GB2431587A

GB2431587A - Tissue support

Info

Publication number: GB2431587A
Application number: GB0621285A
Authority: GB
Inventors: Duncan Martin
Original assignee: University of Dundee
Current assignee: University of Dundee
Priority date: 2005-10-26
Filing date: 2006-10-26
Publication date: 2007-05-02
Also published as: GB0621285D0; GB0521797D0

Abstract

A tissue support apparatus 10, primarily for use during breast intraoperative radiotherapy procedures, comprises one or more tissue support members 14 coupled to a base support member 12 and extending outwardly therefrom, wherein said tissue support members 12 are plastically deformable to adopt a shape for use in supporting body tissue. In one disclosed embodiment the base member 12 defines an aperture 16 adapted to be positioned over a breast 18. The apparatus may be formed from a malleable metal or alloy such as lead with a cover material. Each support may have a hole (22, fig 3) which act as suture anchor points.

Description

TISSUE SUPPORT

FIELD OF THE INVENTION

The present invention relates to a device for use in supporting tissue, particularly during a clinical procedure. More specifically, but not exclusively, the present invention relates to a device for supporting breast tissue during intraoperative radiotherapy.

BACKGROUND TO THE INVENTION

There are many circumstances during clinical procedures, particularly surgical procedures, where tissue support and manipulation is necessary to permit the procedure to be properly performed. Additionally, tissue which is normally relatively flexible and flaccid may require a form of rigid support to permit proper analysis and treatment etc. For example, tissue may be required to be held in a particular form or position to be engaged by a surgical instrument. This requirement may be achieved by known instruments such as forceps or the like. However, these often offer little independent support, and in some cases may require to be held by a surgeon or his assistant. Additionally, tissue support may be achieved directly using the surgeon's hands and fingers. However, this may be very difficult if not impossible in some circumstances, such as where the operating site provides limited access, or where the instruments to subsequently be utilised are relatively large and as such would be obstructed by the surgeons hands. Furthermore, direct manipulation and support of the tissue in this manner would provide the surgeon with only one free hand to carry out the required procedure, which may be undesired.

Tissue manipulation and support is of particular importance in operative procedures such as lumpectomies which involve the surgical excision of a volume of diseased breast tissue. In such procedures there is a risk that excision is not complete, arid that malignant cells remain in the breast adjacent to the operative site. To prevent recurrence and spreading of the disease, these cells must be destroyed. Recent surgical practices include the use of intraoperative radiotherapy (IORT) which utilises a device which generates X-rays to be transmitted into the target breast tissue. In use, the X-ray emitting part of the device, which conventionally comprises a spherical probe, is placed within the wound created by the lumpectomy. In order to ensure adequate transmission of the X-rays into the target breast tissue the surfaces of the wound must be gently compressed against the surface of the spherical probe. Current methods of achieving this include the use of a purse string Suture to retain the tissue in position against the probe, or using strapless bras to try and influence the tissue. This achieves the required goal in most circumstances, but in some cavity shapes it is necessary to push the breast tissue from outside.

It is among objects of the present invention to obviate or at least mitigate these

and other problems in the prior art.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention, there is provided a tissue support apparatus comprising: a base support member; and a tissue support member coupled to the base support member and extending outwardly therefrom, wherein said tissue support member is plastically deformable and is adapted to be plastically deformed to adopt a shape for use in supporting body tissue.

Advantageously, in use, the base support member may be positioned on or adjacent a patient, and the tissue support member may then be manipulated and plastically deformed to adopt a shape suitable for engaging and supporting a tissue region of a patient. Accordingly, tissue support may be achieved, and also refined, while freeing both hands of a surgeon or other suitably qualified personnel.

Furthermore, once the tissue support member is set in the required shape and position, a sufficient and permanent level of support will be achieved by virtue of said member being plastically deformable.

Preferably, the tissue support member is adapted to support internal and external body tissue. The tissue support member may be adapted to support internal body tissue from a location external of the body cavity, or alternatively, or additionally, from within the body cavity.

Preferably, the tissue support member is malleable such that said member is capable of being repeatedly plastically deformed. This advantageously permits the tissue support member to be continuously adjusted and reformed to achieve an optimum shape and thus support, and furthermore permits the support apparatus to be reused. In a preferred embodiment, the tissue support member comprises a material which presents minimal work hardening and a high resistance to fracturing during deformation, particularly repeated deformation. Preferably, the tissue support member comprises lead. The tissue support member may comprise an alternative malleable metal or metal alloy, such as aluminium, for example. Alternatively further or additionally, the tissue support member may comprise a moulding material such as clay, putty, a synthetic or non-synthetic plastic material, or the like. The moulding S 4 material may be curable, such that the tissue support member may become set when positioned in the required shape or position. Alternatively, the moulding material may be non-curable, such that Continuous manipulation and reforming may be achieved.

Preferably, at least the tissue support member is at least partially encapsulated in a cover material. Advantageously, the cover material may comprise, for example, a polymer, elastomer or the like. Additionally, the cover material is beneficially sterilisable, thus permitting repeated use of the support apparatus while substantially reducing the spread of infection between patients. Advantageously, the base support member may be at least partially encapsulated in a cover material.

Preferably, the tissue support member is integrally formed with the base support member. Alternatively, the tissue support member may be separately formed and subsequently secured to the base support member, for example, by welding, bolting, clamping, or by any other suitable mechanical connection means or the like.

Beneficially, the base support member is plastically deforniable, and preferably comprises a malleable material to permit repeated plastic deformation to be achieved. This arrangement permits the base member to be deformed to adopt a shape suitable for positioning the tissue support member in a desired position or location while providing sufficient and stable support. The base member may comprise lead, aluminium, a moulding material or the like.

In a preferred embodiment, the tissue support member comprises a proximal end region coupled to the base support member, and a distal end region, generally opposite the proximal end region, which is removed or separated from the base support member, thus defining a free end. Alternatively, opposite end regions of the tissue support member may be coupled to the base support member.

Advantageously, the tissue support member may be substantially elongate, and may be rectangular, triangular, partially circular, polygonal or the like.

Advantageously also, the tissue support member may comprise a generally flat sheet like member.

Advantageously, the base support member may comprise a sheet form member. Alternatively, the base support member may comprise a slab, block or the like.

The tissue support member may extend outwardly from a generally planar surface of the base support member. However, in a preferred embodiment, the tissue support member extends from an edge region of the base support member.

Preferably, the edge region of the base support member from which the tissue support member extends is profiled. The profile of the edge region may be selected to conform to the shape of a body part or at least a portion of a body part. The edge profile may be curved or rectilinear, or any suitable combination thereof. In use, the base support member may be positioned such that the profiled edge region is located against or adjacent the required body part, which advantageously also positions the tissue support member adjacent said body part. The tissue support member may then be manipulated and formed to adopt a shape suitable for supporting body tissue in the required manner.

In a preferred embodiment of the present invention, the edge profile is curved and is adapted to generally conform to the shape of at least a portion of a breast or breasts of a patient. Accordingly, in use, the profiled edge may be positioned adjacent a breast or breasts and the tissue support member then manipulated to support breast tissue in the required manner.

Alternatively, or additionally, the base support member may be positioned adjacent an open wound, created for example during a operative procedure, and the tissue support member then being manipulated to support tissue, such as muscle, organs, glandular tissue, fat or the like, around or within the wound, or alternatively removed or partially removed from the wound or body cavity. Such an arrangement may be of particular advantage when used during operative procedures on the trunk of a patient, particularly in the abdominal or chest regions, for example.

The edge region of the base support member, from which the tissue support member extends, preferably defines a periphery of an aperture formed within said base support member. The aperture may be circular, ovoid, polygonal, or any suitable shape. Preferably, the aperture generally conforms to the shape of a body part.

Advantageously, the aperture is adapted for receiving at least a portion of a body part therethrough. In a preferred embodiment, the aperture is adapted to receive at least a portion of a breast or breasts of a patient, and the tissue support member is adapted to support breast tissue, preferably during an operative procedure. Preferably, the tissue support member is adapted to support breast tissue during intraoperative radiotherapy (IORT) procedures, wherein the tissue support member is adapted to support and compress an appropriate region of tissue against an LORT probe. This arrangement enhances the adherence of the breast tissue to the applicator surface that is achieved by the purse string suture and in some cases could eliminate the need for a deeper or any purse string suture.

In an alternative arrangement, the aperture may be of a form adapted to be positioned over an incision or the like, wherein the tissue support member is adapted to be manipulated to support body tissue within the body, accessed via said incision. 7

Preferably, a plurality of tissue support members are provided and coupled to the base support member. Preferably also, the tissue support members are coupled to the edge region of the base support member, preferably around the periphery of an aperture defined by said edge region. Advantageously, the tissue support members may be coupled to one or more sides of the periphery of the aperture. Alternatively, the tissue support members are distributed around the entire periphery of the aperture.

Advantageously, each tissue support member comprises a proximal end region coupled to the edge region of the base support member, and a distal free end region.

Advantageously, when each tissue support member is aligned in the plane of the base support member, the distal end regions of the tissue support members may be positioned adjacent each other, and are preferably located centrally of the aperture.

Beneficially, the aperture may be substantially closed by the tissue support members when said members are positioned in the plane of the base support member.

Conveniently, the tissue support members may form a plurality of leaf portions extending around the periphery of the aperture formed within the base support member.

Beneficially, each tissue support member may be of a generally triangular, rectangular, polygonal or the like form, or any suitable combination thereof. In a preferred arrangement, at least one of the tissue support members is of a generally triangular form, and at least one other tissue support member is of a generally rectangular form. Preferably, where the tissue support members are distributed about the periphery of an aperture in the base member, a plurality of said tissue support members are of a triangular form and are each separated by a tissue support member of a generally rectangular form. This arrangement assists to maxirnise the available * 8 support capability as the alternate forms of support member permit a greater range of supporting forms to be adopted.

Preferably, the tissue support apparatus further comprises anchor means. The anchor means is preferably provided in the tissue support member, and may alternatively, or additionally be provided in the base support member.

Advantageously, the anchor means may provide an anchor for, for example, a portion of tissue. The anchor means may comprise suture anchor means for receiving a suture or sutures which may be additionally secured to a portion of tissue, such as a section or flap of skin. This arrangement is particularly advantageous in surgical applications wherein a section of skin around a surgical incision may be folded back and retained in place by suturing the skin to the support apparatus of the present invention.

According to a second aspect of the present invention, there is provided a breast tissue support apparatus comprising: a base support member defining an aperture therein adapted to be positioned over a breast or breasts of a patient; at least one breast tissue support member coupled to the base support member and extending from a peripheral edge of said aperture, wherein said tissue support member is plastically deformable and is adapted to be plastically deformed to adopt a shape for use in supporting breast tissue.

Preferably, the breast tissue support apparatus is adapted for use in intraoperative radiotherapy (IORT) procedures, wherein said tissue support member is adapted to compress a desired region of breast tissue into intimate contact with an IORT probe.

According to a third aspect of the present invention, there is provided a method of supporting body tissue, said method comprising the steps of: providing a tissue support apparatus having a base support member and a tissue support member mounted thereon, wherein said tissue support member is plastically deformable; positioning said tissue support apparatus adjacent a region of body tissue to be supported; and plastically deforming said tissue support member to adopt a shape to engage and support the body tissue.

Preferably, the method comprises supporting body tissue during a surgical procedure, such as an intraoperative radiotherapy procedure, and in particular during breast intraoperative radiotherapy procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which: Figure 1 is a diagrammatic perspective view from above of a tissue support apparatus in accordance with an embodiment of the present invention; Figure 2 is a diagrammatic perspective view from below of the tissue support apparatus of Figure 1; and Figure 3 is a view of a tissue support apparatus according to an embodiment of the present invention shown in use.

DETAILED DESCRIPTION OF THE DRAWINGS

Reference is first made to Figures 1 and 2 of the drawings in which there is shown perspective views, from above and below respectively, of a tissue support apparatus according to an embodiment of the present invention, wherein the apparatus I0 is generally identified by reference numeral 10. The apparatus 10 is adapted for use in supporting breast tissue, as will be described in detail below, and comprises a base support member 12, generally in the form of a flat sheet member, and a plurality of tissue support members 14 integrally formed therewith and forming leaf portions.

The members 14 are distributed around an aperture 16 formed in the base member 12, best seen in Figure 2, and consist of a plurality of triangular shaped members I 4a and a plurality of generally rectangular shaped members I 4b interposed therebetween.

The apparatus 10 may therefore be formed from a single sheet, wherein an arrangement of slits are cut therethrough in the required maimer to define the support members 14.

The apparatus 1 0 is formed of lead coated in a plastic material. The tissue support members 14 are malleable and capable of being repeatedly plastically deformed. Accordingly, in use, members 14 may be deformed upwardly from the plane of the base member 12, as shown in Figures 1 and 2, with the entire apparatus 10 being positioned over a patient such that a breast is positioned within the aperture 16. The support members 14 may then be manipulated and reformed to be compressed against the breast in order to provide the required degree of support.

This particular use of the apparatus 10 will now be described in further detail with reference to Figure 3, in which the apparatus 10 is shown in use during an operative procedure on a breast, identified by reference numeral 1 8. In the example shown, a lumpectomy has been performed to remove diseased breast tissue via an incision 20. It is to be noted that each support member 14 defines one or more holes 22 which provide suture attachment points for anchoring sections of the skin positioned around the incision 20 to thus be held spread apart by sutures 24.

As noted above, in such lumpectomy procedures there is a risk that malignant cells remain in the breast adjacent to the operative site, and to prevent recurrence and spreading of the disease, these cells must be destroyed. Recent surgical practices include the use of intraoperative radiotherapy (IORT) which utilises an IORT device 26 for transmitting X-rays into the target breast tissue. The device 26 comprises a spherical probe for emitting X-rays, wherein the probe in the arrangement shown in Figure 3 is located within the breast 18, in the wound created by the lumpectomy, the region of which is indicated by reference numeral 28. In order to ensure adequate transmission of the X-rays into the target breast tissue, it is required that the tissue be brought into and retained in intimate contact with the probe of the device 26. The apparatus 10 according to the present invention permits this intimate contact to be achieved and controlled by the surgeon or his assistant in a simple and effective manner, without causing any obstruction to the device 26, as discussed below.

The support members 14 are deformed upwardly from the base member 12 such that the breast 18 may be inserted through the aperture 16 (Figures 1 and 2), and the probe of the device 26 then inserted through the incision 20 and located generally within the wound created by the lumpectomy. Selected support members 14 may then be manipulated by the surgeon to engage and compress the outer surface of the breast 18, thus moving and retaining the target breast tissue into intimate contact with the probe.

The present invention provides significant advantages over prior arrangements. For example, the provision of malleable support members which can be repeatedly plastically deformed allows a large range of breast sizes, and indeed of other body parts to be accommodated, and also allows for a large degree of adjustment and refinement to be made. Additionally, the base member may be readily deformed to accommodate various patient sizes.

It should be understood that the embodiment described herein is exemplary of the present invention and that modifications and variations may be made without departing from the scope of the invention. For example, the apparatus may be formed of any other suitable malleable material. Additionally, the base support member, tissue support members and aperture within the base member may be of any appropriate shape or form. Furthermore, the tissue support members may alternatively, or additionally, be located on an external edge portion of the base member. Still further, the apparatus may be used in alternative surgical procedures, such as in abdominal procedures where the tissue support members may be utilised to retain or support abdominal contents. Additionally, the apparatus may be utilised in dentistry as, for example, a tongue retractor.

Claims

CLAIMS: 1. A tissue support apparatus comprising: a base support

member; and a tissue support member coupled to the base support member and extending outwardly therefrom, wherein said tissue support member is plastically deformable and is adapted to be plastically deformed to adopt a shape for use in supporting body tissue.

2. The tissue support apparatus of claim I, wherein the tissue support member is adapted to support internal and external body tissue.

3. The tissue support apparatus of claim 1 or 2, wherein the tissue support member is adapted to support internal body tissue from a location external of the body cavity.

4. The tissue support apparatus of claim 1, 2 or 3, wherein the tissue support member is malleable.

5. The tissue support apparatus of any preceding claim, wherein the tissue support member comprises a malleable metal or metal alloy.

6. The tissue support apparatus of any preceding claim, wherein the tissue support member comprises lead.

7. The tissue support apparatus of any preceding claim, wherein the tissue support member comprises a moulding material.

8. The tissue support apparatus of claim 7, wherein the moulding material is curable.

9. The tissue support apparatus of claim 7, wherein the moulding material is non-curable.

10. The tissue support apparatus of any preceding claim, wherein at least the tissue support member is at least partially encapsulated in a cover material.

11. The tissue support apparatus of any preceding claim, wherein the base support member is at least partially encapsulated in a cover material.

12. The tissue support apparatus of any preceding claim, wherein the tissue support member is integrally formed with the base support member.

13. The tissue support apparatus of any preceding claim, wherein the base support member is plastically deformable.

14. The tissue support apparatus of any preceding claim, wherein the tissue support member comprises a proximal end region coupled to the base support member, and a distal end region defining a free end.

15. The tissue support apparatus of any preceding claim, wherein the tissue support member comprises a generally flat sheet like member.

16. The tissue support apparatus of any preceding claim, wherein the base support member comprises a sheet form member.

17. The tissue support apparatus of any preceding claim, wherein the tissue support member extends outwardly from a generally planar surface of the base support member.

18. The tissue support apparatus of any preceding claim, wherein the tissue support member extends from an edge region of the base support member.

19. The tissue support apparatus of claim 18, wherein the edge region of the base support member from which the tissue support member extends is profiled.

20. The tissue support apparatus of claim 19, wherein the profile of the edge region is selected to conform to the shape of a body part.

21. The tissue support apparatus of claim 19 or 20, wherein the edge profile is curved and is adapted to generally conform to the shape of at least a portion of a breast of a patient.

22. The tissue support apparatus of any one of claims 1 8 to 21, wherein the edge region of the base support member from which the tissue support member extends defines a periphery of an aperture formed within said base support member.

23. The tissue support apparatus of claim 22, wherein the aperture is adapted to receive at least a portion of a body part therethrough.

24. The tissue support apparatus of claim 23, wherein the body part is a breast.

25. The tissue support apparatus of any preceding claim, wherein the tissue support member is adapted to support breast tissue during intraoperative radiotherapy (IORT) procedures, wherein the tissue support member is adapted to support and compress an appropriate region of tissue against an JORT probe.

26. The tissue support apparatus of any preceding claim, wherein a plurality of tissue support members are provided and coupled to the base support member.

27. The tissue support apparatus of claim 26 when dependent on any one of claims 22 to 25, wherein the tissue support members are distributed around the entire periphery of the aperture.

28. The tissue support member of claim 27, wherein, when each tissue support member is aligned in the plane of the base support member, distal end regions of the tissue support members are positioned adjacent each other.

29. The tissue support member of claim 26, 27 or 28, wherein at least one of the tissue support members is of a generally triangular form, and at least one other tissue support member is of a generally rectangular form.

30. The tissue support apparatus of any preceding claim, further comprising anchor means.

31. The tissue support apparatus of claim 30, wherein the anchor means is provided in the tissue support member.

32. The tissue support apparatus of claim 30 or 31, wherein the anchor means provides an anchor for a portion of tissue.

33. The tissue support apparatus of claim 30, 31 or 32, wherein the anchor means comprises suture anchor means adapted to receive a suture secured to a portion of tissue.

34. A breast tissue support apparatus comprising: a base support member defining an aperture therein adapted to be positioned over a breast or breasts of a patient; at least one breast tissue support member coupled to the base support member and extending from a peripheral edge of said aperture, wherein said tissue support member is plastically deformable and is adapted to be plastically deformed to adopt a shape for use in supporting breast tissue.

35. The breast tissue support apparatus of claim 34, adapted for use in intraoperative radiotherapy (IORT) procedures, wherein said tissue support member is adapted to compress a desired region of breast tissue into intimate contact with an IORT probe.

36. A method of supporting body tissue, said method comprising the steps of: providing a tissue support apparatus having a base support member and a tissue support member mounted thereon, wherein said tissue support member is plastically deformable; positioning said tissue support apparatus adjacent a region of body tissue to be supported; and plastically deforming said tissue support member to adopt a shape to engage and support the body tissue.

37. The method of claim 36, comprising supporting body tissue during a surgical procedure.

38. The method of claim 37, wherein the surgical procedure is a breast intraoperative radiotherapy procedure.