Tissue connector apparatus and methods

Information

  • Patent Grant
  • 7763040
  • Patent Number
    7,763,040
  • Date Filed
    Monday, February 10, 2003
    21 years ago
  • Date Issued
    Tuesday, July 27, 2010
    13 years ago
Abstract
A tissue connector assembly comprising a clip movable between an open configuration and a closed configuration and a mechanical restraining device attached to the clip for restraining the clip in its open configuration. A needle may be releasably attached to the clip. A method for connecting tissues is also disclosed. The method includes inserting a clip through tissue with the clip being biased in an open position by a restraining device secured to the clip, and removing the restraining device from the clip.
Description
FIELD OF THE INVENTION

The present invention relates to instruments and methods for connecting body tissues, or body tissue to prostheses.


BACKGROUND OF THE INVENTION

Minimally invasive surgery has allowed physicians to carry out many surgical procedures with less pain and disability than conventional, open surgery. In performing minimally invasive surgery, the surgeon makes a number of small incisions through the body wall to obtain access to the tissues requiring treatment. Typically, a trocar, which is a pointed, piercing device, is delivered into the body with a cannula. After the trocar pierces the abdominal or thoracic wall, it is removed and the cannula is left with one end in the body cavity, where the operation is to take place, and the other end opening to the outside. A cannula has a small inside diameter, typically 5-10 millimeters, and sometimes up to as much as 20 millimeters. A number of such cannulas are inserted for any given operation.


A viewing instrument, typically including a miniature video camera, or optical telescope is inserted through one of these cannulas and a variety of surgical instruments and refractors are inserted through others. The image provided by the viewing device may be displayed on a video screen or television monitor, affording the surgeon enhanced visual control over the instruments. Because a commonly used viewing instrument is called an “endoscope,” this type of surgery is often referred to as “endoscopic surgery.” In the abdomen, endoscopic procedures are commonly referred to as laparoscopic surgery, and in the chest, as thoracoscopic surgery. Abdominal procedures may take place either inside the abdominal cavity (in the intraperitoneal space) or in a space created behind the abdominal cavity (in the retroperitoneal space). The retroperitoneal space is particularly useful for operations on the aorta and spine or abdominal wall hernia.


Minimally invasive surgery has virtually replaced open surgical techniques for operations such as cholecystectomy and anti-reflux surgery of the esophagus and stomach. This has not occurred in either peripheral vascular surgery or cardiovascular surgery. An important type of vascular surgery is to replace or bypass a diseased, occluded or injured artery. Arterial replacement or bypass grafting has been performed for many years using open surgical techniques and a variety of prosthetic grafts. These grafts are manufactured as fabrics (often from DACRON® (polyester fibers) or TEFLON® (fluorocarbon fibers)) or are prepared as autografts (from the patient's own tissues) or heterografts (from the tissues of animals) or a combination of tissues, semi-synthetic tissues and or alloplastic materials. A graft can be joined to the involved artery in a number of different positions, including end-to-end, end-to-side, and side-to-side. This attachment between artery and graft is known as an anastomosis. Constructing an arterial anastomosis is technically challenging for a surgeon in open surgical procedures, and is almost a technical impossibility using minimally invasive techniques.


Many factors contribute to the difficulty of performing arterial replacement or bypass grafting. See generally, Wylie, Edwin J. et al., Manual of Vascular Surgery, (Springer-Verlag New York), 1980. One such factor is that the tissues to be joined must be precisely aligned with respect to each other to ensure the integrity and patency of the anastomosis. If one of the tissues is affixed too close to its edge, the suture can rip through the tissue and impair both the tissue and the anastomosis. Another factor is that, even after the tissues are properly aligned, it is difficult and time consuming to pass the needle through the tissues, form the knot in the suture material, and ensure that the suture material does not become tangled. These difficulties are exacerbated by the small size of the artery and graft. The arteries subject to peripheral vascular and cardiovascular surgery typically range in diameter from several millimeters to several centimeters. A graft is typically about the same size as the artery to which it is being attached. Another factor contributing to the difficulty of such procedures is the limited time available to complete the procedure. The time the surgeon has to complete an arterial replacement or bypass graft is limited because there is no blood flowing through the artery while the procedure is being done. If blood flow is not promptly restored, sometimes in as little as thirty minutes, the tissue the artery supplies may experience significant damage, or even death (tissue necrosis). In addition, arterial replacement or bypass grafting is made more difficult by the need to accurately place and space many sutures to achieve a permanent hemostatic seal. Precise placement and spacing of sutures is also required to achieve an anastomosis with long-term patency.


Highly trained and experienced surgeons are able to perform arterial replacement and bypass grafting in open surgery using conventional sutures and suturing techniques. A suture has a suture needle that is attached or “swedged on” to a long, trailing suture material. The needle must be precisely controlled and accurately placed through both graft and artery. The trailing suture material must be held with proper tension to keep the graft and artery together, and must be carefully manipulated to prevent the suture material from tangling. In open surgery, these maneuvers can usually be accomplished within the necessary time frame, thus avoiding the subsequent tissue damage (or tissue death) that can result from prolonged occlusion of arterial blood flow.


The difficulty of suturing a graft to an artery using minimally invasive surgical techniques has effectively prevented the safe use of this technology in both peripheral vascular and cardiovascular surgical procedures. When a minimally invasive procedure is done in the abdominal cavity, the retroperitoneal space, or chest, the space in which the operation is performed is more limited, and the exposure to the involved organs is more restricted, than with open surgery. Moreover, in a minimally invasive procedure, the instruments used to assist with the operation are passed into the surgical field through cannulas. When manipulating instruments through cannulas, it is extremely difficult to position tissues in their proper alignment with respect to each other, pass a needle through the tissues, form a knot in the suture material once the tissues are aligned, and prevent the suture material from becoming tangled. Therefore, although there have been isolated reports of vascular anastomoses being formed by minimally invasive surgery, no system has been provided for wide-spread surgical use which would allow such procedures to be performed safely within the prescribed time limits.


As explained above, anastomoses are commonly formed in open surgery by suturing together the tissues to be joined. However, one known system for applying a clip around tissues to be joined in an anastomosis is disclosed in a brochure entitled, “VCS Clip Applier System”, published in 1995 by Auto Suture Company, a Division of U.S. Surgical Corporation. A clip is applied by applying an instrument about the tissue in a nonpenetrating manner, i.e., the clip does not penetrate through the tissues, but rather is clamped down around the tissues. As previously explained, it is imperative in forming an anastomosis that tissues to be joined are properly aligned with respect to each other. The disclosed VCS clip applier has no means for positioning tissues. Before the clip can be applied, the tissues must first be properly positioned with respect to each other, for example by skewering the tissues with a needle as discussed above in common suturing techniques or with forceps to bring the tissues together. It is extremely difficult to perform such positioning techniques in minimally invasive procedures.


Therefore, there is currently a need for other tissue connector assemblies.


SUMMARY OF THE INVENTION

The present invention involves improvements to devices and methods for connecting tissues or tissue(s) and grafts, such as in a vascular anastomosis. The invention generally involves a surgical clip which is self-closing. Preferably, the surgical clip comprises a shape memory material, most preferably nitinol.


According to one aspect of the invention, a tissue connector assembly is provided with a clip movable between an open configuration and a closed configuration, and a mechanical restraining device attached to the clip for restraining the clip in its open configuration. The clip may have a generally U-shaped configuration when in its open configuration.


The mechanical restraining device may include a coil for biasing the clip in its open configuration. Alternatively, the clip may include a tubular wire and the mechanical restraining device may include an elongated member that is positionable within the tubular wire.


According to another aspect of the present invention, a tissue connector assembly generally comprises a clip having a spiral shaped configuration when in a closed configuration and an open configuration wherein the clip is configured to form less than a full 360 degree turn. The spiral may be formed in one plane or may extend from a plane of a first loop of the spiral to form a generally conical shaped helical clip. The spiral shaped configuration of the clip generally provides for tight compression of the connecting tissue and may reduce the amount of surface area of the clip exposed to blood flow in an anastomosis, for example.


A needle may be attached to the clip for piercing tissue/graft material, and may be releasably attached to facilitate removal of the needle after insertion of the clip. The clip is generally small enough to prevent obstruction of a surgeon's view of the tissue being connected and allow for precise control of the clip by the surgeon.


In another aspect of the invention, a locking device is provided for releasably locking the clip in its open configuration. Upon release of the locking device a restraining force is removed from the clip to allow the clip to move to its unbiased, closed position. Advantageously, the locking device may also be arranged to removably connect a needle to the clip. Upon release of the locking device, the needle is disconnected from the clip. Both removal of the needle and release of the biasing force from the clip may occur simultaneously.


A method of the present invention generally includes inserting a clip through tissue with the clip biased in an open position by a restraining device coupled to the clip, and removing the restraining force on the clip to allow the clip to close.


Another aspect of the present invention generally includes inserting a needle and a clip attached to the needle through tissue with an instrument, with the ability to remove the needle from the clip with the same instrument. The present invention may allow a surgeon to single handedly insert and close the clip to connect tissue using a minimum amount of instruments.


The above is a brief description of some deficiencies in the prior art and advantages of the present invention. Other features, advantages, and embodiments of the invention will be apparent to those skilled in the art from the following description, accompanying drawings, and claims.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a front view of a tissue connector assembly of the present invention;



FIG. 2A shows a graft vessel connected to a target vessel with tissue connector assemblies of FIG. 1;



FIG. 2B is a front view of the connected graft and target vessels of FIG. 2A, with portions broken away to show detail;



FIG. 2C is an enlarged view of the tissue connection shown in FIG. 2B;



FIG. 3A is an enlarged view of a fastener of the tissue connector assembly of FIG. 1 shown in a closed position;



FIG. 3B is a side view of the fastener of FIG. 3A;



FIG. 3C is an enlarged view of the fastener in an open position;



FIG. 3D is an enlarged view of an alternate configuration of the fastener shown in a closed position;



FIG. 3E is an enlarged view of an alternate configuration of the fastener shown in a closed position;



FIG. 3F is a side view of the fastener of FIG. 3E;



FIG. 3G is an enlarged view of an alternate configuration of the fastener shown in a closed position;



FIG. 4A is a cross-sectional view of a restraining device of the tissue connector assembly of FIG. 1 in a locked position;



FIG. 4B is a cross-sectional view of the restraining device of FIG. 4A taken in the plane including line 4B-4B;



FIG. 4C is a cross-sectional view of the restraining device of FIG. 4A in an unlocked position;



FIG. 5 is an alternate embodiment of the restraining device of FIG. 4A;



FIG. 6 is a perspective of a second embodiment of a tissue connector assembly of the present invention;



FIG. 7 shows two tissue connector assemblies of FIG. 6 in a first step for connecting a graft vessel to a target vessel;



FIG. 8 shows a second step for connecting the graft vessel to the target vessel;



FIG. 9 shows a third step for connecting the graft vessel to the target vessel; and



FIG. 10 shows an alternate method for connecting the graft vessel to the target vessel with the tissue connector assemblies of FIG. 6.





Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.


DESCRIPTION OF THE INVENTION

Referring now to the drawings, and first to FIG. 1, a tissue connector assembly constructed according to the principles of the present invention is shown and generally indicated with reference numeral 1. The tissue connector assembly 1 may be used to manipulate and align tissues, or tissue and graft with respect to each other and thereafter connect the tissues together (FIGS. 2A-2C). As used herein, the term graft includes any of the following: homografts, xenografts, allografts, alloplastic materials, and combinations of the foregoing. The tissue connector assembly 1 may be used in vascular surgery to replace or bypass a diseased, occluded, or injured artery by connecting a graft vessel 12 to a coronary artery 14 or vein in an anastomosis, for example. The tissue connector assembly 1 may be used in open surgical procedures or in minimally invasive or endoseopic procedures for attaching tissue located in the chest, abdominal cavity, or retroperitoneal space. These examples, however, are provided for illustration and are not meant to be limiting.


In the embodiment shown in FIG. 1, the tissue connector assembly 1 generally comprises a penetrating member 2, and fastener or surgical clip 10 (FIG. 1). A restraining device, generally indicated at 8 and comprising a spring (or coil) 26 and a locking device generally indicated at 4, is connected to the fastener 10 for holding the fastener in a deformed configuration as further described below.


The penetrating member or needle 2 has a sharp pointed tip 30 at its distal end for penetrating tissue. The needle 2 may be bent as shown in FIG. 1, for example. The distal end of the needle 2 is preferably rigid to facilitate penetration of tissue. The remaining length of the needle 2 may be rigid or flexible to facilitate movement of the needle through the tissue as further described below. The tip 30 of the needle 21 may be conical, tapered, or grounded to attain a three or four facet tip, for example. The needle 2 may be made from stainless steel or any other suitable material, such as a polymeric material. It is to be understood that the needle 2 may have a shape or radius of curvature other than the one shown, without departing from the scope of the invention. The needle 2 may be integrally formed with the locking device 4 or may be swaged, welded, threadably attached, or attached by any other suitable means to the locking device.


As shown in FIG. 3A, one embodiment of a fastener 10 comprises a deformable wire 34 made of a shape memory alloy. A nickel titanium (nitinol) based alloy may be used, for example. The nitinol may include additional elements which affect the yield strength of the material or the temperature at which particular pseudoelastic or shape transformation characteristics occur. The transformation temperature may be defined as the temperature at which a shape memory alloy finishes transforming from martensite to austenite upon heating (i.e., Af temperature). The shape memory alloy preferably exhibits pseudoelastic (superelastic) behavior when deformed at a temperature slightly above its transformation temperature. At least a portion, of the shape memory alloy is converted from its austenitic phase to its martensitic phase when the wire is in its deformed configuration. As the stress is removed, the material undergoes a martensitic to austenitic conversion and springs back to its original undeformed configuration. When the wire 34 is positioned within the tissue in its undeformed configuration, a residual stress is present to maintain the tissue tightly together (FIG. 2C). In order for the pseudoelastic wire 34 to retain sufficient compression force in its undeformed configuration, the wire should not be stressed past its yield point in its deformed configuration to allow complete recovery of the wire to its undeformed configuration. The shape memory alloy is preferably selected with a transformation temperature suitable for use with a stopped heart condition where cold cardioplegia has been injected for temporary paralysis of the heart tissue (e.g., temperatures as low as 8-10 degrees Celsius).


It is to be understood that the shape memory alloy may also be heat activated, or a combination of heat activation and pseudoelastic properties may be used, as is well known by those skilled in the art.


The cross-sectional diameter of the wire 34 and length of the wire will vary depending on the specific application. The diameter “d” of the wire 34 may be, for example, between 0.001 and 0.015 inch. For coronary bypass applications, the diameter is preferably between 0.001 and 0.008 inch with a diameter “D” of the loop being between 0.0125 and 0.0875 inch (FIG. 3A). The diameter “D” of the loop of the fastener 120 in its closed position is preferably sized to prevent movement between adjacent tissues. As shown in FIG. 3A, the wire 34 has a circular cross-sectional shape. It is to be understood that the wire may have other cross-sectional shapes such as rectangular, or may be formed from multiple strands without departing from the scope of the invention.


The proximal end of the wire 34 may include a stop 36 having a cross-sectional area greater than the cross-sectional area of the wire and coil 26 to prevent the wire and coil from passing through the tissue (FIG. 3C). The stop 36 may be attached to the end of the wire 34 by welding, gluing or other suitable attachment means or may be formed integrally with the wire by deforming the end of the wire. The stop 36 may also be eliminated to facilitate pulling the fastener completely through the tissue, if, for example, the entire fastener needs to be removed from the vessel during the insertion procedure. The distal end of the wire 34 includes an enlarged portion 38 for engagement with the restraining device 8 as further described below (FIG. 4A). The enlarged portion 38 may be formed by deforming the end of the wire 34 by swaging or arc welding, or attaching by welding, swaging, or other suitable means to form an enlarged portion at the end of the wire.


The wire 34 has an undeformed or closed position (state of configuration) (FIG. 3A) for keeping or connecting tissue together, and a deformed or open position (state or configuration) (FIG. 3C) for insertion of the wire into tissue. The wire 34 is preferably not deformed past its yield point in its open position. Accordingly, it may have a U-shaped configuration in its open position to facilitate insertion of the wire 34 through the tissue. It is to be understood that a U-shaped configuration may be alternatively substituted by an equivalent structure such as C-shaped, V-shaped, J-shaped, and other similarly shaped configurations. The wire 34 is moved from its closed position to its open position by the restraining device 8, as further described below. When in its closed position, the wire 34 forms a loop with the ends of the wire in a generally side-by-side or overlapping orientation (FIG. 3B).


The wire 34 may be formed in the above described shape by first wrapping the wire onto a mandrel and heat treating the wire at approximately 400-500 degrees Celsius for approximately 5 to 30 minutes. The wire 34 is then air quenched at room temperature. The mandrel may have a constant diameter or may be conical in shape.


An alternate configuration of the surgical clip 10 in its closed position is shown in FIG. 3D, and generally indicated at 40. The fastener 40 forms a spiral configuration in its closed position for trapping tissue within a loop formed by the spiral. In its open position, the fastener 40 is configured to form less than a full 360 degree turn.


Another alternate configuration of the surgical clip 10 is shown in FIGS. 3E and 3F in its closed position, and is generally indicated at 41. The fastener 41 is formed in a spiral about a central longitudinal axis A. As shown in FIG. 3F, the fastener 41 has a generally conical shape along the longitudinal axis A, with a decreasing diameter as the radius of curvature of the fastener 41 decreases. The fastener 41 has an inner end portion 45 and an outer end portion 47, with the enlarged portion 38 of the wire being disposed at the outer end portion for engagement with the restraining device 8 (FIG. 3E).


A modification of the fastener is shown in FIG. 3G, and generally indicated at 43. The fastener 43 is same as the fastener 41 described above, except that the enlarged portion 38, which is adapted for engaging a restraining device or releasable mechanism, is positioned at the inner end portion 45 of the fastener. Placement of the restraining device 8 at the inner end portion 45 of the fastener 43 increases the compression force of the wire in its undeformed position on the tissue and decreases the surface area of the fastener exposed to blood flow.


It is to be understood that the fastener 10, 40, 41, 43 may have undeformed or deformed configurations different than those shown herein without departing from the scope of the invention. In addition, a locking clip (not shown) may also be attached to connect the ends of the fastener 10, 40, 41, 43 when the fastener is in its closed position to prevent possible opening of the fastener over time. The locking clip may also be integrally formed with one end of the fastener.


As shown in FIG. 3C, the wire 34 is surrounded by the spring or coil 26 which, along with the locking device 4, restrains the wire in its deformed configuration. The coil 26 comprises a helical wire forming a plurality of loops which define a longitudinal opening 44 for receiving the shape memory alloy wire 34. The coil 26 may be formed from a platinum alloy wire having a cross-sectional diameter of approximately 0.0005-0.005 inch, for example. The wire may have other cross-sectional shapes and be formed of different materials. The coil 26 is preferably sized so that when in its free (uncompressed state) it extends the length of the wire 34 with one end adjacent the stop 36 at the proximal end of the wire and the other end adjacent the enlarged portion 38 at the distal end of the wire (FIG. 3B). It is to be understood that the spring 26 may not extend the full length of the wire. For example, a flange or similar device may be provided on an intermediate portion of the wire 34 to limit movement of the coil along the length of the wire.


When the coil 26 is in its free state (with the wire 34 in its undeformed configuration), loops of the coil are generally spaced from one another and do not exert any significant force on the wire 34 (FIG. 3A). When the coil 26 is compressed (with the wire 34 in its deformed configuration), loops of the coil on the inner portion 46 of the coil are squeezed together with a tight pitch so that the loops are near or contiguous with one another while loops on the outer portion 48 of the coil are spaced from one another (FIG. 3C). This is due to the compressed inner arc length of the coil 26 and the expanded outer arc length of the coil. The compression of the loops on the inner portion 46 of the coil 26 exerts a force on the inner side of the wire 34 which forces the wire to spread open (i.e., tends to straighten the wire from its closed configuration to its open configuration). The end of the coil 26 adjacent the stop 36 is held in a fixed position relative to the wire 34. The opposite end of the coil 26 is free to move along the wire 34 and is held in place when the coil is in its compressed position by the locking device 4 (FIG. 4A).


The locking device 4 shown in FIGS. 1 and 4A-4C comprises a flexible tubular member 50 having a distal end portion 52 coupled to a needle 2 and a proximal end portion 54 releasably attached to the wire 34. The tubular member 50 is movable between a locked position (FIG. 4A) for holding the coil 26 in its compressed position and the wire 34 in its deformed position, and an unlocked position (FIG. 4C) for inserting or releasing the wire and coil. Three slots 58 are formed in the tubular member 50 extending from the proximal end 54 of the member and along at least a portion of the member (FIGS. 4B and 4C). The slots 58 are provided to allow the proximal end 54 of the tubular member 50 to open for insertion and removal of the wire 34 when the tubular member is in its unlocked position (FIG. 4C). It is to be understood that the number of slots 58 and configuration of the slots may vary.


The proximal end 54 of the tubular member 50 includes a bore 62 having a diameter slightly greater than the outer diameter d of the wire 34, but smaller than the diameter of the enlarged portion 38, and smaller than the outer diameter of the coil 26. The bore 62 extends into a cavity 64 sized for receiving the enlarged portion 38 of the wire 34. Member 50 may be described as having an annular flange 61 for releasably securing the enlarged portion 38. As shown in FIG. 4C, upon application of an inwardly directed radial squeezing force on the tubular member 50 the proximal end 54 of the tubular member is opened to allow for insertion or removal of the wire 34. When the force is released (FIG. 4A), the tubular member 50 moves back to its locked position and securely holds the wire 34 in place and compresses the coil 26. A disc 51 may be inserted into the tubular member 50 to act as a fulcrum and cause the proximal end 54 of the tubular member to open upon application of force on the tubular member. Alternatively, the disc 51 may be integrally formed with the tubular member 50. As shown in FIG. 4A, the length l of the bore 62 or flange 61 determines the amount of compression of the coil, which in turn determines the amount of deformation of the wire 34. The greater the length l of the bore 62, the greater the compression of the coil 26 and the more straightening the wire 34 will undergo. The compression of the coil 26 is preferably limited so that the wire 34 is not stressed beyond its yield point. This allows the wire 34 to revert back to its original undeformed configuration and apply sufficient pressure to hold the connected tissue together.


An alternate embodiment of the restraining device is shown in FIG. 5, and generally indicated with reference numeral 70. The restraining device 70 is used with a tubular (hollow) shape memory alloy wire or tube 72 and comprises an elongated member (or mandrel) 74 sized for insertion into the wire. The mandrel 74 is preferably formed from a material which is stiffer than the material of the wire 72 so that upon insertion of the mandrel into the wire, the wire is deformed into its open position. The restraining device 70 includes a stop 76 located at the proximal end of the wire 72. The stop operates to prevent the fastener from being pulled through the tissue, and limits axial movement of the mandrel 74 in the proximal direction (to the right as viewed in FIG. 5). The distal end of the mandrel 74 is releasably attached to the needle 2. It is to be understood that other types of restraining devices may be used without departing from the scope of the invention.


It is to be understood that locking devices other than those described above may be used without departing from the scope of the invention. For example, a locking device (not shown) may comprise a tubular member having an opening formed in a sidewall thereof for receiving an end portion of the wire. The end of the wire may be bent so that it is biased to fit within the opening in the sidewall of the tubular member. An instrument, such as a needle holder may then be used to push the wire away from the opening in the tubular member and release the wire from the tubular member. Various other types of locking devices including a spring detent or bayonet type of device may also be used.


Another embodiment of the tissue connector assembly is shown in FIG. 6 and generally indicated with reference numeral 110. The tissue connector assembly 110 is similar to the tissue connector assembly 1 of the first embodiment, except that a flexible member 118 is inserted between a restraining device 124 and needle 116. FIG. 6 shows the tissue connector assembly 110 with a fastener 120 in an open (deformed) position. The fastener 120 may be the same as the fasteners 10, 40, 41, 43 described above and shown in FIGS. 3A-3G for the tissue connector assembly 1 of the first embodiment, for example. The fastener 120 includes the restraining device 124 comprising a coil 126 and a locking device 128. The locking device 128 is same to the locking device 4 described above and shown in FIGS. 4A-4C, except that the distal end is configured for attachment to the flexible member 118.


The flexible member 118 is attached to the distal end of the locking device 128 with a tapered portion or transition sleeve 156 extending from the locking device to the flexible member 118 to facilitate insertion of the locking device through tissue. The tapered sleeve 156 is preferably sufficiently curved to facilitate movement of the tissue connector assembly 110 through connecting tissue in an anastomosis, for example. The sleeve 156 may be formed from a metal alloy such as stainless steel or a suitable polymeric material. The needle 116 may be swaged into the sleeve 156, or a heat shrink plastic covering may hold the needle in place. The locking device 128 may also be curved.


The flexible member 118 may be in the form of a suture formed from conventional filament material, metal alloy such as nitinol, polymeric material, or any other suitable material. The material may be non-stretchable or stretchable, solid or hollow, and have various cross-sectional diameters. The suture may have a cross-sectional diameter of 0.003 inch, for example. The diameter and length of the suture will vary depending on the specific application. The suture may be attached to the needle 116 by crimping or swaging the needle onto the suture, gluing the suture to the needle, or any other suitable attachment method. The flexible member 118 may have cross-sectional shapes other than the one shown herein.


The needle 116 may be integrally formed with the flexible member 118. The diameter of at least a portion of the needle 116 is preferably greater than the diameter of the flexible member 118 so that the flexible member can easily be pulled through an opening formed in the tissue by the needle.


As noted above, the tissue connector assemblies 1, 110 of this invention have many uses They may be especially useful in minimally invasive surgical procedures including creating an anastomosis between a vascular graft 12 and an artery 14 (FIGS. 2A-2C). The anastomosis may be used to replace or bypass a diseased, occluded or injured artery. A coronary bypass graft procedure requires that a source of arterial blood flow be prepared for subsequent bypass connection to a diseased artery. An arterial graft may be used to provide a source of blood flow, or a free graft may be used and connected at the proximal end to a source of blood flow. Preferably, the source of blood flow is one of any number of existing arteries which may be dissected in preparation for the bypass graft procedure. In many instances it is preferred to use the left internal mammary artery (LIMA) or the right internal mammary artery (RIMA), for example. Other vessels which may be used include the saphenous vein, gastroepiploic artery in the abdomen, radial artery, and other arteries harvested from the patient's body as well as synthetic graft materials, such as DACRON® or GORETEX® (expanded polytetrafluoroethylene). If a free graft vessel is used, the upstream end of the dissected vessel, which is the arterial blood source, will be secured to the aorta to provide the desired bypass blood flow, as is well known by those skilled in the art. The downstream end of the graft vessel is trimmed for attachment to an artery, such as the left anterior descending coronary (LAD). It is to be understood that the anastomosis may be formed in other vessels or tissue.



FIGS. 2A-2C and 7-9 show an exemplary use of the tissue connector assemblies 1, 110 for connecting a graft vessel 12 to an artery 14 (target vessel). In this example, two tissue connector assemblies 110 (FIG. 6) are used to make connections at generally opposite sides of the graft vessel and a plurality of tissue connector assemblies 1 (FIG. 1) are used to make connections between those made with tissue connector assemblies 110. The procedure may be accomplished with a beating heart procedure with the use of a heart stabilizer to keep the heart stable, for example. The procedure may also be performed endoscopically.


The patient is first prepped for standard cardiac surgery. After exposure and control of the artery 14, occlusion and reperfusion may be performed as required. Referring to FIGS. 7-9, after the arteriotomy of the snared graft vessel 12 has been made to the appropriate length, a tissue connector assembly 110 is attached to the free end of the graft vessel along an edge margin of the vessel. In order to attach the connector assembly 110, the surgeon grasps the needle 116 with a needle holder (e.g., surgical pliers, forceps, or any other suitable instrument) and inserts the needle 116 into an end margin of the graft vessel 12 in a direction from the exterior of the vessel to the interior of the vessel. The surgeon then releases the needle 116 and grasps a forward end of the needle which is now located inside the graft vessel 12 and pulls the needle and a portion of the suture 118 through the vessel. The needle 116 is passed through an opening 121 formed in the sidewall of the artery 14 and inserted into the tissue of the artery in a direction from the interior of the artery to the exterior of the artery. The surgeon then grasps the needle 116 located outside the artery 14 and pulls the needle and a portion of the suture 118 through the arterial wall. A second tissue connector assembly 110 may be inserted at a location generally 180 degrees from the location of the first tissue connector in a conventional “heel and toe” arrangement. Alternatively, a number of tissue connectors 110 may be inserted generally around the location of the heel. The graft vessel 12 may then be pulled towards the artery 14 to determine whether the opening 121 formed in the sidewall of the artery is large enough before completing the anastomosis.


Once the tissue connector assemblies 110 are inserted, the graft vessel 12 is positioned above the opening 121 in the sidewall of the artery 14 (FIG. 7). The fasteners 120 and needles 116 are pulled generally away from the artery 14 to reduce the length of the suture 118 between the vessel 12 and artery and “parachute” the vessel onto the artery (FIG. 8). The needles 116 are then pulled away from the artery 14 until the fastener 120 is positioned within the graft vessel 12 and artery with one end of each fastener extending from the vessel and the opposite end of each fastener extending from the artery (FIG. 9). The edges of the graft vessel 12 and artery 14 are positioned adjacent one another to form a continuous interior and exterior surface along the mating portions of the vessel and artery. As shown in FIG. 2C, the tissue is compressed within the fastener 120.


A surgical instrument (e.g., needle holder) is used to radially squeeze each locking device 128 to release the locking device from the fastener 120. Upon removal of the locking device 128, the coil 126 moves to its free uncompressed state which allows the wire 134 to return to its original undeformed closed position (FIG. 2A). As the wires 134 move to their closed position the adjacent tissues of the graft vessel 12 and artery 14 which were previously pulled together during the parachuting of the graft vessel onto the artery, are squeezed together to securely engage the graft vessel and artery (FIGS. 2B and 2C).


The tissue connector assemblies 1 are subsequently inserted at circumferentially spaced locations around the periphery of the graft vessel 12 to sealingly fasten the graft vessel to the artery 14. The needle 2 of the fastener 1 is inserted into the graft vessel 12 from the exterior surface of the graft vessel and pushed through the graft vessel and artery 14 tissue. The needle holder is then used to pull the needle 2 through the arterial wall. An instrument (same needle holder or other suitable instrument) is used to apply a squeezing force to the locking device 4 to release the wire 34 and coil 26 from the needle 2. This allows the coil 26 to move to its uncompressed configuration and the wire 34 to move to its closed position. It should be noted that the tissue connector assemblies 110 may remain in their open position while the tissue connector assemblies 1 are inserted into the tissue and moved to their closed position. The locking devices 128 of the tissue connector assemblies 110 may subsequently be removed from the fasteners 120 to allow the fasteners to move to their closed position. The number and combination of tissue connectors assemblies 1, 110 required to sealingly secure the connecting tissues together may vary. For example, only tissue connector assemblies 1 may be used to complete the entire anastomosis, or only tissue connector assemblies 110 may be used to connect tissues.


It should be noted that as the locking device 4 is squeezed two steps are accomplished. The fastener 10 is released from the locking device 4, thus allowing the coil 26 to uncompress and the wire 34 to move to its closed configuration, and the needle 2 is released from the fastener. Thus, in the embodiment shown, the locking device 4 provides for simultaneous actuating closure of the fastener 10 and release of the needle 2 from the fastener.


The graft vessel 12 may also be parachuted onto the artery 14 in the method shown in FIG. 10. The needles 116 are inserted into the graft vessel 12 and artery 14 as described above and the sutures 118 are pulled through the vessel so that the fasteners 120 are positioned within the vessel. The needles 116 are then pulled away from the artery 14 to “parachute” the graft vessel 12 onto the artery.


Although the coil 126 is shown as remaining on the wire (FIG. 6), it is to be understood that the coil 126 may also be removed from the wire 134, leaving only the wire in the connected tissue.


Although the suturing procedure has been described for an end-to-side anastomosis, it should be appreciated that the procedure is applicable to an end-to-end and side-to-side anastomosis, connecting various tissue structures including single and multiple tissue structures, and puncture sites, and connecting tissue to a prosthetic graft or valve, for example.


It will be observed from the foregoing that the tissue connector assemblies of the present invention have numerous advantages. Importantly, the assemblies are easier and faster to apply than conventional sutures which require tying multiple knots. The assemblies may be used in minimally invasive procedures including endoscopic procedures, and may be inserted single handedly.


All references cited above are incorporated herein by reference.


The above is a detailed description of a particular embodiment of the invention. It is recognized that departures from the disclosed embodiment may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. The full scope of the invention is set out in the claims that follow and their equivalents. Accordingly, the claims and specification should not be construed to unduly narrow the full scope of protection to which the invention is entitled.

Claims
  • 1. A tissue connector assembly comprising a self-closing clip movable between an open configuration and a closed configuration, said clip having a generally U-shaped configuration when in said open configuration, and a mechanical restraining device coupled to said clip for restraining said clip in said open configuration, wherein said restraining device is coupled to said clip such that in at least one state of said restraining device, an entirety of said restraining device moves with movement of said clip in response to a movement force applied to said clip, and further wherein said clip assumes a spiral configuration in said closed configuration.
  • 2. The tissue connector assembly of claim 1 further comprising a needle releasably attached to said clip.
  • 3. The tissue connector assembly of claim 1 wherein at least a portion of said mechanical restraining device remains on said clip when said needle is released from said clip.
  • 4. The tissue connector assembly of claim 1 wherein said clip comprises a wire.
  • 5. The tissue connector assembly of claim 4 wherein said wire is tubular.
  • 6. The tissue connector assembly of claim 4 wherein said wire has a generally circular cross-section.
  • 7. The tissue connector assembly of claim 4 wherein said wire comprises shape memory material.
  • 8. The tissue connector assembly of claim 4 wherein said wire has a first end portion, a second end portion and an elongated member therebetween, said first end portion being coupled to said mechanical restraining device, said second end portion having a cross-sectional area greater than a cross-sectional area of said elongated member.
  • 9. The tissue connector assembly of claim 1 wherein said clip is in a relaxed state when in said closed configuration.
  • 10. The tissue connector assembly of claim 1 wherein said mechanical restraining device comprises a coil surrounding at least a portion of said clip.
  • 11. The tissue connector assembly of claim 10 wherein said coil comprises a plurality of adjacent loops, said coil being compressible with said plurality of adjacent loops being spaced closer to one another along one side of said coil than along an opposite side of said coil.
  • 12. The tissue connector assembly of claim 10 wherein said mechanical restraining device includes a lock releasably engaging said coil, wherein engagement of said lock with said coil biases said clip in said open configuration.
  • 13. The tissue connector assembly of claim 1 wherein said clip comprises a tubular wire and said mechanical restraining device comprises an elongated member positioned in said wire.
  • 14. A tissue connector assembly comprising a self-closing clip having an open configuration and a closed configuration and a coil wound about said clip, wherein said coil is adapted to provide a biasing force to bias said clip in said open configuration, and further wherein a relationship of a longitudinal length of said coil relative to a longitudinal length of said clip differs between said open configuration and said closed configuration.
  • 15. The tissue connector assembly of claim 14 further comprising a needle coupled to said clip.
  • 16. The tissue connector assembly of claim 15 wherein said needle is releasably coupled to said clip.
  • 17. The tissue connector assembly of claim 14 wherein said clip has a generally U-shaped configuration when in said open configuration.
  • 18. The tissue connector assembly of claim 14 wherein said coil surrounds at least a portion of said clip and is arranged to bias said clip in said open configuration.
  • 19. A tissue connector assembly comprising a clip having an open configuration and a closed configuration and a restraint coupled to said clip when in said open configuration, wherein said clip assumes a spiral configuration in said closed configuration, wherein said restraint comprises an elongated member removably insertable into said clip, said clip and said elongated member configured such that said clip assumes said open configuration when said elongated member is inserted into said clip, and said clip transitions to said spiral configuration with removal of said elongated member from said clip.
  • 20. The tissue connector assembly of claim 19 further comprising a needle coupled to said clip.
  • 21. The tissue connector assembly of claim 20 wherein said needle is releasably coupled to said clip.
  • 22. The tissue connector assembly of claim 19 wherein said clip comprises a tubular member and said elongated member is sized for insertion into said tubular member.
  • 23. A tissue connector assembly comprising a clip having an open configuration and a closed configuration and a restraint coupled to said clip when in said open configuration, wherein said clip assumes a spiral configuration in said closed configuration, wherein said clip has a generally U-shaped configuration defined by a continuous, single bend direction along an entire length of said clip when in said open configuration.
  • 24. A tissue connector assembly comprising a clip movable between an open configuration and a closed configuration, said clip having a spiral shaped configuration when in said closed configuration, and an open configuration in which said clip is configured to form less than a full 360 degree turn in extension between opposing terminal ends, wherein said clip has a generally U-shaped configuration when in said open configuration.
  • 25. The tissue connector assembly of claim 24 wherein said clip spirals around a central longitudinal axis when in said closed configuration, said clip having a generally conical shape along said longitudinal axis.
  • 26. The tissue connector assembly of claim 25 wherein said clip has an inner end and an outer end, said inner end having a smaller radius than said outer end, said inner end being coupled to a needle.
  • 27. The tissue connector assembly of claim 24 further comprising a needle releasably attached to said clip.
  • 28. A tissue connector assembly comprising: a surgical clip having a relaxed state;a needle having a sharp distal point;a connector releasably coupling said needle to said clip; anda biasing member associated with said surgical clip;wherein said connector, when coupling said needle to said clip, urges said biasing member to bias said clip away from said relaxed state.
  • 29. The tissue connector assembly of claim 28, wherein said connector comprises a portion forming a recess, and said clip comprises a portion which adapted to mate with said recess.
  • 30. The tissue connector assembly of claim 29, wherein said biasing member comprises a coil surrounding at least a portion of said clip, said coil including a first end restrained from movement in one direction along said clip, and a second movable end, wherein said coupling of said connector with said needle compresses said coil by movement of said second end.
  • 31. A tissue connector assembly comprising a needle, a clip, and a locking device releasably connecting said needle to said clip, said locking device being movable between an open position for insertion and removal of said needle and a closed position for coupling said needle to said clip and biasing said clip in an open configuration.
  • 32. The tissue connector assembly of claim 31 wherein said clip comprises a wire.
  • 33. The tissue connector assembly of claim 32 wherein said wire comprises shape memory material.
  • 34. The tissue connector assembly of claim 31 further comprising a spring for biasing said clip in said open configuration.
  • 35. A method for connecting multiple portions of material, at least one of which comprises tissue, comprising: inserting a clip formed of a wire having opposing first and second terminal tips, which is spring biased away from a closed configuration to an open configuration, through said multiple portions of material, at least one of which comprises tissue, including initially inserting said first tip into said multiple portions of material before any other segment of said clip;mechanically maintaining said clip in said open configuration while inserting said clip through said materials; andallowing said clip to return to said closed configuration and secure a portion of said material therein.
  • 36. The method of claim 35 including maintaining said clip in said open configuration with a locking device.
  • 37. The method of claim 35 wherein said clip is allowed to return to said closed configuration by disengaging said locking device.
  • 38. The method of claim 37 wherein said clip includes a needle coupled to said locking device and said locking device is disengaged by decoupling said needle from said locking device.
  • 39. The method of claim 35 wherein said clip is inserted through a layer of tissue and a layer of graft material.
  • 40. A method for connecting multiple portions of material, at least one of which comprises tissue, said method comprising: inserting a needle having a clip attached thereto through said multiple portions with a needle holder, wherein said needle is initially inserted into said multiple portions followed by said clip, including pulling said needle through said multiple portions with said needle holder; andremoving said needle from said clip with said needle holder, including removing a locking device holding said clip in an open position.
  • 41. The method of claim 40 wherein said removing a locking device comprises applying an inwardly directed radial force to said locking device.
  • 42. The method of claim 40 wherein said removing a locking device comprises uncompressing a coil biasing said clip in said open position.
  • 43. The method of claim 40, wherein said inserting said needle includes grasping, releasing, and re-grasping said needle with said needle holder.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 09/090,305, entitled Tissue Connector Apparatus and Methods and filed Jun. 3, 1998, now U.S. Pat. No. 6,641,593, which application is incorporated by reference in its entirety and to which priority is claimed under 35 U.S.C. §120.

US Referenced Citations (563)
Number Name Date Kind
43098 Cooper Jun 1864 A
636728 Kindel Nov 1899 A
655190 Bramson Aug 1900 A
1087186 Scholfield Feb 1914 A
1167014 O'Brien Jan 1916 A
1539221 John May 1925 A
1583271 Biro May 1926 A
1625602 Gould et al. Apr 1927 A
1867624 Hoffman Jul 1932 A
2201610 Dawson May 1940 A
2240330 Flagg et al. Apr 1941 A
2256382 Dole Sep 1941 A
2264679 Ravel Dec 1941 A
2413142 Jones et al. Dec 1946 A
2430293 Howells Nov 1947 A
2505358 Gusberg et al. Apr 1950 A
2516710 Mascolo Jul 1950 A
2715486 Marcoff-Moghadam et al. Aug 1955 A
2890519 Storz, Jr. Jun 1959 A
2940452 Smialowski Jun 1960 A
3055689 Jorgensen Sep 1962 A
3057355 Smialowski Oct 1962 A
3082426 Miles Mar 1963 A
3125095 Kaufman et al. Mar 1964 A
3143742 Cromie Aug 1964 A
3150379 Brown Sep 1964 A
3180337 Smialowski Apr 1965 A
3249104 Hohnstein May 1966 A
3274658 Pile Sep 1966 A
3452742 Muller Jul 1969 A
3462802 Merser Aug 1969 A
3506012 Brown Apr 1970 A
3509882 Blake May 1970 A
3547103 Cook Dec 1970 A
3570497 Lemole Mar 1971 A
3608095 Barry Sep 1971 A
3638654 Akuba Feb 1972 A
3656185 Carpentier Apr 1972 A
RE27391 Merser Jun 1972 E
3753438 Wood et al. Aug 1973 A
3776237 Hill et al. Dec 1973 A
3802438 Wolvek Apr 1974 A
3825009 Williams Jul 1974 A
3837345 Matar Sep 1974 A
3874388 King et al. Apr 1975 A
3875648 Bone Apr 1975 A
3905403 Smith et al. Sep 1975 A
3908662 Razqulov et al. Sep 1975 A
3910281 Kletschka et al. Oct 1975 A
3958576 Komiya May 1976 A
3976079 Samuels Aug 1976 A
3995619 Glatzer Dec 1976 A
4006747 Kronenthal et al. Feb 1977 A
4018228 Goosen Apr 1977 A
4038725 Keefe Aug 1977 A
4042979 Angell Aug 1977 A
4073179 Hickey et al. Feb 1978 A
4103690 Harris Aug 1978 A
4111206 Vishnevsky et al. Sep 1978 A
4129059 Van Eck Dec 1978 A
4140125 Smith Feb 1979 A
4170990 Baumgart et al. Oct 1979 A
4185636 Gabbay et al. Jan 1980 A
4192315 Hilzinger et al. Mar 1980 A
4214587 Sakura Jul 1980 A
4217902 March Aug 1980 A
4243048 Griffin Jan 1981 A
4324248 Perlin Apr 1982 A
4341226 Peters Jul 1982 A
4345601 Fukuda Aug 1982 A
4352358 Angelchik Oct 1982 A
4366819 Kaster Jan 1983 A
4396139 Hall et al. Aug 1983 A
4416266 Baucom Nov 1983 A
4456017 Miles Jun 1984 A
4465071 Samuels et al. Aug 1984 A
4470415 Wozniak Sep 1984 A
4470533 Schuler Sep 1984 A
4474181 Schenck Oct 1984 A
4485816 Krumme Dec 1984 A
4492229 Grunwald Jan 1985 A
4522207 Klieman et al. Jun 1985 A
4523592 Daniel Jun 1985 A
4532927 Miksza Aug 1985 A
4535764 Ebert Aug 1985 A
4549545 Levy Oct 1985 A
4553542 Schenck et al. Nov 1985 A
4576605 Kaidash et al. Mar 1986 A
4586502 Bedi et al. May 1986 A
4586503 Kirsch et al. May 1986 A
4593693 Schenck Jun 1986 A
4595007 Mericle Jun 1986 A
4612932 Caspar et al. Sep 1986 A
4622970 Wozniak Nov 1986 A
4624255 Schenck et al. Nov 1986 A
4637380 Orejola Jan 1987 A
4641652 Hutterer et al. Feb 1987 A
4665906 Jervis May 1987 A
4665917 Clanton et al. May 1987 A
4683895 Pohndorf Aug 1987 A
4706362 Strausburg Nov 1987 A
4719917 Barrows et al. Jan 1988 A
4719924 Crittenden et al. Jan 1988 A
4730615 Sutherland et al. Mar 1988 A
4732151 Jones Mar 1988 A
4809695 Gwathmey et al. Mar 1989 A
4820298 Leveen et al. Apr 1989 A
4844318 Kunreuther Jul 1989 A
4873975 Walsh et al. Oct 1989 A
4890615 Caspari et al. Jan 1990 A
4896668 Popoff et al. Jan 1990 A
4899744 Fujitsuka et al. Feb 1990 A
4901721 Hakki Feb 1990 A
4923461 Caspari et al. May 1990 A
4924866 Yoon May 1990 A
4926860 Stice et al. May 1990 A
4929240 Kirsch et al. May 1990 A
4930674 Barak Jun 1990 A
4932955 Merz et al. Jun 1990 A
4935027 Yoon Jun 1990 A
4950015 Nejib et al. Aug 1990 A
4950283 Dzubow et al. Aug 1990 A
4950285 Wilk Aug 1990 A
4957498 Caspari et al. Sep 1990 A
4983176 Cushman et al. Jan 1991 A
4990152 Yoon Feb 1991 A
4991567 McCuen et al. Feb 1991 A
4994069 Ritchart et al. Feb 1991 A
4997439 Chen Mar 1991 A
5002550 Li Mar 1991 A
5002562 Oberlander Mar 1991 A
5002563 Pyka et al. Mar 1991 A
5007920 Torre Apr 1991 A
5011481 Myers et al. Apr 1991 A
5020713 Kunreuther Jun 1991 A
5026379 Yoon Jun 1991 A
5032127 Frazee et al. Jul 1991 A
5035692 Lyon et al. Jul 1991 A
5035702 Taheri Jul 1991 A
5042707 Taheri Aug 1991 A
5047047 Yoon Sep 1991 A
5053047 Yoon Oct 1991 A
5064431 Gilbertson et al. Nov 1991 A
5074874 Yoon et al. Dec 1991 A
5088692 Weiler Feb 1992 A
5100418 Yoon et al. Mar 1992 A
5100421 Christoudias Mar 1992 A
5104407 Lam et al. Apr 1992 A
5119983 Green et al. Jun 1992 A
5123913 Wilk et al. Jun 1992 A
5127413 Ebert Jul 1992 A
5129913 Ruppert Jul 1992 A
5152769 Baber Oct 1992 A
5154189 Oberlander Oct 1992 A
5158566 Pianetti Oct 1992 A
5171250 Yoon Dec 1992 A
5171252 Friedland Dec 1992 A
5174087 Bruno Dec 1992 A
5178634 Ramos Martinez Jan 1993 A
5192294 Blake Mar 1993 A
5196022 Bilweis Mar 1993 A
5196023 Martin Mar 1993 A
5201880 Wright et al. Apr 1993 A
5207694 Broome May 1993 A
5217027 Hermens Jun 1993 A
5219358 Bendel et al. Jun 1993 A
5221259 Weldon et al. Jun 1993 A
5222961 Nakao et al. Jun 1993 A
5222976 Yoon Jun 1993 A
5234447 Kaster et al. Aug 1993 A
5236440 Hlavacek Aug 1993 A
5242456 Nash et al. Sep 1993 A
5242457 Akopov et al. Sep 1993 A
5246443 Mai Sep 1993 A
5250053 Snyder Oct 1993 A
5250071 Palermo Oct 1993 A
5258011 Drews Nov 1993 A
5261917 Hasson et al. Nov 1993 A
5269783 Sander Dec 1993 A
5269809 Hayhurst et al. Dec 1993 A
5282825 Muck et al. Feb 1994 A
5290289 Sanders et al. Mar 1994 A
5304117 Wilk Apr 1994 A
5304204 Bregen Apr 1994 A
5306296 Wright et al. Apr 1994 A
5312436 Coffey et al. May 1994 A
5314468 Ramos Martinez May 1994 A
5330503 Yoon Jul 1994 A
5334196 Scott et al. Aug 1994 A
5336233 Chen Aug 1994 A
5336239 Gimpelson Aug 1994 A
5346459 Allen Sep 1994 A
5350419 Bendel et al. Sep 1994 A
5350420 Cosgrove et al. Sep 1994 A
5353804 Kornberg et al. Oct 1994 A
5355897 Pietrafitta et al. Oct 1994 A
5356424 Buzerak et al. Oct 1994 A
5362294 Seitzinger Nov 1994 A
5364406 Sewell Nov 1994 A
5366459 Yoon Nov 1994 A
5366462 Kaster et al. Nov 1994 A
5366479 McGarry et al. Nov 1994 A
5374268 Sander Dec 1994 A
5376096 Foster Dec 1994 A
5376101 Green et al. Dec 1994 A
5382259 Phelps et al. Jan 1995 A
5383904 Totakura et al. Jan 1995 A
5387227 Grice Feb 1995 A
5403331 Chesterfield Apr 1995 A
5403333 Kaster et al. Apr 1995 A
5403338 Milo Apr 1995 A
5403346 Loeser Apr 1995 A
5413584 Schulze May 1995 A
5417684 Jackson et al. May 1995 A
5417700 Egan May 1995 A
5423821 Pasque Jun 1995 A
5431666 Sauer et al. Jul 1995 A
5437680 Yoon Aug 1995 A
5437681 Meade et al. Aug 1995 A
5437685 Blasnik Aug 1995 A
5439479 Shichman et al. Aug 1995 A
5445167 Yoon et al. Aug 1995 A
5445644 Pietrafitta et al. Aug 1995 A
5450860 O'Connor Sep 1995 A
5451231 Rabenau et al. Sep 1995 A
5452733 Sterman et al. Sep 1995 A
5454834 Boebel et al. Oct 1995 A
5456246 Schmieding et al. Oct 1995 A
5462561 Voda Oct 1995 A
5474557 Mai Dec 1995 A
5480405 Yoon Jan 1996 A
5486187 Schenck Jan 1996 A
5486197 Le et al. Jan 1996 A
5488958 Topel et al. Feb 1996 A
5496334 Klundt et al. Mar 1996 A
5499990 Schulken et al. Mar 1996 A
5500000 Feagin et al. Mar 1996 A
5522884 Wright Jun 1996 A
5527342 Pietrzak et al. Jun 1996 A
5533236 Tseng Jul 1996 A
5538509 Dunlap et al. Jul 1996 A
5545214 Stevens Aug 1996 A
5549619 Peters et al. Aug 1996 A
5556411 Taoda et al. Sep 1996 A
5562685 Mollenauer et al. Oct 1996 A
5569205 Hart et al. Oct 1996 A
5569274 Rapacki et al. Oct 1996 A
5569301 Granger et al. Oct 1996 A
5571119 Atala Nov 1996 A
5571175 Vanney et al. Nov 1996 A
5582616 Bolduc et al. Dec 1996 A
5582619 Ken Dec 1996 A
5584879 Reimold et al. Dec 1996 A
5586983 Sanders et al. Dec 1996 A
5591179 Edelstein Jan 1997 A
5593414 Shipp et al. Jan 1997 A
5593424 Northrup, III Jan 1997 A
5597378 Jervis Jan 1997 A
5601571 Moss Feb 1997 A
5601572 Middleman et al. Feb 1997 A
5601600 Ton Feb 1997 A
5603718 Xu Feb 1997 A
5609608 Benett et al. Mar 1997 A
5628757 Hasson May 1997 A
5630540 Blewett May 1997 A
5632752 Buelna May 1997 A
5632753 Loeser May 1997 A
5643295 Yoon Jul 1997 A
5643305 Al-Tameem Jul 1997 A
5645568 Chervitz et al. Jul 1997 A
5653716 Malo et al. Aug 1997 A
5653718 Yoon Aug 1997 A
5658312 Green et al. Aug 1997 A
5660186 Bachir Aug 1997 A
5665109 Yoon Sep 1997 A
5669918 Balazs et al. Sep 1997 A
5676670 Kim Oct 1997 A
5683417 Cooper Nov 1997 A
5690662 Chiu et al. Nov 1997 A
5695504 Gifford, III et al. Dec 1997 A
5695505 Yoon Dec 1997 A
5697913 Sierocuk et al. Dec 1997 A
5697943 Sauer et al. Dec 1997 A
5700270 Peyser et al. Dec 1997 A
5700271 Whitfield et al. Dec 1997 A
5702412 Popov et al. Dec 1997 A
5707362 Yoon Jan 1998 A
5707380 Hinchliffe et al. Jan 1998 A
5709693 Taylor Jan 1998 A
5709695 Northrup, III Jan 1998 A
5715987 Kelley et al. Feb 1998 A
5720755 Dakov Feb 1998 A
5725539 Matern Mar 1998 A
5725542 Yoon Mar 1998 A
5728135 Bregen et al. Mar 1998 A
5732872 Bolduc et al. Mar 1998 A
5735290 Sterman et al. Apr 1998 A
5746753 Sullivan et al. May 1998 A
5755778 Kleshinski May 1998 A
5766189 Matsumo Jun 1998 A
5769870 Salahich et al. Jun 1998 A
5779718 Green et al. Jul 1998 A
5782397 Koukline Jul 1998 A
5782844 Yoon et al. Jul 1998 A
5797920 Kim Aug 1998 A
5797933 Snow et al. Aug 1998 A
5797934 Rygaard Aug 1998 A
5797960 Stevens et al. Aug 1998 A
5799661 Boyd et al. Sep 1998 A
5799857 Robertson et al. Sep 1998 A
5810848 Hayhurst Sep 1998 A
5810851 Yoon Sep 1998 A
5810853 Yoon Sep 1998 A
5810882 Bolduc et al. Sep 1998 A
5817113 Gifford, III et al. Oct 1998 A
5820631 Nobles Oct 1998 A
5824002 Gentelia et al. Oct 1998 A
5824008 Bolduc et al. Oct 1998 A
5827265 Glinsky et al. Oct 1998 A
5827316 Young et al. Oct 1998 A
5830221 Stein et al. Nov 1998 A
5830222 Makower Nov 1998 A
5833698 Hinchliffe Nov 1998 A
5849019 Yoon Dec 1998 A
5851216 Allen Dec 1998 A
5855614 Stevens et al. Jan 1999 A
5868702 Stevens et al. Feb 1999 A
5868763 Spence et al. Feb 1999 A
5871528 Camps et al. Feb 1999 A
5879371 Gardiner et al. Mar 1999 A
5881943 Heck et al. Mar 1999 A
5882340 Yoon Mar 1999 A
5891130 Palermo et al. Apr 1999 A
5891160 Williamson, IV et al. Apr 1999 A
5893369 LeMole Apr 1999 A
5893865 Swindle et al. Apr 1999 A
5893886 Zegdi et al. Apr 1999 A
5895394 Kienzle et al. Apr 1999 A
5897565 Foster Apr 1999 A
5904697 Gifford, III et al. May 1999 A
5908428 Scirica et al. Jun 1999 A
5911352 Racenet et al. Jun 1999 A
5919207 Taheri Jul 1999 A
5931842 Goldsteen et al. Aug 1999 A
5941434 Green Aug 1999 A
5941442 Geiste et al. Aug 1999 A
5941888 Wallace et al. Aug 1999 A
5941908 Goldsteen et al. Aug 1999 A
5944730 Nobles et al. Aug 1999 A
5951576 Wakabayashi Sep 1999 A
5951600 Lemelson Sep 1999 A
5954735 Rygaard Sep 1999 A
5957363 Heck Sep 1999 A
5957938 Zhu et al. Sep 1999 A
5957940 Tanner et al. Sep 1999 A
5961481 Sterman et al. Oct 1999 A
5961539 Northrup, III et al. Oct 1999 A
5964772 Bolduc et al. Oct 1999 A
5964782 Lafontaine et al. Oct 1999 A
5972024 Northrup et al. Oct 1999 A
5976159 Bolduc et al. Nov 1999 A
5976161 Kirsch et al. Nov 1999 A
5976164 Bencini et al. Nov 1999 A
5976178 Goldsteen et al. Nov 1999 A
5984917 Fleischman et al. Nov 1999 A
5984959 Robertson et al. Nov 1999 A
5989242 Saadat et al. Nov 1999 A
5989268 Pugsley, Jr. et al. Nov 1999 A
5989276 Houser et al. Nov 1999 A
5989278 Mueller Nov 1999 A
5993468 Rygaard Nov 1999 A
5997556 Tanner Dec 1999 A
6001110 Adams Dec 1999 A
6007544 Kim Dec 1999 A
6010531 Donlon et al. Jan 2000 A
6013084 Ken et al. Jan 2000 A
6022367 Sherts Feb 2000 A
6024748 Manzo et al. Feb 2000 A
6032849 Mastri et al. Mar 2000 A
6033419 Hamblin, Jr. et al. Mar 2000 A
6036699 Andreas et al. Mar 2000 A
6036703 Evans et al. Mar 2000 A
6036710 McGarry et al. Mar 2000 A
6042607 Williamson et al. Mar 2000 A
6056751 Fenton May 2000 A
6063070 Eder May 2000 A
6066148 Rygaard May 2000 A
6074401 Gardiner et al. Jun 2000 A
6074418 Buchanan et al. Jun 2000 A
6077291 Das Jun 2000 A
6080114 Russin Jun 2000 A
6083237 Huitema et al. Jul 2000 A
6106538 Shiber Aug 2000 A
6110188 Narciso Aug 2000 A
6113611 Allen et al. Sep 2000 A
6113612 Swanson et al. Sep 2000 A
6120524 Taheri Sep 2000 A
6132438 Fleischman et al. Oct 2000 A
6139540 Rost et al. Oct 2000 A
6143004 Davis et al. Nov 2000 A
6149658 Gardiner et al. Nov 2000 A
6152935 Kammerer et al. Nov 2000 A
6152937 Peterson et al. Nov 2000 A
6159165 Ferrera et al. Dec 2000 A
6159225 Makower Dec 2000 A
6165183 Kuehn et al. Dec 2000 A
6165185 Shennib et al. Dec 2000 A
6171320 Monassevitch Jan 2001 B1
6171321 Gifford, III et al. Jan 2001 B1
6176413 Heck et al. Jan 2001 B1
6176864 Chapman Jan 2001 B1
6179840 Bowman Jan 2001 B1
6179848 Solem Jan 2001 B1
6179849 Yencho et al. Jan 2001 B1
6183512 Howanec et al. Feb 2001 B1
6190373 Palermo et al. Feb 2001 B1
6193733 Adams Feb 2001 B1
6193734 Bolduc et al. Feb 2001 B1
6197037 Hair Mar 2001 B1
6217611 Klostermeyer Apr 2001 B1
6221083 Mayer Apr 2001 B1
6241738 Dereume Jun 2001 B1
6241741 Duhaylongsod et al. Jun 2001 B1
6248117 Blatter Jun 2001 B1
6250308 Cox Jun 2001 B1
6254615 Bolduc et al. Jul 2001 B1
6269819 Oz et al. Aug 2001 B1
6280460 Bolduc et al. Aug 2001 B1
6283979 Mers Kelly et al. Sep 2001 B1
6283993 Cosgrove et al. Sep 2001 B1
6296622 Kurz et al. Oct 2001 B1
6296656 Bolduc et al. Oct 2001 B1
6306141 Jervis Oct 2001 B1
6332893 Mortier et al. Dec 2001 B1
6346074 Roth Feb 2002 B1
6346112 Adams Feb 2002 B2
6350269 Shipp et al. Feb 2002 B1
6352543 Cole Mar 2002 B1
6358258 Arcia et al. Mar 2002 B1
6361559 Houser et al. Mar 2002 B1
6368348 Gabbay Apr 2002 B1
6371964 Vargas et al. Apr 2002 B1
6387105 Gifford, III et al. May 2002 B1
6391038 Vargas et al. May 2002 B2
6402764 Hendricksen et al. Jun 2002 B1
6406492 Lytle Jun 2002 B1
6406493 Tu et al. Jun 2002 B1
6409739 Nobles et al. Jun 2002 B1
6409758 Stobie et al. Jun 2002 B2
6416527 Berg et al. Jul 2002 B1
6418597 Deschenes et al. Jul 2002 B1
6419658 Restelli et al. Jul 2002 B1
6419681 Vargas et al. Jul 2002 B1
6419695 Gabbay Jul 2002 B1
6425900 Knodel et al. Jul 2002 B1
6428550 Vargas et al. Aug 2002 B1
6428555 Koster, Jr. Aug 2002 B1
6451048 Berg et al. Sep 2002 B1
6461320 Yencho et al. Oct 2002 B1
6475222 Berg et al. Nov 2002 B1
6478804 Vargas et al. Nov 2002 B2
6485496 Suyker et al. Nov 2002 B1
6491707 Makower et al. Dec 2002 B2
6497671 Ferrera et al. Dec 2002 B2
6497710 Yencho et al. Dec 2002 B2
6514265 Ho et al. Feb 2003 B2
6517558 Gittings et al. Feb 2003 B2
6524338 Gundry Feb 2003 B1
6533812 Swanson et al. Mar 2003 B2
6537288 Vargas et al. Mar 2003 B2
6547799 Hess et al. Apr 2003 B2
6551332 Nguyen et al. Apr 2003 B1
6562053 Schulze et al. May 2003 B2
6575985 Knight et al. Jun 2003 B2
6589255 Schulze et al. Jul 2003 B2
6607541 Gardiner et al. Aug 2003 B1
6607542 Wild et al. Aug 2003 B1
6613059 Schaller et al. Sep 2003 B2
6629988 Weadock Oct 2003 B2
6635214 Rapacki et al. Oct 2003 B2
6641593 Schaller et al. Nov 2003 B1
6648900 Fleischman et al. Nov 2003 B2
6651670 Rapacki et al. Nov 2003 B2
6651672 Roth Nov 2003 B2
6652540 Cole et al. Nov 2003 B1
6652541 Vargas et al. Nov 2003 B1
6660015 Berg et al. Dec 2003 B1
6682540 Sancoff et al. Jan 2004 B1
6695859 Golden et al. Feb 2004 B1
6702826 Liddicoat et al. Mar 2004 B2
6709442 Miller et al. Mar 2004 B2
6712829 Schulze Mar 2004 B2
6719768 Cole et al. Apr 2004 B1
6743243 Roy et al. Jun 2004 B1
6749622 McGuckin et al. Jun 2004 B2
6776782 Schulze Aug 2004 B2
6776784 Ginn Aug 2004 B2
6776785 Yencho et al. Aug 2004 B1
6802847 Carson et al. Oct 2004 B1
6821286 Carranza et al. Nov 2004 B1
6869444 Gabbay Mar 2005 B2
6913607 Ainsworth et al. Jul 2005 B2
6918917 Nguyen et al. Jul 2005 B1
6921407 Nguyen et al. Jul 2005 B2
6926730 Nguyen et al. Aug 2005 B1
6945980 Nguyen et al. Sep 2005 B2
6955679 Hendricksen et al. Oct 2005 B1
6960221 Ho et al. Nov 2005 B2
6979337 Kato Dec 2005 B2
6979338 Loshakove et al. Dec 2005 B1
7022131 Derowe et al. Apr 2006 B1
7056330 Gayton Jun 2006 B2
7063711 Loshakove et al. Jun 2006 B1
7070618 Streeter Jul 2006 B2
7182769 Ainsworth et al. Feb 2007 B2
7220268 Blatter May 2007 B2
20010018592 Schaller et al. Aug 2001 A1
20010018593 Nguyen et al. Aug 2001 A1
20010018611 Solem et al. Aug 2001 A1
20010021856 Bolduc et al. Sep 2001 A1
20010047181 Ho et al. Nov 2001 A1
20020010490 Schaller et al. Jan 2002 A1
20020042623 Blatter et al. Apr 2002 A1
20020082614 Logan et al. Jun 2002 A1
20020099395 Acampora et al. Jul 2002 A1
20020151916 Muramatsu et al. Oct 2002 A1
20020165561 Ainsworth et al. Nov 2002 A1
20020173803 Yang et al. Nov 2002 A1
20030074012 Nguyen et al. Apr 2003 A1
20030078603 Schaller et al. Apr 2003 A1
20030083742 Spence et al. May 2003 A1
20030093118 Ho et al. May 2003 A1
20030125755 Schaller et al. Jul 2003 A1
20030191481 Nguyen et al. Oct 2003 A1
20030195531 Gardiner et al. Oct 2003 A1
20030199974 Lee et al. Oct 2003 A1
20040050393 Golden et al. Mar 2004 A1
20040068276 Golden et al. Apr 2004 A1
20040102797 Golden et al. May 2004 A1
20040111099 Nguyen et al. Jun 2004 A1
20040138685 Clague et al. Jul 2004 A1
20040176663 Edoga Sep 2004 A1
20040193259 Gabbay Sep 2004 A1
20050004582 Edoga Jan 2005 A1
20050021054 Ainsworth et al. Jan 2005 A1
20050043749 Breton et al. Feb 2005 A1
20050065601 Lee et al. Mar 2005 A1
20050070924 Schaller et al. Mar 2005 A1
20050075659 Realyvasquez et al. Apr 2005 A1
20050075667 Schaller et al. Apr 2005 A1
20050080454 Drews Apr 2005 A1
20050101975 Nguyen et al. May 2005 A1
20050107871 Realyvasquez et al. May 2005 A1
20050131429 Ho et al. Jun 2005 A1
20050267572 Schoon et al. Dec 2005 A1
20060004389 Nguyen et al. Jan 2006 A1
20060253143 Edoga Nov 2006 A1
20060271081 Realyvasquez Nov 2006 A1
20060293701 Ainsworth et al. Dec 2006 A1
20070010835 Breton et al. Jan 2007 A1
20070027461 Gardiner et al. Feb 2007 A1
20070106313 Golden et al. May 2007 A1
20070142848 Ainsworth et al. Jun 2007 A1
Foreign Referenced Citations (107)
Number Date Country
21 99 99 Mar 1910 DE
0377052 Jun 1923 DE
27 03 529 Aug 1978 DE
32 03 410 May 1981 DE
32 27 984 Feb 1984 DE
3504202 Aug 1985 DE
41 33 800 Jan 1993 DE
44 02 058 Apr 1995 DE
195 47 617 Sep 1997 DE
19732234 Jan 1999 DE
0072232 Feb 1983 EP
0122046 Mar 1983 EP
0 121 362 Oct 1984 EP
0129441 Dec 1984 EP
0130037 Jan 1985 EP
0140557 May 1985 EP
0 326 426 Aug 1989 EP
0409569 Jan 1991 EP
0 432 692 Jun 1991 EP
0 478 949 Apr 1992 EP
0 494 636 Jul 1992 EP
0 559 429 Sep 1993 EP
0598529 May 1994 EP
0 419 597 Dec 1994 EP
0632999 Jan 1995 EP
0 641 546 Mar 1995 EP
0656191 Jun 1995 EP
0687446 Dec 1995 EP
0705568 Apr 1996 EP
0 711 532 May 1996 EP
0 734 697 Oct 1996 EP
0705569 Oct 1996 EP
0 537 955 Dec 1996 EP
0 778 005 Jun 1997 EP
0 815 795 Jan 1998 EP
2 223 410 Apr 1990 GB
07308322 Nov 1995 JP
08336544 Dec 1996 JP
10-337291 Dec 1998 JP
2110222 May 1998 RU
577022 Oct 1977 SU
1186199 Oct 1985 SU
1456109 Feb 1989 SU
1560133 Apr 1990 SU
9006725 Jun 1990 WO
9009149 Aug 1990 WO
9014795 Dec 1990 WO
9107916 Jun 1991 WO
9108708 Jun 1991 WO
9117712 Nov 1991 WO
9205828 Apr 1992 WO
9212676 Aug 1992 WO
9222041 Dec 1992 WO
9301750 Feb 1993 WO
9320756 Oct 1993 WO
9415535 Jul 1994 WO
9415537 Jul 1994 WO
9600035 Jan 1996 WO
9606565 Mar 1996 WO
9638090 Dec 1996 WO
9712555 Apr 1997 WO
9716122 May 1997 WO
9727898 Aug 1997 WO
9728744 Aug 1997 WO
9731575 Sep 1997 WO
9732526 Sep 1997 WO
9740754 Nov 1997 WO
9742881 Nov 1997 WO
9819636 May 1998 WO
9830153 Jul 1998 WO
9842262 Oct 1998 WO
9848707 Nov 1998 WO
9852475 Nov 1998 WO
9907294 Feb 1999 WO
9912484 Mar 1999 WO
9915088 Apr 1999 WO
9937218 Jul 1999 WO
9962406 Dec 1999 WO
9962408 Dec 1999 WO
9962409 Dec 1999 WO
9962415 Dec 1999 WO
9963910 Dec 1999 WO
9965409 Dec 1999 WO
0003759 Jan 2000 WO
0015144 Mar 2000 WO
0059380 Oct 2000 WO
0060995 Oct 2000 WO
0064381 Nov 2000 WO
0074603 Dec 2000 WO
0119292 Mar 2001 WO
0126557 Apr 2001 WO
0126586 Apr 2001 WO
0128432 Apr 2001 WO
0154618 Aug 2001 WO
0174254 Oct 2001 WO
0213701 Feb 2002 WO
0213702 Feb 2002 WO
0230295 Apr 2002 WO
0230298 Apr 2002 WO
0234143 May 2002 WO
02080779 Oct 2002 WO
02080780 Oct 2002 WO
02087425 Nov 2002 WO
03053289 Jul 2003 WO
03088875 Oct 2003 WO
2005011468 Feb 2005 WO
2005058170 Jun 2005 WO
Related Publications (1)
Number Date Country
20030125755 A1 Jul 2003 US
Continuations (1)
Number Date Country
Parent 09090305 Jun 1998 US
Child 10364064 US