Patent ID: 12232759

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following surgical description may be employed for using the surgical device shown in the figures in at least three different surgeries: Endoscopic Carpal Tunnel Release (Hand), Endoscopic Cubital Tunnel Release (Elbow), and Endoscopic Plantar Fasciitis Release (Heel).

After making an incision, the surgeon may use a dilator10(FIG.1) to dilate the surgical area. The dilator may be about 6 inches long and taper at a broader end14to a narrow end12from 6 mm to 4 mm. The dilator may include hand grips16marked to minimize slipping.

To make room for the guide device to fit atop and below the targeted ligament or fascia, the surgeon may insert the device100,300,400in order to compartmentalize the ligament or fascia. The surgeon may then use the endoscope that has been inserted through a cameral passage or hole to visualize the ligament or fascia area to ensure that there are no other parts of the anatomy, such as nerves or tendons, obstructing the incision path.

If the incision path is clear, the surgeon can either antegrade cut or retrograde cut the ligament or fascia in a safe environment by inserting the knife through the appropriate slot, because the device or guide has helped the surgeon to compartmentalize the ligament or fascia to be incised, isolating it from other parts of the anatomy that could otherwise be in jeopardy of being inadvertently cut.

The endoscopic camera and the knife may work independently of each other inside the guide, making it safer for the surgeon to look ahead of the knife when needed.

FIG.1is a drawing of the surgical device100for assistance in endoscopic surgical procedures, especially those discussed above but not necessarily limited thereto.

The surgical device100may be 100 mm in length, 8 mm wide, and constructed from ABS plastic. The device100may be hollow and cylindrical with 3 mm-thick plastic prongs110separated by a 2 mm gap130.FIG.2shows one end of the device100, which is closed with the exception of three holes: the upper and lower circular holes140may be each 2.5 mm in diameter, may be used for the endoscopic camera, and may be located on either side of the 5 mm long slot150used for the knife. The location of the upper and lower circular holes140on either side of the slot150gives the surgeon the ability to use the endoscopic camera to visualize the surgical field more comprehensively from many angles before a cut is made to avoid damaging other portions of the anatomy.

FIGS.6A and6Bshow tools like the knife (600) and wire605for use with the device100,300, or400. In use, a surgeon may grasp the knife600or wire605by a handle610that may include finger cutouts for a thumb612and fingers614. The tool600,605may comprise both a handle portion610and working portion620. On the knife600, the working portion620is sized to fit within the slot150,380and includes a blade630for performing the incisions as the blade moves within the slot150,380.

The wire tool605operates similarly to the knife tool600except that its working end620includes a narrow wire end635for removing fine tissue or moving a nerve out of the way of a later incision by the knife tool600. The wire end635may extend in any direction (upwards towards the viewer as shown inFIG.6Bbeing on alternative) but importantly fits within the knife slot.

The guide device100may include a wedge-shaped protrusion160at a terminal end of one (or both) of the prongs110that may help in clearing tissue from within the gap130. The wedge may be sharp, extend only from the narrow terminal end115of the prongs110or extend across the width of the prong110.

FIGS.3A-3Dshow an alternate embodiment of the device fromFIG.2. As can be seen inFIG.3A, the device300includes prongs310separated by a gap330similar to the geometry ofFIGS.1and2. The device300's prongs310have a narrow terminal end315opposite a head portion320having finger cutouts340that in combination help in grasping the device300. This head portion320helps in device300insertion into the patient as well as removal, and also positioning the device300during surgery.

The head portion end face325has a tool opening350therein. The tool opening350passes through the head portion320and is in fluid communication with the gap330. The tool opening may include a camera opening360and a blade slot380separated by an open space370that allows for a small tool insertion to remove unwanted tissue or other waste from the scope or camera opening.

The camera opening is for scope insertion, and allows the surgeon to inspect the incision, ensure the area to be incised is clear of nerves, and generally allow the surgeon to see the work to be performed. As can be best seen inFIG.4B, the camera may travel within one of the prongs310within a camera groove312formed along and within each prong310. A second groove314may also include room for the tools600,605.

The guide device400inFIGS.4A-Cis similar to the one inFIGS.3A-3Dexcept for finger grooves490. These finger grooves490extend into the head portion420and serve two purposes: First, they act to help a surgeon grasp the guide400during insertion, when slipping tools can be a problem. Second the finger grooves490help with cooling the device400during manufacture, allowing for uniform cooling and thus, decrease defect formation.

FIG.5shows a further alternate design of the device500. Within this device, a shelf565extends to divide the camera opening halves560a, and560b. This helps support the scope when inserted into the camera openings.

FIGS.7and8show an alternate embodiment of the guide device700. The device has two prongs710that extend from a head portion720. At a terminal end715of each prong710, an engaging tooth717protrudes into the gap730. The teeth717in practice may better engage tissue and prevent movement of the guide700during surgery. The teeth717also may prevent unwanted ingress of surrounding tissue into the gap730, which improves visibility in the gap and also may prevent unnecessary tissue damage. The teeth717are preferably shaped with rounded edges to prevent catching on tissue.

The guide head portion720may include finger cutouts or portions740to assist a user in manipulating the guide700, and these finger portions may extend from four sides of the guide to allow for easy manipulation.

It should be appreciated that similar to the guide400inFIG.4C, the guide700ofFIGS.7-13may include channels712within its prongs710for receiving the blade cutting tool900and/or camera1210.

As best seen inFIGS.8and8A, a tool opening750extends from the head portion720end face725and joins one or the other of the channels712. The tool opening750has a blade slot780and a camera opening760. The camera opening may be split by a guide portion765that acts as a stabilizer for the camera1210(seeFIGS.12A,12B, and13) extending into the gap730.

FIGS.9,10, and10Ashow an embodiment of the blade cutting tool900that includes a blade portion910and handle920. The blade portion910has a cutting blade930for cutting tissue. The V-shape cutting blade930may be used, or a straight blade is possible. The material for the cutting blade may be any durable material not subject to fracture or chipping, with stainless steel being a preferred material due to its durability.

The handle920, which may be some hardened plastic or formable material that may be sterile, may be grasped around its exterior perimeter921, which may include finger cutout portions (not shown) to promote easier grasping. The handle920may include a blade receiving slot922that receives the blade910securely in the handle920. The blade910may be secured to the handle920shortly after forming the handle such that it hardens around the blade910, or the blade910may be press fit into the handle920. As shown inFIG.10A, the blade portion910includes a handle engagement end932that engages the handle920, and in particular in a molded configuration where the handle920engages the handle engagement end932during the molding process, contains blade cutouts934to better-secure the blade portion910to the handle portion920.

The handle920includes handle camera opening924separated by a slot divider925. The handle camera openings924receive an endoscopic camera1210with an optical end1220that serves as the optics for a practitioner. The camera1210extends through the handle camera opening924into the guide camera opening760, as shown inFIGS.12A,12B, and13. The slot divider925guides and stabilizes the camera1210. In use, the camera1210, blade cutting tool900, and guide700can all move independently of one another, which allows for better visibility (camera1210), cutting accuracy (cutting tool900) and tissue engagement (guide700), as a practitioner moves each one during a surgery.

FIGS.11,12A,1B, and13show the blade910entering the blade receiving slot780, extending into the gap730and stopping when the blade cutting tool900bottom face929engages the guide700top face725.FIG.12Ashows the blade910and camera1210in phantom within the guide700.

FIG.14is yet another embodiment of a guide1400showing a similar cross section to that shown in8A-8A but with a guide similar to that shown inFIGS.11and12Aconfigured to receive the blade. In this guide1400, the gap1410narrows from the prongs1405towards the handle1420from a wider gap1410bto a narrower gap1410a. This narrowing gap follows the human geometry of the nerve, better gathering the nerve in the gap1410and preventing the tissue from bunching or folding in a uniform gap.

Similarly, the guide divider1465may also have a thickness that narrows from a divider thicker portion1465bto a narrower portion1465ato improve performance.

InFIG.14, the dimensions shown in mm have been found to work well in practice in the surgeries mentioned above.

The device guide described herein may be shipped in sterile packaging to ensure sterility in use, which overcomes the issues with certain steel guides that must be sterilized on each use. Because it is plastic, the device may be discarded after use and easily replaced, thus making it less expensive than a stainless-steel tool but also safer. Similarly, the blade shown in inFIGS.9-13may be steel but in such a small quantity, may also be discarded.

In use, the device may encompass the transverse ligament therefore avoiding the challenge of synovium and fat dropping into view when cutting the ligament. This improves visibility because the surgeon isn't cutting underneath the ligament but encapsulating the ligament and cutting either antegrade or retrograde and seeing the ligament with a top view as well as bottom view while cutting.

Further, the top and bottom portions of the guide encompass the ligament and that makes the guide safer for ECTR.

As shown herein, the guide is as a unitary construction molded in plastic, although it is possible to 3D print the guide as well. Multi-piece construction is possible and may be advantageous in certain contexts.

The device is also made to accommodate both left and right hand for same procedure by just turning it upside down to always cut on the ulnar safe side of the hand, which is the ulnar side of anatomy.

While the invention has been described with reference to the embodiments above, a person of ordinary skill in the art would understand that various changes or modifications may be made thereto without departing from the scope of the claims.