Vacuum closure device

Abstract

This invention relates to the design of tissue covering elements for use in vacuum assisted tissue apposition systems, wherein the geometry of the covering elements favours the application of contractile forces over compressive or extensive forces at the tissue interface.

Claims

1. A method of closing a wound, the method comprising; locating a tissue stabilizing element at a wound site, the wound site comprising wound margins; applying a negative pressure to the tissue stabilizing element, wherein the tissue stabilizing element under negative pressure exerts a contractile force to the wound margins, drawing the wound margins toward a center of the wound, wherein the tissue stabilizing element contracts more in a direction parallel to a skin surface surrounding the wound than in a direction perpendicular to the skin surface and contracts anisotropically parallel to the skin surface.

2. The method of claim 1, wherein the tissue stabilizing element is placed above the skin surface.

3. The method of claim 1, further comprising forming a vacuum seal at the wound site.

4. The method of claim 1, further comprising connecting a source of negative pressure.

5. The method of claim 1, wherein the tissue stabilizing element comprises a plurality of flat, internal faces.

6. A method of exerting a closing force on a wound, the method comprising; positioning a tissue stabilizing element at a wound site so as to create a substantially sealed space between the tissue stabilizing element and the wound; reducing the pressure in the substantially sealed space between the tissue stabilizing element and the wound, thereby contracting the tissue stabilizing element in a first linear direction that is toward a center or a centerline of the tissue stabilizing element and parallel to the wound surface, wherein the tissue stabilizing element contracts more in the first linear direction than in a second linear direction that is parallel to the wound surface, the second linear direction being perpendicular to the first linear direction.

7. The method of claim 6, wherein contracting the tissue stabilizing element exerts a net contractile force on the wound in the first direction.

8. The method of claim 6, further comprising contracting the tissue stabilizing element in the first direction that is toward the center or centerline of the tissue covering element more than in a second direction that is transverse to the first direction, thereby contracting the wound in said first direction more than in said second direction.

9. The method of claim 6, wherein the tissue stabilizing element comprises a plurality of flat, internal faces.

10. A tissue stabilizing element for use in a vacuum assisted closure system, the tissue stabilizing element comprising: a stabilizing portion comprising a plurality of flat, internal surfaces, the stabilizing portion configured to be positioned at a wound; wherein the stabilizing portion is configured to contract to a greater extent along a first direction relative to a second direction upon application of negative pressure, the first direction parallel to the wound and the second direction perpendicular to the wound; wherein the flat, internal surfaces are configured to collapse toward one another upon application of negative pressure; and wherein the stabilizing portion is configured to apply a closing force to the wound along the first direction.

11. The tissue stabilizing element of claim 10, further comprising a vacuum connection aperture.

12. The tissue stabilizing element of claim 11, wherein the aperture is configured to connect to a conduit, the conduit configured to deliver negative pressure.

13. The tissue stabilizing element of claim 10, wherein the stabilizing portion is configured for placement over the wound.

14. The tissue stabilizing element of claim 10, wherein the stabilizing portion comprises a plurality of angles between the internal surfaces, the angles configured to decrease upon application of negative pressure.

15. The tissue stabilizing element of claim 10, wherein the stabilizing portion is transparent.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will now be described, for illustrative purposes only, with reference to the accompanying Examples and Figures, wherein the Figures illustrate:

(2) FIG. 1: Force vectors generated within hypothetical tissue cavities. (a) Force vectors generated by a conventional tissue covering element when applied to (a) a cavity wound (b,c) and to a largely flat or convex wound.

(3) FIG. 2: Illustrates a substantially flat wound.

(4) FIG. 3: Embodiments of the tissue covering element of the present invention.

(5) FIG. 4: The distribution of surface area angles for any given tissue covering element can be represented in a histogram.

(6) FIG. 5: Determining the optimal dimension of the tissue covering element.

(7) FIG. 6: Relationship between the dimension of the tissue covering element and the forces generated.

(8) FIG. 7: A schematic of tissue covering element for application to largely flat circular wounds in locations of isotropic skin tension.

(9) FIG. 8: A schematic of tissue covering element for application to largely flat wounds in locations of anisotropic skin tension.

(10) FIG. 9: A schematic of tissue covering element for application to a limb or bone tissue defect.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

(11) FIG. 1 illustrates the forces generated by conventional tissue covering elements when applied to (a) cavity tissue defect and (b,c) substantially flat or convex tissue defects. (a) the tissue covering element 1 is applied to wound 2 within tissue 3. This is a cavity tissue defect. The application of a partial vacuum generates substantially equal compressive and contractile forces. This is optimal for the healing mechanism of this wound type. (b) the tissue covering element 1 is applied to wound 2 within tissue 3. This is a shallow, largely flat tissue defect. The application of a partial vacuum generates predominantly compressive forces and minimal contractile forces. This is sub-optimal for the healing mechanism of this wound type in which there is a desire for contraction of the margin of the wound in the direction of the closure. (c) the tissue covering element 1 is a molded cover which is applied to wound 2 within tissue 3 to form a vacuum cavity above the wound. The surfaces of the covering element are predominantly parallel to the surface of the wound. The application of a partial vacuum generates predominantly compressive forces and minimal contractile forces. This is sub-optimal for the healing mechanism of this wound type in which there is a desire for contraction of the margin of the wound in the direction of the closure.

(12) FIG. 2 illustrates a substantially flat tissue defect. Such a wound has surfaces with vertical dimensions (z) no greater than 20% of the shortest of the other dimensions (x) and (y).

(13) FIG. 3 illustrates various embodiments of the present invention. In (a) the tissue covering element 1 which is applied to a substantially flat or convex tissue defect 3 comprises a plurality of corrugations which generate a net force parallel to the tissue surface, thereby generating a contractile force in the direction of closure of the wound. In (b) the tissue covering substantial net force is parallel to the tissue surface. In the embodiment illustrated in (c) the tissue covering element 2 comprises a base member 4a and 4b which is applied to the tissue surface 3. From this base member the walls 5a and 5b extend to the apex, thereby forming an inverted “V” shaped cavity above the surgical incision. The base member 4a and 4b and the walls 5a and 5b are made of a relatively inflexible material, with a flexible hinge 6a 6b forming the junction between the base member 4a and 4b and the walls 5a and 5b and a further flexible hinge 6c provided along the apex of the “V”. A vacuum connection port 7 is provided on one of the wall elements.

(14) The distribution of surface area angles for any given tissue covering element can be represented in a histogram. FIG. 4 illustrates this for the following tissue covering element designs: (a) a conventional negative pressure cover geometry (b) a cover geometry with 30° surface incidence angle (c) a cover geometry with 45° surface incidence angle (d) a hemispherical cover geometry (e) a cover geometry with 900 surface incidence angle (f) a cover geometry with 900 surface incidence angle (larger surface area than in (e)

(15) FIG. 5 illustrates the optimal geometry of the tissue covering element relative to the tissue defect. The tissue defect has a desired axis of contraction between pOints A and B. The dimension of the tissue covering element aligned between A and B is preferably longer than the direct length labelled X.

(16) FIG. 6 illustrates that for any perimeter length the force generated perpendicular to a flat surface of attachment is constant. It can also be seen that forces generated parallel to the flat surface (contractile) scale directly in proportion to the vertical height of the corrugation divided by half its period length.
Force=Pressure×Area

(17) In the example illustrated in FIG. 6, let perimeter length x be directly proportional to surface area y (true for simple designs pictured in FIGS. 6 and 9). For a constant vacuum pressure p, the resolved forces generated from the surfaces shown in FIG. 6a are shown in FIG. 6b.

(18) FIG. 7 is a schematic of a tissue covering element for application to largely flat circular wounds in locations of isotropic skin tension. The tissue covering element is a corrugated concentric ring structure. The centre of the element may be convex or concave when viewed from above.

(19) FIG. 8 is a schematic of a tissue covering element for application to largely flat circular wounds in locations of anisotropic skin tension. The tissue covering element is a multiple inverted ‘V’ ‘concertina configuration. The lines of the concertina folds being positioned parallel to local Langer's lines to effect wound closure.

(20) The tissue covering element 11 is substantially square. An adhesive 12 forms a peripheral border around the tissue contacting surface of the tissue covering element. The element 11 further comprises a bridging element which is formed of a plurality of separated inverted V-shaped elements 13. The V-shaped elements are hinged, to allow greater flexibility. First 14a and second (not shown) hinges are provided at the join between the inverted V-shaped element and the upper surface of the tissue contacting surface (ie the surface that faces upwards away from the tissue). A third hinge 14c is provided at the apex of the inverted “V”. The arrows “X” illustrate the direction of local Langers' lines. The arrows “Y” illustrate the direction of contraction generated under vacuum.

(21) For application to convex surfaces, such as the extremities of the body or the bones of the body, a tissue covering element 21 having a cylindrical concertina configuration is desirable (similar to a shock absorber ‘boot’) as illustrated in FIG. 9. The proximal 21a and distal 21b ends of the tissue covering element are fixed to the limb or bone 22 (defect positioned under the tissue covering element). The lines of the concertina folds being perpendicular to the longitudinal axis of the limb 25. The arrow “Y” illustrates the direction of contraction generated under vacuum.

EXAMPLES

Example 1: Construction of the Incision Closure Device Pictured in FIG. 3c

(22) A device of the design pictured in FIG. 6 was moulded using a transparent, heat-curable medical grade silicone elastomer. The device had a dome-profiled pressure cracking valve (Minivalve International B. V.) cast into one of it's cavity faces. The flat surfaces of the inverted ‘V’ section of the device was reinforced with pre-cured mechanically stiff silicone elastomer.

Example 2: Incision Closure with the Device of Example 1

(23) The device prepared in Example 1 was positioned over a gaping linear incision made into a porcine belly cadaver. Partial vacuum was applied to the device via the crack-valve port. A pressure of −100 mmHg was achieved relative to ambient atmospheric pressure (660 mmHg absolute pressure). The device deformed by hinging about the highest point of the inverted ‘V’ section, causing contraction of the tissue around the incision in a direction perpendicular to it, thus achieving closure of the wound.

Example 3: Construction of Device for the Closure of Open Area Wounds in Langer's Line Neutral Locations

(24) A design of the concept pictured in FIG. 7 was moulded using a heatcurable medical grade silicone elastomer. The mould used was a collapsible funnel (Normann, Copenhagen) in the collapsed position. When the elastomer was cured, the concentric finned device was removed by opening the funnel.

Example 4: Radial Contraction of Tissue with the Device of Example 3

(25) The device prepared in Example 3 was modified with a central luer lock fitting and connected to a partial vacuum of −100 mmHg relative to ambient atmospheric pressure. The device was positioned on a living person's abdomen and allowed to seal. The device corrugated under the reduced internal pressure and exerted a radial contractile force on the adjoining tissue in the direction of the centre of the device. Tissue was contracted by approximately 15% of the original device diameter.