US 3817250 A
The surgical device herein set forth is adapted for use in emergency tracheostomy procedures, as well as other procedures wherein rapid penetration for aspiration, ventilation and visualization is desired. The device carries an improved split needle, which needle expands under the influence of an airway tube in a more reliable and reproducible fashion than before. The device carries a positive means for limiting penetration into the skin, as well as having means for clearing obstructions in the airway tube.
Description (OCR text may contain errors)
United States Patent 191 Weiss et al.
[111 3,817,250 June 18, 1974 INSTRUMENT FOR PERFORMING A TRACHEOSTOMY AND OTHER SURGICAL PROCEDURES  Inventors: Sol Weiss, Encino; David T. Kline, Sherman Oaks, both of Calif.
 Assignee: International Medical Devices, Inc.,
Beverly Hills, Calif.
1  Filed: Oct. 24, 1972  Appl. No.: 299,941
 us. Cl. 128/305, 128/347  Int. Cl..... ..A61b 17/32, A6lb 17/34  Field of Search 128/305, 329, 351
 References Cited UNITED STATES PATENTS 300,285 6/1884 Russell .l 128/305 3,039,469 6/1962 Fountain... 128/351 3,182,663 5/1965 Abelson.... 128/305 3,330,278 7/1967 Santomieri Primary Examiner-Channing L. Pace Attorney, Agent, or Firm-l. Morley Drucker 57 ABSTRACT The surgical device herein set forth is adapted for use in emergency tracheostomy procedures, as well as other procedures wherein rapid penetration for aspiration, ventilation and visualization is desired. The device carries an improved split needle, which needle expands under the influence of an airway tube in a more reliable and reproducible fashion than before. The device carries a positive means for limiting penetration into the skin, as well as having means for clearing 0bstructions in the airway tube.
16 Claims, 14 Drawing Figures PATENIEDJuaIa nan 3L817L250 INSTRUMENT FOR PERFORMING A TRACHEOSTOMY AND OTHER SURGICAL I PROCEDURES BACKGROUND or THE INVENTION Tracheostomy is an operation for the purpose of relieving an obstruction of the respiratory passage. The background and origin of the operation is set forth in some detail in US. Pat. No. 3,688,773 incorporated herein by reference.
The device set forth in said US. Pat. No. 3,688,773 is believed to be a major advance in the art of performing tracheostomies under emergency conditions and is well suited for its purpose. The device described in said patent comprises an expandable needle, enlarged in a rear section and tapering to an end cutting portion so as to form a means for puncturing skin and tissue, etc. The needle is preferably formed in two halves which are held together in a resilient manner. The needle is then inserted into the affected area, e.g., the trachea. The internal dimensions of the needle are suchthat when an air tube of from 3-6 min..is thereafter inserted therethrough, the needle halves are spreadbythe air tube passing'therethrough and in this way, the air tube contacts the tracheal area and immediately. allows the patient to breathe.
This invention relates to certain further improve- SUMMARY or THE INVENTION The major improvements in the device described and claimed in Pat. No. 3,688,773 maybe set forth as follows: j j
a. The needle halves are pivoted away from each other, under the influence of the airwaytube,in a more reliable and reproducible fashion, than. was hitherto possible. I I b. The end of the needle is formed with indexing means for alignment of the needle halves so as to insure that the needle ends will mate into a smooth arcuate cutting edge even after repeated use. c. An effective limiting means preventing overinsertion or underinsertion of the needle is provided by means of a collar attached to the expandable needle. This collaralso functions with the needle to allow reliable and reproducible. expansion of the needle halves under the influence of the airway tube which is inserted after the needle has made its penetration into the affected area. The collar is also provided with appropriate openings so as to enable increased air communication from the exterior of the device into intermediate portions of the air tube. e i l d. A means of clearing the entrance of the airway tube is provided together with means to minimize any fragmentation as the entrance is cleared. This means is referred to hereinafter as the obturator."
e. The device is provided with integrally formed tiedown rings whereby the device, after insertion into the affected area of the patient, can be firmly attached to the patient, if desired.
In addition to the foregoing, the present device has other advantages which will become clear from the description and drawings. This surgical device may not only be used in tracheostomy procedures but may be used in a number of medical procedures wherein aspiration, ventilation, andvisualization are desired as in the device set forth in U.S. Pat. No. 3,688,773. Furthermore, this device enables a variety of sizes of airway tubes to be inserted througha single needle because of the expandable nature of the needle. It has been found thata standard airway tube of 5 to 6 mm is sufficient in most cases; however, the inner diameter of the airway tube may be varied from 3 to 7 mm. if desired in anyparticular case and the device may be provided with a set of airway tubes of varying diameter together, with the needle, collar and several obturators.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows the surgical device of the invention in use and inserted into the trachea;
FIG. 2 is a longitudinal, axial, cross-sectional view of the surgical device of the invention, showing the needle inserted'into a patient and showing the air tube and obturator positioned for insertion through the needle; FIG. 3 is a cross-sectional view, of the, surgical device, taken along its longitudinal axis showing the needle, air tube and obturator in fully inserted position in the patients FIG. 4 is a perspective view of the Surgicaldevice of my invention showing the needle and attached collar, and showing the lower portions only of the air tube and obturator; I
FIG. 5 is a cross-sectional view of the surgical device, taken along the longitudinal axis, showing the needle and air tube in fully inserted positionwith the obturator removed; I
FIG. 6 is a fragmentary cross-sectional view taken alongthe line 6-6 of FIG. 2;
FIG..7 is an enlarged cross-sectional view taken along the line 7-7 of FIG. 2;
the line 14-14 of FIG. 4.
DESCRIPTION OF THE PREFERRED EMBODIMENT The surgical device of this invention, designated generally by the numeral 20 in the drawings comprises four major parts, the needle 22,the collar 24, which houses the needle and performs other important functions, the airway tube 26, and the obturator 28.
As shown in FIGS. 2-5, the needle 22is preferably made. in two similar halves 22a, 22b, each half carrying projecting ears or hinge pins 30, 32, at the rear (or proximal end thereof) thereof for positioning into collar 24 as will be described.
The needle 22 is provided with an oversized diameter at the proximal portions thereof 37a, 37b, with respect to the airway tube 26 to be moved therethrough, as clearly seen in FIGS. 3 and 5 of the drawings. The needle 22 is of undersized normal diameter, with respect to the airway tube 26 to be passed therethrough, at its forward (or distal) portions 36a, 36b again as clearly seen in FIGS. 3 and 5. The proximal needle portions 37a, 37b fare smoothly into the distal portions 36a, 36b by means of intermediate conical portions 38a, 38b.
The airway tube 26 used is always cylindrical, but different sized tubes may be required. The internal diameter of the airway tube 26 will vary from about 3-6 mm. depending on the use to which the device is to be put, and other factors such as the size of the patient. Therefore, the internal diameter of the proximal portion of the needle 22 is usually greater than 6 mm. whereas the normal (unexpanded) diameter of the distal portion of the needle 22 is less than 3 mm. in diameter. The cutting edges 34a, 34b of the distal needle portions 36a, 36b are honed to a fine sharpness for cutting the skin and tissue of the affected area, e.g., the trachea. These cutting edges 34a, 36b together form an arcuate, smooth, cutting edge 34 biased with respect to the longitudinal axis of the needle 22. (See FIGS. 2 and 4). The needle halves 22a, 22b are resiliently held together by means of an elastic band or O-ring 40 placed around the rear portions 37a, 37b of the-needle 22. The needle 22 and airway tube 26 are preferably made of a metal such as stainless steel. The cutting edges 34a, 36b of the needle 22 are provided with alignment means or indexing means 42, as most clearly seen in FIGS. 5, 7 and 8. The alignment means 42 preferably takes the form of a small, truncated metal tube which is silver-soldered into the concavity of the leading cutting edge 34a of needle half 22a. The diameter of the tubular alignment means 42 is such that, while it nests snugly into the concavity of edge 34a, it projects below the cutting edge 34a, as seen in FIG. 7 and into the concavity of the trailing cutting edge 34b, when the needle halves 22a, 22b are adjacent each other. If the needle halves 22a, 22b are slightly misaligned, after repeated use of the device 20, the alignment means 42 cures any such misalignment by shifting leading cutting edge 34b intoalignment with trailing cutting edge 34a.
Referring now specifically to FIGS. 2, 12 and 13, another feature of the surgical device is shown. In cross-section, the internal diameter of the needle 22 is smoothly rounded throughout. The external portions of the needle 22, however, are provided with a fairly sharp V-shaped configuration (see FIGS. 12 and .13) commencing from about the middle of the distal portions 36a, 36b of the needle 22 and terminating at a circumferential line within the intermediate conical portions 38a, 38b of the needle 22 preferably at about the sectional line where FIG. 13 is taken. The V- shaped exterior of the needle 22, as described, permits much easier penetration thereof into the hard fibrous cartilage of the tracheal area, than does a smooth, rounded exterior.
The needle 22 is held within a collar 24, the collar 24 being preferably made of a tough plastic material, e.g., a polycarbonate. The collar has many other functions as will be described.
The collar 24 is formed with a generally tubular housing 50, the diameter of the housing beinglarger than the external diameter of the proximal portions 37a, 37b of the needle 22. The collar housing is open at both ends and is provided, at its proximal end, with a'pair of diametrically opposed rectangular recesses 69 within which the outwardly projecting hinge pins 30, 32 of the needle 22 fit, as best shown in FIGS.,2, 4, 6 and 14. This arrangement of parts allows easy assembly of the needle 22 within the collar 24. Thus, one need merely place the needle halves 22a, 22b, together so that the hinge pins 30, 32 are in abutment and move the needle 22 through the collar housing 50 until the hinge pins 30, 32 are nested snugly into hinge recesses 69. Then, a plastic cap 54 having an internal bearing surface 57 is preferably adhesively affixed to the collar housing so that the bearing surface 57 abuts the hinge pins 30, 32 and prevents any movement thereof in the direction of the longitudinal axis of the needle 22.
The cap 54 has a bore passing therethrough, which bore is in communication with the internal bore 33 of the needle 22. (See FIGS. 3 and 5). The bore 55 is of a large enough diameter to enable an airway tube 26 of 3-6 mm. in diameter or greater to be passed therethrough and into bore 33 of the needle 22.
The hinge pins 30, 32 on needle halves 22a, 22b, respectively, have facing or internal surfaces 44, 45. When the device 20 is not in use, these facing surfaces 44, 45 assume the position shown in FIGS. 2 and 14, wherein they are partially bearing on each other and partially non-bearing due'to the fact that the facing surfaces 44, 45 have portions that angle away from each other. If an airway tube 26 of small internal diameter is thrust downwardly through the needle 22, as shown in FIGS. 3 and 5, the needle halves 22a, 22b expand, and rotate or pivot about hinge pins 30, 32 until the angular portion of the facing surfaces 44, 45 abut each other. No further needle expansion can take place because of .this abutment of the angular portion of the facing surfaces 44, 45 of the hinge pins 30, 32. The hinge pins 30, 32 having a diverging angle formed between their facing surfaces will be termed herein and in the claims as rocking hinge pins, and the recesses 69 will be termed hinge recesses.
In some instances, the collar housing 50 will limit the expansion of the needle 22. Thus, if an airway tube of large diameter, e.g., 8-9 mm. overall is employed, the interior surface of the collar housing 50 may be in abutment with the outer surface of the needle before the facing surfaces 44, 45 of the rocking hinge pins are in full abutment.
The outward needle expansion is thus limited in one of two ways thereby minimizing fragmentation of tissue adjacent the penetrated area. Also, the collarneedleassembly and hinged rocking pin assembly enables the device 20 to give reliable and reproducible results.
The distal end 53 of the tubular collar housing 50 terminates at an angle of substantially less than with respect to the longitudinal axis of the needle 22; the angle preferably formed therebetween is about 30. The surgical device 20, when used as a tracheostomy device, is inserted into the skin and underlying cricothyroid membrane, along the angle shown in FIG. 2, and the distal end 53 of the collar housing 50 effectively limits the extent to which the needle 22 may be inserted into the affected area. The aforedescribed limiting means is more effective than that shown in US. Pat. No. 3,688,773 because the distal end 53 is spaced from the needle 22, and this discontinuity is a more positive limiting means. Furthermore, part of the distal end 53 makes an acute angle with the skin rather than an obtuse angle, and this acute angulation is a more effective limiting means than that shown in U.S. Pat. No.
The collar 50 carries a pair of projections 52, which will be referred to herein as stabilizer tips. The stabilizer tips 52 are best seen in FIG. 4, and enable the user of the device 20 to firmly grasp the collar 50, and attached needle 22, by placing the index finger and middle finger of one hand behind each of the tips 52 while placing the thumb of the same hand on the outer end 56 of the cap 54. (See FIG. 2, especially). In this positioning, the device 20 can readily be used surgically with one hand operation.
After the surgical device 20 is positioned in the affected area, a hollow, tubular, airway tube 26 and obturator 28 are inserted into and through bore 55 of cap 54, and thence through bore 33 f. needle 22 until the flared end 66 of the airway tube 26 contacts the outer end 56 of the cap 54. In this position (as shown in FIG.
3) the distal end 67 of the air tube 26 extends just beyond the tip of the needle edges 34a, 34b.
The obturator 28 has a tubular body 70 and is provided with a small bore 71. It also has a blunted distal end 74 which, upon full insertion through the airway tube 26, projects just beyond the distal end 67 of airway tube 26. The blunted end 74 enables the obturator to-clear the entrance to the bore 60 of the airway tube 26 quickly and efficiently. The obturator 28 is provided with a handle means 72, which, in this embodiment, takes the form of an enlarged button 72 affixed to the obturator body 70. The button 72 isprovided with a bore 72a, and the end of the tubular body 70 of the obturator fits snugly into bore 72a. The bore 72a is in as shown in FIG. 2 and manipulated until a rush of air is heard. The airway tube 26 and obturator 28 (therewithin) are then inserted throughthe needle 22, as shown in FIG. 3. The obturator 28 removesobstructions from the entrance of the airway tube 26, and is removed immediately. The cleared airway tube 26 may then be connected to oxygen inlet: or other respiratory aid if desired. 7
The surgical device 20 may be stably positioned around the neck of the patient by means of thread 61 or the likebeing passed through the openings 59a of tiedown rings 59 integrally formed on collar housing 50. The thread 61 is affixed to the tiedown rings 59 and thence tied around the neck of the: patient, as shown in communication with bore 71 and with the outside air by means of opening 76. See FIGS. 2, 3 and 10.
The obturator 26 is removed from the airway tube 28 after the entrance thereto is clear. The bore 60 of the airway tube 26 is now in direct communication with the atmosphere, and oxygen may be passed intothe airway tube 26, through a universal or other type of adaptor 80, if dBSII'Ed.Th external configuration of cap 54 may be further varied so as to provide for ready attachment to specific oxygen input means or other respiratory aids.
It should be noted that the external surfaces of cap 54 merges smoothly with the external surfaces of collar. housing 50, and the mutual external surfaces thereof are so formed as to readily receive thereon universal adaptor means. i
To increase air communication of the affected area with the outside openings62 are provided, in the walls of the airway tube 26 near the front end thereof, as well as intermediate or rearward openings or slots 64. The collar 24 is also provided with cutouts or openings 68 in the distal end 53 of the collar housing 50 as best seen in FIG. 4. These openings 68 are in proximity to the slots 64, as seen in FIG. 5, and are provided so that an additional effective air communication path to the airway tube .can be utilized via intermediate areas in the airway tube 26.
To perform a surgical procedure, e.g., a tracheostomy, the surgical device 20 is held asshown in FIG. 2 (without the airway tube 26 and obturator'28). The arcuate'cutting edge 34 is then pushed into the trachea FIG. 1.
While a preferred embodiment of our invention has been shown and described, modifications thereof will appear, and we therefore do not wish to be restricted to the precise description set forth herein, but to the claims which follow.
We claim? i p l. A surgical deyice adapted to puncture human skin which comprises:
a hollow needle having a proximal end portion and a distal end of a normal internal diameter, said distal end of said needle comprising at least two sections which, taken together, terminate in a cutting edge so as to form a means for puncturing skin;
means for holding saidsections of said'distal end of said needle together and to enable said sections of said distal end of said needle to be separable from each other and expand radially from the said normal internal diameter of said distal end;
an airway tube movable through said needle from the proximal end portion thereof to the distal end thereof, said airway tube being of larger outer diameter than the said normal internal diameter of said distal end of said needle whereby to expand radially said distal end of said needle from its normal internal diameter as said airway tube is moved through the distal end of said needle;
a collar member secured to said needle at an area remote from said distal end of said needle, the distal end of said collar member terminating short of said cutting edge of said needle when viewed in side elevation, the distal end of said collar member limiting the length of penetration of said needle into said human skin; and v a cavity means formed in said collar member, said cavity means enabling expansion of said needle to take place therewithin as said airway tube is moved through said needle.
2. The surgical device of claim ll wherein said collar member is partly tubular and said distal end of said collar member is spaced radially from said needle.
3 The surgical device of claim 1 wherein a line drawn parallel to said leading edge of said collar forms both an acute and obtuse angle with a line drawn through the longitudinal axis of said needle, when viewed in side elevation.
4. The surgical device of claim 1 wherein said distal end of said collar member has openings therein, second openings are provided inthe walls of said airway tube intermediate the ends of saidairway tube, said openings in said collar member increasing air communication with said second openings in said airway tube.
5. The surgical device of claim 1 wherein said proximal end portion of said needle is split into two sections, each section of which is provided with pivotal means for pivotal movement within said collar member.
6. The surgical device of claim 1 wherein said needle is formed in two cooperating halves each half of said needle having a hollow concavity formed therein near the cutting edge thereof, an alignment member affixed within the concavity of one of said halves of said needle near the cutting edge thereof and projecting slightly beyond the side edges of said half of said needle, so that the concavity of the other half of the said needle will substantially enclose said alignment member when said needle is in its non-expanded position.
7. The surgical device of claim 1 having a tubular member of smaller diameter than the inside diameter of said airway tube adapted to move through said airway tube and clear obstructions therefrom.
8. The surgical device of claim 1 having a pair of radial projection means projecting from said collar member of a size such that the ends of the fingers of a user of said device can grasp each of said radial projection means.
9. The surgical device of claim 5 wherein said pivotal means comprises laterally projecting ears having facing surfaces that diverge.
10. The surgical device of claim 1 wherein said air way tube has a stop means limiting movement of said airway tube from the proximal end portion of said needle to the distal end of said needle.
11. .The surgical device of claim 10 wherein said stop means comprises a flared end of enlarged diameter with respect to the diameter of said airway tube.
12. The surgical device of claim 1 wherein said collar member has means formed on the exterior surface thereof onto which tying threads can be affixed.
13. The surgical device of claim I wherein said airway tube has an internal diameter of from about 3-6 14. The surgical device of claim 1 wherein said collar member limits the radial expansion of said needle.
15. The surgical device of claim 9 wherein the facing surfaces of said projecting ears, when in abutment, limit the radial expansion of said needle.
16. The surgical device of claim 1 wherein said needle has an intermediate section connecting said proximal end portion and said distal end of said needle, and the external cross-section of said needle is substantially V-shaped commencing in the distal end of said needle and terminating in said intermediate section of said needle. 1