US20230035295A1 - Systems and methods for closing portions of body tissue - Google Patents

Abstract

A system for closing a blood vessel includes a housing having a proximal end and a distal end and configured to be held in the hand of a user, an elongate body extending from the distal end of the housing, a distal housing having a proximal end coupled to a distal end of the elongate body and having a cavity including an opening on a side of the distal housing, a lumen passing through the elongate body and terminating at the cavity of the distal housing and configured to couple to a vacuum source, a sensor carried by the distal housing adjacent the cavity and configured for identifying a blood vessel, wherein the lumen is configured to maintain a vacuum within the cavity when a probe having a vessel closure module is inserted within the lumen and the vessel closure module is within the cavity.

Description

• This application is a continuation of U.S. patent application Ser. No. 15/898,616, filed on Feb. 18, 2018, which claims the benefit of priority to U.S. Provisional Application No. 62/460,837, filed on Feb. 19, 2017, both of which are incorporated by reference in their entirety herein for all purposes. Priority is claimed pursuant to 35 U.S.C. § 120 and 35 U.S.C. § 119.
BACKGROUND OF THE INVENTIONField of the Invention
• The field of the invention generally relates to a system for closing or modifying tissue in the body of a subject. Such tissue may include one or more blood vessels, such as a hemorrhoidal artery. More particularly, the present invention relates to methods and apparatus to treat hemorrhoids without subjecting patients to pain, or with minimal pain.
Description of the Related Art
• Currently, several medical conditions require that a section of tissue be closed or ligated at a portion internal to the body of a subject. The location of the tissue may be within a naturally occurring duct, cavity, organ, or vessel of the body, or may be within an opening created in a surgical procedure.
SUMMARY OF THE INVENTION
• In one embodiment of the present disclosure, a system for closing a blood vessel includes a housing having a proximal end and a distal end and configured to be held in the hand of a user, an elongate body extending from the distal end of the housing and configured for insertion into the rectum of a subject, a distal housing having a proximal end coupled to a distal end of the elongate body, and having a cavity communicating with an opening on a side of the distal housing, a lumen extending through the elongate body and communicating with the cavity of the distal housing, the lumen configured to couple to a vacuum source, a sensor carried by the distal housing at or adjacent the cavity and configured for identifying a blood vessel, and wherein the lumen is configured to allow the insertion and removal of a probe having a distally-located vessel closure module, and wherein the lumen is configured to maintain a vacuum within the cavity when the probe is within the lumen with the vessel closure module within the cavity.
• In another embodiment of the present disclosure, a method for closing a blood vessel includes the steps of providing a system for closing a blood vessel including a housing having a proximal end and a distal end and configured to be held in the hand of a user, an elongate body extending from the distal end of the housing and configured for insertion into the rectum of a subject, a distal housing having a proximal end coupled to a distal end of the elongate body, and having a cavity therein, the cavity communicating with an opening on a side of the distal housing, a lumen extending through the elongate body and communicating with the cavity of the distal housing, the lumen configured to couple to a vacuum source, a sensor carried by the distal housing at or adjacent the cavity and configured for identifying a blood vessel, and wherein the lumen is further configured to allow the insertion and removal of a probe having a distally-located vessel closure module, and wherein the lumen is configured to maintain a vacuum within the cavity when the probe is within the lumen with the vessel closure module within the cavity, placing the distal housing within a internal structure of a subject, identifying at least partially with the sensor a blood vessel to be closed, inserting a first probe having a first vessel closure module into the lumen such that the first vessel closure module is at least partially within the cavity, coupling a vacuum source to the lumen, such that at least a portion of the blood vessel is pulled into the cavity, and at least partially closing the blood vessel with the first vessel closure module.
• In still another embodiment of the present disclosure, a system for closing a blood vessel includes a clip having a first jaw and a second jaw, the first and second jaws configured to be movable with respect to each other between a closed state and an open state, each of the first and second jaws including a proximal end and a distal end, and having an aperture carried thereon and a first guiding feature at or adjacent the proximal end, wherein the clip is biased in the closed state, an elongate body configured for insertion adjacent a blood vessel within a subject, first and second pins, each pin having a first end coupled to the body and a free second end, the second end of the first pin and the second end of the second pin separated by a distance d₂, wherein the aperture of the first jaw of the clip is configured to be slidably carried by at least the second end of the first pin and the aperture of the second jaw of the clip is configured to be slidably carried by at least the second end of the second pin, such that the clip is held in its open state, second and third guiding features carried by the body, the second guiding feature configured to interface with the first guiding feature of the first jaw of the clip and the third guiding feature configured to interface with the first guiding feature of the second jaw of the clip, and a displacement element movably coupled to the body and configured to change the relative displacement between the clip and the first and second pins in a first direction, so as to cause the aperture of the first jaw to disassociate with the second end of the first pin and the aperture of the second jaw to disassociate with the second end of the second pin allowing the clip to move towards its closed state, wherein movement of the clip towards its closed state causes the first guiding features of the first and second jaws to interface with the second and third guiding features to move the clip in relation to the body in a second direction different from the first direction.
• In yet another embodiment of the present disclosure, a system for closing a blood vessel includes a clip having a first jaw and a second jaw, the first and second jaws configured to be movable with respect to each other between a closed state and an open state, each of the first and second jaws including a proximal end and a distal end, and having an aperture carried thereon and a first guiding feature at or adjacent the proximal end, wherein the clip is biased in the closed state, an elongate body configured for insertion adjacent a blood vessel within a subject, first and second pins, each pin having a first end coupled to the body and a free second end, the second end of the first pin and the second end of the second pin separated by a distance d₂, wherein the aperture of the first jaw of the clip is configured to be slidably carried by at least the second end of the first pin and the aperture of the second jaw of the clip is configured to be slidably carried by at least the second end of the second pin, such that the clip is held in its open state, second and third guiding features carried by the body, the second guiding feature configured to interface with the first guiding feature of the first jaw of the clip and the third guiding feature configured to interface with the first guiding feature of the second jaw of the clip, and a displacement element movably coupled to the body and configured to change the relative displacement between the clip and the first and second pins in a first direction, so as to cause the aperture of the first jaw to disassociate with the second end of the first pin and the aperture of the second jaw to disassociate with the second end of the second pin allowing the clip to move towards its closed state, wherein movement of the clip towards its closed state is at least temporarily controlled by the interface between the second and third guiding features with the first guiding features of the first and second jaws, such that a distance between the distal ends of the first and second jaws decreases at a faster rate than a distance between the proximal ends of the first and second jaws.
• In still another embodiment of the present disclosure, a system for closing a blood vessel includes a housing having a proximal end and a distal end and configured to be held in the hand of a user, an elongate body extending from the distal end of the housing and configured for insertion adjacent a blood vessel within a subject, a distal housing having a proximal end coupled to a distal end of the elongate body, and having a cavity contained therein, the cavity including an opening on a side of the distal housing, a lumen passing through the elongate body and terminating at the cavity of the distal housing, the lumen configured to couple to a vacuum source, a sensor carried by the distal housing adjacent the cavity and configured for identifying a blood vessel, and wherein the lumen is configured to allow the insertion and removal of a probe having a vessel closure module carried at its distal end, and wherein the lumen is configured to maintain a vacuum within the cavity when the probe is within the lumen and the vessel closure module is within the cavity.
• In yet another embodiment of the present disclosure, a method for closing a blood vessel includes providing a system including a housing having a proximal end and a distal end and configured to be held in the hand of a user, an elongate body extending from the distal end of the housing and configured for insertion adjacent a blood vessel within a subject, a distal housing having a proximal end coupled to a distal end of the elongate body, and having a cavity contained therein, the cavity including an opening on a side of the distal housing, a lumen passing through the elongate body and terminating at the cavity of the distal housing, the lumen configured to couple to a vacuum source, wherein the lumen is configured to allow the insertion and removal of a probe having a vessel closure module carried at its distal end, and wherein the lumen is configured to maintain a vacuum within the cavity when the probe is within the lumen and the vessel closure module is within the cavity, and a sensor carried by the distal housing adjacent the cavity and configured for identifying a blood vessel, placing the distal housing within an internal structure of a subject, identifying at least partially with the sensor a blood vessel to be closed, inserting a first probe having a first vessel closure module into the lumen such that the first vessel closure module is at least partially within the cavity, coupling a vacuum source to the lumen, such that at least a portion of the blood vessel is pulled into the cavity, and at least partially closing the blood vessel with the first vessel closure module.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG.1 is a perspective view of a clip application system according to an embodiment of the disclosure.
• FIG.2 is a detail view of the interior of a distal housing of the clip application system.
• FIG.3A is a perspective view of a clip according to an embodiment of the disclosure.
• FIG.3B is a perspective view of the clip ofFIG.3A applied to tissue of a patient to close a hemorrhoidal artery.
• FIG.4 is a block diagram of a clip application system according to an embodiment of the disclosure.
• FIG.5 is a view of the distal end of the clip application system.
• FIG.6 is a sectional view of the clip application system ofFIG.5, taken along line6-6.
• FIG.7 is a detail view of the clip application system ofFIG.6, withincircular area7.
• FIG.8 is a detail view of the clip application system ofFIG.6, withinoval area8.
• FIG.9 is an exploded view of a blocking member within a distal end of the distal housing of the clip application system.
• FIG.10A is a perspective view of a locking element of the clip application system in a first position according to an embodiment of the disclosure.
• FIG.10B is a perspective view of the locking element in a second position.
• FIG.11 is a sectional view of the distal housing of the clip application system prior to actuating a clip.
• FIG.12 is a sectional view of the distal housing of the clip application system upon actuating a clip.
• FIG.13 is a cross-sectional view of the distal housing of the clip application system showing the location of the distal clip prior to actuating the distal clip.
• FIG.14 is an isolated view of the distal clip in relation to guiding features, according to an embodiment of the disclosure.
• FIG.15 is an elevation view of a system for closing a blood vessel according to an embodiment of the disclosure.
• FIG.16 is an elevation view of the system ofFIG.15 in use.
• FIG.17 is an elevation view of a system for closing a blood vessel according to an embodiment of the disclosure.
• FIG.18 is an elevation view of the system ofFIG.17 in use.
• FIG.19 is an elevation view of a system for closing a blood vessel according to an embodiment of the disclosure.
• FIG.20 is an elevation view of the system ofFIG.19 in use.
• FIG.21 is a flow chart of a method for closing a blood vessel according to an embodiment of the disclosure.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
• The present invention relates to a system for closing or modifying tissue in the body of a subject. The system may be configured for applying one or more clips to tissue in the body of a subject. The system may alternatively be configured to incorporate other modes for closing the tissue of the patient, which do not include clips. The system may be configured to close a blood vessel, such as a hemorrhoidal artery, and may include one or more sensors for identifying the blood vessel. The one or more sensors may include ultrasound sensors configured to use Doppler sensing. The system may include the controlled application of a vacuum to pull tissue into a distal housing, so that one or more clips may be applied to the tissue.
• FIG.1 illustrates aclip application system100 according to an embodiment of the disclosure. Theclip application system100 includes ahousing102 which is coupled to adistal housing104 via atubular shaft106. Thedistal housing104 has adistal end108 and aproximal end110, and thetubular shaft106 has adistal end112 and aproximal end114. Thehousing102 also has adistal end116 and aproximal end118. Thedistal end112 of thetubular shaft106 is coupled to theproximal end110 of thedistal housing104 and theproximal end114 of thetubular shaft106 is coupled to thedistal end116 of thehousing102. Thedistal housing104 is configured to be placed within a natural or artificial opening, duct, cavity, vessel, or organ of the body of a subject, for example, a patient. Thedistal housing104 is in some embodiments configured to be inserted into the anus and rectum of a subject, for placement adjacent a blood vessel, such as a hemorrhoidal artery. Thehousing102 is configured to be gripped by one or both hands of an operator or user. In some embodiments, thehousing102 may be gripped by a first hand of the user and atransverse extension120 may be gripped by the second hand of the user, thus allowing controlled rotation of thehousing102,tubular shaft106, anddistal housing104. In other embodiments, as described further herein, thetubular shaft106 anddistal housing104 may be rotated in relation to thehousing102. Either way, thetransverse extension120 may comprise a transverse or partially transverse rod, and may be used as a visual indicator of the rotational orientation status of thedistal housing104 in relation to a particular portion of tissue. One ormore depth markings122 may be printed, cut, etched or otherwise placed on thetubular shaft106, in order to serve as a visual depth indicator. Thedepth markings122 may be used to determine or estimate the inserted depth of thedistal housing104 within the body of the subject.
• FIG.2 illustrates anunderside126 of thedistal housing104, which includes acavity124 configured to engage tissue via a vacuum pathway, which will be described later. For the application of vacuum, a tubing128 (FIG.1) extends from thehousing102 and is coupled to aconnector130, which in turn is configured to be coupled to a vacuum source. Avacuum button132 is carried on thehousing102 and may be operated by the hand of the user (e.g., by the thumb) in order to selectively apply a vacuum. One ormore clips134a-dare carried by thedistal housing104, and are deliverable therefrom. Twoultrasound Doppler sensors136,138, carried within thecavity124, are shown inFIG.2, but any number of sensors may be used, including one, two, three, or more. In an alternative embodiment, theDoppler sensor136,138 may be replaced by other types of sensors, including infra-red, near infra-red, optical coherence tomography (OCT), or optical fiber imaging. Afirst Doppler sensor136 is shown oriented toward theunderside126 of thedistal housing104. ThisDoppler sensor136 may be used, for example, to locate an artery to close with one or more of theclips134a-d. Asecond Doppler sensor138 is shown oriented towards the interior of thecavity124, and may be used to judge the effect of clip placement over a tissue mass that has been pulled into thecavity124. Thesecond Doppler sensor138 may also be used to determine whether a blood vessel, such as an artery, has been successfully closed by the one ormore clips134a-d. Returning toFIG.1, atrigger140 is movably coupled to thehousing102 and is configured to deliver the one ormore clips134a-d. In some embodiments, thevacuum button132 is coupled to thetrigger140. For example, thetrigger140 may be configured to not function when thevacuum button132 is not depressed, and to function only when thevacuum button132 is depressed. As another example, thevacuum button132 may unlock a locking feature (of the trigger140) when thevacuum button132 is depressed.
• Aclip134 is illustrated in a substantially closed state inFIG.3A and in a partially closed state inFIG.3B. Theclip134 comprises a base142 having aproximal portion144 and two opposingjaws146,148. In some embodiments, theclip134 comprises a base142 that comprises a metallic material configured to provide a biasing force. The metallic material may comprise a superelastic or shape-memory material such as a nickel titanium alloy (Nitinol). Thebase142 includesends150 having locking features152, which may comprise a bent or curved end, as shown, or in alternative embodiments, an otherwise enlarged end (ball, bead, cap, etc.). The locking features152 are configured to snap withinrespective snap cavities154. Thelocking feature152 may permanently snap into the snap cavity154 (i.e., not be removable) or may releasably snap into thesnap cavity154. Eachjaw146,148 has aproximal end156 and adistal end158. The base142 may be biased in a manner such that theclip134 is in a normally substantially closed state or condition, as inFIG.3A, such that when it is delivered over tissue, it is self-closing. Theclip134 is shown inFIG.3B compressing tissue160 so as to close thelumen166 of ahemorrhoidal artery162 at anocclusion region164. In some embodiments, the distal ends158 of thejaws146,148 include teeth168a-c, which may be configured to engage each other when the clip is in a substantially closed state (FIG.3A). For example,tooth168cmay be configured to fit within agap170 betweenteeth168aand168b. As seen inFIG.3B, when theclip134 is in the partially closed state or condition, thetooth168cmay not fully engage with theteeth168a,168b, but the teeth168a-cmay still serve to engage thetissue160, for example, to steady or secure theclip134 and maintain it in place.Arms172 extending from theproximal portion144 of the base142 toward theends150 may at least partially be guided or encased withinchannels174 in thejaws146,148. Theproximal end156 of eachjaw146,148 may include guidingfeatures176, which will be described in more detail herein.Apertures178,180 in thejaws146,148 are also shown inFIGS.3A and3B, and will described in more detail herein. Theapertures178,180 may comprise holes, grooves, slits, cavities, channels, or other features, substantially extending between afirst side182 and asecond side184 of eachjaw146,148. Theapertures178,180 may comprise holes which extend through thejaws146,148, as shown inFIGS.3A and3B, or may instead extend along an internal or external exterior of thejaws146,148. Thejaws146,148 may be formed of a large number of different metallic or polymeric materials, including stainless steel, nitinol, nylon, ABS or polycarbonate.Apertures180 and/or178 may be configured to allow releasable engagement with a loading tool (not shown), which is configured to load one or more of theclips134 in to thedistal housing104. The loading tool may be a hand-held device which is configured to releasably carry one or more of theclips134.
• Returning toFIG.2, theclips134a-dare shown within thecavity124 of thedistal housing104 in a forced-open state. Theclip application system100 is configured to release theclips134a-d(e.g., one at a time) over tissue so that they move toward their substantially closed state due to the bias in thebase142.
• Theclip application system100 is illustrated inFIG.4 with theconnector130 coupled to acontrol unit200 comprising avacuum source202 and aDoppler console204. Though in alternative embodiments, thevacuum source202 andDoppler console204 may be separate, inFIG.4, they are shown integrated into thesingle control unit200. In alternative embodiments, thevacuum source202 may simply comprise a lockable, medium or large bore syringe, a vacuum bottle, or a hospital or clinic vacuum line. Thevacuum source202 may include a vacuum pump which can be coupled to theconnector130. Theconnector130 includes anelectrical connector206 to theDoppler console204, shown connector via one ormore conductors208. Turning toFIGS.5-7, theelectrical connector206 is electrically coupled to theDoppler sensors136,138 via one ormore cables210 which extend through the interior of theclip application system100. TheDoppler console204 supplies voltage via battery or wall outlet-based electricity to power theDoppler sensors136,138, and in turn receives signals from theDoppler sensors136,138. The Doppler console204 (FIG.4) may include acontrol panel212 for operating theDoppler console204 and theDoppler sensors136,138. TheDoppler console204 may include multiple channels, for example a first channel configured to connect with the signals related toDoppler sensor136 and a second channel configured to connect with the signals related toDoppler sensor138. Aswitch214 on thecontrol panel212 is used to switch between the first channel and the second channel. In some embodiments, theswitch214 is an automatic switch or relay, that activates and selects theDoppler sensor138 automatically whenever the vacuum or suction is applied (e.g., by depression of the vacuum button132). The word “vacuum” used herein is not intended to mean a theoretically complete vacuum (where no molecules are present), but rather a generally negative pressure. Any of the controls on the control panel may be hard wired mechanical switches, or touch sensitive, or even voice-controlled. Aloudspeaker216 is configured to allow a user to listen to audio feedback which is proportional to returned Doppler signals. The double-ended arrows inFIG.7 represent the bi-directional travel of ultrasound signals. Adisplay218 may also be configured to indicate information related to the operation of theDoppler console204. A separate display may be used to monitor the condition of thevacuum source202, or thedisplay218 itself may be configured to include this information.
• FIG.8 illustrates a detailed sectional view of thehousing102 and its components.Grips220 on the exterior of thehousing102 are configured to allow thehousing102 to be gripped easily by the user's hand. In one gripping style, the user's palm is wrapped around anupper portion222 of the housing, and one to three fingers are engaged with thegrips220. The user is now able to maintain the position of thehousing102, while having access to thevacuum button132 with the thumb and to thetrigger140 with the index finger and/or other finger. With the connector206 (FIG.4) coupled to thevacuum source202, and with thevacuum button132 in a non-depressed state, as shown inFIG.8, air surrounding thehousing102 is continuously aspirated into anopening228 in thevacuum button132 and into a vacuum channel224 via pathway226 (dashed line). Thus, no significant vacuum is applied to thecavity124 of thedistal housing104. In use, theclip application system100 may be inserted in this condition by the user into a duct, tract, etc. in the body of the subject and manipulated such that thecavity124 of thedistal housing104 is placed in a desired location, for example, adjacent an artery. Theswitch214 of the Doppler console204 (FIG.4) may be operated to assure that a particular Doppler sensor (e.g., Doppler sensor136) is selected to sense the location of an artery which is desired for closure/occlusion. Then the desired location including target tissue is identified, the user may manipulate the housing using thetransverse extension120 and/or thedepth markings122 to rotate and or longitudinally displace thedistal housing104 so that thecavity124 is adjacent the target tissue.
• When the user desires to apply vacuum to force the target tissue into thecavity124 of thedistal housing104, the user depresses thevacuum button132 in direction A, causing aperimeter seal230 coupled to thevacuum button132 to seal onto thesurface232 of thehousing102. Theperimeter seal230 may comprise an o-ring, a gasket, or any other type of seal that effectively closes the external access of theopening228. With thevacuum button132 depressed and theperimeter seal230 engaging thesurface232 of thehousing102, a vacuum is now applied to thecavity124 of thedistal housing104, as shown in pathway234 (dotted line) via thelumen236 of thetubular shaft106. Also, when thevacuum button132 is depressed in direction A, a connectingelement238, secured to thevacuum button132, is also displaced in direction A. One or more o-ring seals240, or other seals, seal around the connectingelement238 to prevent unwanted internal leak paths. The connectingelement238 is secured to a lockingmember242 which is thus also moved in the direction A. The outside of the lockingmember242 is shown inFIGS.10A and10B, and includes anindentation244 into which is fit aspring member246. Thespring member246 extends within theindentation244, and engages thehousing102 at itsextreme end297. Thespring member246 has a slight curve in its unstressed configuration (FIG.10A), and will selectively bow (FIG.10B) when a force F is placed on the locking member242 (via thevacuum button132 and the connecting element238). Thus, thespring member246 will cause the lockingmember242 to return to the position ofFIG.10A when finger pressure is released from the vacuum button. When thevacuum button132 is not depressed, anabutment248 of the lockingmember242 blocks longitudinal displacement of afirst rack250. Thetrigger140 is attached in a cam relationship to thefirst rack250 with apin252 of thefirst rack250 engaging aslot254 of thetrigger140.Pivot pin256 rotatably couples thetrigger140 to thehousing102. Thus, when theabutment248 of the lockingmember242 blocks the longitudinal displacement of thefirst rack250, thefirst rack250 in turn blocks movement of thetrigger140. Thus, thetrigger140 is incapable of delivering anyclips134a-dunless a vacuum is applied to thecavity124 of the distal housing104 (via the depression of the vacuum button132). This helps prevent anyclips134a-dbeing delivered when tissue is not pulled within thecavity124 of thehousing104, thus increasing safety of the procedure.
• When the user depresses thevacuum button132 and thereby moves theabutment248 of the lockingmember242 to a position below thefirst rack250, the longitudinal displacement of thefirst rack250 is no longer blocked, as arelief258 in the lockingmember242 is now positioned adjacent thefirst rack250. Thus, the user is now capable of depressing thetrigger140 in direction B (in relation to the pivot pin256) to deliver one ormore clips134a-d, as will be described later. Aspring260 is contained in arecess262 in thetrigger140, and has afirst arm264 which engages thetrigger140 and asecond arm266 which engages asurface268 of thehousing102. Thus, when the user releases thedepressed trigger140, the trigger moves in a direction opposite of direction B, and returns to its original position. Referring to bothFIG.7 andFIG.8, a proximal inner pushingtube270 abuts a distal inner pushingtube272 at anabutment location274 within thetubular shaft106, such that distal longitudinal movement (to the left inFIG.8) of the proximal inner pushingtube270 will push the distal inner pushingtube272 in a distal direction within thetubular shaft106. Theproximal end276 of thetubular shaft106 is sealed within thehousing102 by a first o-ring278, and anouter diameter surface280 of thetubular shaft106 is sealed with thehousing102 by a second o-ring282, thus maintaining any vacuum applied within thetubular shaft106 without leakage. Thetubular shaft106 is additionally bonded (adhesive, epoxy, welding, etc.) to thehousing102 so that thehousing102 and thetubular shaft106 turn in unison. Adistal cap284 may be attached to thehousing102 in order to secure thetubular shaft106 and its internal components together, and to allow them to be rotated (by virtue of the transverse extension120) in relation to thehousing102. One of thedistal cap284 or thehousing102 may have a circumferentially extending male or female feature which is configured to engage with a female or male feature on the other of thedistal cap284 or thehousing102. For example, thedistal cap284 may include a circumferentially extending slot or groove and thehousing102 may include a pin that is configured to slide within the circumferentially extending groove. In some embodiments, the circumferentially extending groove extends less than a full rotation. For example, the groove may extend between about 180° and 355°, or between about 270° and about 355°, or between about 330° and about 355°. This final example allows almost a complete rotation of thedistal housing104 in relation to thehousing102. The proximal inner pushingtube270 is coupled to a spring-loadeddual pawl286 having apin288, afirst pawl290, and asecond pawl292. The spring-loadeddual pawl286 may be constructed from a superelastic material (Nitinol, nickel titanium alloy). Thepin288 is inserted through atransverse hole294 in the proximal inner pushingtube270 so that the twopawls290,292 longitudinally displace in unison with the proximal inner pushingtube270.
• With thevacuum button132 depressed and the desired tissue sucked into thecavity124 of the distal housing104 (which may be confirmed via the Doppler sensor138), the user depresses thetrigger140 causing thefirst rack250 to be moved distally. Movement of thefirst rack250 in this distal direction causes engagement with the end of thefirst pawl290 thus moving thefirst pawl290 distally and, via engagement of thepin288 in thetransverse hole294, also causing the proximal inner pushingtube270 to be moved distally. Asecond rack296 is rigidly secured to thehousing102 with first andsecond pins298. As thefirst rack250, thefirst pawl290, and the proximal inner pushingtube270 move distally, thesecond pawl292 repeatedly slips (ratchets) over thesecond rack296. Theexterior surface300 of the proximal inner pushingtube270 is dynamically sealed to thehousing102 by an o-ring302. As depicted inFIG.8, thehousing102 is a clamshell design with two halves, and may include multiple gaskets299 (or alternatively, adhesive, epoxy, or vacuum grease lines) to maintain vacuums within channels such as vacuum channel224. The proximal inner pushingtube270 thus pushes the distal inner pushingtube272 distally within thetubular shaft106. As shown inFIG.7, the distal inner pushingtube272 is bonded or molded to aframe304. Alternatively, the contours and features of theframe304 may be integral to the distal inner pushingtube272. Still alternatively, the contours and features of theframe304 may be separate from the distal inner pushingtube272, and may be, for example, carried within thedistal housing104. Adistal surface306 on the distal inner pushingtube272 abuts aproximal side184 of theproximal clip134d. As the distal inner pushingtube272 moves distally in relation to thedistal housing104, thedistal surface306 pushes theproximal clip134dwhich thus pushes theother clips134c,134b,134ain a stack distally. Referring also toFIG.9, a spring-loadedblock308 having aspring wire310 extending therefrom is telescopically displaceable within adistal portion312 of thedistal housing104. Initially, thespring wire310 produces a biasing force f (FIG.7) against theinterior314 of thedistal portion312 of thedistal housing104 which forces theproximal surface316 of the spring-loadedblock308 against adistal side182 of thedistal clip134a. This thus forces the apertures178 (FIG.3A) in thejaws146,148 of the entire stack ofclips134a-dto remain onpins318,320 (FIGS.11-13) which extend from thehousing102. The proximal ends322 of eachpin318,320 are secured to thehousing102, while the distal ends324 are free.
• When thedistal clip134ais forced off of the distal ends324 of thepins318,320 by the forward displacement of thedistal surface306 of the distal inner pushingtube272, thedistal side182 of thedistal clip134apushes against theproximal surface316 of the spring-loadedblock308, thus forcing it forward into theinterior314 of thedistal portion312 of thedistal housing104 against the biasing force of thespring wire310. Thus, theclips134a-dand the spring-loadedblock308 are moved from the position illustrated inFIG.11 to the position illustrated inFIG.12. Thedistal clip134ainFIG.12 is able to exit thecavity124 of thedistal housing104. Additionally, a pair ofpins326,328 extend from thehousing102. The proximal ends330 of eachpin326,328 are secured to thehousing102, while the distal ends332 are free. As shown inFIG.13, thepins326,328 are not configured to pass through any aperture in thejaws146,148, but instead are configured to protect the teeth168a-cof the jaws (FIG.3B) and/or to protect tissue from being lacerated or punctured by the teeth168a-cwhen the tissue is drawn into thecavity124 of the distal housing104 (e.g., by vacuum). In some embodiments, apin326,328 may have a diameter or transverse dimension d which is greater than or approximately equal to a profile thickness p of the tooth (or other feature). In some embodiments, the distal ends332 of thepins326,328 are at the same longitudinal extension (location) as the distal ends324 of thepins318,320. Thus, when aclip134 is pushed off of thepins318,320, theclip134 is also longitudinally cleared from thepins326,328, allowing the clip to move from thecavity124 of thedistal housing104, asclip134adoes inFIG.12, in generally perpendicular direction D.
• Theclip134ais pushed longitudinally (direction C inFIG.12), causing it to clear theends324,332 of thepins318,320,326,328 and then move in the generally perpendicular direction D. This is demonstrated byFIG.13, which shows theclip134aimmediately prior to being pushed off of theends324,332 of thepins318,320,326,328, andFIG.14, which shows theclip134aimmediately after it has been pushed off of theends324,332 of thepins318,320,326,328, and as it is being guided by guidingfeatures334,336 of theframe304. InFIG.14, only theclip134aand theframe304 are depicted, in order to better demonstrate their dynamic relationship. InFIG.13, prior to the release of theclip134a, thepins318,320 hold thejaws146,148 such that the guiding features176 are deeply engaged with the guiding features334,336 of theframe304. When theclip134ais released, as inFIG.14, thebase142 begins to close, which brings the distal ends158 of thejaws146,148 toward each other (arrows X₁, X₂). The guiding features334,336 momentarily maintain a separation between the proximal ends156 of thejaws146,148, even as theclip134abegins to move or eject (arrow y) in relation to the frame304 (and in relation to the distal housing104). Thus, thejaw146 rotates in one direction (arrow Z₁) in relation to thelongitudinal axis340 and thejaw148 rotates in a substantially opposite direction (arrow Z₂) in relation to thelongitudinal axis340. The rotational movement of eachjaw146,148 causes aproximal tip342 of eachjaw146,148 to contact a bottom surface points344a-bwith normal force vectors (N₁, N₂). The summation of normal force vectors N₁and N₂has a net direction substantially equivalent to the direction of arrow y, thus ejecting theclip134aaway from theframe304, and hence, away from thedistal housing104. Because the guiding features334,336 initially maintain a separation between the proximal ends156 of thejaws146,148 while the distal ends158 are closing, theclip134ais able to more reliably embrace or encircle the target tissue that is within thecavity124 of thedistal housing104, as theclip134abegins it ejection. This better ensures sufficient closure of the tissue and of any blood vessel that is within the tissue mass. Any of the guiding features176,334,336 of thejaws146,148 orframe304 may have a curvilinear shape so that, for example, the motion of the clip is not abrupt and/or does not have too much friction or other resistance. In some embodiments, any of the guiding features176,334,336 may include a recess and or a protrusion.
• Returning now toFIG.8, once theclip134ais applied by depressingtrigger140, the user then releases thetrigger140, which returns back to its initial position via the biasing of thespring260. As thespring260 forces thetrigger140 back to its initial, biased, position, the engagement of thepin252 of thefirst rack250 and theslot254 of thetrigger140 causes thefirst rack250 to move proximally (in a negative longitudinal direction). Because the proximal inner pushingtube270 and the spring-loadeddual pawl286 cannot move backwards (proximally) in relation to thesecond rack296, instead, thefirst pawl290 ratchets over the teeth (one or more tooth) of thefirst rack250. The user may now repeat the steps described either deliver thenext clip134binto the same tissue mass, or to release thevacuum button132 and move thedistal housing104 to a different location, then repeating the application of a vacuum, and the delivery of thenext clip134b. The ratcheting of the spring-loadeddual pawl286 with thefirst rack250 and thesecond rack296 allows multiple clips to be applied in succession. The blocking of the mostdistal clip134 at theends324,332 of thepins318,320,326,328 by the action of the spring-loadedblock308 having aspring wire310 assures that only oneclip134 is delivered at a time. In some embodiments,pin318 and pin320 are substantially parallel to each other, so that theclips134 maintain a particular angular orientation between the twojaws146,148 the entire time that theclips134 are slid along or over thepins318,320. In other embodiments,pin318 and pin320 diverge, in other words, the distance between them increases towards their distal ends324. Thus, theclips134 are caused to become more and more open as they are pushed distally along thepins318,320. In other embodiments,pin318 and pin320 converge, in other words, the distance between them decreases towards their distal ends324. Thus, theclips134 are caused to become less and less open as they are pushed distally along thepins318,320. Any of these configurations may be used for different purposes, such as to make more space in the outer portion of thedistal housing104 in its proximal end, to make more space in the inner portion of the distal housing in its proximal end, or to actively actuate the clip134 (either increasing or decreasing its angle), which may be done to assure that it is not stuck in any one position.
• In some embodiments, thepins318,320 are configured to hold only oneclip134. In other embodiments, thepins318,320 are configured to hold two or more clips, for example two to ten clips, or four clips, as depicted herein. Eachpin318,320 may have a free portion length L and eachclip134 may have a thickness t (fromside182 to side184). Thickness t may in some cases be the maximum thickness of theclip134. In some embodiments, free portion length L is greater than thickness t, so as to fit at least one clip. In some embodiments, free portion length L is at least twice thickness t, so as to fit at least two clips. In some embodiments, free portion length L is at least three times thickness t, so as to fit at least three clips. In some embodiments, free portion length L is at least four times thickness t, so as to fit at least four clips. In some embodiments, free portion length L is at least five times thickness t, so as to fit at least five clips.
• Many of the elements of theclip application system100, including thehousing102 anddistal housing104, may comprise a number of polymeric materials, which may be formed from a variety of materials including polycarbonate or acrylonitrile butadiene styrene (ABS). The components of thehousing102 anddistal housing104 may be injection molded, blow molded, rotational molded, or may be machined, such as by CNC machining. Other components of theclip application system100 may be formed from stainless steel, such as 300 series, or more specifically, 302 or 304 stainless steel. O-rings or seals may comprise Buna-N, EPDM, EPR, silicone, or other elastomers and thermoplastic elastomers.
• All of the embodiments described herein may be replaced by similar devices that incorporate cauterization, ligation, or staples, among other modalities, in conjunction with, or instead of theclips134. A system for closure of ablood vessel400 is illustrated inFIGS.15-16 according to an embodiment of the disclosure. Ahousing408 is coupled to atubular shaft410, which is coupled to adistal housing406. Thedistal housing406 includes acavity412 having anopening414 at the side of thedistal housing406. A lumen416 (e.g., channel) extends between aproximal opening418 and theopening414 in thedistal housing406. Thelumen416 is configured for accommodating placement of one ormore probes402, each having ashaft420 with avessel closure module404 at its distal end. InFIG.15, thevessel closure module404 comprises a looped wire configured for cauterizing a mass of tissue, including a blood vessel. Other cautery elements may replace the looped wire in other embodiments, such as a pair of opposing jaws. These may include monopolar or bipolar driven elements. Theprobe402 may be controlled via acontrol module422, which includes an operational switch424 (e.g., “cautery off/cautery on” via a toggle, slide, or other modality) and adisplay426. As with the other embodiments presented herein, avacuum source428 is configured to be coupled to thecavity412 of thedistal housing406, in this case, via thelumen416. Anextension tube430 couples thevacuum source428 to thelumen416 via aconnector432. A vacuum is applied by avacuum button434 which is operable by the hand of a user. Thedistal housing406 may be rotated along with thetubular shaft410 by rotating adistal cap436 andtransverse extension438. In embodiments that incorporate one or more Doppler sensors, a Doppler console440 (which may be similar to Doppler console204) is coupled to the Doppler sensor(s) via theconnector432. A spring-loadedlever442 may be carried by thehousing408, to aid in the advancement of theprobe402, for example, by the repetitive, longitudinally-directed frictional engagement of theshaft420. For example, each time thelever442 is depressed, theshaft420 is frictionally engaged and theshaft420 is advanced distally a particular finite longitudinal distance in relation to thehousing408 andtubular shaft410. The release of thelever442, because it undoes the frictional engagement with theshaft420, does not move theshaft420 longitudinally. Theconnector432 includes aseal444 which may be configured in several different manners. First, theseal444 may be a permanent seal, such as a duckbill valve or spring-activated valve, so that theproximal opening418 is closed (sealed) when noprobes402 are within thelumen416, and so that theproximal opening418 seals around the diameter of theshaft420 when theprobe402 is within the lumen. Alternatively, theseal444 may be configured to seal only when theprobe402 is within the lumen, and may comprise an o-ring, a Touhy-Borst or a spring-loaded valve. An introducer may be used to more easily insert thevessel closure module404 of theprobe402 into thelumen416.
• FIG.16 shows theprobe402 inserted into thelumen416, and with theclosure module404 advanced so that it is within thecavity412 of thedistal housing406. In use, the user applies a vacuum to thecavity412 by pressing thevacuum button434. The target tissue is pulled into thecavity412 and thevessel closure module404 is activated. For example, the tissue is cauterized, to close the blood vessel within the tissue (e.g., hemorrhoidal artery, etc.). If more than onevessel closure module404 needs to be applied to the tissue (or to more than one portion of the tissue), then theprobe402 may be removed from thelumen416, and anotherprobe402 may be advanced through thelumen416, with the treatment steps repeated. This may be repeated with any number ofdifferent probes402, including probes of more than one modality (cautery, clip, staple, ligator, etc.). Thehousing408/tubular shaft410/distal housing406 thus together can, in some cases, maintain a particular position adjacent to target tissue, while a number ofdifferent probes402 can quickly and easily be advanced, applied, and removed in succession, to fully treat the target tissue. The speed of the procedure can thus be increased, because thedistal housing406 does not have to be readvanced or repositioned. Additionally, the sizes of thetubular shaft410 anddistal housing406 can be reduced, for easier passage through body tracts or cavities, as they only need to accommodate asingle probe402 orvessel closure module404 at a time, and not fit multiple probes or modules.
• The system for closure of ablood vessel400 is depicted as a cautery device, but in alternative embodiments thevessel closure module404 may instead comprise a clamp, or clip that is deliverable from thedistal housing406, or a suture, ligation structure, or staple.
• A system for closure of ablood vessel500 is illustrated inFIGS.17-18 according to an embodiment of the disclosure. Ahousing508 is coupled to atubular shaft510, which is coupled to adistal housing506. Thedistal housing506 includes acavity512 having anopening514 at the side of thedistal housing506. A lumen516 (e.g., channel) extends between aproximal opening518 and theopening514 in thedistal housing506. Thelumen516 is configured for accommodating placement of one ormore probes502, each having ashaft520 with avessel closure module504 at its distal end. InFIG.17, thevessel closure module504 comprises a ligation band for ligating a mass of tissue, including a blood vessel. Other ligation elements may replace the ligation band in other embodiments, such as string, wire, filament, fiber, or other tieable structures. Theprobe502 may be controlled via acontrol module522, which includes aswitch524 and/or aslide525 and adisplay526. Theswitch524 may be configured to automatically cause aloop527 of the ligation band (vessel closure module504) to close, for example in a slip knot or noose-like manner. Theslide525 may also cause theloop527 to close, but in a manual manner (by being slid by one or more fingers of the user's hand). As with the other embodiments presented herein, avacuum source528 is configured to be coupled to thecavity512 of thedistal housing506, in this case, via thelumen516. Anextension tube530 couples thevacuum source528 to thelumen516 via aconnector532. A vacuum is applied by avacuum button534 which is operable by the hand of a user. Thedistal housing506 may be rotated along with thetubular shaft510 by rotating adistal cap536 andtransverse extension538. In embodiments that incorporate one or more Doppler sensors, a Doppler console540 (which may be similar to Doppler console204) is coupled to the Doppler sensor(s) via theconnector532. A spring-loadedlever542 may be carried by thehousing508, to aid in the advancement of theprobe502, for example, by the repetitive, longitudinally-directed frictional engagement of theshaft520. For example, each time thelever542 is depressed, theshaft520 is frictionally engaged and theshaft520 is advanced distally a particular finite longitudinal distance in relation to thehousing508 andtubular shaft510. The release of thelever542, because it undoes the frictional engagement with theshaft520, does not move theshaft520 longitudinally. Theconnector532 includes aseal544 which may be configured in several different manners. First, theseal544 may be a permanent seal, such as a duckbill valve or spring-activated valve, so that theproximal opening518 is closed (sealed) when noprobes502 are within thelumen516, and so that theproximal opening518 seals around the diameter of theshaft520 when theprobe502 is within the lumen. Alternatively, theseal544 may be configured to seal only when theprobe502 is within the lumen, and may comprise an o-ring, a Touhy-Borst or a spring-loaded valve. An introducer may be used to more easily insert thevessel closure module504 of theprobe508 into thelumen516.
• FIG.18 shows theprobe502 inserted into thelumen516, and with theclosure module504 advanced so that it is within thecavity512 of thedistal housing506. In use, the user applies a vacuum to thecavity512 by pressing thevacuum button534. The target tissue is pulled into thecavity512 and thevessel closure module504 is activated. For example, the tissue is ligated, to close the blood vessel within the tissue (e.g., hemorrhoidal artery, etc.). If more than onevessel closure module504 needs to be applied to the tissue (or to more than one portion of the tissue), then theprobe502 may be removed from thelumen516, and anotherprobe502 may be advanced through thelumen516, with the treatment steps repeated. This may be repeated with any number ofdifferent probes502, including probes of more than one modality (cautery, clip, staple, ligator, etc.). Thehousing508/tubular shaft510/distal housing506 thus together can, in some cases, maintain a particular position adjacent to target tissue, while a number ofdifferent probes502 can quickly and easily be advanced, applied, and removed in succession, to fully treat the target tissue. The speed of the procedure can thus be increased, because thedistal housing506 does not have to be readvanced or repositioned. Additionally, the sizes of thetubular shaft510 anddistal housing506 can be reduced, for easier passage through body tracts or cavities, as they only need to accommodate asingle probe502 orvessel closure module504 at a time, and not fit multiple probes or modules.
• A system for closure of ablood vessel600 is illustrated inFIGS.19-20 according to an embodiment of the disclosure. Ahousing608 is coupled to atubular shaft610, which is coupled to adistal housing606. Thedistal housing606 includes acavity612 having anopening614 at the side of thedistal housing606. A lumen616 (e.g., channel) extends between aproximal opening618 and theopening614 in thedistal housing606. Thelumen616 is configured for accommodating placement of one ormore probes602, each having ashaft620 with avessel closure module604 at its distal end. InFIG.19, thevessel closure module604 comprises a clamp for closing a mass of tissue, including a blood vessel. Theprobe602 may be controlled via acontrol module622, which includes aswitch624 and/or ahandle629 having atrigger625, and adisplay626. Theswitch624 may be configured to automatically cause a pair ofjaws627a,627bof the clamp (vessel closure module604) to close. Theswitch624 may be operated by the user to apply a current to thejaws627a,627b, in order to cauterize the tissue. Alternatively, or in conjunction, theswitch624 may cause thejaws627a,627bto automatically close. The user may in some cases cause the clamp to close first, and then, while the clamp is closed, apply the current (cauterize). In other cases, the user may apply the current and then close the clamp while the current is being applied. Alternatively, theswitch624 may be used to detach the clamp from theprobe602, if the clamp is a detachable/implantable clip. As with the other embodiments presented herein, avacuum source628 is configured to be coupled to thecavity612 of thedistal housing606, in this case, via thelumen616. Anextension tube630 couples thevacuum source628 to thelumen616 via aconnector632. A vacuum is applied by avacuum button634 which is operable by the hand of a user. Thedistal housing606 may be rotated along with thetubular shaft610 by rotating adistal cap636 andtransverse extension638. In embodiments that incorporate one or more Doppler sensors, a Doppler console640 (which may be similar to Doppler console204) is coupled to the Doppler sensor(s) via theconnector632. A spring-loadedlever642 may be carried by thehousing608, to aid in the advancement of theprobe602, for example, by the repetitive, longitudinally-directed frictional engagement of theshaft620. For example, each time thelever642 is depressed, theshaft620 is frictionally engaged and theshaft620 is advanced distally a particular finite longitudinal distance in relation to thehousing608 andtubular shaft610. The release of thelever642, because it undoes the frictional engagement with theshaft620, does not move theshaft620 longitudinally. Theconnector632 includes aseal644 which may be configured in several different manners. First, theseal644 may be a permanent seal, such as a duckbill valve or spring-activated valve, so that theproximal opening618 is closed (sealed) when noprobes602 are within thelumen616, and so that theproximal opening618 seals around the diameter of theshaft620 when theprobe602 is within the lumen. Alternatively, theseal644 may be configured to seal only when theprobe602 is within the lumen, and may comprise an o-ring, a Touhy-Borst or a spring-loaded valve. An introducer may be used to more easily insert thevessel closure module604 of theprobe602 into thelumen616.
• FIG.20 shows theprobe602 inserted into thelumen616, and with theclosure module604 advanced so that it is within thecavity612 of thedistal housing606. In use, the user applies a vacuum to thecavity612 by pressing thevacuum button634. The target tissue is pulled into thecavity612 and thevessel closure module604 is activated. For example, the tissue is clamped, to close the blood vessel within the tissue (e.g., hemorrhoidal artery, etc.). If more than onevessel closure module604 needs to be applied to the tissue (or to more than one portion of the tissue), then theprobe602 may be removed from thelumen616, and anotherprobe602 may be advanced through thelumen616, with the treatment steps repeated. This may be repeated with any number ofdifferent probes602, including probes of more than one modality (cautery, clip, staple, ligator, etc.). Thehousing608/tubular shaft610/distal housing606 thus together can, in some cases, maintain a particular position adjacent to target tissue, while a number ofdifferent probes602 can quickly and easily be advanced, applied, and removed in succession, to fully treat the target tissue. The speed of the procedure can thus be increased, because thedistal housing606 does not have to be readvanced or repositioned. Additionally, the sizes of thetubular shaft610 anddistal housing606 can be reduced, for easier passage through body tracts or cavities, as they only need to accommodate asingle probe602 orvessel closure module604 at a time, and not fit multiple probes or modules.
• FIG.21 illustrates a method for closing a blood vessel. The method may include closing a hemorrhoidal artery in a subject, for example, by placement of a device within a natural lumen or cavity of the subject, adjacent the hemorrhoidal artery. Instep700, a system is provided which is configured for placement adjacent a blood vessel. The system may comprise the system for closure of ablood vessel400 ofFIGS.15 and16, or the system for closure of ablood vessel500 ofFIGS.17 and18, or the system for closure of ablood vessel600 ofFIGS.19 and20, or another system having similar characteristics or parallel indications. In some embodiments, the system may include a housing having a proximal end and a distal end and configured to be held in the hand of a user. The system further includes an elongate body extending from the distal end of the housing and configured for insertion adjacent a blood vessel within a subject. In some embodiments, the elongate body is configured for insertion within a natural lumen or cavity of the subject. In some embodiments, the elongate body is configured for insertion into the anus of the subject. In some embodiments, the elongate body is configured for insertion into the rectum of the subject. The system further includes a distal housing having a proximal end coupled to the distal end of the elongate body, and having a cavity contained therein. The cavity may include an opening on a side of the distal housing. The system further includes a lumen passing through the elongate body and terminating at the cavity of the distal housing. The lumen is configured to couple to a vacuum source and is configured to allow the insertion and removal of a probe having a vessel closure module carried at its distal end. The lumen is configured to maintain a vacuum within the cavity when the probe is within the lumen and the vessel closure module is within the cavity. The system further includes a sensor carried by the distal housing adjacent the cavity and configured for identifying a blood vessel. The sensor may include one or more of: a Doppler sensor, an infra-red sensor, a near infra-red sensor, an optical coherence tomography (OCT) sensor, and may or may not include one or more optical fibers.
• Instep702, the distal housing of the system is placed within an internal structure of a subject to be treated. The distal housing of the system may be placed in a natural lumen or cavity, which may or may not include the anus and/or the rectum. In step704 a blood vessel is identified at least partially by use of the sensor. For example, the sensor is operated while the user moves the distal housing until the sensor detects the blood vessel at a location adjacent the distal housing. The distal housing may be moved by the user by the manipulation of the housing and/or the elongate body. Either may be pushed distally, pulled proximally, or rotated in a generally clockwise manner or a generally counter-clockwise manner, or a combination of any of the above. Instep706, a first probe having a first vessel closure module is inserted at least partially inserted into the cavity. This may be done after the blood vessel is identified, but in some cases, the first probe may actually be inserted into the cavity prior to the identification of the blood vessel or even prior to the placing of the distal housing within the internal structure of the subject.
• Instep708, the lumen is coupled to a vacuum source, which may include a syringe, a vacuum pump, a vacuum chamber, or other device for applying a vacuum. The coupling of the vacuum source allows a vacuum (negative pressure) to be applied at the cavity, thus allowing tissue of the subject to be pulled into the cavity to facilitate treatment of the tissue. The tissue may for example include the blood vessel which is intended for closure. Instep710, the blood vessel is at least partially closed by operation of the first vessel closure module of the first probe. In some embodiments, the first vessel closure module may comprise a cautery device, and may comprise a wire loop or two opposing jaws (e.g., clamp). The first vessel closure module may at least partially close the blood vessel via cautery. In some embodiments, the first vessel closure module may comprise a ligation tie or other ligator. In some embodiments, the first vessel closure module may comprise a clamp. In some embodiments, the first vessel closure module may comprise a clip. Though the blood vessel may be completely closed by the first vessel closure module, it may also be desired to remove the first vessel closure module and replace it with another (i.e., second) vessel closure module, either a vessel closure module similar to the first vessel closure module, or a vessel closure module having a different structure or modality. In some cases, the second vessel closure module may be carried by the first probe that was used in conjunction with the first vessel closure module. For example, the first vessel closure module may be removed from the first probe and the second vessel closure module may be attached to the first probe. In other cases, a second probe having a second vessel closure module may be used to replace the first probe having the first vessel closure module.
• Instep712, the first probe is removed from the lumen. In some cases, for example, cases wherein the treatment of the blood vessel has been completed, the procedure may be ended afterstep712. In other cases, further treatment may be desired, and thus step706 is repeated, but now with a second probe having a second vessel closure module (or the first probe which has had its first vessel closure module replaced or augmented by the second vessel closure module). One or more of the other steps may be repeated with the second probe/vessel closure module combination. A number of different probes and/or vessel closure modules may be inserted (step706), operated (step710), and removed (step712). Up to 5, 10, 20, or more different probes may be used in any procedure. The stability and location maintenance of thehousing408,508,608, thetubular shaft410,510,610 and thedistal housing406,506,606 allow for rapid removal and replacement ofprobes402,502,602. The coupling of the vacuum source (step708) may be maintained throughout, or may continually be applied. A combination of different modalities of vessel closure modules may be used, or different geometries or sizes of vessel closure modules or probes may be used. In some cases, the user may start with a small vessel closure module progress, probe-by-probe to larger and larger vessel closure modules, or start with a low energy vessel closure module and progress to high energy vessel closure modules. On other cases, the user may begin with a large or high energy vessel closure module that performs the majority of the closure procedure, and then replace the vessel closure module with one or more smaller or lower energy vessel closure modules to “touch up” or to finish the procedure. In some cases, multiple probes having the same type of vessel closure module may be used, for example, a new vessel closure module to replace a worn out or exhausted vessel closure module.
• The sensor allows correct or desired placement of the distal housing, and the sensor and/or the supporting structure of the housing, elongate body, and distal housing allows this placement to be maintained once it is achieved. Thus, a user does not need to continually insert the distal housing or rotate the distal housing to find the target anatomy. Simple insertion and removal of multiple probes can be quickly and accurately performed, thus allowing for a rapid and efficient procedure. At any time, a slight adjustment to the location of the distal housing may be performed by operating the sensor and determining the desired location of the distal housing in relation to the blood vessel.
• The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.
• While embodiments have been shown and described, various modifications may be made without departing from the scope of the inventive concepts disclosed herein.

Claims (3)

What is claimed is:

1. A system for closing a blood vessel, comprising:

a housing having a proximal end and a distal end and configured to be held in the hand of a user;

an elongate body extending from the distal end of the housing and configured for insertion into the rectum of a subject;

a distal housing having a proximal end coupled to a distal end of the elongate body, and having a cavity therein, the cavity communicating with an opening on a side of the distal housing;

a lumen extending through the elongate body and communicating with the cavity of the distal housing, the lumen configured to couple to a vacuum source;

a sensor carried by the distal housing at or adjacent the cavity and configured for identifying a blood vessel; and

wherein the lumen is further configured to allow the insertion and removal of a probe having a distally-located vessel closure module, and wherein the lumen is configured to maintain a vacuum within the cavity when the probe is extended through the lumen with the vessel closure module within the cavity.

2. A method for producing the system ofclaim 1.

3. A method of using the system ofclaim 1.

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