WO2012149053A1

WO2012149053A1 - Apparatus and method for airway injection

Info

Publication number: WO2012149053A1
Application number: PCT/US2012/035046
Authority: WO
Inventors: Sanjay M. ATHAVALE; Sravan Choudary DHULIPALA; Phil SLUDER; Satakal KHALSA
Original assignee: Vanderbilt University
Priority date: 2011-04-25
Filing date: 2012-04-25
Publication date: 2012-11-01

Abstract

An instrument and method for airway injections. The instrument includes a device having a handle that is attached to a rod, a base, a sleeve and a removable needle assembly. The rod has a first end coupled to the handle and a second end. The base is at least partially coupled to the rod, and includes an actuator mechanism positioned near the first end of the rod and the handle. The sleeve is coupled to the second end of the rod. The instrument includes a removable needle assembly positioned near the second end of the rod. The needle assembly is linked to the actuator mechanism and configured to move around the rod with movement of the actuator mechanism.

Description

APPARATUS AND METHOD FOR AIRWAY INJECTION

RELATED APPLICATIONS

[0001] This application claims priority to co-pending U.S. Provisional Patent Application No. 61/478,887 filed on April 25, 2011, the entire contents of which are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] This invention was made with government support under grant UL1 RR024975-01 awarded by the National Center of Research Resources and the National Institutes of Health. The government has certain rights in the invention.

FIELD OF THE INVENTION

[0003] The present invention relates to devices and methods for airway injections. BACKGROUND OF THE INVENTION

[0004] Injection of a variety of materials into the larynx, subglottis and trachea has widespread applications in the field of Otolaryngology. Pathologic conditions that are treated using airway injections include, but are not limited to, unilateral vocal fold paralysis, subglottic stenosis, and recurrent respiratory papillomatosis. Materials that are injected into different locations within the airway include, for example, Kenalog, Cidofovir, Cymetra, autologous fat, and Radiesse.

[0005] Currently, there are three methods by which a substance can be delivered to a given tissue within the airway: transcervical, transoral, and laryngoscopic. Though the transcervical and transoral approaches are both effective and repeatable they are performed less routinely because they require a high level of skill and expertise on the part of the surgeon, and a high level of cooperation on the part of the patient. On the other hand, laryngoscopic airway injection is performed under general anesthesia in the operating room and is therefore the most common method of airway injection. SUMMARY OF THE INVENTION

[0006] The preferred method by which a substance is delivered to a given tissue within an airway is laryngoscopic airway injection. There are two methods by which an otolaryngologist can successfully evaluate, navigate, and inject an airway using the direct laryngoscopic method while a patient is under general anesthesia. Both methods involve the same first two steps. First, the airway is exposed via direct laryngoscopy. Then, the airway is evaluated using 0 degree, 30 degree, and/or 70 degree Hopkins rod telescopes. In the first method, an injection instrument is held in one hand, while the Hopkins rod is held in the other hand. The injection is done under direct endoscopic visualization. In the second method, an operating microscope is used to more closely monitor the injection while freeing up both hands for the injection process. The fact that the endoscope apparatus and the injection apparatus are separate devices is disadvantageous and inconvenient to the surgeon. Therefore, one goal of an embodiment of this invention is to combine the endoscope apparatus and the injection apparatus into a single device for airway injection. As a single device, the airway injector enables the surgeon to accomplish both evaluation of the airway and injection of the material into the airway with one hand thereby permitting the surgeon to manipulate tissues around the injection with a free hand.

[0007] In one embodiment, the invention provides a medical device or instrument including a handle, a rod, a base, a sleeve, and a removable need assembly. The rod includes a first end that is coupled to the handle and a second end. The base is at least partially coupled to the rod and includes an actuator mechanism positioned near the first end of the rod and the handle. The sleeve is coupled to the second end of the rod and supports a removable needle assembly positioned near the second end of the rod. The needle assembly is linked to the actuator mechanism and configured to move around the rod with movement of the actuator mechanism.

[0008] In another embodiment, the invention provides a medical device or instrument including a handle, a Hopkins rod, a base, a sleeve, a removable needle assembly, a syringe and a camera. The Hopkins rod includes a first end coupled to the handle and a second end. The base is at least partially coupled to the rod. The base also includes an actuator mechanism positioned near the first end of the rod and the handle. The sleeve is coupled to a distal end of the base, and the removable needle assembly, which is linked to the actuator mechanism and configured to move around the rod with movement of the actuator mechanism, is positioned near the second end of the rod. The syringe is coupled to the handle and in fluid communication with the needle assembly. The camera is coupled to the Hopkins rod.

[0009] In another embodiment, the invention provides a method for airway injection. The method includes coupling a needle assembly to a rod having a first end and a second end. The needle assembly is coupled to the second end and linked to an actuator mechanism that is coupled to the first end. Further, the needle assembly in fluid communication with a syringe. The method further includes advancing the rod into the airway and actuating the actuator mechanism to rotate the needle assembly into a desired position in the airway. The method additionally includes actuating the syringe to inject a substance into the desired position in the airway.

[0010] Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a perspective view of a rod telescope used in laryngoscopic airway injections.

[0012] FIG. 2 is a perspective view of a first side of a medical instrument for airway injections including a device used in conjunction with the rod telescope of FIG. 1 according to one embodiment of the invention.

[0013] FIG. 3 is a perspective view of a base of the device illustrated of FIG. 2.

[0014] FIGS. 4 and 5 are enlarged perspective views of the base of FIG. 3 in relation to a sleeve of the device illustrated in FIG. 2.

[0015] FIG. 6 is a perspective view of the medical instrument of FIG. 2.

[0016] FIG. 7 is an enlarged perspective view of a portion of the device illustrated in FIG. 2. [0017] FIG. 8 is an enlarged perspective view of a portion of the medical instrument illustrated in FIG. 2 with the sleeve included in phantom.

[0018] FIG. 9 is a perspective view of the medical instrument illustrated in FIG. 2 without the camera and light source attached.

[0019] FIG. 10 is a first side view of the medical instrument illustrated in FIG. 9. [0020] FIG. 11 is a second side view of the medical instrument illustrated in FIG. 9. [0021] FIG. 12 is a top view of the medical instrument illustrated in FIG. 9. [0022] FIG. 13 is a rear view of the medical instrument illustrated in FIG. 9. [0023] FIG. 14 is a front view of the medical instrument illustrated in FIG. 9. DETAILED DESCRIPTION

[0024] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms "mounted," "connected," "supported," and "coupled" and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings.

[0025] Although directional references, such as upper, lower, downward, upward, rearward, bottom, front, rear, etc., may be made herein in describing the drawings, these references are made relative to the drawings (as normally viewed) for convenience. These directions are not intended to be taken literally or limit the present invention in any form. In addition, terms such as "first," "second," and "third" are used herein for purposes of description and are not intended to indicate or imply relative importance or significance.

[0026] FIG. 1 illustrates an assembly (i.e., rod telescope) 20 that is used in conjunction with an auxiliary injection device for airway injections. The rod telescope 20 includes a rod 30 having a first end 22 and a second end 28. The first end 22 is coupled to a camera 24 and a light source 26. The rod 30 includes a hollow pathway or conduit 32 that extends between the first end 22 and the second end 28 along an axis A. The camera 24 and light source 26 extend through the conduit 32 such that when the rod 30 is inserted into a patient, the camera 24 and light source 26 are used to illuminate and evaluate, respectively, an airway or other anatomical pathway.

[0027] FIGS. 2-14 illustrate a device 10 that is coupled to the rod telescope 20 for use as a single instrument 25 for airway injection. The device 10, according to one embodiment of the invention, includes a base 44, a sleeve 48, a handle 52, a syringe 56, tubing 60 and a needle assembly 64. With reference to FIGS. 3-5, the base 44 at least partially surrounds the rod 30 and includes a first end 68 and a second end 72. The first end 68 of the base 44 abuts a connection point 34 on the rod telescope where the camera 24, rod 30, and cord 36 of the light source 26 intersect. The second end 72 of the base 44 extends from the first end 68 towards the second end 28 of the rod. The base 44 further includes an actuator mechanism 76 (i.e., a slide mechanism) having a first and second projection 80, 84 on the first end 68 and a third projection 88 on the second end 72 connected along a slide 74 (see FIG. 8). The actuator mechanism 76 is coupled to the sleeve 48. The second end 72 of the base 44 includes a recess 92 that receives a first end 96 of the sleeve 48. The sleeve 48 extends along the rod 30 beyond the second end 72 of the base 44 towards a second end 100 of the sleeve 48. The sleeve 48 further includes a first section 104 and a second section 108. The first section 104 includes a groove or channel 112 that accommodates the third projection 88 of the actuator mechanism 76 (best seen in FIG. 8). As illustrated, the first section 104 covers about half of the rod 30 leaving a portion of the rod 30 exposed. The second section 108 at least partially surrounds the rod 30. The second section 108 includes a portion 116 that secures the tubing 60 between the rod 30 and the sleeve 48. [0028] With reference to FIGS. 5-7, the tubing 60 of the device 10 couples the needle assembly 64 to an outlet 120 of the syringe 56. The length of the tubing 60, as illustrated, is greater than the distance between the outlet 120 of the syringe 56 and the needle assembly 64. The tubing 60 wraps around the device 10 to prevent obstruction of the surgical field. The tubing 60 supports an inner conduit or pathway 124. The tubing 60 is surrounded at a distal end 128 by a body 132 of the needle assembly 64, which couples the inner conduit 122 of the tubing 60 with a needle tip 136. A first end 140 of the body 130 is configured to rest against the rod 30 (FIGS. 9-11). Therefore, the needle tip 136 is oriented such that it is never out of view of the camera 24. The needle tip 136 projects from a second end 144 of the body 132.

[0029] Further with respect to FIGS. 5-7, the syringe 56 includes a body portion 148 and a plunger 152. The body 148 of the syringe 56, which contains an injectable material, is secured within a housing 156 of the handle 52 such that the outlet 120 faces opposite the needle assembly 64. Therefore, the plunger 152 of the syringe 56 is configured to be depressed in a direction 160 opposite the needle assembly 64 and parallel to the axis A. The plunger 152 is configured to act like a trigger thereby allowing an ergonomic reversed pushing motion, which can be achieved using only one finger (i.e., the index finger).

[0030] The housing 156 of the handle 52 surrounds and secures the rod 30, base 44, and syringe 56. The housing 156 includes a first and a second groove 164, 168. The first groove 164 accommodates the body 148 of the syringe 56. The second groove 168 is generally T-shaped and is configured to accommodate the base 44 and rod 30, when assembled. The handle 52 secures the syringe 56 such that it is located below the base 44. The configuration of the device 10 in relation to the rod 30 serves the added function of securing the cord 36 of the light source 26 and the syringe 56 within the housing 156. The handle 52 is therefore located between the second end 28 of the rod 30 and the camera 24 and light source 26. The handle 52 prevents translational motion of the rod 30.

[0031] To assemble the instrument 10, the first end 68 of the base 44 with the built-in actuator mechanism 76 is applied to the second end 28 of the rod 30. In the illustrated embodiment the base 44 is a cylindrical, hollow tube, and the second end 28 if the rod 30 is inserted into the first end 68 of the base 44. In alternate embodiments, the base 44 may be a half of a hollow tube, which is frictionally fit onto a portion of the rod of the rod 30. The sleeve 48 is then coupled to the base 44 such that the first end 96 of the sleeve 48 is received within the recess 92 of the second end 72 of the base 44. Therefore, the base 44 and sleeve 48 slide along the rod 30 from the second end 28 to the first end 22 until the first end 68 of the base 44 abuts the connection point 34. At this point, the base 44 and sleeve 48 are coupled to and cover at least a portion of the rod 30. The rod telescope 20 including the base 44 and the sleeve 48 are then inserted into the T-shaped groove 168 of the handle 52. Then the syringe 56 is coupled to the handle 52 in the first groove 164 thereby trapping the cord 36 of the light source 26. The outlet 120 of the syringe 56 faces the camera 24 and light source 26, opposite the second end 28 of the rod 30. The plunger 152 of the syringe 56 is therefore configured similarly to a trigger such that it is depressed in a reversed pushing motion (i.e., towards the camera and light source). The tubing 60 is strung from the outlet 120 through the portion 116 of the sleeve 148 to the second end 28 of the rod 30 where the needle assembly 64 is coupled to the distal end 128 of the tubing 60.

[0032] In operation, the instrument 25 is held by the surgeon in one hand such that the index finger is placed on the actuator mechanism 76. The surgeon rotates the needle assembly 64 clockwise by sliding the actuator mechanism 76 in a direction 172 from the first end 22 of the rod 30 to the second end 28 in order to insert and position the needle tip 136. The surgeon rotates the needle assembly 64 counterclockwise by sliding the actuator mechanism 76 in the direction 160 from the second end 28 of the rod 30 to the first end 22 in order to position and retract the needle tip 136. During the sliding action, the third projection 88 is guided by the channel 112, which is a gradual arc about the circumference of the sleeve 48. Therefore, linear motion of the actuator mechanism 76 is converted into rotational motion of the sleeve 48 as the third projection 88, moves along the channel 112 thereby causing the sleeve 48 to rotate accordingly. Linear motion of the actuator mechanism is limited by the two projections on the first end of the base. The sleeve 48 and the needle assembly 64, which is secured by the tubing 60 between the sleeve 48 and rod 30, are rotatable to each side of the instrument 10 by 180 degrees from a top 176 of the instrument 10 thereby creating 360 degrees of motion about the axis A. Once the needle tip 136 has been appropriately positioned around the second end 28 of the rod 30, the surgeon advances the needle tip 136 into the tissue (not shown) for injection. Using at least one finger, the surgeon ejects the contents of the syringe 56 into the connected tubing 60 by depressing the plunger 152 in the direction 160. The contents of the syringe 56 travel through the inner conduit 124 of the tubing 60 and is ejected into the tissue through the needle tip 136. The needle tip 136 is then retracted and the instrument 25 is removed from the airway.

[0033] The use of the above-described instrument has many advantages. For example, FIGS. 9-14 emphasize the sleek design of the assembled instrument. In the absence of the camera 24 and light source 26, the alignment of the handle 52, syringe 56, base 44, sleeve 48, and needle assembly 64 illustrates the streamlined and ergonomic appearance of the instrument. The streamlined and ergonomic design enables the user (i.e., the surgeon) to easily grip the instrument to perform an airway injection. The ability to rotate the need tip about the camera end with a single sliding motion of the index finger enables the surgeon to approach airway tissue from multiple angle such that injections are more delivered more precisely to the tissue. Further, this design allows the surgeon to view and control the needle tip at all times.

Additionally, the instrument has been designed to be usable with either the right or the left hand. Finally, because the instrument is substantially modular in that it can be assembled to function both as an evaluation tool before the needle assembly is coupled and an injection tool after the needle assembly is coupled. The simple assembly process above allows the needle assembly to be attached and removed quickly during a procedure.

[0034] In the illustrated embodiment, the device 10 is sized to accommodate a Hopkins Rod having a standard 4 mm diameter and a 30 cm length. Other embodiments of the device can be assembled to be used with other suitably sized Hopkins Rods. It is contemplated that the diameter device can have a maximum diameter of up to about 7 mm.

[0035] Thus, the invention provides, among other things, a unified framework for collision detection and localization of contacts along continuum robots. Various features and advantages of the invention are set forth in the following claims.

Claims

CLAIMS What is claimed is:

1. A medical instrument comprising: a handle; a rod having a first end coupled to the handle and a second end; a base at least partially coupled to the rod, the base including an actuator mechanism positioned near the first end of the rod and the handle; a sleeve coupled to the second end of the rod; and a removable needle assembly positioned near the second end of the rod, the needle assembly linked to the actuator mechanism and configured to move around the rod with movement of the actuator mechanism.

2. The medical instrument of claim 1 further comprising a syringe coupled to the handle and in fluid communication with the needle assembly via tubing.

3. The medical instrument of claim 2 wherein the tubing extends from the syringe and along the base and the rod to the sleeve, and further wherein the tubing extends through a channel formed between the rod and sleeve.

4. The medical instrument of claim 2 wherein the tubing extends from the syringe and along the base and the rod to a conduit positioned within the sleeve, and further wherein the needle assembly is coupled to the conduit thereby linking the tubing and the needle assembly in fluid communication.

5. The medical instrument of claim 1 further comprising a camera coupled to the rod.

6. The medical instrument of claim 1 wherein the needle assembly moves in a clockwise direction around the rod when the actuator mechanism is moved from the first end of the rod toward the second end of the rod when viewed at the first end.

7. The medical instrument of claim 6 wherein movement of the needle assembly includes movement of the sleeve.

8. The medical instrument of claim 1 wherein the needle assembly moves in a

counterclockwise direction around the rod when the actuator mechanism is moved from the second end of the rod toward the first end of the rod when viewed at the first end.

9. The medical instrument of claim 8 wherein movement of the needle assembly includes movement of the sleeve.

10. The medical instrument of claim 1 wherein the handle includes a T-shaped channel formed therein, and wherein the rod being coupled to a portion of the T-shaped channel prevents translation of the rod with respect to the handle.

11. A medical instrument comprising: a handle; a Hopkins rod having a first end coupled to the handle and a second end; a base at least partially coupled to the rod, the base including an actuator mechanism positioned near the first end of the rod and the handle; a sleeve coupled to a distal end of the base; a removable needle assembly positioned near the second end of the rod, the needle assembly linked to the actuator mechanism and configured to move around the rod with movement of the actuator mechanism; a syringe coupled to the handle and in fluid communication with the needle assembly; and a camera coupled to the Hopkins rod.

12. The medical instrument of claim 11, further comprising a tube configured to couple the syringe to the needle assembly, and wherein the tube extends from the syringe and along the base to the sleeve, and further wherein the tube extends through a channel formed between the rod and the sleeve.

13. The medical instrument of claim 12 wherein the needle assembly rotates in a first direction around the rod when the actuator mechanism is moved from the first end of the rod toward the second end of the rod.

14. The medical instrument of claim 13 wherein the needle assembly is configured to rotate up to about 180 degrees from its starting position in the first direction.

15. The medical instrument of claim 14 wherein movement of the needle assembly includes movement of the sleeve.

16. The medical instrument of claim 13 wherein the first direction is in a clockwise direction when viewed at the first end.

17. The medical instrument of claim 13 wherein the needle assembly rotates in a second direction opposite the first direction around the rod when the actuator mechanism is moved from the second end of the rod toward the first end of the rod.

18. The medical instrument of claim 17 wherein the needle assembly is configured to rotate up to about 180 degrees from its starting position in the second direction.

19. The medical instrument of claim 18 wherein movement of the needle assembly includes movement of the sleeve.

20. The medical instrument of claim 17 wherein the second direction is in a counterclockwise direction when viewed at the first end.

21. A method for airway injection, the method comprising: coupling a needle assembly to a rod having a first end and a second end, the needle assembly coupled to the second end and being linked to an actuator mechanism coupled to the first end, the needle assembly in fluid communication with a syringe; advancing the rod into the airway; actuating the actuator mechanism to rotate the needle assembly into a desired position in the airway; and actuating the syringe to inject a substance into the desired position in the airway.

22. The method of claim 21 wherein the advancing and actuating steps are a single-handed operation.

23. The method of claim 21 further comprising attaching a base assembly to the rod, and wherein the needle assembly is coupleable to the base assembly.