Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
1997-09-24
2003-05-20
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
Reexamination Certificate
active
06565594
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to tunneling devices which are implantable in a body, and more specifically to tunneling devices that include a flexible covering to protect the device from contamination during the handling and implantation of the device in the body. A tunneling device of the present invention may optionally include a tunneler tip that allows for attachment of the tunneling device to a tunneler instrument during the implantation process.
BACKGROUND OF THE INVENTION
It is commonly known that cardiac bypass surgery is a means to divert the flow of blood around arteries or veins that have become occluded or stenosed, and thus eliminate an impediment to the requirement of blood flow. A vascular graft which is a tubular device that is suitable for implantation in the body is used to reestablish or redirect the flow of blood beyond the blockage area. Surgical implantation procedures require placement of the vascular graft within the subcutaneous tissue. Vascular graft implantation requires the creation of an anatomic or subcutaneous pathway commonly called a graft tunnel. Tunneling is a required surgical step in the vascular bypass procedure for all peripheral, vascular access and extra anatomical graft locations which result in localized dissection injury to tissue. The tunnel diameter relative to the implant diameter, as well as the abrasive force exerted by the implant during insertion have a significant impact on the resultant trauma to this tissue and its healing response to both the blunt dissection of the tunnel space tissue and the vascular graft material.
It is advantageous in the clinical setting to minimize trauma to this tissue through the use of an improved tunneling technique and implant device. The conventional approach to creating a graft tunnel or space for the vascular graft is with the use of a rigid rod like device called a graft tunneler or tunneler instrument. Tunneler instruments come in varying sizes. They are usually very bulky, and require cleaning and sterilization before reuse. Improper size selection of the tunneler instrument or improper tunneling technique may result in a larger than required tunnel path through the tissue. An example of a tunneler instrument which has been designed to minimize the problem of oversizing a tissue tunnel is the KELLY-WICK tunneling set from Bard® Impra®, which is specifically designed for the implantation of vascular grafts without a tunnel sheath. Hence, this instrument is a “sheathless” system that draws a vascular graft through the dissected tissue tunnel which is created by a insertion of a rigid, bullet tipped rod through a skin incision, and forced horizontally through the subcutaneous tissue.
These type of tunneler instruments are reusable but expensive, and consequently hospitals often maintain only a limited supply of these instruments for operating room use. Since these instruments are reusable, they must be cleaned, packaged and resterilized between use. Frequently in emergency vascular surgery situations, the proper sized tunneling tip, whether it be a specific diameter, length or size, is not readily available. Consequently, the surgeon is forced to use an improper sized bullet tip (not matched to the outside diameter of the implant), or use a make-shift device. This may result in the creation of a vascular graft tunnel that is too large or too small for the graft, causing unnecessary or increased patient complications. If the tunneler instrument used creates a tunnel track that is too large for the size vascular graft being implanted, the tubular graft will not fit snugly within the tunnel and large “tunnel spaces” will exit along the entire length of the graft. This event is considered to be a major contributor to postoperative graft complications such as wound inflammation, graft material infection, and or seroma formation about the outside space of implanted graft. With an improper or “over-sized” tunnel, a significant amount of blood may pool and collect around the entire length of the implant, causing postoperative graft failure due to poor healing of the localized tissue, graft infection, and painful tissue swelling due to fluid accumulation between the dissected tissue and the implant.
Using a tunneler instrument to create a tunnel for the insertion and implantation of the vascular graft, the rigid rod like device is forcefully passed through the subcutaneous tissue horizontally between two surgically prepared incisions, until the bullet tip end is exposed at the second incision or exit wound. Once this tunneler tip is exposed, the tubular vascular graft material is placed over the bullet tipped device and tied onto the end of the indwelling tunneler rod tip with a sterile suture thread. The surgeon must carefully tie the graft to the tunneler rod with several suture knots, so as to avoid the graft from slipping off of the tunneler tip when pulled beneath the skin and into the implant position. After the vascular graft has been pulled through the dissected tissue cavity into final position, the vascular graft is then cut free at the tied end of the tunneler rod. Since the graft is exposed to the operative wound during attachment and insertion of the graft, the sterility and purity of the graft material are compromised. The process of suturing the graft to the tunneler rod and the manipulation of the graft by the surgeon further compromise the sterility of the device as a result of this “hands on” contact. Handling of the graft material during a tunneling procedure by contact with the nurse's and surgeon's gloves also increases the risk of infection by contamination from glove contact and operative wound/skin surface contact.
Another source of tissue trauma and postoperative graft complications can be created by the graft material itself due to the way the surgeon ties the graft to the tunneler. If not carefully prepared by the surgeon, part of the graft material may freely protrude over the tunneler instrument rod, forming a lip of free graft material in front of the suture tie. When the graft is forcibly pulled into and through the dissected tissue tunnel, such pulling action causes this graft material to compress, bunch up and create an abrupt or raised area in front of the suture tie which bluntly plows through the tissue, increasing the diameter of the tunnel and effectively increasing the amount of device drag in an abrasive manner, further traumatizing tissue along the entire tunnel track. This plowing action not only increases the potential for even more undesirable bleeding and tunnel track inflammation, but makes more work for the surgeon during graft insertion, particularly during long peripheral and extra anatomical bypass. This forceful graft insertion technique and risk of patient complications occurs with all commercially available vascular grafts when used with “sheathless” tunneler instruments.
“Pre-wetting” of the vascular graft material is another undesirable complication that occurs with traditional sheathless tunnelers. Since vascular grafts are constructed from porous biomaterials designed to encourage rapid cell ingrowth following implantation, for example vascular grafts made from expanded polytetrafluoroethylene (PTFE), it is known that microporous graft materials should not be “pre-wetted” or “presoaked” with blood. These conditions lead to fluid leakage through the graft material once blood flow is restored within the implant, much the way a canvas tent would leak in a rain storm. If, during insertion of the graft with a traditional sheathless tunneler instrument, the tunneler tip is undersized in comparison to the outside diameter of the graft being implanted, the leading 2-5 cm length of graft material will become completely saturated with blood during the process of dragging the graft through the tissue. This is caused by the pressure placed on the tissue during graft insertion due to the initial under-sized tunnel tract. Since the thickness of the graft material adds to the outer diameter of the original bullet tip outer
Cross David P.
Herweck Steve A.
Atrium Medical Corporation
Isabella David J.
Lahive & Cockfield LLP
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