(19)
(11)EP 2 988 677 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
26.06.2019 Bulletin 2019/26

(21)Application number: 14731430.6

(22)Date of filing:  25.04.2014
(51)International Patent Classification (IPC): 
A61B 17/00(2006.01)
(86)International application number:
PCT/US2014/035484
(87)International publication number:
WO 2014/176521 (30.10.2014 Gazette  2014/44)

(54)

TISSUE STABILIZATION AND REPAIR DEVICE

GEWEBESTABILISIERUNGS- UND REPARATURVORRICHTUNG

DISPOSITIF DE STABILISATION ET DE REPARATION DE TISSU


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 26.04.2013 US 201313871826

(43)Date of publication of application:
02.03.2016 Bulletin 2016/09

(73)Proprietor: Medtronic Xomed, Inc.
Jacksonville, FL 32216 (US)

(72)Inventor:
  • HISSONG, James B.
    Jacksonville, FL 32224 (US)

(74)Representative: Dehns 
St. Brides House 10 Salisbury Square
London EC4Y 8JD
London EC4Y 8JD (GB)


(56)References cited: : 
WO-A1-03/022457
US-A- 5 108 403
US-A- 3 943 628
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Background



    [0001] Following surgery on an internal structure of the body, a surgeon utilizes sutures or other mechanisms to assist in healing the internal structure properly. For example, during septal surgery, a surgeon dissects a portion of the septal lining during the procedure. Once the surgery is complete, the surgeon folds back the septal lining to its original location. In order to heal properly, the surgeon applies a suture to the septal lining and septum in order for the septal lining to heal in place. Attaching a suture within an interior cavity of the patient can be difficult using current approaches, as a surgeon handles both an endoscope and tools to install the suture.

    [0002] US 3,943,628, WO 03/022457 and US 5,108,403 are all concerned with tissue repair.

    Summary



    [0003] A method of stabilizing and repairing tissue includes providing a device having a tissue engagement structure surrounding an opening of an elongated cannula. The cannula extends from a proximal end to a distal end and defines a lumen. The device is positioned within a cavity that includes a first tissue structure and a second tissue structure at least partially separated from the first tissue structure. A free end of the second tissue structure is gripped with the tissue engagement structure. The second tissue structure is moved toward the first tissue structure using the tissue engagement structure. An adhesive is dispensed through the opening to the first tissue structure and the second tissue structure.

    [0004] A device includes an elongated cannula with an opening positioned at its distal end. A tissue engagement structure is affixed proximate the distal end of the cannula and extends distally beyond the opening. The tissue engagement structure includes a gripping structure to engage and control tissue. An adhesive is dispensed through the opening of the cannula to repair tissue.

    Brief Description of the Drawings



    [0005] 

    Figs. 1 and 2 are isometric views of a tissue stabilization and repair device.

    Fig. 3 is a schematic diagram of the device of Fig. 1 gripping a portion of tissue.

    Fig. 4 is a schematic diagram of the device of Fig. 1 stabilizing and repairing a portion of tissue.


    Detailed Description



    [0006] Figs. 1 and 2 illustrate an isometric view of a tissue stabilization and repair device 10 that includes an elongated cannula 12 and a tissue engagement structure 14. The cannula 12 extends from a first, proximal end 16 to a second, distal end 18. The cannula 12 defines an interior lumen 20 extending along the cannula 12 from the proximal end 16 to the distal end 18. Distal end 18 includes a beveled tip 22 defining an elongated opening 24. During use, an adhesive (e.g., cyanoacrylate or other fast curing adhesive) is positioned within lumen 20 at the proximal end 16. The adhesive is then delivered through the lumen 20 to the opening 24. The proximal end 16 can be configured to receive the adhesive from a suitable adhesive dispenser. For example, the dispenser can be a syringe with a plunger that is connectable to proximal end 16, wherein the plunger is used to move the adhesive along the lumen 20 to opening 24. In another example, the dispenser can be a tube filled with adhesive that is connected to proximal end 16 and squeezed to move the adhesive along lumen 20 to opening 24 or the tip end 16 can be integral with the adhesive container.

    [0007] Engagement structure 14 assists in stabilizing tissue to be repaired. In particular, the engagement structure 14 extends distally beyond the distal end 18 of the cannula 12 and includes a base portion 30, a distal tissue engagement portion 32 and opposed legs 34 and 36 extending from the base portion 30 and positioned on one or either side of cannula 12. Base portion 30 is generally planar and configured to engage and stabilize a portion of tissue while adhesive is applied through opening 24 to a portion of tissue to be repaired. Legs 34 and 36 are coupled to cannula 12 and, in one embodiment, allow for relative movement between the tissue engagement portion 32 and cannula 12. For example, the legs 34 and 36 can be formed with sufficient flexibility to deflect with respect to the tissue engagement portion 32 such that cannula 12 rotates with respect to the tissue engagement portion 32 when a force is applied to the tissue engagement portion 32. In another example, cannula 12 can be rotatably coupled to legs 34 and 36 to rotate relative thereto when a force is applied to tissue engagement portion 32.

    [0008] Tissue engaging portion 32 includes one or more teeth extending from the base portion 30 and is positioned spaced apart from the distal end 18 and opening 24 of cannula 12. In particular, the base portion 30 is positioned between the opening 24 and the distal engagement portion 32, the distal engagement portion 32 positioned at an end of the base portion 30 opposite the proximal end 16 of the cannula 12. The distal engagement portion 32 can extend from base portion 30 at various angles, for example, at least 45 degrees, at least 60 degrees, at least 90 degrees, greater than 90 degrees, etc. Illustratively, distal engagement portion 32 includes a first tooth 40, a second tooth 42 and a third tooth 44. The second tooth 42 is positioned between the first tooth 40 and third tooth 44 and is illustrated as having a larger surface area than either tooth 40 or tooth 44. It will be appreciated that any number of teeth (e.g., at least one, three, five) can be provided that extend from the base portion to assist in engaging tissue. Additionally, the teeth can be different sizes as desired.

    [0009] As illustrated in Figs. 3 and 4, during a method of tissue stabilization and repair, device 10 is inserted into a cavity 60 (e.g., a sinus cavity) including a first tissue structure 62 (e.g., a septal wall) and a second tissue structure 64 (e.g., a septal lining) at least partially separated from the first tissue structure 62. In the embodiment illustrated, the second tissue structure 64 is fixed to the first tissue structure 62 at a first end 66 and free from the first tissue structure 62 at a second end 68. To repair separation of the second tissue structure 64 from the first tissue structure 62, the distal engagement portion 32 engages the second tissue structure 64 (e.g., at the second end 68) and moves the second tissue structure 64 to engage the first tissue structure 62. In particular, second end 68 is brought into contact or in close proximity to the first tissue structure 62 as illustrated in Fig. 4.

    [0010] Once device 10 has positioned second tissue structure 64 into place, a force (i.e., pressure, indicated by arrow P) can be applied to device 10 to push second tissue structure 64 against first tissue structure 62. In one embodiment, the pressure causes cannula 12 to flex with respect to tissue engagement portion 32. For example, the pressure can cause legs 34 and 36, along with distal end 18 of cannula 12, to rotate with respect to the tissue engagement portion 32. Alternatively, or in addition to, distal end 18 can be rotatably coupled to legs 34 and 36 to facilitate flexing of the cannula 12 with respect to the tissue engagement portion 32. In one embodiment, flexing of the cannula 12 rotates beveled tip 22 such that the beveled tip 22 is orientated substantially parallel to the first tissue structure 62. Regardless of the orientation of beveled tip 22 with respect to the first tissue structure 62, an adhesive 70 can be dispensed through opening 24. The adhesive 70 is dispensed to adhere the second tissue structure 64 to the first tissue structure 62. After the adhesive 70 is dispensed, device 10 can be removed from cavity 60, allowing the adhesive 70 to cure in order to adhere the second tissue structure 64 to the first tissue structure 62. Alternatively, the pressure to first tissue structure 62 can be applied while adhesive 70 cures sufficiently to hold the first tissue structure 62 and second tissue structure 64 together.

    [0011] Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the scope of the invention as defined by the claims.


    Claims

    1. A tissue stabilization and repair device (10), comprising:

    an elongated cannula (12) extending from a proximal end (16) to a distal end (18) and defining a lumen (20) including an opening (24) at the distal end; and

    a tissue engagement structure(14) attached to the cannula and extending distally beyond the opening, the tissue engagement structure including a base portion (30) and a tissue engaging portion (32) wherein the tissue engaging portion extends from the base portion, and the base portion is positioned between the opening and the tissue engaging portion, and further characterized in that the tissue engaging portion includes a plurality of teeth (40, 42, 44)


     
    2. The tissue stabilization and repair device of claim 1, wherein the elongated cannula defines a beveled tip (22) at the distal end.
     
    3. The device of claim 1 or 2, where the tissue engagement structure further includes a plurality of legs (34, 36) extending from the base portion and attached to the cannula.
     
    4. The device of any preceding claim, wherein the tissue engaging portion deflects relative to the distal end of the cannula upon a force being applied to the tissue engaging portion.
     
    5. The device of any preceding claim, further comprising an adhesive positioned within the lumen.
     
    6. The device of any preceding claim, wherein the base portion is substantially planar.
     


    Ansprüche

    1. Gewebestabilisierungs- und Reparaturvorrichtung (10), umfassend:

    eine längliche Kanüle (12), die sich von einem proximalen Ende (16) zu einem distalen Ende (18) erstreckt und ein Lumen (20) festlegt, das am distalen Ende eine Öffnung (24) beinhaltet; und

    eine Gewebeerfassungskonstruktion (14), die an der Kanüle befestigt ist und sich distal über die Öffnung hinaus erstreckt, wobei die Gewebeerfassungskonstruktion einen Basisabschnitt (30) und einen Gewebeerfassungsabschnitt (32) beinhaltet, wobei sich der Gewebeerfassungsabschnitt vom Basisabschnitt erstreckt, und wobei der Basisabschnitt zwischen der Öffnung und dem Gewebeerfassungsabschnitt angeordnet ist und weiterhin dadurch gekennzeichnet, dass der Gewebeerfassungsabschnitt eine Vielzahl von Zähnen (40, 42, 44) beinhaltet


     
    2. Gewebestabilisierungs- und Reparaturvorrichtung nach Anspruch 1, wobei die längliche Kanüle am distalen Ende eine abgefaste Spitze (22) festlegt.
     
    3. Vorrichtung nach Anspruch 1 oder 2, wobei die Gewebeerfassungskonstruktion weiterhin eine Vielzahl von Schenkeln (34, 36) beinhaltet, die sich vom Basisabschnitt erstrecken und an der Kanüle befestigt sind.
     
    4. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei der Gewebeerfassungsabschnitt nach Anlegen einer Kraft am Gewebeerfassungsabschnitt im Verhältnis zum distalen Ende der Kanüle abgelenkt wird.
     
    5. Vorrichtung nach einem der vorhergehenden Ansprüche, weiterhin umfassend ein innerhalb des Lumens angeordnetes Klebemittel.
     
    6. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei der Basisabschnitt im Wesentlichen planar ist.
     


    Revendications

    1. Dispositif de stabilisation et de réparation de tissu (10), comprenant :

    une canule allongée (12) s'étendant d'une extrémité proximale (16) à une extrémité distale (18) et définissant une lumière (20) incluant une ouverture (24) au niveau de l'extrémité distale ; et

    une structure de mise en prise de tissu (14) fixée à la canule et s'étendant de manière distale au-delà de l'ouverture, la structure de mise en prise de tissu incluant une partie de base (30) et une partie de mise en prise de tissu (32), dans lequel la partie de mise en prise de tissu s'étend depuis la partie de base, et la partie de base est placée entre l'ouverture et la partie de mise en prise de tissu, et caractérisé en outre en ce que la partie de mise en prise de tissu comprend une pluralité de dents (40, 42, 44)


     
    2. Dispositif de stabilisation et de réparation de tissu selon la revendication 1, dans lequel la canule allongée définit une pointe biseautée (22) au niveau de l'extrémité distale.
     
    3. Dispositif selon la revendication 1 ou 2, dans lequel la structure de mise en prise de tissu comprend en outre une pluralité de pieds (34, 36) s'étendant depuis la partie de base et fixés à la canule.
     
    4. Dispositif selon une quelconque revendication précédente, dans lequel la partie de mise en prise de tissu dévie par rapport à l'extrémité distale de la canule lors de l'application d'une force sur la partie de mise en prise de tissu.
     
    5. Dispositif selon une quelconque revendication précédente, comprenant en outre un adhésif placé à l'intérieur de la lumière.
     
    6. Dispositif selon une quelconque revendication précédente, dans lequel la partie de base est sensiblement plane.
     




    Drawing

















    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description