IL207667A - Device for attaching a patch to a biological tissue - Google Patents

Description

A DEVICE FOR ATTACHING A PATCH TO A BIOLOGICAL TISSUE Agent Ref: 0037591 L Agent: Borochov, Korakh & Co.

Applicant: Polytouch Medical Ltd.

WO 2010/0468!)3 PCT/IL2()II9/«()()!J85 A DEVICE FOR ATTACHING A PATCH TO A BIOLOGICAL TISSUE FI ELD OF TH E INVENTION This invention generally relates to a device and method for repairing biological tissue aperture. More specifical ly, the present invention relates to a device and method for attaching a patch to a biological tissue, namely via biological glue.

BACKGROUND An object of the present invention is to provide apparatus and a method for perform ing corrective surgery on internal wounds such as hernia where invasion of the patient's body tissues is minimized and resultant trauma is reduced.

A hernia is a protrusion of a tissue, structure, or part of an organ through the muscular tissue or the membrane by which it is normally contained. In other words a hernia is a defect in the abdominal wall through which a portion of the intra-abdom inal contents can protrude. This often causes discomfort and an unsightly, visible bulge in (he abdomen. When such a hernia defect occurs in the abdominal region, conventional corrective surgery has required opening the abdominal cavity by surgical incision through the major abdom inal muscles. While this technique provides for effective corrective surgery of the hernia defect, it has the disadvantage o f requiring a hospital stay of as much as a week, during which pain is frequently intense, and it requires an extended period of recuperation. A fter the conventional surgery patients frequently cannot return to a full range of activity and work schedule for a month or more. Accord ingly, medical science has sought alternative techn iques that are less traumatic to the patient and provide for more rapid recovery.

Laparoscopy is the science o f introducing a viewing instrument through a port into a patient's body, typically the abdominal cavity, to view its contents. This technique has been used for diagnostic purposes for more than 75 years. Operative laparoscopy is performed through tiny openings in the abdominal wall called ports. In most surgical techniques several ports, frequently three to six, are used. Through one port is inserted the viewing device, which conventionally comprises a fiber optic rod or bundle having a video camera affixed to the outer end to receive and display images from inside the body. The various surgical instruments are inserted through other ports to do the surgery that normal ly would be performed through an open incision through the abdominal wall. Because the laparoscopic surgical techniques require only very small holes through the abdominal wall or other portions of the body, a patient undergoing such surgery may frequently leave the hospital within one day after the surgery and resume a ful l range of normal activities within a few days thereafter.

In repairing hernia the physician needs to first deploy the patch and then to attach/anchor the patch to the tissue.

There are many patents and patent applications relating to anchoring means (see for example US patent 6,447,524). Traditional anchors used in surgery include clips, staples, or sutures, and may also be referred to as tissue anchors. These devices are usually made of a biocompatible material (or are coated with a biocompatible material), so that they can be safely implanted into the body. Most tissue anchors secure the tissue by i mpaling it with one or more posts or legs that are bent or crimped to lock the tissue into position . Thus, most traditional anchors are rigid or are inflexibly attached to the tissue. For example PCT no. wo0702 l 834 describes an anchor having two curved legs that cross in a single turning direction to form a loop. Those two curved legs are adapted to penetrate tissue i n a curved pathway. US patent 4,485,8 1 6 (8 1 6') describes surgical staple made of shape memory alloy. The staple is placed in contact o f the tissue and then heated. The heating causes the staple to change its shape thus, penetrating the tissue.

US patent 6,893,452 ('452) describes a tissue attachment device that facil i tates wound healing by holding soft tissue together under i mproved distribution of tension and with m inimal di sruption of the wound interface and its nutrient supplies. The device has multiple sites for grasping the tissue using tines or prongs or other generally sharp, projecting points, protruding from a si ngle, supportive backing. One of the embod iments descri bed in '452 is the use of sharp projecting points protruding from the supportive backing in two different angles.

US patent 6,517,584 ('584) describes a hernia patch which includes at least one anchoring device made of shape memory material. The anchoring devices are initially secured to the prosthesis by being interlaced through a web mesh constituting the prosthesis. The attachment is obtained by altering the attachment element's shape from rectilinear to a loop shape due to heat induced shape memory effect.

Yet other patent l iterature relates to devices for endoscopic application of surgical staples adapted to attach surgical mesh to a body tissue.

An example of such a teaching is to be found in US patent 5,364,004, US patent 5,662,662, US patent 5,634,584, US patent 5 ,560,224, US patent 5,588,58 1 and in US patent 5,626,587.

There are a few patent and patent literatures relating to deployment of patches. For example US patent 5836961 ('961) which relates to an apparatus used for developing an anatomic space for laparoscopic hernia repair and a patch for use therewith. The apparatus of patent '961 comprises a tubular introducer member having a bore extending there through . Λ tunneling shaft is sl idabty mounted in the bore and has proximal and distal extremities including a bul let-shaped tip. A rounded tunneling member is mounted on the distal extremity of the tunneling shaft. The apparatus comprises an inflatable balloon. Means is provided on the bal loon for removably securing the balloon to the tunneling shaft. Means is also provided for forming a balloon in flation l umen for inflating the balloon. The balloon is wrapped on the tunneling shaft. A sleeve substantially encloses the bal loon and is carried by the tunnel ing shaft. The sleeve is provided with a weakened region extending longitudinally thereof, permitting ihe sleeve to be removed whereby the balloon can be unwrapped and inflated so that it l ies general ly in a plane. The bal loon as it is being inflated creates forces general ly perpendicular to the plane of the ball oon to cause pul ling apart of the tissue along a natural plane to provide the anatomic space.

Another example for deploying the patch can be found in US patent No. 5370650 (' 650) which relates to an apparatus for positioning surgical implants adjacent to body tissue to facil itate the fastening of the i mplant to the body tissue. Patent '650 provides an apparatus for positioning surgical implants adjacent to body tissue, comprising an outer tube having a proximal end, a distal end and a longitudinal axis; an inner rod at least partially disposed within the outer tube and sl idable along said longitudinal axis. The inner rod has a proximal and a d istal end portions. The i nner rod distal end portion further comprises articulating means for pivoting at an angle with respect to the longitudinal axis. A looped support member having first and second end portions fixedly secured to said distal end portion of the inner rod; and a surgical implant releasably secured to the looped support member.

VVO 2010/046893 PCT/I L2009/00<)!>85 More patent literature can be found in US patent No. 4, 190,042 which discloses a resilient surgical retractor which in an unstressed condition forms a hook-like appendage at the distal end of the retractor.

Another patent literature relates to a perpendicular deployment of the patch. An example of such teaching can be found in US patent no. 5405360 (see fig. 6). There are many advantages for the lateral deployment over the perpend icular deployment. One of which is the considerably large amount of articu lation that will be needed in order to properly position the patch with respect to the hernia. The other one relates to the fact that the abdominal cavity contains a limited space; hence the use of large patches will be l imited.

A l l those patent and patent application demonstrate attachment means for attaching the patch to the tissue or means for deploying the patch within the body. However none of the literature found relates to a device especial ly adapted to deploy and attached a patch to a biological tissue.

Thus, there is stil l a long felt need for a device that can be used for both deploying and attaching a patch to a biological tissue namely via a biological glue.

SUMMARY OF THE IN VENTION It is one object of the present invention to provide a deployment and attachment device (DAD) comprising: a. deployment mechanism adapted to lateral ly deploy a patch; and, b. at least one glue dispensing system (GDS), in communication with said dep loying mechan ism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 19; wherein said G DS comprising: i. at least one glue reservoir (GR) 1 16 adapted to accommodate glue 1 19; and, ii. at least one glue dispensing tube (GDT) 1 1 7, in communication with said GR 1 16, adapted to homogeneously disperse glue 1 1 along substantially the entire margins area of said patch.

It is another object of the present invention to provide the DA D as defined above, wherein said DAD is characterize by having a distal portion, adapted to be inserted into a body and a WO 2/8 It is another object of the present invention to provide the DAD as defined above, wherein said GR 1 16 is reversible coupled to said lube 103.

WO 2010/046893 PCT/lL200i)/0001)85 It is another object of the present invention to provide the DA D as defined above, said proximal portion comprising at least one handle located outside said body; said handle adapted to (i) reversib!y transform said FA from said closed configuration to said open configuration; (i i) disperse said glue on said patch; and, (iii) lateral articulate said DAD.

It is another object of the present invention to provide the DAD as defined above, wherein said GR 1 16 is reversible coupled to said handle in said proximal portion.

It is another object of the present invention to provide the DAD as defined above, wherein said GR 1 16 comprising at least one hook 506 adapted to be reversibly inserted into at least one socket 507 located in said tube 1 03.

It is another object of the present invention to provide the DAD as defined above, wherein said gl ue is selected from a group consisting of fibrin sealant (FS), Cyanoacrylate or any other glue suitable for cl inical use.

It is another object of the present invention to provide the DAD as defined above, additionally comprising a lateral articulating mechan ism adapted to provide lateral articulation to said DAD such that said patch can be properly place with respect to said hernia. it is another object of the present invention to provide the DAD as defined above, additionally comprising a vertical articulating mechanism adapted to provide vertical articulation to said DA D such that said patch can be properly place with respect to said hernia.

It is another object of the present invention to provide the DAD as defined above, wherein said glue dispensing tube ( 1 1 7) is coupled to at least one selected from a group consisting of FA ( 104), pDA or dDA or any combination thereof.

It is another object of the present invention to provide the DAD as defined above, wherei n said glue dispensing tube ( 1 1 7) is reversibly coup led to said patch ( 1 06).

It is another object of the present invention to provide the DAD as defined above, wherein said GDT 1 1 7 comprises at least one nozzle I 18 adapted to d isperse said glue on said patch.

It is another object of the present invention to provide the DAD as defined above, wherein said nozzles 1 1 8 are pre inserted through said patch such that at least a portion of said nozzles 1 18 protrude out of said patch 106.

It is another object of the present invention to provide the DAD as defined above, wherein said patch used is a non-pores patch.

It is another object of the present invention to provide the DAD as defined above, wherein said pre inserted nozzles 1 18 are adapted to provide attachment between said GDT 1 17 and said patch 106.

It is another object of the present invention to provide the DAD as defined above, wherein said nozzles 1 18 comprising at least two openings facing to two opposite directions of said patch. It is another object of the present invention to provide the DAD as defined above, additionally comprising at least one piston 302 internally coupled to said GR 1 16; said piston 302 is adapted to reciprocal move along the GR's longitudinal axis such that said glue is extracted from said GR 1 16 to said GDT 1 1 7.

It is another object of the present invention to provide the DAD as defined above, wherein said piston 302 is driven by means selected from a group consisting of pneumatic means, mechanic means, hydraulic means or any combination thereof.

It is another object of the present invention to provide the DAD as defined above, wherein said piston is pneumatically driven via compressed gas.

It is another object of the present invention to provide the DAD as defined above, wherein said GR I 16 is adapted to accommodate a multi-component glue.

It is another object of the present invention to provide the DAD as defined above, wherein said GR 1 16 is divided into at least two sealed sub cavities 308, 309 by at least one partition 310. It is another object of the present invention to provide the DAD as defined above, wherein each sub cavity 308, 309 is coupled to a single mixing cavity 31 1 , It is another object of the present invention to provide the DAD as defined above, additionally comprising at least one membrane 314 adapted to prevent any unwanted extraction of said glue components.

It is another object of the present invention to provide the DAD as defined above, wherein said GDT 1 1 7 is characterized by an oval cross section so as to reduce the overall cross section area of said distal portion 101 in said 'closed configuration'.

It is another object of the present invention to provide the DAD as defined above, wherein said FA ( 104) comprises means adapted to at least partially reversibly connect said patch (106) to said FA ( 104). it is another object of the present invention to provide the DAD as defined above, wherein said glue reservoir (GR) 1 16 is separately provided.

It is another object of the present invention to provide a method for deploying and attaching a patch to a biological tissue. The method comprising steps selected inter alia from : a. obtaining a deployment and attachment device (DAD) comprising: i. deployment mechanism adapted to lateral ly deploy a patch; and, i i. at least one glue dispensing system (GDS), in communication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 19; said GDS comprising: (a) at least one glue reservoir (G ) 1 16 accommodating glue 1 19; and, (b) at least one glue dispensing tube (GDT) 1 17, in communication with said GR I ! 6; b. attaching said patch to said DAD; c. introducing said patch into said body cavity; d. deploying said patch ; e. homogeneously dispersing glue 1 1 9 along substantial ly the entire margins area of said patch; and, f. adjacently bringing said patch into contact with said biological tissue, thereby attaching said patch to said biological tissue.

It is another object of the present invention to provide a method for deploying and attach ing a patch to a biological tissue. The method comprising steps selected inter alia fronv a. obtaining a deployment and attachment device (DAD) comprising: i. deployment mechanism adapted to laterally deploy a patch; and, ii. at least one gl ue dispensing system (GDS), in commun ication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 1 ; said DA D is characterize by having a d istal portion, adapted to be inserted into a body and a proximal portion, located adj acent to a user; said distal portion and said proximal portion are interconnected along a main longitudinal axis via a tube ( 1 03); said tube ( 103) having a proximal end (TP) connected to said proximal portion, and a distal end (TD); said tube ( 103) is adapted to at least partial ly accommodate a central shaft ( 1 05); said central shaft ( 105) is characterized by a proximal end (CSP) accommodated within said tube and a distal end (CSD) protruding out of said TD; said central shaft is adapted to reciprocal ly move parallel to said main longitudinal axis within said tube; said GR ( 1 16) is in communication with at least one gl ue dispensing tube ( 1 1 7); said distal portion comprises: (i) at least two frame arms (FA) ( 104) adapted to be reversibly coupled to said patch; (ii) at least two proximal deployment arms (pDA) ( 108a, 108b) hingelike connected to said TD and to the proximal end of said two FA; (iii) at least two distal deployment arms (dDA) ( 108c, 1 08d) hinge-like connected to said CSD and to the distal end of said two FA; each of said pDAs and dDAs ( 1 08a, 1 8b, 1 08c, I 08d) is characterized by a plural ity of configurations, at least one of said configurations is a parallel configuration in which each of said pDAs and dDAs is substantial ly paral lel to said central shaft ( 105); and, at least one of said configurations is a substantially perpendicular configuration in which each of said pDA and dDA is substantial ly perpendicular to said central shaft ( 105); said FAs ( 104) are characterized by a closed configuration in wh ich said pDAs and dDAs are in said parallel configuration; and, a deployed con figuration at wh ich said pDAs and dDAs are i n said substantially perpendicular con figuration such that said patch is deployed; b. reversibly attaching said patch to said FAs; c. adj usting said patch on said FAs; d. introducing said d istal portion into said body cavity; e. reversibly transforming said FA from said closed con figurat ion to said deployed con figuration; thereby deploying said patch; f. homogeneously dispersing glue 1 1 9 along substantial ly the entire margins area of said patch; g. adjacently bringing said patch into contact with said biological tissue, thereby attaching said patch to said biological tissue.

It is another object of the present invention to provide the method as defined above, additionally comprising step of detaching said patch from said FA.

It is another object of the present invention to provide the method as defined above, additional ly comprising step of transforming said FA from said deployed configuration to said closed configuration.

It is another object of the present invention to provide the method as defined above, additionally comprising step of extracting said DA D from said body cavity.

It is another object of the present invention to provide the method as defined above, additionally comprising step of laterally articulating said DAD so as said patch is orientated with respect to the treated defect.

It is another object of the present invention to provide the method as defined above, additionally comprising step of vertically articulating said DA D.

It is another object of the present invention to provide the method as defined above, additionally comprising step of reversibly coupl ing said GR 1 1 6 to said tube 103 prior to said patch inserti on. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said glue from a group consisting of fibrin glue, Cyanoacrylate or any other glue suitable for clinical use.

It is another object of the present invention to provide the method as defined above, additionally comprising step of coupling said glue dispensing tube ( 1 1 7) to at least one selected from a group consisti ng of FA ( 104), pDA or dDA or any combinat ion thereof.

It is another object of the present invention to provide the method as defined above, add itionally comprising step of reversibly coupling said glue di spensing tube ( 1 1 7) to said patch ( 1 06).

It is another object of the present invention to provide the method as defi ned above, additionally comprising step of providing said GDT 1 17 with at least one nozzle 1 1 8 adapted to disperse said glue on said patch.

It is another object of the present i nvention to provide the method as defined above, additionally comprising step of inserting said nozzles 1 18 through said patch such that at least a portion of said nozzles 1 18 protrude out of said patch 106 prior to step (d) of introducing.

It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said patch to be a non-pores patch.

WO 2010/046893 PCT/I L200i>/ Oi>85 It is another object of the present invention to provide the method as defined above, additional ly comprising step of internally coupling to said GR ( 1 16) at least one piston 302 adapted to reciprocal move along the GR's longitudinal axis such that said glue is extracted from said GR 1 16 to said GDT 1 17.

It is another object of the present invention to provide the method as defined above, additionally comprising step of driving said piston 302 by means selected from a group consisting of pneumatic means via compressed gas, mechanic means, hydraul ic means or any combination thereof.

It is another object of the present invention to provide the method as defined above, additional ly comprising step of accommodating within said GR 1 16 a multi-component glue.

It is still an object of the present invention to provide the method as defined above, additionally comprising step of dividing said GR 1 16 into at least two sealed sub cavities 308, 309 by at least one partition 3 10.

It is lastly an object of the present invention to provide the method as defined above, additionally comprising step of selecting the cross section area of said GDT 1 1 7 from an oval cross section so as to reduce the overal l cross section area of said distal portion 101 in said ' closed configuration' .

BRIEF DESCRIPTION OF THE DRA WINGS The i nvention is herein described, by way of example only, with reference to the accompanying drawings, wherein: Fig. I A illustrates an embodiment said PDD 1 00; Fig. 1 B il lustrates the close con iguration of said PDD 1 00; Fig. I C il lustrates the deployed configuration of said PDD 100; Fig. I D provides a closer view of the d istal portion of the DAD 100 in the deployed configuration.

Figs. 2A-2B illustrate the glue dispensing system (GDS); Figs 3A-3 B i llustrate another embodiment of PDD 100 and GDS 1 15 in which said glue 1 1 9 is appl ied directly to the top side of said patch 106; Figs. 3C-3D which illustrate a cross section view of a single nozzle 1 18 and describes the gluing process; Fig. 3E illustrates the detachment between the distal portion 101 and the patch 106; Figs. 3 F-3G illustrate an alternative embodiment of said nozzle 1 1 8; Figs. 4A-4E illustrates another embodiment of the GR 1 16; Figs. 4F-4G illustrate another embodiment of the GR 1 16 in which a multi-component glue is utilized.

Figs. 5A-5 D which il lustrate another embodiment of said GR 1 16.

Figs. 5C-5 F i llustrate the coupling process of the GR 1 1 6 to the tube 1 03 in a 3D isometric view and Figs 5G-5J respectively i llustrate the same process in a lateral cross section.

Fig. 6 illustrates a perpendicular deployment.

DETA IL DESCRI PTION OF THE SPECI FIC EM BODI MENTS The fol lowing description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modi fications, however, is adapted to remain apparent to those ski lled in the art, since the generic principles of the present invent ion have been defined speci fical ly to provides means and method for providing a an attachment between a patch and a tissue via a biological glue.

WO 2()1 /0468<»3 PCT/I L20(li>/00l>985 The present invention provides a deployment and attachment device (DAD) which serves as a tool for insertion, deployment, placement and attachment of a prosthetic hernia mesh during laparoscopic hernia rapier surgery; wherein said DAD comprised a glue dispensing system (GDS) adapted to provide an attachment between said patch and the patient's tissue.

The present invention provides a deployment and attachment device (DAD) comprising: c. deployment mechanism adapted to laterally deploy a patch; and, d. at least one glue dispensing system (GDS), in communication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 19; wherein said GDS comprising: Ί. at least one glue reservoir (G ) 1 16 adapted to accommodate glue 1 19; and, ii . at least one glue dispensing tube (GDT) 1 1 7, in communication with said GR 1 16, adapted to homogeneously disperse glue 1 19 along substantially the entire margins area of said patch.

It is another object of the present invention to provide the DAD as defined above, wherein said DAD is characterize by having a distal portion, adapted to be inserted into a body and a proximal portion, located adjacent to a user; said distal portion and said proximal portion are interconnected along a main longi tud inal ax is via a tube ( 103); said tube ( 1 03) having a proximal end (TP) connected to said proximal portion, and a distal end (TD); said tube ( 1 03) is adapted to at least partially accommodate a central shaft ( 1 05); said central shaft ( 105) is characterized by a prox imal end (CSP) accommodated within said tube and a distal end (CSD) protrud ing out of said TD; said central shaft is adapted to reciprocally move paral lel to said main longitud inal axis within said tube; said GR ( 1 16) is in communication with said at least one glue dispensing tube ( 1 1 7); said distal portion comprises: (i) at least two frame arms (FA) ( 104) adapted to be reversibly coupled to said patch; (ii) at least two proximal deployment arms (pDA) ( 1 08a, 108b) hinge-l ike connected to said TD and to the prox imal end of said two FA; (ii i) at least two distal deployment arms (d DA) ( 1 08c, 108d) hinge-like connected to said CSD and to the distal end of said two FA; each of said pDA and dDA ( 108a, 108b, 108c, 108d) is characterized by a plurality of configurations, at least one of said configurations is a parallel configuration in which each of said pDA and dDA is substantially parallel to said central shaft ( 105); and, at least one of said configurations is a substantial ly perpendicular configuration in which each of said pDA and dDA is substantial ly perpendicular to said central shaft ( 105); said FAs (104) are characterized by a closed configuration in which said pDAs and dDAs are in said parallel configuration; and, a deployed configuration at which said pDAs and dDAs are in said substantially perpend icular con figuration such that said patch is deployed; said FA arc adapted to reversibly transform from said closed configuration to said deployed configuration by (i) said reciprocal movement of said central shaft ( 105) towards and away from said proximal portion; and, (ii) said transformation of each of said DAs from said parallel configuration to said perpendicu lar configuration, such that said deployment of said patch is at least partially reversible.

The present invention also provides a method for attaching a patch to a biological tissue during a surgery utilizing said DA D and G DS.

The method comprising steps selected inter alia from: a. obtai ning a deployment and attachment device (DA D) comprising: i. deployment mechanism adapted to laterally deploy a patch; and, ii. at least one glue dispensing system (GDS), in communication with said deploying mechan ism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 1 ; said GDS comprising: (a) at least one glue reservoir (GR) 1 16 accommodating glue 1 19; and, (b) at least one glue dispensing tube (GDT) 1 17, in comm unication with said GR 1 1 ; b. attaching said patch to said DAD; c. introducing said patch into said body cavity; d. deploying said patch; WO 2<> ll)/04f>8!>3 PCT/tL2UO9/0Ol>985 e. homogeneously dispersing glue 1 19 along substantially the entire margins area of said patch; and, f. adjacently bringing said patch into contact with said biological tissue, thereby attaching said patch to said biological tissue.

It is another object of the present invention to provide a method for deploying and attaching a patch to a biological tissue. The method comprising steps selected inter alia from: a. obtaining a deployment and attachment device (DAD) comprising: i. deployment mechanism adapted to lateral ly deploy a patch; and, ii . at least one glue dispensing system (GDS), in communication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 19; said DAD is characterize by having a distal portion, adapted to be inserted into a body and a proximal portion, located adjacent to a user; said distal portion and said proximal portion are i nterconnected along a main longitudinal axis via a tube ( 103); said tube ( 103) having a proximal end (TP) connected to said proximal portion, and a distal end (TD); said tube ( 1 03) is adapted to at least partially accommodate a central shaft (105); said central shaft (105) is characterized by a proximal end (CSP) accommodated within said tube and a distal end (CSD) protruding out of said TD; said central shaft is adapted to reciprocally move paral lel to said main longitudinal ax is within said tube; said G R ( 1 1 6) is in communication with at least one gl ue d ispensi ng tube ( 1 1 7); said distal portion comprises: (i) at least two frame arms (FA) ( 104) adapted to be reversibly coupled to said patch; (i t) at least two proximal deployment arms (pDA) ( 108a, 1 08b) h inge-like connected to said TD and to the proximal end of said two FA ; WO 2(Μ0/0468ί>3 PCT/I L2009/000985 (iii) at least two distal deployment arms (dDA) ( 108c, 108d) hinge-like connected to said CSD and to the distal end of said two FA; each of said pDAs and dDAs ( 108a, 108b, 108c, I 08d) is characterized by a plurality of configurations, at least one of said configurations is a parallel configuration in which each of said pDAs and dDAs is substantially parallel to said central shaft ( 105); and, at least one of said configurations is a substantial ly perpend icular con figuration in which each of said pDA and dDA is substantially perpendicular to said central shaft ( 105); said FAs ( 104) are characterized by a closed con figuration in which said pDAs and dDAs are in said parallel configuration; and, a deployed configuration at which said pDAs and dDAs are in said substantially perpendicular configuration such that said patch is deployed; b. reversibly attaching said patch to said FAs; c. adjusting said patch on said FAs; d. introducing said distal portion into said body cavity; e. reversibly trans form ing said FA from said closed configuration to said deployed con figuration; thereby deploying said patch; f. homogeneously d ispersing glue 1 19 along substantial ly the entire margins area of said patch; g. adjacently bringing said patch into contact with said biological tissue, thereby attaching said patch lo said biological tissue.

It should be emphasized that some of the major advantages of the present invention, with respect to the prior art, is lo provide a fast and rel iable method for dispensing glue on top of a hernia mesh/patch duri ng laparoscopic hernia surgery, thus, enabling an attachment between the patch and the patient's tissue.

The term "Hernia" refers hereinafter for umbil ical hern ia, hiatal hernia, ventral hernia, postoperative hern ia, epi gastric hern ia, spiegel ian hernia, i nguinal hernia and femoral hernia, generally any abdominal wall related hern ia.

WO 2010/046893 PCT71 L200i>/00(l 85 The term "hinge" or "hinge-like connection" refers hereinafter as to a type of bearing that connects two sol id objects, typical ly allowing only a limited angle of rotation between them. Two objects connected by an ideal hinge rotate relative to each other about a fixed axis of rotation (the geometrical axis of the hinge). Hinges may be made of flexible material or of moving components.

The term "hinge like connection" can refer to a standard hinge or to a living hinge (i.e., a thin flexible hinge (flexure bearing) made from plastic that joins two rigid parts together while al lowing them to bend along the line of the hinge).

The term "biological glue" refers hereinafter to any biological glue which can provide adhesion between a l iving biological tissue and a synthetic or biological material (e.g., hernia patch/mesh); thus, provid ing an attachment between said tissue and said patch/mesh. The glue can be either multi component glue - e.g. fibrin glue or fibrin sealant (FS). Or single component glue - e.g. Cyanoacrylate or any other glue suitable for clinical use.

The term 'controlled deployment' refers hereinafter to a patch deployment which is continuous; i.e., the deployment is not binary but analogous - there are several deployment levels. Th is is in contrast so conventional deployment system is now days (sec for example patent 5,370,650), in which the deployment of the patch rel ies upon the elasticity of a loop member surrounding the patch such that the patch can be either fully folded or fully unfolded. No intermediate are enabled . In the present invention there can be several deployment stages.

According to a preferred embodiment of the present invention, the DA D device provided is adapted to provide a contro l led deployment of the patch.

The term 'bidirectional1 or 'fully reversible deployment' refers hereinafter to the deployment of the patch , which according to the present invention, is fully reversible. In other words, the patch deployment is bidirectional, i .e., the patch can be fully folded (i.e., deployed within the body) and then, i f the surgeon desires, the patch can be fully un folded simply by the reconfiguration of the flexible arms from the initial stage to the final stage and vice versa.

According to a preferred embodiment of the present invention, the DAD device provided is adapted to provide a bidirectional or fully reversible deployment of the patch.

The term "minimally invasive su rgery" refers hereinafter to procedures that avoid open invasive surgery in favor of closed or local surgery with fewer traumas. Furthermore, the term refers to a procedure that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage possible.

The term "articulation" refers hereinafter to a joint or juncture between two segments of the device. The articulating means of the present invention provides the abil ity to better adjust the device to the curvature of the treated tissue.

The term "orien tation" refers hereinafter to the rotation of the mesh within the abdominal cavity so as to fit to the hernia. Usual ly the mesh is not symmetric in shape (i.e., rectangular or i.e., el l ipse) - therefore it has d i fferent directions. By rotating the mesh within the abdominal cavity - one can decide which direction is turned where.

The term "adj usting" refers hereinafter to roll ing, folding and winding of the patch, thus preparing and enabl ing the insertion of said patch into the abdominal cavity.

The term " lateral deployment" refers hereinafter to a deployment in wh ich the plane of the deployed patch is substantially parallel to the main longitudinal axis of the trocar or the DAD 1 00 and hence of the tube 103 or the central shaft 105.

The term " perpendicular deployment " refers hereinafter to a deployment in which the plane of the deployed patch is substantially is perpendicular to the main longitudinal axis of the DAD 1 00 or the trocar). An example of a perpendicu lar deployment is given in fig. 6, which is a preferred embod iment of the deployment illustrated in US patent 5,405,360.

Before explaining the figures, it should be understood that the invention is not limited in its application to the detai ls of construction and the arrangement of the components set forth in the fo llowing description or illustrated in the drawings. The invention can be carried out in various ways.

Generally speaking, each deployment and attachment device (DAD) ! OO comprises at least two portions: a distal portion 101 and a proximal portion 102. The proximal portion is adapted to remain outside the body, adjacently to the user and the distal portion 101 is adapted to be inserted into the body.

The distal portion comprises at least one frame arm 104 to which the patch is attached to. The distal portion is characterized by two main configurations: a 'closed configuration' in which the DAD enables insertion of said mesh into the abdominal cavity and 'deployed configuration' in which the patch 106 is spread via the distal portion outer frames.

Reference is now made to Fig 1 A illustrating an embodiment said DAD 100. As described, the DAD 100 comprises (i) a deployment mechanism adapted to deploy and to enable proper placement o f the patch within the abdominal cavity; and, (ii) an attachment mechanism between the patch and the biological tissue.

The attachment mechanism d isclosed in the present application is a glue d ispensing system (GDS) which attaches said patch to a biological tissue within a body cavity via a biological glue.

The DA D comprises two main portions: distal portion 1 1 , and a prox imal portion 1 02. The two portions are interconnected via a tube 1 03.

The distal portion 1 0 1 is adapted to be reversibly inserted into a body cavity (namely the abdominal cavity) during a surgery (namely, minimal invasive surgeries) via a trocar.

The distal portion enables the deployment and the properly orientation and placement of a prosthetic hernia repair patch 1 06 with respect to the patient's tissue 120 surface.

The distal portion comprises: (a) at least two frame arms (FA) 104; (b) at least 4 deployment arms (DA) 1 08; and, (c) a central shaft 105 (which interconnects the distal portion and the proximal portion of te DA D 1 00) adapted to rec iprocal ly move within tube 103.

WO 2010/046893 PCT/1L2II09/000«J85 It should be emphasized that the main role of the central shaft is to provide the DAD in the deployed configuration with sufficiently stiffness and back support (to the deployed patch) so as to provide a rigid enough device that allows proper mesh rolling and insertion, especially when dealing with large and thick patches.

The DAs 108 can be divided into two groups: 2 DAs (108a and 108b) which are proximally located with respect to tube 103 and 2 DAs (I08d and 108c) which are distally located with respect to tube 103.

The proximal DAs (108a and 108b) are connected to the tube's 103 distal end and to the FA 104. The distal DAs (108c and I08d) are connected to the central shaft 105 and to the FAs 104. All said connections are hinge connections.

Each of said DAs (108) is characterized by a plurality of configurations. One of said configuration is a parallel configuration in which the DA is substantially parallel to said central shaft (105).

Another one of said configuration is an angled configuration in which said DA are located at an angle A with respect to said central shaft (105). Angle A can be at a range of about 0 degrees to about 180 degrees.

In the 'closed configuration' the deployment arms (DA) 108 are in the parallel configuration and in the 'deployed configuration' the deployment arms (DA) 108 are in the substantially perpendicular configuration (i.e., Angle A is about 90 degrees).

Reference is now made to Figs 1B-IC which illustrate the DAD 100 in its close configuration and in its deployed configuration. The close configuration is described in Fig IB while the deployed configuration is describe in Fig IC.

In the parallel configuration of said DAs 108 the DAD 100 is in its close configuration and in the angled configuration of said DAs 108, the DAD 100 is in its deployed configuration.

It should be emphasized that the patch deployment mechanism disclosed in the present application enables a patch deployment which is lateral deployment (i.e., the patch is deployed substantially paral lel to the main longitudinal axis of the DAD 100 and hence of the tube 103 or the central shaft 105).

Such a deployment has several advantages over a perpendicular patch deployment mechanism (i.e., the plane of the deployed patch is perpendicular to the main longitudinal axis of the device or the trocar), among whi ch the fol lowing: ( 1 ) Since in most cases the patch is inserted laterally with respect to the hernia defect, a perpendicular deployment will require a great amount of articulation in order to bring the patch into proper alignment with respect to the hernia defect. Such amount of articulation performance will be extreme difficult to perform at the confined abdominal space; (2) The fact that the patch is deployed substantially perpendicu larly to the trocar limits the size of the patch that can be used. In a perpendicular deployment (as in lateral deployment), the entire patch's size has to be introduced into the abdominal cavity, since the abdominal cavity has no su fficient depth to allow such spreading/deployment of large patches (i.e. larger than about 15cm at one of their edges), the size of the patches that could be used wil l be limited.

The patch/mesh/net 106 is reversibly attached to the FAs 104 by at least one reversible connection clip (CC) 1 07, adapted to hold said patch 1 06 attached to DAD 100 during adjustment of the patch (e.g., rolling and insertion into the abdominal cavity) and during the deployment of said patch .

Since the CCs 1 07 enable a reversible attachment between the patch and the DAD, the CCs 107 additionally al low detachment between said patch 106 and the DAD 1 00 once the patch 106 is substantially secured to the tissue 120.

Said CCs 107 can be an integral part of the FAs 104 or a separate part which arc combined and secured to the DAD 1 00 during the product assembly.

According to one embodiment, the distal portion 101 can be rotated laterally (i .e. left and right with regards to tube 103) and vertically (i .e. up and down with respect to the tube 103), such that the patch could be properly al igned and oriented within the abdominal cavity with regards to the hern ia. Said lateral articulation is control led by at least one articulation wire 1 10.

The proximal portion 102 comprises a deployment lever 1 13 which provides the surgeon with the ability to control the deployment process; and an articulation lever 1 14 which provides the surgeon with the abi lity to control lateral articulation angle of the distal portion.

Reference is now made to figure I D which provides a closer view of the distal portion of the DAD 100 in the deployed configuration.

The figure also illustrates another embodiment of the present invention, in wh ich extension arms 109 are provided. Such arms 109 are merely extensions of FAs 104 and are adapted to provide better support for patch 1 06.

Reference is now made to figures 2A and 2B il lustrating the glue dispensing system (GDS). In general, the glue dispensing system (GDS) 1 15, as provided by the present invention, comprises a glue reservoir (GR) 1 1 6, which contains glue 1 1 9, and at least one glue dispensing tube (GDT) 1 17.

Each GDT 1 1 7 comprises at least one nozzle 1 1 8 from which glue 1 17 exits.

Once the patch 1 06 is deployed within the patient's abdom inal cavity (but before it comes into contact with the tissue) said glue 1 1 9 is forced out from the glue reservoir (GR) 1 1 6 via said GDT 1 1 7 and said nozzle I 1 8.

According to one embodiment of the present invention, the glue is homogeneously spread on the patch prior to any contact between the patch and the tissue. Said glue is spread on the tissue prior to any contact so as to enable said giue to better disperses on the patch and to provide homogeneously spreading.

It should be emphasized that each DA D 100 can comprise one or more GDS 1 1 5.

Once the glue comes out of nozzle 1 18, it is spread on top of the patch 1 06. Once the glue 1 19 covers at least a portion of the top surface of the patch 1 06, the surgeon can place the patch at its desired location on the patient's tissue, via said DA D 100.

According to a preferred embodiment of the present invention, the gl ue is spread near the perimeter of the patch.

Once suitable adhesion between patch 106 and the tissue 120 is obtained, DAD 1 00 is disconnected from the patch 106, along with said GDS 1 1 5, and extracted out of the patient's body.

The present invention discloses several embodiments of said GDS 1 15.

Reference is made again to Figs 2A 1 , 2A2- 28 which describe one embodiment of said GDS 1 15. According to this embodiment said glue reservoir (GR) 1 1 6 is located as close as possible to the distal end of the DAD 1 00.

Placing the GR 1 16 as close as possible to the distal end of the DAD m inimized the total length of the GDT 1 1 7 needed, such that the path length in which the glue 'travels' prior to reaching the patch is min imized. Therefore, the amount of wasted glue is minim ized.

According to this embod iment, the GDT 1 1 7 encircles the distal end of said DAD 100 (i.e., the frame arms FA 104 and the deployment arms 1 08) and forms a loop around the same such that, when the patch is deployed, the GDT is in contact with substantially the entire perimeter (i.e., the outer surface or margins) of said patch so as to dispense the glue on said perimeter (i.e., outer surface or margins) of the patch. I n such a way the contact area is increased and hence a better attachment is provided.

Such a feature is highly important since it provides better/stronger attachment between the tissue and the patch. Said better attachment is enabled since the glue is dispersed over a su rface (preferably over the entire the outer surface or margins) of the patch which provides a plurality of contacts points.

This is in contrast to an attachment mechanism which provides attachment in a few preselected contact points; such an attachment is likely to provide a weak attachment.

The two ends ( 1 17a, 1 17b, sec Fig. 2A2) of the loop formed from said GDT 1 1 7 are connected to the GR 1 16 such that glue can be extracted from the two end of said GDT 1 17 so as to better optimize the glue dispersing onto the patch.

GDT 1 17 is attached to the frame arms FA 104 and the deployment arms 108 of the DAD 100 such that once the distal portion 101 is in its 'deployed con figuration ', said GDT 1 17 is located substantially along the edges of said patch 106.

Reference is now made to figure 2A2 which illustrates the distal portion of the DAD in which the GDT 1 17 is coupled to the FA 104 and the deployment arms 1 08 and is located substantially on the perimeter of the patch 106 (the patch 106 is not shown).

According to one embodiment, the GDT 1 1 7 is characterized by an oval cross section in order to reduce the overall cross section area of the distal portion 101 while it is in its 'closed configuration ' .

According to another embodiment, the GDT 1 1 7 comprises numerous nozzles 1 18, each of which is facing the patch 1 06.

According to this embod iment patch 106 used is porous, therefore, once glue 1 19 flows out of nozzles 1 1 8 to the bottom side of patch 1 06 (i.e. the side facing the viscera) it passes through the pores of the patch 1 06 to its top side (i .e. the side facing the fascia), thus forming an adhesive layer along patch 's 1 06 edges (see Fig 2B).

Once the glue is applied, the surgeon can press patch 106 to the tissue 1 20 in its proper location with respect to the tissue 120.

Once the glue is substantially cured, the DAD 100, together with the GDS 1 16 can be detached from patch 106 and extracted out of the patient' s body.

Reference is now being made to Figs 3A-3C i llustrating another embod iment of DA D 100 and GDS 1 1 5 in which said glue 1 19 is appl ied directly to the top side of said patch 1 06.

WO 20J0/046893 PCT/I L20(W(>0(>985 Such direct application is required when non porous patches are utilized; hence the glue can not pass through the patch.

According to this embodiment, the GDT 1 1 7 is pre-connected to patch 106 such that each of the nozzles 1 1 8 are pre inserted through said patch and emerge out of the top side of patch 106.

In such a way the top end of each of the nozzles 1 1 8 protrude out of the top section of the patch 106 (see Fig. 3 A, 3B and 3C).

In a preferred embodiment, an attachment between GDT 1 1 7 and patch 106 can be obtained via the special configurations of the nozzles 1 1 8 (e.g., an expanding top portion which 'holds' the GDT 1 17 to the patch 1 06).

The GDT 1 17 can be rolled and inserted together with patch 1 06 (see Fig 3A) wh ile the GDT 1 1 7 is attached to DA D 100 in at least one section, preferably only at the FAs 104.

Reference is now being made to Figs. 3C-3D which i llustrate a cross section view of a single nozzle 1 1 8 during the glu i ng process.

According to th is embodiment, at the initial stage, GDT 1 17 and nozzles 1 1 8 contains no glue (see Fig. 3C), such that G DT 1 1 7 can collapse to its minimal cross section while it is rol led together with the patch 1 06.

Once the patch is inserted to the abdominal cavity and deployed, glue 1 19 is forced out from G 1 16 into GDT 1 17 and out of nozzle 1 1 8 on top of patch 106, forming an adhesive layer (see Fig. 3D).

Next, patch 106 is forced onto the tissue 1 20, via the DA D 100 (said step is needed in order to obtain said adhesion between patch 106 and tissue 120).

Once glue 1 19 is cured, the distal portion is pulled away from tissue 1 20. Said pulling detaches the distal portion 1 0 1 from the patch 106. S ince the GDT 1 1 7 is connected to the distal portion (e.g., to the FAs 104 or to the D As 1 08) it is also pulled away from the patch (see Fig. 3 E).

WO 2 l (l/ 4f»8W PCT/IL2009/000985 Reference is now being made to Figs. 3 F-3G which describe an alternative embodiment of said nozzle 1 1 8.

According to one embodiment, described in Fig. 3F, nozzle 1 1 8 comprises at least two openings facing two opposite directions.

Such configuration increases the patch's area which comes into contact with the glue, once the glue 1 1 9 is forced out of the nozzle 1 1 8. Furthermore, such an embodiment can provide said attachment between the patch and the GDT 1 17.

According to another embodiment described in Fig. 3G, two nozzles 1 18 emerge out of GDT 1 17 in a tilted direction. The nozzles are inserted to patch in two separate points, therefore providing an improve glue dispensing coverage; in addition this configuration is preferable since this configuration also holds GDT 1 1 7 attached to patch 106.

Reference is now being made to Figs 4A-4E which describes an embodiment of the GR 1 16. According to th is embodiment said G R 1 16 is characterized by an elongated cylinder coupled to the tube 103 at its d istal end (see Fig. 4A).

Said cylinder comprises at least one hollow channel 301 along its longitud inal axis. Said channel 301 allows the central shaft 105 and the articulation wire 1 10 to pass through the GR 1 16 to the distal portion 1 0 1 of the DA D.

It shou ld be mentioned that for the purpose of i llustration on ly, tube 103 was removed from Fig 4A.

A piston 302 is located inside the G R 1 1 6 and partially encircles the channel 301 . The piston 302 is adapted to reciprocal move along the GR 's longitud inal axis.

GDT 1 1 7 is connected to the d istal portion of said GR 1 1 6.

Piston 302 is adapted to reciprocally move within the internal cavity of said GR 1 16 along the longitudinal axis o f the same.

Said piston 302 d ivides the internal cavity of said GR 1 1 6 into two separate cavities: a glue cavity 303 and an empty back cavity 304 (see Fig. 4B).

WO 2010/046893 PC 171L200 /OIIOi>85 Said glue 1 19 is initial ly located inside the glue cavity 303 which capture the entire GR 1 16 internal space (i .e., the empty back cavity 304 is close to nothing). As piston 302 moves towards the distal portion of the DAD the empty cavity 304 enlarges while the glue cavity decreases (since the glue is extracted from the G R 1 1 6 and into the GDT 1 1 7).

A membrane 314 is located at the distal end of the glue cavity 303, and prevents the glue from entering said GDT 1 1 7 before glue activation (i.e., the membrane 3 14 prevent the glue from exiting the GR 1 16 during e.g., storage and device insertion).

At least one aperture 305 is located at the distal end of the GR 1 16 through which said glue 1 19 is forced into the GDT 1 17. Wh i le the glue 1 1 9 is compressed by piston 302, membrane 3 14 bursts, allowing the glue to flow to GDT 1 1 7 through aperture 305.

According to this embodiment, said forcing (i.e., appl ication of force on the glue) is performed by pushing piston 302 toward the distal end of G R 1 1 6 (see Fig. 4C).

The piston can be pneumatically driven forward by fill ing the back cavity 304 with a compressed gas com ing from a compressed gas canister located at the proximal portion 102.

The gas passes through tube 306. A lternatively, said piston 302 can be mechanically pushed forward by a shaft 307 coming from the proximal portion 1 02 (see Figs 4D-4 E).

Reference is now being made to Figs 4F-4G which describes another embod iment of the GR 1 16 which utilizes multi-component glue (e.g. fibrin glue).

According to this embod iment, the internal cavity of said GR 1 16 is divided to several sub cavit ies 308, 309 by at least one partition 10. Each cavity 308, 309 is connected to a single mixing cavity 3 I I via holes 3 1 2, 3 13 located at the distal end of each cavity 308, 309. Said holes 3 12, 313 arc initially blocked by two membranes 3 14 which prevents early m ixing of the gl ue components during shipping and storage. Said membranes 3 14 is adapted to collapse once the two glue components are forced out by pistons 302. Said mixing cavity 3 1 1 is connected to the GDT 1 1 7 by at least one aperture 305 located at the distal port ion of said GR 1 16. Once dispensing of the glue is required, piston 302 is pushed forward, either pneumatical ly, hydraul ical ly or mechan ically, hence forcing the glue components from the cavities 308, 309, WO 2(Ι 10/()4(ί«ί>3 PCT/I L2009/00(I985 into the mixing cavity 3 1 1 . In the mixing cavity 3 1 1 the two glue components are m ixed, and flow into the GDT 1 17 through aperture/s 305 (see Fig. 4G).

It shou ld be pointed out that using two components glue (such as fibrin sealant), the G 1 16 will accommodate the two compounds in two separate and sealed compartments, such that no mixing of the two components during storage occurs.

Reference is now being made to Figs 5A-5D wh ich describe an embodiment of said GR 1 16. According to this embod iment the GR 1 1 6 is provided as a separate part from said DAD 100. Furthermore, said GR 1 1 6 can be assembled by the medical staff at the operation room prior to the insertion of the device into the abdominal cavity.

In such an embod iment, the glue can be stored separately and far away from the DAD 100. Such separate storing of the glue is needed when ever the glue 1 1 9 requires special storage condition (e.g., cryogenic cooling).

Providing a device which enables a reversible coupl ing between a glue reservoir and the DAD 100 is highly important and ad vantageous in cases wh ich the glue require special storage condition (e.g. cryogenic cooling) prevent from the entire device being stored in a special storage facil ity, substantial ly increasing operation costs.

According to this embodiment, the GR 1 1 6 is cylindrically shaped and is characterized by a cross sectional area and diameter which are identical to the diameter of tube 103.

The GR 1 1 6, as was described above, is open at its proximal end. The G R 1 1 6 is characterized by a groove 50 1 along its bottom side (see Fig. 5A ).

A hollow bar 502 (which is an i ntegral part of the tube 103, sec fig. 5 B) is adapted to be fitted within said groove 501.

Bar 502 is hol low so as to al low the central shaft 105 and the articulation wires 1 10 to pass through it to the distal portion 101 .

Piston 302 is characterized by the same dimensions and shape as of the internal dimensions of cylinder. Yet more, piston 302 is adapted to reciprocally move along its longitude axis (see Fig. 5Λ). The movement of said piston applies pressure on the glue and presses the glue 1 19 out of GR 1 16 and into GDT 1 17.

Once GR 1 16 is coupled to tube 103, piston 302 can be pressed forward (towards the distal end of the DAD 100) by at least one rod 505 (see Fig. 5B); alternatively said pressing can be accomplished by hydraulic or pneumatic means.

The gl ue passes from GR 1 16 into GDT 1 17 through a glue port 503 which is located at the distal end of GR 1 16 (see Fig. 5C). Said port 503 is adapted to be fitted into socket 504 at tube 103 (Figs 5G-5J).

Socket 504 is connected to GDT 1 17 via a hole 509 allowing glue 1 1 9 to flow from GR 1 1 6 to GDT 1 17 once GR 1 16 is completely coupled to tube 103.

Reference is now being made to Fi gs 5C-5J which i llustrate the process of coupling the GR 1 16 to the DAD 100, namely to tube 103.

Figs. 5C-5 F i l lustrate the process in a 3 D isometric view and Figs. 5G-5J respectively il lustrate the same process in a lateral cross sectional view.

Figs. 5C-5J i l lustrate the initial stage of said reversible coupling.

A hook 506 is located at the proximal end of said GR 1 16. Said hook 506 is adapted to be inserted into socket 507 at tube 1 03 during said reversible coupling of said G R 1 16 to tube 103.

According to this embodiment, in order for the GR 1 16 to be coupled to the tube 103, said glue port 503 is spring-l ike coupled to said G R 1 16 such that during the coupl ing it can retract into the GR 1 1 6 (see Figs. 5G-5J).

A spring 508 keeps said port 503 extruding out of G R 1 16 when said GR is not coupled to the tube 103.

At the first stage of insertion (Figs 5D - in 3D view and Fig. 5H in a 2D view) said hook 506 is inserted into socket 507. At the next stage (Figs 5E - in 3D view and 51 in a 2D view) the di stal portion of said GR 1 16 is lowered toward tube 1 03 whi le hook 506 acts as a hinge between GR Π 6 and tube 103.

VVO 2010/046893 PC 17I L20(»9/0(I Port 503, together with hook 506, are also holding GR 1 16 attached to tube 103.

Once the GR is secured to tube 103, the glue can flow from the GR 1 16 to the GDT 1 1 7 via a channel 509.

The following steps describe the entire procedure in a minimal invasive surgery whilst using the above described system : 1 . The patch 1 06 is rcversibly connected to the distal portion 10 ! of said DAD. 2. The GR 1 1 6 in assembled with the DAD (i.e., reversibly coupled to tube 1 03). 3. The DAD i s transformed into its 'closed configuration1 and patch 106 is folded/rolled in order to allow its insertion into the abdominal cavity. 4. The folded patch 106 together with the GDS 1 1 5 is inserted to a body cavity through a standard min i mal invasive port, or through any other incision. 5. The patch 106 together with the attached glue dispensing tube 1 1 7 is unfolded by pulling the deployment leaver ! 1 3 (thus, transforming the distal portion 101 into its 'deployed con figuration) . 6. The glue is forced out form the GR 1 16, by pushing the piston 302. 7. The glue is dispensed through the nozzles, and spread on top of the patch 1 06 (the nozzles are either pre inserted i nto the patch or not - i.e. when a porous patch is used). 8. The patch 1 06 is brought to be in contact with the tissue. 9. The patch is held in place until the glue is stabil izes (i.e., at least partially cured), and a sufficient attachment is ach ieved. 10. The patch is d isconnected from the deployment system . 1 1 . The deployment system and thus the glue dispensing tube GDT 1 17 are pul led away . 12. The deployment system is closed (i.e., transforms from its deployed configuration to its 'closed configuration') and removed from the body cavity together with the GDT 1 1 7.

In the foregoing description, embodiments of the invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.

Claims (45)

WO 201 l)/04f>8!>3 PC'171 L2I)()9/I)0(I!>85 Claims

1. . A deployment and attachment device (DAD) comprising: a. deployment mechanism adapted to laterally deploy a patch; and, b. at least one glue dispensing system (GDS), in communication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 19; wherein said GDS comprising: i. at least one glue reservoir (GR) 1 1 6 adapted to accommodate glue 1 19; and, i i. at least one glue dispensing tube (GDT) 1 17, in communication with said GR 1 1 6, adapted to homogeneously disperse glue 1 19 along substantially the entire margins area of said patch.

2. The DAD according to claim 1 , wherein said DA D is characterize by having a distal portion, adapted to be inserted into a body and a proximal portion, located adjacent to a user; said distal portion and said proximal portion are interconnected along a main longitudinal axis via a tube ( 1 03); said tube ( 103) having a proximal end (TP) connected to said proximal portion, and a distal end (TD); said tu be ( 1 03) is adapted to at least partially accommodate a centra! shaft ( ! 05); said central shaft ( 1 05) is characterized by a proximal end (CSP) accommodated within said tube and a distal end (CSD) protrud ing out of said TD; said central shaft is adapted to reciprocally move parallel to said main longitudinal axis within said tube; said GR ( 1 1 6) is in commun ication with said at least one glue dispensing tube ( 1 1 7); said d istal portion comprises: (i) at least two frame arms (FA) ( 1 04) adapted to be reversibly coupled to said patch; (i i) at least two proximal deployment arms (pDA) ( 1 08a, 108b) h inge-like connected to said TD and to the proximal end of said two FA; (i i i) at least two distal deployment arms (d DA) ( 108c, 1 08d) hinge-li ke connected to said CSD and to the distal end of said two FA; WO 2010/046893 PCT/1L200!)/OI)0985 each of said pDA and dDA (108a, I08b, 108c, I08d) is characterized by a plurality of configurations, at least one of said configurations is a parallel configuration in which each of said pDA and dDA is substantially parallel to said central shaft (105); and, at least one of said configurations is a substantially perpendicular configuration in which each of said pDA and dDA is substantially perpendicular to said central shaft (105); said FAs (104) are characterized by a closed configuration in which said pDAs and dDAs are in said parallel configuration; and, a deployed configuration at which said pDAs and dDAs are in said substantially perpendicular configuration such that said patch is deployed; said FA are adapted to reversibly transform from said closed configuration to said deployed configuration by (i) said reciprocal movement of said central shaft (105) towards and away from said proximal portion; and, (u) said transformation of each of said DAs from said parallel configuration to said perpendicular configuration, such that said deployment of said patch is at least partially reversible.

3. The DAD according to claim I , wherein said GR 1 16 is reversible coupled to said tube 103.

4. The DAD according to claim I , said proximal portion comprising at least one handle located outside said body; said handle adapted to (i) reversibly transform said FA from said closed configuration to said open con iguration; (ii) disperse said glue on said patch; and, (iii) lateral articulate said DAD.

5. The DAD according to claim 4, wherein said GR 1 16 is reversible coupled to said handle in said proximal portion.

6. The DAD according to claim 3, wherein said GR 1 16 comprising at least one hook 506 adapted to be reversibly inserted into at least one socket 507 located in said tube 103.

7. The DAD according to claim 1 , wherein said glue is selected from a group consisting of fibrin sealant (FS), Cyanoacrytate or any other glue suitable for clinical use.

8. The DAD according to claim 2, additionally comprising a lateral articulating mechanism adapted to provide lateral articulation to said DAD such that said patch can be properly place with respect to said hernia.

9. The DAD according to claim 2, additionally comprising a vertical articulating mechanism adapted to provide vertical articulation to said DAD such that said patch can be properly place with respect to said hernia.

10. The DAD according to claim I, wherein said glue dispensing tube (117) is coupled to at least one selected from a group consisting of FA (104), pDA or dDA or any combination thereof.

11. The DAD according to either one of claims 1 or 10, wherein said glue dispensing tube (! 17) is reversibly coupled to said patch (106).

12. The DAD according to claim 1, wherein said GDT 117 comprises at least one nozzle 118 adapted to disperse said glue on said patch.

13. The DAD according to claim 12, wherein said nozzles 118 are pre inserted through said patch such that at least a portion of said nozzles 118 protrude out of said patch 106.

14. 1 . The DAD according to claim 1 , wherein said patch used is a non-pores patch.

15. The DAD according to claim 12, wherein said pre inserted nozzles 118 are adapted to provide attachment between said GDT 117 and said patch 106.

16. The DAD according to claim 12, wherein said nozzles 118 comprising at least two openings facing to two opposite directions of said patch.

17. The DAD according to claim 1, additionally comprising at least one piston 302 internally coupled to said GR 116; said piston 302 is adapted to reciprocal move along the GR's longitudinal axis such that said glue is extracted from said GR 116 to said GDT 117.

18. The DAD according to claim 17, wherein said piston 302 is driven by means selected from a group consisting of pneumatic means, mechanic means, hydraulic means or any combination thereof.

19. The DAD according to claim 17, wherein said piston is pneumatically driven via compressed gas.

20. The DAD according to claim 1, wherein said GR 116 is adapted to accommodate a multi- component glue.

21. The DAD accordtng to claim 20, wherein said GR 116 is divided into at least two sealed sub cavities 308, 309 by at least one partition 10.

22. The DAD according to claim 21, wherein each sub cavity 308, 309 is coupled to a single mixing cavity 311.

23. The DAD according to either one of claims 1, 17 or 20 additionally comprising at least one membrane 314 adapted to prevent any unwanted extraction of said glue components.

24. The DA D according to claim I , wherein said GDT 1 1 7 is characterized by an oval cross section so as to reduce the overall cross section area of said distal portion 101 in said 'closed configuration'.

25. The DAD according to claim I , wherein said FA ( 104) comprises means adapted to at least partially reversibly connect said patch ( 106) to said FA ( 1 04).

26. The DA D according to claim I , wherein said glue reservoir (GR) 1 16 is separately provided.

27. A method for deploying and attaching a patch to a biological tissue , said method comprising steps of: a. obtaining a deployment and attachment device (DAD) comprising: i. deployment mechanism adapted to laterally deploy a patch; and, ii. at least one glue dispensing system (GDS), in communication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue 1 1 ; said GDS comprising: (a) at least one gl ue reservoir (GR) 1 1 6 accommodating glue 1 19; and, (b) at least one glue dispensing tube (GDT) 1 1 7, in communication with said GR 1 16; b. attaching said patch to said DAD; c. introducing sard patch into said body cavity; d . deploying said patch; e. homogeneously dispersing glue 1 19 along substantially the entire margins area of said patch ; and, f. adjacently bringing said patch into contact with said biological tissue, thereby attaching said patch to said biological tissue.

28. A method for deploying and attaching a patch to a biological tissue; said method comprising steps of: a. obtaining a deployment and attachment device (DAD) comprising: i . deployment mechanism adapted to lateral ly deploy a patch ; and, i i. at least one glue dispensing system (GDS), in communication with said deploying mechanism and said patch, adapted to attach said patch to a biological tissue within a body cavity via a biological glue i 19; 6893 PCT/IL2OIW0OW85 said DAD is characterize by having a distal portion, adapted to be inserted into a body and a proximal portion, located adjacent to a user; said distal portion and said proximal portion are interconnected along a main longitudinal axis via a tube ( 103); said tube (103) having a proximal end (TP) connected to said proximal portion, and a distal end (TD); sard tube (103) is adapted to at least partially accommodate a central shaft (105); said central shaft ( 105) is characterized by a proximal end (CSP) accommodated within said tube and a distal end (CSD) protruding out of said TD; said central shaft is adapted to reciprocally move parallel to said main longitudinal axis within said tube; said GR (1 16) is in communication with at least one glue dispensing tube (1 17); said distal portion comprises: (i) at least two frame arms (FA) ( 104) adapted to be reversibly coupled to said patch; (ii) at least two proximal deployment arms (pDA) ( 108a, 108b) hinge-like connected to said TD and to the proximal end of said two FA; (iii) at least two distal deployment arms (dDA) (108c, 108d) hinge-like connected to said CSD and to the distal end of said two FA; each of said pDAs and dDAs (108a, 108b, 108c, I 08d) is characterized by a plurality of configurations, at least one of said configurations is a parallel configuration in which each of said pDAs and dDAs is substantially parallel to said central shaft (105); and, at least one of said configurations is a substantially perpendicular configuration in which each of said pDA and dDA is substantially perpendicular to said central shaft (105); said FAs (104) are characterized by a closed configuration in which said pDAs and dDAs are in said parallel configuration; and, a deployed configuration at which said pDAs and dDAs are in said substantially perpendicular configuration such that said patch is deployed; b. reversibiy attaching said patch to said FAs; c. adjusting said patch on said FAs; d. introducing said distal portion into said body cavity; e. reversibiy transforming said FA from said closed configuration to said deployed configuration; thereby deploying said patch; f. homogeneously dispersing glue 1 19 along substantial ly the entire margins area of said patch; g. adjacently bringing said patch into contact with said biological tissue, thereby attaching said patch to said biological tissue.

29. The method according to claim 28, additional ly comprising step of detaching said patch from said FA.

30. The method according to claim 28, additionally comprising step of transforming said FA from said deployed configuration to said closed configuration.

31. 3 1 . The method according to claim 30, additionally comprising step of extracting said DAD from said body cavity.

32. The method according to claim 28, additionally comprising step of laterally articulating said DAD so as said patch is orientated with respect to the treated defect.

33. The method according to claim 28, additionally comprising step of vertically articulating said DAD.

34. The method according to claim 28, additionally comprising step of reversibiy coupling said GK 1 16 to said tube 1 03 prior to said patch insertion .

35. The method according to claim 28, add itionally comprising step of selecting said glue from a group consisting of fibrin glue, Cyanoacrylate or any other glue suitable for clinical use.

36. The method according to claim 28, add itional ly comprising step of coupling said glue dispensing tube ( 1 1 7) to at least one selected from a group consisting of FA ( 104), pDA or d DA or any combination thereof.

37. The method according to claim 28, additionally comprising step of reversibiy coupling said glue d ispensing tube ( 1 17) to said patch ( 1 06).

38. The method according to claim 28, additionally comprising step of providing said GDT 1 1 7 with at least one nozzle 1 1 8 adapted to disperse said gl ue on said patch. WO 2010/0 6W3 PCI7]L2W)9/0(KW85

39. The method according to claim 28, additional ly comprising step of inserting said nozzles 1 1 8 through said patch such that at least a portion of said nozzles 1 1 8 protrude out of said patch 106 prior to step (d) of introducing.

40. The method according to claim 28, additionally comprising step of selecti ng said patch to be a non-pores patch,

41. The method according to claim 28, additional ly comprising step of internally coupling to said GR ( 1 16) at least one piston 302 adapted to reciprocal move along the GR's longitudinal axis such that said glue is extracted from said GR 1 16 to said GDT i 1 7.

42. The method according to claim 41 , additionally comprising step of driving said piston 302 by means selected from a group consisting of pneumatic means via compressed gas, mechanic means, hydraul ic means or any combination thereof.

43. The method according to claim 28, additionally comprising step of accommodating within said GR 1 16 a multi-component glue.

44. The method according to claim 28, additional ly comprising step of dividing said GR 1 16 into at least two sealed sub cavities 308, 309 by at least one partition 3 1 0.

45. The method according to claim 28, add itional ly comprising step of selecting the cross section area o f said GDT 1 17 from an oval cross sect ion so as to reduce the overal l cross section area of said distal portion 1 01 in said ' cl osed configurati on ' .