Patent Application
20090240266
1. Field of the Art
The present embodiments relate to devices and methods or occluding bodily vessels. More particularly, the embodiments relate to methods and devices for a vas-occlusive procedure, including a spring clip that permanently occludes the vas deferens.
2. Description of Related Art
The vasectomy is one of the most common male sterilization techniques, providing an effective long-term contraception method. Typically, in a vasectomy procedure the vas deferens, the vessel connecting the testicles to the prostate, is cut with the cut ends cauterized or sealed shut with suture or clips, typically with a portion of the vas being removed. While this procedure is highly effective for contraception, its results are permanent. The reversal of a vasectomy performed in this way is difficult requiring a microsurgical procedure to re-attach the severed ends of the vas deferens. Typically the reversal procedure cannot be performed endoscopically, which increases patient discomfort and recovery time. Moreover, the success rates of the reversal procedure are not very high—some patients never regain full functionality.
Other non-surgical methods and devices have been developed, such as the insertion of an intra-vas device that blocks or plugs the vas. For example, a device having a plug and a collar may be applied to a vessel such that when the plug is inserted into the lumen of the vas to block the vessel, a collar surrounds the vas to prevent it from dilating.
Another non-surgical method involves the occlusion of the vas deferens with a locking clip or clamp, whereby locking the clip or clamp effectively seals the vessel, blocking flow therethrough. The locking clip may be inserted and locked endoscopically.
The description herein of certain advantages of known devices and methods is not intended to limit the scope of the embodiments. Indeed, the embodiments may include some or all of devices and methods described above without suffering from the same disadvantages.
It is a feature of an embodiment to provide a vessel occlusion clip having a spring coil, a first leg, and a second leg. The spring coil has a first terminal end and a second terminal end. The first leg is joined on its proximal end with the first terminal end of the spring coil. The second leg is joined on its proximal end with the second terminal end of the spring coil. Each of the first and second legs comprises a vessel occlusion portion comprising an inner surface adapted to contact and occlude a vessel. The inner surface of each vessel occlusion portion has a proximal projection extending inward from the proximal end of the vessel occlusion portion, a distal projection extending inward from the distal end of the vessel occlusion portion, and a substantially planar central region disposed therebetween. The spring coil provides a torsional force that biases the first and second legs inward toward a closed position, in which at least a portion of the distal projections of the vessel occlusion portions of said first and second legs are in forced contact, and at least a portion of the proximal projections of the vessel occlusion portions of said first and second legs are in forced contact, forming a vessel occluding space between the substantially planar central regions of the vessel occlusion portions of said first and second legs.
It is another feature of an embodiment to provide an applicator for implanting an occlusion clip. The applicator has an applicator having a front end and a back end and a tapered applicator tip at the front end, having an opening therein. The applicator has a clip guide at least partially located within the applicator tip, and extending through the opening. The clip guide has a pivotally connected upper and lower guide jaws configured to pivot between an open and a closed position. The guide jaws each comprise a least one longitudinally extending groove adapted to slidingly engage a occlusion clip. The applicator also has a first pusher arm disposed within the housing that is adapted to move the clip guide jaws from the open position to the closed position by pushing on at least one of the upper guide jaw and the lower guide jaw. The applicator has a second pusher arm disposed within the housing, that is adapted to slide an occlusion clip forward in the longitudinally extending grooves of the clip guide. The applicator has an actuator that is adapted to be manipulated from the exterior of the applicator housing and moves between an initial position and a triggered position. The actuator is operably coupled with the first pusher arm and the second pusher arm. Manipulation of the actuator to the triggered position causes the first pusher arm to move the guide jaws from the open position to the closed position, and causes the second pusher arm to slide the occlusion clip forward along the longitudinally extending grooves until the clip is expelled from the clip guide.
It is yet another feature of an embodiment to provide a method for occluding a target vessel. The method involves providing an occlusion clip comprising a first leg, a second leg, and a spring coil joined to the proximal end of the first leg and the second leg. The first and second legs each has at its distal end a pair or laterally-extending clip guide projections. The method further includes providing a clip applicator for manipulating and implanting an occlusion clip about the target vessel. The clip applicator comprises a housing having an applicator tip and a clip guide located adjacent the applicator tip for receiving, manipulating and ejecting the occlusion clip. The clip guide has upper and lower jaws each configured for receiving a portion of the occlusion clip and for slidably engaging and guiding the at least one clip guide projection of either the first or second leg. The upper and lower jaws are pivotably connected for rotation between an open jaw position and a closed jaw position. The method further includes pre-loading the occlusion clip into the clip applicator so that each pair of laterally-extending clip guide projections is engaged by and seated within a corresponding one of said guide jaws and so that the spring and the proximal ends of the legs are oriented in a proximal direction relative to the clip applicator. With the upper and lower jaw guides in the open jaw position, the method comprises manipulating the clip applicator so that the upper and lower guide jaws of the clip guide surround a target vessel. The method also comprises causing the upper and lower jaws to move from the open jaw position to the closed jaw position to engage the target vessel and causing the occlusion clip to slide in a distal direction along the upper and lower jaws until the laterally extending clip guide projections drop out of the respective grooves of the upper and lower guide jaws. This allows the clip to close about the target vessel.
These and other objects, features, and advantages of the present invention will appear more fully from the following description of the exemplary embodiments of the invention.
The present invention, together with further objects and advantages, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, in the several Figures of which like reference numerals identify like elements, and in which:
These and other objects, features and advantages will appear more fully from the following detailed description of the preferred embodiments.
Various embodiments described herein provide devices and methods for temporarily or permanently occluding bodily vessels, such as the vas deferens. For purposes of clarity and illustration only, the present embodiments generally are described in relation to vasectomy clips and clip application devices. It should be appreciated, however, that the devices and methods described herein are not limited to these specific embodiments and details, which are exemplary only. It is further understood that one possessing ordinary skill in the art, in like devices and methods, would appreciate the use of the invention for its intended purposes and benefits in any number of alternative embodiments, depending on specific design and other needs.
The embodiments will now be described more fully with reference to the accompanying drawings in which some, but not all, embodiments are illustrated.
With reference to
As shown in
The clip preferably is designed to provide a compressive but non-scissoring action to the occluded vessel. As shown in the Figures, spring ends 112 and 114 extend from opposite sides of the spring coil, so that the distance in the transverse direction between spring ends 112 and 114 is roughly equivalent to the width of the spring coil. Consequently, spring connector portions 122 and 142, which are joined to and extend from the spring ends, are laterally spaced at a distance roughly equivalent to the width of the spring coil, each being laterally spaced from the longitudinal centerline of the clip. Spring connector portions 122 and 124 also are vertically spaced at a distance roughly equivalent to the height of the spring coil.
Each spring connector portion 122 and 142 is joined on its distal end to a respective vessel occlusion portions 124 or 144. Vessel occlusion portion 124 is defined in part by an inner tissue contact surface 126 and an outer surface 128, which are connected by side surfaces 125. Likewise, vessel occlusion portion 144 is defined in part by an inner tissue contact surface 146 and an outer surface 148, connected by side surfaces 145. Each of inner tissue contact surfaces 126 and 146 generally is defined by a generally planar central surface (127, 147), an inward extending projection near the proximal end (132, 152) and inward extending projection near the distal end (136, 156). As illustrated in the Figures, the inward extending projections 132, 152, 136, 156 have a tapered configuration but it is understood that projections 132, 152, 136, 156 may have any shape suitable for the exemplary embodiments described herein. Preferably, the surfaces, edges, and corners of vessel occlusion portions 124 and 144 have radiused contours so as not to provide a sharp edge that may sever the occluded vessel, or other tissue.
When the clip 100 is in its closed position, opposed inner tissue contact surfaces 126 and 146 are brought together in an opposed facing relationship, wherein at least a portion of opposed inner tissue contact surfaces 126 and 146 forcibly abut. Preferably, when the clip is in the closed position, the inner tissue contact surfaces 126 and 146 have substantially the same transverse and longitudinal dimensions, and their respective transverse and longitudinal axes are aligned. With the inner tissue contact surfaces 126, 146 in an aligned configuration, the closed clip exerts a compressive rather than shearing or scissoring force on the occluded vessel.
To prevent the first or second leg from shifting in a transverse direction under the torsional closure force provided by the spring, a transverse alignment mechanism may be provided. For example, one or more transverse alignment elements may be provided on the distal edges of vessel occlusion portions 124 or 144, to ensure that opposed vessel occlusion portions of the first leg 120 and second leg 140 remain aligned when the clip is in a closed position. As shown in the embodiment illustrated in
The longitudinal dimension of the inner tissue contact surfaces must be at least large enough that the entire width of the occluded vessel fits between the proximal and distal edges. The overall shape and area of the inner tissue contact surfaces should be designed to optimize the size and stability of the clip and the pressure it exerts on the vessel. One of ordinary skill in the art, guided by the teachings herein, would be able to specify dimensions for the inner surface contact areas so that the clip is suitable for its intended purpose. For example by increasing the area of the inner tissue contact surfaces increases, the pressure exerted by the clip at any given point decreases.
When clip 100 is brought to its closed position, a portion of opposed inner tissue contact surfaces 126, 146 forcibly abut. Preferably, at least a portion of the respective proximal edges (132, 152) and distal edges (134, 154) of opposed inner tissue contact surfaces (126, 146) forcibly abut, leaving a void between the convex central portions of opposed inner tissue contact surfaces. The void between the opposed inner tissue contact surfaces defines a vessel occlusion space, as shown in
Preferably, at least of the inner tissue contacting surfaces has at least one longitudinally extending ridge. In the embodiment shown in
The spring 110 provides a biased torsional force to legs 120 and 140, forcing them to a closed position. Spring 110 should provide sufficient force to close the clip 100 and occlude the vessel contained therein. One of ordinary skill in the art would appreciate that if spring 110 provides insufficient closure force, then the clip 100 cannot fully occlude the target vessel, which renders the clip ineffective for sterilization purposes.
The force that spring 100 provides to clip 100 is critical to the functionality of the clip. Preferably spring 110 provides from about 0.5 pounds force to about 1.0 pounds force between legs 120 and 140. In addition to closure force, the spring 110 should have sufficient resistance and durability that it will not allow clip 100 to open under normal in vivo conditions. Once implanted, clip 100 is intended to permanently occlude the target vessel throughout the life of the clip 110. If the tissue of the vessel wall changes due to necrosis and peristalsis and the like, spring 110 and clip 100 should continue to maintain occlusion of the vessel. Spring 110 also should be sufficiently flexible to enable the clip 100 to be opened with minimal spring stress so that it may be applied to the vessel with force.
One of ordinary skill in the art, guided by the teachings provided herein, would understand how to design or specify a spring coil suitable for the clip, having the physical properties described herein. For example, one or more of the following parameters may affect the strength and durability of the spring material of the spring coil; number of coil wraps within the spring coil; thickness (gauge) of the coil material; relative angle of the terminal ends of the spring coil. The spring may be constructed of any material suitable for human implantation and capable of providing the other properties mentioned herein. Suitable materials include metals, polymers, ceramics, and the like, or combinations or composites thereof. Preferably, the spring is made of a metal such as tantalum, titanium, stainless steel, or an alloy thereof. More preferably the spring is made of titanium.
Preferably, the configuration of the spring coil of the clips has an advantage of eliminating the need for a latch or hinge while assuring that the torsional closure force does not decrease as the vessel shrinks after application. Preferably, the clip 100 is configured so that when legs 120, 140 are separated, the diameter of the spring coil 110 increases, which decreases the biasing torsional closure force of the spring 110. Conversely, when legs 120, 140 are released so as to return to the closed position, the diameter of the spring 110 decreases, and the biased torsional closure force exerted by spring 110 increases. Thus, the closure force exerted by legs 120 and 140 on a vessel occluded between the legs increases as the legs 120 and 140 approach each other. Where a vessel is occluded by legs 120 and 140, and the vessel becomes smaller because of a reduction in swelling, necrosis, or peristalsis the pressure exerted by the clip 100 on the vessel increases or nominally decreases, maintaining full occlusion on the vessel.
Spring connecting portions 122, 142, should provide sufficient strength, stiffness and resistance to maintain the clip 100 in a closed position for the life of the clip. The spring connecting portions may be made of any material suitable for human implantation and capable of providing the other properties mentioned herein. Suitable materials include metals, polymers, ceramics, and the like, or combinations or composites thereof. The spring connecting portions may be made of the same or different material than the spring. Preferably, the spring connecting portions are made of a metal such as tantalum, titanium, stainless steel, or an alloy thereof. More preferably the spring connecting portions are made of titanium.
Spring connecting portions 122, 142 may be joined to the respective spring ends 112, 114 in any suitable fashion. For example, the spring connecting portion and spring may be joined together by chemical bonding or welding. Alternatively, spring connecting portions and spring may be formed as a single part, with the spring connecting portions extending from the spring coil.
Vessel occlusion portions 124 and 144 may be constructed of any material suitable for human implantation and capable of providing the other properties provided herein. Suitable materials include metals, polymers, ceramics, and the like, or combinations or composites thereof. Preferably, the vessel occlusion portions are constructed of an implantable grade plastic. Vessel occlusion portions 124, 144, may be joined to the respective spring connecting portions 122, 142, in any suitable fashion. Alternatively, the vessel occlusion portion and the spring connecting portion may be constructed as a single part. In one embodiment, vessel occlusion portions 124, 144, are constructed of an implantable grade plastic that is overmolded to the spring connecting portions.
While the purpose of clip 100 is to be implanted into a body, and to occlude a target vessel, such as the vas deferens, various embodiments provide a clip applicator to enable a user (such as a surgeon) to implant the clip, and to attach it about a target vessel to occlude the vessel. As described above, clip 100 is configured so that its initial state it is in the closed position with spring 110 producing a positive closure force against first leg 120 and second leg 140. Therefore, the clip applicator must be configured to overcome the spring force of clip 100, to open the clip to create sufficient space between legs 120 and to receive the target vessel. Preferably, the clip applicator also provides a useful tool for enabling the user to guide the clip 100 to a position in which it can surround the target vessel. Preferably, the applicator provides a mechanism for releasing the clip 100 so that it successfully closes about the target vessel to occlude it.
With reference to
An actuator illustrated in the Figures as slide button 220) is provided on the external surface of the housing 210. The actuator may be manipulated by the user to perform one or more designated functions. An suitable actuator device may be used for this purpose, including mechanical or electrical actuators such as push buttons, slide buttons, triggers, and other like devices. One of ordinary skill in the art, guided by the teachings herein, would understand how to specify an actuator suitable for this device. In certain embodiments, more than one actuator may be provided, each actuator performing designated functions. In
At one end of the applicator 200 is an applicator tip 230, having an opening 232, from which clip 100 is manipulated and ejected. Preferably, the housing 210 tapers around the applicator tip 230 toward opening 232 so that the tip and opening have a smaller diameter than the rest of the applicator. Preferably, the size or diameter of the tip 230 and opening 232 are small enough to provide good visibility to the user, so that they can see the tip 230 and clip 100, and call guide it into place. Projecting from opening 232 are two leg guides 234 and 236. The leg guides are intended to open and close the legs 120, 140 of clip 100 so that it may be properly implanted. The first leg guide 234 is configured to hold and guide the first leg 120 of clip 100. The second leg guide 236 is configured to hold and guide the second leg 140 of clip 100. First and second leg guides 234 and 236 are pivotally connected so that they open and close in a jaw-like fashion. The proximal edges of guides 234 and 236 re attached to pivot 238, while distal edges of guides 234 and 236 move about the pivot 238 axis. In the embodiment illustrated in
As discussed above, and illustrated in
The grooves 235a, 235b and 237a, 237b extend at least a portion of the length of respective leg guides 234 and 236. Each groove is defined on the inner surface of the leg guide by a lip or rail which helps to keep the side projections seated within the leg guide during applicator operation. The grooves provide a means for seating and securing the clip 100 within the applicator tip 230 during use of the applicator 200, and also provide a means for manipulating legs 120, 140 of the clip in the longitudinal and vertical direction so that the clip may be opened, closed, and ejected. For example, side projections may ride forward and back in the longitudinal direction of the groove to enable the clip to be seated and ejected; legs 120 and 140 may be opened or closed when the leg guides 234 and 236 are opened or closed and the grooves exert an opening or closing force against the side projections.
Anchor spring 226 is attached on a first end to the slide button carriage 224 and on a second end, to an anchor post 212 that is connected to the housing 210. The anchor spring 226 is a biased spring that exerts a retractive force on the slide button carriage 224, to keep the slide button 220 in a retracted position in the slide button groove 222 when no other forces are applied to the slide button 220. When a user pushes on the slide button 220 with enough force to overcome the retractive force of the anchor spring 226, the slide button 220 moves forward in groove 222, and slide button carriage 224 moves forward in the housing.
The slide button carriage 224 is operably connected to other mechanisms in the housing, to perform certain functions when the slide button 220 moves forward or backward. In the embodiment of
First pusher arm mechanism 240 performs the function of forcing first leg guide 234 about its pivot from an opened position (shown in
Second pusher arm mechanism 250 performs the function of pushing the clip 100 longitudinally within the applicator 200, and eventually ejecting clip 100 from the tip of the applicator 200. Second pusher arm mechanism 250 has arm 252 that extends in the longitudinal direction of the applicator 200, and is joined on one end to slider button carriage 244. The opposite end of arm 252 terminates with a cradle 254 that is adapted to push on the spring end of clip 100, and move it in longitudinal direction, corresponding to the action of 252. Ultimately, when slide button carriage 224 is substantially in its fully forward position, the arm 252 and cradle 254 eject the clip 100 from the applicator tip 230. Preferably, the second pusher arm mechanism 250 is configured so that it does not engage clip 100 until after the first pusher arm mechanism 240 has started to close first leg guide 234, and even more preferably the second pusher arm mechanism 250 is configured so that it does not engage clip 100 until after the first pusher arm mechanism has fully closed first leg guide 234. Once the cradle 254 engages the spring end of clip 100, it pushes it in the longitudinal direction. As it is being pushed, the side projections 130 and 150 slide forward within the respective grooves 235a, 235b, 237a and 237b in the leg guides 234 and 236. The proximal end of each of the grooves is open, so that when the side projections are forced beyond the proximal end, they slide out of the grooves, and the clip is released from the guides and ejected from the tip. Once the clip 100 is fully ejected from applicator 200, the spring action of the clip 100 keeps the clip in its fully closed position.
In the embodiment described above, the actuator provides a two-stage action. As slide button 220 (the actuator) moves forward, the first pusher arm mechanism 240 engages the first leg guide 134, closing it about pivot 238, which closes clip 100. Then, as the slide button 220 continues to move forward, the second pusher arm mechanism 250 engages the spring end of clip 100 and pushes it forward in the leg guides, until it is ejected from the applicator.
In other embodiments, the actuator may trigger alternative, or additional functions. For example, certain embodiments provide a means for retracting the leg guides (or other equivalent devices) may retract away, from the clip and occluded vessel during the ejection process. Other embodiments provide additional means for assisting the user in isolating and manipulating the target vessel into the proper location of the clip. One of ordinary skill in the art, guided by the teachings herein, would understand how to use the applicator to perform such alternative or additional functions to improve the capability of the applicator.
The applicator 200, and its various components may be formed from any material suitable for use as described herein. Because the applicator will be used in a medical procedure, the materials should be capable of sterilization. Many of the parts will beneficially be constructed of a moldable material, such as a polymer, so that the various contours and features may be provided in the mold design, rather than separately attached.
The applicator and clip described above are useful in medical procedures requiring permanent occlusion of a vessel. One exemplary procedure is a vasectomy procedure, in which the vas deferens vessels are targeted for occlusion. In an exemplary embodiment, a user such as a surgeon, may occlude a vas deferens vessel using the applicator 200 and clip 100. In this embodiment, one or more applicators 200 may be provided to the user for the procedure. Preferably the one or more applicators 200 are provided to the user in a sterilized condition. Preferably, the one or more applicators are provided to the user with a clip 100 reloaded, such that the side projections 130 and 150 of clip legs 120, 140, are seated in the grooves 235a, 235b, 237a, 237b of respective leg guides 234, 236. The clip 100 may be pre-loaded in an open position, or in a closed position. If the clip 100 is provided in the closed position, then the applicator must have a means, such as an actuator, for opening the clip 100. The opened clip 100 should be configured in the applicator 200 so that the opened end of the clip faces outward, providing a region for receiving the target vessel.
In alternative embodiments, the applicator 200 may be provided to the user without a loaded clip, so that the user must load a clip. In such instances, the user may require training as to how to load the clip. One or more additional clip loading devices may be provided to assist the user in loading the clip into the applicator. However, the consistency may be improved where the clip is preloaded in the applicator 200 for the user. In other embodiments, the applicator 200 may be adapted to be preloaded with multiple clips, such as a cartridge of clips. However, because this applicator is designed to be used in a sterile medical procedure, it is preferred that a single-use applicator be provided to the user with one pre-loaded clip.
The user may prepare the region for implantation using any suitable means. Once the target vessel is located and is made accessible to the user, then the applicator 200 may be used to implant or attach the clip 100 the target vessel. The user may isolate the target vessel, and manipulate the vessel and the applicator 200, to place the vessel between the legs 120, 140 of open clip 100, so that the vessel lies in a transverse direction across the vessel occlusion portions 122, 142 of the legs, with the entire cross section of the vessel contained within this region. Once the user has managed to manipulate the vessel into this location, the user pushes the slide button actuator 220 forward, activating the first pusher arm mechanism 240, which closes first guide leg 234 about its pivot 238, as described in more detail above. Once the slide button actuator 220 is pushed far enough forward, the first guide leg 234 fully closes, and the clip 100 closes about the vessel, occluding the vessel.
The user will then continue to push the slide button actuator 220 forward, activating the second pusher arm mechanism 250, which pushes the clip 100 in the longitudinal direction toward and out of the applicator tip 230. During this longitudinal movement, the side projections 130 and 150 of clip 100 glide along corresponding grooves 235a, 235b, 237a, 237b in the leg guides 234, 236. Once the slide button actuator 220 is pushed far enough forward, the side projections drop out of their respective grooves, so that the clip 100 is ejected from the applicator 200. At this point, the clip 100 is in a fully closed position, occluding the target vessel.
Once used, the applicator 200 may be disposable, or may be reusable. For example, in an embodiment in which applicator 200 is reusable, applicator 200 may be returned to the manufacturer or distributor so that it may be sterilized, preloaded, and packaged so that it may be reused. Preferably, the applicator 200 is made disposable.
While clip 100 is intended to provide permanent occlusion of a vessel, preferably clip 100 may be removed from the vessel, enabling fluid communication through the vessel. To remove the clip 100, a user must apply an opening force to legs 120, 140, that is sufficient to overcome the closing force provided by spring 110. The user may use a device similar to clip applicator 200 to remove the clip. Preferably a clip removal device is configured to open legs 120, 140, such as by attaching to side projections 130 and 150, and applying a force to the projections to open the legs.
The embodiments of the present inventions are not to be limited in scope by the specific embodiments described herein. Various modifications are intended to fall within the scope of the following appended claims. Further, although some of the embodiments of the present invention have been described herein in the context of a particular implementation in a particular environment for a particular purpose, those of ordinary skill in the art should recognize that its usefulness is not limited thereto and that the embodiments of the present inventions can be beneficially implemented in any number of environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the embodiments of the present inventions as disclosed herein. While the foregoing description includes many details and specificities, it is to be understood that these have been included for purposes of explanation only, and are not to be interpreted as limitations of the invention. Many modifications to the embodiments described above can be made without departing from the spirit and scope of the invention.
