WO2002009593A1 - Suture reinforcing device - Google Patents

Suture reinforcing device Download PDF

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Publication number
WO2002009593A1
WO2002009593A1 PCT/FR2000/002182 FR0002182W WO0209593A1 WO 2002009593 A1 WO2002009593 A1 WO 2002009593A1 FR 0002182 W FR0002182 W FR 0002182W WO 0209593 A1 WO0209593 A1 WO 0209593A1
Authority
WO
WIPO (PCT)
Prior art keywords
fabric
device according
material
device
alginate
Prior art date
Application number
PCT/FR2000/002182
Other languages
French (fr)
Inventor
Philippe Maingault
Original Assignee
Les Laboratoires Brothier
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Les Laboratoires Brothier filed Critical Les Laboratoires Brothier
Priority to PCT/FR2000/002182 priority Critical patent/WO2002009593A1/en
Publication of WO2002009593A1 publication Critical patent/WO2002009593A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/042Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292Reinforcements for staple line, e.g. pledgets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive

Abstract

The invention concerns a device comprising a polysaccharide material fabric, at least partly coated with a polymer-based hydrophilic and water soluble material, designed to provide water tightness and shape to the fabric. The fabric and the alginate coating material can be respectively calcium alginate and alginate. The invention is very applicable to suture reinforcements, in the field of thoracic surgery.

Description

REINFORCING DEVICE SUTURE

In surgery, including thoracic surgery, it is appropriate, after certain operations such as partial resection or organ rupture, to suture the severed tissue using staples or son, for example.

A suture staples, to use this example, takes place using a gripper stapler ^ 'having two branches, one being the staple magazine function and the other acting as an anvil. Suturing the two edges of a wound, for example, one takes the two lips between the two legs of the clip and then actuates the latter thereby causing the laying of a row of staples closing the wound. With the staples used, which are generally metallic, there is a significant risk of tissue disruption. To overcome this drawback, it is known to use suture reinforcing devices. There are mainly two types.

The suture reinforcement devices of the first type consist of collagen films. They are absorbable and promote wound healing. However, collagen virus poses safety problems and its use has been banned by some laws. In addition, collagen-based devices are difficult to shape, so that they can only be used in sheets need to be ligated to the branches of the clamp stapler prior to the laying of staples.

The suture reinforcement devices of the second type consist of PTFE sheaths (polytetrafluoroethylene). This is of an inert thermoplastic material which is easy to shape. PTFE sheaths bonk therefore easily on the branches of the clip stapler. However, these sleeves have several disadvantages. For one, they are not resorbable and as any prosthesis, are prone to bacterial contamination. On the other hand, tissue holes created by staples let through the blood and air, which can be troublesome in the case of pulmonary resection in particular. Finally, the PTFE has no biological activity and therefore does not promote wound healing. However, should the suture reinforcement devices, in addition to good mechanical strength, have an effective action to promote hemostasis, cessation of the air passage (aerostasis) and scarring.

The present invention provides a suture reinforcing device overall more satisfactory than those of the prior art.

To this end, the invention relates to a suture reinforcement means comprising a cloth polysaccharide-based material, and means for sealing the fabric.

Advantageously there is provided means for shaping the fabric.

With this, the device can be easily formed into sheath, for example, to be fitted onto a suture stapler clamp arm.

In a particular embodiment, the means for sealing the fabric are arranged to seal the tissue in liquid media.

With this, the fabric becomes tight upon contact with blood.

Advantageously, the fabric is coated at least partly of a hydrophilic material to seal the tissue.

Also advantageously, the coating of the fabric material is hydxosoluble.

In contact with blood, the coating material liquefies and is responsible for the biological fluid. Thus, due to the molecular mobility and the swelling by absorption of body fluid, the coating material completely covers the fabric and, if necessary, envelope staples. He closes.! Therefor the interstices of the fabric and the perforations staples. After laying on the sutured tissue, the device is completely sealed and thus fully playing its role aerostatic and hemostasis.

In another embodiment, the means for sealing tissue includes a sealing material completely covering the fabric. Advantageously, the fabric is coated at least partially with a material based on a polymer for sealing and shaping of the fabric.

The coating material thus plays a dual role. For one, it helps to seal the device and, secondly, it gives it sufficient mechanical strength for its formatting.

Advantageously, the polymer comprises a polysaccharide, without excluding protein.

Preferably, the polymer comprises at least one elements of the group comprising alginate and hyaluronic acid.

More preferably, the fabric is alginate based material.

The fabric may be a knit or a woven web.

The invention will be better understood using the following description of the suture reinforcement device of the invention, according to two particular embodiments, with reference to the accompanying drawings wherein:

- Figure 1 shows a diagram of a suture stapler clamp and two suture reinforcing devices according to one of the embodiments;

- Figures 2 to 8 show successive manufacturing steps of one of the suture devices of Figure 1 and

- Figure 9 shows successive manufacturing steps of the suturing device according to another embodiment.

The suture reinforcement devices 1, 2, shown in Figure 1, each consist of a knitted sheath, ie in knitted fabric, jersey, intended to be fitted on an arm 4, 5 of a gripper stapler suture 3, in this case the clamp sold under the reference MULTIFIRE GIA 80 by the Auto suture society.

Suture stapler clamp 3 comprises two limbs 4, 5, one 4 acting as the staple magazine and the other 5 acting as an anvil. The two arms 4, 5 have here a generally parallelepipedic shape. For suturing two sectioned parts, having fitted the devices 1 and 2 respectively on the charger branch 4 and the anvil leg 5 of the clip 3, it takes the two sectioned parts between the two arms 4, 5 of the pliers 3 and actuates thereof, thereby posing a row of staples joining the two parts.

The fabric of each device 1 (2) suture reinforcement is made of calcium alginate and partially coated with a coating material based on polymer, in the case of the alginate.

The alginate coating is waterproof, water-soluble and hydrophilic. Due to these properties, when the device 1 (2) is in liquid medium, and in particular -in contact with blood, the alginate coating is intended to soften and absorb body fluid, swelling, which it allows to spread over the entire surface of the fabric and the cover completely, thus ensuring the airtightness and liquid of the device 1 (2).

In addition, the alginate coating gives the fabric a certain rigidity, allowing its shaping. The device 1 (2) is here formed into parallelepipedic form sheath, complementary to that of the branch 4 (5) of the suture clip 3 on which it is intended to be fitted.

The alginate coating plays a dual role. On the one hand, it is intended to seal the device 1 (2) and, secondly, it allows the shaping sleeve parallelepiped.

The manufacturing process of the device 1 intended to be fitted on the loader arm of the clamp 3 will now be described.

To manufacture the device 1, it takes a linear knitting machine which is supplied by calcium alginate fibers. Using this art, a tubular knitted fabric is carried out 6 Jersey (Figure 2). Knitting the diameter is such that its perimeter, in cross section, is substantially equal to that of the branch 4 of the suture clamp 3 on which the device 1 is intended to be fitted. In this case, for the device 1 intended to be fitted on the branch charger 4, the diameter of the sleeve must be equal to 15 mm. For the device 2 to be fitted onto the anvil part 5, the diameter of the sheath should be equal to 13 mm.

6 is threaded knitting on a form 7 as shown in Figures 3 and 4. The shape is non-stick material, in this case by the trademark Teflon material, and reproduces the shape of the branch clamp 4 suture 3, on which the device 1 is intended to be fitted. Then immersed shape 7 dressed knitting 6, 8 in a bath containing an aqueous solution of 3% alginate ester, in order to coat the fabric 6 (Figure 5).

Is then removed from the form 7, dressed knitting 6 out of 8, the bath by a drive upward movement, and is scraped knitting 6, using flexible scrapers 9 (Figure 6). This removes the excess of coating alginate solution so that the coating material only partially covers the fabric 6.

In an oven by 45 ° C (Figure 7), dried with hot air knitting 6 partially coated, which stiffens it dries. Knitting 6 then takes the form of a parallelepipedic casing having a certain rigidity, a complementary shape to that of the branch 1 of the suture clamp 3 on which the device 1 is intended to be fitted. This sheath constitutes the device 1.

Finally, the device is removed from the form 1 7, pushing it with the aid of stops 10 (Figure 8).

The method of manufacturing the device 2, intended to be fitted onto the anvil part of the clamp 3, is similar to the method just described.

The use of suture reinforcing devices 1, 2 will now be explained, in a particular example consisting in the suture of the two lips of a wound.

Is threaded in advance the devices 1 and 2 respectively on the charger branch 4 and the anvil 5 of the branch clamp 3. We take the two edges of the wound between the two arms 4, 5 of the gripper 3 then actuates celle- above by causing the laying of a row of staples closing the wound. The reinforcing devices 1, 2 are thus stapled against the wound to either side thereof, and the reinforcing during healing. Then the legs 4 is removed, 5 out of the devices 1, 2, by cutting the latter in the longitudinal direction, in the part facing the stapled tissue.

The alginate present in the tissue and into the coating material, has particularly advantageous intrinsic properties for sutures. On the one hand, it facilitates tissue healing by activation of cells involved in this phenomenon. On the other hand, it gives good mechanical resistance mechanisms to reinforce the wound sutured during healing. It is also hemostatic and absorbable.

In contact with blood, the alginate coating softens and load biological fluid, so that it spreads all over the tissue surface of the device and casing staples, thereby closing in all the interstices of the fabric and perforations created by staples. Thanks to this, the devices 1, 2 become tight and thus prevent the passage of bodily fluids and air through the interstices of the fabric and the perforations staples. The devices 1, 2 and play their full role and haemostatic aérostatique.

In another embodiment, instead of sheath, the device consists of a compress plate 18, of rectangular shape.

The manufacturing process of the device 18 will now be described with reference to Figure 9.

Taking a linear knitting loom 11 which is supplied by calcium alginate fibers. Using this art, it produces a flat strip 12 of knit jersey, here a width equal to five centimeters, and winding the knitted tape 12 around a roller.

the knit tape 12 and immersed is unwound in a bath 13 containing a 3% aqueous solution of alginate ester to coat the knitted fabric 12. Then it exits from the bath 13 the knitted tape 12 coated and it is passed between two calender rolls in cold 14, 15. this removes the excess coating of alginate solution, so that the knitted fabric 12 is covered only partially coating the base material alginate.

The knitting is then passed through a hot air oven 16, here 45 ° C, 'in order to dry it and so stiffen.

At the outlet of oven 16, by means of a cutting device 17 is cut the knitted tape 12 in the lengthwise direction to obtain a plurality of pads 18 suture reinforcement here size 5cmx5cm. Instead of calcium alginate, tissue suture reinforcement device may be any alginate material and generally based polysaccharide.

The coating material may generally be based on a polymer for sealing and shaping of the device. The polymer may include alginate, hyaluronic acid, or more generally a polysaccharide.

The fabric could be totally covered with a waterproof coating material such as an alginate based material or hyaluronic acid, or any other waterproof polymer.

Instead of stockinette, knitting could be in any other cell types. Finally, the fabric may be a woven web.

It will be noted that the fabric of the suture reinforcement device which has just been described is an excellent cell culture medium, due to its hydrophilicity and its mechanical strength.

Claims

1 - suture reinforcement device comprising a fabric polysaccharide-based material, and means for sealing the fabric.
2- Device according to claim 1, wherein there is provided means for shaping the fabric.
3- Device according to one of claims 1 and 2, wherein the means for sealing tissue are arranged to seal the tissue in liquid media.
4- Device according to one of claims 1 to 3, wherein the fabric is coated at least partly of a hydrophilic material to seal the tissue.
5- Device according to one of claims 1 to 4, wherein the coating of the fabric material is water soluble.
6. Device according to one of claims 1 and 2, wherein the means for sealing tissue includes a sealing material layer completely covering the fabric.
the device according to one of claims 1 to 6, wherein the fabric is coated at least partially with a material based on a polymer for sealing and shaping of the fabric.
8- A device according to claim 7, wherein the polymer comprises a polysaccharide.
9- Apparatus according to one of claims 7 and 8, wherein the polymer comprises at least one elements of the group comprising alginate and hyaluronic acid.
10- Device according to one of claims 1 to 9, wherein the fabric is a knitted fabric.
11 - Device according to one of claims 1 to 9, wherein the fabric is a woven web. 12- Device according to one of claims 1 to 11, wherein the. fabric is alginate based material.
13- Device according to one of claims 1 to 12, wherein the fabric is constructed as a sheath.
14- Use of the device according to one of claims 1 to 13 as cell culture medium.
PCT/FR2000/002182 2000-07-28 2000-07-28 Suture reinforcing device WO2002009593A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/FR2000/002182 WO2002009593A1 (en) 2000-07-28 2000-07-28 Suture reinforcing device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/FR2000/002182 WO2002009593A1 (en) 2000-07-28 2000-07-28 Suture reinforcing device
AU7010000A AU7010000A (en) 2000-07-28 2000-07-28 Suture reinforcing device

Publications (1)

Publication Number Publication Date
WO2002009593A1 true WO2002009593A1 (en) 2002-02-07

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2000/002182 WO2002009593A1 (en) 2000-07-28 2000-07-28 Suture reinforcing device

Country Status (2)

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AU (1) AU7010000A (en)
WO (1) WO2002009593A1 (en)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8453904B2 (en) 2007-10-08 2013-06-04 W. L. Gore & Associates, Inc. Apparatus for supplying surgical staple line reinforcement
US8899464B2 (en) 2011-10-03 2014-12-02 Ethicon Endo-Surgery, Inc. Attachment of surgical staple buttress to cartridge
US8985429B2 (en) 2011-09-23 2015-03-24 Ethicon Endo-Surgery, Inc. Surgical stapling device with adjunct material application feature
US8998059B2 (en) 2011-08-01 2015-04-07 Ethicon Endo-Surgery, Inc. Adjunct therapy device having driver with cavity for hemostatic agent
US8998060B2 (en) 2011-09-13 2015-04-07 Ethicon Endo-Surgery, Inc. Resistive heated surgical staple cartridge with phase change sealant
US9089326B2 (en) 2011-10-07 2015-07-28 Ethicon Endo-Surgery, Inc. Dual staple cartridge for surgical stapler
US9101359B2 (en) 2011-09-13 2015-08-11 Ethicon Endo-Surgery, Inc. Surgical staple cartridge with self-dispensing staple buttress
US9125649B2 (en) 2011-09-15 2015-09-08 Ethicon Endo-Surgery, Inc. Surgical instrument with filled staple
US9198644B2 (en) 2011-09-22 2015-12-01 Ethicon Endo-Surgery, Inc. Anvil cartridge for surgical fastening device
US9254180B2 (en) 2011-09-15 2016-02-09 Ethicon Endo-Surgery, Inc. Surgical instrument with staple reinforcement clip
US9393018B2 (en) 2011-09-22 2016-07-19 Ethicon Endo-Surgery, Inc. Surgical staple assembly with hemostatic feature
US9492170B2 (en) 2011-08-10 2016-11-15 Ethicon Endo-Surgery, Inc. Device for applying adjunct in endoscopic procedure
US9999408B2 (en) 2011-09-14 2018-06-19 Ethicon Endo-Surgery, Inc. Surgical instrument with fluid fillable buttress

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0577373A2 (en) * 1992-06-29 1994-01-05 Ethicon Inc. Method and apparatus for achieving hemostasis along a staple line
US5397324A (en) * 1993-03-10 1995-03-14 Carroll; Brendan J. Surgical stapler instrument and method for vascular hemostasis
WO1997017023A1 (en) * 1995-11-07 1997-05-15 Fusion Medical Technologies, Inc. Methods and articles for fusing polysaccharide-containing matrix layers to tissue
WO1998043543A1 (en) * 1997-03-31 1998-10-08 Kabushikikaisha Igaki Iryo Sekkei Suture retaining member for use in medical treatment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0577373A2 (en) * 1992-06-29 1994-01-05 Ethicon Inc. Method and apparatus for achieving hemostasis along a staple line
US5397324A (en) * 1993-03-10 1995-03-14 Carroll; Brendan J. Surgical stapler instrument and method for vascular hemostasis
WO1997017023A1 (en) * 1995-11-07 1997-05-15 Fusion Medical Technologies, Inc. Methods and articles for fusing polysaccharide-containing matrix layers to tissue
WO1998043543A1 (en) * 1997-03-31 1998-10-08 Kabushikikaisha Igaki Iryo Sekkei Suture retaining member for use in medical treatment
EP0922435A1 (en) * 1997-03-31 1999-06-16 Kabushikikaisha Igaki Iryo Sekkei Suture retaining member for use in medical treatment

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8453904B2 (en) 2007-10-08 2013-06-04 W. L. Gore & Associates, Inc. Apparatus for supplying surgical staple line reinforcement
US8998059B2 (en) 2011-08-01 2015-04-07 Ethicon Endo-Surgery, Inc. Adjunct therapy device having driver with cavity for hemostatic agent
US9492170B2 (en) 2011-08-10 2016-11-15 Ethicon Endo-Surgery, Inc. Device for applying adjunct in endoscopic procedure
US8998060B2 (en) 2011-09-13 2015-04-07 Ethicon Endo-Surgery, Inc. Resistive heated surgical staple cartridge with phase change sealant
US9101359B2 (en) 2011-09-13 2015-08-11 Ethicon Endo-Surgery, Inc. Surgical staple cartridge with self-dispensing staple buttress
US9999408B2 (en) 2011-09-14 2018-06-19 Ethicon Endo-Surgery, Inc. Surgical instrument with fluid fillable buttress
US9125649B2 (en) 2011-09-15 2015-09-08 Ethicon Endo-Surgery, Inc. Surgical instrument with filled staple
US9254180B2 (en) 2011-09-15 2016-02-09 Ethicon Endo-Surgery, Inc. Surgical instrument with staple reinforcement clip
US9198644B2 (en) 2011-09-22 2015-12-01 Ethicon Endo-Surgery, Inc. Anvil cartridge for surgical fastening device
US9393018B2 (en) 2011-09-22 2016-07-19 Ethicon Endo-Surgery, Inc. Surgical staple assembly with hemostatic feature
US8985429B2 (en) 2011-09-23 2015-03-24 Ethicon Endo-Surgery, Inc. Surgical stapling device with adjunct material application feature
US8899464B2 (en) 2011-10-03 2014-12-02 Ethicon Endo-Surgery, Inc. Attachment of surgical staple buttress to cartridge
US9089326B2 (en) 2011-10-07 2015-07-28 Ethicon Endo-Surgery, Inc. Dual staple cartridge for surgical stapler

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