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1. Field of Invention
A surgical suture staple and an application appliance for the secure and permanent attachment of a soft tissue to a bone provides a staple having a first and second metal or composite pin which will not adversely affect the bone within which it is attached, the first and second pin connected by a synthetic fiber suture. At least one suture is swedged into each first pin near an upper pin head and either swedged into or adjustably attached through the second pin also near an upper pin head, the first and second pins further comprising an extendable securing means which prevents the first and second pin from being removed from the bone within which it is implanted and a depression within the upper pin head receiving the driving end of an application appliance. The first and second pins are driven into a bone slightly below the bone surface on each side of a soft tissue being anchored to the bone, the suture securing the soft tissue with or without penetration.
2. Description of Prior Art
The following United States patents were discovered and are disclosed within this application for utility patent. All relate to surgical staples and suturing devices.
A hard and soft tissue closure device and method is disclosed in U.S. Pat. No. 6,485,504 to Johnson, which discloses a sleeve which is driven through a bone within which is inserted a suture or a staple or a two piece pin component. The penetrating device and the connecting devices are shown in multiple embodiments. A piton-like device providing an anchor point to a bone for a suture to be secured is disclosed in U.S. Pat. No. 6,200,330 to Benderev, which includes a t least two prongs that flare out into a direction perpendicular to the direction of insertion. U.S. Pat. No. 6,149,658 to Gardiner provides a suture staple apparatus for constructing a graft to artery anastomosis as well as application to other soft tissue anastomoses, the suture staple comprising a needle, a pin, a base and a flange, with the needle penetrating the soft tissue and the pin, base and flange provided to seal the graft and artery together. A great deal of the disclosure is dedicated to the mechanical instrument to apply the suture staple in addition to the actual suture staple.
Most similar, although patently distinct from the present invention, is a device for applying a meniscal staple, disclosed in U.S. Pat. No. 6,190,401 to Green, the staple being associated relevant prior art. However, that device is disclosed as having two needles having a sharp tip at one end and a blunt end within connecting leg members connected together by a flexible member, such as a suture, the anchor members having a plurality of barb-like projections, each barb having a tapered projection to allow for the anchor member to be pushed into the tissue, but restricts withdrawal of the anchor member once inserted. This is suture staple is also generally described as a reabsorbable meniscal staple. The remainder of the patent is devoted to disclosure of the mechanical device used to apply the suture staple, being a springloaded triggered staple gun with a pair of driving rods which exert a driving force to the blunt end of the suture staple, with the driving rods applying a uniform and common driving force to both blunt ends with equal force. The stated purpose of the device is to attache a menicus in a joint to a bone. It appears that the pins are withdrawn once the anchor members are inserted into the target tissue.
In addition to the above noted patents, several surgical anchors and sutures are disclosed in published advertisements most commonly found in orthopedic journals and periodicals, including products advertised by CONMED™. Additionally, use in the field of arthroscopic surgery for surgical anchors and sutures is indicated in numerous articles, including Intraoperative Arthroscopic Suture Anchor Reloading; Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol. 21, No. 7 (July), 2005: P 898, et.seq.
The field of orthopedic surgery has made numerous advances in surgical appliances and instruments, especially in dealing with means to reattach torn soft tissues to bone or other soft tissues. In many cases, this reattachment requires some device which is implanted into a bone that connects to a suture which is used to tie the soft tissue to the bone, whether permanently or temporarily. Staples or anchors are generally used as the implant device attached or installed into the bone which either include pre-threaded sutures or locations for sutures to be subsequently attached. Methods of application of the implant device to the bone either require a mechanical “gun” or stapler or in the type anchors having an outer thread, a screwdriver or ratchet-type device or employ the use of a surgical hammer. Sutures are either passed through the implant device prior to their insertion or installation, already attached using a technique known in the art as “swedging” or the sutures are passed through ports, eyelets or sockets in the implant device subsequent to the insertion or installation.
In most cases, the sutures are disclosed as being inserted through the soft tissue, actually sewing the soft tissue to the implant device. Soft tissue can be torn and weakened during this suturing process, and in many cases, multiple sutures are required to disperse the stress forces of a single suture through soft tissue by requiring multiple penetrations of the soft tissue while attaching the soft tissue to the implant device, indicated in the prior art by multiple colored sutures in a singular implant device.
It would be useful in the field of arthroscopic surgery to provide a suture staple device which allows for the primary or secondary attachment of a soft tissue to a bone with and without penetration of the soft tissue. The present device provides at least one pair of penetrating bone pins joined together either by a fixed length of suture material or an adjustable length of suture material, the penetrating pins, provided in several useful embodiments having differing suture connections applied to the bone on either side of or sometimes through the soft tissue to be attached to the bone, with the suture material securing the soft tissue to the bone without or without necessary penetration of the soft tissue by the suture, to be used alone or in combination with other arthroscopic securing devices.
Several embodiments of the penetrating bone pins include a different means of suture attachment, some having one or more pre-attached permanently connected sutures, or having orifices which allow for simply passing a suture through the pin or having an orifice that locks the suture into a fixed position by tension after adjustments to the length of the suture connected to another pin has been made.
The following drawings are submitted with this utility patent application.
A suture staple device 10 for the primary or secondary attachment of a soft tissue 100 to a bone 200 with or without requiring penetration of the soft tissue, shown in
The pin 20 is provided in at least four embodiments, including a first embodiment referenced as a single swedged pin 20a, a second embodiment referenced as a passage suture pin 20b, a third embodiment referenced as a double swedged swedged pin 20c, and a fourth embodiment referenced as an adjustable locking passage suture pin 20d. Any combination of the four embodiments of the pins 20a-20d may be utilized, depending on the application need of the surgical repair to be conducted to attach soft tissue 100 to the bone 200.
The single swedged pin 20a, shown in
The passage suture pin 20b, shown in
The double swedged pin 20c, shown in
The adjustable locking passage pin 20d, shown in
Insertion of the pins 20 into the bone 200 occurs during the surgical repair, most preferably during an arthroscopic surgical procedure, although application can also be applied during an open surgical procedure. In some cases, the soft tissue 100 is sutured together at a site of a tear prior to securing the soft tissue 100 to the bone 200, after which time the application of the suture staple device 10 occurs. In other cases, as surgeon may prefer to attach the soft tissue 100 to the bone 200 prior to repair of the torn soft tissue. Installation of the suture staple device 10 comprises the steps of loading at least one pin 20 attached to a suture 80 into the upper end 45 of at least one cylindrical insertion barrel 43 with the tapered point 29 directed towards the lower end 46 of the outer insertion tube 42, although the outer insertion tube 42 provides for the simultaneous installation of two pins 20, preferably connected by a suture 80 prior to installation, as indicated in
When installing the single swedged pin 20a or the double swedged pin 20c, the pin may be driven completely within the bone 200, with the upper pin head 21 slightly below the surface 202 of the bone 200, as shown in
Use of the attachment appliance 40 over other prior art attachment devices, especially those using some type of spring or air powered staple application device, is not recommended for use with the current suture staple device 10, because the surgeon must have control over the depth of the pin 20 into the bone 200 during the insertion and suture application process to insure that the soft tissue 200 is not strangled or cut during application of the suture staple device 10 to the bone 200. In addition, as the pins 20 may be partially inserted during theading or adjustment of the suture 80, only the lower end 27 of the pin 20 may be inserted within the bone 200 until the suture 80 is properly adjusted, with the upper pin head 21 of the pin 20 driven into the bone 200 after suture adjustment.
Choices of materials for the pins 20 are preferably a biocompatible product including nytenol, stainless steel, titanium, or a non-deformable polymer. The suture 80 is preferably may of a flexible thread made of polyester, polypropylene, nylon or other biocompatible and nonabsorbable material, but could also be made from a thin cable of a polymeric material.
While the invention has been particularly shown and described with reference to a preferred embodiment thereof, it will be understood by those skilled in the art that changes in form and detail may be made therein without departing from the spirit and scope of the invention.