Patent ID: 12251095

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.

DETAILED DESCRIPTION

FIG.1Ais a perspective view of one embodiment of a prosthetic suturing device150.FIG.1Bis a partially exposed perspective view of the prosthetic suturing device150ofFIG.1Awith a portion of the housing158removed. The prosthetic suturing device150has a guide tip152that defines a cuff receiving area154. The cuff receiving area154is 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 tip152is coupled to a shaft156at a distal end156D of the shaft156. The prosthetic suturing device also has a housing158to which a handle160is pivotably coupled at pivot point162. The handle160is biased by spring164towards a handle stop166which is formed from part of the housing158. A hard stop167is also located in the housing158, in order to limit the travel of the handle160when squeezed in a direction174.

Shaft holders168couple a proximal end156P of the shaft156to the housing158. First and second needles170,172are in horizontal alignment where they are coupled to the handle160within the housing158. In this embodiment, the needles170,172are routed by a needle guide tube (not visible in this view) so as to be in vertical alignment near the cuff-receiving area154. Movement174of the portion of the handle160outside of the housing158towards the grip175of the housing158will move the needles170,172across the cuff receiving area154. Since the grip175is part of the housing158, portions of this specification may indicate that certain components are coupled to the grip175, which is accurate because the grip is part of the housing.

FIG.2is an exploded perspective view of the prosthetic suturing device ofFIG.1B. The distal ends170E,172E of the first and second needles170,172are each configured to engage a suture adapter (not shown here, but will be discussed later). A needle guide tube176having first and second spiral tracks178,180is inserted into the proximal end156P of the shaft156, and shaft holders168are placed over the distal end156D of the shaft156and coupled to the proximal end156P of the shaft. The distal end156D of the shaft156is coupled to the guide tip152. A distal end176D of the needle guide tube176abuts or lies close to a proximal portion152P of the guide tip152inside a distal end156D of the shaft156. Starting with the needle ends170E,172E, the first and second needles170,172are inserted into the first and second spiral tracks178,180of the needle guide tube176as will be discussed below. The spiral tracks178,180take the needles170,172from 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 needle172will be located below the first needle170. Before the first needle170is fully inserted, a ferrule release spring182may be inserted into a slot on the top of the guide tip152so that it rests against the second needle172. Then, the first needle170can be fully inserted, compressing the ferrule release spring182between the two needles170,172.

A first ball end184is located on the proximal end of the first needle170. Similarly, a second ball end186is located on the proximal end of the second needle172. The second and first ball ends186,184may be inserted into a side opening188in the handle160. A top needle slot190allows the needles170,172to move into the handle160, and then the needles170,172can be pivoted down into forward slots192,194, respectively, also formed in the handle160. This couples the needles170,172to the handle160. The forward slots192,194maintain the horizontal needle spacing at the proximal end of the device.

The pivot point162of the handle160may be aligned in a pivot boss198formed in the housing158. The shaft holders168may be held and supported by a variety of features on the inside of the housing158. Such features are not illustrated for simplicity, but are well known to those skilled in the art. Although only one half of the housing158is 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 handle160and bracing of the shaft holders168.

The hard stop167may be mounted in a hard stop boss196to limit travel of the handle160, while a lower end200of spring164may be coupled to a fixed spring attachment point202on the housing. An upper end204of the spring164may be hooked onto a handle spring attachment point206.

FIG.3Ais an enlarged perspective view of one embodiment of a needle guide tube176for a prosthetic suturing device.FIGS.3B,3C, and3Dare side, back, and front elevational views, respectively, of the needle guide tube176ofFIG.3A. In this embodiment, the needle guide tube176has a first spiral track178and a second spiral track180. Looking at the back view ofFIG.3C, it can be seen that the spiral tracks178,180will 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 ofFIG.3D, it can be seen that the spiral tracks178,180will have guided the needles into a vertical alignment near the guide tip (not shown in this view). The spiral tracks178,180can provide support for a thinner needle so that the needles do not buckle when rotated to a different orientation. The needle guide tube176may also have a keyed portion208for mating with and/or aligning with a corresponding feature on the guide tip to ensure the needles exit the needle guide tube176and pass smoothly into the guide tip152.

FIGS.4and5are enlarged perspective views of one embodiment of a guide tip152for a prosthetic suturing device shown from distal and proximal perspectives, respectively. Passages pass within the proximal end152P of the guide tip152, guiding the first and second needles170,172towards first and second needle guides210,212, respectively. The needle guides210,212help to guide the needles170,172through the cuff receiving area154defined by the guide tip152.

The guide tip152also has first and second adapter receiving apertures214,216, located in the distal end152D of the guide tip152. The adapter receiving apertures214,216are configured to hold first and second suture adapters218,220, respectively. The suture adapters218,220may each be coupled to a different end of a suture222. The suture adapters218,220are designed to be engaged by the ends170E,172E of the first and second needles, respectively, such that the needles170,172, when contacting the adapters218,220will be able to pull the adapters218,220(and therefore, the ends of the suture222) back through the cuff receiving area. One non-limiting example of suitable adapters include ferrules into which the needle tips170E,172E may be pressed. For convenience, this specification will refer to the adapters218,220as ferrules. Similarly, the specification will also refer to the adapter receiving apertures214,216as ferrule holders, but it should be understood that the broader interpretations apply where the claims are concerned, unless otherwise specified.

The distal end152D of the guide tip152also defines first and second suture removal passages234,236which are in communication with the first and second ferrule holders214,216. The removal passages234,236allow the suture222which is coupled to the ferrules218,220to be routed out the distal end152D of the device after the ferrules218,220are placed into the ferrule holders214,216.

The ferrule receiving apertures214,216each have flared ends facing the cuff receiving area154. 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 needles170,172will be advanced, piercing the sewing cuff and continuing on to couple with the ferrules218,220before 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 apertures214,216, so the flared ends are helpful in preventing the sewing cuff material from becoming jammed between the needles170,172and their respective ferrule receiving apertures214,216.

This embodiment of a guide tip152also 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 tip152has a first proximal horizontal needle alignment guide224P adjacent the first needle guide210. Similarly, the guide tip152has a second proximal horizontal needle alignment guide226P adjacent the second needle guide212. The guide tip152also has a first distal horizontal needle alignment guide224D and a second distal horizontal needle alignment guide226D adjacent the first and second ferrule receiving apertures214,216, respectively. As a sewing cuff is moved horizontally in relation to these horizontal needle alignment guides224P,224D,226P,226D, the intended horizontal penetration location of the needle relative the cuff can be judged from the alignment guides.

The guide tip152also has a first proximal vertical needle alignment guide228P adjacent the first needle guide210. Similarly, the guide tip152has a second proximal vertical needle alignment guide230P adjacent the second needle guide212. The guide tip152also has a first distal vertical needle alignment guide228D and a second distal vertical needle alignment guide230D adjacent the first and second ferrule receiving apertures214,216, respectively. As a sewing cuff is moved vertically in relation to these vertical needle alignment guides228P,228D,230P,230D, the intended vertical penetration location of the needle relative the cuff can be judged from the alignment guides.

The guide tip152also has a left central alignment guide232L and a right central alignment guide232R which are located on a plane substantially central to the first and second ferrule holders214,216for further needle visualization.

FIG.6Bis a partially cross-sectioned side view of the prosthetic suturing device150ofFIG.1Bwith the needles170,172in a retracted position.FIG.6Ais a top view of the device150fromFIG.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 needles170,172are oriented in a horizontal row, but they are spiraled inside the device to be aligned to pass vertically into the cuff receiving area154. In the retracted position ofFIG.6B, the ends of the needles170,172are located just inside the guide tip152on the proximal side of the cuff receiving area154.

FIG.7Bis a partially cross-sectioned side view of the prosthetic suturing device150ofFIG.1B, with the ends of the needles170E,172E in a partially engaged position as they pass through the cuff-receiving area154.FIG.7Ais a top view of the device fromFIG.7B, hiding the handle, housing, spring, and hard stop in order to more clearly shown the proximal needle orientation. The handle160has been moved174toward the housing grip175, causing the needles170,172to be moved in a distal direction238.

FIG.8Bis a partially cross-sectioned side view of the prosthetic suturing device150ofFIG.1B, with the ends of the needles170E,172E in a fully engaged position and coupled to the suture ferrules218,220held in the distal end of the guide tip152.FIG.8Ais a top view of the device fromFIG.8B, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. The handle160has contacted the hard stop167to prevent the needles170E,172E from pressing too hard into the ferrules218,220.

FIG.9Bis a partially cross-sectioned side view of the prosthetic suturing device150ofFIG.1B, with the needles170,172partially retracted and pulling the suture ferrules218,220and suture222back through the cuff receiving area154.FIG.9Ais a top view of the device fromFIG.9B, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. The handle160has been partially released, and the spring164has caused the handle to move242away from the housing grip175, thereby causing the needles170,172to move in a proximal direction240.

FIG.10Bis a partially cross-sectioned side view of the prosthetic suturing device150ofFIG.1B, with the needles170,172fully retracted.FIG.10Ais a top view of the device fromFIG.10B, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. The position of the needles170,172inFIG.10Bis the position the needles170,172take when the user is not applying force to the handle160.FIG.10Cis an enlarged partial cross-sectional view of the guide tip152fromFIG.10B, showing the ferrules218,220coupled to the ends of the needles170E,172E being held distally to the ferrule removal spring182. The ferrule removal spring182has a first edge244which rides on the first needle170and which is positioned to push the ferrule218off of the first needle170if the needle170is moved more in a proximal direction. The ferrule removal spring182also has a second edge246which rides the second needle172and which is positioned to push the ferrule220off of the second needle172if the needle172is moved more in a proximal direction. As it stands in the view ofFIG.10C, however, the ferrules218,220are still coupled to their respective needle ends170E,172E. The suture222has been pulled through the cuff receiving area154on a path where the needles170,172had 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 suture222would have been pulled back through the sewing cuff in two locations (where the first and second needles170,172had passed).

The view ofFIG.10Calso offers a cross-sectional look at the first and second ferrule receiving apertures214,216. The flared end248of the first ferrule receiving aperture214and the flared end250of the second ferrule receiving aperture216can be seen more clearly in this view.

FIG.11Bis a partially cross-sectioned side view of the prosthetic suturing device150ofFIG.1B, with the needles170,172hyper-retracted.FIG.11Ais a top view of the device fromFIG.11B, hiding the handle, housing, spring, and hard stop in order to more clearly show the proximal needle orientation. InFIG.11B, the user has applied a force to the handle160in a direction away242from the grip175. The handle160may contact the handle stop166which can be designed to flex or give in order to allow the handle to move in this direction242. This causes the needles170,172to retract more than the normal resting state ofFIG.10Bin a proximal direction240.FIG.11Cis an enlarged partial cross-sectional view of the guide tip152fromFIG.11B, showing what happens when the needles170,172are hyper-retracted in this fashion. The ferrules218,220are decoupled from the ends of the needles170E,172E after having been pushed off of the needles170E,172E by the ferrule removal spring182. This allows the suture to be removed from the device150, 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.12is an exploded perspective view of another embodiment of a prosthetic suturing device251. 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 tube252, this one having a first straight track254and a second straight track256, is placed into a proximal end257P of shaft257. A guide tip152is placed into a distal end257D of the shaft257, and a notch258of the needle guide tube252is aligned with a key260of the guide tip152inside of the shaft257. A shaft holder262is coupled to grooves264of the shaft257.

A drive rod266has a ball end268on a proximal end of the drive rod266. The distal end of the drive rod266is coupled to a drive block270. The ball end268of the drive rod266is placed into a side opening272in the handle274, while the drive rod is pulled across a top slot276and down a forward slot278in the handle. A first needle280has an end280E configured to engage a suture adapter, such as a ferrule. The first needle280also has a proximal needle end280P. A second needle282has an end282E configured to engage a suture adapter such as a ferrule. The second needle282also has a proximal needle end282P. The second needle282is placed into the second straight track256of the needle guide tube252, end282E first. The ferrule release spring182may be placed into a slot in the top of the guide tip152and rested on the second needle282. The first needle280may then be placed into the first straight track254of the needle guide tube252, end280E first, so that the spring182is compressed between the two needles280,282as in previous embodiments.

A needle connector284has first and second connector holes286,288into which the proximal ends of the first and second needles280P,282P are placed, such that the proximal ends280P,282P are coupled to their respective connector holes286,288. The needle connector284is coupled to a connector receptacle290in the drive block270, completing the link between the needles280,282and the handle274.

The pivot point162of the handle274may be aligned in a pivot boss198formed in the housing158. The shaft holder262may be held and supported by a variety of features on the inside of the housing158. Such features are not illustrated for simplicity, but are well known to those skilled in the art. Although only one half of the housing158is 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 handle274and bracing of the shaft holder262.

The hard stop167may be mounted in a hard stop boss196to limit travel of the handle274, while a lower end200of spring164may be coupled to a fixed spring attachment point202on the housing. An upper end204of the spring164may be hooked onto a handle spring attachment point206.

FIG.13is a partially exposed side view of the prosthetic suturing device251ofFIG.12. When the handle274is squeezed292towards the grip175, the first and second needles280,282are moved distally through the cuff receiving area154in a manner as shown in the previous embodiments.

FIG.14is a perspective view of one embodiment of a guide tip152for a prosthetic suturing device. Most features of this embodiment of a guide tip152have been discussed above, however, this embodiment can also be seen to have first and second proximal needle guides294,296. These guides294,296work with the needle guides210,212(not visible in this view, but discussed previously) in order to help guide the needles280,282through the cuff receiving area while maintaining an expected vertical alignment and spacing between the needles280,282.

Depending on the embodiment, the needle guides294,296in the guide tip152may be used to force needles which start horizontally into a vertical alignment without the need for a needle guide tube.FIG.15illustrates just such an embodiment, and is a partially exposed partial cross-sectional perspective view of another embodiment of a prosthetic suturing device298, utilizing the guide tip ofFIG.14without a needle guide tube. The features of this embodiment are just like those of the embodiment ofFIG.1B, however, this device298does not use the a needle guide tube. Instead, the needles170,172start horizontally as held by the handle160, but are then twisted into vertical orientation by the guide tip152. 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.16is a partially exposed side view of a further embodiment of a prosthetic suturing device300. This embodiment only has a single needle302and a place for a corresponding ferrule holder in the guide tip304, but the cuff receiving area is still facing left while the handle160and grip175substantially point down (as in previous embodiments).

FIG.17is a partially exposed side view of another embodiment of a prosthetic suturing device306. In this embodiment, the guide tip308has a vertical opening (rather than a horizontal opening like previous embodiments) which defines a cuff receiving area. The needles170,172in this embodiment are aligned horizontally, and otherwise, this device operates like the previous embodiments.

FIGS.18A-18Fillustrate one example of a surgical usage of an embodiment of a prosthetic suturing device. For convenience, only the guide tip152of the device is shown inFIGS.18A-18F. The guide tip152is like that ofFIGS.4and5, and as noted in the examples above, there are many actuator examples which would result in the vertically aligned needles170,172illustrated here. The surgical situation of this example is as follows, and as illustrated inFIG.18A: In preparation for installation of a replacement anatomical structure312(here, illustrated as a replacement heart valve), a suture222has been sewn through a tissue315inside 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 ferrules218,220were removed from the minimally invasive suturing device and then loaded into the ferrule holders in the distal end of the guide tip152outside of the patient. The replacement anatomical structure312, having a sewing cuff314, is standing by.

As shown inFIG.18B, the sewing cuff314of the replacement valve312is placed316into the cuff receiving area154of the guide tip152. 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 valve312with the other hand. As shown inFIG.18C, the device handle (not shown) is squeezed to cause the needles170,172to move distally318, pierce the sewing cuff314, and then engage the ferrules218,220with respective ends170E,172E of the needles170,172. As shown in18D, the device handle (not shown) is released to cause the needle ends170E,172E to move proximally320back through the sewing cuff314, pulling the ferrules218,220and the suture222back through the sewing cuff as well. As shown inFIG.18E, the replacement anatomical structure312can be removed322from the from the cuff receiving area154while the ferrules218,220remain coupled to the needles170,172in the proximal end of the guide tip152. Although the suture222is still illustrated as passing through the ferrule holders in the distal end of the device, it should be understood that the suture222can be removed from the ferrule holders by passing it through the suture removal passages234,236. As shown inFIG.18F, the needles170,172may be further moved in a proximal direction324(as discussed above) so that the ferrules218,220are pushed off of the needles170,172by the ferrule removal spring182, thereby releasing the ferrules218,220to move free326of 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 cuff314. 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.

Various advantages of a prosthetic suturing device have been discussed above. Embodiments discussed herein have been described by way of example in this specification. It will be apparent to those skilled in the art that the forgoing detailed disclosure is intended to be presented by way of example only, and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and the scope of the claimed invention. Additionally, the recited order of processing elements or sequences, or the use of numbers, letters, or other designations therefore, is not intended to limit the claims to any order, except as may be specified in the claims. Accordingly, the invention is limited only by the following claims and equivalents thereto.