Patent Application
20180272090
The present disclosure relates generally to medical instruments and methods, and in particular to a medical instrument and method for a percutaneous procedure.
A tracheal tube is typically a catheter that is inserted into the trachea for the purpose of providing an airway for a patient. An endotracheal tube is a specific type of tracheal tube that is inserted through the mouth (orotracheal) or nose (nasotracheal). Such endotracheal tubes are in contrast to a tracheostomy tube, which is inserted into a tracheostoma following a tracheostomy procedure, and a tracheal button, which may also be inserted into a puncture through the paratracheal skin into the trachea.
An endotracheal tube may be cuffed or uncuffed. Cuffed endotracheal tubes include a cuff that can be inflated to minimize the passage of secretions from the upper respiratory tract downward into the lungs of a patient.
The following are of interest: U.S. Pat. Nos. 1,598,283; 2,892,458; 3,688,774; 3,996,939; 4,211,234; 4,223,411; 4,280,492; 4,304,228; 4,305,392; 4,315,505; 4,327,721; 4,449,523; 4,459,984; 4,469,100; 4,573,460; 4,584,998; 4,589,410; 4,596,248; 4,607,635; 4,627,433; 4,632,108; 4,637,389; 4,762,125; 4,834,087; 4,840,173; 4,852,565; 5,056,515; 5,067,497; 5,107,828; 5,123,922; 5,201,310; 5,217,008; 5,218,970; 5,255,676; 5,297,546; 5,329,921; 5,339,808; 5,343,857; 5,349,950; 5,391,205; 5,392,775; 5,458,139; 5,497,768; 5,507,279; 5,515,844; 5,584,288; 5,599,333; RE35,595; 5,687,767; 5,688,256; 5,746,199; 5,771,888; 5,957,978; 6,053,167; 6,089,225; 6,102,038; 6,105,577; 6,135,110; 6,135,111; 6,463,927; 6,722,367; 6,814,007; 7,404,329; 8,573,220; U.S. Patent Publication Nos: 2003/0084905; 2004/0123868; 2016/028239; 2016/0102312; foreign/international patent publications: DE 25 05 123; DE 34 06 294; DE 37 20 482; DE 38 13 705; DE 195 13 831; DE 101 09 935; WO 99/07428; WO 99/12599; WO 00/32262; other publications: Quick Reference Guide to Shiley's “Quality-Of Life” Line of Tracheostomy Products, 1991; Granuloma Associated with Fenestrated Tracheostomy Tubes, Padmanabhan Siddharth, MD, PhD, FACS and Lawrence Mazzarella, Md., FACS, Case Reports, vol. 150, August 1985, pp. 279-280; Technical Support Information Connections with the Passy-Muir Tracheostomy and Ventilator Speaking Valves, one sheet; Tracheostomy and Laryngectomy Tubes, pp. 568 and 572; Tracheostomy Tube Adult Home Care Guide, Shiley Tracheostomy Products, Mallinckrodt Medical pp. 1-40; D. Hessler, MD, K. Rehder, MD and S. W. Karveth, MD, “Tracheostomy Cannula for Speaking During Artificial Respiration”, Anesthesiology, vol. 25, No. 5, pp. 719-721 (1964). No representation is intended by this listing that a thorough search of all material prior art has been conducted, or that no better art than that listed is available.
According to one aspect of the disclosure, a medical instrument system is disclosed. The medical instrument system comprises a tissue shield sized to be advanced into a lumen of an endotracheal tube. The tissue shield includes a barrier plate sized and shaped to extend outwardly the distal end of the endotracheal tube and block a medical tool from contacting a posterior wall of the patient's trachea. The system may also comprise an endotracheal tube including a distal end sized to be positioned in a patient's trachea, a proximal end configured to extend outwardly from one of the patient's mouth and the patient's nose, and a lumen extending between the distal end and the proximal end. In some embodiments, the medical tool may be a cutting tool such as, for example, a percutaneous needle. Additionally, in some embodiments, the barrier plate to sized and shaped to block the medical tool from puncturing a posterior wall of the patient's trachea.
In some embodiments, the system may also comprise an elongated tube sized to be positioned in the lumen of the endotracheal tube. The tissue shield may include a cylindrical body sized to be received a passageway defined in the elongated tube. The barrier plate may be secured to, and extend distally away from, the cylindrical body.
In some embodiments, the elongated tube may include a plurality of corrugations, and the cylindrical body of the tissue shield may include a rib sized to be positioned in one of the corrugations to secure the shield to the elongated tube. Additionally, in some embodiments, system may comprise a medical instrument including a cable sized to be advanced into the lumen of the endotracheal tube. The tissue shield may be secured to a distal end of the cable of the surgical instrument.
In some embodiments, the medical instrument includes a laryngoscope. In some embodiments, the cable may be a stylette.
Additionally, in some embodiments, the system may comprise an elongated tube sized to be positioned in the lumen of the endotracheal tube. The tissue shield may be secured to a distal end of the elongated tube. In some embodiments, the elongated tube and the tissue shield may be formed as a single monolithic component. In some embodiments, the tissue shield may be configured to be detached from the elongated tube.
In some embodiments, the barrier plate may include a curved wall that extends around a longitudinal axis from a first edge to a second edge, and an opening is defined between the first edge and the second edge of the curved wall, the opening being sized cover a predetermined portion of a patient's soft tissue. Additionally, in some embodiments, the curved wall may be formed from a semi-flexible plastic. In some embodiments, the curved wall may be formed from silicone.
In some embodiments, the endotracheal tube may include an inflatable cuff positioned between the distal end and the proximal end.
According to another aspect, a medical instrument system comprises an elongated tube sized to be positioned in an endotracheal tube, the elongated tube having a distal end, a proximal end, and an outer surface devoid of any openings between the distal end and the proximal end. The system also comprises a tissue shield secured to the distal end of the elongated tube. The shield includes a barrier plate sized and shaped to block a cutting tool from puncturing a posterior wall of the patient's trachea.
According to another aspect, a medical instrument system comprises an elongated tube sized to be positioned in an endotracheal tube, the elongated tube having a distal end, a proximal end, and an outer surface devoid of any openings between the distal end and the proximal end. The system also comprises a tissue shield secured to the distal end of the elongated tube. The shield includes a barrier plate sized and shaped to block a medical tool from contacting a posterior wall of the patient's trachea.
In some embodiments, the elongated tube and the tissue shield may be formed as a single monolithic component. Additionally, in some embodiments, the tissue shield may be configured to be detached from the elongated tube.
In some embodiments, the tissue shield may include a cylindrical body sized to be received a passageway defined in the elongated tube, and the barrier plate may be secured to, and extend distally away from, the cylindrical body.
In some embodiments, the elongated tube may include a plurality of corrugations, and the cylindrical body of the tissue shield may include a rib sized to be positioned in one of the corrugations to secure the shield to the elongated tube.
According to another aspect, a medical instrument system comprises a surgical instrument including a cable sized to be advanced into an endotracheal tube, and a tissue shield secured to a distal end of the cable. The tissue shield includes a barrier plate sized and shaped to prevent a cutting tool from puncturing a posterior wall of the patient's trachea.
According to another aspect, a method of forming an incision in a patient's neck in advance of implanting a tracheal device is disclosed. The method comprises sliding an endotracheal tube to move the distal end of the endotracheal tube proximally within the patient's trachea, moving a tissue shield outward from the distal end of the endotracheal tube to position a barrier plate of the shield in the patient's trachea between an anterior wall of the patient's trachea and a posterior wall of the patient's trachea, inserting a medical or surgical tool through the anterior wall of the patient's trachea to form an incision, and advancing the surgical tool into engagement with the barrier plate of the shield.
In some embodiments, the method also comprises withdrawing an elongated tube from the endotracheal tube, and attaching the tissue shield to a distal end of the elongated tube. The step of moving the shield outward from the distal end of the endotracheal tube may include inserting the elongated tube with the tissue shield attached to its distal end into the endotracheal tube.
In some embodiments, the method may comprise inserting the tissue shield attached to a distal end of a laryngoscope into the endotracheal tube, and advancing the tissue shield and the distal end of the laryngoscope toward the distal end of the endotracheal tube.
In some embodiments, the method may further comprise inserting the tissue shield attached to a distal end of a stylette into the endotracheal tube, and advancing the tissue shield and the distal end of the stylette toward the distal end of the endotracheal tube.
According to another aspect, a method of forming an incision in a patient's neck in advance of implanting a tracheal device is disclosed. The method comprises positioning a tissue shield in a patient's trachea between an anterior wall of the patient's trachea and a posterior wall of the patient's trachea, inserting a medical or surgical tool through the anterior wall of the patient's trachea to form an incision, and advancing the surgical tool into engagement with the tissue shield.
In some embodiments, positioning the tissue shield in the patient's trachea between the anterior wall of the patient's trachea and the posterior wall of the patient's trachea may include advancing the tissue shield along the outer surface of another medical instrument. Additionally, in some embodiments, the medical instrument may be an endotracheal tube. In some embodiments, the method may comprise inserting the tissue shield attached to a distal end of a laryngoscope into the patient's trachea. In some embodiments, the method may further comprise inserting the tissue shield attached to a distal end of a stylette into the patient's trachea.
In some embodiments, the method also comprises withdrawing an elongated tube from an endotracheal tube, and attaching the tissue shield to a distal end of the elongated tube. The step of positioning the tissue shield in the patient's trachea between the anterior wall of the patient's trachea and the posterior wall of the patient's trachea may include inserting the elongated tube with the tissue shield attached to its distal end into the endotracheal tube.
In some embodiments, the method may comprise inserting the tissue shield attached to a distal end of a laryngoscope into the endotracheal tube, and advancing the tissue shield and the distal end of the laryngoscope toward the distal end of the endotracheal tube.
In some embodiments, the method may further comprise inserting the tissue shield attached to a distal end of a stylette into the endotracheal tube, and advancing the tissue shield and the distal end of the stylette toward the distal end of the endotracheal tube.
The detailed description particularly refers to the following figures, in which:
While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Terms representing anatomical references, such as anterior, posterior, medial, lateral, superior, inferior, etcetera, may be used throughout the specification in reference to the surgical tools and medical instruments described herein as well as in reference to the patient's natural anatomy. Such terms have well-understood meanings in both the study of anatomy and the field of orthopaedics. Use of such anatomical reference terms in the written description and claims is intended to be consistent with their well-understood meanings unless noted otherwise.
Referring now to
The outer endotracheal tube 12 includes an elongated curved body 20 that extends from a proximal end 22 to a distal end 24. The curved body 20 has a circular opening 26 defined in the proximal end 22 and another circular opening 28 defined in the opposite distal end 24. A lumen 30 extends between the openings 26, 28 and has a curvature corresponding to the curvature of the body 20. The tube 12 is rigid and formed from a biocompatible plastic resin, but it should be appreciated that in other embodiments other suitable materials may be used.
The outer endotracheal tube 12 has a rim 32 that extends outwardly from the proximal end 22. A pair of locking flanges 34 extend outwardly from the rim 32 on opposite sides of the proximal opening 26. As described in greater detail below, the flanges 34 are sized to receive corresponding locking tabs 36 of the elongated tube 14 to secure the elongated tube 14 to the endotracheal tube 12. In the illustrative embodiment, the rim 32, the locking flanges 34, and the elongated curved body 20 are formed as a single monolithic component. It should be appreciated that in other embodiments they may be formed as separate components that are later assembled.
As shown in
In the illustrative embodiment, an inflatable cuff 42 is attached to the curved body 20 near the distal end 24 such that the cuff 42 lies in the patient's trachea during use. As shown in
As shown in
As described above, the endotracheal tube system 10 also includes an inner elongated tube 14 configured for insertion into the outer tube 12. As shown in
The elongated tube 14 as a proximal opening 72 defined in the port 66 and an opposite distal opening 74 defined in the end 64 of the corrugated body 60. A passageway 76 extends between the openings 72, 74 and is sized to permit the passage of oxygen and other gases from a ventilator (not shown) or other medical device attached to the port 66 downward into the patient's lungs. In the illustrative embodiment, the corrugated body 60 and the port 66 are formed as a single semi-flexible monolithic component from a biocompatible plastic resin. In that way, the corrugated body 60 conforms to the shape of the curved lumen 30 of the outer tube 12 when the corrugated body 60 is positioned in the lumen 30. In the illustrative embodiment, the flange 68 and locking tabs 36 are rigid and formed separately from biocompatible plastic resin.
Although only a single elongated tube 14 is shown in
As described above, the system 10 also includes a tissue shield 16 that is configured to be attached to the inner tube 14. The tissue shield is configured to be positioned in the patient's trachea to prevent contact between various medical instruments used in percutaneous procedures and the patient's posterior tracheal wall, as described in greater detail below. It should be appreciated that in other embodiments the tissue shield and the elongated tube may be formed as a single monolithic component rather than as separate components as shown in
As shown in
The barrier plate 82 of the tissue shield 16 extends from the distal end 88 of the cylindrical body 84. In the illustrative embodiment, the barrier plate 82 includes a corrugated body 100 that extends to a distal tip 102. The corrugated body 100 has an open end 104 at the distal tip 102 and an elongated slot 106 that extends proximally from the open end 104. The slot 106 is defined between a pair of edges 110 of the barrier plate 82, and the barrier plate 82 has a curved inner wall 112 that connects the edges 110. As shown in
In the illustrative embodiment, the plug 80 is rigid and is formed from a bio compatible plastic resin. The barrier plate 82 is semi-flexible and is also formed from a biocompatible plastic resin. In the illustrative embodiment, the barrier plate 82 is formed from silicone. In other embodiments, it may be formed from any medical-grade material. The barrier plate 82 and the plug 80 are formed separately before being assembled as the tissue shield 16. It should be appreciated that in other embodiments the barrier plate and the plug may be formed as a single monolithic component.
As described above, the tissue shield 16 may be attached to the elongated tube 14 for insertion into the endotracheal tube 12. To do so, a surgeon or other user may align the proximal end 86 of the tissue shield 16 with the distal opening 74 of the elongated tube 14. The user may then advance the proximal end 86 into the distal opening 74 to engage the annular rib 90 of the tissue shield 16 with the corrugations of the elongated tube 14. The user may continue to advance the tissue shield 16 proximally until the proximal edge of the barrier plate 82 engages the distal end 64 of the elongated tube 14.
The tissue shield 16 includes an alignment guide 120 that is formed on the outer surface of the barrier plate 82, as shown in
The user may then align the distal tip 102 of the tissue shield 16 with the proximal opening 26 of the endotracheal tube 12. The user may advance the distal tip 102 into the opening 26, along the lumen 30 of the endotracheal tube 12, and out of the distal opening 28 of the endotracheal tube 12. As shown in
As described above, the system 10 includes multiple inner elongated tubes 14 for use with the outer endotracheal tube 12 so that the endotracheal tube 12 may remain positioned in a patient's trachea while the inner tube 14 is removed for cleaning and/or replacement with another inner tube.
Referring now to
An inner elongated tube 14 is shown positioned in the lumen 30 of the endotracheal tube 12. When positioned with its locking tabs 36 engaged with the flanges 34 of the endotracheal tube 12, the distal opening 74 of the elongated tube 14 is positioned adjacent to the distal opening 28 of the tube 12. As shown in
During the percutaneous tracheostomy, the inner elongated tube 14 may be removed from the outer endotracheal tube 12. The inner elongated tube 14 can be replaced by disconnecting it from the ventilator, releasing the locking tabs 136 from the flanges 134 and withdrawing the elongated tube 14 from the lumen 30 of the outer endotracheal tube 12. The surgeon or other user may then attach the tissue shield 16 to the distal end of the withdrawn elongated tube 14 as described above, or the surgeon may attach the tissue shield 16 to a new/ fresh elongated tube 14. The surgeon may then insert the tissue shield 16 and the elongated tube 14 into the lumen 30 of the outer endotracheal tube 12 as described above.
As shown in
As shown in
The surgeon may then continue with the remaining steps of the percutaneous tracheostomy procedure. For example, the surgeon may advance a cannula 192 over the needle 182 and into the incision 190. The surgeon may then introduce a guidewire 194 through the cannula 192, as shown in
As shown in
As described above, the passageways 76, 96 of the elongated tube 14 and the tissue shield 16, respectively, are sized to receive a probe of a laryngoscope. In that way, the surgeon may observe the movement of the needle 182 relative to the patient's trachea 158 through the laryngoscope. Additionally, surgeon may perform the other steps of the tracheostomy using the laryngoscope to observe the region of interest within the patient's trachea 158.
As described above, the tissue shield 16 may be formed as a single monolithic component with the elongated tube 14. As shown in
In the illustrative embodiment, the barrier plate 282 is configured to contract such that it may be positioned in the lumen 30 of the endotracheal tube 12 (see
Referring now to
The tissue shield 416 also includes a solid plug 318 that may be attached to, for example, the probe of an endoscope or other surgical instrument. The shield 416 also includes a barrier plate 282 including the features described above in regard to
Referring now to
The tissue shield 516 includes a barrier plate 518 that extends from the probe tip 508 to a distal tip 520. In the illustrative embodiment, the barrier plate 518 includes a corrugated body 522 that extends to the distal tip 520. A corrugated body as an open end 524 at the distal tip 520, and an elongated slot 526 that extends proximally from the open end 524. The slot 526 is defined between a pair of edges 530 of the barrier plate 518, and the barrier plate 518 has a curved inner wall 532 that extends between the edges 530. The inner wall 532 defines a channel 534. The channel 534 and the elongated slot 526 are sized to receive a cutting tip of a percutaneous needle or other cutting tool.
Referring now to
It should be appreciated that, although the tissue shields shown and described above each include curved inner walls that define the channel that receives the cutting tip of a cutting tool, in other embodiments the inner wall may be substantially flat or take other shapes suitable for engaging a needle, catheter, or other surgical or medical tool to capture or redirect those tools away from the patient's soft tissue. It should also be appreciated that in other embodiments other biocompatible materials having sufficient strength and rigidity may be used to make the tissue shields.
While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.
There are a plurality of advantages of the present disclosure arising from the various features of the method, apparatus, and system described herein. It will be noted that alternative embodiments of the method, apparatus, and system of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the method, apparatus, and system that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure as defined by the appended claims.
