Devices and Methods for a Directional Surgical Device

Abstract

Devices and methods are provided for simplifying and improving the placement of stabilizing orthopedic pins, wires, and / or screws in the pelvis during minimally invasive surgery. A surgical instrument guiding device is used, which includes an adjustable friction clamp for positioning and securing a cannula, and also includes a probe having a blunt non-penetrating tip. The probe and the friction clamp are oriented such that the probe and the surgical instrument held by the friction clamp are perpendicular to each other. In use, the blunt probe is introduced through a small incision and advanced by blunt dissection until the blunt tip is positioned at a desired anatomical landmark on the pelvic surface. The cannula inserted through the friction clamp is advanced until the tip of the cannula is within about 2 cm of the blunt tip of the probe; then orthopedic pins, wires, and / or screws can be introduced through the cannula and inserted to provide stability. In some embodiments, the blunt probe is hollow.

Description

Field of the Invention

[0001] The field of the present invention is devices and methods for orienting surgical devices relative to the human pelvis, particularly in the case where the surgical device is a trocar. Background Art

[0002] The following description includes information that may be helpful in understanding the present invention. This is not an admission that any of the information provided herein is prior art or relevant to the currently claimed invention, nor is it an admission that any publication specifically or implicitly referenced is prior art. All publications identified herein are hereby incorporated by reference as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. When the definition or use of a term in an incorporated reference is inconsistent with or contrary to the term definition provided herein, the term definition provided herein applies and the term definition in the reference does not apply.

[0003] Although minimally invasive surgery (e.g., keyhole surgery) has reduced discomfort and recovery time, the use of small incisions (typically 2 cm or less) has complicated proper visualization of the surgical area and made proper instrument positioning challenging. When performing such surgery within a body cavity, visualization can be assisted by introducing an absorbable gas (e.g., CO2) and introducing a camera and lighting into the open space. However, this method is not practical in closed or relatively closed spaces.

[0004] To this end, various methods have been implemented to assist in correctly positioning surgical devices for minimally invasive surgery within closed or relatively closed body parts (such as inside the skull, within or near a joint space, etc.). For example, U.S. Patent No. 5,776,144 describes an instrument for fixing a spherical ball to the skull and mounting a rotary holder for a surgical instrument on the spherical ball. Similarly, British Patent No. 903308 describes a device for positioning a surgical instrument, in which a base fixed to the skull supports a grid of rotary rods that assist in supporting and orienting the surgical instrument. However, this method requires a relatively large area of hard bone for firmly mounting the base portion of these devices. In addition, the installation process itself generates small bone fragments, which are undesirable in or near joint bone surfaces.

[0005] In related methods, U.S. Patent No. 8,636,745 describes a device that aids in the positioning of orthopedic pins for stabilizing fractures. The device has two cylindrical portions that are mounted at right angles to each other in a rotatable manner. The cylindrical portions have through-holes through which such orthopedic pins can be placed. After placing one orthopedic pin, one of the cylindrical portions of the device is positioned such that the inserted pin passes through a set of through-holes. The set of through-holes is rotated to be positioned in the remaining cylindrical portion for the correct positioning of a second orthopedic pin. However, in this method, the placement accuracy of the second pin depends on the non-guided placement of the first pin.

[0006] U.S. Patent No. 5,776,143 describes a device for orienting a surgical tool by providing a base having three legs with a rotatable base. In use, the three legs are placed on markers located on the surface of a patient's body, and the rotatable base supports and orients the surgical instrument. However, if such markers are located in a relatively mobile or compressible body surface area (such as the abdominal surface), the accuracy of instrument placement is affected.

[0007] Collette and Cassard's "The Tape Locking Screw Technique (TLS): A news ACL reconstruction method using a short hamstring graft" published in Orthopaedics & Traumatology: Surgery & Research (2011) 97:555 - 559 describes the use of tibial and femoral aiming devices that provide support for a cannula and a probe attached to opposite ends of an adjustable bow handle. The probe is positioned relative to the bone surface and stabilizes the handle, and the handle is rotated to orient the cannula for inserting a surgical needle. However, the probe of such a device typically has a sharp tip that is partially inserted into the surface of the bone. While this provides stability, it hinders the ability to move the probe if the initial placement proves to be incorrect and also generates bone fragments (which are undesirable in or near the opposing joint surface).

[0008] Accordingly, there is still a need for a simple and effective device that allows for highly precise and repeatable placement of surgical devices for minimally invasive orthopedic surgery while eliminating or minimizing unnecessary damage to the bone surface. SUMMARY OF THE INVENTION

[0009] The subject matter of the present invention provides devices and methods for simplifying and improving the accuracy of placement of stabilizing pins, wires, and / or screws during minimally invasive orthopedic surgery.

[0010] One embodiment of the inventive concept is a surgical instrument guiding device for positioning a surgical instrument (e.g., a surgical cannula) relative to the human pelvis, which includes a handle having a first end and a second end, a blunt probe having a blunt tip at the first end, and a friction clamp at the second end. The friction clamp is configured to hold the surgical instrument such that when properly adjusted, it can slide (i.e., slidably engage) within the friction clamp, and the friction clamp is oriented such that when the surgical instrument is placed in the friction clamp, it is oriented perpendicular to the blunt probe. The blunt tip of the blunt probe can be circular or substantially flat. In the blunt probe having a circular tip, the blunt probe has a circular cross-section that decreases as the distance from the first end increases, and the radius of curvature of the blunt tip is less than or equal to about 25% of the maximum radius of the circular cross-section or about 5% to about 25%. In some embodiments, the blunt probe is hollow, e.g., to allow passage and placement of a stabilizing wire or needle.

[0011] Another embodiment of the inventive concept is a surgical instrument assembly for the human pelvis, which includes a surgical cannula having an outlet and a surgical instrument guiding device. The surgical instrument guiding device includes a handle having a first end and a second end, a blunt probe having a blunt tip at the first end, and a friction clamp at the second end. The friction clamp is configured to hold the surgical instrument such that when properly adjusted, it can slide (i.e., slidably engage) within the friction clamp, and the friction clamp is oriented such that when the surgical instrument is placed in the friction clamp, it is oriented perpendicular to the blunt probe. The blunt tip of the blunt probe can be circular or substantially flat. In the blunt probe having a circular tip, the blunt probe has a circular cross-section that decreases as the distance from the first end increases, and the radius of curvature of the blunt tip is less than or equal to about 25% of the maximum radius of the circular cross-section or about 5% to about 25%. In some embodiments, the blunt probe is hollow, e.g., to allow passage and placement of a stabilizing wire or needle. The surgical cannula engages with the friction clamp, and when the surgical cannula is fully inserted into the friction clamp, the outlet of the surgical cannula is within 2 cm of the blunt tip. The surgical cannula can include an inlet and an internal passage connecting the inlet and the outlet, and the inlet, the internal passage, and the outlet are sized to guide a surgical needle or screw.

[0012] Another embodiment of the inventive concept is a method of positioning a surgical instrument relative to the pelvis using a surgical instrument guiding device that includes a handle having a first end and a second end, a blunt probe located at the first end and having a blunt tip, and a friction clamp located at the second end and configured to slidably engage the surgical instrument. The friction clamp is oriented such that the surgical instrument is oriented perpendicular to the blunt probe when engaged with the friction clamp, such that the blunt tip contacts the bone surface of the pelvis. The surgical instrument guiding device is positioned such that the blunt tip can be moved across the bone surface of the pelvis to identify anatomical landmarks. The position of the surgical instrument guiding device is maintained when the anatomical landmarks are identified. The surgical instrument (e.g., a cannula) is slidably engaged with the friction clamp such that the surgical instrument is oriented perpendicular to the blunt probe and is advanced through the friction clamp until the exit of the surgical instrument is at a distance equal to or less than about 2 cm from the blunt tip of the blunt probe. In some embodiments, the surgical instrument is engaged with the friction clamp before the blunt tip is moved across the bone surface of the pelvis. If the surgical instrument is a cannula, such cannula can include an inlet, an outlet, and an internal channel connecting the inlet and the outlet, and the method can include the step of introducing a surgical needle or screw into the internal channel. In a preferred embodiment, during the surgical procedure, the blunt tip of the blunt probe does not penetrate the bone surface of the pelvis. The blunt tip of the blunt probe can be substantially flat or can be rounded. If rounded, the radius of curvature of the blunt tip can be less than or equal to about 25% of the maximum radius of the circular cross-section or from 5% to 25%. In some embodiments, the blunt probe is hollow and the method includes the step of introducing a stabilizing pin or wire into the internal channel of the blunt probe.

[0013] Various objects, features, aspects and advantages of the subject matter of the present invention will become more apparent from the following detailed description of the preferred embodiments and the accompanying drawings, in which like numerals represent like components. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 An embodiment of the tool of the inventive concept and a cannula that can be used with such tool are depicted. In use, the cannula (150) is inserted through the friction clamp (140) of the tool such that it is oriented at a right angle to the blunt probe (120) for precise anatomical positioning.

[0015] Figure 2 An enlarged view of the end portion of the blunt probe (200) and a view of the blunt tip (210) of the probe are provided. While a flat tip is shown, any suitable non-penetrating configuration can be used.

[0016] Figure 3 The placement of the surgical guiding device of the inventive concept is shown, where the cannula is placed within the friction clamp, providing the correct positioning and orientation of the surgical screw into the pelvis. Detailed implementation manners

[0017] The devices and methods of the present inventive concept provide a stabilization and guidance tool that facilitates the insertion of stabilization pins, wires, and / or hollow screws into the bones of the pelvis for internal fixation using minimally invasive techniques. The devices of the present inventive concept include a handle with a blunt-tipped non-penetrating probe. Such a blunt-tipped probe can be introduced through a small incision (<1 cm) in the skin and advanced through the tissue by blunt dissection. This blunt-tipped non-penetrating probe can be advanced until it contacts the pelvic bone, and the blunt nature of the probe tip prevents damage to the cortical bone layer and / or delicate joint tissues. Once the blunt-tipped probe contacts the desired anatomical landmark on the pelvis, a cannula or similar instrument can be introduced through a friction fitting or similar device that aligns the main (longitudinal) axis of the cannula or surgical device at a right angle to the blunt-tipped probe. The cannula or similar device can then be advanced through the tissue to reach the desired target area, which is identified at least in part by placing the blunt tip of the blunt-tipped probe at the desired anatomical landmark. Fixation devices (such as wires, pins, hollow screws, etc.) are then passed through the internal channel of the cannula or similar device and inserted into the bone in the appropriate position and orientation.

[0018] It should be understood that the devices and methods of the present inventive concept ensure that the guide pin for the hollow screw can be accurately placed in the pelvic bone towards any location within the pelvis with a minimal chance of penetrating the cortical bone and damaging the hip joint surface.

[0019] The following discussion provides many example embodiments of the subject matter of the present invention. Although each embodiment represents a single combination of inventive elements, the subject matter of the invention is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment includes elements A, B, and C, and a second embodiment includes elements B and D, the subject matter of the present invention is also considered to include the other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0020] As used herein, unless the context otherwise requires, the term "coupled to" is intended to include both direct coupling (where two elements coupled to each other are in contact with each other) and indirect coupling (where at least one additional element is located between the two elements). Thus, the terms "coupled to" and "coupled with" are used synonymously. As used throughout the description herein and in the claims that follow, the meanings of "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.

[0021] Unless the context requires otherwise, all ranges recited herein are to be construed as including their endpoints, and open ranges are to be interpreted to include only commercially practicable values. Similarly, all lists of numerical values are to be considered to include intermediate values, unless the context indicates otherwise.

[0022] The recitation of numerical ranges herein is merely a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value within a range is incorporated into the specification as if it were individually recited herein. Unless otherwise indicated herein or clearly contradicted by context, all methods described herein can be performed in any suitable order. The use of any and all examples, or exemplary language (e.g., "such as") provided herein with respect to certain embodiments of the present invention is intended merely to better illuminate the invention and is not a limitation on the scope of the invention claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0023] The grouping of alternative elements or embodiments of the invention disclosed herein should not be construed as a limitation. Each member of the group can be individually recited and claimed, or can be combined with any other member of the group or other elements found herein. For convenience and / or patentability reasons, one or more members of the group can be included in or deleted from the group. When any such inclusion or deletion occurs, the specification is hereby considered to include the modified group, thus satisfying the written description of all Markush groups used in the appended claims.

[0024] The apparatus, system, and method of the present inventive concept provide or employ a novel aiming guide for minimally invasive, intuitive, reliable, and safe placement of a surgical device (e.g., a trocar), which can be used to position and / or insert a stabilizing pin, wire, and / or hollow screw along one or more trajectories into the pelvic bone. Figure 1 An example of the aiming device or surgical guidance device of the present inventive concept is shown. The aiming device (100) includes a blunt probe (120) coupled to one end of a handle (110), which does not penetrate and / or fix to the bone surface of the pelvis during use. The other end of the handle includes a friction clamp (140) or similar device, which can engage a surgical trocar (150) (or similar device) such that the surgical trocar can be advanced (i.e., slidably engaged) by sliding it along its length through the friction clamp, but can be fixed by adjusting the tension of the clamp. The friction clamp is oriented such that the axis of the surgical trocar engaged in the friction clamp is oriented at a right angle to the blunt (i.e., non-penetrating) probe. As Figure 1As shown, in some embodiments, the handle has a fixed length and configuration. In other embodiments, the handle may be extendable to adjust the distance between the blunt probe (120) and the friction clamp (140) without changing their relative orientation.

[0025] In use, the blunt probe is advanced through an incision in the skin into the pelvic region until the blunt (i.e., non-penetrating) tip (130) of the blunt probe contacts the bone surface of the pelvis but does not penetrate into the bone. Figure 2 An enlarged view of the blunt probe (200) and its blunt tip (210) is provided. In this example, the blunt tip (210) is depicted as flat, but may have any suitable non-penetrating configuration. The user can then move the aiming device to translate the blunt probe across the pelvic surface until the desired anatomical landmark is identified (e.g., via tactile feedback of the probe, imaging, etc.). During this positioning process, the surgical cannula can be engaged with the friction clamp. Alternatively, after such positioning, the surgical cannula can be engaged with the friction clamp. When the blunt probe is placed at the desired anatomical landmark on the pelvic surface, the surgical cannula is advanced through the friction clamp until the outlet of the cannula is very close (e.g., at about 2 cm or within about 2 cm, or from about 0.5 cm to about 2 cm) to the blunt tip of the blunt probe. This positioning can be determined using imaging, by recording the penetration depth (e.g., by using markings provided on the surgical cannula) or any suitable technique. Figure 3 A typical placement of the surgical guidance device with the cannula placed within the friction clamp during S2A1 screw placement on a human pelvis is shown.

[0026] Once the cannula is properly positioned, the friction clamp can be tightened to prevent further advancement of the cannula. In a preferred embodiment, this tightening can be achieved by releasing the manual pressure applied to a portion of the friction clamp. Once the cannula is so fixed, the stabilization pin, wire, and / or hollow screw can be advanced through the inlet and internal channel of the cannula and exit through the outlet of the cannula, which is correctly positioned to insert into the bone material of the pelvis.

[0027] In some embodiments, after inserting a needle, wire, or screw into the pelvis, the cannula can be withdrawn and the aiming guide or device reoriented for insertion of a second stabilizing needle, wire, and / or hollow screw. In some embodiments, reorientation is achieved without moving the blunt tip of the blunt probe away from the desired anatomical landmark, e.g., by rotating the aiming guide while keeping the blunt probe against the bone. In other embodiments, the blunt tip of the blunt probe can be moved to a different desired anatomical target before reinserting the cannula. In such embodiments, the blunt probe can be removed through the initial incision and reinserted through a new incision, or the blunt tip can be advanced to the new anatomical target while inserting by translating the blunt tip of the blunt probe across the pelvic surface.

[0028] As described above, the blunt probe has a blunt tip designed not to penetrate the bone or damage the relatively thin cortex of the pelvic bone. Such a blunt tip can be substantially flat (e.g., deviating less than 10% from a plane oriented perpendicular to the main axis of the blunt probe). Alternatively, the blunt tip can be rounded. For example, the blunt probe can have a circular cross-section that decreases along the length of the probe as it moves away from its connection point to the handle. The blunt tip of such a blunt probe can have a radius (for a flat tip) or radius of curvature (for a rounded tip) that is less than about 25%, 20%, 15%, 10%, or 5% of the maximum radius of the blunt probe, or within any range between these values. The blunt probe can be designed to be inserted through a small incision in the skin (e.g., less than 1 cm) and advanced through deeper muscle tissue near the pelvis by blunt dissection, thereby minimizing damage to the bone surface and / or muscle tissue. Such a blunt probe is configured to be placed in contact with one or more specific landmarks of the pelvic bone according to the desired direction of the wire, needle, or hollow screw.

[0029] As described above, the handle has a friction or pressure clamp that allows for the slidable positioning of a surgical cannula inserted through the clamp opening. Such a cannula can be slid to a desired position, and when the cannula is locked in place, the user can use that position to observe the entry point of the guide needle. In a preferred embodiment, the cannula can slide when finger pressure is applied to the friction clamp, and the cannula is fixed in place when such finger pressure is released.

[0030] When positioned in the desired orientation, a guide needle or screw of the desired diameter can be drilled into the bone while being positioned via the cannula, perpendicular to the orientation of the blunt probe, and at a distance less than 2 cm, from 0.5 cm to 2 cm, or preferably from 10 to 15 mm from the blunt tip of the blunt probe.

[0031] In some embodiments, the probe can also be hollow (i.e., include an inlet, an end outlet, and an internal channel connecting the inlet and the outlet) to allow placement of a stabilizing device (such as a Kirschner wire) for temporarily stabilizing the cannula insertion of the screw guiding needle.

[0032] As described above, in some embodiments, the position of the blunt probe and / or the cannula can be determined by imaging. To this end, all or part of the guiding device and / or the cannula can include a radiopaque material (such as stainless steel). In some embodiments, the device and / or system of the present inventive concept can be entirely composed of a radiopaque material. In other embodiments, the device and / or system of the present inventive concept can be composed of a radiolucent material (such as a polymer) and incorporate radiopaque portions for imaging purposes. Similarly, in some embodiments, the blunt probe and / or the cannula of the device and system of the present inventive concept can include visible markings along its length, which provide information to the user about the insertion depth for facilitating correct positioning.

[0033] In practice, the device for placing screws in the pelvis has multiple uses, including positioning and inserting S2 sacroiliac screws (posterior approach), posterior column screws (antegrade insertion along the pelvic brim), anterior column screws (antegrade insertion outside the ileum), iliac column screws (retrograde insertion through the anterior inferior iliac spine (AIIS)), iliac column screws (antegrade insertion through the posterior superior iliac spine (PUS)), and / or posterior column screws (retrograde insertion through the ischial tuberosity).

[0034] It will be apparent to those skilled in the art that more modifications are possible without departing from the inventive concept herein. Thus, the subject matter of the present invention is not limited except as by the spirit of the appended claims. Additionally, in interpreting the specification and claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprising" and "including" should be interpreted to refer to elements, components, or steps in a non-exclusive manner, indicating that the recited elements, components, or steps can be present, used, or combined with other elements, components, or steps not expressly recited. When the specification and claims refer to at least one thing selected from the group consisting of A, B, C.... and N, the text should be interpreted to require only one element from the group, rather than A plus N or B plus N, etc.

Claims

1. A surgical instrument guiding device for positioning a surgical instrument relative to a human pelvis, comprising: A handle having a first end and a second end; A blunt probe located at the first end and including a blunt tip, the blunt probe being straight; And A friction clamp located at the second end and configured to slidably engage a surgical instrument, wherein the friction clamp is oriented such that the surgical instrument is oriented perpendicular to the blunt probe when engaged with the friction clamp, and the relative orientation of the friction clamp and the blunt probe remains constant, Wherein the blunt tip has a radius less than 25% of the maximum radius of the blunt probe or a curvature radius less than or equal to 25% of the maximum radius of the blunt probe.

2. The surgical instrument guiding device according to claim 1, wherein, The friction clamp is sized to slidably engage a surgical cannula.

3. The surgical instrument guiding device according to claim 1 or 2, wherein, The blunt tip is substantially flat.

4. The surgical instrument guiding device according to any one of claims 1 to 3, wherein, The blunt tip is round.

5. The surgical instrument guiding device according to claim 4, wherein, The blunt probe has a circular cross-section that decreases as the distance from the first end increases, and wherein the curvature radius of the blunt tip is less than or equal to approximately 25% of the maximum radius of the circular cross-section.

6. The surgical instrument guiding device according to claim 5, wherein, The curvature radius of the blunt tip is 5% to 25% of the maximum radius of the circular cross-section.

7. The surgical instrument guiding device according to any one of claims 1 to 6, wherein, The blunt probe is hollow.

8. A surgical instrument assembly for a human pelvis, comprising: A surgical cannula including an outlet; and A surgical instrument guiding device, comprising: A handle having a first end and a second end; A blunt probe located at the first end and including a blunt tip, the blunt probe being straight; and A friction clamp located at the second end and configured to slidably engage the surgical cannula, wherein the friction clamp is oriented such that the surgical cannula is oriented perpendicular to the blunt probe when engaged with the friction clamp, and the relative orientation of the friction clamp and the blunt probe remains unchanged, Wherein the blunt tip has a radius less than 25% of the maximum radius of the blunt probe or a curvature radius less than or equal to 25% of the maximum radius of the blunt probe, Wherein when the surgical cannula is fully inserted into the friction clamp, the outlet of the surgical cannula is within 2 cm of the blunt tip.

9. The surgical instrument assembly according to claim 8, wherein, The surgical cannula includes an inlet and an internal channel connecting the inlet and the outlet, wherein the inlet, the internal channel, and the outlet are sized to guide a surgical needle or a surgical screw.

10. The surgical instrument assembly according to claim 8 or 9, wherein, The blunt tip is substantially flat.

11. The surgical instrument assembly according to any one of claims 8 to 10, wherein, The blunt tip is round.

12. The surgical instrument assembly according to claim 11, wherein, The blunt probe has a circular cross-section that decreases as the distance from the first end increases, and wherein the curvature radius of the blunt tip is less than or equal to approximately 25% of the maximum radius of the circular cross-section.

13. The surgical instrument assembly according to claim 11, wherein, The curvature radius of the blunt tip is 5% to 25% of the maximum radius of the circular cross-section.

14. The surgical instrument assembly according to any one of claims 8 to 13, wherein, The blunt probe is hollow.

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