The invention relates to a system and method for performing a surgical procedure, and in particular, to a medical kit or system that includes an introducer/guide pin system that enables rapid and accurate depth measurement.
A minimally invasive procedure is a medical procedure that is performed through the skin or an anatomical opening. In contrast to an open procedure for the same purpose, a minimally invasive procedure will generally be less traumatic to the patient and result in a reduced recovery period.
However, there are numerous challenges that minimally invasive procedures present. For example, minimally invasive procedures are typically more time-consuming than their open procedure analogues due to the challenges of working within a constrained operative pathway. In addition, without direct visual feedback into the operative location, accurately selecting, sizing, placing, and/or applying minimally invasive surgical instruments and/or treatment materials/devices can be difficult.
For example, in a conventional open posterior fixation procedure (typically performed to aid spinal fusion), screws and rods are fastened into pedicles or across facet joints of a spinal column to immobilize two or more vertebrae. An open procedure allows the surgeon to select and place appropriately sized pedicle or facet screws based on unobstructed observation of the relevant vertebral structure(s).
However, performing a minimally invasive posterior fixation to aid spinal fusion procedure means that the surgeon must select and place the fixation hardware based on more indirect assessments, such as x-ray fluoroscopy or percutaneous measurement tools. Unfortunately, fluoroscopy does not provide a highly precise indication of dimensional measurements. To obtain greater measurement accuracy, dedicated percutaneous measurement tools can be used, but the use of such tools can increase procedure cost (due to extra tools required) and duration/complexity (due to extra procedural steps).
Accordingly, it is desirable to provide minimally invasive surgical tools that enable efficient and accurate measurement of internal anatomical regions is desired.
By incorporating measurement indicators into the guide pin and introducer used to define and create the access path for a minimally invasive procedure, accurate and efficient depth measurements can be generated for appropriate sizing, selecting, and/or usage of devices and tools used in the procedure. Eliminating the need for supplemental measurement instruments/steps while still providing precise measurement data can not only enhance the safety and likelihood of success for the procedure, but can also beneficially reduce procedure duration and cost.
In one embodiment, a system for performing a medical procedure includes an introducer for creating a passage through tissue and a guide pin sized to pass through a lumen in the introducer. The introducer includes an elongate shaft with a distal tip and an indicator element. The guide pin includes a marker element, such that when the guide pin is within the introducer lumen, the indicator element in cooperation with the marker element indicates the distance the guide pin extends beyond the distal tip of the introducer.
In various embodiments, the marker element can be a single or multiple marks or features on the guide pin that can be compared to/detected by the indicator element on the introducer. In one embodiment, the indicator element includes a window to the introducer lumen and a series of tick marks adjacent to the window. The position of the marks/features on the guide pin relative to the series of tick marks on the indicator element can then be used to determine the position of the guide pin relative to the introducer.
In other embodiments, the indicator element can be a sensor, detector, or mechanism that responds to the marker element on the guide pin. The output of the sensor, detector, or mechanism can then be used to determine the position of the guide pin relative to the introducer.
In one embodiment, the system can include a bone screw driver tool, and the measurement capabilities of the introducer/guide pin combination can be used to select an appropriately-sized bone screw for deployment using the bone screw driver. Such an embodiment can further include a drill bit with optional depth indicators and/or removable depth stop that can be used in the drilling of a pilot hole for the installation of the bone screw. The depth indicators/depth stop can be used in conjunction with a working cannula to ensure that a pilot hole of appropriate depth is created, based on the measurement taken by the introducer/guide pin combination.
In another embodiment, the system can include inflatable bone tamps or other bone void creation devices of varying sizes. The measurement capabilities of the introducer/guide pin combination can be used to select an appropriately sized inflatable bone tamp (e.g., balloon length) or other bone void creation device to create an optimally-sized void within a vertebra for subsequent filling with bone filler material, as in balloon kyphoplasty.
In another embodiment, the system can include a cannulated needle with internal stylet for creating an initial trajectory into the subject body and to the internal anatomical target. The internal stylet can then be removed from the needle lumen, which can then be used to guide the guide pin to the target, at which point the guide pin can be driven to the desired depth into the target and the needle removed. The introducer (inserted into the working cannula) can then be placed over the guide pin and placed against the anatomical target to enable measurement of the guide pin depth within the target.
In another embodiment, the system can include an introducer stylet that can be removably placed within, and substantially fill, the introducer lumen. With the introducer stylet in place, the introducer can be driven directly into the subject body and to the surface of the internal anatomical target. The introducer stylet can then be removed and replaced with the guide pin, and can then be driven to the desired depth into the target, with the depth measurement being indicated by the indicator element/marker element combination.
As will be realized by those of skilled in the art, many different embodiments of an introducer/guide pin device, systems, kits, and/or methods of using an introducer/guide pin device according to the present invention are possible. Additional uses, advantages, and features of the invention are set forth in the illustrative embodiments discussed in the detailed description herein and will become more apparent to those skilled in the art upon examination of the following.
By incorporating measurement indicia into the guide pin and introducer used to create the access path for a minimally invasive procedure, accurate and efficient depth measurements can be generated for use in selecting appropriately-sized tools/devices for use in the procedure.
In the context of the present disclosure, “anterior” refers to in front of the spinal column (ventral); “posterior” refers to behind the column (dorsal). The terms “proximal” and “distal” are defined with respect to the surgeon performing the operation. Thus, with respect to components used by the surgeon, the end of a component that is normally held by or is closest to the surgeon during use is considered to be proximal, and the end of a component that is placed into a patient or is furthest from the surgeon during use is considered to be distal.
In one embodiment, a system 190 of functional instruments shown in
As described in greater detail below, guide pin 120 and introducer 130 are used to place working cannula 140 in a patient to create an access path for a medical procedure. The medical procedure can then be performed through working cannula 140 using additional tools 150 (e.g., needle/stylet, drill, curette, facet/pedicle screw driver, an inflatable bone tamp, and/or a cement delivery tool). Instructions for use 160 provide guidance as to how to use the instruments in system 190, and can include directions for performing any of the techniques described herein or alternatives.
Introducer 130 includes an elongate shaft 131, a handle 132, a distal tip 134, and a longitudinal lumen 133. Tip 134 of introducer 130 is tapered (e.g., conical, bullet-shaped, rounded, or any other transition from a smaller to larger diameter) to allow shaft 131 to be more easily advanced through soft tissue.
Guide pin 120 is sized to fit within lumen 133 of introducer 130. Guide pin 120 further includes a marker element 121 at a proximal portion of guide pin 120, and introducer 130 further includes an indicator element 135 at a proximal portion of introducer 130. As described in greater detail below, marker element 121 and indicator element 135 cooperatively enable rapid and accurate determination of the extension of guide pin 120 beyond tip 134, without the need for additional measurement instruments. This extension (depth) measurement can then be used to select appropriately-sized tools and/or medical devices for subsequent use in the procedure being performed.
Note that for exemplary purposes, marker element 121 on guide pin 120 is depicted as a single dark mark or band. However, in various other embodiments, marker element 121 can take any form that permits positional information to be determined via indicator element 135 on introducer 130. For example, marker element 121 can include multiple markings, either evenly spaced or unevenly spaced. Alternatively, marker element 121 could include one or more features, such as grooves or raised elements in guide pin 120, or could even include one or more alternative materials at specific locations.
Similarly, indicator element 135 can take a variety of forms and constructions. For exemplary purposes, indicator element 135 is depicted as a ruler-type feature that includes a series tick marks adjacent to a window to allow the position of marker element 121 to be seen relative to the tick marks. In such an embodiment, the window of indicator element 135 (and in one embodiment, the entire handle 132) could be made out of a clear material, or the window could simply be an opening in introducer 130.
In various other embodiments, indicator element 135 could be a displacement sensor (e.g., linear encoder, hall effect sensor, LVDT, mechanical counter, etc.), proximity sensor (e.g., a magnetic, inductive, optical, or reflective sensor), or any other type of element responsive to (i.e., capable of detecting and/or tracking) marker element 121 on guide pin 120.
Note further that indicator element 135 is depicted as being located within handle 132 of introducer 135 for exemplary purposes only. In various other embodiments, indicator element 135 could be located on shaft 131 (rendering handle 132 an optional element of introducer 130) or on the surface of handle 132. In various other embodiments, handle 132 can be removable or even eliminated from introducer 130.
Working cannula 140 is slipped over shaft 131 of introducer 130 and is optionally interlocked with handle 132 to prevent relative rotation. Then, as shown in
At this point, the distance D between tip 134 of introducer 130 and the distal tip 122 of guide pin 120 is a key sizing parameter for subsequent steps in the medical procedure. For example, in certain posterior fixation procedures, the pedicles or facets of adjacent vertebrae are rigidly connected using screws, rods, plates or other structures to minimize relative motion of the vertebrae and thereby reduce pain caused by such relative motion. Thus, if target 110 represents a pair of adjacent vertebrae to be fixed in a posterior fixation to aid spinal fusion procedure, distance D could be indicative of the length of bone screw required to properly provide fixation of vertebrae across a facet joint (i.e., the thread engagement length necessary to ensure secure fastening without excessive vertebral penetration).
Accordingly, accurate determination of distance D can be critical to ensuring a successful patient outcome. By providing marker element 121 on guide pin 120, and corresponding indicator element 135 on introducer 130, the distance D can be read directly from the portion of introducer 130 external to subject 100. In the embodiment shown in
Once distance D is determined from indicator element 135 and marker 121, introducer 130 and guide pin 120 can be removed from subject 100, leaving working cannula 140 in place. Optionally, working cannula 140 can be pushed into contact with target 110. In this manner, working cannula 140 provides an access path to target 110 for subsequent steps in the medical procedure. These subsequent steps can then be performed using tools (e.g., optional tools 150 of system 190) and/or devices selected based on the determination of distance D depicted in
Note that although
For example,
In another embodiment, stylet 175 in
As described above with respect to
In any event, once guide pin 120 and introducer 130 are placed within subject 100, an extension depth D of distal tip 122 of guide pin 120 beyond tip 134 of introducer 130 is measured in a READ GUIDE PIN/INTRODUCER INTERFACE step 220. Specifically, as described with respect to
As noted above, while a simple graphical system (single marker on guide pin 120 aligned with tick marks on introducer 130) is depicted and described with respect to
Then, in a SELECT/USE DEVICE ACCORDING TO MEASUREMENT step 230, a tool, implant, device, or any other element of the medical procedure is selected and/or used based on the measurement taken in step 220. The procedure is then carried out in a COMPLETE PROCEDURE USING DEVICE step 240. Various procedural uses of the measurement information of step 220 will be readily apparent.
For example, a particular depth D measured in step 220 could indicate that a pedicle or facet screw of a particular length/size would be required for proper fixation in a spinal fusion process. Alternatively, a particular depth D could indicate that a vertebral compression fracture would be best treated by performing a kyphoplasty procedure using an inflatable bone tamp of a particular size, or by performing a vertebroplasty procedure in which the cement delivery nozzle is placed at a particular location within the vertebra. Various other procedural uses of the measurement information of step 220 will be readily apparent.
In one embodiment, system 190 described with respect to
One such exemplary bone screw delivery system 390 is shown in
In one embodiment, a posterior fixation procedure can be performed via transpedicular access. Specifically, the procedure can involve the posterior fixation of the two lateral facet joints of a single vertebra through a single percutaneous access point (“transpedicular access”). For example,
To identify an appropriate percutaneous access point, the patient can be positioned such that the superior endplate of the inferior vertebra 319 has the appearance of a single line. A skin scribe can then be made along the mid pedicle and lateral border (point P1) and the medial border of the pedicle and superior endplate of the inferior vertebra 319 (point P2). A line L2 can then be drawn through points P1 and P2. The intersection point P3 of line L2 and the body (spine) midline L1 indicates the appropriate skin incision location for percutaneous access.
In this manner, access can be provided that minimizes the number of incisions required for a posterior fixation procedure. However, various other approaches will be readily apparent, and the techniques described herein are not limited to any particular access path(s) or procedure.
Once an access point has been selected, the procedure using system 390 (in this case a posterior fixation involving immobilizing adjacent vertebrae through the facet joint), cannulated needle 370 can be docked onto the desired location on a spine 310, as shown in
Introducer 330 can then be inserted over guide pin 320 (after removal of needle 370) and pushed through soft tissue (not shown for clarity) until tip 334 makes contact with the entry point on spine 310, as shown in
In the example shown, the alignment between marker element 321 and the tick mark 30 on indicator element 335 represents the depth of the tip of guide pin 320 relative to the surface entry point on spine 310. Therefore, a facet screw having an appropriate length can be selected based on this measured depth. For example, in one embodiment, each tick mark of indicator element 335 corresponds to a specific bone screw size, and the tick mark closest to marker element 321 determines the screw size selection.
In this manner, guide pin 320 and introducer 330 not only define the trajectory and target location for the eventual placement of a facet screw in spine 310, but also provide accurate sizing information that can be used to ensure appropriate facet screw selection and installation, as described in greater detail below.
Next, as shown in
Drill bit 352 can then be inserted over guide pin 320 and into cannula 340 to drill across facet joint 311 and into pedicle 312 until spacer clip 353 makes contact with the proximal end of cannula 340, as shown in
Drill bit 352 can then be removed and a cannulated screw 355 and screw driver 351 can be inserted over guide pin 320, as shown in
Then, after any final fastening steps have been completed (e.g., facet screw nut tightening, retention feature deployment, or any other post-delivery action), driver 351, guide pin 320, and cannula 340 can be removed from the subject, leaving facet screw 355 fully and accurately placed within spine 310, as shown in the magnified detail in
In another embodiment, system 190 described with respect to
The use of such a system would begin with the placing of guide pin 320 and introducer 330 (along with cannula 340) at a target vertebra 313, as shown in
The resulting measurement could then be used to select an appropriately sized IBT 356 as shown in
Additionally or alternatively, the measurement taken using guide pin 320 and introducer 330 could be used delivery of bone filler material (e.g., bone cement) to a kyphoplasty, vertebroplasty, or any other bone target. For example,
In a kyphoplasty procedure, target region 314 can be the void created by IBT 356 shown in
In a vertebroplasty procedure, target region 314 can be the region spanned by the extension of guide pin 320 into vertebra 313 as described with respect to
While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Thus, the breadth and scope of the invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims and their equivalents. While the invention has been particularly shown and described with reference to specific embodiments thereof, it will be understood that various changes in form and details may be made.