Patent Description:
Modem advances in cardiac surgery have made it possible to replace heart valves using minimally invasive surgical techniques. As minimally invasive techniques have improved, surgeons are able to operate on patients through smaller and smaller access holes, resulting in less perioperative pain and shorter recovery times. A main focus of innovations in minimally invasive cardiac surgery has been on the tools which pass into the patient, through the small access holes, to place suture stitches more efficiently and reliably. By focusing on improvements to these steps of the surgical procedures, patients are able to be on cardio-pulmonary bypass machines for shorter times, thereby improving patient outcomes. Resultant efficiency improvements while working within the patient further help to reduce stress and fatigue on surgeons.

It would also be advantageous to focus on efficiency outside of the patient. Surgical teams are regularly working to streamline their own processes to enable surgeons to be as efficient as possible. In many minimally invasive surgical procedures, the ends of sutures which have been stitched within a patient are brought back out of the patient through one of the access sites so that the suture ends can be kept organized and then stitched through a sewing ring of a prosthetic device. Unfortunately, the suture ends often have adapters which were previously used to enable a corresponding minimally invasive suturing device to manipulate the suture ends within the patient. While it might be possible to reload the adapters (and therefore the suture ends) into the minimally invasive suturing device, such devices (meant for in-patient use and suturing tissue) are often not compatible with suturing a sewing cuff of a prosthetic device. As a result, surgical teams are forced to cut off the adapters and thread each suture onto a needle in order to manually stitch each suture end through a prosthetic valve's sewing cuff. For many cardiac surgical procedures, unfortunately, this can increase the overall time a patient is on cardio-pulmonary bypass (CPB). Longer CPB times are associated with complications of the inflammatory system, heart, lungs, kidneys, and brain. Therefore, it would be desirable to have a prosthetic suturing device that is compatible with one or more suture adapters which have been used with a minimally invasive surgical suturing device and which has features to increase the efficiency of a surgical team and reduce CPB time.

The human heart relies on a series of one-way valves to help control the flow of blood through the chambers of the heart. For example, referring to <FIG>, deoxygenated blood returns to the heart <NUM>, via the superior vena cava <NUM> and the inferior vena cava <NUM>, entering the right atrium <NUM>. The heart muscle tissue contracts in a rhythmic, coordinated heartbeat, first with an atrial contraction which aids blood in the right atrium <NUM> to pass through the tricuspid valve <NUM> and into the right ventricle <NUM>. Following atrial contraction, ventricular contraction occurs and the tricuspid valve <NUM> closes. Ventricular contraction is stronger than atrial contraction, assisting blood flow through the pulmonic valve <NUM>, out of the heart <NUM> via the pulmonary artery <NUM>, and to the lungs (not shown) for oxygenation. Following the ventricular contraction, the pulmonic valve <NUM> closes, preventing the backwards flow of blood from the pulmonary artery <NUM> into the heart <NUM>.

Oxygenated blood returns to the heart <NUM>, via the pulmonary veins <NUM>, entering the left atrium <NUM>. Left atrial contraction assists blood in the left atrium <NUM> to pass through the mitral valve <NUM> and into the left ventricle <NUM>. Following the atrial contraction, ensuing ventricular contraction causes mitral valve <NUM> closure, and pushes oxygenated blood from the left ventricle <NUM> through the aortic valve <NUM> and into the aorta <NUM> where it then circulates throughout the body. Following left ventricular contraction, the aortic valve <NUM> closes, preventing the backwards flow of blood from the aorta <NUM> into the heart <NUM>.

Unfortunately, one or more of a person's heart valves <NUM>, <NUM>, <NUM>, and <NUM> can have or develop problems which adversely affect their function and, consequently, negatively impact the person's health. Generally, problems with heart valves can be organized into two categories: regurgitation and/or stenosis. Regurgitation occurs if a heart valve does not seal tightly, thereby allowing blood to flow back into a chamber rather than advancing through and out of the heart. This can cause the heart to work harder to remain an effective pump. Regurgitation is frequently observed when the mitral valve <NUM> prolapses (extends back) into the left atrium <NUM> during a ventricular contraction. Stenosis, by contrast, is when a heart valve does not fully patent due to stiff or fused leaflets, blood flow tract narrowing, or obstructive material buildup (e.g., calcium). The resultant narrowed outflow causes the heart to work harder to pump blood through it, possibly leading to heart failure.

Fortunately, advances in cardiac surgery, and in particular the evolution of reliable cardio-pulmonary bypass (CPB), have enabled open heart and less-invasive methods for heart valve replacement. During CPB, deoxygenated blood is diverted from the superior vena cava <NUM> and inferior vena cava <NUM> in or near the right atrium <NUM> of the heart <NUM>, brought outside the body to a CPB machine, reoxygenated, and returned to the body at the aorta <NUM>, or other great arterial vessels, thereby bypassing the heart <NUM> and making it possible to stop the heart <NUM> for cardiac surgery.

Unfortunately, while such cardiac procedures have become common-place, they are not without risks. In particular, extended time on a CPB machine can increase a patient's chances of developing complications involving the inflammatory system, heart, lungs, kidneys, brain, etc. An inflammatory response can be triggered by blood coming into contact with the foreign substances of the tubing leading to the CPB machine and the components of the machine itself. These types of inflammatory responses can damage the endothelium (inner layer of cells) of blood vessels, making them more susceptible to platelet and clot adhesion, and ultimately to an increased chance of atherosclerosis and other cardiovascular complications. Additionally, aortic clamping, necessary to establish the CPB, may cause inadequate blood flow to certain organs, for example, the heart, lungs, kidneys, or brain, thereby leading to possible ischemic damage to those organs. The risks of complications due to CPB increase dramatically with the amount of time a patient is actively connected to the CPB machine. Accordingly, surgeons rely on a combination of specialized skills, knowledge, technologies, and teamwork to operate as efficiently as possible in order to minimize a patient's time on CPB.

Depending on the number of valves being replaced for a patient, a typical heart valve replacement surgery can last between two to six hours, one to two hours of which can be spent on a CPB machine. While the patient is on CPB, the surgeon must gain access to the heart valve, remove the pathologic valve tissue as necessary, and install a replacement valve at the location of the original valve. The valve installation process, typically requiring suture placement and fastening, can be very time consuming, especially when surgeons are operating through small access sites when employing less-invasive techniques to reduce surgical trauma. Furthermore, a large number of sutures and their loose ends must be effectively managed to track which suture ends go together and ensure the sutures do not get tangled. As an example, <FIG> schematically illustrates a surgical situation during a minimally invasive aortic valve replacement. The defective valve tissue has been removed and multiple sutures <NUM> have been placed into the tissue of the aortic root. These sutures <NUM> must be managed and sewn through a sewing cuff of a replacement valve <NUM> before the valve <NUM> is slid down the suture lines and into the aortic root where the suture ends will be secured to anchor the heart valve <NUM>. The suture management and the sewing into the cuff can be very time consuming. Therefore, there is a need for devices and methods which enable surgeons to operate more efficiently during surgery to replace pathologic anatomical structures, such as, but not limited to, replacement heart valves. Such devices and methods can reduce the amount of time patients need to be attached to a CPB machine, thereby reducing the likelihood of CPB-related side effects. Faster cardiac operations offer additional benefits, such as reduced surgical team fatigue and more efficient use of critical resources. Expediting cardiac surgery can also improve patient outcomes.

<CIT> discloses a needle cartridge which is adapted to be attached to a receiver on a surgical suturing device. The cartridge comprises an arced needle and a suture, and a needle driver operable to drive the needle in a circular path.

<CIT> discloses a surgical device for attaching a first hollow organ to a second hollow organ and creating a passageway therebetween. The device includes a first member comprising a first prong for entering a wall of the first hollow organ and a second prong for entering a wall of the second hollow organ. The device further includes a second member having a plow for incising at least one of the hollow organs so as to create a passageway between the hollow organs. The second member further includes a plurality of needle paths on either side of the plow for guiding a needle through the walls of the hollow organ on either side of the passageway. The device further includes a means for driving a needle, having a suture attached thereto, so as to attach the hollow organs together. DUPONT, "General Design Principles for DuPont Engineering Polymers (Design guide - Module I)", INTERNET CITATION, (<NUM>), URL:.

It will be appreciated that for purposes of clarity and where deemed appropriate, reference numerals have been repeated in the figures to indicate corresponding features, and that the various elements in the drawings have not necessarily been drawn to scale in order to better show the features.

<FIG> is a perspective view of one embodiment of a prosthetic suturing device <NUM>. <FIG> is a partially exposed perspective view of the prosthetic suturing device <NUM> of <FIG> with a portion of the housing <NUM> removed. The prosthetic suturing device <NUM> has a guide tip <NUM> that defines a cuff receiving area <NUM>. The cuff receiving area <NUM> is configured to receive a portion of a sewing cuff of a replacement anatomical structure. Examples of a replacement anatomical structure may include, but are not limited to, synthetic replacement heart valves and natural tissue replacement heart valves. The sewing cuff on such a replacement anatomical structure is designed to be sewn with suture against one or more tissue sites inside a patient so that the replacement anatomical structure is held in a desired location. It should be understood that the term "suture", as used herein, is intended to cover any thread, cable, wire, filament, strand, line, yarn, gut, or similar structure, whether natural and/or synthetic, in monofilament, composite filament, or multifilament form (whether braided, woven, twisted, or otherwise held together), as well as equivalents, substitutions, combinations, and pluralities thereof for such materials and structures. Furthermore, for convenience, this specification will often utilize the example of a sewing cuff on a replacement heart valve, however, it should be understood that other types of replacement anatomical structures are contemplated as well. Such replacement anatomical structures having sewing cuffs are known to those skilled in the art.

The guide tip <NUM> is coupled to a shaft <NUM> at a distal end 156D of the shaft <NUM>. The prosthetic suturing device also has a housing <NUM> to which a handle <NUM> is pivotably coupled at pivot point <NUM>. The handle <NUM> is biased by spring <NUM> towards a handle stop <NUM> which is formed from part of the housing <NUM>. A hard stop <NUM> is also located in the housing <NUM>, in order to limit the travel of the handle <NUM> when squeezed in a direction <NUM>.

Shaft holders <NUM> couple a proximal end 156P of the shaft <NUM> to the housing <NUM>. First and second needles <NUM>, <NUM> are in horizontal alignment where they are coupled to the handle <NUM> within the housing <NUM>. In this embodiment, the needles <NUM>, <NUM> are routed by a needle guide tube (not visible in this view) so as to be in vertical alignment near the cuff-receiving area <NUM>. Movement <NUM> of the portion of the handle <NUM> outside of the housing <NUM> towards the grip <NUM> of the housing <NUM> will move the needles <NUM>, <NUM> across the cuff receiving area <NUM>. Since the grip <NUM> is part of the housing <NUM>, portions of this specification may indicate that certain components are coupled to the grip <NUM>, which is accurate because the grip is part of the housing.

<FIG> is an exploded perspective view of the prosthetic suturing device of <FIG>. The distal ends 170E, 172E of the first and second needles <NUM>, <NUM> are each configured to engage a suture adapter (not shown here, but will be discussed later). A needle guide tube <NUM> having first and second spiral tracks <NUM>, <NUM> is inserted into the proximal end 156P of the shaft <NUM>, and shaft holders <NUM> are placed over the distal end 156D of the shaft <NUM> and coupled to the proximal end 156P of the shaft. The distal end 156D of the shaft <NUM> is coupled to the guide tip <NUM>. A distal end 176D of the needle guide tube <NUM> abuts or lies close to a proximal portion 152P of the guide tip <NUM> inside a distal end 156D of the shaft <NUM>. Starting with the needle ends 170E, 172E, the first and second needles <NUM>, <NUM> are inserted into the first and second spiral tracks <NUM>, <NUM> of the needle guide tube <NUM> as will be discussed below. The spiral tracks <NUM>, <NUM> take the needles <NUM>, <NUM> from a horizontal orientation to a vertical orientation at the proximal end of the device.

In the vertical orientation of the needles at the proximal end of the device, the second needle <NUM> will be located below the first needle <NUM>. Before the first needle <NUM> is fully inserted, a ferrule release spring <NUM> may be inserted into a slot on the top of the guide tip <NUM> so that it rests against the second needle <NUM>. Then, the first needle <NUM> can be fully inserted, compressing the ferrule release spring <NUM> between the two needles <NUM>, <NUM>.

A first ball end <NUM> is located on the proximal end of the first needle <NUM>. Similarly, a second ball end <NUM> is located on the proximal end of the second needle <NUM>. The second and first ball ends <NUM>, <NUM> may be inserted into a side opening <NUM> in the handle <NUM>. A top needle slot <NUM> allows the needles <NUM>, <NUM> to move into the handle <NUM>, and then the needles <NUM>, <NUM> can be pivoted down into forward slots <NUM>, <NUM>, respectively, also formed in the handle <NUM>. This couples the needles <NUM>, <NUM> to the handle <NUM>. The forward slots <NUM>, <NUM> maintain the horizontal needle spacing at the proximal end of the device.

The pivot point <NUM> of the handle <NUM> may be aligned in a pivot boss <NUM> formed in the housing <NUM>. The shaft holders <NUM> may be held and supported by a variety of features on the inside of the housing <NUM>. Such features are not illustrated for simplicity, but are well known to those skilled in the art. Although only one half of the housing <NUM> is shown in this exploded view, it should be understood that a complementary half of the housing is also present (though not shown) and would have similar boss features to allow pivoting of the handle <NUM> and bracing of the shaft holders <NUM>.

The hard stop <NUM> may be mounted in a hard stop boss <NUM> to limit travel of the handle <NUM>, while a lower end <NUM> of spring <NUM> may be coupled to a fixed spring attachment point <NUM> on the housing. An upper end <NUM> of the spring <NUM> may be hooked onto a handle spring attachment point <NUM>.

<FIG> is an enlarged perspective view of one embodiment of a needle guide tube <NUM> for a prosthetic suturing device. <FIG> are side, back, and front elevational views, respectively, of the needle guide tube <NUM> of <FIG>. In this embodiment, the needle guide tube <NUM> has a first spiral track <NUM> and a second spiral track <NUM>. Looking at the back view of <FIG>, it can be seen that the spiral tracks <NUM>, <NUM> will receive the first and second needles (not shown in this view) in a horizontal alignment from a proximal end of the device. Looking at the front view of <FIG>, it can be seen that the spiral tracks <NUM>, <NUM> will have guided the needles into a vertical alignment near the guide tip (not shown in this view). The spiral tracks <NUM>, <NUM> can provide support for a thinner needle so that the needles do not buckle when rotated to a different orientation. The needle guide tube <NUM> may also have a keyed portion <NUM> for mating with and/or aligning with a corresponding feature on the guide tip to ensure the needles exit the needle guide tube <NUM> and pass smoothly into the guide tip <NUM>.

<FIG> are enlarged perspective views of one embodiment of a guide tip <NUM> for a prosthetic suturing device shown from distal and proximal perspectives, respectively. Passages pass within the proximal end 152P of the guide tip <NUM>, guiding the first and second needles <NUM>, <NUM> towards first and second needle guides <NUM>, <NUM>, respectively. The needle guides <NUM>, <NUM> help to guide the needles <NUM>, <NUM> through the cuff receiving area <NUM> defined by the guide tip <NUM>.

The guide tip <NUM> also has first and second adapter receiving apertures <NUM>, <NUM>, located in the distal end 152D of the guide tip <NUM>. The adapter receiving apertures <NUM>, <NUM> are configured to hold first and second suture adapters <NUM>, <NUM>, respectively. The suture adapters <NUM>, <NUM> may each be coupled to a different end of a suture <NUM>. The suture adapters <NUM>, <NUM> are designed to be engaged by the ends 170E, 172E of the first and second needles, respectively, such that the needles <NUM>, <NUM>, when contacting the adapters <NUM>, <NUM> will be able to pull the adapters <NUM>, <NUM> (and therefore, the ends of the suture <NUM>) back through the cuff receiving area. One non-limiting example of suitable adapters include ferrules into which the needle tips 170E, 172E may be pressed. For convenience, this specification will refer to the adapters <NUM>, <NUM> as ferrules. Similarly, the specification will also refer to the adapter receiving apertures <NUM>, <NUM> as ferrule holders, but it should be understood that the broader interpretations apply where the claims are concerned, unless otherwise specified.

The distal end 152D of the guide tip <NUM> also defines first and second suture removal passages <NUM>, <NUM> which are in communication with the first and second ferrule holders <NUM>, <NUM>. The removal passages <NUM>, <NUM> allow the suture <NUM> which is coupled to the ferrules <NUM>, <NUM> to be routed out the distal end 152D of the device after the ferrules <NUM>, <NUM> are placed into the ferrule holders <NUM>, <NUM>.

The ferrule receiving apertures <NUM>, <NUM> each have flared ends facing the cuff receiving area <NUM>. As will be shown and discussed in more detail later in this specification, a sewing cuff of a replacement heart valve will be placed into the cuff receiving area, and then the needles <NUM>, <NUM> will be advanced, piercing the sewing cuff and continuing on to couple with the ferrules <NUM>, <NUM> before being withdrawn to pull the suture ends back through the sewing cuff. The sewing cuff material will tend to be pushed into the ferrule receiving apertures <NUM>, <NUM>, so the flared ends are helpful in preventing the sewing cuff material from becoming jammed between the needles <NUM>, <NUM> and their respective ferrule receiving apertures <NUM>, <NUM>.

This embodiment of a guide tip <NUM> also has many different alignment guides for helping a user to visualize where the needles (which are mainly hidden from the user) will contact the sewing cuff. For example, the guide tip <NUM> has a first proximal horizontal needle alignment guide 224P adjacent the first needle guide <NUM>. Similarly, the guide tip <NUM> has a second proximal horizontal needle alignment guide 226P adjacent the second needle guide <NUM>. The guide tip <NUM> also has a first distal horizontal needle alignment guide 224D and a second distal horizontal needle alignment guide 226D adjacent the first and second ferrule receiving apertures <NUM>, <NUM>, respectively. As a sewing cuff is moved horizontally in relation to these horizontal needle alignment guides 224P, 224D, 226P, 226D, the intended horizontal penetration location of the needle relative the cuff can be judged from the alignment guides.

The guide tip <NUM> also has a first proximal vertical needle alignment guide 228P adjacent the first needle guide <NUM>. Similarly, the guide tip <NUM> has a second proximal vertical needle alignment guide 230P adjacent the second needle guide <NUM>. The guide tip <NUM> also has a first distal vertical needle alignment guide 228D and a second distal vertical needle alignment guide 230D adjacent the first and second ferrule receiving apertures <NUM>, <NUM>, respectively. As a sewing cuff is moved vertically in relation to these vertical needle alignment guides 228P, 228D, 230P, 230D, the intended vertical penetration location of the needle relative the cuff can be judged from the alignment guides.

The guide tip <NUM> also has a left central alignment guide <NUM> and a right central alignment guide 232R which are located on a plane substantially central to the first and second ferrule holders <NUM>, <NUM> for further needle visualization.

<FIG> is a partially cross-sectioned side view of the prosthetic suturing device <NUM> of <FIG> with the needles <NUM>, <NUM> in a retracted position. <FIG> is a top view of the device <NUM> from FIG. 6B, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. In this embodiment, on the proximal end, the needles <NUM>, <NUM> are oriented in a horizontal row, but they are spiraled inside the device to be aligned to pass vertically into the cuff receiving area <NUM>. In the retracted position of <FIG>, the ends of the needles <NUM>, <NUM> are located just inside the guide tip <NUM> on the proximal side of the cuff receiving area <NUM>.

<FIG> is a partially cross-sectioned side view of the prosthetic suturing device <NUM> of <FIG>, with the ends of the needles 170E, 172E in a partially engaged position as they pass through the cuff-receiving area <NUM>. <FIG> is a top view of the device from <FIG>, hiding the handle, housing, spring, and hard stop in order to more clearly shown the proximal needle orientation. The handle <NUM> has been moved <NUM> toward the housing grip <NUM>, causing the needles <NUM>, <NUM> to be moved in a distal direction <NUM>.

<FIG> is a partially cross-sectioned side view of the prosthetic suturing device <NUM> of <FIG>, with the ends of the needles 170E, 172E in a fully engaged position and coupled to the suture ferrules <NUM>, <NUM> held in the distal end of the guide tip <NUM>. <FIG> is a top view of the device from <FIG>, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. The handle <NUM> has contacted the hard stop <NUM> to prevent the needles 170E, 172E from pressing too hard into the ferrules <NUM>, <NUM>.

<FIG> is a partially cross-sectioned side view of the prosthetic suturing device <NUM> of <FIG>, with the needles <NUM>, <NUM> partially retracted and pulling the suture ferrules <NUM>, <NUM> and suture <NUM> back through the cuff receiving area <NUM>. <FIG> is a top view of the device from <FIG>, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. The handle <NUM> has been partially released, and the spring <NUM> has caused the handle to move <NUM> away from the housing grip <NUM>, thereby causing the needles <NUM>, <NUM> to move in a proximal direction <NUM>.

<FIG> is a partially cross-sectioned side view of the prosthetic suturing device <NUM> of <FIG>, with the needles <NUM>, <NUM> fully retracted. <FIG> is a top view of the device from <FIG>, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. The position of the needles <NUM>, <NUM> in <FIG> is the position the needles <NUM>, <NUM> take when the user is not applying force to the handle <NUM>. <FIG> is an enlarged partial cross-sectional view of the guide tip <NUM> from <FIG>, showing the ferrules <NUM>, <NUM> coupled to the ends of the needles 170E, 172E being held distally to the ferrule removal spring <NUM>. The ferrule removal spring <NUM> has a first edge <NUM> which rides on the first needle <NUM> and which is positioned to push the ferrule <NUM> off of the first needle <NUM> if the needle <NUM> is moved more in a proximal direction. The ferrule removal spring <NUM> also has a second edge <NUM> which rides the second needle <NUM> and which is positioned to push the ferrule <NUM> off of the second needle <NUM> if the needle <NUM> is moved more in a proximal direction. As it stands in the view of <FIG>, however, the ferrules <NUM>, <NUM> are still coupled to their respective needle ends 170E, 172E. The suture <NUM> has been pulled through the cuff receiving area <NUM> on a path where the needles <NUM>, <NUM> had been pulled back. As will be shown and described in later figures, if there had been a sewing cuff located in the cuff receiving area, the suture <NUM> would have been pulled back through the sewing cuff in two locations (where the first and second needles <NUM>, <NUM> had passed).

The view of <FIG> also offers a cross-sectional look at the first and second ferrule receiving apertures <NUM>, <NUM>. The flared end <NUM> of the first ferrule receiving aperture <NUM> and the flared end <NUM> of the second ferrule receiving aperture <NUM> can be seen more clearly in this view.

<FIG> is a partially cross-sectioned side view of the prosthetic suturing device <NUM> of <FIG>, with the needles <NUM>, <NUM> hyper-retracted. <FIG> is a top view of the device from <FIG>, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. In <FIG>, the user has applied a force to the handle <NUM> in a direction away <NUM> from the grip <NUM>. The handle <NUM> may contact the handle stop <NUM> which can be designed to flex or give in order to allow the handle to move in this direction <NUM>. This causes the needles <NUM>, <NUM> to retract more than the normal resting state of <FIG> in a proximal direction <NUM>. <FIG> is an enlarged partial cross-sectional view of the guide tip <NUM> from <FIG>, showing what happens when the needles <NUM>, <NUM> are hyper-retracted in this fashion. The ferrules <NUM>, <NUM> are decoupled from the ends of the needles 170E, 172E after having been pushed off of the needles 170E, 172E by the ferrule removal spring <NUM>. This allows the suture to be removed from the device <NUM>, and a new set of ferrules may be loaded into the device. This can be helpful in a cardiac surgery where there are often many pairs of suture ends which have been sewn into tissue and which then have to be sewn into corresponding positions in a sewing cuff of a replacement anatomical structure.

<FIG> is an exploded perspective view of another embodiment of a prosthetic suturing device <NUM>. The main difference between this embodiment and the previous embodiments is that the needles retain a vertical alignment throughout, rather than starting in a horizontal alignment and then being twisted into a vertical alignment. A needle guide tube <NUM>, this one having a first straight track <NUM> and a second straight track <NUM>, is placed into a proximal end 257P of shaft <NUM>. A guide tip <NUM> is placed into a distal end 257D of the shaft <NUM>, and a notch <NUM> of the needle guide tube <NUM> is aligned with a key <NUM> of the guide tip <NUM> inside of the shaft <NUM>. A shaft holder <NUM> is coupled to grooves <NUM> of the shaft <NUM>.

A drive rod <NUM> has a ball end <NUM> on a proximal end of the drive rod <NUM>. The distal end of the drive rod <NUM> is coupled to a drive block <NUM>. The ball end <NUM> of the drive rod <NUM> is placed into a side opening <NUM> in the handle <NUM>, while the drive rod is pulled across a top slot <NUM> and down a forward slot <NUM> in the handle. A first needle <NUM> has an end 280E configured to engage a suture adapter, such as a ferrule. The first needle <NUM> also has a proximal needle end 280P. A second needle <NUM> has an end 282E configured to engage a suture adapter such as a ferrule. The second needle <NUM> also has a proximal needle end 282P. The second needle <NUM> is placed into the second straight track <NUM> of the needle guide tube <NUM>, end 282E first. The ferrule release spring <NUM> may be placed into a slot in the top of the guide tip <NUM> and rested on the second needle <NUM>. The first needle <NUM> may then be placed into the first straight track <NUM> of the needle guide tube <NUM>, end 280E first, so that the spring <NUM> is compressed between the two needles <NUM>, <NUM> as in previous embodiments.

A needle connector <NUM> has first and second connector holes <NUM>, <NUM> into which the proximal ends of the first and second needles 280P, 282P are placed, such that the proximal ends 280P, 282P are coupled to their respective connector holes <NUM>, <NUM>. The needle connector <NUM> is coupled to a connector receptacle <NUM> in the drive block <NUM>, completing the link between the needles <NUM>, <NUM> and the handle <NUM>.

The pivot point <NUM> of the handle <NUM> may be aligned in a pivot boss <NUM> formed in the housing <NUM>. The shaft holder <NUM> may be held and supported by a variety of features on the inside of the housing <NUM>. Such features are not illustrated for simplicity, but are well known to those skilled in the art. Although only one half of the housing <NUM> is shown in this exploded view, it should be understood that a complementary half of the housing is also present (though not shown) and would have similar boss features to allow pivoting of the handle <NUM> and bracing of the shaft holder <NUM>.

<NUM> is a partially exposed side view of the prosthetic suturing device <NUM> of <FIG>. When the handle <NUM> is squeezed <NUM> towards the grip <NUM>, the first and second needles <NUM>, <NUM> are moved distally through the cuff receiving area <NUM> in a manner as shown in the previous embodiments.

<FIG> is a perspective view of one embodiment of a guide tip <NUM> for a prosthetic suturing device. Most features of this embodiment of a guide tip <NUM> have been discussed above, however, this embodiment can also be seen to have first and second proximal needle guides <NUM>, <NUM>. These guides <NUM>, <NUM> work with the needle guides <NUM>, <NUM> (not visible in this view, but discussed previously) in order to help guide the needles <NUM>, <NUM> through the cuff receiving area while maintaining an expected vertical alignment and spacing between the needles <NUM>, <NUM>.

Depending on the embodiment, the needle guides <NUM>, <NUM> in the guide tip <NUM> may be used to force needles which start horizontally into a vertical alignment without the need for a needle guide tube. <FIG> illustrates just such an embodiment, and is a partially exposed partial cross-sectional perspective view of another embodiment of a prosthetic suturing device <NUM>, utilizing the guide tip of <FIG> without a needle guide tube. The features of this embodiment are just like those of the embodiment of <FIG>, however, this device <NUM> does not use the a needle guide tube. Instead, the needles <NUM>, <NUM> start horizontally as held by the handle <NUM>, but are then twisted into vertical orientation by the guide tip <NUM>. In order to prevent the needles from buckling, it may be necessary to go with a heavier gauge needle when a suture guide tube is not used.

<FIG> is a partially exposed side view of a further embodiment of a prosthetic suturing device <NUM>. This embodiment only has a single needle <NUM> and a place for a corresponding ferrule holder in the guide tip <NUM>, but the cuff receiving area is still facing left while the handle <NUM> and grip <NUM> substantially point down (as in previous embodiments).

<FIG> is a partially exposed side view of another embodiment of a prosthetic suturing device <NUM>. In this embodiment, the guide tip <NUM> has a vertical opening (rather than a horizontal opening like previous embodiments) which defines a cuff receiving area. The needles <NUM>, <NUM> in this embodiment are aligned horizontally, and otherwise, this device operates like the previous embodiments.

<FIG> illustrate one example of a surgical usage of an embodiment of a prosthetic suturing device. For convenience, only the guide tip <NUM> of the device is shown in <FIG>. The guide tip <NUM> is like that of <FIG>, and as noted in the examples above, there are many actuator examples which would result in the vertically aligned needles <NUM>, <NUM> illustrated here. The surgical situation of this example is as follows, and as illustrated in <FIG>: In preparation for installation of a replacement anatomical structure <NUM> (here, illustrated as a replacement heart valve), a suture <NUM> has been sewn through a tissue <NUM> inside of a patient. This could have been done by hand, but preferably with a minimally invasive suturing device which is compatible with ferrules (or some other type of suture adapter). The ferrules <NUM>, <NUM> were removed from the minimally invasive suturing device and then loaded into the ferrule holders in the distal end of the guide tip <NUM> outside of the patient. The replacement anatomical structure <NUM>, having a sewing cuff <NUM>, is standing by.

As shown in <FIG>, the sewing cuff <NUM> of the replacement valve <NUM> is placed <NUM> into the cuff receiving area <NUM> of the guide tip <NUM>. As described previously, the needle alignment guides can be used to help position the sewing cuff as desired. Since the cuff receiving area faces to the side, while the handle and grip face substantially downward, it is easier for a surgeon to hold the suturing device with one hand while positioning the valve <NUM> with the other hand. As shown in <FIG>, the device handle (not shown) is squeezed to cause the needles <NUM>, <NUM> to move distally <NUM>, pierce the sewing cuff <NUM>, and then engage the ferrules <NUM>, <NUM> with respective ends 170E, 172E of the needles <NUM>, <NUM>. As shown in 19D, the device handle (not shown) is released to cause the needle ends 170E, 172E to move proximally <NUM> back through the sewing cuff <NUM>, pulling the ferrules <NUM>, <NUM> and the suture <NUM> back through the sewing cuff as well. As shown in <FIG>, the replacement anatomical structure <NUM> can be removed <NUM> from the from the cuff receiving area <NUM> while the ferrules <NUM>, <NUM> remain coupled to the needles <NUM>, <NUM> in the proximal end of the guide tip <NUM>. Although the suture <NUM> is still illustrated as passing through the ferrule holders in the distal end of the device, it should be understood that the suture <NUM> can be removed from the ferrule holders by passing it through the suture removal passages <NUM>, <NUM>. As shown in <FIG>, the needles <NUM>, <NUM> may be further moved in a proximal direction <NUM> (as discussed above) so that the ferrules <NUM>, <NUM> are pushed off of the needles <NUM>, <NUM> by the ferrule removal spring <NUM>, thereby releasing the ferrules <NUM>, <NUM> to move free <NUM> of the device. By loading other suture ends into the device, this process can be repeated with other suture pairs around the circumference of the sewing cuff <NUM>. This device and method greatly simplify and speed up the process of placing sutures through a sewing cuff of a replacement anatomical structure. Once the desired number of suture ends have been passed through the sewing cuff, those skilled in the art know how to run the replacement anatomical structure down the sutures and against the tissue where the sutures were first placed. The pairs of suture ends may then be tied off with hand-tied or mechanical knots as desired.

<FIG> is a perspective view of one embodiment of a surgical suturing device <NUM> and one embodiment of a magazine <NUM> for the surgical suturing device <NUM>. The surgical suturing device <NUM> has a housing <NUM> and an actuator <NUM> (only the lever handle <NUM> of which may be seen in this view). The suturing device also has a tip <NUM> which has a suture magazine receiver <NUM>. The suturing device <NUM> also has an indexer. Most of the features of the indexer cannot be seen in this view, with the exception of the indexer's push button <NUM> which can be seen in this view. The indexer is operationally coupled to the suture magazine receiver <NUM> to be able to move the suture magazine <NUM> (once installed) from one suturing position to another. This indexing movement will be discussed in more detail in later views. In <FIG>, the magazine <NUM> is shown separated from the surgical suturing device. In <FIG>, the magazine <NUM> is shown installed in the suture magazine receiver <NUM> of the suturing device. Details of the magazine <NUM> will be discussed in more detail later in this description.

<FIG> is an exploded view of the surgical suturing device of <FIG>. For assembly, a pair of needles 342A, 342B is passed down through an opening <NUM> in the push button <NUM> (push control) where they can be inserted into a needle receiver <NUM> in the actuator handle <NUM>. A needle pin <NUM> (which may be pre-attached to the two needles) holds the needles pivotably in place in the handle <NUM>. The distal end of the needles 350A, 350B rests in needle guides 352A, 352B formed by middle <NUM> and top <NUM> portions of the device tip which are coupled together around the needles 342A, 342B. A forward stop <NUM> and a stop spring <NUM> are set into respective grooves of a bottom portion <NUM> of the device tip. An indexing flexure <NUM> is coupled to a pusher <NUM> which is then set into a pushing channel <NUM> of the tip bottom. For later reference, the indexing flexure <NUM> has a primary cam <NUM> and the pusher <NUM> has a secondary cam <NUM>. A pusher spring element <NUM> is slid over the proximal end <NUM> of the pusher <NUM> and the proximal end <NUM> of the pusher <NUM> is coupled to the push button <NUM>. The pusher spring <NUM> is compressed between the forward end <NUM> of the push button <NUM> and a pusher spring receiver <NUM> of the tip formed when the bottom <NUM> of the tip is coupled to the middle <NUM> of the device tip. A pivot point <NUM> of the handle <NUM> is aligned with pivot bosses <NUM> of the housing <NUM> as the two portions of the housing <NUM> are brought together. The housing <NUM> also holds the tip <NUM> (made of upper, middle, and lower portions <NUM>, <NUM>, and <NUM>) and provides a slideable guide for the push button <NUM>.

<FIG> is an exploded view of the suturing magazine <NUM> of <FIG>. It has a plurality of suturing positions 386A-386F. In this embodiment, each suturing position 386A-386F has two ferrule holders 388A, 388B to correspond to the two needles 342A, 342B of the suturing device <NUM>. Other embodiments may have more or fewer ferrule holders in each suturing position. A ferrule holder is configured to hold a ferrule which is attached to the end of a suture. A ferrule is an object which can be picked up by a needle which comes into contact with it. Embodiments of ferrules will be discussed further below. In many cardiac surgical procedures, the sutures which have been sewn into the heart tissue where a replacement valve will be anchored will often have ferrules attached to their ends. The suture ferrules can be installed by a surgeon, or someone on his/her staff, into the ferrule holders 388A, 388B of the magazine. In this embodiment, the ferrules on two ends of the same suture may be placed into ferrule holders 388A, 388B of the same suture position in the magazine. The positions 386A-386F in a magazine may be filled in order so that the suture ends are managed, tracked, and kept untangled. Although this embodiment shows a magazine with six suture positions 386A-386F, other embodiments may have fewer or more suture positions.

As will be seen in the discussion below, after the magazine <NUM> has been inserted into a suturing device <NUM>, the needles 342A, 342B can traverse over the magazine <NUM> on their way to the ferrules which are held in the ferrule holders 388A, 388B. In order to help keep the needles 342A, 342B aligned with the ferrules as the needles 342A, 342B move, this embodiment of the magazine <NUM> has two needle alignment guides 390A, 390B in line with each ferrule holder 388A, 388B, respectively. Other embodiments may have fewer or more alignment guides for each needle.

The magazine <NUM> has a ferrule remover <NUM> and a ferrule gate <NUM> which are spaced apart and held in place by a ferrule capture <NUM>. In this embodiment, the ferrule gate <NUM> is a distal ferrule spring and the ferrule remover <NUM> is a proximal ferrule spring. The ferrule remover <NUM> and the ferrule gate <NUM> may each be a series of separate components or one continuous component. The operation of the ferrule gate <NUM> , the ferrule remover <NUM>, and the ferrule capture <NUM> will be discussed in more detail below, but it should be noted that the ferrule capture <NUM> may advantageously be made of a transparent or translucent material in some embodiments to facilitate observation of ferrules which should become captured therein. A sewing cuff receiver <NUM> is located between the ferrule holders 388A, 388B and the ferrule capture <NUM>.

This embodiment of a magazine also has a cutter <NUM> which can be held in a portion of the magazine <NUM> for convenient cutting of sutures when needed. The cutter <NUM> can be recessed to avoid injury to the people handling the magazine <NUM> or to the patient. Other embodiments may not have a cutter.

This embodiment of the magazine <NUM> further has one or more direction indicators <NUM> to assist the operator in determining the correct direction to insert the magazine <NUM> into the suturing device.

Embodiments of the magazine will also have an indexable feature configured to enable the magazine to be moved between the plurality of suturing positions. The indexable feature can include, but is not limited to, one or more of the following features: one or more primary cam paths, one or more secondary cam paths, and/or one or more stop receivers, examples of which will be discussed in more detail below. Other embodiments of the indexable feature may include a gear rack.

<FIG> show top, front, left, right, bottom, and rear (upside-down) elevational views, respectively, of the magazine of <FIG>. In addition to the features already discussed, the primary cam paths 404A-404F, the secondary cam paths 406A-406F, and stop receivers 408A-408F can be seen more clearly. A receiver mating <NUM> feature is also visible. Some embodiments may not have a receiver mating feature, but a magazine's receiver mating feature is configured to engage a corresponding magazine mating feature in the magazine receiver of the suturing device.

<FIG> shows an embodiment of the magazine <NUM> inserted into the magazine receiver <NUM> of the suturing device <NUM>. One half of the housing <NUM> has been removed, along with the middle and top portions of the tip so that some of the hidden elements may more clearly be seen. The tip of the stop spring <NUM> has engaged the first stop receiver 408A on the magazine, and the first suturing position 386A is in alignment with the two device needles 342A, 342B. The stop spring <NUM> may be seen more clearly in the exposed top view of <FIG>, showing the sewing device from the top. The ramped shape of the tip <NUM> of the stop spring <NUM> facilitates movement of the magazine <NUM> (when installed) in a single direction if an external force is applied. Additionally, the forward stop <NUM> is normally protruding upward into a stop receiver on the bottom of the magazine. The forward stop <NUM> may be seen more clearly in the exposed side view of <FIG>. The tip <NUM> of the forward stop <NUM> rises into the suture magazine receiver <NUM> to help hold the magazine in a given suturing position, but the forward stop may be disengaged, as will be discussed in more detail below.

Ferrules may be loaded into the magazine either after, or preferably before, the magazine is inserted into the suturing device. <FIG> illustrates a partial cross-sectional side view of a magazine <NUM> having a ferrule 416A loaded into a suture holder 388A. The magazine <NUM> is loaded into the suturing device to the first suturing position, and the visible needle 342A is aligned with the ferrule 416A in the ferrule holder 388A. The ferrule remover <NUM> and the ferrule gate <NUM> are protruding slightly into a passage <NUM> of ferrule capture. A replacement anatomical device <NUM> (in this example, a replacement heart valve) has been placed into a sewing cuff receiver <NUM> of the magazine <NUM>.

In <FIG>, the needle 342A has been actuated in a distal direction <NUM>, causing it to pass against the ferrule remover spring <NUM> (pushing it down), pass through the passage <NUM> in the ferrule capture, pass against the ferrule gate spring <NUM> (pushing it down), pass through the sewing cuff <NUM> of the replacement valve <NUM>, and into contact with the ferrule 416A at the end of the suture <NUM>. In this embodiment, the tip of the needle fits within the ferrule and holds onto the ferrule.

In <FIG>, the needle 342A has been partially withdrawn in a proximal direction <NUM> so that the ferrule 416A and its attached suture <NUM> are pulled back through the sewing cuff <NUM>, over the ferrule gate spring <NUM>, and into the passage <NUM> of the ferrule capture. The ferrule 416A held by the needle 342A tip in the ferrule capture <NUM> may be seen more clearly in the enlarged view of <FIG>. In the enlarged view of <FIG>, as the needle 342A continues in a proximal direction, an edge of the ferrule remover spring <NUM> catches on the lip of the ferrule 416A and starts to remove the ferrule 416A from the needle's 342A tip. As shown in <FIG>, as the needle 342A continues in the proximal direction <NUM>, the ferrule 416A is completely removed from the needle 342A and held in the ferrule capture <NUM>. The ferrule trap ensures that the ferrule does not pull back out of the ferrule capture <NUM>, even if the suture <NUM> attached thereto is pulled.

27A-<NUM> show a similar sewing process for a single suturing position in a partially exposed view which highlights the dual needle embodiment. <FIG> illustrates the magazine <NUM> having been indexed to a second suturing position, and the replacement valve is being rotated and placed back into the sewing cuff receiver so that the needles may penetrate the sewing cuff at another position to pull the second suture set back through. The second stitch would occur much like the first, just with a second set of ferrules attached to the ends of a second suture.

<FIG> schematically illustrate one embodiment of how the indexer portion of the suturing device and the indexable feature of the magazine work together to index or move the magazine from one suturing position to another. The viewpoint of <FIG> is from the bottom of the device, and for clarity, the device tip is shown as being transparent with visible edges so the features of the magazine behind it may more clearly be seen with solid lines. For simplicity, certain portions of the device are not shown in <FIG> to provide clarity to the explanation.

In <FIG>, the primary cam <NUM> of the indexing flexure <NUM> is seen resting in its track <NUM> of the device tip <NUM> in a retracted position, while the pusher <NUM> and the secondary cam <NUM> coupled to it are also in retracted positions. We can tell the magazine <NUM> is in a first suturing position because the stop spring <NUM> is engaged in the first stop receiver 408A on the side of the magazine. The tip <NUM> of the forward stop <NUM> is also engaging a depression in the magazine.

In <FIG>, the pusher <NUM> has started to move in a distal <NUM> direction, causing the primary cam <NUM> to move into contact with the primary cam path 404A of the magazine <NUM>. Additionally, the forward portion <NUM> of the pusher <NUM> engages the forward stop <NUM>, pushing it out of engagement with the magazine <NUM> (This movement of the forward stop <NUM> is towards the viewer in the orientation of <FIG>, away from the magazine <NUM> so that the tip of the forward stop no longer engages the depression in the magazine).

In <FIG>, the pusher <NUM> continues to move distally <NUM>, and the interference of the primary cam <NUM> with a ramped wall of the primary cam path 404A causes the magazine <NUM> to start to move in a direction lateral <NUM> to the pusher movement The secondary cam <NUM> on the pusher <NUM> also is aligned to enter the secondary cam path 406A defined by the magazine <NUM>. Since the magazine <NUM> is moving, the stop spring <NUM> has been pushed out of the stop receiver 408A in the magazine <NUM>.

In <FIG> and <FIG>, the pusher <NUM> continues moving in a distal direction, causing the primary and secondary cams <NUM>, <NUM> to move down the primary and secondary cam paths 404A, 406A, respectively, resulting in more lateral movement <NUM> of the magazine.

In <FIG>, the pusher <NUM> continues moving in a distal direction <NUM>, causing the primary and secondary cams <NUM>, <NUM> to move onto respective portions of the primary and secondary cam paths 404A, 406A which are parallel <NUM> to the motion of the pusher <NUM>. At this point, the lateral movement of the magazine will stop, even if the pusher <NUM> continues to move forward as in <FIG>. The stop spring <NUM> has engaged the second stop receiver 408B, and the indexing movement has been accomplished in this embodiment with just the distal movement of the pusher <NUM>. Although not shown in this view, the needles are now aligned with the second set of ferrules in the second suturing position. If pressure on the pusher <NUM> is released, the pusher spring (not shown here) will retract the pusher and the primary and secondary cams <NUM>, <NUM>. The indexing may then be repeated as desired.

Thus far, all of the illustrated embodiments show separate controls for needle actuation and indexing. The handle lever actuates the needles and the push button (coupled to the pusher) causes a magazine to index. However, as will be apparent to those skilled in the art, it is possible to have both functions controlled by a single actuator. As one example, energy could be stored in an energy storage spring as the lever is squeezed. Then, as the lever is released, and once the needles were clear of the magazine, the energy stored in the storage spring could be used to drive the indexing movement. In other embodiments, movement of the lever in a first direction could engage the needles, which might be spring biased to automatically retract at the end of a lever stroke. Movement of the lever back to the starting direction could cause indexing to occur.

Furthermore, the indexing and needle actuation could be accomplished in a wide variety of other ways. All manner of alternatives will be apparent to those skilled in the art upon reading this specification. As some non-limiting examples, the actuator or the indexer may include one or more levers, gears, pulleys, friction wheels, solenoids, motors, or any combination thereof. When those skilled in the art consider other actuator embodiments, such as electronically controlled actuators, many ways will become apparent for a single "actuator", from the user's point of view, to instigate the needle actuation and the magazine indexing, rather than having two manual controls.

<FIG> is a side view of another embodiment of a magazine <NUM> for a suturing device. While the sewing cuff receiver of the previously discussed embodiments was symmetrical from a side view, this embodiment has an asymmetrical sewing cuff receiver <NUM> when viewed from this side view. Depending on the embodiment, the shape of the sewing cuff receiver <NUM> may be designed to conform to the shape of a particular sewing cuff. In some embodiments, the sewing cuff receiver may have a ramp <NUM>, curve, or slope to enable surgeons to prop the sewing cuff inserted therein at a desired height, thereby offering surgeons more control over suture placement.

<FIG> schematically illustrate different side views of a suture magazine receiver <NUM>, <NUM>, <NUM>, <NUM>, respectively, in a suturing device (only the device tip is pictured). Each of the different embodiments in <FIG> has a magazine receiver with a differing number of receiving surfaces. The magazine receiver <NUM> of <FIG> has four receiving surfaces 446A, 446B, 446C, 446D. The magazine receiver <NUM> of <FIG> has three receiving surfaces 448A, 448B, 448C. The magazine receiver <NUM> of <FIG> has two receiving surfaces 450A, 450B. The magazine receiver <NUM> of <FIG> has one receiving surface 452A. The receiving surfaces can help guide a magazine when inserted therein. <FIG> also include different embodiments of magazine mating features <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. The magazine mating features can be protruding <NUM>, <NUM>, <NUM>, <NUM>, or they can be inset <NUM>, or any combination thereof. Any number (zero or greater) of magazine mating features may be included in the magazine receiver. The magazine mating features may have any desired shape, and not all mating features need to be used for any given magazine, depending on the embodiment. This might enable a single suturing device to interact with different magazines having a variety of different corresponding mating features.

<FIG> illustrates one embodiment of a suture magazine <NUM> installed in the suture magazine receiver of <FIG> illustrates one embodiment of a suture magazine <NUM> installed in the suture magazine receiver of <FIG> illustrates one embodiment of a suture magazine <NUM> installed in the suture magazine receiver of <FIG> illustrates one embodiment of a suture magazine <NUM> installed in the suture magazine receiver of <FIG>. Each magazine in <FIG> has one or more receiver mating features which correspond to the magazine mating features of the magazine receiver. For example, magazine <NUM> has receiver mating feature <NUM> which corresponds to magazine mating feature <NUM>. Magazine <NUM> has receiver mating feature <NUM> which corresponds to magazine mating feature <NUM>. Magazine <NUM> has receiver mating feature <NUM> which corresponds to mating feature <NUM>. Magazine <NUM> has receiver mating features <NUM>, <NUM> which correspond to magazine mating features <NUM>, <NUM>, respectively.

<FIG> illustrates one embodiment of a surgical suturing device <NUM> having a cassette receiver <NUM>. <FIG> is the surgical suturing device <NUM> of <FIG> in a partially exposed view. A handle <NUM> is pivotable around a pivot point <NUM> supported by the housing <NUM>. A spring <NUM> coupled between the handle <NUM> and the housing <NUM> biases the handle <NUM> away from a grip <NUM>. Two needle drivers <NUM> are coupled to the handle <NUM>. The needle drivers <NUM> extend through a receiver component <NUM>, ending in a cassette receiver <NUM>. The ends <NUM> of the needles drivers <NUM> are visible in the cassette receiver <NUM>.

<FIG> is an exploded view of the surgical suturing device of <FIG>. The needle drivers in this embodiment each have two components: a proximal component <NUM> for coupling to the handle <NUM> and a distal component <NUM> that connects to the proximal component. There are two sets of proximal and distal components <NUM>, <NUM> which make up the needle drivers. Each proximal component <NUM> has a first mating feature <NUM> which is passed through an opening <NUM> in the receiver component <NUM>. Each distal component <NUM> of the needle drivers has a second mating feature <NUM> which is inserted into a corresponding guide slot <NUM> in the cassette receiver <NUM> side of the receiver component <NUM> where the respective mating features <NUM>, <NUM> for each needle driver are then coupled together inside the receiver component <NUM>.

Each proximal component <NUM> of the needle drivers has a respective ball <NUM> which is fits into a respective hole <NUM> of the handle <NUM> while the proximal components <NUM> are in an upright position (perpendicular to the orientation shown in <FIG>). Only one of the holes <NUM> is visible in this view, but the other hole <NUM> is symmetrically placed on the opposite side of the handle <NUM>. Once the balls <NUM> have been placed into the holes <NUM>, the proximal components <NUM> of the needle drivers can be maneuvered down into slots <NUM>. The pivot point <NUM> extends to both sides of the handle <NUM> and is aligned within a pivot boss <NUM> of the housing <NUM>. The receiving component <NUM> has features <NUM> (one of which is visible in this view) which are configured to be held by corresponding features in the housing <NUM>. Such alignment features are known to those skilled in the art and are not shown in the housing <NUM> for simplicity. The housing <NUM> also has an opening <NUM> which is configured to help align the receiver component <NUM>. The spring <NUM> is attached between a hook <NUM> on the handle <NUM> and a post <NUM> which is part of the housing <NUM>. The spring <NUM> pulls on the hook <NUM>, causing the handle <NUM> to rotate around the pivot point <NUM> until the handle <NUM> contacts a stop <NUM> on the housing <NUM>. When in use, the handle <NUM> will be squeezed towards the grip <NUM>. A motion limiter <NUM> is installed into a corresponding receiver <NUM> in the housing <NUM>. The motion limiter <NUM> provides a limit to the range of motion of the squeezed handle <NUM>. Only one half of the housing <NUM> is shown in the exploded view of <FIG>, but a corresponding half (not shown) aligns with the pivot point <NUM>, the motion limiter <NUM>, and the receiver component <NUM> while coupling to the half of the housing <NUM> which is shown to complete the assembly.

<FIG> is an enlarged, exposed view of the ends <NUM> of the needle drivers <NUM> in an exposed view of a portion of the surgical suturing device of <FIG>. The end <NUM> (distal) of each needle driver <NUM> has a needle receiver <NUM>. <FIG> is an enlarged view of the needle receivers <NUM> and the cassette receiver <NUM> of the surgical suturing device of <FIG>. The cassette receiver <NUM> has pivot receivers <NUM>, a needle release <NUM>, multiple alignment slots <NUM>, and multiple retention features <NUM> which will be discussed in more detail below.

<FIG> are different perspective views of a cassette <NUM> embodiment for use with the surgical suturing device of <FIG>. The cassette <NUM> houses two needles (not visible in this view) within a base <NUM> and a cover <NUM> which are coupled together. It is one advantage of this system that the needles are kept inside the cassette <NUM> because it reduces the opportunity for the surgical staff and surgeon to be cut during an operation by an exposed sharp needle. By necessity, patients are treated as though their blood carries harmful pathogens, so it is always disconcerting when someone on a surgical team is cut or poked by a needle. By keeping the needles within the cassette <NUM>, away from skin, surgical procedures involving this cassette can be safer. There are a variety of ways the base <NUM> and cover <NUM> can be coupled together, including, but not limited to by latching, by gluing, and by welding. In this embodiment, the base <NUM> has multiple base latches <NUM> which engage slots in the cover <NUM>, as well as multiple cover latches <NUM> which engage slots in the base <NUM>. The cassette <NUM> has multiple pivots <NUM> (one of which is visible in <FIG>, but the other is symmetrically located on the opposite side). The cassette <NUM> also has an alignment tab <NUM> on each side of the cassette <NUM>. The cover <NUM> has two flexible arms <NUM> which may be pinched inwardly. Each of the flexible arms <NUM> has a retention latch <NUM> (one of which is visible in <FIG>, but the other is symmetrically located on the other flexible arm). The base <NUM> has two proximal openings <NUM> where the proximal ends of the needles (not shown) inside the cassette <NUM> are accessible. In other embodiments, the two proximal openings <NUM> may be combined into one shared proximal opening <NUM> by removing the dividing piece <NUM> between the two openings <NUM>. The base <NUM> also has two distal openings <NUM> from which distal ends of the needles (not shown) may be extended. The cover <NUM> defines two ferrule holders <NUM> and two exit slots <NUM> for suture coupled to ferrules. Ferrules are not installed in the cassette of <FIG>. The base <NUM> and cover <NUM> work together to define a cuff receiving area <NUM> between the distal openings <NUM> and the ferrule holders <NUM>. The base <NUM> also defines a release slot <NUM> which is sized to allow the needle release from the cassette receiver (see <FIG>) to pass.

<FIG> is an exploded view of the cassette <NUM> of <FIG> which enables us to see the internal components of the cassette <NUM>. The base <NUM> has needle guides <NUM> within which respective needles <NUM> are placed. The proximal end of each needle <NUM> is configured as a connector end 576C which has a slot <NUM> to mate with the needle receivers <NUM> of the suturing device when the cassette <NUM> is installed in the device. The distal end of the needles <NUM> are pointed into a tip 576T which will be able to penetrate a sewing cuff of a prosthetic replacement heart valve and engage a ferrule held in the ferrule holders of the cassette. Each needle <NUM> also has a needle cuff relief <NUM> which will be discussed later in more detail. Each needle <NUM> also has a latch feature <NUM> configured to be engaged by latch ends <NUM> of a flexible latch <NUM> inside the cassette <NUM>. When the needles <NUM> are in the needle guides <NUM> of the base <NUM>, the flexible latch <NUM> with two latch ends <NUM> is coupled at a distal end 586D of the flexible latch <NUM> to corresponding key features <NUM> in the base <NUM>. The needles <NUM> are positioned so that the latch ends <NUM> fall into the latch features <NUM> on the needles <NUM>, thereby restraining the needles <NUM> from moving out of the cassette <NUM>. The cover <NUM> is attached to seal everything up and also to help constrain the needles <NUM> and the flexible latch <NUM>. As mentioned, this design has the advantage of keeping the needles away from the operating staff and the patient to improve safety for all involved.

<FIG> are top, front, left, right, back, and bottom views of the cassette of <FIG>.

<FIG> is a perspective view of a surgical situation where a suture <NUM> has been stitched into a tissue <NUM> and ferrules <NUM> on the ends of the suture <NUM> are ready to be placed into the cassette of <FIG>. As will be discussed later in this specification, the ferrules are configured to couple to needle tips. The ferrules may be coupled to the suture ends using a variety of techniques, including, but not limited to gluing, crimping, or a combination thereof. In particular, the cassette <NUM> has guide funnels <NUM> leading into the ferrule holders <NUM> to make it easier for operating staff to pull the ferrules <NUM> into the ferrule holders <NUM>.

<FIG> illustrates the ferrules <NUM> of <FIG> having been installed into the cassette <NUM> of <FIG>. <FIG> is an enlarged view of the distal end of the cassette <NUM> from <FIG> showing the ferrules <NUM> installed in the ferrule holders <NUM> of the cassette <NUM>. <FIG> illustrates multiple cassettes <NUM> in a surgical situation where each cassette <NUM> is coupled to ferrules (not visible in this view) on the ends of a different, respective sutures <NUM> that have been stitched into a patient. The suture ends leading to each cassette <NUM> are being held by one or more suture organizers <NUM>. Once a desired number of sutures <NUM> have been placed into a patient, for example, for emplacement of a replacement heart valve, each cassette <NUM> can then be loaded into the surgical suturing device (such as the device of <FIG>) in preparation for further stitching the suture <NUM> through a sewing cuff of the replacement heart valve. <FIG> shows a partially exposed view of the back side of the cassette <NUM> of <FIG> to illustrate the connector ends 576C of the needles in the cassette <NUM> and how they are configured to mate with the needle receivers <NUM> (on the distal end of the needle drivers) of the surgical suturing device <NUM>.

<FIG> illustrates the cassette <NUM> of <FIG> ready to be loaded into the cassette receiver <NUM> of the suturing device <NUM> of <FIG>. As shown in <FIG> and <FIG>, the pivots <NUM> (only one of which is visible in this view) of the cassette <NUM> are placed into alignment with pivot receivers <NUM> in the cassette receiver <NUM>. <FIG> is an enlarged view of the cassette <NUM> and cassette receiver <NUM> of <FIG>. The alignment of the pivots <NUM> with the pivot receivers <NUM> can be clearly seen in this view. As shown in <FIG> in conjunction with <FIG>, the cassette <NUM> is then rotated down around the cassette pivots <NUM> so that the alignment tabs <NUM> on the cassette <NUM> move into the alignment slots <NUM> of the cassette receiver <NUM>. As this occurs, the needle release <NUM> of the cassette receiver <NUM> pushes up into the release slot <NUM> of the cassette <NUM>, the connector ends 576C of the needles <NUM> are coupled to the needle receivers <NUM> of the suturing device <NUM>, and the retention latches <NUM> of the flexible arms <NUM> on the cassette <NUM> engage the retention features <NUM> of the cassette receiver <NUM> so that the cassette <NUM> is held firmly in place.

<FIG> is a partial cross-sectional view of the cassette <NUM> installed in the cassette receiver <NUM> of the suturing device. When the needle release <NUM> passes up through the release slot <NUM>, it deflects the flexible latch <NUM> upwards, causing the latch ends <NUM> to move out of the latch features in the needles (not shown in this view). The needles are held by the needle drivers, but they are now free to move if the needle drivers are moved.

<FIG> are partially exposed views illustrating how the surgical suturing device <NUM>, with its installed cassette <NUM>, may be used to place a suture stitch in a sewing cuff <NUM> of a replacement heart valve <NUM>. In <FIG>, a replacement heart valve <NUM> having a sewing cuff <NUM> is shown. A cassette <NUM> is loaded into the suturing device <NUM>. The cassette <NUM> has two ferrules <NUM> loaded into the cassette's ferrule holders, and the ferrules <NUM> are each attached to the ends of the same suture <NUM>. The suture <NUM> has already been stitched through tissue, for example an aortic root adjacent to where the replacement heart valve will eventually be installed. The sewing cuff <NUM> is positioned below the cuff receiver <NUM>, and then, as illustrated in <FIG>, the sewing cuff <NUM> is positioned within the cuff receiver <NUM>. As shown in <FIG>, the handle <NUM> may be squeezed towards the grip <NUM>, and this will cause the needle drivers <NUM> to move distally. In the view of <FIG>, the handle <NUM> has not been illustrated as pivoted so that the motion arrow <NUM> can indicate its path of travel. However, the needle drivers <NUM> are assumed to have moved the needles <NUM>. This drives the needles <NUM> out of the cassette <NUM>, through the sewing cuff <NUM>, and into contact with the ferrules <NUM>. This can better be seen in the enlarged view of <FIG>. The sewing cuff material <NUM> is stretched in a distal direction when the needles <NUM> pass through it. The needles <NUM> in this embodiment, however, have a needle cuff relief <NUM> which allows the sewing cuff <NUM> to straighten back out before the needles <NUM> are fully retracted, thereby decreasing the likelihood of the needles <NUM> jamming in the sewing cuff <NUM>. Some embodiments may not have a needle cuff relief <NUM>. As shown in <FIG>, the handle <NUM> can be released, causing the needle drivers <NUM> to retract the needles <NUM> back into the cassette <NUM>. Since the needles <NUM> are now coupled to the ferrules <NUM>, this pulls the ferrules <NUM> and suture <NUM> back through the sewing cuff <NUM>. This can be seen more clearly in the enlarged view of <FIG>. As shown in <FIG>, the replacement valve <NUM> can be removed from the cuff receiver <NUM> with the suture <NUM> stitched through it. As shown in the enlarged view of <FIG>, the needles <NUM> and ferrules <NUM> are kept protected within the cassette <NUM>. As shown in <FIG>, the flexible arms <NUM> of the cassette <NUM> may be pinched in to disengage the retention latches of the cassette from the retention features of the cassette receiver. This, then, allows the cassette <NUM> to be pivoted up on the pivots as shown in <FIG> and then removed from the cassette receiver <NUM>. This can be repeated as needed with other cassettes <NUM> until all of the sutures have been placed through the sewing cuff <NUM> of the replacement valve <NUM> as illustrated in the surgical situation of <FIG>. The cassettes <NUM> still hold the ferrules on the suture ends, and the needles remain out of reach in each cassette <NUM>. The sutures <NUM> may be cut to sever the cassettes <NUM> from the suture ends as needed. The cassettes <NUM> can also assist with suture management by keeping the pairs of suture ends together and separate from other suture ends until needed.

<FIG> illustrates one embodiment of a magazine <NUM> having multiple cassettes <NUM>. This embodiment combines the concepts of the magazine used earlier with the concept of the cassette more recently discussed.

<FIG> illustrates another embodiment of a surgical suturing device <NUM> having a cassette receiver <NUM>. This embodiment is similar to the embodiment of <FIG>, except that the needle drivers <NUM> (more visible in the exposed view of <FIG> and the exploded view of <FIG>) are all one piece and the needle receivers <NUM> on the needle drivers <NUM> have a different shape. <FIG> is an enlarged view of a portion of the needle drivers <NUM> in an exposed view of a portion of the surgical suturing device of <FIG>. <FIG> is an enlarged view of the needle receivers <NUM> and the cassette receiver <NUM> of the surgical suturing device <NUM> of <FIG>. In this embodiment, the needle receivers <NUM> are shaped to receive a ball connector from a needle in a cassette.

<FIG> are different perspective views of another cassette <NUM> embodiment for use with the surgical suturing device of <FIG>. This cassette <NUM> is similar to the cassette of <FIG>, but has slightly different latching between the cover and the base, has slightly differently shaped pivots <NUM>, has different needles (not visible in this view), and includes a loading alignment guide <NUM> on the distal end of the cassette <NUM>. The loading alignment guide <NUM> will be discussed in more detail later in this specification.

<FIG> is an exploded view of the cassette of <FIG>. As noted above, the latching in this cassette is slightly different than the previous cassette. The previous cassette included latches which flexed and snapped into place. This cassette has latches which pass from the base <NUM> through the cover <NUM> and then require the base <NUM> and cover <NUM> to slide relative to each other in order to secure the latches in place. As noted previously, a wide variety of other techniques known to those skilled in the art exist for coupling the cover to the base. The needles <NUM> are different, too, in <FIG>. This embodiment does not have a needle cuff relief, and the connector ends 618C are ball-shaped to fit the different needle receivers <NUM> of the suturing device embodiment of <FIG> and <FIG>.

<FIG> is a perspective view of a surgical situation where a suture <NUM> has been stitched into a tissue <NUM> and ferrules <NUM> on the ends of the suture <NUM> are ready to be placed into the cassette <NUM> of <FIG>. <FIG> illustrates the ferrules <NUM> of <FIG> having been installed into the cassette <NUM> of <FIG>. The description of these FIGS. is similar to that of <FIG>. <FIG> is an enlarged view of the distal end of the cassette from <FIG> showing the ferrules <NUM> installed in the cassette.

<FIG> illustrate how a suturing device <NUM> for placing stitches in tissue may be coupled to the cassette <NUM> in order to facilitate loading of the ferrules <NUM> into the cassette <NUM>. As shown in <FIG>, the tissue suturing device <NUM> has a tissue bite area <NUM>. As known to those skilled in the art, tissue may be positioned in the tissue bite area <NUM> and then a tissue needle <NUM> may be extended from the position shown in <FIG>, through the tissue in the tissue bite area <NUM>, and into contact with one or more ferrules <NUM> which are held in corresponding one or more ferrule holders <NUM> for the tissue suturing device <NUM>. The tissue needle <NUM> can then be withdrawn back through the tissue to the position shown in <FIG> with the ferrules <NUM> attached as shown in <FIG>. The tissue suturing device <NUM> can be removed from the tissue and the suture end(s) <NUM> coupled to the ferrules <NUM> will be pulled away from the tissue, too. For example, the tissue suturing device <NUM> could be used to place a stitch into an aortic root and then the device could be pulled out of a minimally invasive opening through which it had been placed to make the stitch. The tissue suturing device <NUM> also has the ability to move the needle <NUM> so that the ferrule <NUM> is pushed against a ferrule removal device <NUM> which will push the ferrule <NUM> off of the needle <NUM>. In some embodiments, an operator may use this ferrule release feature <NUM> to release the ferrule <NUM> and then the ferrule <NUM> may be loaded by hand into the ferrule holder <NUM> of the cassette <NUM>. In this embodiment, however, the cassette <NUM> has a cassette nose <NUM> which is shaped to fit into the tissue bite area <NUM> of the tissue suturing device <NUM> as illustrated in <FIG>. The loading alignment guide <NUM> mates with a corresponding feature on the tissue suturing device <NUM> to ensure the ferrule <NUM> and suture <NUM> coupled to the tissue needle <NUM> are in alignment with the ferrule holder <NUM> of the cassette <NUM>. Depending on the embodiment, the ferrule and/or suture may be partially in the funnel opening leading to the cassette ferrule holder <NUM> while the ferrule is still attached to the tissue needle. When the ferrule removal feature <NUM> on the tissue suturing device <NUM> is activated, as shown in <FIG>, the ferrule <NUM> is released from the tissue needle <NUM>. Now, an operator may pull distally on the suture <NUM> to seat the ferrule <NUM> in the cassette ferrule holder <NUM> as shown in <FIG>. Finally, as illustrated in <FIG>, the cassette <NUM> with the loaded ferrule <NUM> (or ferrules <NUM>) may be removed from the tissue suturing device <NUM>. This may be an easier and quicker way to load the ferrules <NUM> into the cassette <NUM> and it also has the advantage of keeping the ferrules <NUM> aligned by not providing an opportunity for the ferrules <NUM> to be mistakenly placed in an incorrect ferrule holder <NUM> (which could cause unwanted tangling of suture lines).

<FIG> is similar to <FIG>, but showing the cassette <NUM> and cassette receiver <NUM> of <FIG> and <FIG>, respectively.

Claim 1:
A cassette (<NUM>; <NUM>) for use in a prosthetic suturing device (<NUM>; <NUM>), the cassette (<NUM>; <NUM>) configured to be loaded into a cassette receiver (<NUM>) of the suturing device (<NUM>, <NUM>) and comprising:
a base (<NUM>);
a cover (<NUM>) coupled to the base (<NUM>) by latching, gluing, or welding; and
one or more needles (<NUM>; <NUM>) guided by the base (<NUM>) and the cover (<NUM>); characterised in that
the base (<NUM>) comprises:
a pair of alignment tabs (<NUM>) configured to move into alignment slots (<NUM>) of the cassette receiver (<NUM>); and
a pair of pivots (<NUM>; <NUM>) configured to be placed into alignment with pivot receivers (<NUM>) in the cassette receiver (<NUM>), thereby allowing the cassette (<NUM>) to be rotated down around the cassette pivots (<NUM>; <NUM>) so that the alignment tabs (<NUM>) move into the alignment slots (<NUM>) of the cassette receiver (<NUM>); and
whereby
the cover (<NUM>):
comprises two flexible arms (<NUM>) each having a retention latch (<NUM>) configured to engage retention features (<NUM>) of the cassette receiver (<NUM>) so that the cassette (<NUM>) is held firmly in place; and characterized in that the cover
defines one or more ferrule holders (<NUM>; <NUM>).