Surgical closure having ease of assembly

Abstract

A sutureless closure device for drawing the edges of an incision together. The device comprises first and second surgical tape members for application to opposite sides of a wound or incision. The first tape member carries tie member anchors, and the second tape member carries tie member receiving slides. Tie members connect respective anchors and slides, causing the two tape members to be biased together, which holds the incision closed. The device then functions as a splint to protect the healing wound against disruptive forces. In accordance with this invention, separate locking means are used to lock the tie members in the slides, after as much adjustment as necessary, which results in greater ease of assembly and adjustment of the surgical closure device after emplacement about an incision site. Also, for added ease of assembly and to promote longitudinal skin alignment, the tie member anchors and receiving slides are each defined by a unitary flexible, elongated member having ports defined therethrough.

Parent Case Text

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of my co-pending application Ser. No. 209,165, filed Dec. 17, 1971; which in turn is a continuation-in-part of my application Ser. No. 123,559, filed Mar. 12, 1971, now U.S. Pat. No. 3,698,395.

Description

BACKGROUND OF THE INVENTION

Sutureless surgical closures are valuable since they may be used to close an incision, which may be an involuntarily-received wound, a surgical incision, or the like, in a fraction of the time that is required by a conventional suture technique of incision closing.

As a further advantage, the pain, the patient's possible flinching or other resistance, the scars which may result from the suture penetration of the tissue, and the irritating effect of the sutures themselves, can be avoided by the use of surgical closures, particularly of a type disclosed in the above-cited U.S. Pat. No. 3,698,395, and co-pending application Ser. No. 209,165. These closures do not irritate the healing wound nor its immediate vicinity and do not invade deeper tissues. They promote patient comfort and safeguard his well being by preventing infection, inflammation and possible contamination of deeper tissues. Removal is easy and painless.

A difficulty, however, has been encountered in the use of the sutureless incision closure members of the prior art, and particularly the more advanced types which use tie strips or members for connecting the two tape members together for wound closure. For example, in previous embodiments, some practical difficulties have been encountered in applying, adjusting and aligning the devices, so that the incision is held closed along its entire length under a uniform and desired pressure. This generally takes some adjustment on the part of the surgeon, in obtaining proper skin apposition. Unsatisfactory skin apposition was occasionally noted at the time of device removal.

Furthermore, some patients complained of skin irritation due to impingement of the skin by the stray edges of the plastic anchor and receiving members.

In accordance with this invention, a sutureless surgical closure is provided which may be easily assembled, applied and adjusted for alignment, and readjusted as often as necessary prior to locking the device. Furthermore, the device may be selectively locked as desired with a variable degree of closing pressure or firmness along its length. In the preferred device of this invention, the tie members connecting the two halves of the device may be distributed along the length of the device in any manner desired to meet variable and unexpected situations in suture closing. The anchor and receiving members are softer and less bulky to prevent skin irritation and promote patient comfort.

Accordingly, this invention provides a structure which is more convenient and flexible in its use.

DESCRIPTION OF THE INVENTION

A surgical closure is provided in accordance with this invention which comprises: a first surgical tape member for application to one side of an incision, and a second surgical tape member for application to the other side of the incision. The first tape member carries a plurality of tie member anchors, while the second surgical tape member carries a plurality of tie member receiving slides. Tie members are provided for carrying by the anchors, while portions of the tie members are received in the slides.

In accordance with this invention, tie member locking means, initially separate from the remaining parts of the device are provided for cooperating with the slides, to grasp and retain the tie members in desired positions relative to the slides. Each locking means thus can be actuated for the first time after the positions of the tie members have been adjusted in the slides as many times as desired, and the surgeon is satisfied as to the placement of the surgical closure about the incision. Thus it is unnecessary to repeatedly unlock the tie members as position adjustments are made.

Preferably, the plurality of tie member anchors are defined by a unitary, flexible, elongated member, defining a plurality of tie member receiving anchor ports therein. These anchor ports function as the tie member anchors defined above.

Each tie member also may define an enlarged end portion which is too large to pass through the anchor ports. Accordingly, the tie member may be placed through the anchor ports and the other projecting end at each tie member may then fit into a tie member receiving slide, and thereafter be secured there by a locking means.

It is also preferable for the tie member receiving slides to be defined by a second, unitary, flexible, elongated member having a plurality of tie member receiving slide ports defined therethrough to function as the receiving slides. Preferably, the slide ports are also small enough to prevent passage of the enlarged end portions of tie members.

An advantage of the flexible, unitary members described above is that they can be fabricated to define a large number of potential anchor ports and slide ports, so that the surgeon has latitude and discretion as to the placement of the elongated tie members, in a manner responsive to his professional discretion as to how the distribution of incision closing pressures should be arranged.

Also, the device acts as a splint, holding the skin firmly in position. This aids the healing process by preventing any force from disrupting or moving the skin defining the wound. Also, this device may remain on the patient for a relatively long time, providing continued approximating, support and protection for the healing wound and promoting cohesiveness of the healing process producing a reliably strong and cosmetically appealing scar. Prolonged use of the device is particularly preferred where skin apposition is imperfect since such inadequacies are correctable by continued splinting.

In the drawings,

FIG. 1 is a perspective view of one embodiment of the invention of this application.

FIG. 2 is a fragmentary perspective view of a device similar to that of FIG. 1, but modified in the manner shown.

FIG. 3 is a fragmentary perspective view of a third modification of the device of FIG. 1.

FIG. 4 is a plan view of the device of FIG. 1, but with a different arrangement of elongated tie members used therein.

FIG. 5 is a longitudinal sectional view taken along Line 5--5 of FIG. 1.

Referring to the drawings, FIGS. 1 and 5 show a preferred embodiment of surgical closure 10 of this application. A first surgical tape member 12 is shown in position of use on one side of an incision 14, which may be the result of an injury, or, alternatively, a surgical incision. Second surgical tape member 16 is positioned on the other side of incision 14.

Tape members 12 and 16 may be made of conventional surgical adhesive tape, or any other adhesive bandaging material which is not excessively toxic to the skin, and can thus remain adhering to the skin for a matter of days or weeks.

Unitary, flexible, elongated member 18 is glued or otherwise secured to tape member 12 by a glue such as cyanocrylate cement or the like (e.g. Eastman 910 adhesive, sold by the Eastman Kodak Company of Rochester, N.Y.).

Elongated member 18 defines a substantial number of tie member anchor ports 20, passing through member 18, which are proportioned to receive a tie member 22 in the manner shown. Member 18 may be made of rubber to be flexible, and also to provide frictional locking of tie members as they rest on the rubber surface of member 18. If desired, the frictional locking of tie members against member 18 can be used as the chief retention technique for the device.

Preferably, more ports 20 are present than the number of tie members contemplated for use, to provide flexibility and choice in their manner of placement.

Tie member 22 is typically a generally semi-rigid rectilinear (e.g. rectangular) bar made of plastic or the like, so that it is easily positioned by manual passage through their respective ports in which it resides.

Each tie member 22 has an enlarged end portion 24, which is too large to pass through anchor ports 20, and thus serves as a one-way retention means for tie members 22, preventing their complete passage through ports 20.

A second, flexible elongated member 26, which is generally similar in construction to first member 18, and is preferably made of rubber for good frictional retention of the members 22, is attached by similar gluing or the like to surgical tape member 16. Elongated member 26 is shown to define a large member of tie member receiving slide ports 28, passing through member 26, and generally corresponding in size and distribution to ports 20 of elongated member 18. As shown, each tie member 22 passes through an anchor port 20 and a corresponding slide port 28.

Anchor port 20 and corresponding slide port 28 are part of elongated members 18 and 26. As each tie member 22 is pulled from its free end 22a or pushed from enlarged end 24 it causes elongated member 18 with attached tape member 12 to draw closer to elongated member 26 with attached tape member 16, exerting an incision-closing force between them.

Each tie member 22 defines a plurality of serrations 30 along one side thereof.

Accordingly, first and second surgical tape members 12, 16 may be placed in position on opposite sides of an incision. Thereafter, little or no readjustment of the positioning of the surgical tape members is usually required, because the surgeon has an alternative means of adjustment by judicious choice of the respective ports 20, 28 that he elects to pass tie members 22 through.

The surgeon therefore selects the positioning of tie members 22 as he desires.

Thereafter, the tie members are locked into position by sleeve members 32, which can be pressed against elongated member 26 to urge it and second surgical tape member 16 toward tape member 12, thus exerting closing force on the incision 14.

As shown in FIG. 5, serrations 30 may be engaged by pawl 34 of sleeve member 32.

Sleeve member 32 may be manually advanced with any of a large range of desired pressures against the elongated member 26 for achieving the specific, desired incision closure pressure. The desired pressure can then be retained by the holding action of any individual serration of the group of serrations 30, acting against pawl 34.

If it is desired to adjust the incision closure pressure or to discontinue it, spring member 36 may be manually actuated upwardly to disengage pawl 34, thus removing the pressure imparted by sleeve member 32. The tie member 22 can then be adjusted to loosen or tighten the closure, or it can be removed.

FIG. 4 shows the device of FIG. 1 in which more tie members have been applied for additional and more precise incision closing force. It can also be seen that the tie members 22 may be arranged in a nonuniform or asymmetrical pattern. As shown therein, two of the tie members 22' have been reversed, being threaded first through ports 28 so that their enlarged end 24a press against elongated member 26 rather than member 18. Tie members 22 may be positioned in either direction as shown in FIG. 4, and in any pattern and number as desired by the surgeon.

As a further advantage of this invention, additional tie members 22 may be installed in the device of this invention after device 10 has closed the incision, if, in the judgment of the surgeon, such is required. This can be done without releasing pressure on the incision, with the consequent danger of bleeding and infection.

It will be noted that a maximum number of tie members can be installed for maximum closure force, if they are emplaced in alternatingly reversed configuration, in which a sleeve member 32 of one tie member is bracketed by enlarged ends 24 of adjacent tie members, as shown in FIG. 4.

Turning to FIG. 2, an embodiment similar to FIG. 1 is disclosed in which the respective tie member anchor members 35 and tie member receiving slides 37, are spaced, separate members rather than part of a continuous, elongated member as in FIG. 1. This structure might have advantage for use on a curved body surface, for example the sealing of a deep and long transverse curved or irregular incision on an arm or leg, since the surgical closure of FIG. 2 will exhibit a maximum degree of flexibility.

The device of FIG. 3 is similar to that of FIG. 1, and especially FIG. 2, except that elongated tie member 38 is of circular cross-section rather than the rectangular or square cross-section of tie member 22 of FIGS. 1 and 2. Tie member anchor 40 defines a correspondingly cylindrical aperture for receiving tie member 38, as do tie member receiving slides 42. Locking sleeve members 44 are also appropriately modified to fit this new arrangement, but function in a manner similar to that disclosed in FIG. 5.

The particular embodiment of FIG. 3 is shown to have removable sheets 46, conventionally made of a typical commercial plastic formulation for the purpose of protecting the pressure sensitive adhesive on the bottom of first and second surgical tape members 12a and 16a. A hand grip member 48 is provided by folding a piece of surgical tape member 12a, 16a double, for ease of removal of sheets 46. Such large folded releasing tabs are applicable in all the closures disclosed and are provided for ease of handling of the closure device.

The above has been offered for illustrative purposes only, and is not to be considered as limiting the invention of this application, which is as defined in the claims below.

Claims

I claim:

1. A surgical closure which comprises: a first surgical tape member for application to one side of an incision; a second surgical tape member for application to the other side of an incision; said first surgical tape member being provided with a plurality of tie member anchors and said second surgical tape member having a plurality of tie member receiving slide ports, the improvement comprising, in combination, elongated tie members removably connected to said anchors for coupling to said anchors while a portion of said tie members are received in said slide ports, and separate, tie members locking means removably connected to said tie members, for cooperating with said slide ports to grasp and retain said tie members in desired positions within said slide ports, said locking means comprising sleeve members proportioned to receive said tie members in sliding relationship within the bores of said sleeve members.

2. A surgical closure as described in claim 1, said tie members each defining a plurality of transverse serrations, and said sleeve members each defining a releasable locking pawl for grasping a serration of said tie member.

3. The closure of claim 2 in which said tie member is a generally semi-rigid bar.

4. The closure of claim 3 in which said bar is generally rectilinear in cross-section.

5. The closure of claim 4 in which said tie member receiving slides and said tie anchors are each arranged in a linear array.

6. The closure of claim 5 in which said tie member anchors are defined by a unitary, flexible, elongated member defining a plurality of the member receiving anchor ports therein, each tie member defining an enlarged end portion which is too large to pass through said anchor ports.

7. The closure of claim 6 in which said tie member receiving slides are defined by a second, unitary, flexible elongated member having a plurality of tie member receiving slide ports defined therethrough, said ports being too small to permit passage of said enlarged end portion.

8. The closure of claim 7 in which the number of each of said anchor ports and slide ports present is greater than said number of said tie members present, to provide the user with flexibility and choice of tie member placement for the most desirable incision closing effect.

9. The closure of claim 8 in which said tie member anchors and tie member receiving slides are made of rubber, to frictionally retain said tie members.

10. A surgical closure which comprises a first surgical tape member for application to one side of an incision; a second surgical tape member for application to the other side of an incision; said first surgical tape member being provided with a plurality of tie member receiving anchors and said second surgical tape member having a plurality of tie member receiving slide ports, the improvement comprising, in combination, tie members removably connected to said anchors for connection to said anchors while a portion of said tie members are received in said slide ports; and means for retaining said tie members in said slide ports for biasing said first and second surgical tape members together for wound closure; said tie member receiving slide ports having axes which are generally parallel to said second surgical tape member surface and generally normal to the incision facing edge of said second tape member, said tie member anchors being defined by a unitary, flexible, elongated member defining a plurality of tie member receiving anchor ports therein, whereby each tie member can be anchored by insertion into a tie member receiving anchor port, said tie members having sufficient rigidity to permit sliding insertion of said tie members into said tie member receiving slide ports and said tie member receiving anchor ports, each said tie member having an enlarged end portion for abutting one of said ports on the side of its associated elongated member which is remote from said incision to prevent passage of said tie member therethrough.

11. The closure of claim 10 in which said tie member receiving slide ports are defined by a second, unitary, flexible, elongated member.

12. The closure of claim 11 in which said means for retaining the tie members in said slide ports comprises sleeve members proportioned to receive said tie members in sliding relationship within the bores of said sleeve members, said tie members each defining a plurality of transverse serrations, and said sleeve members each defining a releasable locking pawl for grasping a serration of said tie member, wherein said sleeve member is placed on said tie member in a position adjacent the side of said second flexible, elongated member which is remote from the incision, to permit said second elongated member and said sleeve member to cooperate to prevent withdrawl of said tie member through its associated slide port.

13. The closure of claim 12 in which said tie member is a generally semi-rigid bar.

14. The closure of claim 14 in which the tie member is generally rectilinear in cross-section.