One piece channel suture package.

description

The present invention relates to needle holders and in particular to one-piece molded holders and packages forming a channel for retaining and dispensing sutures containing needles attached thereto.

When packing surgical needles that include surgical needles to which sutures are attached, it is important that the needle and its suture attached to it are easily removed from the package in a sweaty motion. released from the package and the suture should be gently unpacked, without getting caught in the package and without getting tangled * It is also known that suture materials, in particular monofilaments such as ^wcatgut^w, polydioxanone and the like 'especially in the case of' high deniers' harden during storage, ie tend to have 'memory * so that they retain the shape of their position in the package after removal from the package.' it must be designed in such a way that any tight bends or bends necessary to wrap the suture are eliminated. Furthermore, it is desirable that the suture packs can be manufactured economically in large quantities, A manufacturing process intended for this purpose is a process in which the suture package is formed of two rigidly molded, molded, embossed or molded polymeric elements. be used for wrapping and securing suture in purpose-designed rafters »These packages also allow the maintenance of fine tolerances required when performing a precision design»

Molded, embossed or thermoformed polymeric suture packs as described above are known from U.S. Patent Nos. 3,972,418 (Schuler et al) 4,442,898 (Thyea et al), 4,549,649 (Soshdy), 4,699,271 (Lin eoln et al. ) and U.S. Patent Application^s 236 057, entitled ^tt¥ rap rap Suture Package^w, filed August 24, 1988 * This latter patent application describes a two-piece oval suture package in which a suture wrapping and retaining channel is formed. 0 The channel is completely delivered by fitting an upper part of the package to a lower part of the package to completely close the wound suture in the channel. by passing the suture fixed through a vent opening in the inner wall of the canal.

This two-piece package requires two-piece molding or stamping to form the package, which is relatively expensive and requires the assembly of the two pieces in combination with the suture wrapping in the package. packaging providing a single channel package by using a single piece of packaging * Such a package

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Τ '' · with one piece would simplify molding and packaging handling © would reduce product cost »

In accordance with the principles of the present invention there is described a one-piece needle and suture support in which an oval-shaped channel for suture retention is formed. One end of the suture exits the oval channel in the center direction. of the oval and is attached to a needle located in the

Oval channel The oval channel includes smoothly rounded end sections having any sharp folds or curves which would induce an undesirable memory of the suture # The oval channel formed on an open side to which a number is attached is eliminated. with hinged doors »Once the suture is wound in the open canal, the doors are folded over the open side of the channel © locked in place to retain the suture within the channel. The illustrated embodiments describe two techniques for immobilizing the doors and another embodiment utilizes a paper cover to complete the closure channel »To provide easy suture winding» the bottom of the channel is perforated for applying a void to the channel during suture winding »The void will pull the suture into the channel and it will remain in place until the channel is closed by the doors or paper cover. A needle housing for retaining the needle in the center of the package is also described. A preferred embodiment »the needle housing is lined with an auxiliary flap to allow the needle to be conveniently grasped by a forceps»

The figures of the attached drawings represent

Fig. 1 is a plan view of a one-piece suture package in accordance with the principles of the present invention.

Fig. 2 is a cross-sectional view of the suture package of Fig. 1;

Figs 5a, 5b and 5c are detailed views of the hinged doors of the suture package of Figs. 1 and 2j

Figs. 4a and 4b, partial plan and section views

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cross section of the needle holder of the suture package of FIG.

FIG. 5 is an assembly drawing of the suture package of FIG. 1 with a paper cover j.

Fig. 6 is a plan view of a suture package according to the present invention using another locking mechanism for the channel doors; and

Fig. 7 is a further embodiment of the suture package according to the present invention using a paper cover to close the suture winding channel.

With reference to fig. 1 and 2, there is shown a single piece package 10 according to the present invention, in plan view and in cross-sectional view. The package may be formed from any surgically compatible polymeric materials, for example polyester, polyethylene, polyvinyl chloride (PVe), polypropylene or polystyrene plastics *

The package includes a central floor area (18) which is surrounded by an oval outer channel (12) which has two straight / attached sections connected by two semicircular end sections. The channel is defined by an inner wall (14) extending upwardly from the area of; floor. At the lower wall 14, portions of the door locking means are formed at certain intervals.

The lower and outer periphery of the channel (12) is defined by a curved portion (16) of the package extending outwardly from the interior wall (14) at floor level (18) and curving towards up to approximately the elevation of the inner wall (14). Axes at the outer periphery of the curved section (16) are several hinged doors (20). The doors are hinged at a height that is slightly less than the maximum height of the outer periphery of the curved section and the inner wall, so that when they fold the doors over the canal and stand in place,. the upper surfaces of the doors are aligned with the upper height of the outer periphery of the inner wall.

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In each door a portion of the door locking means * is formed including a retaining opening (26) limited by a door locking protrusion (28) and two ribs (36).

Located within the oval channel is a needle housing which includes dug and rigid needle holders (54) and (56) # which are described in more detail below. * Next to the needle housing is a defined auxiliary tab (50) » by a cutout (52) * A portion of the inner wall (14) is eliminated in the vicinity of the needle housing to form a vent (40) in the end wall through which the needle suture has access to the channel (12) _t between the doors (20) @ (20 **) «The bottom of the channel (12) formed by the curved section (16) is periodically drilled with holes (80) and (82) around the periphery of the channel *

Fig. 3a is a partial cross-sectional view of the carton of Fig. 1 showing enlargement. a hinged door (20) and the channel (12) * The hinging hinge (22) of the door (20) is fixed to the outer periphery of the channel at an elevation just below the upper channel elevation on either side of the hinge. * so that the door is aligned with the top of the channel when it is fronted * The door locking means (24) includes a door locking opening (26) and a door locking protrusion (28) «A protrusion (33) is formed at the edge of the edge. rib 36 is located at each end of the door lock opening 26

Referring simultaneously to fig. 3c * a retaining column (305 'is formed in the lower wall (14) # opposite 1 hinged door (20) »Along the inner wall, at each end of the retaining column # two spacers (38) are formed # as also shown in FIG. 1. From the retention column (30) into the package (i.e., the floor (18)) # there is a protrusion (32) of the retention column.

When the door 20 is closed and retained to maintain the suture within the channel 12, it has the cross-sectional appearance shown in FIG. 5b. The upper part of the retention post 50 fits into place. in the door retaining opening (26) and the door retaining protrusion (28) engages around the retaining protrusion (52) of the retaining column to lock the door in the closed position. The door is prevented from sliding off in the presence of lateral compression by the abutment of the edge (54) of the opening (26) against the edges of the spacers (5θ)&gt; which prevents disengagement of the two protrusions * When the door is closed, the The sides of the door were rimmed 44 as shown in FIG. 5c, placing the upper surface of the door in alignment with the upper part of the interior wall (14). The ribs (56) at each end of the opening (26) fit into the openings (42) at each end of the retention column (50) * The ribs (56) and the spacers (5θ) serve to prevent suture from lock or be caught in the door locking means. As the fig. 5b illustrates the curved ribs (56) and the spacers (58).¹ ensure that the suture is spaced from the applied door opening and bridged between it and the retention post, preventing the suture from being caught between these two elements either during closing of the door or during removal of the suture. of the channel »

Referring to Figs. 4a and 4b, there is shown in more detail the needle housing of the carton of Fig. 1. The needle housing comprises a wall (60) extending upwardly from the central floor (18) of the housing. Packaging * The wall (60) is periodically interrupted by openings and the ends of the wall are inclined into the openings as shown in (62) and (64) to form needle holders (56) and (54). 0 Needle holder 56 has the ends of the inclined walls fixed to the underlying floor of the package, allowing only minimal movement and minimal bending of the inclined ends when a needle is inserted between the same. This relatively rigid needle holder (56) will thus only retain a needle of reasonably adapted thickness. In comparison, the package floor under the needle holder 54 has been dug by removing the area of ​​the floor indicated in 528 which allows the slanted ends of the needle holder overjacents flex and bend slightly when inserting the needle into the wall opening. Thus, the dug needle holder (54) can adapt to a relatively wide range of needle thicknesses compared to the rigid needle holder (56). In addition, the dug needle holder (54) is dug upwards in a small dimension from the surface of the floor, which causes a needle to be securely retained in the dug space below the ends of the sloped walls, as illustrated. in fig. 4b.

Figs. 1 and 4b show that the needle housing contains two rigid needle holders and two dug needle holders. This allows the package 10 to retain either a needle-suture at one end, or a needle-sutured at both ends, with a choice of two types of needle holder. With the choice of two types of needle caps, the packaging can be adapted to a wide range of needle thicknesses »

Referring to Fig. 5, there is shown a package (10) mounted with a needle (2) and a suture (4) with a paper cover (90). The package is easily assembled by placing the package (10) on a mounting platform with a certain number of legs extending upwards. Two of the bolts are aligned to extend upward through holes 66 and 68 in the center of the package to hold the package in its platform mounting position. Eight other bolts extend upward and are aligned to pass through. channel holes 82 (see Fig. 1).

The platform is opened below the remaining holes 80 of the channel, and air is drawn through the holes 80 by a vacuum device. With the packaging thus placed,

The needle in the coso needle holder is shown in the drawing and a loop is formed with the suture (4) above the end._t extending through the hole (66), then down through the ventilation hole (40) and into the channel (12). The clockwise suture is then wound around the pears extend through the holes 82. It can be seen from Fig. 1 that the holes 82 extend inwardly towards the center of the package at a distance greater than the size of the holes. extend near the inner wall (14), When the suture is wound around the pins and then the pins are removed from the holes, the suture will be placed loosely in the center of the channel (12) since the pins serve to keep the suture away from the inner wall of the channel during coiling. a distance corresponding to the thickness of the pera. While the suture is wound around the legs, the air flow through the holes 80 will drag the suture down into the channel. When the end or 'tail' of the suture is reached, the air flow will also drag that tail to the bottom of the channel. With the suture fully wound in the channel, the doors which are retained in the post columns are folded and closed. retaining the anterior canal wall * The legs of the holes 66, 68 and 82 are then removed.

The paper cover 90 is then wiped over the top of the package to completely protect the suture and needle from any further contact during final assembly of the package. The cover 90 includes an incision line 94. for tearing, whereby the head is preferably tore when clinging to the tear-off corner (96) for the opening * The cover (90) also includes a number of perforated pulling appendages (92), These appendages are located so that they are aligned with one of the closed doors (20). * When the appendages are pressed down, the outer edges of the appendages latch elastically under the edges of the projections (99) of the doors and with which they are attached. are aligned, which means

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have the cover in place of the package (10). The fully closed suture package is then ready to be wrapped in a final wrapper which generally comprises the airtight sealing of the package in a wrapping sheet.

When the package is to be opened, the user grips the corner (96) to tear and tear the housing and cover downward, causing the cover (90) to open along the line with the tear incision (94) * This uncovers the portion of the package to the right of the needle holder wall (60), with the needle point still protected by the left cover of the holder. The user then grasps the needle with a forceps. Since the needle is flush with the package floor, making it difficult to safely grasp the needle with the tip of the forceps, the auxiliary flap (50) is provided. When the user presses the tip of the forceps against the auxiliary flap, it will sag, folding away from the needle, thus allowing the user to pass the tip of the forceps beyond the needle »The needle can then be securely grasped. with the tip of the forceps and remove it from the holder *

In addition, when the package is crimped in a foil wrapper, the silver of the foil lining the package behind the needle may be confused with the silver needle, making it difficult to distinguish the needle from that refleeor bottom. The auxiliary flap (50) avoids this problem by having a contrasting background behind the needle. * The polymeric package can be struck or colored with a white, milky or any other contrasting color, which will highlight the needle in front of the auxiliary flap. * The flap also covers the foil wrap behind the flap * This contrasting bottom makes it easier to see very thin needles clearly in the package.

Fig. 5 shows a ramp 67 formed to the right of the auxiliary flap position. The ramp 67 is also shown in FIG. 1 The purpose of the ramp 67 is to guide the needle rod up and out of the package during removal without being trapped in the inner wall 14 of the channel.

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at the oval end of the package *

Good conventional 8-wound suture package, the suture is wound from its attachment point on the needle stem to the needle tip * where the 8-shaped loop is placed. This configuration may cause the needle tip attach to a suture loop and damage the suture * However, in a package according to the present invention * it can be seen that the suture forms the right side of the needle shaft, around the hole (66) and downwards. , through the vent hole (40). This winding pattern keeps the suture withdrawn to the right of the needle and needle tip. When the needle is lifted from the needle holder and the suture is pulled from the canal # the suture is held to the right of the needle tip and away from it * without possible damage *

Fig. 6 is a plan view of another embodiment of the present invention. The package 110 of FIG. 6 is similar to the embodiment of FIG. 1 containing a central floor (118), an interior channel wall (114), an oval channel (112), and hinged doors (120). In this embodiment # the door locking means includes a certain number of columns (150) located around the outer surface of the wall (114)&gt; in the alignment of the doors (120). The columns (150) are offset from the surface of the wall (114) to provide suture spacers relative to the wall. (114). The door locking means also includes two holes (124) formed in each door (120).

When hinged doors are closed, the columns 150 fit perfectly into the door frames 124 and are forcibly adjusted to retain the closed doors. The columns 150 may alternatively be sized to extend through the doors. allowing the ends of the columns to be stamped to lock the closed doors in place.

As the embodiment of fig. 1, the package 110 includes a needle housing including a holder.

rigid and dug needle strips (156) and (154) formed on a needle support wall (160) * On one side of an auxiliary flap, the package (1105 te®) is an auxiliary opening (150) closed to the floor of the package near the Needle Housing The user can safely grasp a needle to be withdrawn by squeezing the needle at the end of a needle and extending the tip of the staff into the auxiliary opening (150). In this embodiment, a contrasting bottom of the shell would preferably be placed behind the auxiliary opening * so that the silver needle would be easily seen by the user *

Fig. 7 illustrates another embodiment of the present invention in which the open suture winding channel is closed by a paper cover (190). The casing 210 of this embodiment is similar to Fig. 6, with a channel 212 and a number of columns 250 extending upwardly from the interior wall of the channel, but this embodiment does not contains any hinged door * Once the needle has been placed in the needle holder and the suture wound in the channel (212), a paper cover (190) is placed over the open package with cover holes (192) aligned with and seated in the columns (230) * The ends of the columns extending through the cover are then softened or stamped to retain the cover in its place. The paper cover further includes a cover flap 195 overlying the needle position of the package. The cover flap is hinged to the cover 190 at 194. When the package θ its shell is cut open from the corner (196), the hinged flap (185) swings down on its hinge to uncover a cutting area (198) of the underlying cover * The needle and suturing may be achieved and unpacked through this cut area (198) while channel (212) remains. completely closed by the paper cover (190) *