The present disclosure relates to dissection devices for forming an anatomical space within a body, and, in particular, to balloon dissection devices, with multiple detachable balloons permitting selection of the optimal balloon for use with a patient.
During certain surgical procedures, it is necessary to dissect tissue layers to form an anatomical space for accessing a surgical site, and within which surgical instruments may be manipulated. For example, in hernia repair surgery, it is necessary to form an anatomical operative cavity within the extra peritoneal space in order to dissect fascia tissue layers from the peritoneum and access the hernia site. Various balloon dissectors are known for performing the tissue dissection procedure used in hernia repair surgery. Depending on the patient and procedure being performed, different shapes and sizes of balloons are used in performing tissue dissection procedures.
While the currently known tissue dissection devices are useful, it would be beneficial to have a kit possessing multiple detachable balloons to optimize use with individual patients in surgical procedures requiring dissection of tissue layers.
The present disclosure is directed to a dissection and access kit including a balloon dissector assembly having a balloon dissector shaft and a plurality of detachable balloons. Each balloon is releasably attachable to the balloon dissector shaft prior to use and then disconnected following use in order to be disposed. By providing balloons that are releasably secured to the balloon dissector shaft, a clinician is able to select a balloon best suited to a particular surgical procedure.
In one aspect of the disclosure, a kit for a dissection and access system includes a cannula assembly having a cannula housing and an access cannula, an obturator insertable into the access cannula, and a dissector assembly insertable into the access cannula. The dissector assembly has an elongate shaft and a distal tip. At least one dissection balloon includes an inflatable portion and a connector for releasable attachment to the distal tip.
In embodiments, at least one spacer is releasably attached to the elongate shaft for limiting a depth of insertion of the elongate shaft of the dissector assembly into a body of a patient.
In some embodiments, a seal is provided for placement between the distal tip of the elongate shaft and the connector.
In certain embodiments, the distal tip of the elongate shaft and the connector possess threads permitting the distal tip and connector to be threadably attached.
In embodiments, the distal tip of the elongate shaft is releasably attached to the connector by a bayonet configuration.
In some embodiments, the distal tip possesses an open end with slots on an inner surface of the elongate shaft. The slots extend proximally along the inner wall of the elongate shaft to form recesses thereon. The connector possesses a proximal end configured to fit within the open end of elongate shaft. An outer surface of the proximal end possesses tabs that extend from the outer surface of the connector and are configured to be slidably received within the slots of the open end of the elongate shaft.
In certain embodiments, the distal tip of the elongate shaft is releasably attached to the connector by a locking collar.
In embodiments, the at least one dissection balloon includes a plurality of round balloons of different sizes.
In some embodiments, the at least one dissection balloon includes a plurality of oval balloons of different sizes.
In certain embodiments, the at least one dissection balloon includes at least one round balloon and at least one oval balloon.
In embodiments, the at least one spacer has a shape of a disc having a lateral slit therein and a hole at its center.
In another aspect of the disclosure, a method of forming a balloon dissector assembly for use in a system for dissecting tissue is disclosed including the steps of obtaining a kit including a balloon dissector assembly having an elongate shaft and a distal tip, and a plurality of dissection balloons, wherein each of the dissection balloons has an inflatable portion and a connector for releasable attachment to the distal tip; selecting one of the plurality of dissection balloons for use; and releasably attaching the selected dissection balloon to the distal tip of the elongate shaft.
In embodiments, the kit further includes at least one spacer for limiting a depth of insertion of the elongate shaft of the balloon dissector assembly into a body of a patient.
In some embodiments, the method further includes placing the at least one spacer along the elongate shaft of the balloon dissector assembly to limit a depth of insertion of the elongate shaft of the balloon dissector assembly into a body of a patient.
In embodiments, the method further includes placing a seal between the distal tip of the elongate shaft and the connector.
In embodiments, the distal tip of the elongate shaft and the connector are threadably attached.
In embodiments, the distal tip of the elongate shaft is releasably attached to the connector by a bayonet configuration.
In embodiments, the distal tip of the elongate shaft is releasably attached to the connector by a locking collar.
In embodiments, a round balloon of desired size is selected as the dissection balloon.
In embodiments, an oval balloon of desired size is selected as the dissection balloon.
In embodiments, the at least one spacer has a shape of a disc having a lateral slit therein and a hole at its center. The lateral slit is placed along the elongate shaft of the dissector assembly and the spacer is pushed perpendicular to the axis of the elongate shaft so that the sides of the slit move away from the shaft until the shaft lies within the hole in the center of the spacer.
Various embodiments are described herein with reference to the drawings wherein:
Dissection and access kits including a balloon dissector assembly in accordance with embodiments of the present disclosure are shown in
Referring to
The elongate shaft 12 includes an inflation port 18 for inflating the dissection balloon 20, 30. In order to inflate the dissection balloon 20, 30 a source of inflation pressure is releasably attached to the inflation port 18 and pressurized fluid is introduced through the inflation port 18 and communicated along axis 5-5 to the dissection balloon 20, 30.
As noted above, balloons of varying shapes and sizes may be supplied with a kit of the present disclosure permitting increased variability in the procedures that require dissector balloons of varying shapes. Suitable shapes include round balloons as depicted in
Turning to
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Other coupling configurations for attaching a distal tip 114 of an elongate shaft 112 of a balloon dissector assembly 110 with a connector 150 of balloons (not shown) are contemplated. For example, as depicted in
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Yet another configuration for attaching a distal tip 214 of an elongate shaft 212 of a balloon dissector assembly with a connector 250 of a balloon is depicted in
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Referring to
In embodiments, to further enhance the variability of the kit of the present disclosure, removable spacers 300 may be provided to vary the working length of the balloon dissector assembly 410. More specifically, the removable spacers 300 may be added between the dissector assembly 410 and the cannula assembly 610 to reduce the overall working length of the shaft 12 of the balloon dissector assembly 410, i.e., to reduce the extent to which the balloon dissector assembly 10 extends from the distal end of cannula assembly 610 into a body cavity. Suitable spacers 300 are depicted in
The provision of a spacer between the cannula assembly 610 and the balloon dissector assembly 410 makes it possible to vary the depth of insertion of a balloon 20 of the balloon dissector assembly 410 of the present disclosure into a body cavity. Placement of more than one spacer 300 may further limit the depth of insertion of the balloon dissector assembly 410, thus providing a practitioner with a means to vary depth of insertion to suit the needs of a patient in view of the procedure being performed. As the spacer(s) 300 are releasably mounted on the instrument, the spacer 300 can be fitted on the medical instrument when the need arises. Moreover, the releasability of the spacer 300 permits altering the depths of insertion of the balloons 20, 30 of the balloon dissector assembly 410. This can be done so that the use of the balloon dissector assembly 410 can be adapted with the greatest possible variation to the anatomical circumstances in question.
Additional details regarding the system, including the components utilized in the system, methods for its production, and methods for its use, include those disclosed in U.S. Pat. No. 8,540,745, the entire disclosure of which is incorporated by reference herein.
The balloon dissector assembly 410 is used for dissecting tissue along natural tissue planes in general, laparoscopic, vascular endoscopic, plastic or reconstructive surgery or other procedures requiring the separation of tissue. Where prior devices would require different working lengths and different balloons thereon, requiring multiple systems on hand for use in a procedure, kits of the present disclosure permit customization of both the balloon utilized for dissection as well as the working length of the system.
The material of the balloon may be elastic, so as to follow a path of least resistance in the body, inelastic so as to assume a predetermined shape upon inflation, or a combination of elastic and inelastic materials. The balloon dissector and cannula assembly may be used in hernia repair, bladder neck suspension or other procedures requiring the separation of tissue. The balloon dissector and cannula assemblies can be made from any medical grade material, including metals and plastics. The apparatus is made using well-known techniques.
In embodiments, round balloons may be formed of an elastic material, while laterally extending oval balloons may be inelastic.
The dissection balloon may be inflated with any medical grade fluid, such as saline, CO2, or any other fluid. The balloons may be inflated using a syringe, mechanically or manually operated pump or other means. The ports for inflating the balloons may be used with one-way valves, check valves, or any other valve arrangement for inflating the balloons.
The shape of the dissection balloon can vary upon the area of use in the anatomical structure. For example, the balloon may have the round shape of a globe, a flattened round shape, may include a longitudinally oval shape or other shapes such as kidney shaped, laterally extending, etc., depending on the need of the surgeon. The selection of balloon is left up to the surgeon. Once the desired balloon is selected by the surgeon, it is affixed to the distal tip of the elongate shaft of the balloon dissector assembly as described in the above embodiments, which include by use of threadable attachment, the use of a bayonet attachment, the use of a locking collar, etc.
Similarly, as noted above, the desired working length of the system may be optimized for the patient in view of the intended procedure with the use of the spacers affixed to the elongate shaft of the balloon dissector assembly, and/or any other shaft of the dissector obturator or balloon cannula assembly. Again, the more spacers added to the shaft, the shorter the working length of the system, which is decided upon by the surgeon at the time of the procedure.
Once the kit of the present disclosure has been used to assemble a desired system, a suitably sized incision is made in the patient's skin. Next, the assembled balloon dissector assembly 410 and the balloon cannula assembly 610 are inserted into the incision, using the dissector obturator 510 to tunnel a passage beyond the point of incision.
Inflation pressure is supplied through the inflation port 28 from a suitable outside source and is communicated to the dissection balloon 20. As pressure is applied, the dissection balloon 20 expands. The expansion of dissection balloon dissects surrounding tissue along natural tissue planes. Once the desired space is created, the dissection balloon 20 is deflated by disengaging the inflation source from the inflation port 28 and/or connecting the inflation port 20 to a source of vacuum.
The balloon dissector assembly 410 is removed from the cannula assembly 610 and surgical instruments are introduced to the surgical site through the cannula. Examples of such surgical instruments include, but are not limited to, endoscopes, surgical suturing devices, and surgical device applicators.
For example, in alternative embodiments, the dissector obturator 510 is removed and replaced with an endoscope. Then, the balloon dissector assembly 410 and the cannula assembly 610 are inserted into the skin incision and the dissector balloon 20 is inflated as discussed above. The scope is used for supporting the balloon 20, as well as for viewing the space to be dissected prior to, during, and after dissection.
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, other configurations of securing a balloon to a balloon dissector assembly may be provided to form a system of the present disclosure. Additionally, other balloon shapes and construction such as, for example elastic, inelastic, oval, kidney shaped, along with constructions providing differential expansion characteristics may be provided. Further, the terminology of similar components with the various embodiments should not be construed as specific to any particular embodiment. Thus, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/254,391 filed Nov. 12, 2015, the entire disclosure of which is incorporated by reference herein.
Number | Date | Country | |
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62254391 | Nov 2015 | US |