Surgical device for cutting tissue

Abstract

The surgical device includes an elongated handle and at least one cutting assembly at the end of the handle. The at least one cutting assembly includes an elevator, a retainer disposed above the elevator, and at least one cutting blade positioned between the elevator and the retainer. The surgical device can be used to cut tissue, such as the dura mater, during brain surgery.

Description

[Technical Field]

[0001] This PCT international application claims priority to U.S. Patent Application No. 63 / 377,613, filed with the U.S. Patent and Trademark Office on September 29, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to a surgical device for cutting tissue, and in particular, the surgical device can be used to cut the dura mater during brain surgery. [Background technology]

[0003] Typically, dura incisions during brain surgery are performed by two surgeons: one surgeon retracts the incised dura while the other uses scissors or a dental instrument with a cutting edge. Both procedures are time-consuming and carry the risk of damaging the underlying brain.

[0004] The surgical device of the present invention is useful for cutting the dura mater during brain surgery requiring access to the subdural space (e.g., trauma surgery, tumor removal surgery, etc.) The surgical device is particularly suited to reducing the risk of damaging the brain beneath the dura mater and shortening the time required to cut the dura mater.

[0005] The surgical device of the present invention houses a separate cutting blade, allowing a single surgeon to safely and easily incise the dura only to the extent necessary. No power source is required, allowing maximum control of the device to the single surgeon, further enhancing safety. Summary of the Invention [Means for solving the problem]

[0006] In a first embodiment of the present invention, a surgical device is provided that includes an elongated handle and at least one cutting assembly at an end of the handle, the at least one cutting assembly including an elevator, a retainer positioned or disposed above the elevator, and at least one cutting blade between the elevator and the retainer and recessed from an opening formed by a distal end of the elevator and the distal end of the retainer.

[0007] In addition to the above-described embodiment, the present invention provides a surgical device in a second embodiment, in which the length of the elevator is longer than the length of the retainer.

[0008] In addition to any of the previously described embodiments, the present invention provides in a third embodiment a surgical device in which the elevator is curved at its upper or top edge and / or its lower or bottom edge such that there is an upward curve at the outer or distal end.

[0009] In addition to any of the previously described embodiments, the present invention provides, in a fourth embodiment, a surgical device in which the retainer is angled relative to the longitudinal axis defined by the handle.

[0010] In addition to any of the previously described embodiments, the present invention provides, in a fifth embodiment, a surgical device in which at least one cutting blade is angled relative to a longitudinal axis defined by the handle.

[0011] In addition to any of the previously described embodiments, the present invention provides, in a sixth embodiment, a surgical device in which at least one of the elevator or the retainer is substantially flat.

[0012] In addition to any of the above-described embodiments, the present invention provides, in a seventh embodiment, a surgical device in which the height of the opening is about 2 mm to about 5 mm.

[0013] In addition to any of the above-described embodiments, in an eighth embodiment, the present invention provides a surgical device wherein the handle has a length of about 10 cm to about 20 cm and / or a diameter of about 0.3 cm to about 1.0 cm.

[0014] In addition to any of the above-described embodiments, in a ninth embodiment, the present invention provides a surgical device wherein the retainer has a length of about 0.5 cm to about 1.5 cm, and / or the elevator has a length of about 0.5 cm to about 2.0 cm.

[0015] In addition to any of the previous embodiments, the present invention provides in a tenth embodiment a surgical device further comprising means for attaching and / or replacing at least one cutting blade.

[0016] In addition to any of the above-described embodiments, in an eleventh embodiment, the present invention provides a surgical device, wherein the elevator is configured to lift dural tissue and the retainer is configured to hold the dural tissue during brain surgery.

[0017] In addition to any of the above embodiments, the present invention provides, in a twelfth embodiment, a surgical device that does not have a power source and / or is not connectable to a power source.

[0018] In addition to any of the previously described embodiments, the present invention provides, in a thirteenth embodiment, a surgical device that does not have a cutting blade shield and / or a rotor mechanism.

[0019] In a first method embodiment, the present invention provides a method for cutting tissue, comprising the steps of providing a surgical device as described in any of the previous embodiments, forming an opening in tissue, and cutting the tissue with at least one cutting blade.

[0020] In addition to the method embodiments described above, the present invention provides, in a second method embodiment, a tissue cutting method including the steps of providing a surgical device described in any of the previous embodiments, forming an opening in the dural tissue, elevating the dural tissue from at least one of the brain, skin, or fat with a dural elevator and maintaining the elevated position of the dural tissue with a dural retainer, and cutting the dural tissue with at least one cutting blade. [Brief explanation of the drawings]

[0021] [Figure 1] 1 shows a side view of a surgical device according to one embodiment of the present invention. [Figure 2] 1 illustrates a method of use of one embodiment of a surgical device operated by the hand of a surgeon. [Figure 3A] 2 shows a close-up side view of one end of the surgical device of FIG. 1. [Figure 3B] 3B shows a front view of the surgical device of FIG. 3A. [Figure 3C] 3B shows an elevated perspective view of a method of cutting the dura using the surgical device of FIG. 3A. [Figure 4] 1 shows a perspective view of a surgical device according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0022] The present invention relates to a surgical device for cutting tissue. In particular, the surgical device can be used to cut the dura mater during brain surgery. However, it can be readily appreciated that the surgical device can be used in other types of surgery to cut any desired tissue plane. For example, the surgical device can be used to cut a fascial layer when performing a fasciotomy.

[0023] In this detailed description, references to "one embodiment," "one embodiment," or "in an embodiment" mean that the referenced feature is included in at least one embodiment of the present invention. Furthermore, separate references to "one embodiment," "one embodiment," or "embodiment" do not necessarily refer to the same embodiment, but such embodiments are not mutually exclusive unless stated to be mutually exclusive, except as would be readily apparent to one of ordinary skill in the art. Thus, the present invention may include any various combinations and / or integrations of the embodiments described herein.

[0024] As used herein, "substantially," "approximately," "about," and other terms of degree are relative modifiers intended to indicate an acceptable variation from the property so modified (e.g., ±0.1%, ±0.5%, ±1.0%, ±2%, ±5%, ±10%, ±20%). They are not intended to be limited to the absolute value or property that they modify, but rather, to the contrary, preferably comprise more physical or functional properties that are close to or approximate such physical or functional properties.

[0025] FIG. 1 shows a side view of a surgical device 5 for cutting tissue according to one embodiment of the present invention. Surgical device 5 includes an elongated handle 10. In certain embodiments, handle 10 may be about 10 cm to about 20 cm in length and about 0.3 cm to about 1.0 cm in diameter. The length and diameter may be selected to balance durability and ease of fine motor control.

[0026] In embodiments, the handle 10 may comprise a durable, non-flexible material, such as a metal (e.g., stainless steel, carbon steel) or a surgical-grade plastic (e.g., polycarbonate, polyethylene, polypropylene, acrylonitrile butadiene styrene). The body of the handle may include at least one knurled area 7 that provides a gripping surface for stabilizing the instrument during a surgical procedure. The surgical device may have an overall length of about 15 cm to about 25 cm.

[0027] In the present invention, the surgical device 5 has at least one cutting assembly 15. The cutting assembly may be located at one end of the handle 10 or at both ends thereof. The at least one cutting assembly 15 includes an elevator 20, a retainer 25 positioned above the elevator 20, and at least one cutting blade 30 extending between the elevator 20 and the retainer 25. In embodiments, the elevator and the retainer may not be laterally aligned.

[0028] In certain embodiments, elevator 20 may be substantially perpendicular to the longitudinal axis of handle 10 and may be substantially flat, as shown in Figure 1. In another embodiment, elevator 20 may be curved at its lower or bottom edge and / or upper or top edge such that there is an upward curve at its outer or distal end, as shown in Figure 4. Elevator 20 provides a surface for pulling up and lifting tissue, such as the dura mater, from the brain.

[0029] In embodiments, elevator 20 may be approximately 0.5 cm to 2.0 cm in length, e.g., 0.5 cm to 1.0 cm, so that elevator 20 is long enough to lift the dura sufficiently to visualize the surface to be cut, but not so long that the bone edges obstruct movement of the device as the surgeon approaches the edges of the skull opening (craniotomy).

[0030] In certain embodiments, retainer 25 may be approximately 0.5 cm to 1.5 cm in length. In embodiments, as shown in FIG. 1, retainer 25 may extend outward from handle 10 substantially perpendicular to the longitudinal axis of the handle and at least partially above elevator 20. Retainer 25 presents the dura or other similar tissue surface to cutting blade 30 as the surgeon guides the surgical device along a desired path to open the dura or cut tissue. In embodiments, retainer 25 may be substantially flat. In another embodiment, retainer 25 or its edges may be angled relative to the longitudinal axis of the handle, as shown in FIG. 4.

[0031] At least one cutting blade 30 is positioned or disposed at the junction between the elevator 20 and the retainer 25 and is recessed from an opening formed by the distal end of the elevator and the distal end of the retainer. The opening may be about 2 mm to about 5 mm, e.g., about 2.5 mm to about 3 mm, to accommodate the thickness of the dura or other tissue and to allow the retainer 25 to protect the surrounding tissue from the at least one cutting blade 30. The cutting blade may be substantially perpendicular to the elevator and retainer (FIG. 1) or angled if the elevator 20 is curved and / or the retainer 25 is angled as described above (FIG. 4). In the present invention, neither the elevator nor the retainer functions as a cutting surface.

[0032] At least one cutting blade 30 may be made of plastic or metal. In certain embodiments, at least one cutting blade 30 may be a standard #5 surgical blade. In embodiments, the entire cutting assembly 15 may be positioned perpendicular to the longitudinal axis of the handle 10 or angled upward or downward (e.g., 20°-50°) to provide the surgeon with flexibility in cutting tissue from different angles or locations. In embodiments, the cutting assembly 15 is movable or adjustable to any angle desired by the surgeon.

[0033] In embodiments, the elevator and / or retainer does not have any portions or protrusions extending upward or downward from its edge or surface at the opening configured to protect tissue from the at least one cutting blade. Thus, in embodiments, there is no cutting blade shield. Also, there is no rotor mechanism for deploying or retracting the cutting blade or shield.

[0034] In certain embodiments, at least one cutting blade 30 may be an electrocautery blade (e.g., a monopolar or unipolar cautery blade). This configuration allows for cutting the surface of the blood vessel while cauterizing bleeding. Electrocautery blades require a power source.

[0035] In certain embodiments, the handle 10 may include means for attaching and / or replacing at least one cutting blade 30, including, but not limited to, one or more screws, bolts, or grooves. The at least one cutting blade 30 may need to be replaced when it becomes dull or when the surgical device must be sterilized for a new surgical procedure and / or a new patient.

[0036] Figure 3A shows a close-up view of the cutting assembly of surgical device 5 according to one embodiment of the present invention. Figure 3B shows a front view of surgical device 5 of Figure 3A.

[0037] 2 and 3C show a schematic diagram of a method for using the surgical device of the present invention as manipulated by a surgeon's hand. The illustration of the brain includes layers of skin, fat, and skull; beneath these layers is the dura mater and brain. As shown, the surgeon pulls on the surgical device 5 while maintaining a gentle upward pressure. Maintaining upward pressure, the dura mater is raised from the brain's surface using the elevator 20 and maintained in position by the retainer 25. At least one cutting blade 30 is used to cut the dura mater without damaging other surrounding tissues or structures (e.g., brain structures directly beneath the dura mater layer). [Industrial Applicability]

[0038] The present invention is a surgical device for cutting tissue, which can be used, in particular, to cut the dura mater during brain surgery.

[0039] While the present invention has been described in terms of certain exemplary and alternative embodiments, it is not limited to these embodiments. Alternative embodiments, implementations, and modifications that still fall within the scope of the invention may be made by those skilled in the art, especially in light of the foregoing teachings.

[0040] Those skilled in the art will recognize that various adaptations and modifications of the exemplary and alternative embodiments described above can be made without departing from the scope and spirit of the invention. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

Claims

1. A long, slender handle and at least one cutting assembly at an end of the handle; At least one of the cutting assemblies includes: Elevators and a retainer positioned or disposed above the elevator; at least one cutting blade between the elevator and the retainer and recessed from an opening formed by a distal end of the elevator and a distal end of the retainer.

2. The surgical device of claim 1 , wherein the elevator has a length greater than a length of the retainer.

3. The surgical device of claim 1 , wherein the elevator is curved at its upper side or edge and / or its lower side or edge such that there is an upward curve at its outer or distal end.

4. The surgical device of any one of claims 1 to 3, wherein the retainer is angled relative to a longitudinal axis defined by the handle.

5. The surgical device of any one of claims 1 to 3, wherein at least one of the cutting blades is angled.

6. The surgical device of any one of claims 1 to 2, wherein at least one of the elevator or the retainer is substantially flat.

7. The surgical device of any one of claims 1 to 3, wherein the opening is between about 2 mm and about 5 mm in height.

8. The surgical device of any one of claims 1 to 3, wherein the handle is about 10 cm to about 20 cm in length.

9. The surgical device of any one of claims 1 to 3, wherein the handle has a diameter of about 0.3 cm to about 1.0 cm.

10. The surgical device of any one of claims 1 to 3, wherein the retainer is about 0.5 cm to about 1.5 cm in length.

11. The surgical device of any one of claims 1 to 3, wherein the elevator is about 0.5 cm to about 2.0 cm in length.

12. The surgical device of any one of claims 1 to 3, further comprising means for attaching and / or replacing at least one said cutting blade.

13. The surgical device of any one of claims 1 to 3, wherein at least one of the cutting blades comprises an electrocautery blade.

14. The surgical device of any one of claims 1 to 3, wherein the elevator is configured to lift dural tissue and the retainer is configured to hold dural tissue during brain surgery.

15. A surgical device according to any one of claims 1 to 3, which does not have a power source and / or is not connectable to a power source.

16. The surgical device of any one of claims 1 to 3, wherein the surgical device does not have a cutting blade shield and / or a rotor mechanism.

17. Providing a surgical device according to any one of claims 1 to 3; forming an opening in tissue; and cutting the tissue with at least one of the cutting blades.

18. 18. The tissue cutting method of claim 17, wherein the tissue includes dura tissue, and the method further comprises the steps of elevating the dura tissue from at least one of brain, skin, or fat with the elevator and maintaining the elevated position of the dura tissue with the retainer.

19. 19. The method of claim 17 or 18, performed by a single surgeon.

20. 19. The method of claim 17 or 18, performed without a power source for the surgical device.

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