BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a tissue perforation device positioned over a non-extended abdominal wall;
FIG. 2 is a bottom view of the perforation device of FIG. 1;
FIG. 3 is a side view of the perforation device of FIG. 1 exhibiting an extended abdominal wall forming an abdominal wall bubble;
FIGS. 4A and 4B provide a perspective view (FIG. 4A) and a side elevation view (FIG. 4B) of a vacuum housing incorporating a valved port for introduction of a penetrator according to an embodiment of the invention;
FIGS. 5A and 5B provide a perspective view (FIG. 5A) and a side elevation view (FIG. 5B) of a vacuum housing incorporating a valved port for introduction of a penetrator according to another embodiment of the invention;
FIGS. 6A and 6B provide a side elevation view (FIG. 6A) and a top plan view (FIG. 6B) of a vacuum housing incorporating a tear away insert according to a further embodiment of the invention;
FIGS. 7A and 7B provide a side elevation view (FIG. 7A) and a top plan view (FIG. 7B) of a split shell vacuum housing according to a further embodiment of the invention; and
FIG. 8 provides a side elevation view of a seal according to a further embodiment of the invention; and
FIG. 9 provides a side elevation view of a vacuum release according to a further embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
The invention provides several improvements to the prior art device discussed above in connection with FIGS. 1-3.
FIGURES. 4-A and 4-B provide a perspective view (FIG. 4A) and a side elevation view (FIG. 4B) of a vacuum housing 40 incorporating a valved port 42 for introduction of a penetrator. In FIGS. 4A and 4B, the housing includes a valved port having a valve control 44 and a conduit 49 which allows admission of a needle or trocar or other pentrating device in the housing. The valved port 42 is secured to the housing 40 by a plurality of ribbed extensions 43. The housing 40 also includes a sealing surface 48 for sealing the housing to an individual's skin surface. Additionally, a side-mounted vacuum port 41 is coupled to the housing. The vacuum port 41 incorporates a nipple 45 for attachment to an external source of vacuum and a bleed conduit 47 for allowing entry of air into the housing. A valve control 46 is operable to couple the vacuum to the housing via the vacuum port nipple 45, to purge the vacuum from the housing via the purge port 47, or to seal the vacuum port so that neither the vacuum port nipple 45 nor the purge port 47 are coupled to the interior of the housing 40.
FIGS. 5A and 5B provide a perspective view (FIG. 5A) and a side elevation (FIG. 5B) of a vacuum housing 50 incorporating a valved port 52 for introduction of a penetrator according to another embodiment of the invention. In FIGS., 5A and 5B, a housing 50 includes a valved port 52 which includes a conduit 59 which allows admission of a needle or trocar or other penetrating device into the housing and a valve control 54. In this embodiment of the invention, the ribbed members 53 which support the valved port 52 have a reduced profile which allows a user to grasp and operate the valve control 54 with less effort. As with the embodiment of FIGS. 4A and 4B, the housing 50 includes a sealing surface 58 for sealing the housing to an individual's skin surface. Also included is a vacuum port 51 which incorporates a vacuum port nipple 55, a bleed port 57, and a control valve 56, which operate in the same manner as similar elements discussed above in connection with FIGS. 4A/4B.
Significant in the embodiment of FIGS. 4A/4B and 5A/5B is the provision of a valved port. Accordingly, these embodiments to the invention provide the vacuum port nipple on the side of the housing. This permits ready user access to the valve port control (42; FIGS. 4A/4B and 52; FIGS. 5A/5B). The valve assembly of the valved port is preferably a two or three-way valve. In the open position, the valve allows a vacuum to be created within the housing and in the venting position, the housing is vented to the atmosphere. Thus, when the device is used, for example, to lift a patient's abdominal tissue the valve is set to the closed or vacuum position, and when the device is to be released from the individual, the valve is turned to the open position to release the vacuum.
Significant to the invention is the use of a compression seal fitting for the valved port. One use of the invention is in, for example, laparoscopic procedures and intervascular procedures. A typical top fitting of a compression seal fitting could be used in this embodiment of the invention. Such assembly is a fitting that allows passage of a catheter or guide wire through a port into an artery without leaking blood back through the port. The top fitting comprises a valve that allows access of a tool through the port, while maintaining a seal having sufficient integrity to prevent the leakage of blood back through the port to the opening through which the tool is introduced. In the invention herein, any fitting is used that allows the introduction of tools through the port once the housing has drawn a vacuum and lifted the patient's abdominal, for example, tissue upwardly into the housing, where the valve may be tightened sufficiently to hold the tool in place, for example to maintain a stationary location for a penetrator while vacuum is applied, such that the tissue is lifted into the penetrator, in one embodiment, by application of vacuum to the housing. The size of tool accommodated by the port is a function of, inter alia, the diameter of the O-ring or other sealing surface within the port of the valve. Thus, in some applications an O-ring may be chosen that is sufficient to seal the port entirely in the absence of a tool therein. In other embodiments, the size of the port is sufficient, when the valve is closed, to prevent most leakage into the housing of the atmosphere as vacuum is applied, and yet provide a sufficient opening to allow introduction of a tool without the risk of damaging the seal and the valve during introduction of the tool therethrough. Thus, the vacuum port may allow for complete sealing of the port, or only partial sealing of the port as desired. In both cases, the valve is adjustable to allow the port to be open sufficiently, in the first case to admit atmosphere into the housing, and in the second case to permit entry therein of a tool.
Because the vacuum port has an adjustment valve, the embodiments of FIGS. 4A/4B and 5A/5B include support ribs, as discussed above. The support ribs are struts to impart sufficient strength to the housing at the point at which the vacuum port is added such that the housing does not break or crack as the valve adjustment is twisted to open and close the port. In some embodiments of the invention, the cylinder portion of the valve is integrally molded with the support in the housing itself to allow manufacture of the housing, support, and valve cylinder as a single assembly. In other embodiments, the vacuum port may be attached to the housing with a washer and nut, or by gluing thereto. In yet other embodiments of the invention, the entire dome of the housing, including the vacuum port could be detachable from the housing, such that different sized ports with different valve arrangements could be interchanged with a common housing.
The embodiments of the invention discussed above in connection with FIGS. 4A/4B and 5A/5B may be used with various types of devices such as Veress needles and trocars. In the case of using a Veress needle at a first portion of the procedure, the Veress needle may be used in connection with the housing and vacuum to create a pneumoperitoneum. After the pneumoperitoneum is created, the Veress needle may be removed from the individual and the housing may be lifted away. At that point, a trocar may be inserted into the individual and a laparoscopic or endoscopic procedure may then be pursued. In another embodiment, a trocar may be inserted without first creating a pneumoperitoneum. Once the tissue is drawn upwardly in the dome by application of a vacuum and the body cavity wall is pulled upwardly, the trocar may be introduced into the body tissue or the body tissue may be pulled directly over the trocar. At this point, it is not necessary to remove the trocar until the end of the procedure. In such case, it would be advantageous to remove the housing (see FIGS. 6A/6B discussed below).
As discussed above in connection with FIGS. 4A/4B and 5A/5B, one embodiment includes support ribs that go further up the shaft of the vacuum port (FIGS. 4A/4B) than that of the other embodiment (FIGS. 5A/5B). In either embodiment, the housing maintains the same volume of tissue. However, as discussed above one embodiment provides larger ribs or struts for support, e.g. in a preferred embodiment of about 22 millimeters, as opposed to an embodiment which provides shallower ribs or struts, e.g. in a preferred embodiment of about 15 millimeters. As discussed above, this latter arrangement provides more space for grasping the valve.
FIGS. 6A and 6B provide a side elevation view (FIG. 6A) and a top plan view (FIG. 6B) of a vacuum housing 60 incorporating a tear-away insert 62 according to a further embodiment of the invention. As discussed above, previous inventions have used vacuums to create a space between the skin and the underlying organs to allow safe introduction of a Veress needle for purposes of initiating a laparoscopic procedure. However, these devices are limited to a small diaphragm or portal to maintain vacuum while introducing the Veress needle. Later during the procedure, the Veress needle is exchanged for a larger diameter trocar which is required to deliver devices into the portal for a laparoscopic procedure. The embodiment of the invention shown in FIGS. 6A/6B allows direct introduction of larger devices, such as trocars, which obviates the need for the preliminary step of using a smaller Veress needle to first institute the implementation of a pneumoperitoneum with a device that is smaller than a trocar, and which must ultimately be deployed for the laparoscopic procedure. This embodiment of the invention includes a bell-like, at least partially transparent, housing 60 that is secured to the surface of the individual's skin 64. In a first embodiment, the housing has a removable plug or insert 62 at the top or apex of the bell portion of the housing through which the trocar 61 is placed. The trocar may be either partially or fully pre-loaded through the bell plug or insert to maintain a seal while vacuum is instituted, or it may be placed through the seal after the bell is secured and the vacuum is initiated. Once the vacuum has been implemented, the skin and underlying tissue and fat layers are physically raised above the underlying organs, and the trocar can be safely advanced through this tissue into the body to allow implementation of the laparoscopic procedure. Once the trocar has penetrated the tissue, a pneumoperitoneum can be applied as well by the introduction of insufflating medium into the patient's body cavity. At this point, the housing can be removed, for example by breaking a seal between the insert plug and housing, and raising the housing upwards around the removable plug and trocar and out of the sterile field. The removable plug can then be removed. The plug can be a tear-away, split-wing type device 63 that breaks in two or that opens when pulled apart, or it can be a clamshell hinge-type device. In an alternative embodiment (see FIGS. 7A/7B), the entire bell itself may be a tear-away or a clamshell device which facilitates removal thereof so that the trocar may be fully advanced into the fully deployed position for surgical use.
FIGS. 7A and 7B provide a side elevation view (FIG. 7A) and a top plan view (FIG. 7B) of a split shell vacuum housing 70 according to a further embodiment of the invention. In this embodiment of the invention, the housing 70 includes a hinge 72 and seal 71, which may be a clasp like seal. The housing has sufficient integrity along the hinge and clasp-like seal to allow maintenance of the vacuum during the initial portion of the procedure when the tissues and skin are lifted away from the internal organs of the patient. As discussed above, a trocar 61 is introduced into the housing through a port 73. Once the trocar has penetrated the tissue of the patient and a pneumoperitoneum (if desired) is established, the housing is opened along the sides, and the halves of the housing are spread apart along the hinge. The housing is then readily removed and the procedure may go forward without the housing being in the way of the surgeon performing the procedure. While a hinge and clasp seal are shown in FIGS. 7A/7B, those skilled in the art will appreciate that other arrangements may be used to provide a housing that may separate into two or more sections. For example, the housing may include a bead and mating groove that allows the sections of the housing to seal together, or the housing may be secured by engaging a groove of a resilient silicon member with respective edges of two or more housing hemispheres. This allows the housing to be quickly separated into multiple sections. Further, the housing may be held together by a temporary adhesive seal that is readily dissolved.
The housing used to connect to the invention is typically made of a rigid plastic or metal material that does not always produce adequate skin seals on patients having less elastic or thinner skin, e.g. the elderly or hirsute. FIG. 8 provides a side elevation view of a seal according to a further embodiment of the invention. In this embodiment of the invention, which operates in connection with a housing that is commonly a rigid clear plastic and that is not elastic or conformable, a rubber or elastomeric seal, gasket, or O-ring 81 is placed over a lip at the bottom edge of the housing 80 and makes contact with the patient's skin. The material for the seal may be bonded or press fit over the lip of the housing. Alternatively, a similar result may be obtained by applying a gel-like material on the edge of the housing that contacts the patient's skin or by placing such material directly on the skin of the patient. This embodiment of the invention not only improves the seal quality, but also prevents damage to the skin of the patients, especially those with thinner or less elastic skin.
FIG. 9 provides a side elevation view of a vacuum release according to a further embodiment of the invention. This embodiment of the invention allows easier release of vacuum from the housing once the needle or trocar has been introduced. While pressure within the housing could be released by disconnecting the source of vacuum, for example by using a two or three-way valve in the vacuum tubing feeding the housing as discussed above, the invention according to FIG. 9. releases vacuum by allowing user to depress a diaphragm 82 on the housing 80 or by alternatively removing a plug placed in the housing.
Although the invention is described herein with reference to the preferred embodiment, one skilled in the art will readily appreciate that other applications may be substituted for those set forth herein without departing from the spirit and scope of the present invention. Accordingly, the invention should only be limited by the Claims included below.
Patent Application
20080058851
