two-component apparatus to separate the peritoneum from the overlying layer near the groin, with the apparatus inserted through an incision near the umbilicus. FIGS. 9A-9H are longitudinal cross sections of the abdomen, wherein:
FIG. 14 is a partially side elevational, partially side cross-sectional view of the FIG. 10 apparatus (with balloon 512 inflated and endoscope 515' substituted for obturator 515).
FIG. 17 is a cross-sectional view of the balloon of FIG. 16, taken along line A--A.
FIG. 18 is a cross-sectional view of the balloon of FIG. 16, taken along line B--B.
FIG. 24A is a plan view of three component sheets of yet another dissection balloon designed in accordance with the invention.
FIGS. 26-35 show a method of using the inventive apparatus (such as that of FIGS. 10-14) to separate the peritoneum from the overlying layer near the groin, with the apparatus inserted through an incision near the umbilicus. FIGS. 26-35 are longitudinal cross sections of the abdomen, wherein:
FIG. 36 is an perspective view of a balloon assembly for use in alternative embodiments of the invention.
Throughout the disclosure, including in the claims, the term "balloon" is used in a broad sense to denote any inflatable structure, regardless of the elasticity of the material comprising it. For example, the term balloon is employed to denote both a thin-walled, inflatable structure consisting of material of low elasticity (which does not stretch significantly during inflation), and also a thin-walled, inflatable structure consisting of highly elastic material such as a sheet of urethane (which does stretch significantly during inflation). In preferred embodiments to be described, the invention employs a balloon having nonuniform elasticity,(elasticity which varies from one place to another on the balloon's surface).
Throughout the disclosure, the term "one-component" apparatus denotes, with reference to an apparatus for tissue dissection and instrument anchoring, an apparatus having a cannula, wherein after the cannula is inserted into a patient, it remains in the patient during tissue dissection using the apparatus and during anchoring of the apparatus in the patient to enable performance of medical procedures (subsequent to dissection) using the apparatus.
Mouth 512B of dissection balloon 512 is attached (preferably by glue) to tube portion 564 of housing 513, as shown in FIGS. 14 and 12. With reference to FIG. 14, the apparatus is preferably assembled by removably attaching the distal face of housing 513 (the left face in FIG. 14) to the proximal face of housing 509 (such as by snap fitting or bayonet fitting means). Elongated neck 512A of balloon 512 is extended through tube portion 564 of housing 513, through the central channel of housing 509, and through cannula 505. Endoscope 515' is inserted through seal 560 of housing 513, and (within balloon 512) through tube portion 564 of housing 513, the central channel of housing 509, and cannula 505 until the distal end 515A of endoscope 515' abuts window member 508 at the distal end of balloon 512 (as shown in FIG. 14).
Before the apparatus is first used, balloon 512 is packed against obturator 515 so as to occupy a small volume (as shown in FIG. 10), so that the packed balloon 512 does not significantly impede insertion of obturator 515 into the patient. At an appropriate time during use of the apparatus (e.g., before or during inflation of balloon 512), balloon 512 is expanded (inflated as shown in FIG. 14) to occupy a larger volume. Obturator 515 is withdrawn and replaced by an endoscope (e.g., endoscope 515' of FIG. 14) for viewing the patient through window 508 of balloon 512. Alternatively, before the apparatus is first used, balloon 512 is packed against an endoscope (e.g., endoscope 515') so as to occupy a small volume, so that the packed balloon 512 does not significantly impede insertion of the endoscope into the patient, and allows visualization of anatomy during insertion of the device.
Insufflation valve 511 is used to supply insufflation gas or liquid into a working space within the patient. Valve 511 is typically used when obturator 515 (or endoscope 515'), the dissection balloon assembly comprising balloon 512 and housing 513, and ring 514 have been removed from the remaining portion (the tissue retraction and instrument anchoring subassembly) of the FIG. 10 apparatus (and valve 521 has been closed, and the anchoring assembly comprising collar 504 and clamp 503 has been locked to anchor the remaining portion of the apparatus to the patient). Valve 511 is opened by inserting an inflation device into it. When opened, valve 511 provides a path for insufflation fluid to flow through the channel surrounded by cannula 505 into the working space (sealed by expanded balloon 517 and the clamp assembly 503, 504 (and provides a path for allowing insufflation fluid to escape out from the working space through valve 511.
We next describe a preferred structure of the dissection balloon assembly in more detail with reference to FIG. 12. To assemble this assembly, mouth 512B of balloon 512 is glued to a cylindrical rim on the left face of base 562 (as shown in FIG. 12) of housing 513. Tube 564 is glued to a cylindrical rim on the opposite face of base 562, and the neck 512A of balloon 512 is pulled to the right through base 562 and tube 564 into the configuration shown in FIG. 12. Then, cover 566 is glued to base 562 to form housing 513. Thus, when inflation port 531 of cover 566 is opened, inflation fluid can be pumped through port 531 and the volume enclosed by housing 513 into mouth 512B of balloon 512. Main seal 560 is glued around the central orifice through cover 566, to provide a fluid seal preventing fluid from escaping out through this orifice when an obturator or other rod-shaped instrument is inserted through the orifice into the interior of balloon 512. Typically, the assembled FIG. 10 apparatus is packaged with an obturator such as obturator 515 extending through seal 560 into the interior of balloon 512. At various times during use of the apparatus, the obturator is removed and replaced by an endoscope (e.g., endoscope 515' of FIG. 14) having the same or similar outer dimensions. Seal 560 is preferably made of rubber or another elastomer.
Any of the balloon cannula systems of referenced U.S. Ser. No. 08/365,096 can be employed in alternative implementations of the present invention, e.g., to provide a supporting portion which extends into the interior of the dissection balloon to provide support for the dissection balloon during inflation.
We next describe preferred implementations of dissection balloon 512 (and variations thereon) in more detail. FIGS. 16-18 show a first preferred embodiment of balloon 512.
In the embodiment of FIGS. 16-18, balloon 512 includes: first and second sheets 513A and 513B attached together at seam 512C such as by RF (radio frequency) welding; and neck reinforcing sheet 513C attached to sheet 513A (such as by RF welding) at neck 512A of balloon 512. Preferably, sheets 513A and 513B are polyurethane sheets of 0.002 inch thickness (each having high elasticity so that it stretches substantially during inflation) and sheet 513C is made of material having low elasticity (e.g., polyester film, or a multilayer film commercially available from Rexham comprising polyurethane and polyester layers) so that it does not stretch significantly during inflation. This preferred embodiment (with window 508 attached to its distal end), when inflated, has the appearance shown in FIGS. 18C and 18D, where FIG. 18C is an elevational view of the distal end of the inflated balloon and FIG. 18D is a side elevational view of the distal end of the inflated balloon.
A preferred technique for manufacturing balloon 512 of FIG. 16 is to bond together sheets 513A and 513B with a weld (indicated by the dashed line around the periphery of FIG. 16) of width X around the sheets' peripheries, and then to bond sheets 513A and 513C together with a weld of width X around their peripheries. Then, the weld is trimmed to a width Y (in FIG. 16, the trimmed weld's outer periphery is the solid line around the periphery of seam 512C. Then, end portion 512E is formed by cutting bonded sheets 513A and 513B along line 512F (shown in FIG. 16). The latter cut gives end portion 512E a cylindrical shape to which a suitable window 508 (made of rigid material) can be glued.
The width W of balloon 512 of FIG. 16 is longer than the length (the distance from line B--B to line 512F) of balloon 512, in order to increase the lateral extent of the tissue layers dissected by this balloon when it is inflated. In a typical implementation of balloon 512 of FIG. 16, width W is 6.8 inches, length L of sheet 513C is 5.875 inches, width Z of reinforcing sheet 513C is 0.82 inch, width X of the original (untrimmed) weld around the periphery of balloon 512 is 0.125 inch, and width Y of the trimmed weld around the periphery of balloon 512 is 0.06 inch.
Each of FIGS. 19, 20, and 21 is a side elevational view of a balloon window for attachment to the distal end of the inventive dissection balloon, as window 508 is attached to the distal end of balloon 512 of apparatus 600 of the embodiment of FIGS. 10-14. The window shown in each of FIGS. 19-21 is preferably composed of transparent, rigid material such as polished, clear polycarbonate or acrylic material. The window of each of FIGS. 19-21 (and window 508 of FIGS. 10 and 14) functions mechanically to separate tissue layers when pushed against the tissue layers by a rigid obturator (or a rigid endoscope such as endoscope 515' of FIG. 14 whose distal end 515A is pushed against window 508 as shown in FIG. 14). In alternative embodiments, the window of the inventive balloon is transparent and either rigid or non-rigid, but sufficiently strong to retain a desired optical shape while (and after) being pushed against tissue layers by a rigid obturator (or other rigid instrument) deployed within the dissection balloon.
The window of each of FIGS. 19-21 has a circular groove 508A around its generally cylindrical side wall, so that end portion 512E of dissection balloon 512 shown in FIG. 16 (or a corresponding end portion of alternative embodiment of the inventive dissection balloon) can be conveniently glued to groove 508A. Alternatively, it can be stepped or formed in another fashion with a surface conducive to gluing or mechanical fastening, and can have a hollow base for accepting the distal end of an endoscope or obturator (as does the window of FIGS. 21A and 21B to be discussed below).
The window of FIGS. 21A and 21B is a lens, which has a flat rear optical surface 508F and a curved front optical surface 508G. Surface 508G has a curvature chosen to achieve the desired lens optical properties. The window of FIGS. 21A and 21B has a cylindrical skirt 508H which extends in the proximal direction (away from front surface 308G) from the periphery of surface 508F. Skirt 508H has multiple functions: to provide a surface conducive to gluing or mechanical fastening of a dissection balloon to the window; and (after the balloon has been attached to the window) to guide the distal end of an endoscope or obturator within the balloon into engagement with surface 508F and allow for positive control and manipulation of the balloon in response to movement of the endoscope or obturator (without tearing the balloon).
As an alternative (or in addition) to employing a cup-shaped window (such as the skirted window of FIGS. 21A and 21B), the balloon itself is shaped so that when the window is attached to the balloon's distal end, the balloon defmes a channel that guides the distal end of an endoscope or obturator within the balloon into engagement with the window. Such a channel also allows for positive control and manipulation of the balloon in response to movement of the endoscope or obturator (without tearing the balloon). An example of a dissection balloon having such a shape is dissection balloon 912 of FIG. 21C, whose distal end portion 912A is tapered to define a channel for receiving and capturing an obturator (or endoscope) 515. When obturator (or endoscope) 515 is moved, the force (e.g., frictional force) it exerts on distal end portion 912A allows for positive control and manipulation of balloon 912 in response to such movement.
The dissection balloon of the invention can have the alternative shape shown in FIG. 22. Dissection balloon 512' of FIG. 22 is identical to dissection balloon 512 of FIG. 16 except in that it has a circular cross-section (having radius R in the plane of FIG. 22 as shown) rather than an oblong cross-section (as does balloon 512 in the plane of FIG. 16). As shown in FIG. 22, balloon 512' includes rectangular neck reinforcing sheet 513C', but some alternative versions of balloon 512' do not include such a neck reinforcing sheet. The same materials can be used to manufacture balloon 512' (and each variation on balloon 512') as are used to manufacture each corresponding version of balloon 512. In a typical implementation of balloon 512' including neck reinforcing sheet 513C' as shown in FIG. 22, radius R is 2.125 inches, width Z of the neck reinforcing sheet is 0.82 inch, and length L of the neck reinforcing sheet is 5.875 inches.
Numerous other implementations of dissection balloons (and/or anchoring balloons) having nonuniform elasticity are contemplated. For example, dissection balloon 712 of FIG. 23 has nonuniform elasticity selected to achieve desired inflated shape and pressure. Dissection balloon 712 includes a first large sheet 700 bonded (such as by RF-welding around the periphery of FIG. 23) to a second large sheet (identical to sheet 700 but not visible in FIG. 23). The two large sheets are made of material having low elasticity (preferably a multilayer film commercially available from Rexham comprising polyurethane and polyester layers, but alternatively a film of other material such-as polyester). Two disk-shaped sheets 704 of material having high elasticity (preferably, polyurethane) are bonded to each large sheet. For example, two disk-shaped sheets 704 are bonded (such as by RF-welding) to sheet 700, each at annular weld region 702 as shown in FIG. 23. Each disk-shaped sheet 704 bonded to large sheet 700 is RF-welded to the corresponding disk-shaped sheet (the disk-shaped sheet below it, and thus not visible in FIG. 23) at annular weld region 708 shown in FIG. 23. Thus, when balloon 712 is inflated, its inelastic large sheets do not stretch significantly, but the elastic annular regions surrounding welds 708 do stretch significantly (and thus function as elastic baffles). As a result, balloon 712 has a very flat profile (in the sense that its inflated height in a direction perpendicular to the plane of FIG. 23 is very small relative to its maximum dimension in the plane of FIG. 23), it can be inflated to a greater pressure (when compared to a balloon made entirely of the inelastic material), and the stresses at its welds are more evenly distributed (when compared to a balloon made of two inelastic sheets bonded together at a single long weld).
In a variation on the FIG. 24 embodiment to be described with reference to FIG. 24A, the dissection balloon also has nonuniform elasticity selected to achieve desired inflated shape and pressure. This dissection balloon consists of a six sheets (three of which are shown in FIG. 24A, and the other three of which are identical to those shown in FIG. 24A). The six sheets are bonded together (such as by RF-welding). Four of the sheets are lateral end sheets 722' made of material having high elasticity (preferably, polyurethane). The two other sheets 720' are central sheets made of material having lower elasticity (or lower heat deflection temperature sensitivity) than sheets 722'. To construct the balloon, two end sheets 722' are bonded to the lateral edges of each central sheet 720' to make a composite sheet, one composite sheet is placed on the other (with the peripheries of the two composite sheets matched), and the two composite sheets are then bonded together around their matched peripheries.
With reference again to FIGS. 10-14, the apparatus of FIGS. 10 and 14 is designed so that insufflation can be performed after obturator 515 (or endoscope 515'), the dissection balloon assembly (comprising balloon 512 and housing 513), and ring 514 have been removed from the anchoring and tissue retraction assembly (comprising elements 509, 503, 504, 505, and 517), and after valve 521 has been closed, balloon 517 has been inflated, and collar 504 and clamp 503 have been locked to anchor the tissue retraction assembly to the patient. After removal of obturator 515, ring 514, and the dissection balloon assembly, an endoscope (or other instrument) can be inserted through the end port of housing 509 (thereby displacing flapper valve 521), and through cannula 505 into the working space within the patient (in order to view the working space or perform some medical procedure therein). However, alternative embodiments of the invention enable such a viewing operation (or medical procedure) to be performed (unimpeded by the dissection balloon) in other ways.
To implement a viewing operation or medical procedure (in a manner unimpeded by dissection balloon 512, such as where it is not desired to view through a window mounted at the balloon's distal end), balloon 512 is deflated (the inflation gas escapes out through the opened valve in port 631), the endoscope or obturator is removed from within balloon 512 and port 674, and lever 670 is then pushed down to align port 672 with aligned channels 664A and 666A. This translation of lever 670 causes lever 670 to move mouth 512B of the balloon downward, so that the portion of balloon neck 512A adjacent to mouth 512B moves against tapered section 665 of member 664, away from the aligned longitudinal axes of channels 664A and 666A. In this configuration, an endoscope (or other instrument) can be inserted through central channel 666A of member 666, through port 672, and through channel 664 (but not into the interior of balloon 512) into the working space within the patient (to enable viewing of the working space, or performance of a medical procedure therein, in a manner unobstructed by the dissection balloon).
As an alternative to implementing the FIG. 25 embodiment (but with use of a long-necked dissection balloon deployed through a cannula such as cannula 505 of FIG. 10, with a rigid window such as window 508 of FIG. 10 attached to the balloon's distal end), it may be desirable to attach the window to the distal end of the dissection balloon non-permanently, such as by a tether or hinge (e.g., a living hinge), rather than permanently (e.g., by glue). Then, at the end of tunneling using the inflated balloon, the balloon is deflated, the obturator or endoscope employed for tunneling is removed from within the balloon, the non-permanently attached window is moved away (e.g., rotated on its hinge, or pushed away but retained on a tether) from the longitudinal axis of the cannula Then, a surgical instrument or endoscope can be inserted through the cannula into the working space within the patient in a manner unimpeded by the window but without removing the balloon from the cannula. Where the window is tethered, it can be pushed out the distal end of the cannula after tunneling (so as to dangle on the tether in the balloon or between the dissected tissue layers), or the tether can be pulled out through the proximal end of the cannula (to remove the tethered window from the working space within the patient).
With reference to FIGS. 26-35, we next describe an embodiment of the inventive method for using an apparatus (such as that of FIGS. 10-14) having a long-necked dissection balloon deployed through a cannula and having a window at its distal end. For specificity, FIGS. 26-35 are described with reference to the embodiment of FIGS. 10-14 which includes dissection balloon 512, deployed through cannula 505, which has a rigid window 508 (which can be a lens) mounted at its distal end, and which also has an endoscope 515' deployed through cannula 505 and balloon 512 (with the distal end of the endoscope abutting window 508). For the purpose of illustration only, the method is described in the context of separating the peritoneum from the properitoneal fascia in the course of repairing a hernia Variations on the described embodiment (and in the apparatus employed to perform it) are useful for performing other medical procedures throughout the body.
As shown in FIG. 26, an incision about 12-15 mm long is made in the abdominal wall AW, and is carried through the abdominal wall as far as, and including, the properitoneal fat layer FL. The incision is made at the umbilicus U. The distal end of the apparatus (i.e., window 508 and the distal portion of balloon 512 to which window 508 is attached) is lubricated and then inserted into the incision to bring the distal end into contact with the peritoneum. Additional gentle pressure is exerted on the proximal end of endoscope 515', which presses window 508 against the peritoneum, thereby detaching the part of the peritoneum in the immediate vicinity of the incision from the overlying layer (as shown in FIG. 27). In subsequent steps, the apparatus is advanced along the posterior surface of the peritoneum (toward the right in FIG. 26) until the distal end of the device is located at or near the groin.
Alternatively, in any of the dissection steps of the method, an obturator or other instrument (having substantially the same shape as endoscope 515') can be substituted for endoscope 515'. Such other instrument can be removed and replaced by an endoscope at any time to enable viewing of the space within the dissected tissue using the endoscope.
At any time, including during inflation of dissection balloon 512 and during advancement of window 508 between layers of tissue in the patient, the patient can be viewed by light that has propagated through window 508 into endoscope 515'. To inflate balloon 512, a source of a suitable inflation fluid (not shown, but as previously described), is connected to port 531 which protrudes from dissection balloon housing 513, and the flow of inflation fluid is turned to inflate dissection balloon 512 at least partially (as shown in FIG. 28). Balloon 512 expands between the peritoneum P and the properitoneal fat layer FL and progressively detaches an increasing area of the peritoneum from the overlying tissue over the entire dissection area. When using the preferred embodiment of the apparatus in which balloon 512 has an oval profile when expanded (in the sense that its expanded width is much greater than its expanded height), balloon 512 should be packed and the apparatus deployed so that expanded balloon 512's largest cross-sectional area is parallel to the tissue layers being dissected (the largest cross-sectional area should be oriented in a plane perpendicular to the plane of FIG. 28 to maximize the area of the tissue dissection while minimizing trauma to the patient).
With reference to FIGS. 29-32, balloon 512 may be inflated and deflated a number of times, rather than just once, to dissect progressively the tissue layers. After inflating balloon 512 the first time (thereby partially dissecting the tissue layers), the inflation fluid in balloon 512 is vented and balloon 512 returns to its collapsed state, as shown in FIG. 29. The peritoneum DP that was separated by balloon 512 remains detached from the overlying layer. The apparatus, including collapsed dissection balloon 512, is then manipulated to advance the distal end (window 508) to the limit of detached peritoneum DP in the direction of the groin, as shown in FIG. 30. Endoscope 515' enables the position of the distal end relative to the detached part of the peritoneum to be observed.
Balloon 512 is then inflated again thereby increasing the extent of the detached part of the peritoneum towards the groin, as shown in FIG. 31. The extent of the detached part of the peritoneum is increased in the direction from the umbilicus to the groin, but is not significantly increased in the direction transverse to this direction. Endoscope 515' is again used to observe the extent of the separation (in the manner described above).
The "tunneling" process of collapsing dissection balloon 512, advancing the distal end of the apparatus to the limit of the detached part of the peritoneum in the direction of the groin, holding the distal end in position, and re-inflating the dissection balloon, is repeated until the detached part of the peritoneum includes the site of the hernia. Care should be exercised to avoid dissecting tissue below the pubic bone, and to avoid forcing the dissection balloon downward into the deep pelvis in a manner that would cause trauma to the bladder.
Then, dissection balloon 512 is deflated (by removing endoscope 515' from the proximal end of the apparatus while ring 514 remains in place to hold the flapper valve within housing 509 open). Then, the dissection balloon assembly (comprising housing 513 and deflated balloon 512) and ring 514 are removed from the retraction and anchoring assembly of the apparatus, leaving the retraction and anchoring assembly shown in FIG. 33 (with the flapper valve within housing 509 closed as a result of removal of ring 514). Then, a suitable source of inflation fluid is attached to anchor balloon inflation valve 510, and anchor balloon 517 is inflated, leaving the retraction and anchoring assembly in the configuration shown in FIG. 33. When fully inflated, anchor balloon 517 should not be in direct contact with the bladder's surface.
Then clamp 503 is advanced along cannula 505 toward the incision in the patient (preferably also, housing 509 is pulled back away from the incision in the patient), and clamp 503 is locked in a position along cannula 505 in which clamp 503 compresses foam collar 504 against the patient (as shown in FIG. 34). In this configuration, collar 504 helps to immobilize the anchoring and retraction assembly (including housing 509 and cannula 505) to the patient, and collar 504 applies a modest compressive force to the tissue between clamp 503 and inflated anchoring balloon 517, thereby helping balloon 517 form a seal to limit the escape of insufflation gas from working space WS within the patient out through tunnel T (between collar 504 and balloon 517 in the patient) during subsequent medical procedures. Inflated anchor balloon 517 itself preferably provides a substantially gas-tight seal with the entrance of the tunnel T. Of course, in alternative embodiments, anchor balloon 519 (described with reference to FIG. 15) is employed rather than anchor balloon 517 shown in various ones of FIGS. 26-35.
As shown in FIG. 36, balloon 901 is formed from first sheet 913 and second sheet 915 (connected at seam 943) in a manner described above with reference to FIGS. 16-18. Balloon 901 is preferably made of the materials and fabricated in the manner described above in connection with FIGS. 16-24, and can be elastic, inelastic, or partially elastic and partially inelastic.
A preferred method of packing balloon 901 will be described with reference to FIGS. 38-42. As shown in FIG. 38, first lateral portion 917 of balloon 901 is initially displaced inwardly (i.e., pushed "inside-out" into the interior of the balloon). Although it is preferred to displace first portion 917 in a direction perpendicular to the longitudinal axis of the balloon's neck 901A, first portion 917 can alternatively be displaced inwardly in any other direction.
Inwardly-displaced portion 917 is then rolled up using a rolling device 921 inserted through neck 901A. Referring to FIGS. 39 and 40, rolling device 921 includes two rolling rods 923 for grasping first inwardly-displaced portion 917, when rods 923 are disposed in the interior of the balloon. Each rod 923 has a diameter of about 1/8 inch and rods 923 are separated by a gap of preferably less than 1/16 inch. The gap size and diameter of the rods 923 may vary, depending on the thickness of the balloon material. Furthermore, the rolling device 921 may include any other feature for grasping the inwardly displaced portion, such as a pair of jaws, a clamp or a pair of elastically deformable arms. The rolling device has a knurled handle 925 which is gripped to manipulate it.
Rolling device 921 is rotated to roll the portion 917 as shown in FIG. 41 into a roll 931 (shown in FIG. 42). After portion 917 has been rolled into a sufficiently compact roll 931, second lateral portion 927 of balloon 901 (opposite first portion 917) is displaced inwardly and rolled in the same manner as portion 917 to form a roll 929 (shown in FIG. 42). An obturator (or endoscope) 935 is positioned through neck 901A of balloon 901 between rolls 929 and 931 to provide structural support for balloon 901 during insertion into the patient. Rolls 929, 931 are positioned on opposite sides of obturator (or endoscope) 935 with obturator (or endoscope) 935 preferably including concave portions 938 for receiving the rolls 929, 931. The two rolls 929, 931 (and the portion of element 935 between them) are then encased within sheath 933, which is similar or identical to sheath 506 described above in conjunction with the apparatus of FIGS. 10-14.
First and second inwardly-displaced portions 917, 927 can alternatively be rolled in a conventional manner from opposing lateral sides after portions 917,927 have been displaced inward as shown in FIGS. 46 and 47. In this case, displaced first and second portions 917, 927 divide balloon 901 into an upper part 939 and a lower part 941. The upper part 939, first portion 917, and lower part 941 are then rolled up in a conventional manner as shown in FIG. 47. When balloon 901 is rolled in the manner shown in FIGS. 46-47, the balloon 901 will suffer the problem of relatively high differential motion between balloon 901 and the adjacent tissue layers during initial inflation and deployment, however, during the end of the inflation, the balloon will have relatively low differential motion relative to the tissue layers. This method of packing a balloon is useful when problematic internal structures are positioned laterally outward from the obturator. When the balloon is formed from first and second sheets 913, 915, the upper and lower parts 939, 941 are preferably formed by the first and second sheets, respectively. By configuring balloon 901 in this manner, the first and second portions include a part of seam 943 between the first and second sheets 913, 915. When coupling the first and second sheets 913, 915 together with an RF weld, seam 943 forms a relatively thin, rigid periphery which can cut or otherwise traumatize the tissue layers. Referring to FIG. 43, seam 943 everts into a space 945 between the tissue layers along the lateral edges of balloon 901 thereby minimizig contact between seam 943 and the tissue layers.
A balloon 901' having a number of inwardly-displaced portions in the form of accordion-folds 947 (when inflated) as shown in FIG. 48 can be employed in place of balloon 901 of FIGS. 36-37. FIG. 48 also shows obturator (or endoscope) 935 within balloon 901' (having been inserted through neck 902' of balloon 901'). FIG. 49 shows balloon 901' of FIG. 48 in a compact, deflated state.
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