AU4270400A - A connecting device for use in the creation of a vascular bypass - Google Patents

Description

A CONNECTING DEVICE FOR USE IN THE CREATION OF A VASCULAR BYPASS This invention relates to a connecting device for use in the creation of a vascular bypass.

This is a divisional application of Australian patent application no. 32951/97. In Australian patent application no. 32951/97 a catheter apparatus and a method for creating a vascular bypass in vivo is disclosed. In that application, applicant has identified that the cuff member is an important feature of the invention.

g The reason for this is that it is highly desirable to provide a means whereby a vascular segment can be anchored to a blood vessel during bypass surgery :15 without the need for invasive surgical techniques. The applicant has identified that, by providing a connecting device that can be used together with a suitable apparatus, such as an obturator, it would be possible to achieve such connection, without the invasive surgical procedures usually required.

20 According to a first aspect of the invention there is provided a connecting device for use in the creation of a vascular bypass, the connecting device including .oo at least one connecting member, the, or each, connecting member S"being receivable through a blood vessel wall so that a first end portion of the, or each, connecting member is receivable in a lumen of the blood vessel at least the first end portions being deformable, upon the exertion of a pressure on the end portions, into a condition in which the, or each, connecting member is anchored to the blood vessel, with at least one opposed, second end portion being configured so that the, or each, second end portion can be attached to a prosthetic or harvested vascular segment.

The first and second end portions of the, or each, connecting member may have substantially the same configurations.

The connecting device may include a single connecting member, the connecting member having a hollow body. The hollow body of the connecting member may be defined by a mesh of the deformable material.

The deformable material of the mesh may be selected from stainless steel, nickel/titanium alloys, aluminium/nickel alloys, graphite carbon, metallic blends of carbon, polyamides such as nylon, polyacrylates such as polyacrylic acid, polycarbonates such as poly [2,2-bis (4-hydroxyphenyl)] propone and polysiloxones.

15 The hollow body may be pre-stressed about a region intermediate the end portions to facilitate outward deformation of the first end portion.

In one embodiment, the mesh may be defined by a plurality of wires that are intertwined to define a repeating hexagonal structure. The wires may be connected 20 together so that the end portions are deformable in the manner described above, while the intermediate portion remains substantially unaltered.

In a further embodiment, the mesh may be defined by a plurality of closed loops, each closed loop being joined at multiple points along a perimeter to adjacent closed loops. The loops at the end portions may be positioned to facilitate deformation of the end portions. In particular, the loops at the end portions may be configured so that the ends portions can be deformed while the region intermediate the end portions remains substantially unchanged.

In another embodiment, the deformable cuff may be formed from a series of overlapping coils, with intersecting portions of the coils fused together to define the mesh.

In all embodiments, the mesh may be covered by at least one bio-compatible coating. The, or each, bio-compatible coating may be of a material that is selected from high temperature pyrongen-free carbon, polytetrafluoroethylene (PTFE), other polyhalogenated carbons, fibronectin, collagen, hydroxyethyl methacrylates (HEMA) and serum albumins.

The hollow body may be of a unitary, one-piece construction. The hollow body may then be scored to facilitate deformation of the end portions.

According to a second aspect of the invention, there is provided a connecting 15 assembly which includes a connecting device, as described above, connected to an end of a vascular segment.

The vascular segment may be selected from one of a saphenous vein, a cephalic vein and a basilic vein.

Instead, the vascular segment may be of a bio-compatible, synthetic material.

A connecting device for use in the creation of a vascular bypass and a connecting assembly, in accordance with this invention, may manifest themselves in a variety of forms. It will be convenient hereinafter to describe in detail some preferred embodiments of the invention with reference to the accompanying drawings. The purpose of this specific description is to instruct persons having an interest in the subject matter of the invention how to carry the invention into practical effect. It is to be clearly understood, however, that the specific nature of this description does not supersede the generality of the preceding broad description. In the drawings: Fig. 1 shows a first embodiment of a connecting device, in accordance with the invention, prior to deformation; Fig. 2 shows the connecting device of Fig. 1 in a deformed condition; Fig. 3 shows a second embodiment of a connecting device, in accordance with the invention, for use in the creation of a vascular bypass; Fig. 4 shows a third embodiment of a connecting device, in accordance with the invention, for use in the creation of a vascular bypass; Fig. 5 shows a fourth embodiment of a connecting device, in accordance with the invention, for use in the creation of a vascular bypass; Fig. 6 shows the connecting device of Fig. 1 connected to a vascular segment to define a connecting assembly, in accordance with the invention, mounted on an obturator of a vascular bypass apparatus; Fig'. 7 shows the connec'ting assembly of Fig. 6 within a lumen of the vascular bypass apparatus; .i 15 Fig. 8 shows a stage in the operation of the apparatus of Fig. 7; 1 Fig. 9 shows a further stage in the operation of the apparatus of Fig. 7; Fig. 10 shows a further stage in the operation of the apparatus of Fig. 7; Fig. 1 shows a further stage in the operation of the apparatus of Fig. 7; eo Fig. 11 shows a further stage in the operation of the apparatus of Fig. 7; and Fig. 12 shows a completed vascular bypass carried out using the connecting 20 device of the invention.

o*oo In Figs 1 and 2 reference numeral 10 generally indicates a connecting device, in accordance with the invention, for use in the creation of a vascular bypass.

The device 10 includes a connecting member 12. The connecting member 12 has a first and a second end portion 14, 16 respectively. The connecting member 12 also has an intermediate portion 18.

The connecting member 12 has a hollow body 20 that is defined by a mesh 22 of the deformable material 24.

The deformable material 24 can be a metal or an alloy. Thus, the deformable material 24 can be one of the following: stainless steel; nickel/titanium alloy; aluminium/nickel alloy; and graphite carbon and metallic blends of carbon.

Instead, the deformable material 24 may be in the form of a synthetic polymer.

Thus, the deformable material can be one of the following: polyamides such as nylon; polyacrylates such as polyacrylic acid; polycarbonates such as poly[2,2-bis (4-hydroxyphenyl)] propone; and polysiloxones.

Where necessary, the deformable material 24 can be covered with a prosthetic coating 26 (Figs 5 et Examples of suitable prosthetic coatings are: High temperature pyrongen-free carbon; polytetrafluoroethylene (PTFE) and other polyhalogenated carbons; 20 fibronectin; collagen; hydroxyethyl methacrylates (HEMA); and S" serum albumins.

The first and second end portions 14, 16 have the same configuration. Thus, it is not necessary for a surgeon to have regard to the particular orientation of the connecting member 12 prior to use thereof.

As can be seen in the drawings, the connecting member 12 is shown as having a generally right circular cylindrical structure throughout its length. It will readily be appreciated that the connecting member 12 can also have a non-uniform or anisotropic structure instead of an isotropic structure. In particular, the connecting member 12 can have any hollow structure, in this particular example.

The mesh 22 is configured so that either of the end portions 14, 16 can be deformed, radially outwardly, as shown in Fig. 2.

In order to facilitate deformation of the end portions 14, 16, the intermediate portion 18 is circumferentially prestressed at 28. It will be appreciated that this circumferential prestressing results in a tendency for the end portions 14, 16 to flare outwardly.

0g The mesh 22 of the connecting member 12 is defined by an open meshwork of :00000 wires 30 which are intertwined in a substantially hexagonal pattern.

In Fig. 3, reference numeral 34 generally indicates a second embodiment of a device, in accordance with the invention, for use in the creation of a vascular bypass. With reference to Figs. 1 and 2, like numerals refer to like parts, unless otherwise specified.

The mesh 22 of the connecting device 34 is defined by a plurality of closed loops 36, each closed loop 36 being jbined at multiple points 38 along its perimeter to adjacent closed loops 36.

The loops 36 at the end portions 14, 16 are positioned, in a spaced manner, to facilitate deformation of the end portions 14, 16.

As with the device 10, the device 34 is also circumferentially prestressed at 40 in the intermediate portion 18.

In Fig. 4, reference numeral 42 generally indicates a third embodiment of a connecting device, in accordance with the invention, for use in the creation of a vascular bypass. With reference to Figs 1 to 3, like numerals refer to like parts, unless otherwise specified.

The connecting member 12 of the connecting device 42 is formed primarily as a series of coiled wires 44. The coiled wires 44 overlap and intersecting portions 46 of the coiled wires 44 are fused together to define the mesh. Again, as with the device 10, 34, the intermediate portion 18 is prestressed at 48 to facilitate deformation of the first and second end portions 14, 16, as described earlier.

The mesh 22 of the connecting device 10, 34, 42 is configured so that deformation of the end portions 14, 16 can occur in a controlled fashion.

15 In Fig. 5, reference numeral 50 generally indicates a fourth embodiment of a connecting device, in accordance with the invention, for use in the creation of a vascular bypass. With reference to Figs 1 to 4, like numerals refer to like parts, oo unless otherwise specified.

20 As with the device 10, 34, 42, the intermediate portion 18 is prestressed at 52 to facilitate deformation of the end portions 14, 16.

S"In this embodiment, the connecting member 12 is not defined by the mesh 22.

Instead, the connecting member 12 is defined by a unitary, one piece structure 54, with the requirement that a material of the structure 54 is deformable, on demand, and is bio-compatible.

In order further to facilitate deformation of the device 50, a body 56 is pre-scored to form a series of intersecting score lines 58. Still further, the first and second end portions 14, 16 have edges 60 which are ridged to facilitate the deformation of the first and second end portions 14, 16.

As can be seen in the drawings, the connecting device 10, 34, 42, 50 is in the form of a substantially cylindrically shaped collar or cuff which is open at its ends, is hollow and has a substantially circular or-oval cross sectional area.

In each of the embodiments, the connecting member 22 is configured so that deformation can occur, on demand, via the application of radial forces by means of suitable equipment.

As can be seen in Fig. 2, deformation results in the end portions 14, 16 being expanded outwardly, flared and bent into a configuration which defines a lip 62. It is to be noted that in each of the embodiments, the connecting member 12 is 15 configured so that the intermediate portion 18 remains substantially unaltered during and after such deformation. Furthermore, the connecting member 12 is configured so that the lip 62 retains structural strength and resiliency subsequent to deformation.

20 In general, the intended functions of the embodiments of the connecting device are twofold in nature. Firstly, the device is intended to engage and become joined to a previously excised vascular segment, or a prosthetic vascular segment, which will serve as a bypass graft in-vivo. Secondly, the device is intended to be positioned within an internal lumen of the unobstructed major blood vessel (such as the aorta) and, thereafter, to become deformed in-situ such that a portion of the cuff becomes positioned and secured to the internal lumen of the unobstructed blood vessel permanently and in a fluid tight manner.

In Fig. 5, reference numeral 64 generally indicates a connecting assembly, in accordance with the invention, which includes the connecting device, also in 9 accordance with the invention, connected to a end 66 of the vascular segment 68.

The vascular segment 68 can be selected from one of a saphenous vein, a cephalic vein and a basilic vein. Instead, the vascular segment 68 can be of a biocompatible, synthetic material.

In those embodiments where the body 20 is formed of a mesh 22, the prosthetic coating 26 facilitates attachment of the vascular segment 68 to the hollow body by suturing or any other suitable connecting procedure. The prosthetic coating 26 also serves to enhance the sealing properties of the connecting device.

In Fig. 6, the connecting assembly 64 is shown within a lumen 70 of a catheter apparatus 71 as described in Australian patent application no 32951/97.

s 0'°.00 It follows that, in particular, the end portions 14, 16 are configured so that they can 15 be deformed, in situ, by an obturator 72 of that apparatus.

Figs 8 to 11 show successive stages in a method for creating a vascular bypass invivo using the connecting device of the invention. In Fig. 12, the lip 62 of the connecting member 12 can be seen engaging a wall 74 of a blood vessel 76. As 20 can be seen in Fig 10, the device is deformed in-situ such that one of the end portions 14, 16 is secured to the wall 74 permanently and in a fluid-tight manner.

An opposed end portion 14, 16 is connected to, for example, a previously excised vascular segment 68 which serves as the bypass graft.

The fact that the intermediate portion and that end portion which is not deformed remain substantially unaltered, greatly facilitates the in vivo use of the connecting device of this invention. The reason for this is that the connection of the vascular segment is not disturbed while the end portion is being deformed.

It will, of course, be realised that the above has been given only by way of illustrative example of the invention and that all such modifications and variations thereto as would be apparent to persons skilled in the art are deemed to fall within the broad scope and ambit of the invention as is herein set forth.

*C *e e

Claims (19)

1. A connecting device for use in the creation of a vascular bypass, the connecting device including at least one connecting member, the, or each, connecting member being receivable through a blood vessel wall so that a first end portion of the, or each, connecting member is receivable in a lumen of the blood vessel, at least the first end portions being deformable, upon the exertion of a pressure on the end portions, into a condition in which the, or each, connecting member is anchored to the blood vessel, with at least one opposed, second end portion being configured so that the, or each, second end portion can be attached to a prosthetic or harvested vascular segment. **o 15

2. A connecting device as claimed in claim 1, in which the first and second end portions of the, or each, connecting member have substantially the same configurations.

3. A connecting device as claimed in claim 2, which includes a single 20 connecting member, the connecting member having a hollow body.

4. A connecting device as claimed in claim 3, in which the hollow body of the connecting member is defined by a mesh of the deformable material.

5. A connecting device as claimed in claim 4, in which the deformable material of the mesh is selected from stainless steel, nickel/titanium alloys, aluminium/nickel alloys, graphite carbon, metallic blends of carbon, polyamides such as nylon, polyacrylates such as polyacrylic acid, polycarbonates such as poly[2,2-bis (4-hydroxyphenyl)] propone and polysiloxones.

6. A connecting device as claimed in claim 4 or claim 5, in which the hollow body is pre-stressed about a region intermediate the end portions to facilitate outward deformation of the first end portion.

7. A connecting device as claimed in any one of claims 4 to 6, inclusive, in which the mesh is defined by a plurality of wires which are intertwined to define a repeating hexagonal pattern.

8. A connecting device as claimed in claim 7, in which the mesh is defined by a plurality of closed loops, each closed loop being joined at multiple points along its perimeter to adjacent closed loops.

9. A connecting device as claimed in claim 8, in which the loops at the end 15 portions are positioned to facilitate deformation of the end portions.

A connecting device as claimed in any one of claims 4 to 6, inclusive, in which the deformable cuff is formed from a series of overlapping coiled wires, with intersecting portions of the coiled wires fused together to define 20 the mesh.

11. A connecting device as claimed in any one of claims 4 to 10, inclusive, in which the mesh is covered by at least one bio-compatible coating.

12. A connecting device as claimed in claim 11, in which the, or each, bio- compatible coating is of a material that is selected from high temperature pyrongen-free carbon, polytetrafluoroethylene (PTFE), other polyhalogenated carbons, fibronectin, collagen, hydroxyethyl methacrylates (HEMA) and serum albumins.

13. A connecting device as claimed in claim 2 or claim 3, in which the connecting member is of a unitary, one-piece construction.

14. A connecting device as claimed in claim 13, in which the connecting member is scored to facilitate deformation of the end portions.

A connecting assembly which includes a connecting device as claimed in any one of the preceding claims, connected to an end of a vascular segment.

16. A connecting assembly as claimed in claim 15, in which the vascular segment is selected from one of a saphenous vein, a cephalic vein and a basilic vein. 15

17. A connecting assembly as claimed in claim 15, in which the vascular o. segment is of a bio-compatible, synthetic material.

18. A new connecting device, substantially as described herein, with reference to the accompanying drawings.

19. A new connecting assembly, substantially as described herein, with reference to the accompanying drawings. DATED THIS TWENTY SEVENTH DAY OF JUNE 2000 BETH ISRAEL DEACONESS MEDICAL CENTER BY PIZZEYS PATENT AND TRADE MARK ATTORNEYS