Traditional “open” surgical approaches to the spine and other organs typically involve extended longitudinal incisions, significant tissue disruption, and substantial blood loss. Recovery from these procedures may be prolonged and may involve significant morbidity as patients cope with rehabilitating damaged and atrophied muscle and scar tissue. In addition to the above intraoperative difficulties and problems with rehabilitation, there is increasing evidence that “open” approaches may significantly devitalize tissue, predisposing to significant rates of infection.
In response to these problems and as a direct result of rising healthcare costs, increasing pressure to reduce hospital stays and improve patient recovery, physicians have expressed significant interest in performing surgical procedures through less invasive techniques. Minimally invasive surgery (MIS) is a term which encompasses a wide range of surgical interventions. These surgical interventions involve accomplishing a surgical goal similar to that of a traditional “open” technique using a technique which involves less disruptive surgical dissection. Examples of MIS include laparoscopic and arthroscopic surgical interventions which typically use several small incisions as opposed to a single larger incision.
In no medical subspecialty has this type of approach sparked more interest than in that of spinal surgery. MIS approaches have been at the forefront of much recent literature. MIS appears to substantially decrease blood loss, complications, recovery times and hospital stays in comparison to traditional methods for procedures such as discectomy, decompression, and cervical and lumbar fusions.
In an embodiment, an expandable cannula includes a proximal end portion having a substantially constant diameter therethrough, and a distal end portion, coupled to the proximal end portion and having a proximal end and a distal end. The distal end portion includes a plurality of panels hinged by “living hinges” to the proximal end portion, and a locking mechanism that stabilizes the distal end portion in one of a contracted position and an expanded position.
In an embodiment, a method gaining access to a surgical site includes: creating a surgical wound; dissecting and dilating the wound to permit insertion of an expandable distal end portion of a cannula; the cannula having a proximal end portion having a substantially constant diameter therethrough; the distal end portion including a plurality of panels, where the panels are coupled to the proximal end portion by hinges formed of thin flexible plastic simultaneously with molding the panels; expanding the distal end portion into an expanded configuration to displace tissue and provide access through the cannula to the surgical site; and locking the distal end portion in the expanded configuration with a mechanical locking mechanism that stabilizes the distal end portion in the expanded configuration
Most MIS procedures in spinal surgery involve nerve decompression performed through a cannula or “tube”. Typically a guidewire is placed under x-ray control to localize the problematic level. A small incision is made over the location of the guidewire and tissue dilators are placed prior to the placement of the cannula in order to access the surgical site and dilate the muscular plane, providing minimal tissue disruption while exposing underlying tissue. While the cannula or “tube” is effective in simple procedures such as lumbar laminectomies and discectomies, more extensive access to the surgical site is required for more involved procedures such as interbody fusion or pedicle screw placement.
Accordingly, MIS retractors which enable more extensive exposure have been developed. The majority of these retractors are fixed “bladed” systems. This type of system typically allows for the retractor to be placed into the surgical bed in a “contracted” position. Once placed, the retractor may then open, providing tissue distraction from the surgical site. Several retractors have been developed which also allow the blades of the retractor to “tilt” or allow further retraction on the distal end than the proximal end. These multi-bladed retractors are frequently cumbersome and clumsy to assemble and deploy, adding several steps and valuable time to the surgical procedure. Other disadvantages of these fixed bladed systems include the issue of tissue “creep” between blades of the system when the retractor is in an expanded position. Also, this type of retractor is fixed in position and allows only a direct longitudinal line of sight between the surgeon and the surgical site. Thus, the surgeons view is limited by the amount of tissue retraction proximally.
In the case of minimally invasive spinal surgery (MIS spine surgery), the extent of exposure is typically limited by the fascial layer lying between the subcutaneous and muscular layers (in lumbar surgery this is the lumbodorsal fascia). Thus, fixed, bladed spinal retractors are limited by this fascial layer in providing the surgeon with direct line of site to the surgical bed. In many instances, the deployment of this type of retractor is cumbersome because of the many arms of the retractor and the multiple movable pieces.
Reference is now made to the figures wherein like parts are referred to by like numerals throughout. Referring generally to the figures, certain embodiments disclosed herein include an expandable cannula including a distal locking mechanism. The terms “expandable cannula” and “retractor” are interchangeable within the following description.
The distal portion has a second proximal end 112, and a second distal end 114. The distal portion 110 is expandable such that it may be in a fully contracted position, a fully expanded position, or a partially expanded position. For example, the distal portion 110, as illustrated in
Distal Portion Embodiments:
For clarity of illustration, the distal portion embodiments below are shown without a proximal portion. However, it should be understood that a proximal portion is coupled to the distal portion as described above.
In one embodiment, the distal portion 210 is made up of a plurality of panels 220. For clarity of illustration, not all panels are labeled. For example, the panels may be “roll out panels” such that the panels of the distal portion 210 radiate outward from a proximal ring 402. Each of these panels is somewhat wider at the second distal end 214 than at an inner portion where the panel attaches to the ring 402 (i.e. where the panels are coupled together). For example, in its structural configuration, the proximal ring 402 is substantially, or is fused to, the second proximal end 212 of the distal portion 210.
In an embodiment, panels 220 are molded of a thermoplastic simultaneously with ring 402, the thermoplastic of panels 220 being relatively thick and inflexible, with thinner, flexible, “living hinge” portions 403 located at junctions between panels 220 and ring 402. “Living hinges” are known in the art of plastic molding. In this embodiment, panels 220 may also have thinned molded fold lines 405 demarcating a lateral portion 407 of each panel 220 from a central rigid portion 409 of each panel 220. Fold lines 405 permit lateral portions 407 to lie out of the plane of central rigid portion 409 such that the panels can fold to an contracted configuration having a same distal diameter 250 as proximal diameter 252 (
In an alternative embodiment, panels 220 are formed of a metal such as stainless steel, with hinges at junctions between panels 220 and ring 440.
In the contracted position, as illustrated in
In an expanded position, as illustrated in
Distal Portion Locking Mechanism:
Locking mechanism 900 includes a locking ring 950 that is coupled to two separate panels 920 that are opposite one another (only one coupled panel 920 is illustrated). Locking mechanism 900 further includes two ladder lock elements 960. Each ladder lock element 960 is located at a panel that is ninety degrees from each of the panels to which locking ring 950 is coupled. Each ladder lock element 960 further includes a plurality of notches 962. Each plurality of notches 962 is adapted such that locking ring 950 may be secured within one of notches 962, as shown. Accordingly, ladder lock element 960 provides a variety of expanded positions. For example, where locking ring 950 is secured within a notch 962(1) that is toward second proximal end 912, a distal end portion 910 is not as expanded as where locking ring 950 is secured within a notch 962(2) that is toward a second distal end 914 of distal end portion 910. In an embodiment, ladder lock element 960 is molded as part of an interior surface of panel 922; in an alternative embodiment ladder lock element 960 is formed as a separate component and bonded to panel 922, in a particular embodiment the panel 922 and lock element 960 are bonded with a solvent-based glue suitable for use with a plastic from which the ladder lock element and panel 922 are formed. It should be noted that the ladder lock element effectively incorporates multiple catches, each catch adapted to secure the locking ring in a different expanded configuration.
Locking mechanism 1100 includes a locking ring 1150 that is coupled to two separate panels 1120 that are opposite one another (only one panel 1120 is illustrated). Locking mechanism 1100 further includes two ladder lock elements 1170. Each ladder lock element 1170 is located at a panel that is ninety degrees from each of the panels to which locking ring 1150 is coupled. Ladder lock element 1170 includes a flexibly attached “zip-tie”-like structure such that locking ring 1150 may be deployed to expand panels 1120 to a plurality of diameters based upon the relation to ladder lock element 1170. The zip-tie-like structure includes multiple teeth or catches and can lock the ring at each of several positions. For example, where “zipped” toward a second proximal end 1112, locking ring 1150 has a smaller diameter, thereby placing a distal portion 1110 into a partially expanded position. However, where “zipped” toward second distal end 1114, locking ring 1150 forces panels 1120 to open to a larger diameter, thereby making the distal portion 1110 be in a more fully expanded position. Accordingly, locking element 1170 provides for a distal end portion 1110 having a variably expandable position.
In an exemplary embodiment, the distal portion of the retractor consists of four blades. Two of these blades are significantly wider at the distal end than the proximal end where they attach to the proximal ring. These wider blades serve as the cranial and caudal retraction blades of the device. The other two blades are essentially the same width from the proximal part to the distal tip or only slightly wider at the distal tip. These blades are placed in between the cranial and caudal retraction blades on either side of the retractor (medial and lateral). The purpose of these blades is to supply a “strut” which binds and stabilizes the hinge of the distal locking ring as it is deployed. Various methods of coupling the hinge of the locking ring to the strut have been described. In a preferred embodiment, a “zip-tie” method of coupling the hinge to the strut would be used. This method would allow the hinge to move distally along the strut as the distal ring unfolds, expanding the retractor into its final position.
The articulation between the proximal, “tubular” portion of the retractor and the distal “expandable” portion of the retractor allows for the proximal portion to me moved in relationship to the distal portion, allowing the surgeon to maximize distal visualization (e.g. increasing the field of view of the surgery site) while minimizing proximal dissection. The articulation may be a simple “hinge” which allows the surgeon to increase his field of view in a single plane. Alternatively, it may be a more complex articulation which allows the relationship of the proximal portion to the distal portion to change in a manner which provides the surgeon with an increased field of visualization in multiple planes. An example of a more complex articulation may be similar to that of a “universal joint” which allows an infinite number of spatial relationships between the proximal and distal portions of the retractor. This relationship may be secured in any position by means of a “friction fit”.
In one embodiment, the retractor may be made of thin metal or plastic in order to remain radiolucent and provide minimal x-ray obstruction to anatomic structures. The inner ring (i.e. the locking ring) is made of metal in order to provide sufficient hoop stresses in the expanded position to overcome resistance from the surrounding tissue and allow expansion of the distal portion of the retractor. In alternate embodiments, the inner ring (i.e. the locking ring) is made of material other than metal that has sufficient strength to overcome the resistance from the surrounding tissue and allow expansion of the distal portion of the retractor. After the surgical procedure is completed, the retractor may once again be collapsed prior to removal by disengaging the inner ring from one of its two points of contact with the inner distal diameter of the distal portion, by flexing the ring, or by cutting the ring.
An alternative embodiment 1300 (
The embodiment of
When the retractor described herein is used, a surgical wound is created by cutting skin and sealing off superficial blood vessels. A probe may be used to dissect tissue while deepening and expanding the wound to permit insertion of the retractor, during which dissection a guidewire and serial dilators may be used to expand and deepen the wound. The retractor or cannula is then inserted into the wound, during which a guidewire may be used to ensure correct placement. During insertion of the retractor, the proximal and distal portions of the retractor are kept aligned, with the distal portion in collapsed position. Once the retractor is inserted to an appropriate depth in the tissue, the distal portion is expanded to a width deemed appropriate as providing adequate access to a surgical site by the surgeon.
The tissue retractor described in the embodiments above has several significant advantages over MIS retractors currently in use. As is common practice with many MIS retractors, this retractor may be introduced into a surgical wound over a guidewire and serial dilators with the proximal and distal portions aligned with each other. However, once appropriately placed, the retractor may then be deployed in the expanded configuration with a simple one-step mechanism which simply involves downward pressure and engagement of the inner ring. In other embodiments, the retractor is deployed by pressing the internal locking strut into a locked position. In this way, this retractor is simple to place and deploy and does not require the surgeon to manipulate many separate blades and moving parts in order to deploy and remove the retractor.
With many MIS retractors currently in use, several blades move independently of each other. While in expanded positions, there are gaps between the blades of these retractors which allow tissue to “creep” between these blades and obstruct the visual field of the surgeon. In the deployed position, this retractor assumes a substantially conical configuration in which the panels of the distal portion remain in some contact with each other providing a continuous field of view and preventing tissue “creep”.
Most current MIS retractors are inserted in a contracted position and then expand by distracting the blades away from each other and tilting the distal tips of the blades outward in order to maximize distal visualization. In this model, though there is increased visualization distally, the plane of expansion is still in a direct line which requires increased tissue dissection proximally and increased incision length in order to provide adequate visualization. The embodiments described herein have an articulation which allows the proximal and distal portions to change their relationship with each other in one or multiple planes. This articulation between the proximal and distal ends of the retractor allows for the surgeon to adjust the retractor in order to achieve maximal visualization of structures within the surgical field while minimizing proximal dissection.
Finally, because the design of current MIS retractors requires retraction of tissue with a fulcrum outside of the patient at the proximal portion of the retractor, most MIS retractors are manufactured of metal in order to overcome the significant strain involved in retracting tissue. The retractor described has the mechanical advantage of having a distal locking mechanism which obviates the need to impart significant force to adjacent tissue proximally. Thus, this retractor may be made of a much softer material such as thin metal or plastic. In this way, this retractor has the advantage of having much less material in place during the surgical procedure which allows for more direct visualization of the surgical bed and much better x-ray interpretation.
Combinations
The expandable cannula or retractor of the present invention may include a variety of features as described above, in a variety of combinations both of the cannula and its method of use. Among these combinations are:
An expandable cannula designated A including a proximal end portion having a substantially constant diameter therethrough; and a distal end portion, coupled to the proximal end portion and having a proximal end and a distal end, the distal end portion further including a plurality of panels, where the panels are coupled to the proximal end portion by hinges formed of thin flexible plastic simultaneously with molding the panels; and a mechanical locking mechanism that stabilizes the distal end portion in one of a contracted position and an expanded position.
An expandable cannula designated AA including the expandable cannula designated A, the locking mechanism including a locking ring coupled to at least two of the plurality of panel located opposite one another; and a locking element.
An expandable cannula designated AB including the expandable cannula designated A or AA wherein the locking element comprises at least one catch adapted to securing the locking ring in the expanded position.
An expandable cannula designated AC including the expandable cannula designated AB wherein the locking element includes a plurality of catches adapted such that the locking ring may be secured in a plurality of expanded positions.
An expandable cannula designated AD including the expandable cannula designated A, where the locking element includes at least one locking strut having at least two rigid members coupled together with a hinge, the rigid members each coupled to a panel of the plurality of panels and a lock for holding the rigid members.
An expandable cannula designated AE including the expandable cannula designated AD wherein the at least one locking strut is locked and stable when the hinge of the strut is configured distal to dead center.
An expandable cannula designated AF including the expandable cannula designated AD or AE wherein a rivet forming a part of the locking strut is engaged in a slot of a component coupled to the proximal end portion, and wherein when the hinge is configured distal to dead center the rivet rests against an end of the slot thereby retaining the strut in expanded configuration.
An expandable cannula designated AG including the expandable cannula designated AF wherein the slot of the component coupled to the proximal end portion further comprises a catch for retaining the strut in expanded configuration.
An expandable cannula designated AH including the expandable cannula designated A or AB, the locking element comprising a ladder lock forming a plurality of notches adapted to secure the locking ring in a plurality of positions; wherein in each position, the distal end portion is expanded to a different degree.
An expandable cannula designated AH including the expandable cannula designated A or AB, the locking element including a zip-tie element such that the locking ring may expand to a plurality of diameters based upon the relation to the zip-tie element.
A method gaining access to a surgical site designated B and including: creating a surgical wound; dissecting and dilating the wound to permit insertion of an expandable distal end portion of a cannula; the cannula having a proximal end portion having a substantially constant diameter therethrough; the distal end portion including a plurality of panels, where the panels are coupled to the proximal end portion by hinges formed of thin flexible plastic simultaneously with molding the panels; expanding the distal end portion into an expanded configuration to displace tissue and provide access through the cannula to the surgical site; and locking the distal end portion in the expanded configuration with a mechanical locking mechanism that stabilizes the distal end portion in the expanded configuration
A method designated BA including the method designated B, wherein the locking mechanism includes a locking ring coupled to at least two of the plurality of panel located opposite one another; and a locking element selected from at least one catch and a locking strut.
A method designated BB including the method designated BA wherein the locking element includes at least one catch adapted to securing the locking ring in the expanded position.
A method designated BC including the method designated BB wherein the locking element comprises a plurality of catches adapted to securing the locking ring in a plurality of expanded positions.
A method designated BD including the method designated BB wherein the locking mechanism includes at least one locking strut comprising at least two rigid members coupled together with a hinge, the rigid members each coupled to a panel of the plurality of panels and a lock for holding the rigid members.
A method designated BE including the method designated BD wherein the at least one locking strut is locked and stable when the hinge of the strut is configured distal to dead center.
A method designated BF including the method designated BD wherein a rivet forming a part of the hinge of the strut is engaged in a slot of a component coupled to the proximal end portion, and wherein when the hinge is configured distal to dead center the rivet rests against an end of the slot thereby retaining the strut in expanded configuration.
A method designated BG including the method designated BF wherein the slot of the component coupled to the proximal end portion further comprises a catch for retaining the strut in expanded configuration.
A method designated BH including the method designated B or BA, the locking element comprising a ladder lock forming a plurality of notches adapted to secure the locking ring in a plurality of positions; wherein in each position, the distal end portion is expanded to a different degree.
A method designated BI including the method designated B or BA, the locking element comprising a zip-tie element such that the locking ring may expand to a plurality of diameters based upon the relation to the zip-tie element.
Changes may be made in the above methods and systems without departing from the scope hereof. It should thus be noted that the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. The following claims are intended to cover all generic and specific features described herein, as well as all statements of the scope of the present method and system, which, as a matter of language, might be said to fall therebetween.
The present application claims priority to U.S. Provisional Patent Application 61/799,631 filed 15 Mar. 2013, incorporated herein by reference.
Number | Date | Country | |
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61799631 | Mar 2013 | US |