Patent Application
20180078328
Embodiments relate to surgical instruments, systems, devices, and/or methods for locating and tracking the position of a nodule.
To surgically remove a nodule or other object, an imaging system can be used to identify the exact location of that object, and a localization wire is inserted into the patient and placed into the nodule. Subsequently, a surgeon can follow the localization wire to the object, and remove it. This process is sometimes referred to as tumor localization, wire localization, pre-surgical nodule localization, or computer aided tomography wire localization.
Between the time that the localization wire is placed and the time that the surgeon removes the object, the localization wire can become dislodged. In the case of pulmonary nodule localization, this can occur because the patient's respiration cycle causes relative movement between the object and the patient's skin, where the localization wire is conventionally affixed.
One conventional solution to this problem is to use a hook-shaped wire, such that traction applied on the wire by respiration is less likely to cause the wire to dislodge from the nodule or other device. However, the proximal (more superficial portion of the hook wire is affixed to the skin which has still resulted in dislodgment or migration of the distal hook portion away form the localization site. This migration can result in trauma to the lung and potential difficulties precisely locating the nodule intraoperatively. Patients can often wait for long periods, up to 12 hours after localization wires are placed, due to surgical suite or CT room scheduling constraints. Some short hook systems have been shown to reduce dislodgement of the localization wire in some patients. Shortcomings of such short hook systems include unsuccessful placement caused by too shallow a puncture with the introducer needle, and some instances of hemorrhages into the lung or pleural space.
In some systems, a coil is used to allow for relative movement of the skin and the nodule or other object. Such a coil is deployed partly in or adjacent to the nodule/surgical target (distal end of coil) and the remainder (proximal end) is positioned in the pleural space, a small potential space between the two layers of the pleura. The pleura are thin coverings that protect and cushion the lungs, positioned between the lungs and chest cavity. Failure to place the coil in the pleural region can result in dislodgement of the distal end of the coil and loss of localization site for the surgeon and potential damage to the soft tissue surrounding the delivery tract, causing injury or hemorrhaging in the patient.
The intra-pleural portion essentially floats within the pleural space preventing traction on the portion of the coil within the lung and potential coil dislodgement. If the portion of the coil that is intended to lie within the pleural space is inadvertently deployed in the more superficial soft tissue tract, the intra-pulmonary portion of the coil will then retract with respiratory motion due to the proximal portion being fixed in place by the superficial soft tissues, thereby resulting in dislodgment from the desired localization site. It is very challenging to precisely place the proximal end within the pleural space as this is often only a collapsed potential space that is not easily localized. In addition to loss of localization site for the surgeon, coil dislodgement can result in injury or hemorrhaging from the lung or tract.
According to embodiments herein, a localization system is described that is not displaced during normal respiration of the patient prior to surgery, and also a system that does not cause injury to the patient by introducing large or complex structures such as hooks or barbs at the site of the nodule.
Embodiments relate to localization structures or systems having elastic, dynamic properties that prevent dislocation prior to surgery. In embodiments, a suture can be attached to a spring or coil, such that the localization system has a coil portion that fixes itself within the desired position and a suture portion that traverses the pleura and tract to the skin site, obviating the challenge to precisely localize and deploy a device within the pleural space. The suture can be trimmed about flush with the skin surface and allowed to retract freely with respiration preventing any traction on the coil portion of the device next to the surgical target within the lung. This ability to expand, contract, and/or move with the patient's respiratory cycle reduces or eliminates the chance that the device will become dislodged, and also enables a surgeon to find the suture within the pleural space more easily.
By attaching the spring or coil to the suture, deployment time can be reduced, limiting radiation exposure and increasing accuracy of localization. Furthermore, since the spring or coil need not be positioned in the pleural space, there is a reduced potential for damage to the soft tissues of the delivery tract as compared to conventional systems. Furthermore, the embodiments described below facilitate nodule resection, allowing the surgeon to follow the easily identifiable suture down to the coil and surgical target.
The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.
Embodiments may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying figures, in which:
While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
Embodiments discussed herein include a suture at the proximal end of a localization system and a coil or other elastic structure attached to the suture. The localization coil extends to the nodule or other object that is to be surgically removed. Respiration of the patient does not cause dislocation of the distal end of the localization coil, because the force exerted on the distal end of the coil is reduced or eliminated as the elastic structure expands or contracts to permit relative movement between the proximal and distal ends.
Arranged within delivery needle 106 are pusher wire 108 and localization structure 110. In use, distal end 104 of delivery needle 106 can be positioned in a patient during aided tomography wire localization or some other method that facilitates placement of localization structure 110 at a nodule. An operator such as a surgeon can manipulate a needle hub 112 having any of a variety of controllers, buttons, or other actuating features (not shown) at proximal end 102 to move pusher wire 108 relative to delivery needle 106. In particular, once distal end 104 is placed at the nodule, pusher wire 108 can be used to keep localization structure 110 in place while delivery needle 106 is removed from the patient.
In embodiments, localization structure 110 can be arranged substantially linearly while housed within delivery needle 106. In such embodiments, as localization structure 110 exits from distal end 104 of delivery needle 106, localization structure 110 or some portion thereof can transition from straight and linear to coiled. This permits the use of a relatively smaller delivery needle 106, as the cross-sectional profile from the distal end 104 need only be wide enough to circumscribe the thickness of the localization structure 110 in its straightened-out form, rather than its coiled form. In some embodiments, localization structure 110 can include a shape memory alloy or other material that permits selectively coiling or un-coiling. In embodiments, delivery needle 106 can be delivered to a surgeon or other operator pre-loaded with pusher wire 108 and localization structure 110.
Localization structure 110 can include both a coiling and a non-coiling portion. For example, in embodiments described herein, localization structure 110 includes a coil portion and a suture portion. In embodiments, it is desirable to position such a coil portion at the nodule.
In a first step 150, an object such as a nodule is located. The nodule or other object can be located using a scout scan using, for example, x-ray, ultrasound, tomography, or any other imaging system.
At a second step 152, a preloaded delivery needle is inserted into the patient. The delivery needle is preloaded in that it includes both a pusher wire (e.g., 108) and a localization structure (e.g., 110). The localization structure (e.g., 110 of
At a third step 154, the pusher wire (e.g., pusher wire 108 of
At a fourth step 156 of the embodiment shown in
At a fifth step 158 (optional), a suture is affixed to the skin of the patient. The suture is positioned at a portion of localization coil 110 near to the proximal end 102, in embodiments. The suture thereby attaches one end of localization coil 110 to the patient's skin while the other end of localization coil is positioned at the nodule identified in first step 150. As described in more detail below, in embodiments it may be preferable to leave the suture unsecured to the skin of the patient, as this permits the suture to move to the pleural space in the chest where it can later be found by the surgeon.
After placement of a guidewire system (e.g., guidewire system 100 of
In embodiments, localization structure 110 can have a length that is between about 8-10 cm, for example about 8.85 cm. In alternative embodiments, nodules may be located relatively closer or further from the skin of the patient, and the length of localization structure 110 can be adjusted accordingly.
Various embodiments will have different widths, in addition to different lengths. In one embodiment, elastic structure 208 is a coil having a diameter of about 8 mm. In alternative embodiments, relatively larger or smaller coils could be used, or elastic structures other than coils could be used. In embodiments, elastic structure 208 is designed to be positioned on the skin of a patient, attached to the skin with a suture or other fastener. In those embodiments, the width of elastic structure 208 is of less importance, as it does not affect the size of the incision that must be made on the patient.
Pleural space 422 is positioned between lung 416 and ribs 420. Lung 416 can move relative to ribs 420 during respiration or other movement of the patient. For example, as depicted in
In order to provide a guidewire to a nodule, conventionally a scan is done of the patient and a needle is inserted between two of the ribs 420 and a coil is deposited. The coil attaches to the nodule and then the surgeon or other operator removes the needle until he or she has positioned the tip of the needle at the pleural space 422. The operator can then deposit the coil into the pleural space 422. For example, this can be accomplished by using a pusher rod to deposit a large quantity of coil at an angle relative to the pleural space 422 when the needle is at exactly the right position.
Depositing a coil in this way can be difficult due to the small thickness of pleural space 522, as well as the relative movement of lung 516 relative to ribs 520 during normal respiration. Further complicating this procedure, nodules 518 positioned in the lower portion (e.g., 416L) can move relatively more with respect to ribs 520, when compared to nodules 518 positioned in the upper portion (e.g., 416U).
Due to tidal movement of lung 616 relative to ribs 620, suture 612 is pulled up and down through pleural space 622. Eventually, the entirety of suture 612 is pulled away from insertion site 626 and into pleural space 622. This is advantageous for a surgeon who later resects nodule 618, because suture 612 is easy to find in pleural space 622 and follow to nodule 618.
Incision 728 is made at a skin surface of body 727, through which a delivery needle or other mechanism can be advanced to nodule 718. Coil 714 is affixed to nodule 718 as a part of the nodule removal procedure described above. Suture 712 is attached to coil 714 as described with respect to
As shown in
Due to the movement of lung 716 due to respiration or repositioning, lung 716 and body 727 can undergo relative movement along the pleural space 722 (e.g., left-to-right or front-to-back with respect to the orientation shown in
Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.
Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.
Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.
Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
The present application claims the benefit of U.S. Provisional Application No. 62/395,454 filed Sep. 16, 2016, which is hereby incorporated herein in its entirety by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62395454 | Sep 2016 | US |
