WO2001056477A2

WO2001056477A2 - Device for facilitating closure of a surgical wound

Info

Publication number: WO2001056477A2
Application number: PCT/ZA2001/000013
Authority: WO
Inventors: Gregory John Ash
Original assignee: Gregory John Ash
Priority date: 2000-02-07
Filing date: 2001-02-06
Publication date: 2001-08-09
Also published as: WO2001056477A3; AU4600301A

Abstract

The invention provides a device suitable for use in surgery to facilitate closure of a surgical or traumatic wound, the device comprising a support structure extending generally in a first plane and at least one pin formation on either side of the support structure which pin formations are secured to the support structure to extend transversely to the plane of the support structure, and wherein at least one of the pin formations features at least one bar structure at or near its free end. The invention also provides a surgical method of closure of a wound involving the use of a device according to the invention.

Description

FIELD OF THE INVENTION

DEVICE FOR USE IN SURGERY

THIS invention relates to a device for use in surgical procedures.

More particularly, this invention relates to the device useful in achieving, or

at least approaching, precise coaption of the deeper [fat] layer of a surgical

wound during a surgical wound closure procedure, thereby to enhance the

prospect of achieving rapid wound healing without complications. The

device is also intended to assist the surgeon in performing the procedures

necessary for achieving such a wound closure in a reasonable time, and not

unduly to prolong the duration of the patient's anaesthesia in seeking to

achieve this goal.

BACKGROUND TO THE INVENTION

When stitching up a surgical incision made through, say, the abdominal wall

of a patient, it is necessary first to stitch together the abutting muscle

segments of the abdominal wall, and then to join the opposing skin

segments by stitching. The fat layer disposed between the skin and the

muscular abdominal wall has a consistency similar to that of butter or

cheese. It accordingly presents no, or, at best, very little anchorage for the

sutures, and cannot reasonably be sutured together. If sutured with

conventional techniques fat enclosed by the suture has diminished blood

supply and often dies and is thus at risk for infection or excessive scar

formation. In an attempt to bring and hold the interposed fat layers on either side of the incision in contact to enable these to reunite, it is

customary to pass large sutures through both the skin and the muscle layers

so as to hold the fat passively and indirectly together. In slim people with a

thin layer of fat, and thus where skin and muscle sutures are close to each

other, this may be effective in keeping fat layers closely abutting to allow

healing. There does, however, remain a potential space in the plane of the

fat. In obese people in particular, the fat layers may recede from each other

creating what is referred to as a " dead space".

Serum and/or blood are prone to collect in this space with the attendant

danger of infection. This retraction of the fat layer may also lead to indented

scars.

In addition, it is common, particularly in plastic surgery to perform surgical

procedures in which large sections of skin and fat are undermined and

removed or moved. One such procedure is known as abdominoplasty,

colloquially known as the "tummy tuck' procedure. In this procedure an

incision extending virtually from hipbone to hipbone is made just above the

pubic area to extend through the skin and underlying fat layer. The skin and

fat layer is then undermined from the underlying muscular abdominal wall to

reveal the muscles of the abdomen up to the ribcage. The vertical muscles

[rectus abdominis] are thereupon stitched close together to provide the

patient with a reduced waistline and a firmer abdominal wall. The undermined skin and fat flap is then stretched over the tightened abdominal

wall and joined by stitching to the edge of the incision made above the pubic

area after excess skin and fat has been trimmed from the flap. It is

technically difficult if not impossible to suture the overlying fat onto the

underlying muscles, both because of the nature of the fat mentioned above

and because the flap itself blocks access. Furthermore, the alignment of the

flap over muscles is difficult to maintain while trying to pass a suture.

Lateral movement is therefore possible between skin/fat flap and muscles

and a huge potential space exists which commonly leads to complications

because of the collection of blood [haematoma] or serum [seroma]. This

occurs despite drainage of the space, which is universally practised. This is

one of the major causes of the need for corrective surgical procedures, or

other treatment following abdominoplasty and other surgical procedures in

which large parts of skin and fat are separated from the underlying muscle.

DESCRIPTION OF THE INVENTION

According to the present invention there is provided a device suitable for use

in surgery to facilitate closure of a surgical wound, the device comprising a

support structure extending generally in a first plane and at least one pin

formation on either side of the support structure which pin formations are

secured to the support structure to extend transversely to the plane of the

support structure, and wherein at least one of the pin formations features at

least one barb structure at or near its free end. The support structure may be in the form of a thin plate. Thus the support

structure may be of circular, elliptical, rectangular, square, triangular or any

other convenient shape. From the opposing surfaces of the plate there

extends a barbed pin or a plurality of barbed pins. The barbed pins

preferably extend normally to the surface of the plated support structure.

In an alternative form of the invention the support structure may comprise a

rod formation with barbed pins extending transversely from the rod

formation. In this arrangement the barbed pins may be disposed in twinned

pairs on opposite sides of the rod formation and along the length thereof.

The barbed pins are however preferably altematingly disposed along the

length to extend away from the rod formation at intervals along the length

thereof and to be disposed in a common plane with the rod structure.

In yet a further alternative arrangement according to the invention there is

provided a device according to the invention in which the support formation

is in the form of a lattice structure composed of a plurality of rod-like

elements which are arranged in two sets of elements which intersect one

another. The two sets of intersecting elements may each comprise a

plurality of elements which extend parallel to each other. Preferably the

support structure comprises two sets of parallel rod structures, the elements

of which sets intersect one another at any suitable angle. Thus, the two sets of rod-like structures may intersect one another at right angles and the rods

may all be equidistantly spaced thereby to define a lattice structure featuring

substantially square interstices. The sets of parallel rod-like structures may,

however, also intersect one another at an angle, thereby to define a lattice

structure featuring diamond-shaped interstices.

The lattice structure may be formed as a unitary structure. Alternatively,

however, it may be manufactured in sets of two configurations of elements

which are capable in use to be integrated with one another to form a lattice

structure of desired size.

In this form of the invention the device may thus be a composite device

made up of a plurality of elongate apertured plates, as first elements, and, as

second elements, a plurality of pins extending transversely thereto to be

disposed in a plane which also contains the rod, the arrangement being such

that in use the pins of the rod elements may be passed through the

apertures in the plate elements to be firmly engaged therein, thereby to form

a sturdy lattice structure substantially disposed in the plane of the rod

structures and featuring pins extending through the plate elements in a

direction normal to that plane.

In all these lattice-type structures, and in the embodiment of the invention

comprising a single rod as a support structure, the rod-like structures may be of any suitable cross-sectional configuration but are preferably round,

rectangular or elliptical in cross-sectional configuration.

The device according to the invention may be produced from any suitable

biocompatible material. Preferably, this material should be slowly absorbable

in vivo. Many examples of such materials are known. Natural polymers

falling in this category include catgut, cellulose derivatives and collagen.

Synthetic polymers may, for example, consist of various aliphatic polyesters.

In U.S. Patent 5,633,343 there is a disclosure of such a biocompatible,

absorbable copolymer. That specification also discloses numerous other U.S.

patents relating to such absorbable polymeric materials which may be useful

in the production of a device in accordance with the present invention. One

suitable material is the polyglycolic acid polymer used in the production of

sutures sold by Ethicon Inc. under the trade name Monocryl^®.

The dimensions of the device may vary according to its application. When to

be used where the soft tissues are thin the pins may be only a millimetre or

less in length and obviously only a few micrometers thick. For use in

abdominal surgery the pins may be of a length measured in centimetres.

The device may in use be cut by means of scissors to appropriate dimensions

and the rods may thus be provided with a weakened zone to facilitate

reducing a sheet of the product to an appropriate dimension. EXAMPLES OF THE INVENTION

Without thereby limiting the scope of the present invention, a preferred

embodiment will now be described with reference to the accompanying

illustrations in which:

Figure 1 is a schematic perspective view of a lattice device according to

the present invention;

Figure 2 a cross-sectional view on line II-II in Figure 1;

Figure 3 is a schematic perspective cross-sectional view through a

surgical wound being stitched up with the utilisation of a device

as illustrated in Figure 1;

Figure 4 is a perspective view of a composite second embodiment of the invention in assembled form;

Figure 5 is an elevational view of a segment of a first element of a

composite second embodiment of the device of the invention of

Figure 4; and

Figure 6 is an elevational view of a segment of a segment of a second

element of the composite second embodiment of the invention

of Figure 4.

The same reference numerals are used in the accompanying drawings to

signify corresponding parts. In Figure 1 there is illustrated a lattice device 1 composed of intersecting

sets of rod structures 2, 3 which are respectively disposed in parallel

relationship relative to one another. Collectively they define a latticework

with square interstices 4. Barbed pins or pins 5 extend normally to the

lattice structure defined by the rod structures. The arrangements of the

barbed pins are shown to be alternating, i.e. not to be coaxially disposed on

opposite sides of the plane of the lattice structure so as to allow or the

surgeon to apply pressure in the direction of the axis of individual or rows of

the barbed pins or pins.

With reference now to the illustration of Figure 3, a skin flap indicated by

numeral 10, such as the flap resulting from the procedure known as

abdominoplasty, is shown to be joined to the remaining skin left during the

procedure at the pubic area 11. First a device as shown in Figure 1 is placed

on the muscular layer of the abdominal wall of the patient and pressure is

applied to the lattice structure to cause the pins 5 to penetrate into the

muscular layer 12 of the abdominal wall. Thereupon the skin flap 10 is

lowered onto the abdominal wall which now features the barbed pin device.

Pressure is applied on the skin surface to cause the pins to penetrate into the

fat layer beneath the skin. Being so anchor the skin flap 10 has a reduced

tendency to withdraw from the edge of the incision at the pubic area of the

patient and lateral movement of the skin/flat flap relative to the muscles

when the patient moves will be reduced almost to zero. This will close the dead space and facilitate rapid healing of the flap onto the underlying

muscles. To further facilitate the wound closure a further section of the

device illustrated in figure 1 is placed between the wound edges to be joined

together. Again slight pressure may be applied to the device to cause the

pins 5 to penetrate into the fat layer on either side of the wound to be

closed. Small stitches 6 passing through and below the skin layer 13 may

now be used to suture the skin edges together. Pressure may beforehand

be applied at an angle to the surface of the skin and directed at the surfaces

of the fat layer 14 of the incision or wound to be closed to ensure proper

penetration of the pins of the device into the fat layer 14 to prevent

subsequent recession of these surfaces, at least to the degree experienced

when stitching is performed without the device of the invention.

Turning now to the arrangement set out in Figures 4 to 6, the surgical device

is shown to comprise a number of elongate plate members 15 which are

disposed in parallel relationship to one another, and a plurality of pinned rod

elements of square cross-sectional configuration 16, also extending parallel

to one another.

The rod elements 16 feature transversely extending pins 17 and 18 and

those pins each feature a number of barbs 17(a) and 18(a). The pins 17 or 18 are passed through apertures 19 provided in the plate

elements 15.

The dimensional configuration of the pins 17 and 18 and the apertures is

such that in use the pins are snugly received through the aperture to be

securely frictionally engaged therein. If desired the shaft of the pin may

include a recessed zone to allow for it to be clipped into the aperture and be

retained by a shoulder of the recessed zone which is not shown in the

drawings.

Since the device is produced from biocompatible material it will not need to

be removed after the operation. In the preferred embodiment it will be

bioabsorbable and so will simply be absorbed by the body.

Clearly many variations of the invention may be devised without thereby

departing from the spirit of the invention. It is anticipated that the pins may

be set at an acute angle to the plane of the lattice structure and opposing

pins may be co-axially mounted, if desired.

Claims

1. A device suitable for use in surgery to facilitate closure of a surgical

wound, the device comprising a support structure extending generally

in a first plane and at least one pin formation on either side of the

support structure which pin formations are secured to the support

structure to extend transversely to the plane of the support structure,

and wherein at least one of the pin formations features at least one

barb structure at or near its free end.

2. The device of claim 1 wherein the support structure is in the form of a

thin plate from the opposing surfaces of which there extend a plurality

of barbed pins, which preferably extend normally to the surface of the

support structure.

3. The device of claim 1 wherein the support structure comprises a rod

formation with barbed pins extending transversely from the rod

formation, the barbed pins being disposed in twinned pairs on

opposite sides of the rod formation and along the length thereof.

4. The device of claim 1 wherein the support formation is in the form of

a lattice structure composed of a plurality of rod-like elements which

are arranged in two sets of elements which intersect one another, the two sets of intersecting elements each comprising a plurality of

elements which extend parallel to each other.

5. The device of claim 4 wherein the support structure comprises two

sets of parallel rod structures, the elements of which sets preferably

intersect one another at right angles and wherein the rods are

preferably equidistantly spaced thereby to define a lattice structure

featuring substantially square interstices.

6. The device of claim 4 or 5 wherein the lattice structure is formed as a

set of two configurations of elements which are capable in use to be

integrated with one another to form a lattice structure of desired size.

7. The device of claim 6 which is a composite device made up of a

plurality of elongate apertured plates, as first elements, and, as

second elements, a plurality of pins extending transversely thereto to

be disposed in a plane which also contains the rod, the arrangement

being such that in use the pins of the rod elements may be passed

through the apertures in the plate elements to be firmly engaged

therein, thereby to form a sturdy lattice structure substantially

disposed in the plane of the rod structures and featuring pins

extending through the plate elements in a direction normal to that

plane.

8. The device of any one of claims 3 to 7 wherein the rod-like structures

are preferably of round, rectangular or elliptical in cross-sectional

configuration.

9. The device of claim 1 produced from a biocompatible material,

preferably, a material which is slowly absorbable in vivo and is most

preferably polyglycolic acid polymer.

10. A method of disclosure of a wound which includes the step of

inserting a device as claimed in any one of claims 1 to 9 into the

wound.