Surgical access device

0001The present invention relates substantially to surgical tools, such as instruments that facilitate the access of a sealed state by the hand of a surgeon, across the body wall into the body cavity.

0002Although some surgical disciplines can seal body cavities or spaces, it is sought to provide surgical tools such as guidewires, endoscopes, as well as mechanisms or instruments that allow the introduction of the surgeon's hand. ing. A representative example of these surgical fields is laparoscopic surgery, which utilizes surgical tools inserted through the abdominal wall to reach the surgical site within the abdominal cavity. In order to increase the space around the surgical site in the abdominal cavity, an infusion gas is typically introduced to inflate the abdominal cavity and lift the abdominal wall. Pressurization of the abdominal cavity is called pneumoperitoneum. In this connection, the need to seal the abdominal cavity or body space arises from the need to maintain pneumoperitoneum, even in the presence of tools.

0003Trocars are commonly used in laparoscopic surgery to allow access to tools. Such a trocar has an elaborate sealing structure with a zero seal that prevents gas leakage in the absence of the tool and a tool seal that prevents gas leakage in the presence of the tool. Have a body. Unfortunately, such tool seals can only accommodate a narrow range of tool diameters. A large number of seal pairs had to be prepared if it was desirable to accommodate a wide range.

0004Some tools, such as the surgeon's hand, are too large for a trocar approach. Under these circumstances, a hand-assisted laparoscopic seal was provided. Such instruments are large, heavy and cumbersome and are often ineffective in providing the required sealing mechanism. Other approach devices, such as Touhy-Borst seals, are used, but these are only used for very small diameter approaches, such as those required by guide wires. ..

0005Each of the prior art instruments has drawbacks that make it difficult or awkward to use. For example, a toy-bolst type seal requires two hands to use and does not form the seal when just about to introduce a guide wire or other device. Current trocar seals and hand-assisted seals require two valves, one valve forming the tool seal when the tool is present and the other valve when the tool is not present. Form a zero seal. For example, hand-assisted instruments require elaborate mechanisms to seal around the surgeon's arm. When the arm was removed, a separate zero seal was needed to prevent the leakage of blood or infusion gas.

<p num="0006"> The present invention relates to a method of manufacturing a gel cap portion of a surgical approach instrument that has come to be placed with respect to an incision provided in the body wall. In this method, a step of preparing an annular cap provided through an opening, a step of preparing a casting mold having a mold cavity, a step of preparing a solvent, and a styrene to rubber ratio of 33 / 67 styrene-ethylene / butylene-styrene polymers are prepared, the solvent and polymer are mixed to form a slurry of about 90% by weight solvent and about 10% by weight polymer, and the slurry is placed in a vacuum chamber. The step of degassing with, the step of filling the mold cavity with styrene, and the slurry and the mold are heated so that the slurry finally reaches a temperature in the range of about 130 ° C to about 250 ° C. It has a step of keeping the solvent within a temperature range and finally changing the slurry into a gel state, a step of cooling the gel to approximately ambient room temperature, and a step of removing the cured gel from the mold.</p><p num="0007"> In one form, the step of preparing the solvent comprises the step of preparing mineral oil. In another form, the degassing step is about 0. Includes the step of applying a vacuum of 79 meters of mercury to the slurry. In another embodiment, the degassing step comprises the step of stirring the slurry while degassing the slurry. In another embodiment, the method further comprises degassing the slurry while it is in the mold. In another embodiment, the method further comprises the step of preheating the slurry before filling the mold cavity with the slurry. In another form, the cooling step comprises immersing the gel in water. In another form, the cooling step comprises air cooling the gel. In another embodiment, the method further comprises the step of inserting a plurality of gas-filled balloons into the slurry in the mold cavity. In another embodiment, the insertion step comprises inserting the balloon into the slurry substantially near the center of the mold cavity. In another embodiment, the insertion step comprises the step of randomly dispersing the balloon in the slurry around the mold cavity over the entire area beyond the center of the mold cavity. In another embodiment, the method further comprises inserting a plurality of solid objects into the slurry in the mold cavity and removing the plurality of solid objects after the gel has hardened. In another form, the insertion step comprises inserting the sphere into the slurry near the center of the mold cavity. In another form, the insertion step comprises inserting a solid object into the slurry substantially near the center of the mold cavity. In another embodiment, the insertion step comprises the step of randomly dispersing the solid object in the slurry around the mold cavity over the entire area beyond the center of the mold cavity. In another form, the method further comprises the step of sterilizing the gel cap by gamma sterilization. In another embodiment, the method further comprises the step of centrifuging the slurry and the mold while heating the slurry. In another form, the method further comprises the step of binding the gel to the cap. In another form, the binding step caps the gel with cyanoacrylate. Includes steps to combine. In another form, the step of preparing the cap comprises the step of preparing a cap made of a plastic material. In another form, the bonding step is to apply a solvent to the gel to dissolve the polystyrene in the gel, to apply a solvent to the cap to dissolve the plastic in the cap, and to bring the gel into contact with the cap for chemistry. Includes a step that allows the bond to occur between the gel and the cap. In another embodiment, the step of preparing the cap comprises the step of preparing a cap with a cylindrical inner wall, the opening of the cap is made up of a cylindrical inner wall, and the cap is made of a polymeric material. The binding step involves binding the cured gel to the cylindrical inner wall of the cap. In another embodiment, the step of preparing the cast mold prepares a mold configured to produce a gel slug having a circumference smaller than the cylindrical inner wall of the cap and a height higher than the height of the cylindrical inner wall of the cap. Including steps. In another embodiment, the method further comprises placing the gel slug within the cylindrical inner wall of the cap. In another form, the joining step involves compression molding the gel slag onto the cylindrical inner wall of the cap. In another form, the binding step comprises heating the gel slag and cap to a temperature sufficient for the polystyrene of the gel and the polymer of the cap to form a bond. In another embodiment, the method further comprises placing the cap within the mold cavity. The filling step includes filling the mold cavity containing the cap with a slurry to bring the slurry into contact with the cap. The heating step includes heating the slurry, cap, and mold so that the slurry eventually changes to a gel state. The gel to which the gel is attached to the cap forms a gel cap. The cooling step includes a step of cooling the gel cap. The removal step includes removing the gel cap from the mold. In another form, The step of preparing the cap includes the step of preparing a cap made of styrene-ethylene / butylene-styrene, and the heating step heats the slurry, cap, and mold to a temperature higher than about 130 ° C and about 130 °. It involves maintaining a temperature above C and finally allowing a bond to form between the cap and the mold. In another embodiment, the step of preparing the cap comprises the step of preparing the cap made of polycarbonate, the heating step heats the slurry, cap, and mold to a temperature of about 150 ° C, maintains the temperature, and finally. Includes steps to allow the bond to form between the cap and the mold.</p><p num="0008"> The above features and advantages of the present invention as well as other features and advantages will be apparent from the description of embodiments made with reference to the relevant drawings.</p>

0009<figref num="1">It is a top view side perspective view of the hand approaching instrument for laparoscopy of this invention.</figref><figref num="2">It is the bottom view side perspective view of the hand approaching instrument for laparoscopy of FIG.</figref><figref num="3">It is a top view of the gel cap provided with the gel pad which has the region where the hardness gradually changes.</figref><figref num="4">It is a side view of the gel cap provided with the gel which a gas-filled pocket is provided in a dispersed state.</figref><figref num="5">FIG. 5 is a plan view of a gel cap including a gel in which gas-filled pockets are provided in a dispersed state.</figref><figref num="6">FIG. 5 is a plan view of a gel cap including a gel in which gas-filled pockets are provided in a dispersed state.</figref><figref num="7">FIG. 5 is a side view of a laparoscopy hand approach device including a gel cap with a gel in which gas pockets are provided in a dispersed state.</figref><figref num="8">It is a plan view side perspective view of the multi-part structure cap, and is the figure which shows the state which the multi-part structure cap has a squeeze type buckle connector formed in the end part of the component which forms this.</figref><figref num="9">It is a top view side perspective view of one of the parts of a cap having a male squeeze release type buckle connector joint at one end and a female squeeze release type buckle connector joint at the other end.</figref><figref num="10">It is a plan view side perspective view of the cap having a gap, and is the figure which shows the state which the latch is rotatably coupled to one side of the gap, and the groove which receives a latch is provided on the other side of the gap.</figref><figref num="11">It is a top view side perspective view of the cap provided with the latch for detachably connecting the cap to the retainer.</figref><figref num="12">It is a side view of the cap of FIG.</figref><figref num="13">It is a top view side perspective view of the hand approaching instrument for laparoscopy of the present invention which has a cap and a retainer, and is the figure which shows the state which has a plurality of snaps which connect the retainer to a cap with release permission.</figref><figref num="14">It is a top view side perspective view of the cap of FIG.</figref><figref num="15">It is a top view side perspective view of the retainer of FIG.</figref><figref num="16">FIG. 5 is a cross-sectional view illustrating the interaction between the cap and retainer of FIG.</figref><figref num="17">It is a top view side perspective view of the hand approaching instrument for laparoscopy of the present invention which has a cap and a retainer, and is the figure which shows the state which has a plurality of snaps which connect the cap to a retainer in a releaseable manner.</figref><figref num="18">It is a top view side perspective view of the cap of FIG.</figref><figref num="19">It is a top view side perspective view of the retainer of FIG.</figref><figref num="20">FIG. 5 is a cross-sectional view illustrating the interaction between the cap and retainer of FIG.</figref><figref num="21">A side view of a laparoscopic hand approach device with a gel cap, retainer, sleeve and retention ring showing a plurality of stabilizers in the form of strings or tethers extending from the retention ring to the gel cap. is there.</figref><figref num="22">A side view of a laparoscopic hand approach device with a gel cap, retainer, sleeve and retention ring showing multiple stabilizers in the form of gussets or webs extending from the retention ring to the gel cap. is there.</figref><figref num="23">It is a top view side perspective view of the hand approach device for laparoscopy provided with a gel cap, a retainer, a sleeve and a holding ring, and is a view showing a state in which a cloth is integrated on the surface of the gel cap.</figref><figref num="24">It is a partial side view of the approach device for hand laparoscopy of FIG. 23.</figref><figref num="25">Top view of a laparoscopic hand approach device with a gel cap, retainer, sleeve and retention ring, where the gel cap has a cavity constructed of cloth and a gel pad is housed in this cavity. It is a figure which shows the state which is present.</figref><figref num="26">It is a bottom view side perspective view of the hand approach device for laparoscopic examination provided with a gel cap, a retainer, a sleeve and a holding ring, and is a view showing a state in which gel pads are provided with a lobe with a multi-pointed head which is in close contact with each other. ..</figref>

00101 and 2 show a form of surgical hand approaching instrument 50 of the present invention. This instrument has a retainer 52 and a cap 54. Both the cap 54 and the retainer 52 are substantially annular, and both are provided with openings through them. The retainer 52 is designed to be placed against the body wall. The retainer 52, in one form, is rigid and can be associated with and / or coupled to the elongated sleeve 56. The surgical hand approach device 50 is designed to be placed with respect to an incision made in the body wall. The surgical hand approach device 50 also facilitates insertion of the tool through the approach device and maintenance of a sealing relationship with the tool.

0011In one form, the elongated sleeve 56 extends through the incision to the point where the attached retention ring 58 contacts the inner portion of the body cavity and provides tension between the retainer 52 outside the body cavity and the retention ring. There is. The retainer 52 can also, in one form, support a portion of the elongated sleeve 56 or otherwise allow the portion of the elongated sleeve to remain located outside the body cavity. In addition, the retainer 52, retention ring 58 and elongated sleeve 56 can be combined to dilate and isolate the incision during the surgical procedure. In one form, the elongated sleeve 56 and its features are, for example, a retractor-type instrument described in U.S. Patent Application No. 10 / 516,198 filed November 30, 2004, which is a U.S. patent application. It is cited by reference and the entire disclosure is assumed as described herein.

0012As shown, the retainer 52 and the retaining ring 58 are circular, but as will be appreciated by those skilled in the art, they may have different dimensions and shapes. In one form, the retainer 52 may be rigid, flexible, or a combination of both. The retention ring 58 should be flexible to facilitate insertion into the body cavity. As described in detail below, the access device 50 has a coupling means that is designed to couple the cap 54 and the retainer 52 to each other.

0013The gel pad 60 may be attached to and attached to the cap 54 such that a gas tight conduit is formed between the cap and the sleeve 56, with or integrally with the cap. The gel pad 66 covers and seals the entire opening of the cap 54. In one form, the gel pad has a plurality of intersecting dead-end slits 62, 64 that form an approach or passage through the gel pad 60. Unlike foam rubber or other similar types of elastic materials, the gel pad 60 provides a gas tight seal around hands or tools of various dimensions and shapes inserted through it.

0014In one form, the gel material that is the constituent material of the gel pad 60 is an elastomer gel. Several such gels are described in U.S. Patent Application No. 10 / 381,220, filed March 20, 2003, with reference to this U.S. Patent, the entire disclosure of which is herein. Quoted as described in. Gels can be prepared by mixing the triblock copolymer with a solvent for midblock. The endblock is typically a thermoplastic material such as styrene, and the midblock is a thermosetting polymer such as isoprene or butadiene, such as styrene-ethylene-butylene-styrene (SEBS). In one form, the solvent used is mineral oil. Heating this mixture or slurry melts the midblock into a network of mineral oil and insoluble endblocks. The resulting network has improved rubbery elasticity (elastomer properties) compared to the parent polymer. In one form, the triblock copolymer used is KRATON. G1651, which has a styrene to rubber ratio of 33/67. Once formed, the gel is substantially permanent and, due to the nature of the end blocks, can be subsequently treated as a thermoplastic elastomer. The mixture or slurry has the lowest temperature at which it becomes rubber, i.e. the lowest gelling temperature (MGT). In one form, this temperature corresponds to the glass transition temperature of the thermoplastic end block plus a few degrees. For example, the MGT of a mixture of KRATON G1651 and mineral oil is about 120 ° C. When the slurry reaches the MGT and the transition to the gel state occurs, the gel becomes more transparent, thereby visually observing when the transfer of the slurry to the gel state is substantially complete and whether the gel can be cooled. There is a way to see and confirm. In addition to triblocks, diblock forms of the material in which styrene is present only at one end of the chemical formula, such as styrene-ethylene / butylene (SEB), can also be used.

0015Given the mass of the slurry to be in a complete gel state, the entire mass of slurry is heated to MGT, and the mass of slurry is allowed for a sufficient amount of time for the end blocks to form an interconnected matrix. , MGT remains heated. The slurry continues to be in the gel state at temperatures above the MGT, until the slurry / gel reaches a temperature at which the components within the slurry / gel begin to decompose or oxidize. For example, when the slurry / gel is heated to a temperature above 250 ° C, the mineral oil in the slurry / gel becomes volatile and begins to oxidize. Oxidation can cause the gel to turn brown and become oily.

0016The rate at which a given amount of slurry forms a gel is determined by the rate at which the entire mass of slurry reaches the MGT. Also, at higher temperatures than the MGT, this speed is further increased as the end block network spreads more quickly.

0017Also, various basic formulations can be mixed with each other to make alloys in order to achieve various intermediate properties. For example, KRATON G1701X is a mixture of 70% SEB and 30% SEBS with an overall styrene to rubber ratio of 28/72. As will be appreciated, an almost infinite number of combinations, alloys and styrene to rubber ratios, each of which can bring benefits to a particular embodiment of the invention, can be formulated. These advantages are typically low dulometer, high elongation and good tear strength.

0018It is envisioned that the gel material may further include silicone, soft urethane, as well as hard plastics that may provide the desired sealing properties with the addition of a foaming agent. The silicone material should be of the type currently used for encapsulation of electronics. Hard plastics include PVC, isoprene, KRATON neat and other KRATON / oil mixtures. In the KRATON / oil mixture, oils such as vegetable oils, petroleum and silicone oils can be used instead of mineral oils.

0019Any of the envisioned gel materials may be modified to achieve various properties, such as improved anti-friction properties, improved appearance and improved wound protection. The additive may be mixed directly into the gel or applied as a surface treatment agent. Other compounds may be added to the gel to alter its properties or provide binding sites or surface charges to aid in subsequent surface modifications. In addition, by adding an oil-based colorant to the slurry, gels of different colors can be made.

0020In one embodiment, the mixture / slurry used in the various embodiments of the cap described herein is composed of about 90% by weight mineral oil and about 10% by weight KRATON G1651. From a thermodynamic point of view, this mixture behaves like mineral oil. Mineral oil has a fairly high heat capacity, so at about 130 ° C it can take 3 or 4 hours to heat a pound of slurry enough to form a homogeneous gel. Once formed, the gels may be identical and should be cooled as quickly as possible if the gels have no apparent detrimental effects. This cooling is, in one form, achieved by flooding with cold water. In another form, the gel may be air cooled. Other cooling methods well known in the art can be used, as will be appreciated by those skilled in the art, and such other cooling methods are assumed to be within the scope of the present invention.

0021Many of the properties of the KRATON / oil mixture will change by adjusting the weight ratio of the ingredients. In general, the higher the proportion of mineral oil, the lower the hardness of the mixture, and the higher the proportion of KRATON, the higher the hardness of the mixture. If the resulting gel is too soft, this can lead to excessive tenting or doming of the gel cap during surgery when gassing the patient's abdominal cavity. Excessive tenting or doming may open slits 62,64, which creates a leak path. In addition, if the gel is too soft, a proper seal may not be obtained. However, the gel should be soft enough to be comfortable for the surgeon and at the same time provide good encapsulation in both the presence and absence of the tool.

0022Copolymers such as KRATON and solvents such as mineral oils may separate if the slurry is left in place for extended periods of time. It is preferable to mix the slurry with a blade having a high shear rate, for example, to make the slurry more homogeneous. However, mixing the slurry may introduce or add air to the slurry. It is good to degas the slurry to remove the air from the slurry. In one form, it is better to degas the slurry in vacuum, for example in a vacuum chamber. In one form, the applied vacuum is preferably 0.79 meters (29.9 inches) of mercury or about 1 atmosphere. It is good to stir the slurry in a vacuum to facilitate the removal of air. During degassing in vacuum, the slurry generally expands, then foams, and then loses volume. It is better to interrupt the vacuum when the bubbling has practically stopped. Degassing the slurry in a vacuum chamber reduces the volume of the slurry by about 10%. Degassing the slurry helps reduce the risk of oxidation of the dry gel.

0023Degassing the slurry tends to harden the resulting gel. The degassed slurry is composed of about 91.6% by weight of mineral oil and about 8.4% by weight of KRATON G1651 in a ratio of 11: 1, resulting in the gel not being degassed and about 90%. It will be composed of% by weight mineral oil and about 10% by weight KRATON G1651 and will have about the same hardness as a gel made of slurry with a ratio of 9: 1.

0024Mineral oil has a lower density than KRATON, these two components separate from each other after mixing, and light mineral oil rises to the top of the vessel. This separation can occur when trying to put a static slurry into a gel state over several hours. The resulting gel by separation may have a high concentration of mineral oil at the top and a low concentration of mineral oil at the bottom, resulting in, for example, a heterogeneous gel. Separation rate is a function of the depth of the slurry being heated or the height of the head. To make a homogeneous gel determination or result for a homogeneous gel, consider a combination of slurry mass and head height, gel curing temperature and rate of energy transfer to the gel.

0025One feature of the cap 70 of the present invention is shown in FIG. 3 with gel pads 72 having different textures in specific regions 74-80. For example, in one form, the gel pad 72 has a first softly closed central sealing region 74, a second region 76 that is less elastic than the first region, and a third region that is less elastic than the second region. It has a region 78, a fourth region 80, etc., which has lower elasticity than the third region. More specifically, the gel pad 72 preferably has three or more concentric regions with different elasticity from each other, the elasticity of each region decreasing as the distance from the first central region 74 increases. .. Areas of progressively less elasticity or flexibility allow for a secure attachment of the gel pad 72 to a support structure, such as the cap 70, while a softer, more flexible layer at or near the center of the gel pad. Retains the desired closure of the high material.

0026In one form, the gel pad 72 has gradient concentric portions 74-80 on which the gel pad is formed or formed by the action of centrifugal force. During gel formation, the slurry is mixed in a centrifuge. Rotating the slurry while forming the gel pad 72 results in density separation, in which case the dense triblock of the slurry moves towards the perimeter of the container containing the rotating slurry and the mineral oil , The density increases toward the center. Thus, a hard gel is formed on the outside of the finished part and a soft gel is formed on the central part of the finished part, which is useful in hand approach seals for laparoscopic surgery. Is.

0027In one form, a long flat rectangular part is used instead of a thin circular part. There are three conventional rotating axes associated with the rectangular part. The first axis passes through the center of the part perpendicular to the major and minor axes of the part. The rotation around the first axis increases the density of the gel at the ends of the part, similar to the rotation of the gel around the midpoint of the short side of the rectangle. However, rotation around the long axis of the rectangle produces a high density gel along the edges of the long sides of the rectangle. The rotation can be changed during the process as in the case of rotary molding, in which case the part will rotate around a number of axes during the process. The axis of rotation need not intersect the centroid of the part or be located within the part itself.

0028The reverse texture layout of the gel pad 70 can be achieved by choosing a lighter density triblock and a denser mineral oil. Other ingredients can be added based on the desired effect, such as additives such as colorants, Inactive Filling Materials, Different Oils, Different Triblock or Diblock Copolymers, Polymers, etc. Examples include plasticizers and decorative items.

0029In one form, the heavy plastic component 82 comprises a gel pad 72 or slurry, which is pulled away from the center towards the outer region of the gel and along with a specific amount of plastic material and oil in the central region 74. Get out of. The outer regions 76-80 of the gel pad 72 contain a denser, heavier plastic material than the central region 74. When a particular gradient portion is achieved for the gel pad 72, the rotation is slowed and the gel pad is allowed to cool.

0030In one form, a heterogeneous gel pad with a soft gel on one side and a harder gel on the other side is commensurate with the timing of energy input into the gel, which can change with the direction of gravity. Achieved with the density separated over time.

0031In FIGS. 4-7, the cap 90 has a gel pad 92 with a plurality of gas pockets 94. The pocket 94 can be formed in the presence of a lightweight foam or balloon or by casting or molding the gel around a sphere or other shaped solid object that is removed after the gel pad 92 has hardened. Foams, balloons, spheres or other shapes may be inserted into the mold cavity either before or after filling the mold cavity with a slurry. In one embodiment, the placement of the gas pocket 94 substantially around the center of the gel pad 92 reduces the resistance of the surgeon to the passage of a hand or tool while reducing the weight of the gel pad and maintaining its closure. Another feature of the gel pad 92 envisions a more random dispersion of gas pockets 94 throughout the region beyond the center of the gel pad, thereby reducing the overall weight of the gel pad.

0032It is preferable to gamma sterilize the gel pad or gel cap in various forms of the present invention. For gel pads and instruments equipped with gel pads, it is desirable that sterilization with gamma rays is relatively or relatively simple, for example, as opposed to sterilization with ethylene oxide. However, under gamma sterilization, large bubbles can form in the gel, which creates potential cosmetic or aesthetic problems for the sterilized instrument. Bubbles are 99% or more indoor air, so the removal of dissolved air in the slurry is done before the slurry is formed into a gel state. For example, it is preferable to degas the slurry through a vacuum as described above to make it into a gel state by heat. Bubbles may still occur in the gel during gamma sterilization, but in one form that disappears over a period of about 24 hours to about 72 hours, the proportion of dissolved gas in the mineral oil at room temperature is about 10%. Removal of air in the gel has the additional effect of hardening the gel. However, this is offset by the softening effect on the gel caused by gamma rays during gamma sterilization.

0033When gamma sterilizing the gel pad, the gel may contain about 90% by weight mineral oil and about 10% by weight KRATON. As mentioned above, degassing the slurry has the effect of hardening the gel. However, gamma rays soften the gel to substantially the same hardness as gels containing about 90% by weight mineral oil and about 10% by weight KRATON that are not degassed and gamma sterilized.

0034In one form, it is preferable to use cyanoacrylates, such as SUPERGLUE or KRAZY GLUE, to bond the gel pad 60 to the cap 54 or to bind or attach it in a different way. The glue can stick to either the rubber or styrene component of the triblock, and the bond is often stronger than the gel material itself. In another form, it is preferable to use a solvent to dissolve the plastic in the cap as well as the polystyrene in the gel pad. A solution of solvent is applied to the gel pad and cap in either spray or dip form. In effect, the solution dissolves both the plastic in the cap and the polystyrene in the gel pad, allowing a chemical bond to form between the two, which persists as the solvent evaporates.

0035It is good to dissolve polyethylene in mineral oil and apply it to the gel pad. The mineral oil does not evaporate and is absorbed into the gel pad over time to give the gel pad a polyethylene layer, which may have some advantageous properties.

0036In one form, the gel pad 60 is cast into a DYNAFLEX or KRATON polymer support structure, eg cap 54. By using KRATON polymer or similar material in the cap, ring adhesion between the gel pad 60 and the cap 54 can be achieved. It can be seen that the polystyrene in the gel pad 60 achieves adhesion to polyphenylene oxide (PPO), polystyrene and other polymers.

0037In the casting method, the gel pad 60 and cap 54 are heated to a temperature above about 130 ° C. and held at this temperature for several hours, eg about 3-4 hours. The temperature used is not enough to deform the cap 204.

0038The cap 54, in one form, is made of a polymer, such as polyethylene (PE). In one form, the polyethylene is low density polyethylene (LDPE) or high density polyethylene (HDPE) or ultra high molecular weight polyethylene (UHMWPE). In one form, the cap 54 is preferably made of a polymer, such as polycarbonate, which can be made by methods including injection molding.

0039The gel consists of mineral oil. PE has a higher molecular weight than mineral oil. Dissolve PE in mineral oil at high temperatures. Thus, the mineral oil in PE and gel pad 60 mixes with each other when both are heated to temperatures above about 130 ° C and held at this temperature state, forming a bond between PE and gel pad. To.

0040In one form, the cap 54 is made of polycarbonate. The polycarbonate on the cap 54 does not form a bond with the gel pad 60 at 130 ° C. However, during casting, by raising the temperature to about 150 ° C for a few minutes, a bond is formed between the gel pad 60 and the cap 54. Therefore, by heating the gel pad 60 and cap 54 to temperatures where both polystyrene and carbonate of the gel exceed these melting points simultaneously, a bond can occur between the gel pad and the cap. As a modification, the gel pad 60 and the cap 54 may be heated to or near the glass transition temperature of the polycarbonate cap to form a bond between the gel pad and the cap.

0041Referring to FIGS. 8-10, caps 100,130 have at least one gap 101,132 along the perimeter of the annulus of the cap. At least one gap 101,132 forms at least one first end 103,134 and at least one second end 105,138 of caps 100,130. The gaps 101,132 facilitate the transition in the cap from the first large perimeter to the second small perimeter. As described in detail below, caps 100,130 have a means of keeping the cap around a second small circumference. When the caps 100, 130 are set around the first large perimeter, it is better to insert or remove the retainer 52 (FIG. 1) into or out of the opening of the cap. The retainer 52 (FIG. 1) shifts the perimeter of the cap to a second small perimeter while the retainer is positioned within the opening of the cap, and maintains the perimeter of the cap around the second small perimeter by means of maintenance means. Can be firmly attached to caps 100 and 130.

0042With reference to FIGS. 8 and 9, the cap 100 has a squeeze release buckle 102 molded into the cap or coupled to the cap in a different way. The cap 100 has a first arcuate body 108 and a second arcuate body 110, and the first arcuate body and the second arcuate body are separated from each other by a first and second gap 101. The first arcuate 108 has a first barbed portion 112 extending from the first end, the first barbed portion extending from the second end of the second arcuate 110. It is designed to be inserted in a snap-fitting mating relationship with the receiver or receiving portion of 2 so that at least one first end 103 of the cap 100 is at least one second end 105 of the cap. Combined with. The other barbed portion 112 preferably extends from the first end of the second arcuate 110, and this barbed portion extends from the second end 105 of the first arcuate 108. It is operatedly inserted in a snap-fitting fitting relationship with another receiving portion 114. In another form, the first arc body 108 has barbed portions 112 provided at each end of the arc body, and the second arc body 110 is provided at each end of the second arc body. It has a corresponding receiving part 114.

0043The first arcuate body 108 and the second arcuate body 110 are arranged adjacent to each other so that the first end 103 of the first arcuate body corresponds to the second end 105 of the second arcuate body, and the first The second end 105 of the arcs corresponds to the first end 103 of the second arcs, but in the state before they were snap-fitted together, these arcs were retainer 52 (Figure). The first large perimeter is constructed so that 1) can be placed between these two arcuate bodies. The barbed portion 112 fits into the corresponding receiver 114 and joins these two arcs together. Each barbed portion has a plurality of elastic arms 122, and protrusions 124 extend from two of these elastic arms. Each receiver 114 has a corresponding side wall 126 that engages a protrusion 124 from the barbed portion, whereby the arms 122 towards each other as the arms slide into the channels 128 constructed by the receivers. Bend. As the protrusion 124 passes through the end of the side wall 126, the arms 122 can bend away from each other. Engagement or contact between the edge of the protrusion 124 and the edge of the end of the side wall 126 prevents the arms 108, 110 from detaching from each other. By joining the two arcs 108,110 together, the defined perimeter is reduced to a second small perimeter to capture or hold the retainer 52 (FIG. 1). By bending the arms 122 toward each other, the barbed portion 112 can disengage from the side wall of the corresponding receiver 114 and slide out of the receiver, thereby allowing the arcuate bodies 108,110 to slide into the retainer 52 (FIG. 1). ) Can be separated and separated.

0044Although not shown, additional spines and receivers within each arc to help interconnect the cap 100 and retainer 52 (Figure 1) or allow the adoption of other dimensions of the cap and / or retainer. It is preferable to provide a snap fitting part for the tool. In one form, the cap 100 has a single gap 101, in which case a single barbed portion 112 and a single receiving portion 114 are provided. In one form, the cap 100 with a single barbed portion 112 and a single receiving portion 114 is preferably provided with a hinge or pivot provided in another portion of the arc.

0045Next, referring to FIG. 10, the cap 130 has a gap or opening 132 along a portion around the cap. The latch 136 is hinged or rotatably coupled to the cap near the first end 134 of the opening 132 of the cap 130. A latch receiver, eg, a hole or channel 140, configured by channel walls 142,144 that are substantially parallel to each other near the second opposed end 138 of the opening 132 is configured to release the latch 136. .. The latch 136 is provided at the shaft 146, one end of which is coupled to the cap 130, and the non-hinge stop end of the latch, which provides an enlarged or spherical head 148 with a circumference or diameter greater than the circumference or diameter of the shaft. Have. The head 148 of the latch 136 is configured to grab it, and the latch is swiveled so that the head fits into and is held in the channel 140 configured by the channel walls 142,144. The width of the channel 140 is smaller than the diameter of the head 148 of the latch 136, and the channel walls 142,144 are elastic so that the walls bend and move away from each other when the latch head is received. Alternatively or additionally, some part of the head 148 can be shrunk to accept and hold the head in the channel 140. In one form, one or more protrusions extend from one or both of the channel walls 142, 144 and fit into the notches provided in the head 148, or vice versa. Secure the latch 136 to channel 140.

0046Thus, with the latch 136 open or not mated to the channel 140, the initial perimeter of the cap 130 allows for easy placement of the retainer 52 (FIG. 1) within this perimeter of the cap. To. Activating the latch 136 closes the cap 130, reducing the size of the perimeter defined by the cap, thereby fixing the cap to the retainer 52 (FIG. 1).

0047Revisiting FIGS. 8-10, with reference to these, the placement of the respective retainers 52 (FIG. 1) within the inner perimeter of the caps is facilitated when the caps 100, 130 are separable or unjoined. The cap is then joined or rejoined to secure the retainer and cap to each other. Thus, as will be appreciated by those skilled in the art, separate parts of the cap and / or retainer may be joined or joined to accommodate the cap and retainer using other forms of coupling or fitting schemes. The perimeters that secure the cap and retainer to each other can be closed or configured, and they may be reversed. In one form, both the retainer or the retainer and the cap are separable, with a coupling scheme and / or a mating scheme in which separate portions are recombined together to secure the cap and retainer to each other.

0048In FIGS. 11 and 12, the retainer 150 has one or more latches 152 that detachably couple the retainer to the cap 54 (FIGS. 1 and 2). In one form, a plurality of latches 152 are spaced along the perimeter of the retainer 150. The latch 152 is hinged or rotatably coupled to the retainer 150, and these latches are spaced apart from each other along the perimeter of the retainer. In one form, each latch is coupled to the retainer 150 with an integral hinge. In the first position, the latch 152 extends laterally from the periphery of the retainer 150 in a substantially coplanar relationship with the retainer. Each latch 152 has a protrusion 156 that extends substantially vertically from the latch. After the cap 54 is placed or fitted on the retainer 150 and / or reversed, the latch 152 is actuated to connect the cap and retainer to each other. Specifically, the latch 152 is rotated towards a cap to a second position, where the latch engages a portion or edge of the cap 54 to attach the retainer to the cap. .. In one form, the engaging portion of the cap 54 is an opening, a hole, a notch, a step, a protrusion or other similar type of receiver or engagement scheme that secures the protrusion of the latch 152 to the cap. ..

0049In one form, one or more of the latch 152 has a notch or opening that correlates with a protrusion or protrusion extending laterally from the cap 54 to connect the retainer 150 to the cap. .. Additional or alternative, although not shown, the cap is hinged along the perimeter of the cap to some part or edge of the retainer so that the cap and retainer are releasably coupled to each other. It is preferable to have one or more latches to engage.

0050Next, referring to FIGS. 13 to 16, the retainer 160 has one or more elastic snaps 162 that detachably join the retainer and the cap 164 to each other. The snap 162 extends from the outer periphery or edge of the retainer 160 in a substantially vertical direction with respect to the substantially flat annular surface 166 of the retainer. The flat annular surface 166 of the retainer 160 secures the sleeve 56 (FIGS. 1 and 2) to the retainer. In one form, the annular surface 166 has a protrusion or hook that captures the sleeve 56 and secures it to the retainer 160 under tension. Also, the edges of the retainer 160 are slightly raised to aid in holding the sleeve 56 and handling the retainer.

0051A large number of snaps 162 should be provided along the perimeter of the retainer 160, spaced apart from each other. In one form, some portion of the edge of the retainer 160 located adjacent to each snap is raised, thereby forming a side wall portion 167 on each side of each snap. The side wall portion 167 protects the snap 162 and strengthens or reinforces the coupling between the retainer 160 and the cap 164 once they are coupled to each other. In addition, the side wall portion 167 facilitates the handling of the retainer 160 and the coupling of the retainer 160 to the cap 164. A corresponding opening or notch 169 is provided along the edge of the cap 164 to accommodate the side wall portion 167 of the retainer 160.

0052Also, each cap 162 has a protrusion 168 that extends substantially vertically and radially inward from the snap. After placing or fitting the cap 54 on and / or vice versa, both are squeezed together. The snap 162 is configured to flex or distort radially outward as the cap and retainer fit together and slide over the corresponding receiving portion 170 of the cap 164, such as the lip or edge. ing. The snap 162 is also configured such that the snap protrusion 168 passes through the receiving portion 170 of the cap 164 and then returns toward the neutral position so that the snap protrusion engages the receiving portion 170 of the cap. The receiving portion 170 is, in one form, an opening, a hole, a notch, a step, a protrusion or other similar type of receiver or engagement scheme that secures the protrusion 168 of the snap 162 to the cap 164. As a variant, one or more of the snaps 162 have a notch or notch that correlates to accept a protrusion or protrusion (not shown) extending from the cap to secure the retainer 160 snap to the cap 164. It has an opening (not shown). The cap 164 and the retainer 160 are each preferably made by injection molding. In addition, the cap 164 and retainer 160 are each preferably made of polycarbonate material.

0053In one form, as shown in FIGS. 17-20, the cap 180 has one or more snaps 182 that detachably couple the cap to the retainer 184. The snap 182 extends vertically from the perimeter of the cap 180 so that it can engage a portion 188 of the retainer 184, such as the corresponding lip portion and / or edge. Each snap 182 has a protrusion 186 that extends substantially vertically and radially inward from this snap. After placing or fitting the cap 180 on the retainer 184 and / or reversing them, both are squeezed together. The snap 182 flexes or distorts radially outward as the cap 180 and retainer fit together and slides over the lip or edge 188 of the retainer 184, thereby causing the sleeve 56 to engage with the cap and retainer. Fix the cap, retainer and sleeve while placed between. Each snap 182 is configured such that the protrusion 186 passes through the lip portion 188 of the retainer 184 and then returns towards the neutral position so that the protrusion of the snap engages the lip portion of the retainer.

0054Next, referring to FIGS. 1 to 20, the retainer and cap described above as one form are rigid, which provides manufacturing advantages and facilitates instrument assembly. Also, in one form, the cap 54,70,90,100,130,164,180 has a cylindrical inner wall 172 (see FIG. 14) to which the gel pad 60 is attached, or the gel pad is attached or attached to the cap in a different way. Thus, the gel pad 60 is attached to the "skeleton" inside the sleeve 56, providing a sealing area between the instrument and the wound, incision and / or body cavity. Also, by coupling or crossing the sleeve, cap and retainer with each other, another sealing region is obtained between the device and the body.

0055By fixing the gel pad 60 to the cylindrical inner wall 172, the thickness of the gel pad and the corresponding caps 54,70,90,100,130,164,180 is minimized along with the overall footprint of the instrument. The reduction in instrument thickness and overall size makes the instrument lighter and allows for easy hand replacement. Also, in a state where the thickness of the gel pad is reduced and the gel pad is substantially flush with or retractable into the cap, it is caused by the gas pressure applied to the body and equipment during gas injection. The "dorming" phenomenon is reduced.

0056In various embodiments of the present invention (FIGS. 11 to 20), the retainer 150, 160, Takashi provided along the outer peripheral portion of the retainer has a Okoshien portion 158,174. Further, the raised edge portion 159,190 is provided along the inner peripheral portion of the retainer 150,184 in one form. The inner circumference defines openings 157,192 through which the sleeve is inserted. The outer raised edges 158,174 help maintain or secure a loosely coupled relationship between the cap and retainer. In one form, the groove 129 (FIG. 8) extends along the perimeter of the cap to accommodate the outer raised edge to further facilitate the bond between the cap and the retainer. Similarly, the medial ridge helps maintain or secure a releaseable bond between the retainer and the sleeve. The inner raised edge also facilitates sealing between the cylindrical inner wall and / or the gel pad, sleeve and retainer. In one form, notches or spaced valleys or openings 155 (FIG. 11) are provided along the medial ridge 159, thereby between the cylindrical inner wall, the gel pad and the retainer. Engagement of the retainer with the cylindrical inner wall and / or gel pad is facilitated as catching is reduced.

0057Some of the mounting means described above can be modified to incorporate the retainer or components on the retainer directly into the sleeve to which the cap is detachably coupled. Similarly, the cap may be incorporated directly into the retainer and / or sleeve to create an irreversible bond between these components.

0058In one embodiment, to cast the gel pad 60 into the cap 54 to form the gel cap 66, the cap is placed in the mold cavity of the casting mold. The mold cavity preferably has a support for the annular wall of the cap 54. The mold should be made of aluminum, copper, brass or other molding material with good heat dissipation properties. However, as will be recognized by those skilled in the art, it is assumed that even other molding materials having low heat dissipation properties can produce acceptable level parts, which are also included in the scope of the present invention.

0059Fill the mold cavity containing the cap 54 with a slurry so that the slurry contacts the cap. The slurry should be preheated to, for example, about 52 ° C (125 ° F) to facilitate filling the voids in the mold cavity with the slurry. Preheating the slurry to a temperature lower than the MGT reduces the viscosity of the slurry, which allows the slurry to flow more easily. As mentioned above, it is good to degas the slurry in vacuum. Fill the mold cavity to remove any air that may have been introduced during the filling of the mold cavity, facilitate the flow of the slurry into the voids in the mold, and then degas the slurry again in the mold. Is good. Heat the cap 54 and the mold containing the slurry, for example in an oven, until the slurry finally reaches a temperature of about 150 ° C. As mentioned above, the slurry becomes a gel at about 120 ° C, but at 150 ° C the gel can bind to the cap 54 made of polycarbonate. Depending on the material used to make up the cap 54, the bond can occur at temperatures other than about 150 ° C. If the cap 54 is made of a material with a melting point below 120 ° C, it is better to mold the gel pad 60, eg gel slug 60, separately and then bond it to the cap. It is preferable to mold the slits 62 and 64 into the gel pad 60 by using an insert in the form of a slit provided in the mold.

0060Once the temperature of the gel pad 60 reaches about 150 ° C., the gel cap 66 may be cooled by, for example, air cooling, cold water immersion or other cooling means well known in the art. At 150 ° C, the gel pad is soft and when deformed during cooling, the gel pad cures in that deformed state. The gel cap 66 should be cooled in the mold to reduce the risk of deforming the gel pad 60. The cooling time may vary based on various parameters including the size and shape of the mold, the amount of gel, the temperature and amount of the cooling medium, the properties of the cooling medium and the molding material. As an example, the cooling time is preferably about 2 hours for air cooling and about 15 minutes for cooling in water. Whether cooling is done with air or water, the final properties of the gel are substantially the same. The gel cap 66 is typically cooled to approximately ambient room temperature, but may be cooled to a lower temperature. When the gel cap 66 is cooled to the freezing point of the gel, that is, about 0 ° C, the gel solidifies and hardens. This may be advantageous for other means of binding the gel pad 60 to the cap 54, for example in a secondary operation. After the gel has hardened, the gel cap 66 can be removed from the mold at any time.

0061The gel pad 60 typically has a sticky surface when removed from the mold. It is preferable to substantially reduce or eliminate the stickiness of the gel pad 60, which is cured by coating the gel cap 66 with powder, for example, cornstarch.

0062As mentioned above, in another embodiment, the gel pad 60 may be molded separately from the cap 54 and bonded to the cap by secondary work, for example bonding. In one embodiment, the gel pad 60 may be molded into a gel slug 60 having an outer circumference smaller than the cylindrical inner wall of the cap 54 to a height higher than the height of the cap. Since the gel pad 60 is molded separately from the cap 54, it is necessary to heat the slurry until the gel pad reaches approximately 120 ° C to complete the transition from slurry to gel and the gel is substantially clear. Only. The gel slug 60 should then be placed within the cylindrical inner wall of the cap 54. The gel slag 60 may be cooled and / or solidified and then placed within the cylindrical inner wall of the cap 54. The gel slug 60 may be bonded to the cap 54 by compression molding with the gel slug compressed in the longitudinal direction, so that the outer peripheral portion of the gel slug expands and presses against the cylindrical inner wall of the cap. The gel slag 60 and cap 54 are heated to a temperature sufficient for the polystyrene of the gel and the polymer of the cap to form a bond between the gel and the cap. Molding the gel slug 60 separately from the cap 54 and later heat-bonding the gel slag to the cap is particularly useful if the cap is made of a material with a lower melting point than the MGT. In such situations, it is better to first mold the gel slag 60 and heat bond it to the cap 54 without melting the cap 54.

0063With reference to FIGS. 21 and 22, the cap 54 has a gel pad 60 attached to, formed on or integrated with the cap, which cap can be attached to a retainer 52 which can be attached to the sleeve 56. .. In one form, an elongated sleeve 56 is attached to a retention ring 58 through an incision, which contacts the inner portion of the body cavity with a retainer 52 located outside the body cavity and a deformable retention ring. Brings tension between. Multiple stabilizers 200-206 extend from the retention ring 58 to the gel pad 60.

0064In one form, the stabilizers 200,206 are dimensionally shaped to prevent excessive bulging of the gel pad 60 in response to increased pressure in the body cavity. The stabilizers 200, 202, in one form, have a plurality of strings or tethers that extend from the retention ring 58 and then through or into the gel pad 60. Stabilizers 204,206 have a plurality of contiguous gel-based gussets or webs extending between the retention ring 58 and the gel pad 60.

0065With reference to FIGS. 23 and 24, the cap 54 has a woven or knitted fabric 210 that is stretchable and / or elastic. The cloth 210 is incorporated into or attached to the surface 211 of the gel pad 60 and is bonded around the cap 54. The cloth 210 serves as a support that suppresses the "dorming" or "bow warp" of the gel pad 60 or cap 54 caused by the influence of the internal inflation gas pressure associated with the inflation of the body cavity. In one form, the first cloth 212 is better integrated with the first surface 214 of the gel pad 60 and bonded around the cap 54, and the second cloth 216 is integrated with the second opposite surface 218. It is better to connect it to the cap. In this way, restraint supports are provided in both directions to minimize uncontrolled deformation of the gel pad when the hand or instrument is placed or retracted through the gel pad.

0066In FIG. 25, the first cloth 220 is bonded around the cap 54 and the second cloth 222 is bonded to the cap at a distance from the first cloth. The cavity 224 is composed of a space between the first cloth 220 and the second cloth 222. It is better to insert the gel pad 60 into the cavity 224 or to hold it in the cavity in a different way. The gel pad 60 may be treated alone to form a preferred dimensional shape and hardness prior to bonding to the cap 54. Generally, the temperature required to process SEBS can substantially deform the associated plastic structure. Therefore, separate treatments and subsequent assembly may be useful in constructing caps with gel pads.

0067Referring to FIG. 26, the gel pad 60 has a multi-pointed lobe 230 that is in close contact with each other up and down. Channels 232 into which the surgeon's hand or instrument can be inserted are formed between the individual lobes of the gel pad 60.

0068Therefore, the present invention provides a hand approaching device and a method for manufacturing the same. Although the present invention has been described for certain embodiments, many additional modifications and modifications will be apparent to those skilled in the art. Therefore, it should be understood that the present invention can be implemented in various modified forms of dimensions and materials other than those specifically described, without departing from the spirit and scope of the invention. Thus, embodiments of the present invention should, in all respects, be understood as exemplary and should not be understood as limiting the invention. The scope of the present invention is defined based on the description of the scope of claims and the equivalent scope thereof, not based on the description of the present specification.

0069The present invention also has the following aspects. (1) A surgical approach instrument that is now placed on the outside of the body wall A cap with an opening and Has a gel pad that is coupled to the cap and seals the opening of the cap, The gel pad provides a seal in both the presence and absence of the tool, and the gel pad is further inserted to reduce the weight of the gel pad and through the gel pad while maintaining the occlusion of the center of the gel pad. A surgical approach instrument characterized by having a gas pocket near the center of the gel pad to reduce the resistance of the tool. (2) The surgical approach device according to paragraph 1, wherein the gas-filled pocket is formed by bubbles or balloons in the gel pad. (Section 3) The surgical approach instrument according to paragraph 1 or 2, further comprising a material that is integrated with the surface of the gel pad and is elastic and extensible. (Item 4) The surgical approach instrument according to paragraph 3, wherein the elastic and stretchable material is a woven fabric. (Section 5) A surgical approach instrument that is now placed on the outside of the body wall A cap with an opening and A gel pad that is attached to the cap to seal the opening of the cap and provides a seal in both the presence and absence of the tool, and in addition. It is characterized by having a soft gel on one side and a heterogeneous gel pad having a harder gel on the other side, which are formed by separating the densities over time in accordance with the timing of energy input to the gel pad. Surgical approach device. (Section 6) Further, it has a first fabric and a second fabric bonded to a cap at a distance from the first fabric, the distance between the first fabric and the second fabric is hollow, and the gel pad is the first. The surgical approach device according to paragraph 1 or 5, which is located in a cavity between the fabric and the second fabric. (Section 7) The surgical approach instrument according to item 1 or 5, further comprising an integrated elastic and extensible material within the gel pad. (Item 8) The cap has a gap along the annular perimeter of the cap, the gap forming the first and second ends of the cap, and in the cap from a perimeter with a large clearance to a perimeter with a small clearance. The surgical approach device according to paragraph 1 or 5, which facilitates the transition. (Section 9) The surgical approach instrument of item 8, further comprising a swivelably coupled latch near the first end of the cap. (Item 10) The surgical approach device according to paragraph 1 or 5, further comprising a retainer removably coupled to the cap. (Section 11) 10. The surgical approach instrument of item 10, wherein the retainer is coupled to a proximal end portion of an elongated sleeve that extends through the body wall. (Section 12) The surgical approach instrument of item 11, further comprising a latch that is swivelly coupled to the retainer and engages the cap. (Section 13) 12. Surgical operation according to item 12, wherein the latch has a protrusion extending orthogonally from the latch and engaging with the cap, and the cap has an engaging portion for receiving the protrusion of the latch. Approach device. (Section 14) 8. The surgical approach instrument of item 8, wherein the cap further comprises a buckle fitting portion such that the first end of the cap is coupled to a second end of the cap that closes the gap. (Section 15) The buckle fitting portion has a barbed portion extending from the first end portion of the cap and a receiving portion extending from the second end portion of the cap, and the barbed portion of the squeeze release type buckle fitting portion. The surgical approach device according to paragraph 14, wherein the receiving portion and the receiving portion are engaged with each other in an meshing relationship. (Section 16) A surgical approach instrument that is now placed against the body wall A cap that is provided with an opening and has a gap along the annular circumference of the cap, the gap forming the first and second ends of the cap, from a larger perimeter to a smaller perimeter. With the cap, which facilitates migration within the cap With a latch swivelably coupled to the cap near the first end of the cap, A latch receiver that is located near the second end of the cap and is openly accepting the latch. A gel pad that is coupled to the cap to seal the opening in the cap and seals the device in the presence or absence of the device. A retainer that is annular and is disposed with respect to the body wall and has the retainer coupled to the proximal portion of an elongated sleeve that extends through the body wall. When the cap has a larger perimeter, the retainer moves in and out of the cap opening and the retainer shifts the perimeter of the cap to a smaller perimeter of the retainer located within the cap opening. A surgical approach instrument that is fixedly coupled to a cap and that engages the latch with the latch receiver to maintain a smaller peripheral circumference of the cap. (Section 17) 16. The surgical approach instrument of paragraph 16, wherein the latch comprises a shaft having a first end swivelably coupled to a first end of a cap ring and a second end having an enlarged compressible head. .. (Section 18) 16. The surgical approach instrument of item 16, wherein the latch has a protrusion that engages with a corresponding notch in the latch receiver. (Section 19) The surgical approach instrument according to paragraph 11 or 16, further comprising a deformable retention ring attached to the distal end to an elongated sleeve. (Item 20) The surgical approach instrument of paragraph 19, further comprising a plurality of gusset or web-based continuous gels extending between the retention ring and the gel pad.