Patent ID: 12239302

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferred embodiment(s) of the invention, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts.

Referring toFIGS.1and2, closure device10is illustrated as having two handle halves12,14that house an automatic mechanism, described in more detail below, which is coupled to the seal assembly20by a flexible pusher rod16and a flexible shaft18. SeeFIG.6. Seal assembly20has a first sealing element22, a knobbed rigid shaft24, an outer floating element26, and a second sealing element28. Knobbed, rigid shaft24has a proximal section30and a distal section32separated by a weakened notch feature34, which is configured to separate seal assembly20from the rest of the closure device10once the automatic deployment and sealing process is complete. The length of the distal section32of knobbed shaft24is dictated by the thickness of the blood vessel wall that can be accommodated. SeeFIG.15. The first sealing element22also has a distal section40configured to interface with the inside wall of a vessel to be sealed, a knobbed, rigid distal shaft section32(which is a part of the knobbed, rigid shaft24), and ankle section42joining the distal section40to the knobbed, rigid distal shaft section32. The ankle section42is attached to distal section40at an angle α, which is preferably at an angle of about 45°. Although other angles may be used, the value of angle α may cause other values of the seal assembly to be changed, as discussed in detail below.

More detailed views of the first sealing element22and the knobbed rigid shaft24are illustrated inFIGS.3A-3D. The first sealing element22has the distal section40, ankle section42and the knobbed, rigid distal shaft section32. The distal section40has a proximal or top surface50, a bottom surface52and an outer peripheral surface56. The proximal or top surface50is preferably configured to engage the interior wall surface142of the blood vessel140(seeFIG.15), which means that the top surface50is preferably flat. However, the top surface50can be of any configuration (e.g., flat, convex, etc.) and still come within the scope of the present invention. The bottom surface52is preferably flat, but may have other configurations. As noted below, the exact configuration of the surfaces50,52may also depend on the strain that is placed on them prior to and during insertion. The outer peripheral surface56is preferably continuous in that it has no discontinuities. That is, the outer peripheral surface56is smooth and has no sharp angles (e.g., 30, 45 or 90° angles). Since the distal section40is to be deformed prior to insertion into the blood vessel140, any sharp angles tend to create stress points, potentially causing the distal section40to be bent/deflected beyond its ability to return to its original configuration. The distal section40has a thickness that increases from the front (or distal) end58to the rear (or proximal) end60. In the embodiment illustrated in the figures, the thickness increases from 0.28 mm at the front end58to 0.30 mm at the rear end60. However, other thicknesses and tapered shapes fall within the scope of the present invention.

Second sealing element28is shown in more detail inFIGS.4A and4B. The second sealing element28has a proximally facing surface80and a sloped distally facing surface82. An internal opening84defined by the internal surface86extends between the proximally facing surface80and the sloped distally facing surface82. The internal surface86has extending therefrom and into the internal opening84projections88that interface with and engage the knobs62with an interference fit such that second sealing element28and knobbed rigid shaft24function as a one way latch assuring an adequate compression force regardless of the blood vessel wall thickness.

The internal opening84of second sealing element28(and floating foot26) have two flat surfaces90on opposite sides of the internal opening84that interface with flat surfaces68,70of knobbed rigid shaft24to provide rotational stability of the seal assembly components26,28thus assuring that the sloped distally facing surface82and the fully deployed floating foot26remain parallel with the distal section40of the first sealing element22and the proximal or top surface50in particular.

FIGS.5A and6Bdepict introducer or outer sleeve100, which is configured to protect seal assembly20from damage when inserting seal assembly20through a hemostatic valve, which, as discussed below and in more detail in the co-pending application, is one method in which the seal assembly is inserted into the patient. Introducer100comprises two halves,102,104, which when assembled together form a generally cylindrical body having two different diameters. Front section106of introducer100has a smaller diameter than rear section108. Front section106with the smaller diameter is configured to be inserted into hemostatic valve and rear section108, having the larger diameter remains proximal to the hemostatic valve. While the two halves102,104can be assembled according to any typical manner, pins110on one of the two halves102,104are configured with a press fit into corresponding mating holes112thus holding halves102,104firmly together.

The introducer100has an opening114that extends between the front section106and the rear section108. However, within the opening114are also grooves116that are configured to accept seal assembly20. The opening114is also configured to receive at least a portion of pusher16of the seal device10.FIG.6is a cross section of seal assembly20in the initial position inside introducer100prior to insertion into a sheath120. SeeFIG.6. The front end58and the rear end60of the distal portion40of first sealing element22are deformed into a configuration such that the distal portion40of first sealing element22is able to pass through the inside dimension of cannula122upon insertion of closure device10resulting in the configuration shown inFIG.6. After exit from distal end of cannula122, the front end58and the rear end60of the distal portion40of first sealing element22return to the initial configuration as shown inFIG.2owing to the configuration shown inFIG.6not exceeding the elastic limit of the material from which the seal assembly20is constructed.

Turning now to the main portion of the closure device10and referring toFIGS.7-13, closure device10comprises two handle halves12,14that housing automatic mechanism150. The automatic mechanism150interfaces with safety latch152, which has a safety slide154that interacts with safety cage156via pin158. The safety latch152operates such that with safety slide154in the distal most position automatic mechanism150cannot be activated. The proximal most position of safety slide154allows automatic activation, explained in more detail below. The pin158is in the center of the underside of safety slide154and passes through handle opening160of handle half12and engages slot162of safety cage156. With the safety slide154in the full distal position, the pin158forces safety cage156into the position shown inFIG.7(to the left looking distally) such that leg164is forced into a slot166in pusher170that locks the movable pusher170against distal movement. The movement of the other parts of the automatic mechanism150are discussed in more detail below. In this position, safety slide154covers the word “READY” (or any other word, mark or appropriate indicia) and exposes the word “SAFE” (or any other word, mark or appropriate indicia) embossed on handle half12. In this position, the safety latch152prevents the automatic mechanism150from premature firing during shipment or handling. With safety slide154in the proximal-most position, the pin158forces safety slide154to the right, thus removing leg164from the slot166in pusher170. In this position the automatic mechanism150is free to initiate when first sealing element22interacts with the inside of vessel wall142. In this configuration safety slide154covers the word “SAFE” and exposes the word “READY” on handle half12.

Flexible pusher rod16is a cannulated cylinder, the proximal end of which is connected by an adhesive or by another appropriate method to the movable pusher170. The movable pusher170has a front portion172with an opening174for engagement with the flexible pusher rod16and to allow the flexible shaft18to pass through front portion172. The pusher170also has a rear portion176that is divided into an upper portion176aand a lower portion176b, the upper portion176aand a lower portion176bdefining an opening178therebetween.

The automatic mechanism150also includes a shaft retaining element180that, in the initial or preactivation stage, is disposed in opening178defined by the upper portion176aand a lower portion176bof pusher170. The shaft retaining element180also has an opening182passing therethrough to allow the flexible shaft18to pass therethrough and extend proximally in the automatic mechanism150. However, the flexible shaft18is fixedly attached to the shaft retaining element180. The flexible shaft18therefore extends almost the entire length of the device10. As noted above, the flexible shaft18is also connected to the knobbed rigid shaft24of the seal assembly20. As explained below, a tensile force on the flexible shaft18causes the automatic mechanism150to fire.

The automatic mechanism150also has a spring190, which is illustrated as a cylindrical spring, but could be any resilient element and have any configuration. The spring190engages, at its proximal end, the proximal end of the handle12,14. The spring190is disposed around a spring retainer194and engages at its distal end, the front end196of the spring retainer194. The spring190is biased against the front end196of the spring retainer194to push the spring retainer194against the pusher170, as described in more detail below.

The automatic mechanism150also has two retention elements200that are rotatably mounted in the housing12,14. The two retention elements200are illustrated as being generally triangular, but could be of any shape or configuration as long as they perform the functions noted below. The retention elements200are disposed to engage the front end196of the spring retainer194and the shaft retaining element180. In fact, each of the two retention elements200engage a notch202on either side of the shaft retaining element180. The retention elements200each have an end portion204, preferably a flat surface, that engages an internal surface of the notches202. As can best be seen inFIG.9, the retention elements200are disposed on round projections206extending upward from the handle14. The projections206could also project downward from the handle12.

The use of the device10will now be described in conjunction withFIGS.12-17.FIGS.12and13are top views of the device with the upper handle half12and the safety latch152removed for clarity and to show pre-firing and post-firing, respectively. InFIG.12, the spring190is compressed by spring retainer194, which when released will provide the kinetic energy to seal the opening in the blood vessel and to break the knobbed rigid shaft24. The spring retainer194, and in particular the front end196, is biased against the retention elements200. The retention elements200cannot move due to the end portion204engaging the internal surface of the notches202of the shaft retaining element180. The front end196of spring retainer194is separated from the pusher170by the retention elements200. Keeping in mind that the shaft retaining element180is secured to the flexible shaft18, which in turn is secured to the knobbed rigid shaft24, pulling on the seal assembly20will cause the flexible shaft18to be pulled distally and move shaft retaining element180distally as well. This allows the retention elements200to rotate outward given the biasing of the front end196of the spring retainer194. The front end196of the spring retainer194can then push pusher170connected to the flexible pusher rod16distally. The effect of this movement is illustrated inFIG.13.

A method of using the current invention in conjunction withFIGS.14-17is as follows: The device10, and in particular the seal assembly20is inserted into sheath introducer100that surrounds and deforms seal assembly20such that seal assembly seal20can pass through sheath valve132. See alsoFIG.6. The device10and sheath introducer100is inserted into a hemostatic valve for insertion into the patient. The device10preferably has a latch210that can be used to attach the device10to the sheath120. This allows for the simultaneous removal of the device10and the sheath120, if the sheath is not removed prior to the activation of the automatic mechanism150. Inserting pusher16through sheath120, including valve132and cannula122, causes at least a portion of seal assembly20to exit the distal end of cannula122and into blood vessel140. SeeFIG.14. A portion of the second sealing element28and the pusher16may be disposed within the blood vessel140. SeeFIG.15. The sheath120may then be removed from the device10. Pulling on the closure device10, the proximal or top surface50of the distal portion40of first sealing element22engages the interior blood vessel wall142. SeeFIG.16. This would also remove the second sealing element28, the outer floating element26, and the pusher16from within the blood vessel140. Continuing to pull on the sealing assembly20and therefore flexible shaft18triggers the automatic mechanism150in the closure device10, which pushes pusher16, and which in turn pushes second sealing element28, and floating foot26distally such that floating foot26is in contact with outer wall of blood vessel140. This will sandwich the second sealing element28against floating foot26, blood vessel140and distal portion40of first sealing element22such that the opening in blood vessel140is hemostatically sealed, as shown inFIG.17.

The initial spring compression is chosen such that accounting for friction losses the remaining kinetic energy is sufficient to break weakened notch feature34of knobbed rigid shaft24resulting in the distal truncated portion of seal assembly20becoming detached from the rest of closure device10and also providing vessel hemostasis as shown inFIG.17. Note that as the user moves sheath120and closure device10proximally activating the automatic process and removes the two latched components, the handle and the sheath, from the body nothing remains in the patient except the bio-absorbable truncated portion of seal assembly20. Thus the entire closure process of sealing and disconnection is automatic requiring no “tactical feel” of the user.

Turning to another embodiment, a closure device300is illustrated inFIGS.18-35, comprises two handle halves312,314housing an automatic mechanism.

More specifically and referring toFIG.19, closure device300comprises two handle halves312,314that housing automatic mechanism150. The automatic mechanism150interfaces with safety latch152, which has a safety slide154that interacts with safety cage156via pin158. The safety latch152operates such that with safety slide154in the distal most position automatic mechanism150cannot be activated. The proximal most position of safety slide154allows automatic activation. The pin158is in the center of the underside of safety slide154and passes through handle opening160of handle half312and engages slot162of safety cage156. With the safety slide154in the full distal position, the pin158forces safety cage156such that leg164is forced into a slot166in pusher170that locks the movable pusher170against distal movement. In this position, safety slide154covers the word “READY” (or any other word, mark or appropriate indicia) and exposes the word “SAFE” (or any other word, mark or appropriate indicia) embossed on handle half312. In this position, the safety latch152prevents the automatic mechanism150from premature firing during shipment or handling. With safety slide154in the proximal-most position, the pin158forces safety slide154to the right, thus removing leg164from the slot166in pusher170. In this position the automatic mechanism150is free to initiate when first sealing element320interacts with the inside of a vessel wall. In this configuration safety slide154covers the word “SAFE” and exposes the word “READY” on handle half312.

Flexible pusher rod316is a cannulated cylinder, the proximal end of which is connected by an adhesive or by another appropriate method to the movable pusher170. The movable pusher170has a front portion172with an opening174for engagement with the flexible pusher rod16and to allow the flexible shaft218to pass through front portion172. The pusher170also has a rear portion176that is divided into an upper portion176aand a lower portion176b, the upper portion176aand a lower portion176bdefining an opening178therebetween.

The automatic mechanism150also includes a shaft retaining element180that, in the initial or preactivation stage, is disposed in opening178defined by the upper portion176aand a lower portion176bof pusher170. The shaft retaining element180also has an opening182passing therethrough to allow the flexible shaft318to pass therethrough and extend proximally in the automatic mechanism150. However, the flexible shaft318is fixedly attached to the shaft retaining element180. The flexible shaft318therefore extends almost the entire length of the device300. As noted above, the flexible shaft318is also connected to the knobbed rigid shaft326of the seal assembly320. A tensile force on the flexible shaft318causes the automatic mechanism150to fire.

The automatic mechanism150also has a spring190, which is illustrated as a cylindrical spring, but could be any resilient element and have any configuration. The spring190engages, at its proximal end, the proximal end of the handle312,314. The spring190is disposed around a spring retainer194and engages at its distal end, the front end196of the spring retainer194. The spring190is biased against the front end196of the spring retainer194to push the spring retainer194against the pusher170, as described in more detail below.

The automatic mechanism150also has two retention elements200that are rotatably mounted in the housing312,314. The two retention elements200are illustrated as being generally triangular but could be of any shape or configuration as long as they perform the functions noted below. The retention elements200are disposed to engage the front end196of the spring retainer194and the shaft retaining element180. In fact, each of the two retention elements200engage a notch202on either side of the shaft retaining element180. The retention elements200each have an end portion204, preferably a flat surface, that engages an internal surface of the notches202. The retention elements200are disposed on round projections206extending upward from the handle314. The projections206could also project downward from the handle312.

The automatic mechanism is coupled to the seal assembly320by a flexible pusher316and a flexible shaft318, as in the prior embodiment. Seal assembly320has a first sealing element322, a flexible member324, a knobbed rigid shaft326, an outer floating element328, and a second sealing element330. Knobbed, rigid shaft326has a proximal section332and a distal section334separated by a weakened notch feature336, which is configured to separate seal assembly320from the rest of the closure device300once the automatic deployment and sealing process is complete. The length of the distal section334of knobbed shaft326is dictated by the thickness of the vessel wall that can be accommodated. The first sealing element322also has a distal section340configured to, with the assistance of the flexible member324, interface with the inside wall of a vessel to be sealed; a knobbed, rigid distal shaft section334(which is a part of the knobbed, rigid shaft326); and ankle section342joining the distal section340to the knobbed, rigid distal shaft section334. The ankle section342is attached to distal section340at an angle α, which is preferably at an angle of about 45°. SeeFIG.22. Although other angles may be used, the value of angle α may cause other values of the seal assembly to be changed. Applicant also notes the that the first sealing element322is formed with the distal section340, ankle section342, and the knobbed, rigid shaft326at the same time and from the same material. As such, the first sealing element322is an integrally formed element and the distal section340is not designed to move relative to the knobbed, rigid distal shaft section334at any time, except through deformity. As indicated in the parent patent, the first sealing element is preferably a one single-piece component.

A more detailed view of the first sealing element322and the knobbed rigid shaft326is presented inFIGS.20A-21. The first sealing element322has the distal section340, ankle section342and the knobbed, rigid distal shaft section334. The distal section340has a proximal or top surface350, a bottom surface352and a heel356. The top surface350can be of any configuration (e.g., flat, convex, etc) and still come within the scope of the present invention. The bottom surface352is preferably flat, but may have other configurations as well. The heel356preferably has a greater thickness than the remainder of the distal section340and, as discussed below is disposed into a cavity in the inserter. The distal section340has a thickness that increases from the front (or distal) end358to the rear (or proximal) end360. In the embodiment illustrated in the figures, the thickness increases from 0.28 mm at the front end358to 0.30 mm at the rear end360. However, other thicknesses and tapered shapes fall within the scope of the present invention.

A top view of the knobbed, rigid shaft326and the first sealing element322is illustrated inFIG.20C. The knobbed, rigid shaft326has a proximal end338that may be connected to the flexible shaft318in any appropriate fashion, e.g., glued, soldered, press-fit, friction fit, etc. Alternatively, the flexible shaft318may also be integral with the knobbed, rigid shaft326, i.e., be formed at the same time with the same material making it an “integral” piece. The knobbed, rigid shaft326has knobs362along the upper surface364and the lower surface366. The knobbed, rigid shaft326also has opposite sides368,370, each side of which includes a groove372that runs along the length of the knobbed, rigid shaft326between the ankle section342and the proximal end338. The grooves372are preferably rectangular (or square) in cross section for reasons that will become apparent below. As such each of the grooves372have a front (or first) surface374and a rear (or second) surface376. It is noted that the front surface374faces the rear portion of the knobbed, rigid shaft326, while the rear surface376faces the front of the knobbed, rigid shaft326. The grooves372cooperate with the other portions of the seal assembly320to ensure that the outer floating element328and the second sealing element330are properly positioned, as discussed in more detail below. Since the grooves372are smaller than the sides368,370, the sides368,370present a flat surface for the outer floating element328, discussed below.

Illustrated inFIGS.24and25is a cross section of the knobbed, rigid shaft326at the weakened notch feature336. The weakened notch feature336has a smaller cross section than any other portion of the knobbed rigid shaft326. This allows for the knobbed, rigid shaft326to be broken at this point upon activation of the insertion device300by exerting a force in the direction of the length of the knobbed, rigid shaft326, causing the knobbed, rigid shaft326to break at the weakened notch feature336. In order to prevent the weakened notch feature336from breaking prematurely, a c-shaped ring may be clipped into the weakened notch feature336as noted above. The width of notch feature336is sized to equal the space between knobs362so that second seal328can easily transition over notch feature336upon automatic activation of device300. The c-shaped ring prevents the knobbed, rigid shaft326from being tilted off center and breaking prematurely.

InFIG.25, the groove372in the knobbed, rigid distal shaft section334preferably flares outward at372aat the weakened notch feature336, to ensure that the outer floating element328and its components float over the weakened notch feature336during operation without skiving on a portion of the groove372at that location.

The flexible member324, along with distal section340, assists in sealing the opening in the vessel wall. The flexible member324is illustrated as being a circular member having an opening378in a middle portion thereof. The flexible member324has a thickness t, which is preferably around 0.2 millimeters. Since the flexible member324is preferably made from 70% L-lactide 30% caprolactone copolymer, it is able to being deformed as described below. As illustrated inFIGS.20B and21, the flexible member324is disposed around the ankle portion342and against the top surface350of the distal section340. Preferably, the flexible member324is attached to the top surface350of the distal section340. It can be attached in any number of ways, including heat-staking or welding the flexible member324to the top surface350, using an approved adhesive between the flexible member324and the top surface350flexible member324. Alternatively, the opening378could be slightly smaller than the diameter of the ankle portion342, preventing the flexible member324from moving along the length of the knobbed, rigid shaft326at the ankle portion342. As explained in more detail below, the flexible member324is disposed between the distal section340and the inner wall of the vessel. See, e.g.,FIG.34.

While the opening378is a contained opening, it is also possible that there be a slit (or small path) from the outside of the flexible member324allowing the flexible member to be disposed around the ankle portion342without having to slide it the length of the knobbed, rigid shaft326.

Second sealing element330is shown in more detail inFIGS.26A and26Band is the same as that illustrated inFIGS.4A and4B. The second sealing element330has a proximally facing surface380and a sloped distally facing surface382. An internal opening384defined by the internal surface386extends between the proximally facing surface380and the sloped distally facing surface382. The internal surface386has extending therefrom and into the internal opening384projections388that interface with and engage the knobs362with an interference fit such that second sealing element330and knobbed, rigid shaft326function as a one way latch assuring an adequate compression force regardless of the blood vessel wall thickness.

Referring toFIG.26B, the internal opening384of second sealing element330have two flat surfaces390on opposite sides of the internal opening384that interface with flat surfaces368,370of knobbed rigid shaft326to provide rotational stability of the seal assembly components328,330, thus assuring that the sloped distally facing surface382and the fully deployed outer floating foot328remain parallel with the distal section340of the first sealing element322and the proximal or top surface350in particular.

The outer floating element328is illustrated in detail inFIGS.27A-28B. The outer floating element328is generally rectangularly shaped and has a rectangularly shaped central aperture400and two protrusions402that extend from the longest side walls404into the aperture400. The outer floating element328has a top surface406and a bottom surface408, which are generally parallel to one another. The protrusions402are configured to engage and allow the outer floating element328to travel along the knobbed, rigid shaft326in the grooves372. The protrusions are somewhat tear drop shaped, but have two flat surfaces, a first flat surface410and a second flat surface412. The outer floating element328also has two inclined surfaces414and416, one at either end of the outer floating element328and defines the ends of the aperture400. The first flat surface410is at an angle ß relative to the top and bottom surfaces406,408of outer floating element328. SeeFIG.23A. Preferably angle β is about a 45 degree angle but could be anywhere between 35 and 55 degrees and still fall within the scope of the present invention. The second flat surface412makes an angle γ relative to the top and bottom surfaces406,408. SeeFIG.27A. Preferably angle γ is about a 19 degree angle but could be anywhere between 15 and 25 degrees and still fall within the scope of the present invention. As would be obvious, the two inclined surfaces414and416are also parallel to the second flat surface412as will be explained below.

Turning toFIGS.28A and28B, the positioning of the outer floating element328will be explained. In both figures, the dotted lines correspond to the surfaces of the knobbed, rigid shaft326presented to the outer floating element328. In particular, the two middle lines correspond to the front (or first) surface374and the rear (or second) surface376of the groove372. Thus, the two protrusions402will slide along between those two middle lines. The two outside lines correspond to the upper364surface and the lower366surface of the outer floating element328. InFIG.28A, the outer floating element328is illustrated in its stored version—to be inserted into, or already in the inserter. Thus, in the position of FIG.28A, the outer floating element328has, relative to the rest of the seal assembly320, the smallest profile and will allow it to pass through a smaller cannula.

FIG.28Billustrates the outer floating element328relative to the knobbed, rigid shaft326after it exits the cannula. That is, the outer floating element328has been engaged by the second sealing element330(not shown in the figures) and because the size of the projections402relative to the groove372, the outer floating element328can rotate (clockwise inFIG.28B) relative to the knobbed, rigid shaft326to be in a position to engage the outside of the vessel. See, e.g.,FIGS.30and31.

An inserter450is illustrated inFIGS.29-31. The embodiment of the inserter450illustrated has a first portion452and a second portion454, which are illustrated as a top half and a bottom half. Naturally, the portions452,454could have other names (e.g., side portions) and still fall within the scope of the present invention. The inserter450has a proximal end456and a distal end458. When the portions452,454are assembled, a longitudinal opening460is created that extends through the inserter450. The inserter450preferably has at the proximal end456a proximal section462that has a constant diameter outer surface and a constant diameter for the longitudinal opening460at the proximal section462. The proximal section462of each of the portions452,454has a number of projections464and openings466. The projections464of one portion452,454correspond to the openings466of the other portion452,454, thereby allowing the two portions452,454to be brought together and aligned for use. Forward of the proximal section462is a reduced diameter area468, which then increases in diameter at470creating a shoulder472before tapering back down to a smaller outer diameter at the distal end458.

The longitudinal opening460in inserter450allows for the seal assembly320to be loaded therein, sterilized, stored, and then used by a doctor. Typically, if a seal assembly is contained within a confined space and then sterilized, the sterilization causes the seal assembly to maintain the configuration in which it is sterilized. Even if the material normally was some shape memory (allowing the material to spring back to its original shape or configuration), the sterilization has been found by the inventor to prevent the materials from returning to their original configuration. Thus, the current inserter450allows for the seal assembly320to be loaded without any real change in configuration. The longitudinal opening460has been designed to hold the first sealing element322, a flexible member324, a knobbed rigid shaft326, an outer floating element328, and a second sealing element330without this issue. To do so, however, the portion454has an aperture474to allow for the heel356of the distal section340to be disposed therein. While the aperture474is illustrated as extending through the portion454, it is possible that there only be a depression, groove, or dimple that does not penetrate all the way through the portion454.

Turning toFIG.30, a cross section of the inserter450with the seal assembly320disposed therein illustrates the position of the seal assembly320within the inserter450. As should be clear, the cross section is through the center of both portions452,454. It should also be noted that the distance D1 of between the two portions452,454of the longitudinal opening460is generally constant. The position of the outer floating element328relative to the knobbed, rigid shaft326and the position of the flexible member324relative to the distal section340allow the inserter to have a minimum size.

FIG.31illustrates the seal assembly320within the inserter450from above the inserter450. In this view, it is clear that the diameter D2 of the longitudinal opening460is larger in the horizontal plane; allowing the flexible member324to hold its original configuration. The longitudinal opening460at the proximal section462is also sized to allow the outer floating element328and the second sealing element330to pass therethrough. The longitudinal opening460at the distal end458is smaller than the diameter D2, but the flexible member324and the distal section340can be deformed and then return to their original shape for use in the patient.

A method of using the current invention in conjunction withFIGS.32-35is as follows: The device300, and in particular the seal assembly320is inserted into inserter450that surrounds seal assembly320such that seal assembly320can pass through sheath valve132and to the sheath120. This allows for the simultaneous removal of the device300and the sheath120, if the sheath is not removed prior to the activation of the automatic mechanism. Inserting pusher316through sheath120, including valve132and cannula122, causes at least a portion of seal assembly320to exit the distal end of cannula122and into blood vessel140. SeeFIG.32. The sheath120may then be removed from the device300. Pulling on the closure device300, the flexible member324and the distal portion340of first sealing element322engages the interior blood vessel wall142. SeeFIG.34. This would also remove the second sealing element330, the outer floating element328, and the pusher316from within the blood vessel140. Continuing to pull on the sealing assembly320, and therefore flexible shaft318, triggers the automatic mechanism150in the closure device300, which pushes pusher316, and which in turn pushes second sealing element330, and the outer floating element328distally such that the outer floating element328is in contact with outer wall of blood vessel140. This will sandwich the outer floating element328, the blood vessel140and the flexible member324between the first and second sealing elements322,330such that the opening in blood vessel140is hemostatically sealed, as shown inFIG.35.

Another embodiment of a closure device500is illustrated inFIGS.36-47. In this embodiment, the closure device500is not automatic, but a semi-automatic device to seal the vessel. The closure device500has a top cover502and a bottom cover504that are connected to one another. The top cover502and the bottom cover504house the pushing assembly506. The pushing assembly506includes a pushing rod508, a pusher510and a button512. As explained in more detail below, the button512is used to move the pusher510, which is fixedly attached to the pushing rod508, to activate the seal assembly320.

The seal assembly320may be and is preferably the same as the seal assembly320discussed in detail above with regard toFIGS.20A-31. As is visible inFIG.37, the seal assembly320has a first sealing element322, a flexible member324, a knobbed rigid shaft326, an outer floating element328, and a second sealing element330. It is possible that the first sealing element322and the flexible member324are a single element—that is a one single-piece component. There may be other configurations of the seal assembly as well, as discussed above. Also inFIGS.24and25is a cross section of the knobbed, rigid shaft326at the weakened notch feature336. The weakened notch feature336has a smaller cross section than any other portion of the knobbed rigid shaft326. This allows for the knobbed, rigid shaft326to be broken at this point upon activation of the closure device500, as discussed in more detail below, by exerting a force in the direction of the length of the knobbed, rigid shaft326, causing the knobbed, rigid shaft326to break at the weakened notch feature336. In order to prevent the weakened notch feature336from breaking prematurely, a c-shaped ring may be clipped into the weakened notch feature336as noted above. The width of notch feature336is sized to equal the space between knobs362so that second seal328can easily transition over notch feature336upon activation of device300. The c-shaped ring prevents the knobbed, rigid shaft326from being tilted off center and breaking prematurely.

Referring toFIGS.38-40the structure of the pushing assembly506will be discussed. The pusher510has an opening514that receives and can have secured therein the pushing rod508. Thus, as the pusher510is moved, so too is the pushing rod508. The pusher510has a foot516that extends in a forward direction (toward the seal assembly320) and is connected by a central portion518to two arms520aand520b. Each of the arms520aand520bhas a top surface522aand522b, respectively. The pusher510also has a button extension526that can receive the button512. As noted in the figures, the surface522aand522bof the arms520a,520bare perpendicular to the foot516.

Turning toFIGS.41and42, the bottom cover504has a central channel530in which the foot516of the pusher510can slide or ride in during operation. The bottom cover504has a plurality of ribs532to provide structural integrity that extend from the inside surface534. There are also posts536to support the top cover502.

The top cover502is illustrated in more detail inFIGS.43and44. The top cover502has a plurality of ribs538also to provide structural integrity and a number of post receptacles540to receive the posts536from the bottom cover504. These structures are preferably attached to the inside surface542. The top cover502also includes an opening544through which the button extension526and button512project to the outside of the top cover502. Extending outwardly to the sides of the top cover502and on either side of the opening544are slots546ato receive the top surfaces522aand522bof the two arms520aand520b. There are another two slots546bat the other end of the opening544. As noted, there are four such slots (two of546aand two of546b) in the illustrated top cover502. However, there could just be two slots, one at each end of the opening544in the top cover502, rather than the two that are illustrated at each end of the opening544.

The top cover502also includes a slot550to support a shaft552that is connected to the seal assembly320as illustrated as discussed above. The shaft552(seeFIG.37) can be secured to the slot550as well as a second slot554at the rear end of the top cover502. Corresponding thereto is also a slot556at the back end of the bottom cover504. SeeFIGS.41and42.

Returning toFIGS.43and45, there are four holes560in the top cover504that function as an indicator as to the position of the two arms520aand520b. Since the holes560are at the end of the slots546aand546b, it is possible to know where the two arms520aand520bare before using the device500. Additionally, the four holes560need not be at the end of the slots546a,546b, but could be anywhere along the slots as long as they are not blocked by the button512.

Having described the components, the operation of the device500will now be explained. First, it is noteworthy that the interior space between the top cover502and the bottom cover504is slightly less than the relaxed position of the pusher510. Thus, when the pusher510is secured within the device500, there is a slight compression of the pusher510—pushing the arms520aand520btoward the foot516. When the pusher510is aligned with the slots546aand546b, the arms520aand520bare biased into the slots546a,546b. To move the button512and the entire pushing assembly506forward, the user must push down and forward on the button512. Some force will be needed to move the arms520aand520bout of the first set of slots546a. The pushing assembly506will move forward to the second set of slots546b, moving the pushing rod508and the second portion (second sealing element330) of the seal assembly320toward the first portion (first sealing element322). As the second portion of the seal assembly320is pushed toward the first portion and sandwiches the blood vessel between the first and second portions of the seal assembly320, there be an increased force required to push the pushing assembly508toward the first portion of the seal assembly320. When that force equals the force required to break the knobbed, rigid shaft326at the weakened notch feature336, the device500will be separated from the seal assembly—preventing any more pressure from being applied to the seal assembly320. Thus, the force applied to sealing the blood vessel is controlled and limited by the force required to break the knobbed, rigid shaft326. As a result, the amount of pressure applied to sealing the blood vessel is tightly controlled by the design of the weakened notch feature336. Thus, too much pressure cannot be applied to seal assembly and if too little pressure is applied, then the device500cannot be removed until the required amount of pressure is applied.

It should also be noted that the second set of slots546bwill stop the movement of the pushing rod508, which coincides with the distance that the pushing rod508and the second portion of the seal assembly320must move to seal the blood vessel. SeeFIG.47showing the movement of the pushing assembly508.

It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.