WO2005092212A1

WO2005092212A1 - Method and apparatus for suturing

Info

Publication number: WO2005092212A1
Application number: PCT/AU2004/001692
Authority: WO
Inventors: Vladimir Breskin; Mikhail Soutorine; Igor Tchepikov
Original assignee: Rintek Systems Pty. Ltd.
Priority date: 2004-03-29
Filing date: 2004-12-02
Publication date: 2005-10-06

Abstract

An apparatus for fastening material including a dispenser (2) with an outlet (5) arranged to be positioned adjacent the material and a shaping section (10) arranged to receive a fastener (9) in a first configuration and to allow the fastener to be dispensed from the outlet and through the material (30,31) in a looped configuration.

Description

METHOD AND APPARATUS FOR SUTURING

Field of the Invention

The invention relates generally to a method and apparatus for fastening particularly, but not exclusively, for suturing in medical applications.

Background of the Invention

It is known to join tissue in medical applications using sutures which may be in the form of a series of threaded stitches. The stitches usually require a surgeon to have reasonably free access to a suture site in order to allow the surgeon to manipulate a threading needle. Manual sewing of the stitches can be somewhat difficult and time consuming in some circumstances. An alternative form of suturing uses staples which are driven out of a head of a stapler device through the tissue and then anchored in place by being deformed on an opposed anvil of the stapler device.

Object of the l-nvention

It is an object of the invention to provide an alternative method and apparatus for fastening material such as body tissue.

Summary of the Invention

In accordance with the invention there is provided an apparatus for fastening material including a dispenser with an outlet arranged to be positioned adjacent the material and a shaping section arranged to receive a fastener in a first configuration and to allow the fastener to be dispensed from the outlet and through the material in a looped configuration.

Preferably, the apparatus includes a plurality of openings and associated shaping sections. Preferably, the shaping sections are defined by curved tubes which communicate with respective guide channels.

In another aspect, there is provided a fastener formed using the apparatus.

In yet another aspect, there is provided a method for dispensing a fastener including driving a fastener in a first configuration through a shaping section of a dispenser so that the fastener is dispensed from an outlet of the dispenser in a looped configuration.

Brief Description of the Drawings

The invention is described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

Figure la is a cross-sectional view of an apparatus for suturing tissue; Figure lb is a front view of the apparatus of Figure la;

Figure 2a is a cross-sectional view showing an alternative form of apparatus;

Figure 2b is a front view of the apparatus of Figure 2a;

Figure 3 is a perspective view of a front end of another apparatus;

Figure 4 is a perspective view of internal tubing of the apparatus of Figure 3; Figure 5 is a cross-sectional view of the apparatus of Figure 3;

Figure 6 is a photograph of a dispenser and piston of the apparatus of Figure 3;

Figure 7 is a photograph of the apparatus of Figure 3;

Figure 8 is a partial sectional view of the apparatus of Figure 3 being used to suture a T- joint; Figure 9 is a partial perspective view of the T-joint of Figure 8;

Figure 10 is a diagrammatic perspective view of another apparatus;

Figure 11 illustrates the apparatus of Figure 10 with tubes in a deployed condition;

Figure 12 illustrates the apparatus of Figure 11, with fasteners getting dispensed;

Figure 13 is a photo graph of the apparatus of Figure 7 being used to secure a prosthesis in an artery;

Figure 14 is a photograph showing fasteners securing the prosthesis to the artery; Figure 15 is a photograph showing the prosthesis fastened to the severed artery; Figure 16 is a photograph showing a weight test applied to the fasteners joining the prosthesis and artery; and

Figure 17 is a perspective view of a fastener of different pitch being formed.

Detailed Description

Referring firstly to Figure 1, an apparatus 1 is shown as comprising a dispenser 2 with a generally elongate tubular body 3 that includes a guide channel 4 which communicates with an outlet 5 via a shaping section 6. The dispenser 2 is adapted to be positioned adjacent two layers of material 7, 8 formed of, for example, biological tissue so that a fastener 9 can exit the outlet and pass directly through the tissue. The shaping section 6 is in the form of a curved tube 10 which is an extension of the guide channel 4 and the walls of the tube serve to shape a fastener passing out of the outlet from a first configuration within the channel to a looped configuration, as shown.

The particular looped configuration of the fastener after it leaves the dispenser 2 is illustrated as circular so that it pierces both layers 7, 8 of tissue at a first location 11 and then returns through the tissue at a second location 12 on an opposite side of an opening 13 in the tissue. The body 3 of the dispenser is provided with a rebate 14 adjacent the outlet 5 to accommodate a free end 15 of the fastener 9 as it loops back toward the outlet 5 so that the fastener 9 can be formed into an overlapped ring structure. The material of the fastener 9 is preferably selected to retain shape memory once it is in the looped configuration.

A cutting blade 16 may also be provided to slide longitudinally of the dispenser in order to sever the fastener 9 once a desired length of the fastener 9 has been dispensed from the outlet 5. Alternatively, the fastener 9 may be dispensed in pre-cut lengths.

An alternative construction of the apparatus 1 of Figure 1 is shown in Figure 2, where like parts are denoted with like reference numerals. The operation of the apparatus 1 shown in

Figure 2 is essentially the same as that described with reference to Figure 1 except that the outlet 5 is provided in a bevelled front end 17 of the dispenser 2 and the fastener 9 is caused to loop in an opposite direction, away from the front end 17. The returned loop of the fastener 9 shown in Figure 2, is again accommodated within a rebate 14 formed in the body 3.

The apparatus of Figure 2 is also shown in a different fastening application, joining two layers 7, 8 of tissue arranged normally of each other, as opposed to the overlapped configuration shown in Figure 1.

A dispenser 2 of another apparatus 1 is shown in Figure 3. Again, like reference numerals are used to denote like parts. The apparatus 1 of Figure 3 includes a central tubular body 3 with a plurality of radially arranged shaping sections 6 which are defined by curved tubes 10. The body 3 has an outer casing 18 which has a rebate 14 associated with each of the tubes 6 to accommodate a returned loop of fasteners dispensed from each of the respective tubes 10. The casing 18 also provides a support surface 19 adjacent each tube 10 to support layers to be joined by the fasteners, when a free end of each fastener is looped back to pierce the tissue as it is formed into a circular configuration.

A perspective view of the arrangement of tubes and guide channels 4 inside the casing 18 is shown in Figure 4. Each tube 10 is fastened relative to the body 3 at a front end 17 of the dispenser 2 and extends lengthwise of the body to communicate with the guide channels 4.

Figure 5 is a cross-sectional view illustrating a length of wire 20 within one of the tubes 10. Each of the guide channels 4 are arranged to initially receive a respective wire 20 which is then transferred into the tube 10. The guide channels 4 subsequently receive a push rod 21 associated with a piston 22, which is arranged to travel lengthwise through the casing 18 in order to force the wire through the shaping section 6 and out through the respective outlet 5.

A perspective view of the apparatus 1 is shown in the photographs of Figures 6 and 7, where the rods 21 and piston 22 are clearly illustrated. The piston 22 is preferably coupled to a drive member 23 which is housed within an elongate conduit 24 which may be screw- fitted to a threaded end 25 of the dispenser 2.

The dispenser 2 may then be positioned in any suitable location where fastening or suturing is required, such as a T-junction 26, as illustrated in Figure 8, where the fasteners 9 are shown in an almost fully dispensed configuration. Once the fasteners 9 are, in fact, fully dispensed, the dispenser 2 may be withdrawn leaving the T-junction secured in the manner illustrated in Figure 9.

Figures 10 and 11 illustrate another apparatus 1, again where like parts are denoted by like reference numerals, in which the outer casing 18 is removed. The apparatus 1 includes a mechanism 27, in the form of a cam or ball structure 28 which is operable to move from a first configuration relative to the tubes 10, as shown in Figure 10, to a retracted second configuration shown in Figure 11, whereby to force the tubes outwardly from a stored position to a radially and/or axially displaced deployed position. Actuation of the mechanism 27 is achieved via a plunger 29. It should be appreciated the mechanism 27 allows the overall radial dimension of the apparatus 1 to be reduced when the tubes 10 are in a stored position and that increases the ease with which the dispenser 2 is delivered to a site for suturing, if access is through a narrow passage such as a vein, artery or other organ. Once in position, the tubes 10 are simply moved into the deployed condition so that the respective outlets 5 are adjacent material layers 7, 8 that need to be fastened. The fasteners 9 may then be dispensed, as illustrated in Figure 12. In the illustrated example, the layer 7 represents an artery (urethra or any tubular organ in the body) or the like and the layer 8 represents a tubular prosthesis.

Figure 13 shows an actual example of the apparatus 1 being used to fasten a prosthesis 30 within an artery 31. The apparatus 1 is the same as that described with reference to Figure 7. h order to attach the prosthesis 30, the artery 31 is initially clamped and an incision 32 is made to insert the prosthesis 30, which is in the form of a sheath, shown covering the dispenser and conduit. Once the prosthesis 30 is appropriately located, the fasteners 9 are dispensed to secure the prosthesis 30 in place and the apparatus 1 is then removed, as illustrated in Figure 14. In this instance, the incision 32 was again stitched and the clamp removed in order to demonstrate the secure anchoring of the prosthesis, which allowed continued blood flow through the artery.

Once successfully demonstrated, the artery 31 was severed and trimmed back in order to more clearly illustrate the nature of attachment between the prosthesis and the artery, as illustrated in Figure 15. A weight test was subsequently applied, as shown in Figure 16, in order to also demonstrate the secure nature of the attachment afforded by the fasteners 9.

The fasteners 9 need not necessarily be used for joining two separate layers of material. For example, the fasteners 9 may be used to join a tear or gap in a single layer of material. A suitable single fastener 9 for that purpose is shown in Figure 17, where like parts are again denoted with like reference numerals. The fastener 9 is, in this instance, in the form of an extended helix or spiral which may be driven out of the tube 10 so as to pierce the material on opposed sides of the gap (not shown) as the fastener 9 is spirally forced from the tube 10. The fastener of Figure 17 could also be used for other applications such as for reinforcing an organ either internally or externally to secure the organ from collapse or expansion, respectively.

It should be noted the pitch of the fastener 9 of Figure 17 is somewhat greater than the fasteners described with reference to previous Figures as a result of a modified orientation of the shaping section 6 or curved tube 10 relative to the feed direction, indicated by arrow A', of the fastener as it is driven into the shaping section 6.

Indeed, the orientation of the tube 10 can be selected so that the fastener 9 is forced transversely of the feed direction A, so as to adopt any desired looped configuration, to achieve a predetermined curvature and pitch between adjacent looped portions of the fastener 9. To further facilitate shaping of the fastener, the tube 10 may have an internal cross-sectional profile, such as oval/elliptical or the like, to peripherally engage an appropriately shaped profile of the fastener and guide the fastener into the looped configuration.

Additionally, the fastener itself may have variable mechanical properties such as temper, along its length so that can be easily notched for separation and/or so that different portions of the fastener have different curvatures, when the fastener is in the looped configuration. Such a fastener may be ideal for use as a conventional stent or the like.

The fastener 9 may also be adapted to carry a dose of drugs/pharmaceuticals in a hollow interior or on a specially treated external surface. Alternatively, the fastener may be used to anchor an implant or dosage delivery device.

The fastener 9 and the method of delivery need not be limited to medical applications. For example, the apparatus 1 and method of dispensing fasteners 9 may have application in relation to joining other forms of material such as fabrics, leather, cardboard, paper, plastics, etc. in any relevant field where fasteners are required.

Claims

CLAIMS:

1. An apparatus for fastening material including a dispenser with an outlet arranged to be positioned adjacent the material and a shaping section arranged to receive a fastener in a first configuration and to allow the fastener to be dispensed from the outlet and through the material in a looped configuration.

2. An apparatus as claimed in claim 1, wherein the dispenser includes a rebate adjacent the opening to accommodate a return looped portion of the fastener.

3. An apparatus as claimed in claim 1 or 2, wherein the shaping section is defined by a curved tube.

4. An apparatus as claimed in claim 3, wherein the tube is curved transversely of a feed direction, along which the fastener is fed into the shaping section.

5. An apparatus as claimed in claim 4, wherein the tube is configured to form the looped fastener in a plane substantially normal to the feed direction.

6. An apparatus as claimed in any one of claims 3 to 5, wherein the tube is configured to form the fastener into a helical looped configuration,

7. An apparatus as claimed in any one of claims 3 to 6, wherein the tube has a cross- sectional profile adapted to peripherally engage and guide the fastener into the looped configuration.

8. An apparatus as claimed in claim 2, wherein the apparatus includes a support surface for supporting the material adjacent the rebate, in order to assist penetration of an end of the fastener through the material as the fastener is looped into the rebate.

9. The apparatus as claimed in any one of claims 1 to 8, wherein the apparatus includes an actuation assembly for forcing the fastener through the dispenser.

10. An apparatus as claimed in claim 9, wherein the actuation assembly includes a push rod arranged to travel lengthwise of the channel.

11. An apparatus as claimed in claim 10, wherein the push rod is coupled to an actuating piston.

12. An apparatus as claimed in any one of claims 1 to 11, wherein the apparatus includes a plurality of openings and associated shaping sections.

13. An apparatus as claimed in claim 12, wherein each shaping section is defined by a curved tube.

14. An apparatus as claimed in claim 12 or 13, wherein the dispenser is in the form of a tubular body and the shaping sections are radially arranged about the body.

15. An apparatus as claimed in claim 14, wherein the shaping sections are adapted to be radially displaced relative to the body.

16. An apparatus as claimed in claim 13, wherein the tubes are movable between an inward stored position and a radially and/or axially displaced deployed position for dispensing the fasteners.

17. An apparatus as claimed in claim 13 or 16, wherein the apparatus includes a cam device operable between first and second positions to move the tubes between the stored and deployed positions.

18. A fastener formed using the apparatus of any one of claims 1 to 17.

19. A fastener as claimed in claim 18, having a coil shape.

20. A fastener as claimed in claim 18 or 19, having a hollow interior.

21. A fastener as claimed in any one of claims 18 to 20, having a cross-sectional profile adapted to be peripherally engaged by the shaping section of the apparatus to facilitate shaping of the fastener into the looped configuration.

22. A fastener as claimed in any one of claims 18 to 21, adapted to carry a dose of pharmaceutical substance.

23. A fastener as claimed in any one of claims 18 to 22, having variable mechanical properties along a length thereof so that different portions of the fastener have different curvatures, when the fastener is in the looped configuration.

24. A fastener as claimed in any one of claims 18 to 23, having a spiral configuration.

25. A fastener as claimed in any one of claims 18 to 24, for use as a stent.

26. A method for dispensing a fastener including driving a fastener in a first configuration through a shaping section of a dispenser so that the fastener is dispensed from an outlet of the dispenser in a looped configuration.

27. A method as claimed in claim 26, wherein the fastener is caused to curve transversely of a feed direction, along which the fastener is driven into the shaping section, so as to adopt the looped configuration.

28. A method as claimed in claim 26 or 27, including passing the fastener through a curved tube, which defines the shaping section, in order to shape the fastener into the looped configuration.

29. A method as claimed in claim 28, wherein the orientation of the tube relative to the feed direction is selected to achieve a predetermined curvature and pitch between adjacent looped portions of the fastener.

30. A method as claimed in any one of claims 26 to 29, wherein the fastener is formed into a helical looped configuration or spiral looped configuration.

31. A method as claimed in any one of claims 26 to 30, including locating the opening of the dispenser adjacent material to be fastened and dispensing the fastener to pass through the material in the looped configuration.

32. A method as claimed in any one of claims 26 to 30, including dispensing the fastener in a spiral configuration internally or externally of an organ, in order to secure the organ against collapse or expansion, respectively.

33. A method as claimed in claim 28, including dispensing a plurality of fasteners from an associated plurality of curved tubes arranged about a periphery of the dispenser.

34. A method as claimed in claim 33, including moving the tubes from an inward stored position to a radially and/or axially displaced deployed position for dispensing the fasteners.

35. A method as claimed in claim 26, wherein the fastener is used to secure an implant or drug dose device.