US20090012545A1 - Apparatus and Methods for Occluding a Hallow Anatomical Structure - Google Patents
Apparatus and Methods for Occluding a Hallow Anatomical Structure Download PDFInfo
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- US20090012545A1 US20090012545A1 US11/994,725 US99472506A US2009012545A1 US 20090012545 A1 US20090012545 A1 US 20090012545A1 US 99472506 A US99472506 A US 99472506A US 2009012545 A1 US2009012545 A1 US 2009012545A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B17/083—Clips, e.g. resilient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
- A61B17/1227—Spring clips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
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Abstract
Description
- This application claims the benefit of U.S. Provisional Application Ser. No. 60/699,309 filed on Jul. 14, 2005, and generally relates to the subject matter disclosed and claimed in U.S. application Ser. No. 10/853,928, filed on May 26, 2004, the disclosures of which are hereby fully incorporated by reference herein.
- The present invention relates generally to surgical methods and apparatus for occluding a hollow tissue structure, such as when occluding vessels, or pedunculated structures such as an appendix, gall bladder or appendages on the heart. More specifically, the present invention relates to a method and device for occluding the left atrial appendage of the heart in either an open surgical procedure or minimally invasive procedure.
- Atrial fibrillation is a common cardiac rhythm disorder that affects more than two million people each year. Until relatively recently, atrial fibrillation was thought to be a nuisance arrhythmia with few consequences. However, recent medical research has uncovered some devastating complications including cardiomyopathy, congestive heart failure and stroke.
- During atrial fibrillation the upper part of the heart beats (quivers) faster than the rest of the heart. This phenomenon is due to the generation of erratic or extra electrical signals which cause the top part of the heart to quiver rapidly and irregularly (fibrillate) as many as 300-600 times per minute. However, the entire heart does not beat that fast. The heart is a muscular pump divided into four chambers, with two atria on the top of the heart and two ventricles on the bottom portion of the heart. Normally, the heartbeat starts in the right atrium when a special group of cells sends an electrical signal. These cells are called the sinoatrial or SA node, sinus node or the heart's “pacemaker.” The signal spreads throughout the atria and to the atrioventricular or AV node. The AV node connects to a group of fibers in the ventricles that conduct the electrical signal. The electrical impulse travels via these specialized fibers to all parts of the ventricles. The specialized fibers are also known as the His-Purkinje system. The electrical signal must follow this exact route for the heart to pump properly. Normally, the heart beats at 60-80 times per minute at rest. This number represents the contractions of the lower heart or ventricles. During atrial fibrillation, electrical signals from other parts of the heart disrupt the heart's normal rhythm and cause the atria to quiver or beat too fast. However, only a small number of these atrial beats make it through the AV node, which acts like a gate to the ventricles. This is fortunate, because a rapid ventricular heartbeat would be much more dangerous and potentially fatal. However, some atrial fibrillation does make it through the AV node making the heart beat faster than normal. An atrial fibrillation attack is usually not life threatening. The most significant danger is stroke.
- Blood usually moves completely through the chambers of the heart. During atrial fibrillation, the heart is not pumping normally or efficiently. The blood begins to pool in the atria and this stagnation of blood can cause the blood to thicken and form clots. These clots are then ejected out of the heart and into the bloodstream where they can lodge in the brain causing a stroke. Atrial fibrillation can make stroke five times more likely than in the general population. When the heart experiences atrial fibrillation there may not be enough blood pumping to the brain or other organs. This can cause dizziness, shortness of breath or organ failure. Untreated atrial fibrillation will also weaken the heart due to phenomenon known as remodeling. The heart, like the rest of the body, adapts to changes. The fast abnormal rhythm in the atria causes electrical changes, and this can enlarge the heart.
- There are three major objectives in the treatment of atrial fibrillation: the restoration of normal sinuous rhythm, control of ventricular rate during atrial fibrillation, and the prevention of blood clot formation. Some methods of treatment for atrial fibrillation include pharmacological therapy, pacemakers, and surgery.
- For the prevention of blood clots, research has demonstrated that the anticoagulant warfarin (e.g., Coumadin®) is effective in reducing the risk of blood clot formation and stroke but it does not totally eliminate the risk. An anticoagulant such as warfarin interferes with the body's natural clotting mechanism. The dosage of warfarin is highly individualized and must be carefully monitored with blood tests to ensure safety. While this pharmacological treatment may significantly reduce the risk of stroke, it also increases the risk of bleeding and may be inappropriate for many atrial fibrillation patients.
- As an alternative to pharmacological therapy, there are a few surgical procedures that isolate the left atrial appendage from the blood's circulatory system. The left atrial appendage is a small hollow extension (i.e., a pedunculated structure) formed off the lateral wall of the left atrium. It has been referred to as a small “windsock” like structure or a small, flat hollow finger-like protrusion. The left atrial appendage usually contracts with the rest of the left atrium during normal heart function thereby continually moving blood throughout the hollow extension. During atrial fibrillation, the left atrial appendage often fails to contract thereby allowing the blood to pool inside the appendage, becoming stagnated. As a result, the blood becomes thicker and thrombus or clot formation may occur. These clots can be slowly ejected from the left atrial appendage into the left atrium and left ventricle, and then released into the bloodstream thereby becoming an obstruction in the brain or other vascular structures. For this reason, it is advantageous to prevent these clots from forming and being dislodged into the bloodstream. One method of preventing the occurrence of clots is to occlude the appendage thus preventing blood from entering and forming clots. This also prevents clots already formed in the appendage from escaping into the bloodstream. Normally, the occlusion of the left atrial appendage is performed in conjunction with other procedures such as a mitral valve replacement or coronary artery bypass procedure and not as the sole reason for the procedure.
- There are several different methods being used today to occlude the left atrial appendage. One method is percutaneous left atrial appendage transcatheter occlusion. A small occlusion device is deployed from a venous access catheter into the left atrium and blocks the opening into the atrial appendage. In order to access the left atrium from the vena cava's right atrium, the surgeon must go through the atrial wall. Many surgeons are uncomfortable with making an opening in this wall without being able to repair it at the end of the procedure. There are also issues of placing an occlusion device inside the heart. If the occlusion device becomes detached within the heart, the result may be fatal.
- Another method of occlusion is placing a loop around the left atrial appendage and cinching it down in a manner similar to a garrote. When trying to place a flaccid loop around an irregular pedunculated structure, it can be difficult to make certain the loop is positioned at the base of the appendage. When cinching the loop, it is very easy to over tighten the loop, and this can result in severing the delicate atrial appendage. Even a partial tear can create problems, including the initial problem of gaining access to repair the tear. This method of occlusion may not always seal the opening between the appendage interior and the atrium. That is, there may still be a partial opening due to the way the appendage wall collapses during cinching of the loop. Such a partial opening could still allow some flow into and out of the atrial appendage, leading to the problems mentioned above. In addition, transforming the relatively flat structure of the appendage onto a round hard mass, as does a cinching method, could lead to other problems.
- Another method of occlusion is to place a linear surgical stapler at the base of the appendage and a left atrial wall and staple the appendage closed. Due to the limited access, the ability to visualize the entire atrial appendage while placing the stapler in the correct location can be a problem. It is very difficult to make certain the staple line makes a complete occlusion of the appendage. Again, a partial occlusion of the appendage can still result in the formation and dislodgement of clots.
- For the aforementioned reasons, it would be desirable to provide improved methods and devices to reliably occlude hollow anatomical structures, including but not limited to the left atrial appendage of the heart, completely and safely. Such methods may be performed during an open-heart surgical procedure such as a valve replacement or coronary artery bypass. It would also be desirable to provide methods and devices that may be used in minimally invasive or less invasive procedures while the heart is beating without placing the patient on a heart-lung bypass machine. A less invasive device may allow, for example, access through either an intercostal space between the ribs or a supra and/or sub-xiphoid approach to gain access to the left atrial appendage. Such devices may allow complete visualization of the left atrial appendage for the surgeon and permit minor placement adjustments to be made before permanent installation is made. The devices would also allow complete occlusion of the left atrial appendage, eliminating the risk of clots forming in the appendage, traveling throughout the bloodstream, and possibly lodging in the brain causing a stroke.
- In one aspect, the present invention is directed to a device for occluding a hollow anatomical structure, with the device including a clamp having at least first and second elongate clamping portions adapted to be placed on opposite sides of the hollow anatomical structure. The first and second elongate clamping portions respectively have ends coupled together with respective resilient urging members configured to urge at least one of the first and second elongate clamping portions toward the other of the first and second elongate clamping portions from an open position into a clamping position to occlude the hollow anatomical structure. The clamp comprises an annular shape configured to surround the hollow anatomical structure in the open position and a flattened shape in the clamping position configured to occlude the hollow interior of the hollow anatomical structure.
- The resilient urging members may normally spring bias at least one of the first and second elongate clamping portions toward the other of the elongate clamping portions. For example, any number of designs may be used for the resilient urging members, including various types of separate or integrally formed spring elements on the clamp. One or more generally U-shaped wire sections may be used at opposite ends, for example. The clamping portions may have tissue engaging surfaces adapted to promote tissue ingrowth, such as a tissue engaging surface having pores with diameters sized from about 200 to about 400 microns. The surface may, for example, comprise a surgical grade fabric. The tissue contacting surface may be a surface that prevents line contact with the hollow anatomical structure thereby spreading a load force exerted by the first and second elongate clamping portions on the tissue. The first and second elongate clamping portions may have complementary shapes in cross section such that the complementary shapes fit together in the clamping position. This may be achieved through either a preformed shape in the elongate clamping portions, or by forming one or both the elongate clamping portions, or at least one or more outer layers thereof, out of a material that is deformable under load. Any other features in the above incorporated patent application may also be incorporated into the device as further disclosed herein.
- In one aspect, the first and second elongate clamping portions and the resilient urging members may be formed from at least one wire member. The wire member may be formed from a material having superelastic properties, such as a nickel-titanium alloy, or from other materials having suitable physical characteristics for achieving the clamping function. Rigid and/or resilient tubular members may be used to cover the wire member second tubular shaped members can, for example, provide more effective load spreading by increasing the diameter of the wire member.
- In another aspect of the invention, tissue blocking members are positioned at opposite ends of the elongate clamping portions and prevent outward egress of clamped tissue beyond the respective ends of the elongate clamping portions.
- In another aspect of the invention, the first and second elongate clamping portions may comprise elongate generally parallel members capable of reorienting into a nonparallel relationship in the clamping position. For example, the generally parallel members may reorient into a nonparallel relationship which converges toward one end of the clamp or the other end of the clamp.
- Apparatus according to the invention may include a clamp with any of the features discussed above, and a clamp delivery and actuation device including first and second jaws for carrying and deploying the clamp onto the hollow anatomical structure.
- Methods according to the invention are also contemplated and generally include use of the device or apparatus as described above including any of the desired features discussed herein.
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FIG. 1A is a perspective view of a first embodiment of a clamp in an open position. -
FIG. 1B shows a perspective view of the clamp in a closed position. -
FIG. 1C is a cross-sectional view of the clamp ofFIG. 1A in its open configuration, showing the wire member, rigid tubular members, and the urging members. -
FIG. 1D is a cross-sectional view of the clamp ofFIG. 1B in its closed configuration, showing the wire member, rigid tubular members, and the urging members. -
FIG. 2 shows a perspective view of the occlusion clamp ofFIGS. 1A-1D and showing the ability to close in a non-parallel fashion. -
FIG. 3 is a perspective view of the first stage of assembly of an alternate embodiment of a clamp, showing a wire member surrounded by rigid tubular members. -
FIG. 4 is a perspective view of the second stage of assembly of the clamp ofFIG. 3 , in which platens have been added over the rigid tubular members. -
FIG. 5 is a perspective view of the clamp ofFIGS. 3 and 4 , once an outer fabric covering has been disposed over the entire surface of the clamp. -
FIG. 6 is a perspective view of a deployment tool used to apply the clamp ofFIG. 5 , with the clamp shown in the closed position. -
FIG. 6A is a cross sectional view taken generally alongline 6A-6A ofFIG. 6 , but illustrating an alternative embodiment of the spreader legs in an open or spread position. -
FIG. 6B is a view similar toFIG. 6A , but illustrating the tool in a closed or clamping position. -
FIG. 7 is a perspective view of the deployment tool and clamp ofFIG. 5 with the clamp shown in the open position. -
FIG. 8 shows the deployment tool and clamp ofFIG. 5 , with the tool holding the clamp in its closed position. -
FIG. 9 shows the deployment tool and clamp ofFIG. 5 , with the tool holding the clamp in a partially open position immediately prior to deployment. -
FIG. 10 shows the deployment tool and clamp ofFIG. 5 , with the tool deploying the clamp over an appendage. -
FIG. 11 shows the clamp ofFIG. 5 having being deployed over an appendage. -
FIG. 12 shows an alternate embodiment of a clamp in which the urging members are closer to the ends of the rigid tubular members. -
FIG. 13 shows an alternate embodiment of a clamp in which the clamping portions are bent to better match anatomy. -
FIG. 14 shows a top view of the clamp ofFIG. 13 . -
FIG. 15 shows an alternate embodiment of a clamp in which the urging members and clamping portions are formed from a flat spring material. -
FIG. 16 shows an alternate embodiment of the clamp ofFIG. 12 having multiple-turn urging members. -
FIG. 17 shows an alternate embodiment of a clamp in which the ends of the clamping portions overlap each other. -
FIG. 18 shows an alternate embodiment of the clamp ofFIG. 15 having a greater space between the clamping portions in the clamping portions' end sections. -
FIG. 19 shows an alternate embodiment of a clamp in which the clamping portions and urging members are made of the same starting stock of material. -
FIG. 19A is a cross-sectional view of the clamp ofFIG. 19 , showing the clamp in its deployed position around an anatomical structure. -
FIG. 20 is an alternate embodiment of the clamp ofFIGS. 19 and 19A made from a tube or roll of sheet metal. -
FIG. 20A is a cross-sectional view of the clamp ofFIG. 20 in its closed, pre-deployment position. -
FIG. 20B is a cross-sectional view of the clamp ofFIGS. 20 and 20A in its deployed position. -
FIG. 21 is a side view of an alternate embodiment of a clamp, in which the urging members are made from elastic bands. -
FIG. 22 is a perspective view of the clamp ofFIG. 21 , showing tissue-blocking fingers protruding from each clamping portion and with corresponding receiving apertures. -
FIG. 23 is a perspective view of the distal end of an endoscopic tool useful for applying a clamp in accordance with the invention. -
FIG. 24A is cross sectional view ofFIG. 23 taken alongline 24A-24A ofFIG. 23 . -
FIG. 24B is a cross sectional view similar toFIG. 24A , but illustrating the tool in a closed or clamping position. -
FIGS. 1A and 1C show one embodiment of a left atrialappendage occlusion clamp 10 in an open position with spaced apartrigid clamping portions 2, 4 and resilient orelastic urging members portion 2, 4. Clampingportions 2, 4 may be tubular, and both clampingportions 2, 4 may be at least substantially parallel to each other when arrest, i.e., when they are not being used to clamp tissue. Clampingportions 2, 4 may also be of substantially equal length or of different length, and each may be of larger outer diameter than the wire that may be used to form each of the urgingmembers urging members portions 2, 4. In this illustrative example, the urgingmembers members portions 2, 4. Of course, other angular orientations are possible as well. -
FIGS. 1B and 1D show thesame clamp 10 ofFIGS. 1A and 1C with the clampingportions 2, 4 in their normally biased together positions. Contact between the clampingportions 2, 4 may occur initially along their entire parallel lengths as shown. Of course, when clampingportions 2, 4 are covered in fabric or other material as later described, contact may occur between the fabric or other material instead. InFIGS. 1A-1D , only the structure and relative positions of therigid members 2, 4 and urgingmembers FIGS. 3 , 4 and 5 which, although describing a slightly different embodiment, show the general steps in the construction of each embodiment. The clampingportions 2, 4 may be made fromrigid tubes wire member 16. In this embodiment, titanium is used for its compatibility with MRI imaging, its biocompatibility and its galvanic compatibility with thewire member 16 when thewire member 16 is formed from superelastic materials such as a nickel titanium alloy. This embodiment and the other embodiments disclosed herein may use a superelastic material such as a nickel titanium alloy to form the urgingmembers portions clamp 10 without permanently deforming the material. These superelastic materials can also be compatible with MRI imaging and easily tolerated as an implant material in the body. The rigidtubular members underlying wire member 16 preferably by mechanically swaging thetitanium tubes wire members 16. Although a single, continuous wire member is shown directed through both clampingportions 2, 4 and urgingmembers clamp 10 of this embodiment may also be made with two or more wires, or with any other suitable components. - As shown in
FIG. 2 , in addition to being able to close on tissue or anatomical structure in a parallel fashion, theclamp 10 can also apply force to the anatomical structure in a nonparallel clamping fashion. This allows theclamp 10 to accommodate non-uniform tissue thickness over the length of the clampingportions 2, 4. In addition, withseparate urging members portions 2, 4 the nonparallel clamping can originate from either side of theclamp 10. The non-parallel clamping feature of this embodiment allows theclamp 10 to accommodate a wide range of hollow anatomical structures with varying wall thicknesses throughout its length and breadth. For example, some anatomical structures such as atrial appendages 40 (FIG. 9 ) of theheart 50 have internal structures called trabeculae, which are non-uniform and very often cause variable thicknesses across one or more of their dimensions. Nonuniform clamping, therefore, can be advantageous in this application for this reason or for other reasons. -
FIG. 3 shows an alternate embodiment of aclamp 60 including two urgingmembers FIGS. 1A-1D . As is the case with thefirst clamp 10, theU-shaped urging members clamp 60 may also lie in planes generally parallel to each other and perpendicular to the axes of the clampingportions FIG. 3 may lie in the lesser force exerted byU-shape urging members portions shape urging members clamp 10 inFIGS. 1A-1D , making it more suitable for clamping of anatomical structures not requiring a relatively high clamping force. The U-shape configuration of the urgingmembers portions FIG. 3 shows a first stage of assembly of theclamp 60, where the rigidtubular members superelastic wire member 61. In this embodiment, mechanical swaging is used to join thetubular members wire 61. However, adhesives or laser welding or other methods of attachment could be easily used instead. Similarly, it will be appreciated that rigidtubular members wire member 61 at all. One may rely, for example, on designing the rigidtubular members wire 61. In addition, the rigidtubular members load spreading platens 67, 69 shown inFIG. 4 , as these alternate shapes may provide a larger area of contact against the anatomical structure to be engaged by theclamp 50. Since different anatomical structures greatly vary from subject to subject, it is advantageous to have a manufacturing method in which the length 71 of theclamp 60 can be easily varied. By cuttingrigid members -
FIG. 4 shows the next step in the assembly of the clamp.Load spreading platens 67, 69 made of plastic or other biocompatible material such as urethane, may be slipped over the titanium or other suitable material tubing that forms rigidtubular members resilient surface 73 to spread the load out onto a larger surface area, thereby preventing point source loading of the tissue which might otherwise result in cutting of the tissue before it has had a chance to become internally fused. Theplatens 67, 69 can be assembled and applied over the rigidtubular members platens 67, 69 can alternatively be manufactured in such a way so as to have a longitudinal split which allows the material to be opened and forced onto the rigidtubular members -
FIG. 5 shows theclamp 60 after afabric cover material 74 made of material such as polyester has been sewn around the clampingportions members material 74 is circular warp knit fabric tube, with a diameter of approximately 4 to 5 mm and made from a combination of 4/100, 2/100 and 1/100 textured polyester. Thematerial 74 may also be heat-treated to cause a velour effect. The fabric orother material 74 is furthermore sewn or otherwise applied over the urgingmembers fabric pieces 77 may be attached at opposite respective ends of clampingportions FIG. 9 ) between the clampingportions fabric pieces 77 act as tissue blocking members or dams at opposite ends of the clamp. This or another tissue blocking feature may also be implemented into any other embodiment. This is desirable as it minimizes the probability of unintentionally leaving any part of the engaged anatomical structure unclamped. Thematerial 77, likematerial 74, can also promote tissue ingrowth. -
FIGS. 6 and 7 show adeployment tool 80 for opening theclamp 60 sufficiently to allow anappendage 40 or other tissue or anatomical structure to be placed between the clampingportions clamp 60 from thedeployment tool 80 to allow the normal closing force of theclamp 60 to be deployed onto theappendage 40 to be treated. Thedeployment tool 80 of this embodiment is a scissor type arrangement withtransverse support members jaws arm deployment tool 80 has twospreader legs Support members handles FIGS. 6 and 7 . Thespreader legs curved receiver portions clamp 60. The receiver portions engage the clamp in opposing directions generally parallel to a plane containing both clampingportions receiver portions portions spreader legs portions clamp 60, thus preventing theclamp 60 from being released prior to proper deployment onto the treatedappendage 40 or other anatomical structure. These may include flat orcurved spreader legs FIGS. 8-10 ) or other manners of releasably joining theclamp 60 to thetool 80. -
FIGS. 6A and 6B illustrate cross sectional views ofclamp 60 held onlegs 82 b′, 82 d′. Identical numerals inFIGS. 6A and 6B represent like elements of structure as compared to the embodiment ofFIG. 6 and, therefore, further description of such elements is not necessary. Like reference numerals with prime (′) marks are slightly modified elements as between the embodiments, and as described further herein. It will be appreciated that only two of four legs are shown inFIGS. 6A and 6B , however, the remaining two legs may be identically designed.Legs 82 b′, 82 d′ haverecesses portions severable sutures FIGS. 8-10 . In this manner, after thelegs 82 b′, 82 d′ are moved from the open or spread position shown inFIG. 6A to the closed or clamping position shown inFIG. 6B to, for example, apply theclamp 60 to the leftatrial appendage 40, thelegs 82 b′, 82 d′ may simply be slipped out from between clampingportions -
FIG. 8 shows thedeployment tool 80 ofFIGS. 6 and 7 with theclamp 60 engaged in thespreader legs clamp 60 may be moved into the general anatomical area where theappendage 40 or other structure is located while theclamp 60 is in a closed position. This can allow for smaller entry wounds and/or easier maneuvering to the clamping site. Theclamp 60 is releasably held ontolegs severable sutures deployment tool 80 to securely but releasably hold theclamp 60 therefore allows for this type of pre-deployment movement to be effected without concern for the possibility of premature or unwanted separation of theclamp 60 from thetool 80. -
FIG. 9 shows adeployment tool 80 partially opening theclamp 60, applying a force sufficient to overcome the bias of the urgingmembers clamp 60 to close the clampingportions tool 80 directs the clamp in a direction generally oriented so that theappendage 40 will be approximately in the region of theannular opening 75 of theclamp 60. Theappendage 40 is placed through theopening 75 of theclamp 60 between the two urgingmembers FIG. 9 , thedeployment tool 80 securely continues to hold theclamp 60 by the clampingportions -
FIG. 10 shows theappendage 40 ofFIGS. 8 and 9 being positioned in theclamp 60. Note that thespreader legs clamp 60 open against the force of the urgingmembers clamp 60 prior to deployment. Theappendage 40 is shown beginning to cross the plane defined by the clampingportions clamp 60, while the points at which thespreader legs portions appendage 40. This prevents direct contact between thespreader legs appendage 40 during deployment or during post-deployment retrieval of thetool 80. AlthoughFIGS. 8-10 show the lateral position of thelegs spreader legs appendage 40, as described above, thelegs -
FIG. 11 shows thetissue clamp 60 having been deployed on anappendage 40. Thesutures spreader legs clamp 60, allowing the full force applied by the urgingmembers appendage 40 by the closing bias of the clampingportions clamp 60. AsFIG. 11 shows, the deployed position of theclamp 60 is such that the urgingmembers portions heart 50, so as to minimize unnecessary or undesirable contact of the urging members with theheart 50. Any other orientation or configuration of urgingmembers - Alternate embodiments show ways to add length to the urging
members members -
FIG. 12 shows an alternate embodiment of a clamp 90 whereby the urgingmembers ends rigid clamping portions Portions members member areas appendage 40 or other structure being left unclamped. The embodiment ofFIG. 12 shows urging members portions clamp 10 ofFIGS. 1A-1D . The urgingmembers straight segments members portions straight segments wire -
FIGS. 13 and 14 show an embodiment of a clamp 100 similar to clamp 90 ofFIG. 12 , however, the shape has been generally adapted to more closely match the anatomy surrounding theappendage 40 or other anatomical structure being treated. In this particular embodiment, therigid clamping portions members heart 50 or other organ or tissue surrounding the anatomical structure being treated. Another advantage of this embodiment is the ability to clamp the anatomical structure (e.g., appendage 40) at different cross-sectional planes, which may be desirable in cases where the thickness of theappendage 40 or similar structure is very irregular, making the clamping profile of this embodiment more desirable than the single cross-sectional plane clamping enabled by theclamp 10 ofFIGS. 1A-1D for example. -
FIG. 15 is yet another embodiment of aclamp 110 in which the urgingmembers rigid members 117, 118 are made of aflat spring material 111 having a generally rectangular cross-section. The construction shown inFIG. 15 is formed by fourseparate segments flat material 111, consisting of two urgingmembers portions 117, 118. The urgingmembers portions 117, 118. Side clips 119 extend from the urgingmembers rigid clamping portions 117, 118 to fix the parts together, frictionally preventing sliding of the urgingmembers portions 117, 118. Theflat clamping portions 117, 118 may be rigid or semi-rigid and can be made of various metallic or nonmetallic materials, or both. A suitable nonmetallic material would be a plastic such as a polycarbonate. A benefit of this type of flat construction lies in the ability to avoid the addition of any load-spreading surface such as theplatens 67, 69 ofFIG. 4 , since the clampingportions 117, 118 already have a relatively larger area of contact with the anatomical structure to be treated. The flat shape of the urgingmembers clamp 10 ofFIGS. 1A-1D similarly results in less point-loading on the clamped tissue or organ or surrounding tissue. The ease of assembly of the embodiment ofclamp 110 can be appreciated as yet another benefit, as the need for the steps of locating and swaging of rigidtubular members flat clamping portions 117, 118 to a desired length to accommodate for smaller anatomical structures and the ease of clip-based assembly regardless of such desired length of the clampingportions 117, 118, is also an advantage of this embodiment. -
FIG. 16 illustrates aclamp 120 in accordance with another embodiment. The construction of this embodiment is similar to that ofFIG. 12 , but the wire forming urgingmembers FIG. 12 . Thus, urgingmembers first loop sections rectilinear segments portions rectilinear segments first segments rectilinear segments rectilinear segments second loop segments 129 a, 129 b. As in the construction of the embodiment ofFIG. 12 , theloop sections members portions members members FIG. 12 . Like an axial spring, the respective ends 131 a, 131 b, 132 a, 132 b of the urgingmembers portions portions FIG. 12 , but with the added benefits that the clamping force exerted on the treated anatomical structure may be of a greater magnitude and lower internal stress may be generated in the urgingmembers -
FIG. 17 shows another embodiment of aclamp 130 in which the ends 133, 134, 135, 136 of each of the clampingportions non-parallel clamping portions areas clamp 130. -
FIG. 18 shows aclamp 140 similar to that ofFIG. 15 but with greater space between therigid members members FIG. 15 in that themiddle section 143 of the C-shape of the urgingmember -
FIGS. 19 and 19A show an alternate embodiment of aclamp 150 in which the clampingportions members clamp 150 until the anatomical structure has atrophied. Additionally, textures or porosity on thetissue gripping surfaces embodiment 150 consists of twoflat clamping portions members members notch -
FIGS. 20 , 20A and 20B show a slight variation of the embodiment ofFIGS. 19 and 19A , depicting a different manufacturing method. Thisclamp 160 is made from a tube or roll formed from sheet-metal. Lower cost manufacturing methods such as roll forming and metal piercing may be more advantageous to reduce the cost of goods versus a multiple step assembly such as that shown in other embodiments. Of course, such benefits must be weighed against any perceived advantages of the more costly designs in use. Thus, this embodiment consists of the removal of part of the surface of a tube or roll 162, with the material thus removed forming theclamp opening 161. A longitudinal split of the tube is then formed intoflat members -
FIGS. 21 and 22 show another embodiment whereby the urgingmembers rigid clamping portions elastic bands portions rigid clamping portions center 178 between the two clampingportions elastic urging members opposite clamping portions Biocompatible urging members rigid members FIG. 5 ) to promote tissue ingrowth and stability until the anatomical structure has had a chance to atrophy. -
FIGS. 23 , 24A and 24B illustrate analternative tool 200 to those discussed inFIGS. 6 , 6A, and 6B. While the tools discussed inFIGS. 6 , 6A and 6B may be used most easily in open surgical methods, it would be desirable to provide systems better suited for less invasive procedures, such as endoscopic procedures. Thetool 200 shown inFIGS. 23 , 24A and 24B is one example of a tool useful in such less invasive procedures and comprises anelongate member 202 shown broken away, but which may be formed with any suitable length for access purposes through a port in the body of a patient (e.g., subxiphoid, intercostal space, etc.). One set oflegs elongate member 202 and/or to other suitablerigid structure 205 either associated with theelongate member 202 or extending within theelongate member 202. Another set oflegs 204 c, 204 d is coupled to arotatable shaft 206 extending within theelongate member 202. The rotatable shaft or actuatingmember 206 may be rotated through the use of a suitable handle or knob (not shown), for example, located at a proximal end of thetool 200 outside the body of the patient, when in use. Thelegs respective recesses portions shaft 206, this will spread the clampingportions FIG. 24A . Rotation of theshaft 206 in the opposite direction will allow the normally closed clampingportions tool 212 further includes one or moreclamp removal members 210 coupled to anotherrotatable shaft 212 that may also be coupled to a proximally located handle or knob (not shown). When thisshaft 212 is rotated after theclamp 60 has been applied as shown inFIG. 24B , theclamp 60 will be urged or pushed away from thelegs FIG. 24B . It will be appreciated that multiple clamp removal members may be provided for contact along the length of theclamp 60 such that a more uniform removal force is applied along the length of theclamp 60. - While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in any and all combinations depending on the needs and preferences of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known.
Claims (28)
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US10314585B2 (en) | 2019-06-11 |
US20150223813A1 (en) | 2015-08-13 |
EP1906842A2 (en) | 2008-04-09 |
EP1906842A4 (en) | 2013-03-13 |
WO2007009099A3 (en) | 2007-06-07 |
EP1906842B1 (en) | 2016-12-21 |
IL188687A0 (en) | 2008-08-07 |
AU2006267056C1 (en) | 2013-03-28 |
AU2006267056B2 (en) | 2012-09-06 |
US20120059400A1 (en) | 2012-03-08 |
CA2614271C (en) | 2014-02-25 |
US20190254672A1 (en) | 2019-08-22 |
CA2614271A1 (en) | 2007-01-18 |
US10166024B2 (en) | 2019-01-01 |
AU2006267056A1 (en) | 2007-01-18 |
JP2009501570A (en) | 2009-01-22 |
WO2007009099A2 (en) | 2007-01-18 |
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