JP4148973B2 - Hermetic surgical access device - Google Patents

Description

  The present invention relates generally to a surgical access device, and more particularly to an access device adapted to be used in a surgical procedure with minimal invasiveness, allowing access to a sealing instrument across a body wall into a body cavity. About.

(Cross-reference with related applications)
This application includes US Provisional Patent Application No. 60 / 241,953 “Hand-Assisted Laparoscopic Apparatus and Method” dated October 19, 2000, as well as PCT Application No. PCT / US01 / 29/682, “Surgical Access” dated September 21, 2001. Non-provisional applications claiming priority from “Apparatus and Methods”, both of which are incorporated herein by reference.

Surgical access to body cavities such as the abdominal cavity is called "open laparotomy" or "closed laparoscopic surgery". Open laparotomy requires a sufficiently sized incision that allows the surgeon to place hands and instruments within the surgical site. In addition, the site needs to be open enough so that the surgeon can clearly see what is being treated. Often multiple laparoscopes, forceps, and sponges are required. All of these devices compete for space within the surgical site.
Laparoscopic or closed surgical procedures eliminate many of the problems associated with open laparotomy. In a typical pressurized laparoscopic procedure, the abdominal wall is punctured and at least one trocar is inserted into the peritoneum. Gas is introduced into the abdominal cavity to lift the abdominal wall from the internal organs. The result is a large, unobstructed surgical area. Additional trocars can be inserted as required for various procedures. A laparoscope is used to provide visibility of the surgical site. In recent years, a number of instruments for laparoscopic techniques have been developed, allowing surgeons a comfortable “remote control” method for various aspects of surgery. Incision, dissection, cauterization, stapling, and suturing have all been addressed by laparoscopic device manufacturers.

  While laparoscopic surgery has many advantages, there are still some complex procedures that make this laparoscopic procedure difficult or dangerous. In these specific cases, it is most reasonable to perform a hybrid procedure. All are desirable if they have visibility in laparoscopic and open surgical areas and controllability of open surgical procedures. However, these two aspects tend to interfere with each other. In fact, some argue that laparoscopic advances are wasted if open surgery is deemed impossible.

  In recent years, a number of enterprising surgeons have developed what they call “hand-assisted” laparoscopic or “handscopy”. This method involves placing the surgeon's hand into the patient's body through an enlarged incision while viewing with a laparoscope. There is no need to perform overly difficult operations without the use of protruding instruments normally used in closed laparoscopic procedures.

  The challenge faced by surgeons now in this surgical procedure is to provide a means to adequately seal the widened incision. The surgeon's hand needs to be comfortably and properly positioned and free to move within the proper range of motion. Furthermore, it should be possible for the surgeon to put his hands in and out of the abdominal cavity without losing pneumoperitoneum.

  Several devices have been proposed so far in an attempt to meet the demands of “handscopy practitioners”. In general, these include an elastic seal that adheres to the incision and is held in place by holding means on one or both sides of the abdominal wall. These devices are generally complex and require several steps to deploy. One of these devices requires applying an adhesive to the outer surface (skin) of the abdominal wall so that the seal adheres to the skin. This requires time for drying as well as application of the adhesive. Allergic reactions and other complex issues must be taken into account when using this product. Another device utilizes a “annular balloon” that is inflated to install and seal the incision. The surgeon must overcome the sealing pressure and friction problems of this device as he hands in and out of the surgical site. Yet another device uses a built-in glove or sleeve. This configuration narrows the range of movement of the hand and impairs the feel of the hand.

  U.S. Pat. No. 5,848,992 discloses a surgical access device that allows an open laparotomy to be converted to laparoscopic. The US patent also discloses the use of such a device in the case of removing a large internal organ. In this case, a sufficiently sized incision is first formed and the incision is sealed with the device upon insertion of the trocar.

  In spite of these devices being proposed, a continuous access to a surgical access device that provides a flexible, simple and complete seal within an incision large enough to insert a human hand. The need still exists.

  The present invention satisfies the need for a surgical access device for use with surgical instruments, including the surgeon's hand. By using this access device, “hand-assisted” laparoscopic procedures are greatly facilitated in a closed surgical environment.

  The present invention utilizes an inner holding member and an outer holding member connected by a flexible, lubricious material. Tension can be applied to at least one of the retaining members to provide sufficient stability to the incision site.

  The present invention also provides a seal that allows the maximum range of hand movement without leaking the injected gas. This seal is formed of a material that well corresponds to the presence of a glove material, such as natural latex, polyisoprene, nitrile, vinyl, or polyurethane.

  In one aspect of the invention, the surgical access device is for facilitating access into a patient's body cavity through an incision in a patient's body wall having an inner surface and an outer surface. The device includes a first holding member shaped to surround the incision in proximity to the outer surface of the body wall. The second holding member is shaped to surround the incision in proximity to the inner surface within the body wall. The thin film extending between the first holding member and the second holding member forms a throat that is adapted to be placed through the incision. A first funnel-shaped portion extends from the first holding member to the throat and a second funnel-shaped portion extends from the second holding member to the throat. The membrane throat has the property of forming an instrument seal when the instrument is present and forming a zero seal when the instrument is not present.

  In another aspect of the present invention, the first holding member has a first portion having a first end and a second end, and a first end of the first holding member. A ring having a movable third end and a second portion having a fourth end movable relative to the second end of the first retaining member. A connecting member is disposed between the first end of the first holding member and the third end of the second holding member. The connecting member is operable to change the distance separating the first end and the third end in order to control the shape of the working channel formed by the thin film. A second connecting member or hinge can be provided between the second end of the first holding member and the fourth end of the second holding member.

  In yet another aspect of the present invention, the first holding member has a variable shape in order to control the shape of the working passage formed of a thin film. The first holding member can be formed as an expandable structure such as a ring. The first retaining member can include a self-expanding foam for a circumferential spring.

  In yet another aspect of the present invention, the surgical access device can include a plurality of inflatable chambers that each extend in a plane through the axis of the device. These chambers generally form a working passage that is adapted to be placed across the body wall. The chamber may be linear or U-shaped.

  In another aspect of the invention, the apparatus includes a first holding member that includes a ring with a plurality of holding portions. The membrane is attached to a plurality of anchors, and these anchors can be joined to the ring with one associated holding to give the membrane the desired shape.

In yet another aspect of the invention, a stabilizer is proposed for supporting an access device that is substantially independent of any movement associated with the body wall.
The above and other features and advantages of the present invention will become more apparent from the following description of preferred embodiments with reference to the associated drawings.

  In FIG. 1, the patient 10 is shown in the prone or supine position. Patient 10 has an abdomen 12 that includes a body cavity or abdominal cavity 16 defined by an abdominal wall 18. A plurality of trocars 20, 21, and 22 are arranged to provide surgical access to the abdominal cavity 16. Various instruments 23, 24, 25 for insertion and use in the trocar 20, 21, 22 are shown.

  FIG. 2 shows a “hand-assisted” laparoscopic procedure. Patient 10 is supine and abdominal cavity 16 is inflated. In addition to the trocars 20, 21, and 22, an additional surgical access device 50 for the surgical incision 100 is disposed. The access device 50 is adapted to receive a surgeon's hand as the surgeon's hand 160 is placed into the abdominal cavity 16 of the patient 10 therethrough. The surgeon can use the inserted hand 160 to perform tasks that are too difficult or unsafe to do with instruments commonly used in laparoscopes. The access device 50 forms an airtight seal so that the abdomen expanded and pressurized in the abdominal cavity 16 is not deflated. The access device 50 can also accommodate large, contaminated samples or diseased organs or tissues. Further, instruments or tools that are otherwise too large for the trocar can be introduced via the access device 50 and then attached to a device driver that is operated via the trocar 20, 21, 22. The sample bag introduced via the trocar can be removed via the access device 50 when it is full.

  The access device 50 is disposed through the surgical incision 100 (FIG. 3), held against the outer abdominal wall 17 by a first holding member or retainer 55, and the inner abdominal wall 18 by a second holding member or retainer 65. Held against. The outer first retainer 55 supports an airtight sleeve or membrane 75 at the first end 76. An inner second retainer 65 supports a hermetic sleeve or membrane 75 at a second opposite end 86. Two opposing ends 76 and 86 maintain a communication surface 77 that passes through the incision 100. The material of the surgical access device 50 provides a durable and impermeable surface for the incised tissue that forms the incision 100.

  With particular reference to FIGS. 4, 5, and 6, the preferred embodiment of the access device 50 has a first end 51, a second end 52, and a central portion 53 in communication. In a preferred embodiment, the first end 51 is outside the body cavity 16 and includes an enlarged adjustable portion 55. The exact shape of the first end portion 55 can be circular, oval, rectangular, square, triangular, or the like. The first end portion 55 is sized and shaped such that the area can be adjusted so that the surface 77 of the sleeve or membrane 75 is properly stretched or tensioned.

  The preferred embodiment of the access device 50 employs a leaf spring 56 biased to an open state. Appropriate tension is applied to the sleeve / film 75 as the opposing ends 57, 58 of the leaf spring 56 spread apart. This applied tension causes a pulling force applied via the communication center portion 53. This force brings the second, inner or distal end 52 of the access device 50 closer to the inner surface of the abdominal wall 18.

  The second holding portion 65 is preferably made of a flexible material that can be inserted into the surgical incision 100 in a folded and reduced profile. The second holding portion 65 is preferably a self-expanding member, or at least preferably has a slightly circular shape or sufficient shape memory to naturally restore to a predetermined shape or state. Such configuration material options may include flexible vinyl, rubber, silicone, or other elastomers. Such materials also include rigid materials such as rigid plastics or metals with hinges or flexible portions.

  Further, each structure of the first holding member 55 or the second holding member 65 is attached with a shape memory metal such as nickel-titanium (NiTinol) or includes such a shape memory metal. The use of molded elastic elements can be included. In any case, the second retaining member 65 can be easily deformed into a state or shape that can be easily introduced into the smallest surgical incision 100 as possible. The second retaining member 65 is not sized and structured to hold the access device 50 in place without causing tissue damage such as moribundity or detachment during the harsh period in which surgery is actively performed. It should be noted that it must not be. A preferred embodiment of the second retaining member 65 includes a soft silicon or vinyl ring 66 having a nickel-titanium support ring encapsulated or insert molded therein. This embodiment can be introduced into the body cavity 16 in a highly deformed state and will recover its preferred shape and size after the introduction is complete.

  Alternatively, the nickel-titanium superelastic and shape memory properties can be derived from the temperature transition properties of the alloy. For example, as the ring 66 cools the second holding member 65 to an easily and highly deformable temperature and then the alloy is warmed to body temperature, the holding member 55 has a predetermined shape, size, or It can be made to return to shape.

  The sleeve / thin film portion 75 is shaped by the tension between the first holding member 55 and the second holding member 65. The sleeve / membrane 75 initially forms an opening 78, which may be a slit, hole, or the like that communicates the exterior and interior of the body cavity 16 via a lumen 80. Lumen 80 has a first state in which the sleeve / membrane 75 is not tensioned and a second state in which the sleeve / membrane 75 is tensioned.

  In a preferred embodiment, tensioning the sleeve / membrane 75 adjusts the lumen 80 to a preferred size and structure. Such a configuration forms a funnel-shaped rounded opening 78 that becomes smaller in diameter at the central portion 53 and further changes to a funnel-shaped enlargement 67 again distally at the second retaining member 65. be able to.

  Preferred embodiment materials for the sleeve / film 75 include non-expandable or non-elastic materials such as polyethylene, polyurethane, or reinforced elastomer. By choosing polyethylene as the material for the sleeve / thin film 75, a surface 77 is obtained that has almost no frictional properties for most glove materials. Since the polyethylene material is not elastic, the sleeve / film 75 will be folded to form discrete “folded” portions 79. This situation allows the sleeve / film 75 material to be radially compressed by the adjacent human tissue so that when no hand or instrument is present in the lumen 80 of the access device 50, The sleeve / film forms a throat 90 or a central portion 53 that is substantially occluded. Thus, when no hand or instrument is present, the throat functions as a zero seal. When a hand or instrument is present in the lumen 80, the fan-folded material in the throat 90 of the sleeve / film 75 will still form an occlusive instrument seal, depending on the size and shape of the inserted hand or instrument. To do. Given that the typical pressure for pneumonectomy is about 0.18 to 0.28 psi, the throat 90 of the present invention is sufficient to form both a zero seal and an instrument seal.

  The embodiment of FIG. 5 is the same as the embodiment of FIG. 4 except that the thin film 75 has a diaphragm structure in the vicinity of the first holding member 55. In this case, the opening 78 is formed as a slit leading to the throat 90 of the access device. In the embodiment of FIG. 5, the folded portion 79 extends to both ends of the slit or opening 78. In the embodiment of FIG. 6, these folded portions 79 are not present.

  7A-7D, a preferred embodiment of the surgical access device 50 of the present invention includes a first retaining member 155 that is folded similar to a “taco”. By folding the first holding member 155, the thin film 75 is relaxed, and the second holding member 65 can be easily inserted into the surgical incision 100 (FIG. 2). Thereafter, unfolding the first retaining member 155 results in the sleeve / film 75 extending as a result of, for example, pulling apart the pair of separable members 156, 157. In this position, the two members 156, 157 of the first holding member 155 are secured in a single plane, ie, flat with the tensioned sleeve / film 75.

  In the preferred embodiment of the foldable first retaining member 155, the opening 78 is elongated and collinear with the fold 159 of the sleeve / thin film 75 and the pair of hinge portions 158 of the first retaining member 155. In another embodiment shown in FIGS. 8A-8D, the opening 78 is elongated and traverses both the fold 159 of the sleeve / thin film 75 and the hinge portion 158 of the first retaining member 155.

  Referring to FIGS. 9 to 17, the illustrated surgical access device 50 includes a first holding member 155, in which case the first holding member 155 has an adjustable area or outer periphery. . In this embodiment, the two separable members 156, 157 of the first retaining member 155 are separated along a common plane by moving a pair of adjustment sleeves 200, 220 that threadably engage the adjustment screws 210, 230. can do. This action tensions the sleeve / membrane 75 in order to allow the opening 78 to be used. There may be several adjustment members 200, 220, for example two, three, four or more, cooperating to stretch the sleeve / membrane 75. This stretching may be uniform or non-uniform.

  With particular reference to FIGS. 11 and 12, another embodiment of the surgical access device 50 shown herein, when an expanding force is applied to the individual members 156, 157, causes these members to move in opposite directions. It has at least one hinge 260 that pivots. In this case, the spreading force is applied by rotating the combination 265 of the screw jack and the finger driving wheel. The resulting non-uniform spreading force makes the opening 78 in a preferred state.

  Referring to FIGS. 13 and 14, another embodiment of a surgical access device 50 according to the present invention is shown, with an elongated opening 78 positioned to extend along its longitudinal centerline 278. This structure is such that the aperture 78 is more closed in the natural state than when the elongated aperture 78 intersects the extension moment. By combining the collinear and lateral extension of the sleeve / membrane 75 and opening 78, the opening of the opening 78 can be made more symmetrical or uniform as a result.

  Referring to FIGS. 15 and 16, another embodiment of a surgical access device 50 according to the present invention is shown. In this embodiment, the separable members 156 and 157 are movable in a single plane between the expanded position shown in FIG. 15 and the reduced position shown in FIG. In this case, the separable member 156 has ends 161 and 163, while the separable member 157 has ends 160 and 162. Foldable separating members 285 and 296 are disposed between the ends 160 and 161 and between the ends 162 and 163, respectively. In the state where the separable members 156 and 157 are contracted, the separating members 285 and 296 are folded, and the first end portions 160 and 162 are in contact with the second end portions 161 and 163, respectively. . When the separable members 156 and 157 are expanded to the expanded state as shown in FIG. 15, these separating members 285 and 296 are expanded from the state beyond the center as shown in FIG. Move to a flat state. In this state, the separating members 285 and 296 maintain the separable members 156 and 157 in an expanded state, thereby causing the membrane 175 to stretch.

  The elongated openings 78 may be oriented either in the same direction as the extension direction or in a direction that intersects. Further embodiments of the surgical access device 50 can include a plurality of foldable separation members 285, 296 where the extension of the sleeve / membrane 75 is more or less uniform. The foldable separating members 285, 296 are made of metal and can be either separate hinges or no hinges or made of plastic and can have separate hinges or "existing" hinges. .

  FIG. 17 illustrates yet another embodiment of a surgical access device 50 according to the present invention. In this case, the first retaining member 155 includes any length of rigid or semi-rigid material made in the shape of a ring or coil 290. Coil 290 has opposing ends 291 and 292, as well as an outer surface 293 and an inner surface 294. As the ends 291, 292 are expanded relative to each other, the diameter and area of the coil 290 increases, resulting in increased tension in the sleeve / membrane 75 attached thereto.

  The position of the coil ends 291 and 292 can be maintained by a series of ratchet teeth 295 and associated ratchet pawls 296. In the illustrated embodiment, ratchet teeth 295 are formed on the outer surface 293 and ratchet pawls 296 are formed on the end 292. Alternatively, a second series of ratchet teeth may be formed on the inner surface 294 and an associated second ratchet pawl may be formed on the end 291. This ratchet structure having both ends and side surfaces provides the first retaining member 155 and concomitantly great potential expandability to the sleeve / thin film 75.

  In this embodiment, the first retaining member 155 and the ratchet teeth 295 and ratchet pawl 296 are preferably constructed from a rigid plastic such as polycarbonate, ABS, PBC, or other filled or unfilled material. . In yet another embodiment, the first retaining member 155 can be formed of metal to be sterilizable and reusable. Such an embodiment may include a disposable sleeve / film 75 and a second retaining member 65.

  Referring now to FIGS. 18, 19, 20, and 21, a surgical access device 50 according to the present invention includes an inflatable or fillable first retaining member 300 and a flexible, foldable or deformable second. The holding member 65 is shown. In a preferred embodiment, the expandable or fillable retaining member 300 includes a closed hollow structure 310 that can be circular or annular. The hollow structure 310 provides very little, if any, stretching force or tension to the sleeve / film 75 when unexpanded or unfilled. However, when expanded, the hollow structure 310 increases in diameter and area resulting in the desired stretch or tension of the sleeve / membrane 75. A preferred embodiment of the hollow structure 310 may be formed of either an elastic material or a non-expandable material.

  Similarly, the sleeve or membrane 75 can be made of an elastic material, but in a preferred embodiment, the membrane 75 is non-expandable. In this embodiment, the expansion of the hollow structure 310 also stretches the sleeve / thin film 75 so that the throat 90 of the access device 50 is also placed under tension. The tension of the throat portion 90 connected to the first holding member 300 and the second holding member 65 draws the second holding member 65 appropriately and causes the inner surface of the abdominal wall 18 (FIG. 1) to be hermetically engaged. . As a result, the periphery of the access device 50 is hermetically sealed. In the embodiment of FIG. 19, the thin film 75 is in the form of a diaphragm.

  With particular attention to FIGS. 20 and 21, the first holding member 300 includes an inflatable or fillable structure 310 and the second holding member 365 has an inflatable or fillable structure. Surgical access device 50 according to the present invention, including 375, is shown. The second holding member 65 can be easily inserted into the body cavity 16 through the incision 100 when the holding member is not inflated or unfilled, and then inflated or filled into the body cavity 16. It is somewhat rigid, that is, it has a defined shape and structure. The first retaining member 300 can then be expanded or filled to provide outer retention of the sleeve / membrane 75 and simultaneous extension or tension. It is also clear that the sleeve / thin film 75 can be formed to have an inflatable double wall structure, but in the case of the embodiment of FIGS. In these illustrated embodiments, the sleeve / thin film 75 connected to the two inflatable or fillable retaining members 300, 365 is formed of a single layer or a single thickness of a non-expandable or non-elastic material. The With this structure, the membrane 75 is not inflatable and relies on the minimum amount of material to be inserted that penetrates the incision 100 along the central or throat 90. In the throat 90 of the access device 50, the sleeve / thin film 75 remains smooth, slippery, thin and non-bulky.

  22 and 23 show another embodiment of the access device 50 of the present invention, in which a generally cylindrical sleeve 450 with an open end is a hollow, inflatable, in axial alignment and communication. It is comprised from the several member 455 which can be filled with. The communication member 455 can be expanded or filled by an expansion tube 458. Particularly when not inflated, the generally cylindrical shape of the access device 450 (FIG. 23) can be easily deformed so that the distal end 460 can be placed through the surgical incision 100 and into the abdominal cavity 16. it can. At the time of expansion or filling, the access device 450 takes the shape of an hourglass, and expands the first holding part 470 and the second holding part 480 connected by the central portion 490.

  This preferred embodiment also requires the use of a non-intumescent or non-elastic material so that friction is minimized and a gloved hand or large instrument is passed through the access device 450. When entering and exiting repeatedly, the material of the central portion 490 does not wrinkle or fold.

  In the illustrated embodiment, the individual inflatable or fillable member 455 prevents material migration and minimizes surface contact between the material and the gloved hand that forms a seal with the abdominal wall 18. An axial chamber and a receiving surface 495 are formed. The lumen of the central portion 490 can be lubricated with a storable thick or viscous material along the seam of the abutting or adjacent inflatable or fillable member 455. This lubrication product also functions to complete a device seal if a gloved hand or device is present, or to complete a zero seal if a gloved hand or device is not present. can do.

  Referring to FIG. 24, a surgical access device 50 according to the present invention is shown in which a compressible helical coil member 500 forms a first retaining member 550. The coil member 500 can be deformed to minimize the tension applied to the sleeve / film 75 and its central portion 560 attached thereto. The second holding member 565 can be deformed and placed in the surgical incision 100 so that when the coil member 500 of the first holding member 550 is released or decompressed, the second holding member 565 properly approaches the inner wall of the body cavity. For packaging and shipping, the coil 500 of the first holding member 550 can be stored in a storage sachet, bag, box, or the like (not shown) with the coil 500 minimized. In this state, the first holding member 550 will provide minimal tension to the sleeve / film 75 attached thereto.

  In the similar embodiment shown in FIG. 25, the second holding member 563 also comprises a second holding coil member 565. This second holding coil member 565 can be introduced through the incision 100 in a miniaturized shape and then decompressed to assume an enlarged diameter. Thereby, the access device 50 having an increased contact area on the inner surface of the abdominal wall 18 can be obtained. When the second retaining member 565 is decompressed and the diameter of the member is increased, the member also functions to stretch or tension the sleeve / membrane 75 attached thereto.

  Referring to FIGS. 26 and 27, a surgical access device 50 according to the present invention adapted to be held in place on the surgical incision 100 by a strap or belt 600 surrounding the abdomen 12 of the patient 10 (FIG. 1). It is shown. In this embodiment, the access device 50 includes a strap or belt 600 and an associated closure member or fastener 610. The access device 50 according to the embodiment of FIG. 26 is shown as a diaphragm seal 615. In the embodiment of FIG. 27, the access device is similar to the access device described in connection with FIG.

  Referring now to FIGS. 28 and 29, a surgical access device 50 having a thin film 75 extending between a first retaining member 55 and a second retaining member 65 is shown. In this embodiment, the first retaining member 55 includes a solid rigid ring 700 disposed in a plane that is substantially perpendicular to the axis of the access device 50. A plurality of slits 710 extending in the radial direction of the ring 700 are formed on the side surface of the ring 700 opposite to the second holding member 65. In this embodiment, a plurality of anchoring bodies 715 are attached to the membrane 75 at various radial positions. The anchoring body 715 is attached to the thin film 75 at the inner end 716 and has an enlarged feature 717 at the outer end 718. In this embodiment, the slit 710 of the ring 700 is sized and shaped to engage and lock at least one of the anchoring bodies 715. In such an embodiment, the enlarged feature 717 can serve to prevent the anchoring body 715 from being pulled back from the slit 710. The enlarged feature 717 functions as a handle that facilitates engagement of each anchoring body 715 when the anchoring body 715 is pulled outward through the associated slit 710 to apply tension to the membrane 75. You can also.

  In such an embodiment, it may be desirable to form the slit 710 to taper toward the bottom of the slit. This makes it easier to compress the associated anchoring body 715 and increases the frictional engagement between the anchoring body 715 and the ring 700. In this way, the anchoring bodies 715 can be collected and adjusted to give the thin film 75 the desired shape and sealing properties. The membrane 75 can be released from the ring 700 by simply lifting the anchor 715 and disengaging the associated slit 710. In FIG. 30, in order to give the thin film 75 an irregular shape, the anchoring body 715 is applied with an uneven tension. This configuration can be compared with that shown in FIG. 31 where the tension is evenly applied to the mooring body in order to give the thin film 75 a regular configuration.

  In FIG. 32, the access device 50 is shown in combination with a stabilizer 800. First, it should be noted that the illustrated access device 50 is the access device generally described with reference to FIGS. 28 to 31. However, it will be apparent that the stabilizer 800 can be adapted to support and function with any of the foregoing embodiments of the access device 50 to achieve the advantages described below. .

  In this embodiment, the stabilizer 800 includes a base portion 803 having a substantially flat structure, and the base portion has a pair of support flanges 805 and 807 extending vertically from both sides thereof. A pair of upstanding arms 810, 812 are pivotally and possibly detachably attached to the associated flanges 805, 807. A transverse member 814 is pivotably and optionally detachably mounted between the arms 810 and 812. In the preferred embodiment, the transverse member 814 is perpendicular to the arms 810 and 812 and parallel to the plane of the base 803. The access device 50 is supported by the cross member 814 with its axis 816 substantially perpendicular to the cross member 814. In this orientation, the first holding member 855 represented by the ring 700 is disposed in a predetermined plane that can pivot with respect to the upright arms 810 and 812 and the base portion 803.

  At the time of surgery, the base portion 803 is placed under the patient in a state of being in contact with the back of the patient 10 (FIG. 1). Upright arms 810 and 812 can then be attached to flanges 805 and 807, respectively, on both sides of patient 10. Lateral member 814 can then be attached to arms 810 and 812.

  The support platform 800 is highly advantageous in hand assisted laparoscopic procedures where a person's hand needs to be removed and inserted several times while maintaining abdominal pressure or pneumoperitoneum. As described above, the sealing mouth or throat 90 (FIG. 4) of the access device 50 needs to be tightly fitted around the surgeon's wrist or arm. When the surgeon's hand is removed, the throat 90 should close tightly to form a zero seal. This closed hermetic contact with the surgeon's hand or arm can cause the shape and particularly height of the abdominal wall 18 (FIG. 1) to vary as the hand enters and exits. If the access device 50 is attached directly to the abdominal wall 18, this movement of the abdominal wall 18 will result in movement of the access device 50, causing movement or misalignment of other surgical instruments such as a laparoscope. . The purpose of the stabilizer 800 is to support the access device 50 independently of the abdominal wall 18. This stabilization reduces the tendency of the access device 50 to move due to the surgeon's hand movement through the abdominal wall 18. This greatly stabilizes the site where the surgical procedure is performed, and in particular the instrument inserted through the access device 50. Proper pivoting of the transverse member 814 and the arms 810 and 812 allows the access device 50 to pivot to the proper position for patients of various body sizes and weights. In another embodiment, the base portion is formed as part of a surgical table, and the base includes at least one support, such as arms 810, 812, extending from one or both of the patients to support the transverse member 814. A member can be provided.

  Now that many embodiments for the access device 50 have been disclosed, many other embodiments that modify the structure and materials will become apparent. Therefore, it is noted that the scope of the invention is not limited to the disclosed embodiments, but only by the appended claims.

1 is a side view of a surgical patient in laparoscopic surgery. FIG. 1 is a front view of a surgical patient in a “hand-assist” surgical procedure. FIG. 1 is a front view of a surgical patient with a preferred embodiment of the present invention in place. FIG. It is a perspective view of the present invention in which two holding members were shown. FIG. 6 is a perspective view according to another embodiment of the present invention. FIG. 6 is a view of the present invention having another outer retaining member. It is a figure which shows the foldable holding member of this invention of the closed state. It is a figure which shows the folding-type holding member of this invention of the open state. It is a figure which shows the folding type holding member of this invention of a half open state. FIG. 4 shows a fully open foldable retaining member with a tensioned sealing material. It is a figure which shows another embodiment of the folding-type holding member of the closed state. FIG. 6 shows another embodiment partially open. It is a figure which shows the holding member opened half which has a sealing opening of a horizontal direction. It is a figure which shows the horizontal sealing opening to which tension | tensile_strength was fully applied along the length direction. FIG. 6 shows an adjustable outer holding member with the sealing part open. FIG. 5 shows an adjustable holding member with a sealed portion in a minimum tension state. FIG. 5 shows an adjustable holding having a combination of a hinge and a screw jack. It is a figure which shows the hinge and screw jack which apply opening tension to a sealing member. FIG. 5 shows a holding member with a sealing material with two screw jack adjustments and in a minimum tension in the lateral position. It is a figure which shows the holding member in which the sealing member is in the maximum tension state. It is a figure which shows embodiment of the holding member in which the tension | tensile_strength of a sealing member is given by the folding type spacer for tension relief. It is a figure which shows the spacer for tension reduction which has applied tension | tensile_strength to the sealing member in the fixed position beyond the center. It is a perspective view of the outer side holding member which has a ratchet for hold | maintaining a sealing material with preferable tension | tensile_strength. FIG. 6 shows another embodiment of the invention in which the outer retaining member is an unexpanded but expandable or fillable hollow torus. FIG. 4 shows an inflatable holding member that has expanded sufficiently to provide a sealing pressure and tensioned the seal. FIG. 6 shows an access device of the present invention having two non-expanded but expandable retaining members and a sealing member with minimal tension. FIG. 5 shows two inflatable holding members fully inflated and a fully tensioned sealing member. FIG. 6 shows another embodiment of the present invention in which the unexpanded retaining member and the sealing portion are integrally formed from a joined tubular section. FIG. 10 shows another embodiment in an expanded state and shaped when the device is inserted into a surgical incision. It is a figure which shows another embodiment whose outer side holding member is a coil spring. It is a figure which shows another embodiment whose outer side holding member and inner side holding member are coil springs. FIG. 6 illustrates another embodiment of the present invention in which a strap is used to maintain a position above the surgical incision. FIG. 6 shows an embodiment of the present invention in which a preferred embodiment of the retaining member and seal is held in place by a strap. FIG. 6 shows another preferred embodiment of the present invention in which the sleeve / film has an anchored tension in a first state. It is a figure which shows the tension mooring body in a 2nd state. It is a figure which shows the mooring body of an irregular and uneven shape. It is a figure which shows the mooring body in a regular and uniform state. It is a perspective view of the access device combined with the stabilizer.

Claims (15)

A combination for facilitating surgery on a patient supported on a surgical table,
An access device comprising a membrane for forming a working channel adapted to be placed across the patient's body wall to provide an instrument access channel into the patient's body cavity;
A stabilizer that supports a portion of the access device that is substantially independent of any movement of the body wall;
Including
A combination wherein the stabilizer comprises a base portion in a fixed relationship to the surgical table and a transverse member in a fixed relationship to a portion of the access device.   The combination of claim 1, further comprising at least one arm extending between the base portion and the transverse member.   3. A combination according to claim 2, characterized in that at least one of said arms has a pivoting relationship with respect to the base part.   4. Combination according to claim 3, characterized in that the transverse member has one axis and is rotatable about the axis relative to the arm.   The combination according to claim 2, characterized in that at least one of said arms is removably attached to said base part.   A combination for facilitating surgery on a patient supported on a surgical table,
  Including an access device and a stabilizer,
  The access device is
  A first portion adapted to be disposed in the vicinity of an outer surface of a patient's body wall, surrounding a body wall incision and having a first end and a second end; A second end provided with a third end movable relative to the first end of the holding member and a fourth end movable relative to the second end of the first holding member. A first holding member comprising:
  A distance between the first end of the first portion and the third end of the second portion, the distance separating the first end and the third end; A coupling member operable to change;
  A second holding member arranged in the vicinity of the inner surface of the patient's body wall and surrounding the incision;
  Extendable between the first retaining member and the second retaining member and adapted to be disposed across the patient's body wall to form a working channel and into the patient's body cavity A membrane that provides instrument access;
  The stabilizer has a base portion in a fixed relationship on a surgical table and a transverse member in a fixed relationship with respect to a portion of the access device, and is generally independent of any movement of the body wall. A combination characterized by supporting an access device.   The first holding member is expanded from the first area size to the second area size, and the first holding member has a second area size which is The combination according to claim 6, wherein the size of the area of the two holding members is larger.   The combination according to claim 6, further comprising at least one arm extending between the base portion and the transverse member.   The combination of claim 8, wherein the at least one arm is in a pivot relationship with respect to the base.   The combination according to claim 9, wherein the transverse member has an axis and is rotatable relative to the arm on the axis.   The combination of claim 8, wherein the at least one arm is removably attached to the base portion.   A combination for facilitating surgery on a patient supported on a surgical table,
  Including an access device and a stabilizer,
  The access device is
  A first retaining member comprising a plurality of retaining portions and including a ring sized and shaped to surround an incision proximate an outer surface of the patient's body wall
  A second holding member sized and shaped to surround the incision in proximity to the inner surface of the body wall;
  A thin film that forms a working channel between the first holding member and the second holding member to provide access to the cavity through the incision;
  A plurality of anchoring bodies with an inner end and an outer end coupled to the membrane, each of the anchoring bodies being associated with one of the holding portions at a specific position along the anchoring body. It comes to detachably engage,
  The stabilizer has a base portion in a fixed relationship on a surgical table and a transverse member in a fixed relationship with respect to a portion of the access device, and is generally independent of any movement of the body wall. A combination characterized by supporting an access device.   13. A combination according to claim 12, wherein each anchoring body is adapted to tension the membrane when pulled outwardly through the associated holding portion.   At least one retaining portion includes a ring portion that forms a groove sized and shaped to support and removably retain the associated anchoring body at a particular location along the anchoring body. 13. A combination according to claim 12, characterized in that   15. A combination according to claim 14, characterized in that the groove is substantially V-shaped.

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