Method of forming bevel oriented needle arrangement

[57] ABSTRACT

A needle and hub unit having a beveled needle or canula point for insertion into a patient, the unit having indicia thereon indicating the orientation of the beveled insertion point; and a method and apparatus of orienting the marketing such beveled needle units by combined vibrational and camming of the canula and thereupon marking the assembled unit.

Claims, 11 Drawing Figures

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PATENTEDMAY 1 6 1972

3,662,457

SHEET 1 OF 3

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FIG. I

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KENNETH W. GORES

INVENTOR

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PATENTED may 16197?

3,662.457

SHEET 2 OF 3

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KENNETH W. GORES

INVENTOR ^J ATTORNEY

PATENTED mat 16 ιοζζ

3,662,457

SHEET 3 OF 3

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FIG. 8

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FIG. 9 FIG.10 FIG. II

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KENNETH W. GORES

INVENTOR

I ' ATTORNEY

3,662,457

METHOD OF FORMING BEVEL ORIENTED NEEDLE ARRANGEMENT

This invention relates to an improved disposable beveled needle unit in which the orientation of the beveled point is indicated by indicia on the needle unit.

It is conventional practice to provide disposable needle units incorporating canula having a beveled point for insertion into a patient. However, it is often extremely difficult to determine the orientation of the bevel forming the point, particularly in the case of very small diameter needles. This problem is particularly troublesome in the dental field, where it is important that the operator know the angular position of the bevel in order to minimize pain at the time of injection as well as post-operative discomfort. This may be readily understood when it is realized that in the case of dental practice the bone is normally very close to the surface of the tissue into which the needle is inserted for injecting the desired anesthetic. This necessitates the insertion of the needle at a substantial angle with respect to the surface of the tissue in order to prevent contact or penetration of the underlying bone. However, such sharply inclined piercing of the tissue is to a substantial degree contra to the normally desired right angled insertion of a canula into tissue for injection purposes in order to minimize injection pain and post-operative discomfort. It is accordingly standard practice in the dental profession to attempt to orient the syringe in a manner such that the bevel side of the point is facing the tissue surface. This desired orientation of the bevel of the canula allows for smoother penetration, minimizes the possibility of traumatizing the periosteum and reduces injection ballooning of the tissue and resultant soft tissue trauma, as is generally well known to those skilled in the dental art.

It is accordingly highly desirable that a disposable needle unit be provided which enables the practitioner to quickly and easily determine the orientation of the bevel.

To this end, it is an important feature of the present invention to provide a disposable needle unit which will enable a practitioner to readily and easily determine the orientation of the bevel.

It is a further feature of the invention to provide a method and apparatus which will enable the manufacture of oriented beveled needle units according to the invention.

Still other objects, features and attendant advantages will become apparent to those skilled in the art through a reading of the following detailed description of a preferred embodiment, methods and apparatus according to the invention, taken in conjunction with the accompanying drawings wherein:

FIG. 1 is a perspective view of a syringe having removably secured thereto a bevel oriented needle according to the present invention.

FIG. 2 is a perspective view of a needle unit according to the present invention.

FIG. 3 is a schemetic perspective view of apparatus for 55 forming the needle unit of FIG. 2.

FIGS. 4-7 are schemetic views illustrating the method of manufacture of the needle unit of FIG. 2, and

FIGS. 8-11 are schemetic views illustrating a modified method and apparatus for manufacture of the needle unit of 60 FIG. 2 according to the invention.

Referring now in detail to the figures of the drawing, in FIG. 1 there is illustrated a syringe having a conventional body or barrel 13 and plunger 15, to the forward end of which is secured, as by threaded engagement with a nipple thereon, an 65 improved needle unit 21, 23 according to the present invention. The needle unit incorporates a canula 21 of metal or other desired material and having beveled points 21α and 21* at its respective forward and butt ends, the bevels being formed on opposite sides in a conventional manner as by 70 grinding of the canula 21. The needle unit includes a hub 23 which may be of any desired configuration and having a threaded interior 23 if so desired for connection to a syringe. The hub 23 may be suitably secured to the canula 21 as through the conventional medium of crimping of the forward 75 neck of the hub about the needle. Orientation of the bevel edge 21α forming the patient insertion point is indicated for ready location by the practioner, through the medium of a visually observable mark 23α on the outer periphery of the hub 23. This mark 23α is preferably on the opposite side of the canula from the bevel 21α forming the patient insertion point, thereby enabling the practioner to easily orient the syringe 11 by viewing the mark 23α and maintaining such away from the surface of the tissue into which the injection is to be made. It will be noted that inasmuch as the bevel 21i forming the butt end point of the canula is on the opposite side of the canula from that of the bevel 21α, the mark or other indicia 23α will be on the same side as the butt end bevel 21b in the preferred embodiment as illustrated.

In the preferred embodiment the mark 23α takes the form of an imprinted painted or inked area which is of sufficient size to enable ease of location by the practioner. It will be appreciated, however, that other indicia may be employed, such as an indentation or raised surface area, either alone or in combination with the employment of different coloration, although it is strongly preferred that the embodiment incorporate a differentially colored mark as indicated at 23α.

Oriented beveled needle units according to the invention 25 may be and are preferably constructed by employing the method and apparatus as next described. A preferred apparatus and method for manufacture is schemetically illustrated in FIG. 3, including a rotary transport table which may be suitably intermittently indexed from position to position 30 about a vertical center axis therefor, to bring each of a plurality of circumferentially spaced arbors 13 into position at circumferentially operational stations. The operational stations are indicated in the schemetic illustration in sequential order, although such may be spaced apart in the employment of the 35 apparatus, with suitable sensing or other operational or nonoperational stations therebetween, such as to indicate such occurences as presence or absence of a needle or canula or a hub.

For convenience and illustration, the arbors 13 are illus40 trated as being unitary with the horizontal plate forming the table 11, although it will be readily appreciated that the arbors 13 may be and are preferably formed as separate elements suitably secured to the plate forming the table 11. Each of the arbors 13 is adapted to receive about its exterior surface a hub 4' 23 which is dropped downwardly thereonto with the skirt 23c engaging the upper surface of the table 11 or other suitable skirt-supporting surface on the exterior of the arbor, and thereby vertically orienting the hub and suitably centering such for subsequent operations. This step is illustrated at the station on the right hand side of FIG. 3. In the clockwise indicated next following station, a needle or canula 21 having oppositely ground beveled ends 21α, 21* is vertically inserted, as by guided gravity drop, through the bore 23Z&gt; formed in the neck 23n of the hub 23. The needle or canula 21 is dropped with its beveled butt end 2 IE extending downwardly, and this end passes through a tapered interior bore 136 formed vertically in the arbor 13. The bore 13* is flared at its upper end to a diameter larger than the bore 23h of the hub 23 so as to prevent lodging of the needle on the top of the arbor 13, and the bore 13* subsequently tapers to a vertical smaller diameter slightly larger than the canula diameter and which may be of substantially straight walled configuration along the lower extent of its length in order to better maintain verticality of the canula 21.

The beveled butt end 21i of the canula strikes against a cam seat 33 which may be suitably formed on a cam seat insert element 31, and which cam seat 33 forms the inclined cam surface base or bottom of the interior bore 136 in arbor 13. The cam seat element 31 may be suitably secured in the table at each arbor position, as by press fit, and alignment thereof may be assisted and assured by employment of a key 31k as is generally illustrated at the first position station of FIG. 3. In order to enable ease of subsequent bevel-orientation-marking of the hub 23, it is desirable that the cam seat 33 face directly

3,662,457 toward the vertical rotational axis of the rotary transport table 11, although such may be differently positioned as may be desired, so long as all arbor positions are substantially identically oriented in this respect and suitable marking orientation is carried out.

The cam seat 33 at each arbor position is inclined with respect to the vertical, and preferably at an identical angle of vertical inclination as the angle of bevel ofthe butt end 216 of the canula 21, thereby forming a substantially flat seat for the bevel 216 upon rotational orientation ofthe canula 21 as will be hereinafter described.

The top end of the cam seat element 31 may be blunted if desired, as indicated at 33α, in order to provide a firm shoulder seat for engagement with a well end shoulder formed in the arbor or table, such blunted end being fully laterally covered and forming no portion of the cam seat 33, and thereby causing no interference in the camming operation as next described. Upon vertical insertion of the canula 21 through the loose fitting bore 236 of the hub 23 and loose fitting bore 136 of arbor 13, the beveled butt end 216 of the canula will strike the cam seat 33, and will thereby be cammed rotationally in one direction or the other about its longitudinal extent, dependent upon the initial orientation of the canula with respect to the cam seat 33, this being self-evident in view of the beveled end configuration 216 and the interfacing inclined cam seat 33. While it is also within the realm of some small degree of possibility that the needle will lodge directly at 180° out of phase with the cam seat, and superficially might . ____________....

not be biased in any direction, in the normal situation the nor- 30 ^{beveI 21i wil1 rest u}P^{on the a}P^ex ofthe cam seat 133, and the mal surface irregularities and the irregular table vibrations of * ' ' ' non-linear character will insure that the canula is rotationally cammed toward and aligned positioned with the cam seat 33 as indicated in FIG. 7 in which the bevel 216 faces and seats on the cam seat 33.

As noted above, vibration is imparted to the transport table 11 in order to effect and facilitate the desired angular rotation and orientation of the canula 21 to the position as shown in FIG. 7. While any suitable vibration imparting means may be employed if so desired, it has been found that in the normal 40 . ^Wbile the invention has been explained in reference to the situation sufficient vibration for full angular orientation is imparted by the normal intermittent movement and indexing of the table 11 from station to station, and as few as one or two intermittent indexing motions of the table are normally suffi- - ------------cient to assure seating ofthe canula 21 in the position shown ⁴⁵ *?^{ay be considered lo} be precisely indicated as the center of in FIG. 7, although it will be appreciated that as many index * “ ''''''°'¹^u' - -* stations, operations, or other vibratory actions may be employed as desired between the canula insertion station and the marking station.

In the illustrated embodiment, the marking station is indicated as the second succeeding station after canula insertion, although as noted above, there will normally be a further station or stations located intermediate these stations for other purposes, such as for sensing the presence of the canula, and such additional station inclusions serve to further insure that the canula 21 is properly aligned and seated on the cam seat 33.

In the fourth arbor station of FIG. 3, as counted from the right, there is schemetically illustrated the conventional crimping operation for crimping the hub neck 23« to the canula 21, as by four reciprocable jaws 41 of suitable construction. In this same operation, or subsequent thereto as may be desired, but preferably at the same station, the hub 23 is marked with a suitable indicia 23α, as by the employment of 65 a reciprocable marker head, which may suitably be an ink pad with ink replenishment means therefor, or such may be formed by colored ink air brush having its indicia forming end directed toward the radially outer (relative to the axis of the transport table) face of the hub 23 at this station, and/or by a 70 marker imprint die, and which may be operated to effect a marking of the hub 23 substantially simultaneously with the crimping of the hub 23 by the jaws 41.

The completed orientation-marked needle unit 21, 23, 23α is illustrated at the fifth station, although it will be appreciated 75 that it may be several subsequent stations before the needle unit may be discharged or removed from the table, as it may be desirable to effect further additional operations on the needle unit, such as applying a friction reducing coating to the canula, etc.

FIGS. 8-11 illustrate a modified embodiment and method for orienting the canula 21 upon its insertion into the bore of the arbor 13. In this embodiment, the bore 1136 has formed at its bottom a cam seat 133 which takes the form of an upstanding knife edge formed at the upper end of a cam seat element 131 which may be suitably secured in place on a plug 131α press fit into the table or arbor or other element and having an alignment key 131*. The cam seat element 131 is disposed offcenter of the guide bore 1136, and has oppositely upwardly inclined knife edge surfaces which meet to form a relatively sharp apex 133α edge.

The off-center spacing of the knife edge cam seat 133 with its oppositely inclined cam faces 1336 is sufficient to enable the canula wall to fit between the vertical edge ofthe cam seat element 131 and the adjacent facing wall of the guide bore 1136. As will be seen from the sequential views shown in FIGS. 8-11, the bevel 216 of the canula 21 will strike the cam seat knife edge 133 and be rotationally cammed toward and to the position of FIG. 11 by the oppositely inclined cam faces 1336, dependent upon which cam face is contacted by the bevel 216 and which will be a function of the initial orientation of the bevel 216.

In the final seated position of the canula 21, the heel of the ,________J opposite beveled end 21α of the canula will be directed away from and in substantially transverse alignment with the linear apex 133α of the cam seat 133, as indicated in FIG. 11. This position corresponds with that of the position illustrated in 35 ^FIG· ^{7 in the} previously described embodiment, and it will be understood that the crimping of the hub to the needle may be readily achieved in the same manner as in FIG. 3, as well as the marking of the hub to indicate the orientation ofthe bevel 21α.

simplified form of a canula having single planar bevels at both ends, it will be appreciated that the invention is equally applicable to those canulae having bi-beveled points, or other multi-bevel angled points, in which instance the orientation the combined bevels, although it will likewise be appreciated that in actual practice due to this combination of bevels it may be feasible to accept orientation ofthe multiple angled bevels within a range of several degrees from the true and precise I center therebetween, it being necessary to consider this aspect from a practical standpoint, particularly in view of the fact that the bevel marking will itself be something of a gross angular marking in its total width as compared to a fine line which would be precisely accurate but difficult to locate visually.

While the invention has been described with respect to several illustrative embodiments, it will be appreciated that various modifications and improvements may be made without departing from the scope and spirit of the invention. Accordingly the invention is not to be limited by the particular illustrative embodiment, but only by the scope of the appended claims.