US20060116717A1 - Articulated center post - Google Patents

Articulated center post Download PDF

Info

Publication number
US20060116717A1
US20060116717A1 US11/328,917 US32891706A US2006116717A1 US 20060116717 A1 US20060116717 A1 US 20060116717A1 US 32891706 A US32891706 A US 32891706A US 2006116717 A1 US2006116717 A1 US 2006116717A1
Authority
US
United States
Prior art keywords
center
socket
occlusion device
head
sleeve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/328,917
Inventor
Joseph Marino
Michael Corcoran
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardia Inc
Original Assignee
Cardia Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cardia Inc filed Critical Cardia Inc
Priority to US11/328,917 priority Critical patent/US20060116717A1/en
Assigned to CARDIA, INC. reassignment CARDIA, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CORCORAN, MICHAEL P., MARINO, JOSEPH A.
Publication of US20060116717A1 publication Critical patent/US20060116717A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592Elastic or resilient implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening

Definitions

  • This invention relates to an occlusion device for the closure of physical apertures, such as vascular or septal apertures. More specifically, this invention relates to an occlusion device for the heart, having an articulated center post which allows the device to better conform to the contours of the heart.
  • occlusion devices are small, implantable devices capable of being delivered to the heart through a catheter. Rather than surgery, a catheter inserted into a major blood vessel allows an occlusion device to be deployed by moving the device through the catheter. This procedure is performed in a cardiac cathlab and avoids the risks and pain associated with open heart surgery.
  • These modern occlusion devices can repair a wide range of cardiac defects, including patent foramen ovale, patent ductus arteriosus, atrial septal defects, ventricular septal defects, and may occlude other cardiac and non-cardiac apertures.
  • occlusion devices capable of being inserted via a catheter
  • button devices collapsible umbrella-like structures, and plug-like devices.
  • a potential draw back to these devices is the difficulty in ensuring that the occluder conforms to the contours of the defect. Poor conformation to the defect results in poor seating of the device which decreases the ability of the device to occlude the defect.
  • Ensuring the proper seating of an occlusion device once it has been deployed poses a continuing challenge given the uneven topography of the vascular and septal walls of each patient's heart.
  • the challenge in designing an occluder which conforms to the uneven topography is compounded by the fact that the contours of each defect in each individual patient are unique.
  • Another obstacle which maybe encountered is the difficulty in readily distinguishing the individual occluder elements in order to determine their position in relation to each other and allow for repositioning, while still maintaining the flexibility needed for better conformation.
  • an occlusion device that will occlude cardiac defects and will match the contours of the heart thereby increasing the life of the device and sealing ability while reducing damage to the surrounding tissue.
  • an occlusion device that prevents rotation of the individual occluder elements around the center post, while still maintaining the needed flexibility to properly position the device and successfully match the contours of the heart.
  • the present invention allows occlusion devices to more effectively close a physical anomaly.
  • the present invention is an occlusion device having a first occluding body, a second occluding body, and an articulated center section.
  • the articulated center section increases the ability of the occlusion device to more accurately conform to the defect.
  • the center section includes a ball and socket joint and means for limiting rotation of the first occluding body relative to the second occluding body.
  • the means for limiting rotation of the first occluding body relative to the second occluding body includes interlocking elements.
  • the interlocking elements include a peg on a ball of the ball and socket joint and a groove on a socket of the ball and socket joint.
  • the interlocking elements include a groove on a ball of the ball and socket joint and a peg on a socket of the ball and socket joint.
  • the occluding bodies are rotationally limited but are still able to articulate, which allows for easier positioning of the occlusion device.
  • FIG. 1 is a perspective view of an occlusion device with an articulated center post.
  • FIG. 2 a is a diagram of a heart with a septal defect.
  • FIG. 2 b is a diagram of an occlusion device being inserted into a defect.
  • FIG. 2 c is a diagram of an occlusion device with an articulated center section being inserted into a defect.
  • FIG. 2 d is a diagram demonstrating the conformation capabilities of an occlusion device with an articulated center.
  • FIG. 3 a is a side view of an articulated center section having two joints.
  • FIG. 3 b is a side view of an articulated center section having three joints.
  • FIG. 4 is a side view of an articulated center section.
  • FIG. 5 a is a side view of a first embodiment of a second center post with rotation-inhibiting capabilities.
  • FIG. 5 b is a perspective view of a first embodiment of a second center post with rotation-inhibiting capabilities.
  • FIG. 6 is a side view of a first embodiment of a first center post with rotation-inhibiting capabilities.
  • FIG. 7 a is a side view of a second sleeve.
  • FIG. 7 b is a perspective side view of a first embodiment of the second sleeve with rotation-inhibiting capabilities.
  • FIG. 8 is a side view of a first sleeve.
  • FIG. 9 is a cross sectional view of an assembled articulated center section combining the first embodiment of a center post with rotation-inhibiting capabilities and the first embodiment of a sleeve with rotation-inhibiting capabilities.
  • FIG. 10 is a sectional view of the center section along section 10 - 10 of FIG. 9 .
  • FIG. 11 is a perspective side view of a second embodiment of a center post with rotation-inhibiting capabilities.
  • FIG. 12 shows a cross sectional view of an assembled articulated center section combining the second embodiment of a center post with rotation-inhibiting capabilities and the second embodiment of a sleeve of a center connector with rotation-inhibiting capabilities.
  • FIG. 13 is a sectional view of the center section along section 13 - 13 of FIG. 12 .
  • FIG. 1 is a top perspective view of occlusion device 10 .
  • occlusion device 10 comprises center section 12 , proximal fixation device 14 , six arms 16 , atraumatic tips 18 , proximal sheet 20 , distal sheet 22 , knob 24 , sutures 28 , and distal fixation device 30 .
  • Proximal and distal fixation devices 14 , 30 are attached to sheets 20 , 22 using sutures 28 .
  • Proximal and distal fixation devices 14 , 30 are connected to center post 12 .
  • One method of connecting arms 16 to center section 12 is to provide center section 12 with drill holes through which arms 16 extend.
  • Atraumatic tips 18 are located at the distal end of each arm 16 and serve to minimize damage to the surrounding tissue.
  • Atraumatic tips 18 provide a place for sutures 28 to attach sheets 20 , 22 to proximal and distal fixation devices 14 , 30 .
  • One method of suturing sheets 20 , 22 to proximal and distal fixation devices 14 , 30 is to provide atraumatic tips 18 with drill holes through which sutures 28 pass. In this way, sheets 20 , 22 are sewn to fixation devices 14 , 30 at atraumatic tips 18 . More specifically, occlusion device 10 is constructed so that proximal and distal fixation devices 14 , 30 are easily collapsible about center section 12 .
  • occlusion device 10 can be folded so that fixation devices 14 , 30 are folded in the axial direction.
  • Proximal and distal sheets 20 , 22 which are attached to proximal and distal fixation devices 14 , 30 are flexible, and can likewise collapse as proximal and distal devices 14 , 30 are folded.
  • center section 12 further comprises knob 24 . Knob 24 allows for occlusion device 10 to be grasped as it is inserted into the body through the catheter.
  • fixation devices 14 , 30 serve to hold proximal and distal sheets 20 , 22 in place to seal the defect.
  • fixation devices 14 , 30 are made of a suitable material capable of shape memory, such as nickel-titanium alloy, commonly called Nitinol.
  • Nitinol is preferably used because it is commercially available, very elastic, non-corrosive, and has a fatigue life greater than that of stainless steel.
  • one embodiment of the present invention relies on making fixation devices 14 , 30 of stranded wire or cables.
  • Center section 12 shown in occlusion device 10 is articulated.
  • the articulation can be accomplished by a variety of methods.
  • the articulation could comprise one or more joints, or hinges. It could also be a spring or a coil. Additionally, a spot specific reduction in the amount of material used to create center section 12 could render portions of center section 12 sufficiently flexible.
  • Center section 12 is preferably formed to have a diameter of between about 8 millimeters and about 0.1 millimeters. In addition, the length of center section 12 is preferably less than about 20 millimeters.
  • Sheets 20 , 22 are comprised of a medical grade polymer in the form of film, foam, gel, or a combination thereof.
  • a medical grade polymer in the form of film, foam, gel, or a combination thereof.
  • One suitable material is DACRON®.
  • a high density polyvinyl alcohol (PVA) foam is used, such as that offered under the trademark IVALON®.
  • foam sheets 20 , 22 may be treated with a thrombosis inhibiting material.
  • a thrombosis inhibiting material is heparin.
  • the size of sheets 20 , 22 may vary to accommodate various sizes of defects. When measured diagonally, the size of sheets 20 , 22 may range from about 15 millimeters to about 45 millimeters. In some instances, it maybe desirable to form sheets 20 , 22 so that they are not both the same size. For instance, one sheet and its associated fixation device can be made smaller (25 millimeters) than the corresponding sheet and its associated fixation device (30 millimeters). This is particularly useful in situations where occlusion device 10 is to be placed at a location in the heart which is close to other nearby cardiac structures. Making sheets 20 , 22 different sizes may assist in providing optimal occlusion of a defect, without affecting other structures of the heart which may be nearby.
  • FIGS. 2 a - 2 d illustrate the method by which occlusion device 10 is deployed.
  • FIG. 2 a is a diagrammatic view of human heart 31 . Shown in FIG. 2 a is right atrium 32 , left atrium 34 , right ventricle 36 , left ventricle 38 . Right atrium 32 is separated from left atrium 34 by atrial septal wall 40 . Right ventricle 36 is separated from left ventricle 38 by ventricular septal wall 42 . Also visible in FIG. 2 a is atrial septal defect 44 located in atrial septal wall 40 , between right atrium 32 and left atrium 34 of heart 31 . Atrial septal defect 44 is one example of a cardiac defect that may be occluded using occlusion device 10 .
  • FIG. 2 b illustrates occlusion device 10 being inserted into a septal defect. Shown is center section 12 , right atrium 32 , left atrium 34 , septal wall 40 , septal defect 44 , catheter 50 , and delivery forceps 52 . As viewed in FIG. 2 b, occlusion device 10 comprises distal side 54 , proximal side 56 , and center section 12 . Occlusion device 10 is being inserted into septal defect 44 from catheter 50 . Occlusion device 10 is tethered to delivery forceps 52 . To insert occlusion device 10 , catheter 50 is positioned proximate septal defect 44 .
  • delivery forceps 52 is used to push occlusion device 10 through catheter 50 so that distal side 54 of occlusion device 10 unfolds in left atrium 34 .
  • distal side 54 has been deployed, proximal side 56 is still folded in catheter 50 .
  • catheter 50 determines the location of and angle at which occlusion device 10 is deployed. Once catheter 50 is properly positioned at septal defect 44 , delivery forceps 52 is used to push occlusion device 10 through septal defect 44 . Distal side 54 of occlusion device 10 is then allowed to expand against septal wall 40 surrounding septal defect 44 .
  • center section 12 is articulated but the articulation remains inside catheter 50 and is therefore immobilized. If center section 12 of occlusion device 10 is not articulated (or articulated but immobilized), center section 12 must enter septal defect 44 following the same angle of insertion as catheter 50 or other delivery device. As a result, the insertion angle is limited by the catheter's angle of insertion.
  • catheter 50 enters the heart at an angle that is not perpendicular to the defective wall.
  • occlusion device 10 cannot enter septal defect 44 properly because the line of center section 12 must follow the same line as catheter 50 .
  • Occlusion device 10 must be forced into septal defect 44 at an angle, which may cause the tissue surrounding defect 44 to become distorted. If the surrounding cardiac tissue is distorted by catheter 50 , it is difficult to determine whether occlusion device 10 will be properly seated once catheter 50 is removed and the tissue returns to its normal state. If occlusion device 10 is not seated properly, blood will continue to flow through septal defect 44 and occlusion device 10 may have to be retrieved and re-deployed. Both doctors and patients prefer to avoid retrieval and re-deployment because it causes additional expense and longer procedure time.
  • FIG. 2 c shows occlusion device 10 with articulated center section 12 being inserted into defect 44 . Shown once again is occlusion device 10 , septal wall 40 , defect 44 , catheter 50 , distal side 54 , and proximal side 56 . Also, shown is joint 62 . In FIG. 2 c, occlusion device 10 has been further advanced through catheter 50 to expose articulated center section 12 comprising joint 62 .
  • the insertion angle of occlusion device 10 is not restricted to that of catheter 50 .
  • Occlusion device 10 can be more easily inserted, because once joint 62 is outside catheter 50 , the angle of insertion can be changed by allowing joint 62 to move.
  • This variable insertion angle allows occlusion device 10 to enter defect 44 at an optimum angle, minimizing distortion of surrounding cardiac tissue. If the tissue is not distorted when occlusion device 10 is deployed, the seating of occlusion device 10 should not change drastically once catheter 50 is removed. Because occlusion device 10 can be properly seated at the first insertion, the number of cases that require retrieval and redeployment should decrease.
  • FIG. 2 d shows occlusion device 10 , which is fully deployed and is occluding defect 44 . Shown in FIG. 2 d is articulated center section 12 , septal wall 40 , defect 44 , distal side 54 , proximal side 56 , and joint 62 . Distal side 54 has been properly positioned, proximal side 56 has been deployed and occlusion device 10 has been released. FIG. 2 d also demonstrates the ability of occlusion device 10 with articulated center section 12 to conform to an irregularly shaped defect 44 .
  • articulated center section 12 allows distal and proximal sides 54 , 56 to conform more readily to the contours of a heart after it is deployed, providing a custom fit to a variety of defects. Often, when implanted, occlusion device 10 is located in an irregularly shaped defect. Having articulated center section 12 allows occlusion device 10 to conform to a broader spectrum of defects.
  • septal wall 40 on the bottom of septal defect 44 may be only a few millimeters thick, but septal wall 40 on the top of septal defect 44 may be much thicker.
  • one side of occlusion device 10 may be bent open further than the other side. The side that is more distorted carries a high static load which increases pressure on the surrounding tissue and also increases the possibility of breakage If center section 12 is articulated, it can bend such that proximal and distal fixation devices 14 , 30 need not be the only the only parts which adjust to fit septal defect 44 .
  • the ability to conform to a variety of heart contours results in better seating, reduces tension (increasing fatigue life), and decreases the likelihood of damage to tissue resulting from breakage and from pressure exerted on surrounding tissue.
  • occlusion device 10 is fully retrievable. To allow occlusion device 10 to be retrievable, as well as ensure that occlusion device 10 fits into a small diameter catheter, it is important to ensure that arms 16 are not of a length that results in atraumatic tips 18 clustering at the same location. If atraumatic tips 18 all cluster at the same location when occlusion device 10 is inside catheter 50 , occlusion device 10 will become too bulky to allow it to be easily moved through catheter 50 .
  • FIG. 3 a is a perspective view of articulated center section 70 , which has double articulation. Shown in FIG. 3 a is knob 24 , articulated center section 70 , first center post 72 , second center post 74 , center connector 76 , joints 78 , and holes 80 . As viewed in FIG. 3 a, center section 70 comprises first center post 72 , second center post 74 , and center connector 76 . Knob 24 is located on second center post 74 . Both first and second center posts 72 , 74 have three holes 80 drilled through them. Center section 70 further comprises two joints 78 which are located on each end of center connector 76 .
  • Joints 78 connect first and second center posts 72 , 74 to center connector 76 and allow for first and second center posts 72 , 74 to rotate relative to center connector 76 .
  • Wire arms 16 ( FIG. 1 ) attach to center section 70 bypassing through holes 80 drilled through first and second center posts 72 , 74 .
  • joint 78 provides the articulation. Though shown with double articulation, articulated center section 70 is not so limited. The number of joints 78 may be varied to accommodate a particular defect or a particular type of defect. For example, one joint may be best for an atrial septal defect while two or three articulations may be best for a larger defect such as patent foramen ovale or a long defect such as patent ductus arteriosus.
  • FIG. 3 b is a side view of articulated center section 90 with triple articulation, which demonstrates the broad range of flexibility possible. Shown is knob 24 , holes 80 , first center post 92 , second center post 94 , two center connectors 96 , joining part 98 , and three joints 100 .
  • the large amount of flexibility allows the occlusion device to conform to a wide variety of defects.
  • FIG. 4 is an enlarged side view of articulated center section 70 , showing center section 70 in more detail. Shown is knob 24 , first center post 72 , second center post 74 , center connector 76 , first sleeve 112 , second sleeve 114 , and two joints 116 , 118 .
  • First sleeve 112 and second sleeve 114 comprise center connector 76 .
  • Second center post 74 connects to center connector 76 by joining second sleeve 114 at joint 116 .
  • First center post 72 connects to center connector 76 by joining first sleeve 112 at joint 118 .
  • occluder elements will be attached to first and second center posts 72 , 74 , as can be seen in FIG. 1 .
  • preventing rotation of the occluder elements may improve the overall positioning of the device. For example, when inserting a device that allows freedom of rotation, if upon the insertion of the device, the arms of a support frame are laying in an undesirable position, such as resting against the aorta, simply manipulating the device to reposition the arms may not be possible because the center post will rotate consistently relative to the occluder element, leaving the arms in the original position.
  • the preliminary loading of the device may be hindered if rotation of the support frames is not prevented.
  • loading the occlusion device into a delivery device or catheter may be more difficult and time-consuming.
  • FIG. 5 a is a side view of a first embodiment of second center post 74 with rotation-inhibiting capabilities. Shown is knob 24 , three holes 80 , second center post 74 , head 120 , first neck 122 , body 124 , second neck 126 , and pegs 138 a - c. Peg 138 d cannot be seen from this perspective. As described with reference to FIG. 1 , three holes 80 are drilled through second center post 74 to allow for attachment of wire arms 16 .
  • Head 120 located at a first end of second center post 74 is connected to body 124 of second center post 74 at first neck 122 .
  • Knob 24 is located on the second end of body 124 and is connected to body 124 by second neck 126 .
  • the body 124 of second center post 74 is preferably smaller in diameter than head 120 .
  • Knob 24 has a smaller diameter than both body 124 and head 120 .
  • head 120 may have a diameter A of about 1.35 millimeters
  • body 124 may have a diameter B of about 1.2 millimeters
  • knob 24 may have a diameter C of about 1.0 millimeter.
  • Knob 24 is configured to allow a delivery forceps to attach to occlusion device 10 as it is pushed through a catheter and allows the forceps to manipulate occlusion device 10 as it is delivered. Likewise, a guide forceps can be used to position occlusion device 10 once it reaches the desired location or to retrieve occlusion device 10 should it not be seated properly. Knob 24 may additionally have a cross sectional area which allows the forceps to rotatably move occlusion device 10 while occlusion device 10 is inserted into septal defect 44 . Second neck 126 is grasped by a forceps so that there is at least some play between the forceps and second neck 126 when pushing occlusion device 10 through a catheter. For example, the guide forceps may engage second neck 126 by means of a claw-like or hook-like end. In an alternate embodiment, knob 24 is threaded to allow for attachment to a threaded guide forceps.
  • FIG. 5 b is a perspective side view of the first embodiment of second center post 74 with rotation-inhibiting capabilities. Shown is knob 24 , center post 74 , holes 80 , head 120 , first neck 122 , body 124 , second neck 126 , and pegs 138 a - 138 d.
  • head 120 includes pegs 138 a - 138 d positioned around its circumference.
  • Pegs 138 a - 138 d are shown evenly spaced to provide articulation about two orthogonal axes when coupled with a center connector, as described in detail in FIG. 9 .
  • FIG. 6 is a perspective view of a first embodiment of first center post 72 with rotation-inhibiting capabilities. Shown is first center post 72 , three holes 80 , head 130 , first neck 132 , body 134 , and pegs 138 a - 138 c. Peg 138 d cannot be seen from this perspective. Once again, three holes 80 are drilled through first center post 72 to allow for attachment of wire arms 16 .
  • First center post 72 is nearly identical to second center post 74 except that it does not include knob 24 or second neck 126 . Because occlusion device 10 only needs to be graspable at one end, a second knob is unnecessary.
  • body 134 of first center post 72 is preferably smaller in diameter than head 130 .
  • head 130 may have a diameter D of about 1.35 millimeters
  • body 134 may have a diameter E of about 1.2 millimeters.
  • a hard metal such as titanium
  • a hard material prevents binding within the joints when the center section if fully assembled.
  • Pegs 138 a - 138 d may be machined directly into the titanium, using a process such as electrical discharge machining.
  • heads 120 , 130 are shown with four pegs 138 a - 138 d, the present invention is not so limited. Heads 120 , 130 may include any number of pegs, including as few as one peg.
  • FIGS. 7 a and 7 b show side and perspective views of second sleeve 114 .
  • FIG. 7 b shows sleeve 114 , channel 139 a, and socket 152 .
  • Channels 139 b - 139 d cannot be seen from this perspective.
  • Channels 139 a - 139 d may be machined directly into the titanium, using a process such as electrical discharge machining.
  • the number of channels 139 a - 139 d formed in socket 152 corresponds to the number of pegs 138 a - 138 d formed on head 120 .
  • Pegs 138 a - 138 d and channels 139 a - 139 d are identically spaced, which allows for pegs 138 a - 138 d and channels 139 a - 139 d to engage upon assembly, as described in FIG. 9 .
  • Sleeve 114 may include any number of channels, including as few as one channel.
  • FIG. 8 is a side view of first sleeve 112 .
  • First sleeve 112 includes cuff 140 , which is configured to fit inside second sleeve 114 when center connector 76 is assembled. As shown more clearly in FIG. 10 , once assembled, sleeves 112 , 114 can be permanently attached at cuff 140 , for example by welding.
  • a hard metal such as titanium is used to construct sleeves 112 , 114 because use of a hard material prevents binding within the joints when the center section is fully assembled.
  • FIG. 9 shows a cross sectional view of an assembled articulated center section combining the first embodiment of a center post with rotation-inhibiting capabilities and the first embodiment of a sleeve of a center connector with rotation-inhibiting capabilities. Shown is knob 24 , first center post 72 , second center post 74 , center connector 76 , holes 80 , first sleeve 112 , second sleeve 114 , head 120 , first neck 122 , body 124 , second neck 126 , head 130 , neck 132 , body 134 , pegs 138 a and 138 c, channels 139 a - 139 c, cuff 140 , first socket 152 , and second socket 154 .
  • Sleeves 112 , 114 have been welded together to form center connector 76 . Pegs 138 b and 138 d, and channel 139 d cannot be seen in this view.
  • FIG. 10 is a sectional view of the first embodiment of the center section along section 10 - 10 of FIG. 9 showing the interaction between pegs 138 a - 138 d located on head 120 and channels 139 a - 139 d located within socket 152 of sleeve 114 . Shown is head 120 , pegs 138 a - 138 d, sleeve 114 , channels 139 a - 139 d, and socket 152 .
  • Socket 152 of sleeve 114 houses head 120 .
  • Pegs 138 a - 138 d located on head 120 engage channels 139 a - 139 d located within socket 152 . While shown with respect to head 120 and sleeve 114 , as shown in FIG. 9 , head 130 and sleeve 112 interact similarly.
  • center posts 72 , 74 are slipped into corresponding sleeves 112 , 114 .
  • the diameter of each head 120 , 130 is less than the diameter of each body 124 , 134 .
  • bodies 124 , 134 are small enough to fit through sockets 152 , 154 but heads 120 , 130 are too large to fit through sockets 152 , 154 .
  • center post 72 is slipped through socket 154 of sleeve 112
  • body 134 extends out through socket 154 .
  • Head 130 remains inside sleeve 112 .
  • center post 74 is placed through socket 152 of sleeve 114
  • body 124 extends out through socket 152 .
  • Head 120 remains inside sleeve 114 .
  • center posts 72 , 74 When inserting center posts 72 , 74 into sleeves 112 , 114 , pegs 138 a - 138 d and channels 139 a - 139 d must be correlated to each other.
  • center post 72 Prior to insertion into sleeve 112 , center post 72 should be rotated so that pegs 138 a - 138 d on head 130 are positioned to slide into corresponding channels 139 a - 139 d located within socket 154 .
  • center post 174 Prior to insertion into sleeve 114 , center post 174 should be rotated so that pegs 138 a - 138 d on head 120 are positioned to slide into corresponding channels 139 a - 139 d located within socket 152 .
  • the resulting assembly forms two ball and socket joints, which are able to articulate (i.e. pivot) but are rotationally inhibited.
  • pegs 138 a - 138 d and channels 139 a - 139 d engage. Since pegs 138 a - 138 d of heads 120 , 130 are housed within channels 139 a - 139 d of sleeves 112 , 114 , the rotational movement of center posts 72 , 74 with respect to central connector 76 is prevented. In other words, center posts 72 , 74 are prevented from turning around an axis extending through sockets 152 , 154 .
  • FIG. 11 is a perspective side view of a second embodiment of a center post with rotation-inhibiting capabilities. Shown is knob 24 , center post 74 , holes 80 , head 120 , first neck 122 , body 124 , second neck 126 , and channels 139 a - 139 b.
  • head 120 includes channels 139 a - 139 b located concentrically around the rounded surface of head 120 .
  • Channels 139 a - 139 b may be evenly spaced to provide better articulation when coupled with a center connector, as described in FIG. 12 .
  • Center post 74 is preferably formed of a hard metal, such as titanium.
  • Channels 139 a - 139 b may be machined directly into the titanium, using a process such as electrical discharge machining.
  • head 120 is shown with two channels 139 a - 139 b, the present invention is not so limited. Head 120 may include any number of channels 139 a - 139 b, including as few as one channel 139 a - 139 b.
  • this embodiment is shown with respect to center post 74 , which includes second neck 126 and knob 24 , channels 139 a - 139 b may be added to a center post that does not include these features, as shown with respect to center post 72 in FIG. 12 .
  • FIG. 12 shows a cross sectional view of an assembled articulated center section combining the second embodiment of a center post with rotation-inhibiting capabilities and the second embodiment of a sleeve of a center connector with rotation-inhibiting capabilities. Shown is knob 24 , first center post 72 , second center post 74 , center connector 76 , holes 80 , first sleeve 112 , second sleeve 114 , head 120 , first neck 122 , body 124 , second neck 126 , head 130 , neck 132 , body 134 , pegs 138 a and 138 c, channels 139 a - 139 b, cuff 140 , first socket 152 , and second socket 154 .
  • Sleeves 112 , 114 have been welded together to comprise center connector 76 . Peg 138 b and peg 138 d cannot be seen from this perspective.
  • FIG. 13 is a sectional view of the first embodiment of the center section along section 13 - 13 of FIG. 12 showing the interaction between pegs 138 a - 138 d located within socket 152 of sleeve 114 and channels 139 a - 139 b located on head 120 . Shown is sleeve 114 , head 120 , pegs 138 a - 138 d, channels 139 a - 139 b, and socket 152 .
  • Socket 152 of sleeve 114 houses head 120 .
  • Pegs 138 a - 138 d located within socket 152 engage channels 139 a - 139 b located on head 120 . While shown with respect to head 120 and sleeve 114 , as shown in FIG. 12 , head 130 and sleeve 112 interact similarly.
  • center posts 72 , 74 are slipped into corresponding sleeves 112 , 114 .
  • the diameter of each head 120 , 130 is less than the diameter of each body 124 , 134 .
  • bodies 124 , 134 are small enough to fit through sockets 152 , 154 but heads 120 , 130 are too large to fit through sockets 152 , 154 .
  • center post 72 is slipped through socket 154 of sleeve 112
  • body 134 extends out through socket 154 .
  • Head 130 remains inside sleeve 112 .
  • center post 74 is placed through socket 152 of sleeve 114
  • body 124 extends out through socket 152 .
  • Head 120 remains inside sleeve 114 .
  • center posts 72 , 74 When inserting center posts 72 , 74 into sleeves 112 , 114 , pegs 138 a - 138 d and channels 139 a - 139 b must be correlated to each other.
  • center post 72 Prior to insertion into sleeve 112 , center post 72 should be rotated so that channels 139 a - 139 b on head 130 are positioned to slide onto corresponding pegs 138 a - 138 d located within socket 154 .
  • center post 174 Prior to insertion into sleeve 114 , center post 174 should be rotated so that channels 139 a - 139 b on head 120 are positioned to slide onto corresponding pegs 138 a - 138 d located within socket 152 .
  • the resulting assembly forms two ball and socket joints, which are able to articulate but are rotationally inhibited.
  • pegs 138 a - 138 d and channels 139 a - 139 b engage. Since pegs 138 a - 138 d of sleeves 112 , 114 are housed within channels 139 a - 139 b of heads 120 , 130 , the rotational movement of center posts 72 , 74 with respect to central connector 76 is prevented. In other words, center posts 72 , 74 are prevented from turning around an axis extending through sockets 152 , 154 . As previously described, preventing rotation of center posts 72 , 74 in relation to sleeves 112 , 114 improves the overall positioning of the device. It also is easier to distinguish individual occluder elements, and the preliminary loading of the occlusion device into a catheter may be simplified.
  • an articulated center post can be adapted for use in any occluding device, including those designed for atrial septal defects, patent ductus arteriosus, and ventricular septal defects.
  • the center section can also be adapted for use in an septal stabilization device.

Abstract

This invention relates to an occlusion device for the heart, having an articulated center post which prevents rotation of the individual occluder elements around the center post, while allowing the device to better conform to the contours of the heart to increase sealing abilities and reduce breakage resulting from conformation pressure.

Description

    CROSS-REFERENCE TO RELATED APPLICATION(S)
  • This application is a continuation-in-part of U.S. application Ser. No. 10/348,865, filed Jan. 22, 2003.
  • BACKGROUND OF THE INVENTION
  • This invention relates to an occlusion device for the closure of physical apertures, such as vascular or septal apertures. More specifically, this invention relates to an occlusion device for the heart, having an articulated center post which allows the device to better conform to the contours of the heart.
  • Normally, permanently repairing certain cardiac defects in adults and children requires open heart surgery, a risky, expensive, and painful procedure. To avoid the risks and discomfort associated with open heart surgery, modern occlusion devices have been developed that are small, implantable devices capable of being delivered to the heart through a catheter. Rather than surgery, a catheter inserted into a major blood vessel allows an occlusion device to be deployed by moving the device through the catheter. This procedure is performed in a cardiac cathlab and avoids the risks and pain associated with open heart surgery. These modern occlusion devices can repair a wide range of cardiac defects, including patent foramen ovale, patent ductus arteriosus, atrial septal defects, ventricular septal defects, and may occlude other cardiac and non-cardiac apertures.
  • There are currently several types of occlusion devices capable of being inserted via a catheter including button devices, collapsible umbrella-like structures, and plug-like devices. A potential draw back to these devices is the difficulty in ensuring that the occluder conforms to the contours of the defect. Poor conformation to the defect results in poor seating of the device which decreases the ability of the device to occlude the defect. Ensuring the proper seating of an occlusion device once it has been deployed poses a continuing challenge given the uneven topography of the vascular and septal walls of each patient's heart. The challenge in designing an occluder which conforms to the uneven topography is compounded by the fact that the contours of each defect in each individual patient are unique.
  • Lack of conformation to the walls of the heart can place significant amounts of stress on the occlusion device and decrease fatigue life. Once deployed, different parts of the occluder may experience more or less stress as a result of the uneven topography. At some point, stressed parts of the occluder may break. Broken parts increase the likelihood of damage to the surrounding tissue and lead to patient anxiety.
  • Another obstacle which maybe encountered is the difficulty in readily distinguishing the individual occluder elements in order to determine their position in relation to each other and allow for repositioning, while still maintaining the flexibility needed for better conformation.
  • Thus, there is a need in the art for an occlusion device that will occlude cardiac defects and will match the contours of the heart thereby increasing the life of the device and sealing ability while reducing damage to the surrounding tissue. There is also a need for an occlusion device that prevents rotation of the individual occluder elements around the center post, while still maintaining the needed flexibility to properly position the device and successfully match the contours of the heart.
  • BRIEF SUMMARY OF THE INVENTION
  • The present invention allows occlusion devices to more effectively close a physical anomaly. The present invention is an occlusion device having a first occluding body, a second occluding body, and an articulated center section. The articulated center section increases the ability of the occlusion device to more accurately conform to the defect.
  • The center section includes a ball and socket joint and means for limiting rotation of the first occluding body relative to the second occluding body. The means for limiting rotation of the first occluding body relative to the second occluding body includes interlocking elements. In a first embodiment, the interlocking elements include a peg on a ball of the ball and socket joint and a groove on a socket of the ball and socket joint. In a second embodiment, the interlocking elements include a groove on a ball of the ball and socket joint and a peg on a socket of the ball and socket joint. The occluding bodies are rotationally limited but are still able to articulate, which allows for easier positioning of the occlusion device.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of an occlusion device with an articulated center post.
  • FIG. 2 a is a diagram of a heart with a septal defect.
  • FIG. 2 b is a diagram of an occlusion device being inserted into a defect.
  • FIG. 2 c is a diagram of an occlusion device with an articulated center section being inserted into a defect.
  • FIG. 2 d is a diagram demonstrating the conformation capabilities of an occlusion device with an articulated center.
  • FIG. 3 a is a side view of an articulated center section having two joints.
  • FIG. 3 b is a side view of an articulated center section having three joints.
  • FIG. 4 is a side view of an articulated center section.
  • FIG. 5 a is a side view of a first embodiment of a second center post with rotation-inhibiting capabilities.
  • FIG. 5 b is a perspective view of a first embodiment of a second center post with rotation-inhibiting capabilities.
  • FIG. 6 is a side view of a first embodiment of a first center post with rotation-inhibiting capabilities.
  • FIG. 7 a is a side view of a second sleeve.
  • FIG. 7 b is a perspective side view of a first embodiment of the second sleeve with rotation-inhibiting capabilities.
  • FIG. 8 is a side view of a first sleeve.
  • FIG. 9 is a cross sectional view of an assembled articulated center section combining the first embodiment of a center post with rotation-inhibiting capabilities and the first embodiment of a sleeve with rotation-inhibiting capabilities.
  • FIG. 10 is a sectional view of the center section along section 10-10 of FIG. 9.
  • FIG. 11 is a perspective side view of a second embodiment of a center post with rotation-inhibiting capabilities.
  • FIG. 12 shows a cross sectional view of an assembled articulated center section combining the second embodiment of a center post with rotation-inhibiting capabilities and the second embodiment of a sleeve of a center connector with rotation-inhibiting capabilities.
  • FIG. 13 is a sectional view of the center section along section 13-13 of FIG. 12.
  • DETAILED DESCRIPTION
  • FIG. 1 is a top perspective view of occlusion device 10. As viewed in FIG. 1, occlusion device 10 comprises center section 12, proximal fixation device 14, six arms 16, atraumatic tips 18, proximal sheet 20, distal sheet 22, knob 24, sutures 28, and distal fixation device 30. Proximal and distal fixation devices 14, 30 are attached to sheets 20, 22 using sutures 28. Proximal and distal fixation devices 14, 30 are connected to center post 12. One method of connecting arms 16 to center section 12 is to provide center section 12 with drill holes through which arms 16 extend. Atraumatic tips 18 are located at the distal end of each arm 16 and serve to minimize damage to the surrounding tissue. Atraumatic tips 18 provide a place for sutures 28 to attach sheets 20, 22 to proximal and distal fixation devices 14, 30. One method of suturing sheets 20, 22 to proximal and distal fixation devices 14, 30 is to provide atraumatic tips 18 with drill holes through which sutures 28 pass. In this way, sheets 20, 22 are sewn to fixation devices 14, 30 at atraumatic tips 18. More specifically, occlusion device 10 is constructed so that proximal and distal fixation devices 14, 30 are easily collapsible about center section 12. Due to this construction, occlusion device 10 can be folded so that fixation devices 14, 30 are folded in the axial direction. Proximal and distal sheets 20, 22, which are attached to proximal and distal fixation devices 14, 30 are flexible, and can likewise collapse as proximal and distal devices 14, 30 are folded. In addition, center section 12 further comprises knob 24. Knob 24 allows for occlusion device 10 to be grasped as it is inserted into the body through the catheter.
  • Once occlusion device 10 is deployed, fixation devices 14, 30 serve to hold proximal and distal sheets 20, 22 in place to seal the defect. To ensure there is sufficient tension to hold sheets 20, 22 in place, fixation devices 14, 30 are made of a suitable material capable of shape memory, such as nickel-titanium alloy, commonly called Nitinol. Nitinol is preferably used because it is commercially available, very elastic, non-corrosive, and has a fatigue life greater than that of stainless steel. To further ensure that fixation devices 14, 30 do not suffer from fatigue failures, one embodiment of the present invention relies on making fixation devices 14, 30 of stranded wire or cables.
  • Center section 12 shown in occlusion device 10 is articulated. The articulation can be accomplished by a variety of methods. The articulation could comprise one or more joints, or hinges. It could also be a spring or a coil. Additionally, a spot specific reduction in the amount of material used to create center section 12 could render portions of center section 12 sufficiently flexible.
  • Center section 12 is preferably formed to have a diameter of between about 8 millimeters and about 0.1 millimeters. In addition, the length of center section 12 is preferably less than about 20 millimeters.
  • Sheets 20, 22 are comprised of a medical grade polymer in the form of film, foam, gel, or a combination thereof. One suitable material is DACRON®. Preferably, a high density polyvinyl alcohol (PVA) foam is used, such as that offered under the trademark IVALON®. To minimize the chance of occlusion device 10 causing a blood clot, foam sheets 20, 22 may be treated with a thrombosis inhibiting material. One such suitable material is heparin.
  • The size of sheets 20, 22 may vary to accommodate various sizes of defects. When measured diagonally, the size of sheets 20, 22 may range from about 15 millimeters to about 45 millimeters. In some instances, it maybe desirable to form sheets 20, 22 so that they are not both the same size. For instance, one sheet and its associated fixation device can be made smaller (25 millimeters) than the corresponding sheet and its associated fixation device (30 millimeters). This is particularly useful in situations where occlusion device 10 is to be placed at a location in the heart which is close to other nearby cardiac structures. Making sheets 20, 22 different sizes may assist in providing optimal occlusion of a defect, without affecting other structures of the heart which may be nearby.
  • FIGS. 2 a-2 d illustrate the method by which occlusion device 10 is deployed. FIG. 2 a is a diagrammatic view of human heart 31. Shown in FIG. 2 a is right atrium 32, left atrium 34, right ventricle 36, left ventricle 38. Right atrium 32 is separated from left atrium 34 by atrial septal wall 40. Right ventricle 36 is separated from left ventricle 38 by ventricular septal wall 42. Also visible in FIG. 2 a is atrial septal defect 44 located in atrial septal wall 40, between right atrium 32 and left atrium 34 of heart 31. Atrial septal defect 44 is one example of a cardiac defect that may be occluded using occlusion device 10.
  • FIG. 2 b illustrates occlusion device 10 being inserted into a septal defect. Shown is center section 12, right atrium 32, left atrium 34, septal wall 40, septal defect 44, catheter 50, and delivery forceps 52. As viewed in FIG. 2 b, occlusion device 10 comprises distal side 54, proximal side 56, and center section 12. Occlusion device 10 is being inserted into septal defect 44 from catheter 50. Occlusion device 10 is tethered to delivery forceps 52. To insert occlusion device 10, catheter 50 is positioned proximate septal defect 44. Next, delivery forceps 52 is used to push occlusion device 10 through catheter 50 so that distal side 54 of occlusion device 10 unfolds in left atrium 34. Although distal side 54 has been deployed, proximal side 56 is still folded in catheter 50.
  • The placement of catheter 50, or other means that guides occlusion device 10 to septal defect 44, determines the location of and angle at which occlusion device 10 is deployed. Once catheter 50 is properly positioned at septal defect 44, delivery forceps 52 is used to push occlusion device 10 through septal defect 44. Distal side 54 of occlusion device 10 is then allowed to expand against septal wall 40 surrounding septal defect 44.
  • In FIG. 2 b, center section 12 is articulated but the articulation remains inside catheter 50 and is therefore immobilized. If center section 12 of occlusion device 10 is not articulated (or articulated but immobilized), center section 12 must enter septal defect 44 following the same angle of insertion as catheter 50 or other delivery device. As a result, the insertion angle is limited by the catheter's angle of insertion.
  • Often, due to limited space, catheter 50 enters the heart at an angle that is not perpendicular to the defective wall. In this situation, occlusion device 10 cannot enter septal defect 44 properly because the line of center section 12 must follow the same line as catheter 50. Occlusion device 10 must be forced into septal defect 44 at an angle, which may cause the tissue surrounding defect 44 to become distorted. If the surrounding cardiac tissue is distorted by catheter 50, it is difficult to determine whether occlusion device 10 will be properly seated once catheter 50 is removed and the tissue returns to its normal state. If occlusion device 10 is not seated properly, blood will continue to flow through septal defect 44 and occlusion device 10 may have to be retrieved and re-deployed. Both doctors and patients prefer to avoid retrieval and re-deployment because it causes additional expense and longer procedure time.
  • FIG. 2 c shows occlusion device 10 with articulated center section 12 being inserted into defect 44. Shown once again is occlusion device 10, septal wall 40, defect 44, catheter 50, distal side 54, and proximal side 56. Also, shown is joint 62. In FIG. 2 c, occlusion device 10 has been further advanced through catheter 50 to expose articulated center section 12 comprising joint 62.
  • When center section 12 is articulated or flexible, the insertion angle of occlusion device 10 is not restricted to that of catheter 50. Occlusion device 10 can be more easily inserted, because once joint 62 is outside catheter 50, the angle of insertion can be changed by allowing joint 62 to move. This variable insertion angle allows occlusion device 10 to enter defect 44 at an optimum angle, minimizing distortion of surrounding cardiac tissue. If the tissue is not distorted when occlusion device 10 is deployed, the seating of occlusion device 10 should not change drastically once catheter 50 is removed. Because occlusion device 10 can be properly seated at the first insertion, the number of cases that require retrieval and redeployment should decrease.
  • FIG. 2 d shows occlusion device 10, which is fully deployed and is occluding defect 44. Shown in FIG. 2 d is articulated center section 12, septal wall 40, defect 44, distal side 54, proximal side 56, and joint 62. Distal side 54 has been properly positioned, proximal side 56 has been deployed and occlusion device 10 has been released. FIG. 2 d also demonstrates the ability of occlusion device 10 with articulated center section 12 to conform to an irregularly shaped defect 44.
  • Another important advantage of the present invention is that articulated center section 12 allows distal and proximal sides 54, 56 to conform more readily to the contours of a heart after it is deployed, providing a custom fit to a variety of defects. Often, when implanted, occlusion device 10 is located in an irregularly shaped defect. Having articulated center section 12 allows occlusion device 10 to conform to a broader spectrum of defects.
  • For instance, as viewed in FIG. 2 d, septal wall 40 on the bottom of septal defect 44 may be only a few millimeters thick, but septal wall 40 on the top of septal defect 44 may be much thicker. In such cases, one side of occlusion device 10 may be bent open further than the other side. The side that is more distorted carries a high static load which increases pressure on the surrounding tissue and also increases the possibility of breakage If center section 12 is articulated, it can bend such that proximal and distal fixation devices 14, 30 need not be the only the only parts which adjust to fit septal defect 44. The ability to conform to a variety of heart contours results in better seating, reduces tension (increasing fatigue life), and decreases the likelihood of damage to tissue resulting from breakage and from pressure exerted on surrounding tissue.
  • Another feature of occlusion device 10 is that it is fully retrievable. To allow occlusion device 10 to be retrievable, as well as ensure that occlusion device 10 fits into a small diameter catheter, it is important to ensure that arms 16 are not of a length that results in atraumatic tips 18 clustering at the same location. If atraumatic tips 18 all cluster at the same location when occlusion device 10 is inside catheter 50, occlusion device 10 will become too bulky to allow it to be easily moved through catheter 50.
  • In situations where occlusion device 10 is not properly deployed and must be retrieved into catheter 50, it is possible to withdraw occlusion device 10 back into catheter 50 by grasping either center section 12 or by grasping any arm 16. When occlusion device 10 is retrieved into catheter 50, both upper and lower arms 16 will be folded in the same direction. Once again it is important to vary the length of upper and lower arms 16, so that when occlusion device 10 is retrieved, atraumantic tips 18 on upper arms 16 do not cluster at the same location as atraumatic tips 18 on lower arms 16.
  • FIG. 3 a is a perspective view of articulated center section 70, which has double articulation. Shown in FIG. 3 a is knob 24, articulated center section 70, first center post 72, second center post 74, center connector 76, joints 78, and holes 80. As viewed in FIG. 3 a, center section 70 comprises first center post 72, second center post 74, and center connector 76. Knob 24 is located on second center post 74. Both first and second center posts 72, 74 have three holes 80 drilled through them. Center section 70 further comprises two joints 78 which are located on each end of center connector 76. Joints 78 connect first and second center posts 72, 74 to center connector 76 and allow for first and second center posts 72, 74 to rotate relative to center connector 76. Wire arms 16 (FIG. 1) attach to center section 70 bypassing through holes 80 drilled through first and second center posts 72, 74.
  • In this example, joint 78 provides the articulation. Though shown with double articulation, articulated center section 70 is not so limited. The number of joints 78 may be varied to accommodate a particular defect or a particular type of defect. For example, one joint may be best for an atrial septal defect while two or three articulations may be best for a larger defect such as patent foramen ovale or a long defect such as patent ductus arteriosus.
  • FIG. 3 b is a side view of articulated center section 90 with triple articulation, which demonstrates the broad range of flexibility possible. Shown is knob 24, holes 80, first center post 92, second center post 94, two center connectors 96, joining part 98, and three joints 100. The large amount of flexibility allows the occlusion device to conform to a wide variety of defects.
  • FIG. 4 is an enlarged side view of articulated center section 70, showing center section 70 in more detail. Shown is knob 24, first center post 72, second center post 74, center connector 76, first sleeve 112, second sleeve 114, and two joints 116, 118.
  • First sleeve 112 and second sleeve 114 comprise center connector 76. Second center post 74 connects to center connector 76 by joining second sleeve 114 at joint 116. First center post 72 connects to center connector 76 by joining first sleeve 112 at joint 118. When the occlusion device is fully assembled, occluder elements will be attached to first and second center posts 72, 74, as can be seen in FIG. 1.
  • There are several disadvantages to allowing the occluder elements to rotate around the articulated center post. First, it is possible that the support arms of one support frame will line up with the arms of the other support frame, making it difficult to distinguish one set from the other set when the occlusion device is viewed on a fluoroscope. As a result, it is more of a challenge to determine the exact position of either support frame because when aligned, the two become indistinguishable.
  • Secondly, preventing rotation of the occluder elements may improve the overall positioning of the device. For example, when inserting a device that allows freedom of rotation, if upon the insertion of the device, the arms of a support frame are laying in an undesirable position, such as resting against the aorta, simply manipulating the device to reposition the arms may not be possible because the center post will rotate consistently relative to the occluder element, leaving the arms in the original position.
  • Finally, the preliminary loading of the device may be hindered if rotation of the support frames is not prevented. When the individual occluder elements rotate consistently, loading the occlusion device into a delivery device or catheter may be more difficult and time-consuming.
  • FIG. 5 a is a side view of a first embodiment of second center post 74 with rotation-inhibiting capabilities. Shown is knob 24, three holes 80, second center post 74, head 120, first neck 122, body 124, second neck 126, and pegs 138 a-c. Peg 138 d cannot be seen from this perspective. As described with reference to FIG. 1, three holes 80 are drilled through second center post 74 to allow for attachment of wire arms 16.
  • Head 120 located at a first end of second center post 74 is connected to body 124 of second center post 74 at first neck 122. Knob 24 is located on the second end of body 124 and is connected to body 124 by second neck 126. To assist in assembly, which is discussed in more detail below, the body 124 of second center post 74 is preferably smaller in diameter than head 120. Knob 24 has a smaller diameter than both body 124 and head 120. For example, head 120 may have a diameter A of about 1.35 millimeters, body 124 may have a diameter B of about 1.2 millimeters, and knob 24 may have a diameter C of about 1.0 millimeter.
  • Knob 24 is configured to allow a delivery forceps to attach to occlusion device 10 as it is pushed through a catheter and allows the forceps to manipulate occlusion device 10 as it is delivered. Likewise, a guide forceps can be used to position occlusion device 10 once it reaches the desired location or to retrieve occlusion device 10 should it not be seated properly. Knob 24 may additionally have a cross sectional area which allows the forceps to rotatably move occlusion device 10 while occlusion device 10 is inserted into septal defect 44. Second neck 126 is grasped by a forceps so that there is at least some play between the forceps and second neck 126 when pushing occlusion device 10 through a catheter. For example, the guide forceps may engage second neck 126 by means of a claw-like or hook-like end. In an alternate embodiment, knob 24 is threaded to allow for attachment to a threaded guide forceps.
  • FIG. 5 b is a perspective side view of the first embodiment of second center post 74 with rotation-inhibiting capabilities. Shown is knob 24, center post 74, holes 80, head 120, first neck 122, body 124, second neck 126, and pegs 138 a-138 d.
  • In this embodiment, head 120 includes pegs 138 a-138 d positioned around its circumference. Pegs 138 a-138 d are shown evenly spaced to provide articulation about two orthogonal axes when coupled with a center connector, as described in detail in FIG. 9.
  • FIG. 6 is a perspective view of a first embodiment of first center post 72 with rotation-inhibiting capabilities. Shown is first center post 72, three holes 80, head 130, first neck 132, body 134, and pegs 138 a-138 c. Peg 138 d cannot be seen from this perspective. Once again, three holes 80 are drilled through first center post 72 to allow for attachment of wire arms 16.
  • First center post 72 is nearly identical to second center post 74 except that it does not include knob 24 or second neck 126. Because occlusion device 10 only needs to be graspable at one end, a second knob is unnecessary. To assist in assembly, body 134 of first center post 72 is preferably smaller in diameter than head 130. For example, head 130 may have a diameter D of about 1.35 millimeters, and body 134 may have a diameter E of about 1.2 millimeters.
  • Preferably, a hard metal, such as titanium, is used to construct center posts 72, 74 because use of a hard material prevents binding within the joints when the center section if fully assembled. Pegs 138 a-138 d may be machined directly into the titanium, using a process such as electrical discharge machining.
  • Although in FIGS. 5 a-6, heads 120, 130 are shown with four pegs 138 a-138 d, the present invention is not so limited. Heads 120, 130 may include any number of pegs, including as few as one peg.
  • FIGS. 7 a and 7 b show side and perspective views of second sleeve 114. FIG. 7 b shows sleeve 114, channel 139 a, and socket 152. Channels 139 b-139 d cannot be seen from this perspective. Channels 139 a-139 d may be machined directly into the titanium, using a process such as electrical discharge machining.
  • The number of channels 139 a-139 d formed in socket 152 corresponds to the number of pegs 138 a-138 d formed on head 120. Pegs 138 a-138 d and channels 139 a-139 d are identically spaced, which allows for pegs 138 a-138 d and channels 139 a-139 d to engage upon assembly, as described in FIG. 9.
  • Although in FIG. 7 b, sleeve 114 is shown with four channels 139 a-139 d, the present invention is not so limited. Sleeve 114 may include any number of channels, including as few as one channel.
  • FIG. 8 is a side view of first sleeve 112. First sleeve 112 includes cuff 140, which is configured to fit inside second sleeve 114 when center connector 76 is assembled. As shown more clearly in FIG. 10, once assembled, sleeves 112, 114 can be permanently attached at cuff 140, for example by welding.
  • Preferably, a hard metal, such as titanium, is used to construct sleeves 112, 114 because use of a hard material prevents binding within the joints when the center section is fully assembled.
  • FIG. 9 shows a cross sectional view of an assembled articulated center section combining the first embodiment of a center post with rotation-inhibiting capabilities and the first embodiment of a sleeve of a center connector with rotation-inhibiting capabilities. Shown is knob 24, first center post 72, second center post 74, center connector 76, holes 80, first sleeve 112, second sleeve 114, head 120, first neck 122, body 124, second neck 126, head 130, neck 132, body 134, pegs 138 a and 138 c, channels 139 a-139 c, cuff 140, first socket 152, and second socket 154. Sleeves 112, 114 have been welded together to form center connector 76. Pegs 138 b and 138 d, and channel 139 d cannot be seen in this view.
  • FIG. 10 is a sectional view of the first embodiment of the center section along section 10-10 of FIG. 9 showing the interaction between pegs 138 a-138 d located on head 120 and channels 139 a-139 d located within socket 152 of sleeve 114. Shown is head 120, pegs 138 a-138 d, sleeve 114, channels 139 a-139 d, and socket 152.
  • Socket 152 of sleeve 114 houses head 120. Pegs 138 a-138 d located on head 120 engage channels 139 a-139 d located within socket 152. While shown with respect to head 120 and sleeve 114, as shown in FIG. 9, head 130 and sleeve 112 interact similarly.
  • To assemble the center section, center posts 72, 74 are slipped into corresponding sleeves 112, 114. As described above with respect to FIGS. 5 a and 6, the diameter of each head 120, 130 is less than the diameter of each body 124, 134. As a result, bodies 124, 134 are small enough to fit through sockets 152, 154 but heads 120, 130 are too large to fit through sockets 152, 154. When center post 72 is slipped through socket 154 of sleeve 112, body 134 extends out through socket 154. Head 130 remains inside sleeve 112. Similarly, once center post 74 is placed through socket 152 of sleeve 114, body 124 extends out through socket 152. Head 120 remains inside sleeve 114.
  • When inserting center posts 72, 74 into sleeves 112, 114, pegs 138 a-138 d and channels 139 a-139 d must be correlated to each other. Prior to insertion into sleeve 112, center post 72 should be rotated so that pegs 138 a-138 d on head 130 are positioned to slide into corresponding channels 139 a-139 d located within socket 154. Likewise, prior to insertion into sleeve 114, center post 174 should be rotated so that pegs 138 a-138 d on head 120 are positioned to slide into corresponding channels 139 a-139 d located within socket 152. Center posts 72, 74 are then inserted into sleeves 112, 114 by sliding pegs 138 a-138 d into corresponding channels 139 a-139 d until necks 122, 132 extend out of sockets 152, 154. Finally, sleeve 112 and sleeve 114 are joined by inserting cuff 140 into sleeve 114, which comprises central connector 76. Once assembled, sleeves 112, 114 may be welded together.
  • The resulting assembly forms two ball and socket joints, which are able to articulate (i.e. pivot) but are rotationally inhibited. As described above, pegs 138 a-138 d and channels 139 a-139 d engage. Since pegs 138 a-138 d of heads 120, 130 are housed within channels 139 a-139 d of sleeves 112, 114, the rotational movement of center posts 72, 74 with respect to central connector 76 is prevented. In other words, center posts 72, 74 are prevented from turning around an axis extending through sockets 152, 154. As previously described, preventing rotation of center posts 72, 74 in relation to sleeves 112, 114 improves the overall positioning of the device. It also is easier to distinguish individual occluder elements, and the preliminary loading of the occlusion device into a catheter may be simplified.
  • In order for the occlusion device to adequately conform to the walls of the heart, flexibility of the device is still needed. In this embodiment, the interaction between pegs 138 a-138 d and channels 139 a-139 d still permits articulated movement of center posts 72, 74. Center posts 72, 74 are able to pivot with respect to center connector 76, while pegs 138 a-138 d and channels 139 a-139 d remain engaged. Because the center section retains the desired flexibility, an occlusion device will have the ability to match the contours of a heart. This results in an increased life for the device, and also improves its sealing ability.
  • FIG. 11 is a perspective side view of a second embodiment of a center post with rotation-inhibiting capabilities. Shown is knob 24, center post 74, holes 80, head 120, first neck 122, body 124, second neck 126, and channels 139 a-139 b.
  • In this embodiment, head 120 includes channels 139 a-139 b located concentrically around the rounded surface of head 120. Channels 139 a-139 b may be evenly spaced to provide better articulation when coupled with a center connector, as described in FIG. 12. Center post 74 is preferably formed of a hard metal, such as titanium. Channels 139 a-139 b may be machined directly into the titanium, using a process such as electrical discharge machining.
  • Although in FIG. 11, head 120 is shown with two channels 139 a-139 b, the present invention is not so limited. Head 120 may include any number of channels 139 a-139 b, including as few as one channel 139 a-139 b. In addition, while this embodiment is shown with respect to center post 74, which includes second neck 126 and knob 24, channels 139 a-139 b may be added to a center post that does not include these features, as shown with respect to center post 72 in FIG. 12.
  • FIG. 12 shows a cross sectional view of an assembled articulated center section combining the second embodiment of a center post with rotation-inhibiting capabilities and the second embodiment of a sleeve of a center connector with rotation-inhibiting capabilities. Shown is knob 24, first center post 72, second center post 74, center connector 76, holes 80, first sleeve 112, second sleeve 114, head 120, first neck 122, body 124, second neck 126, head 130, neck 132, body 134, pegs 138 a and 138 c, channels 139 a-139 b, cuff 140, first socket 152, and second socket 154. Sleeves 112, 114 have been welded together to comprise center connector 76. Peg 138 b and peg 138 d cannot be seen from this perspective.
  • FIG. 13 is a sectional view of the first embodiment of the center section along section 13-13 of FIG. 12 showing the interaction between pegs 138 a-138 d located within socket 152 of sleeve 114 and channels 139 a-139 b located on head 120. Shown is sleeve 114, head 120, pegs 138 a-138 d, channels 139 a-139 b, and socket 152.
  • Socket 152 of sleeve 114 houses head 120. Pegs 138 a-138 d located within socket 152 engage channels 139 a-139 b located on head 120. While shown with respect to head 120 and sleeve 114, as shown in FIG. 12, head 130 and sleeve 112 interact similarly.
  • To assemble the center section, center posts 72, 74 are slipped into corresponding sleeves 112, 114. As described above with respect to FIGS. 5 a and 6, the diameter of each head 120, 130 is less than the diameter of each body 124, 134. As a result, bodies 124, 134 are small enough to fit through sockets 152, 154 but heads 120, 130 are too large to fit through sockets 152, 154. When center post 72 is slipped through socket 154 of sleeve 112, body 134 extends out through socket 154. Head 130 remains inside sleeve 112. Similarly, once center post 74 is placed through socket 152 of sleeve 114, body 124 extends out through socket 152. Head 120 remains inside sleeve 114.
  • When inserting center posts 72, 74 into sleeves 112, 114, pegs 138 a-138 d and channels 139 a-139 b must be correlated to each other. Prior to insertion into sleeve 112, center post 72 should be rotated so that channels 139 a-139 b on head 130 are positioned to slide onto corresponding pegs 138 a-138 d located within socket 154. Likewise, prior to insertion into sleeve 114, center post 174 should be rotated so that channels 139 a-139 b on head 120 are positioned to slide onto corresponding pegs 138 a-138 d located within socket 152. Center posts 72, 74 are then inserted into sleeves 112, 114 by sliding pegs 138 a-138 d into corresponding channels 139 a-139 b until necks 122, 132 extend through sockets 152, 154. Finally, sleeve 112 and sleeve 114 are joined by inserting cuff 140 into sleeve 114, which comprises central connector 76. Once assembled, sleeves 112, 114 may be welded together.
  • The resulting assembly forms two ball and socket joints, which are able to articulate but are rotationally inhibited. As described above, pegs 138 a-138 d and channels 139 a-139 b engage. Since pegs 138 a-138 d of sleeves 112, 114 are housed within channels 139 a-139 b of heads 120, 130, the rotational movement of center posts 72, 74 with respect to central connector 76 is prevented. In other words, center posts 72, 74 are prevented from turning around an axis extending through sockets 152, 154. As previously described, preventing rotation of center posts 72, 74 in relation to sleeves 112, 114 improves the overall positioning of the device. It also is easier to distinguish individual occluder elements, and the preliminary loading of the occlusion device into a catheter may be simplified.
  • In order for the occlusion device to adequately conform to the walls of the heart, flexibility of the device is still needed. In this embodiment, the interaction between pegs 138 a-138 d and channels 139 a-139 b still permits articulated movement of center posts 72, 74. Center posts 72, 74 are able to pivot with respect to center connector 76, while pegs 138 a-138 d and channels 139 a-139 b remain engaged. Because the center section retains the desired flexibility, an occlusion device will have the ability to match the contours of a heart. This results in an increased life for the device, and also improves its sealing ability.
  • Though shown in a patent foramen ovale occlusion device, an articulated center post can be adapted for use in any occluding device, including those designed for atrial septal defects, patent ductus arteriosus, and ventricular septal defects. The center section can also be adapted for use in an septal stabilization device.
  • Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. In particular, any of the applicable features disclosed in related applications U.S. patent application entitled Septal Stabilization Device, Ser. No. 10/349,744, U.S. patent application entitled Hoop Design for Occlusion Device, Ser. No. 10/349,118, Occlusion Device Having Five or More Arms, Ser. No. 10/348,701, and U.S. patent application entitled Laminated Sheets for Use in a Fully Retrievable Occlusion Device, Ser. No. 10/348,864, filed on even date herewith, may be of use in the present invention. Each of these applications is hereby incorporated by reference.
  • Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims (27)

1. An occlusion device comprising:
a first occluding body;
a second occluding body; and
a center section including a ball and socket joint and means for limiting rotation of the first occluding body relative to the second occluding body.
2. The occlusion device of claim 1 wherein the means for limiting rotation of the first occluding body relative to the second occluding body includes interlocking elements.
3. The occlusion device of claim 2 wherein the interlocking elements include a peg on a ball of the ball and socket joint and a groove on a socket of the ball and socket joint.
4. The occlusion device of claim 2 wherein the interlocking elements include a groove on a ball of the ball and socket joint and a peg on a socket of the ball and socket joint.
5. An occlusion device comprising:
a first collapsible support frame;
a second collapsible support frame;
a first center support having a first body, a first neck, and a first head, the first body connected to the first collapsible support frame;
a second center support having a second body, a second neck, and a second head, the second body connected to the second collapsible support frame;
a center connector providing an articulated connection between the first center support and the second center support, the center connector including a first socket in which the first head is movable and a second socket in which the second head is movable;
a first sheet attached to the first collapsible support frame;
means for preventing rotation of the first head in the first socket; and
means for preventing rotation of the second head in the second socket.
6. The occlusion device of claim 5 and further comprising:
a second sheet attached to the second collapsible support frame.
7. The occlusion device of claim 5 wherein each of the first and second collapsible support frames includes a plurality of arms.
8. The occlusion device of claim 7 wherein the first collapsible support frame is oriented relative to the second collapsible support frame to offset the arms of the first collapsible support frame from the arms of the second collapsible support frame.
9. The occlusion device of claim 5 wherein the center connector includes a first sleeve and a second sleeve.
10. The occlusion device of claim 9 wherein the first sleeve contains the first socket.
11. The occlusion device of claim 10 wherein the second sleeve contains the second socket.
12. The occlusion device of claim 11 wherein the first sleeve and second sleeve connect to each other.
13. The occlusion device of claim 5 wherein the means for preventing rotation of the first head in the first socket includes a channel in the first socket.
14. The occlusion device of claim 13 wherein the means for preventing rotation of the first head in the first socket further includes a peg on the first head that is movable in the channel in the first socket.
15. The occlusion device of claim 5 wherein the means for preventing rotation of the second head in the second socket includes a channel in the second socket.
16. The occlusion device of claim 15 wherein the means for preventing rotation of the second head in the second socket further includes a peg on the second head that is movable in the channel in the second socket.
17. The occlusion device of claim 5 wherein the means for preventing rotation of the first head in the first socket includes a peg in the first socket.
18. The occlusion device of claim 17 wherein the means for preventing rotation of the first head in the first socket further includes a channel on the first head for receiving the peg in the first socket.
19. The occlusion device of claim 5 wherein the means for preventing rotation of the second head in the second socket includes a peg in the second socket.
20. The occlusion device of claim 19 wherein the means for preventing rotation of the second head in the second socket further includes a channel on the second head for receiving the peg in the second socket.
21. A center connection for an occlusion device, the center connection comprising:
a first center post having a first body, a first neck, and a first head;
a second center post having a second body, a second neck, and a second head; and
a center connector that engages the first head and the second head to permit articulated movement of the first and second center posts while preventing rotational movement of the first and second center posts with respect to the center connector.
22. The center connection of claim 21 wherein the center connector further comprises a first sleeve and a second sleeve.
23. The center connector of claim 22 wherein the second sleeve has a cuff at a proximal end for attachment to the first sleeve.
24. The center connection of claim 22 wherein the center connector includes a peg.
25. The center connection of claim 22 wherein the first and second heads each comprise a channel which receives a peg on the center connector.
26. The center connection of claim 22 wherein the center connector includes a channel.
27. The center connection of claim 22 wherein the first and second heads each include a peg which engages a channel on the center connector.
US11/328,917 2003-01-22 2006-01-06 Articulated center post Abandoned US20060116717A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/328,917 US20060116717A1 (en) 2003-01-22 2006-01-06 Articulated center post

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/348,865 US7087072B2 (en) 2003-01-22 2003-01-22 Articulated center post
US11/328,917 US20060116717A1 (en) 2003-01-22 2006-01-06 Articulated center post

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US10/348,865 Continuation-In-Part US7087072B2 (en) 2003-01-22 2003-01-22 Articulated center post

Publications (1)

Publication Number Publication Date
US20060116717A1 true US20060116717A1 (en) 2006-06-01

Family

ID=32712643

Family Applications (3)

Application Number Title Priority Date Filing Date
US10/348,865 Expired - Lifetime US7087072B2 (en) 2003-01-22 2003-01-22 Articulated center post
US11/204,303 Abandoned US20050277982A1 (en) 2003-01-22 2005-08-15 Articulated center post
US11/328,917 Abandoned US20060116717A1 (en) 2003-01-22 2006-01-06 Articulated center post

Family Applications Before (2)

Application Number Title Priority Date Filing Date
US10/348,865 Expired - Lifetime US7087072B2 (en) 2003-01-22 2003-01-22 Articulated center post
US11/204,303 Abandoned US20050277982A1 (en) 2003-01-22 2005-08-15 Articulated center post

Country Status (2)

Country Link
US (3) US7087072B2 (en)
WO (1) WO2004066810A2 (en)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130066362A1 (en) * 2006-04-27 2013-03-14 Vueklar Cardiovascular Ltd. Occluder
US8728155B2 (en) 2011-03-21 2014-05-20 Cephea Valve Technologies, Inc. Disk-based valve apparatus and method for the treatment of valve dysfunction
US8870948B1 (en) 2013-07-17 2014-10-28 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
CN105054980A (en) * 2015-09-11 2015-11-18 上海形状记忆合金材料有限公司 Self-adaptive variable angle plugging device
US9439757B2 (en) 2014-12-09 2016-09-13 Cephea Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
CN107126240A (en) * 2017-06-08 2017-09-05 有研医疗器械(北京)有限公司 A kind of occluder for left auricle and its application method
US10143552B2 (en) 2015-05-14 2018-12-04 Cephea Valve Technologies, Inc. Replacement mitral valves
US10368990B2 (en) 2017-01-23 2019-08-06 Cephea Valve Technologies, Inc. Replacement mitral valves
US10470881B2 (en) 2015-05-14 2019-11-12 Cephea Valve Technologies, Inc. Replacement mitral valves
CN111000600A (en) * 2019-12-17 2020-04-14 先健科技(深圳)有限公司 Occluder and occlusion system
US10849746B2 (en) 2015-05-14 2020-12-01 Cephea Valve Technologies, Inc. Cardiac valve delivery devices and systems
US11331187B2 (en) 2016-06-17 2022-05-17 Cephea Valve Technologies, Inc. Cardiac valve delivery devices and systems
US11931252B2 (en) 2019-07-15 2024-03-19 Cephea Valve Technologies, Inc. Disk-based valve apparatus and method for the treatment of valve dysfunction

Families Citing this family (58)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7338514B2 (en) 2001-06-01 2008-03-04 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods and tools, and related methods of use
US6776784B2 (en) 2001-09-06 2004-08-17 Core Medical, Inc. Clip apparatus for closing septal defects and methods of use
US6702835B2 (en) 2001-09-07 2004-03-09 Core Medical, Inc. Needle apparatus for closing septal defects and methods for using such apparatus
US20060052821A1 (en) 2001-09-06 2006-03-09 Ovalis, Inc. Systems and methods for treating septal defects
US7318833B2 (en) 2001-12-19 2008-01-15 Nmt Medical, Inc. PFO closure device with flexible thrombogenic joint and improved dislodgement resistance
EP1467661A4 (en) * 2001-12-19 2008-11-05 Nmt Medical Inc Septal occluder and associated methods
US7976564B2 (en) 2002-05-06 2011-07-12 St. Jude Medical, Cardiology Division, Inc. PFO closure devices and related methods of use
US7115135B2 (en) * 2003-01-22 2006-10-03 Cardia, Inc. Occlusion device having five or more arms
US7780700B2 (en) * 2003-02-04 2010-08-24 ev3 Endovascular, Inc Patent foramen ovale closure system
US20040267306A1 (en) * 2003-04-11 2004-12-30 Velocimed, L.L.C. Closure devices, related delivery methods, and related methods of use
US8372112B2 (en) 2003-04-11 2013-02-12 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods, and related methods of use
US9498366B2 (en) * 2003-07-28 2016-11-22 Baronova, Inc. Devices and methods for pyloric anchoring
US8821521B2 (en) * 2003-07-28 2014-09-02 Baronova, Inc. Gastro-intestinal device and method for treating addiction
US20090259236A2 (en) 2003-07-28 2009-10-15 Baronova, Inc. Gastric retaining devices and methods
US9700450B2 (en) 2003-07-28 2017-07-11 Baronova, Inc. Devices and methods for gastrointestinal stimulation
US8048169B2 (en) * 2003-07-28 2011-11-01 Baronova, Inc. Pyloric valve obstructing devices and methods
DE602004009335T2 (en) * 2003-10-24 2008-07-03 ev3 Endovascular, Inc., Plymouth CLOSING SYSTEM FOR OPEN FORMS OVAL
US9039724B2 (en) * 2004-03-19 2015-05-26 Aga Medical Corporation Device for occluding vascular defects
US8777974B2 (en) 2004-03-19 2014-07-15 Aga Medical Corporation Multi-layer braided structures for occluding vascular defects
US8398670B2 (en) * 2004-03-19 2013-03-19 Aga Medical Corporation Multi-layer braided structures for occluding vascular defects and for occluding fluid flow through portions of the vasculature of the body
US8313505B2 (en) * 2004-03-19 2012-11-20 Aga Medical Corporation Device for occluding vascular defects
US8747453B2 (en) * 2008-02-18 2014-06-10 Aga Medical Corporation Stent/stent graft for reinforcement of vascular abnormalities and associated method
JP4418785B2 (en) * 2004-09-29 2010-02-24 テルモ株式会社 Patent application for patent foramen ovale and instrument for patent foramen ovale
US20060241687A1 (en) * 2005-03-16 2006-10-26 Glaser Erik N Septal occluder with pivot arms and articulating joints
US20060217760A1 (en) * 2005-03-17 2006-09-28 Widomski David R Multi-strand septal occluder
US8372113B2 (en) * 2005-03-24 2013-02-12 W.L. Gore & Associates, Inc. Curved arm intracardiac occluder
US8579936B2 (en) 2005-07-05 2013-11-12 ProMed, Inc. Centering of delivery devices with respect to a septal defect
US7846179B2 (en) 2005-09-01 2010-12-07 Ovalis, Inc. Suture-based systems and methods for treating septal defects
US9259267B2 (en) 2005-09-06 2016-02-16 W.L. Gore & Associates, Inc. Devices and methods for treating cardiac tissue
US7797056B2 (en) 2005-09-06 2010-09-14 Nmt Medical, Inc. Removable intracardiac RF device
DE102005053906A1 (en) * 2005-11-11 2007-05-24 Occlutech Gmbh Occlusion device e.g. for septal defects in medical technology, has interlaced structure of thin wires or threads whereby holder, on its free end, has top section with eyelet in form of cross bore
US7955354B2 (en) * 2005-11-14 2011-06-07 Occlutech Gmbh Occlusion device and surgical instrument and method for its implantation/explantation
US20080215089A1 (en) * 2006-09-21 2008-09-04 Williams Michael S Stomach wall closure devices
GB0625103D0 (en) * 2006-12-15 2007-01-24 Homerton University Hospital N Device for occluding a septal defect
WO2008094691A2 (en) * 2007-02-01 2008-08-07 Cook Incorporated Closure device and method for occluding a bodily passageway
WO2008094706A2 (en) * 2007-02-01 2008-08-07 Cook Incorporated Closure device and method of closing a bodily opening
US8617205B2 (en) 2007-02-01 2013-12-31 Cook Medical Technologies Llc Closure device
US8915958B2 (en) * 2007-06-08 2014-12-23 St. Jude Medical, Inc. Devices for transcatheter prosthetic heart valve implantation and access closure
US8034061B2 (en) * 2007-07-12 2011-10-11 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US8308752B2 (en) * 2007-08-27 2012-11-13 Cook Medical Technologies Llc Barrel occlusion device
US8025495B2 (en) * 2007-08-27 2011-09-27 Cook Medical Technologies Llc Apparatus and method for making a spider occlusion device
US8734483B2 (en) * 2007-08-27 2014-05-27 Cook Medical Technologies Llc Spider PFO closure device
US20090062838A1 (en) * 2007-08-27 2009-03-05 Cook Incorporated Spider device with occlusive barrier
CA2698729C (en) * 2007-09-07 2014-04-22 Baronova, Inc. Device for intermittently obstructing a gastric opening and method of use
US20090118745A1 (en) * 2007-11-06 2009-05-07 Cook Incorporated Patent foramen ovale closure apparatus and method
US10219796B2 (en) * 2009-02-21 2019-03-05 Farideh Roshanali Device for percutaneous transcathertral closure of atrial septal defect by deploying pericardial patch
CH701394A2 (en) * 2009-07-10 2011-01-14 Carag Ag Occluder.
US8715300B2 (en) * 2009-12-05 2014-05-06 Integrated Sensing Systems, Inc. Delivery system, method, and anchor for medical implant placement
EP2506912B1 (en) * 2009-12-05 2021-04-21 Integrated Sensing Systems, Inc. Delivery system, method, and anchor for medical implant placement
US8419767B2 (en) 2010-05-04 2013-04-16 Mustafa H. Al-Qbandi Steerable atrial septal occluder implantation device with flexible neck
WO2012051489A2 (en) 2010-10-15 2012-04-19 Cook Medical Technologies Llc Occlusion device for blocking fluid flow through bodily passages
US9186152B2 (en) 2010-11-12 2015-11-17 W. L. Gore & Associates, Inc. Left atrial appendage occlusive devices
WO2013120082A1 (en) 2012-02-10 2013-08-15 Kassab Ghassan S Methods and uses of biological tissues for various stent and other medical applications
AU2014214700B2 (en) 2013-02-11 2018-01-18 Cook Medical Technologies Llc Expandable support frame and medical device
ES2675373T3 (en) 2013-03-15 2018-07-10 Baronova, Inc. Gastric obstruction device with blockage
CN104173122A (en) * 2014-09-11 2014-12-03 山东省立医院 Plugging device suitable for postoperation perivalvular leakage
US10441258B2 (en) * 2017-06-16 2019-10-15 Cardia, Inc. Uncoupled LAA device
US10993807B2 (en) 2017-11-16 2021-05-04 Medtronic Vascular, Inc. Systems and methods for percutaneously supporting and manipulating a septal wall

Citations (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3874388A (en) * 1973-02-12 1975-04-01 Ochsner Med Found Alton Shunt defect closure system
US4007743A (en) * 1975-10-20 1977-02-15 American Hospital Supply Corporation Opening mechanism for umbrella-like intravascular shunt defect closure device
US4284166A (en) * 1979-04-13 1981-08-18 Gale George A Port devices for bass-reflex speaker enclosures
US4917089A (en) * 1988-08-29 1990-04-17 Sideris Eleftherios B Buttoned device for the transvenous occlusion of intracardiac defects
US5092424A (en) * 1990-12-03 1992-03-03 Bose Corporation Electroacoustical transducing with at least three cascaded subchambers
US5108420A (en) * 1991-02-01 1992-04-28 Temple University Aperture occlusion device
US5171259A (en) * 1990-04-02 1992-12-15 Kanji Inoue Device for nonoperatively occluding a defect
US5284488A (en) * 1992-12-23 1994-02-08 Sideris Eleftherios B Adjustable devices for the occlusion of cardiac defects
US5334137A (en) * 1992-02-21 1994-08-02 Eagle Vision, Inc. Lacrimal fluid control device
US5334217A (en) * 1992-01-21 1994-08-02 Regents Of The University Of Minnesota Septal defect closure device
US5382260A (en) * 1992-10-30 1995-01-17 Interventional Therapeutics Corp. Embolization device and apparatus including an introducer cartridge and method for delivering the same
US5397331A (en) * 1991-11-25 1995-03-14 Cook Incorporated Supporting device and apparatus for inserting the device
US5425744A (en) * 1991-11-05 1995-06-20 C. R. Bard, Inc. Occluder for repair of cardiac and vascular defects
US5433727A (en) * 1994-08-16 1995-07-18 Sideris; Eleftherios B. Centering buttoned device for the occlusion of large defects for occluding
US5451235A (en) * 1991-11-05 1995-09-19 C.R. Bard, Inc. Occluder and method for repair of cardiac and vascular defects
US5634936A (en) * 1995-02-06 1997-06-03 Scimed Life Systems, Inc. Device for closing a septal defect
US5702421A (en) * 1995-01-11 1997-12-30 Schneidt; Bernhard Closure device for closing a vascular opening, such as patent ductus arteriosus
US5709707A (en) * 1995-10-30 1998-01-20 Children's Medical Center Corporation Self-centering umbrella-type septal closure device
US5725552A (en) * 1994-07-08 1998-03-10 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US5741297A (en) * 1996-08-28 1998-04-21 Simon; Morris Daisy occluder and method for septal defect repair
US5904703A (en) * 1996-05-08 1999-05-18 Bard Connaught Occluder device formed from an open cell foam material
US6024756A (en) * 1996-03-22 2000-02-15 Scimed Life Systems, Inc. Method of reversibly closing a septal defect
US6174322B1 (en) * 1997-08-08 2001-01-16 Cardia, Inc. Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum
US6206907B1 (en) * 1999-05-07 2001-03-27 Cardia, Inc. Occlusion device with stranded wire support arms
US6389146B1 (en) * 2000-02-17 2002-05-14 American Technology Corporation Acoustically asymmetric bandpass loudspeaker with multiple acoustic filters
US6551344B2 (en) * 2000-04-26 2003-04-22 Ev3 Inc. Septal defect occluder
US6634455B1 (en) * 1996-02-12 2003-10-21 Yi-Fu Yang Thin-wall multi-concentric sleeve speaker

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE233303C (en) 1911-04-05
DE4222291C1 (en) 1992-07-07 1994-01-20 Krmek Mirko Prosthesis for closing atrial or ventricular-septal defect - comprises two equally shaped units of elastic sprung material with six radially running arms spaced apart by equal edges
GB2269321B (en) 1992-08-05 1996-06-26 Nat Heart & Lung Inst Implantable occluder devices for medical use
US6379368B1 (en) 1999-05-13 2002-04-30 Cardia, Inc. Occlusion device with non-thrombogenic properties

Patent Citations (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3874388A (en) * 1973-02-12 1975-04-01 Ochsner Med Found Alton Shunt defect closure system
US4007743A (en) * 1975-10-20 1977-02-15 American Hospital Supply Corporation Opening mechanism for umbrella-like intravascular shunt defect closure device
US4284166A (en) * 1979-04-13 1981-08-18 Gale George A Port devices for bass-reflex speaker enclosures
US4917089A (en) * 1988-08-29 1990-04-17 Sideris Eleftherios B Buttoned device for the transvenous occlusion of intracardiac defects
US5171259A (en) * 1990-04-02 1992-12-15 Kanji Inoue Device for nonoperatively occluding a defect
US5092424A (en) * 1990-12-03 1992-03-03 Bose Corporation Electroacoustical transducing with at least three cascaded subchambers
US5108420A (en) * 1991-02-01 1992-04-28 Temple University Aperture occlusion device
US5425744A (en) * 1991-11-05 1995-06-20 C. R. Bard, Inc. Occluder for repair of cardiac and vascular defects
US5451235A (en) * 1991-11-05 1995-09-19 C.R. Bard, Inc. Occluder and method for repair of cardiac and vascular defects
US5397331A (en) * 1991-11-25 1995-03-14 Cook Incorporated Supporting device and apparatus for inserting the device
US5334217A (en) * 1992-01-21 1994-08-02 Regents Of The University Of Minnesota Septal defect closure device
US5334137A (en) * 1992-02-21 1994-08-02 Eagle Vision, Inc. Lacrimal fluid control device
US5382260A (en) * 1992-10-30 1995-01-17 Interventional Therapeutics Corp. Embolization device and apparatus including an introducer cartridge and method for delivering the same
US5284488A (en) * 1992-12-23 1994-02-08 Sideris Eleftherios B Adjustable devices for the occlusion of cardiac defects
US5725552A (en) * 1994-07-08 1998-03-10 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US5433727A (en) * 1994-08-16 1995-07-18 Sideris; Eleftherios B. Centering buttoned device for the occlusion of large defects for occluding
US5702421A (en) * 1995-01-11 1997-12-30 Schneidt; Bernhard Closure device for closing a vascular opening, such as patent ductus arteriosus
US5634936A (en) * 1995-02-06 1997-06-03 Scimed Life Systems, Inc. Device for closing a septal defect
US5709707A (en) * 1995-10-30 1998-01-20 Children's Medical Center Corporation Self-centering umbrella-type septal closure device
US6634455B1 (en) * 1996-02-12 2003-10-21 Yi-Fu Yang Thin-wall multi-concentric sleeve speaker
US6024756A (en) * 1996-03-22 2000-02-15 Scimed Life Systems, Inc. Method of reversibly closing a septal defect
US5904703A (en) * 1996-05-08 1999-05-18 Bard Connaught Occluder device formed from an open cell foam material
US5741297A (en) * 1996-08-28 1998-04-21 Simon; Morris Daisy occluder and method for septal defect repair
US6174322B1 (en) * 1997-08-08 2001-01-16 Cardia, Inc. Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum
US6206907B1 (en) * 1999-05-07 2001-03-27 Cardia, Inc. Occlusion device with stranded wire support arms
US6389146B1 (en) * 2000-02-17 2002-05-14 American Technology Corporation Acoustically asymmetric bandpass loudspeaker with multiple acoustic filters
US6551344B2 (en) * 2000-04-26 2003-04-22 Ev3 Inc. Septal defect occluder

Cited By (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8932311B2 (en) * 2006-04-27 2015-01-13 Vueklar Cardiovascular Ltd. Occluder
US20130066362A1 (en) * 2006-04-27 2013-03-14 Vueklar Cardiovascular Ltd. Occluder
US8728155B2 (en) 2011-03-21 2014-05-20 Cephea Valve Technologies, Inc. Disk-based valve apparatus and method for the treatment of valve dysfunction
US10456255B2 (en) 2011-03-21 2019-10-29 Cephea Valve Technologies, Inc. Disk-based valve apparatus and method for the treatment of valve dysfunction
US10149761B2 (en) 2013-07-17 2018-12-11 Cephea Valve Technlologies, Inc. System and method for cardiac valve repair and replacement
US8870948B1 (en) 2013-07-17 2014-10-28 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
US11510780B2 (en) 2013-07-17 2022-11-29 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
US10624742B2 (en) 2013-07-17 2020-04-21 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
US9554899B2 (en) 2013-07-17 2017-01-31 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
US9561103B2 (en) 2013-07-17 2017-02-07 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
US10154906B2 (en) 2013-07-17 2018-12-18 Cephea Valve Technologies, Inc. System and method for cardiac valve repair and replacement
US10869755B2 (en) 2014-12-09 2020-12-22 Cephea Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
US11147665B2 (en) 2014-12-09 2021-10-19 Cepha Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
US9439757B2 (en) 2014-12-09 2016-09-13 Cephea Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
US10433953B2 (en) 2014-12-09 2019-10-08 Cephea Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
US9492273B2 (en) 2014-12-09 2016-11-15 Cephea Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
US10548721B2 (en) 2014-12-09 2020-02-04 Cephea Valve Technologies, Inc. Replacement cardiac valves and methods of use and manufacture
US10470881B2 (en) 2015-05-14 2019-11-12 Cephea Valve Technologies, Inc. Replacement mitral valves
US10555808B2 (en) 2015-05-14 2020-02-11 Cephea Valve Technologies, Inc. Replacement mitral valves
US11786373B2 (en) 2015-05-14 2023-10-17 Cephea Valve Technologies, Inc. Cardiac valve delivery devices and systems
US11617646B2 (en) 2015-05-14 2023-04-04 Cephea Valve Technologies, Inc. Replacement mitral valves
US10849746B2 (en) 2015-05-14 2020-12-01 Cephea Valve Technologies, Inc. Cardiac valve delivery devices and systems
US10143552B2 (en) 2015-05-14 2018-12-04 Cephea Valve Technologies, Inc. Replacement mitral valves
CN105054980A (en) * 2015-09-11 2015-11-18 上海形状记忆合金材料有限公司 Self-adaptive variable angle plugging device
US11331187B2 (en) 2016-06-17 2022-05-17 Cephea Valve Technologies, Inc. Cardiac valve delivery devices and systems
US11058535B2 (en) 2017-01-23 2021-07-13 Cephea Valve Technologies, Inc. Replacement mitral valves
US11090158B2 (en) 2017-01-23 2021-08-17 Cephea Valve Technologies, Inc. Replacement mitral valves
US10368990B2 (en) 2017-01-23 2019-08-06 Cephea Valve Technologies, Inc. Replacement mitral valves
US10828153B2 (en) 2017-01-23 2020-11-10 Cephea Valve Technologies, Inc. Replacement mitral valves
US11633278B2 (en) 2017-01-23 2023-04-25 Cephea Valve Technologies, Inc. Replacement mitral valves
US10568737B2 (en) 2017-01-23 2020-02-25 Cephea Valve Technologies, Inc. Replacement mitral valves
CN107126240A (en) * 2017-06-08 2017-09-05 有研医疗器械(北京)有限公司 A kind of occluder for left auricle and its application method
US11931252B2 (en) 2019-07-15 2024-03-19 Cephea Valve Technologies, Inc. Disk-based valve apparatus and method for the treatment of valve dysfunction
CN111000600A (en) * 2019-12-17 2020-04-14 先健科技(深圳)有限公司 Occluder and occlusion system

Also Published As

Publication number Publication date
US7087072B2 (en) 2006-08-08
WO2004066810A2 (en) 2004-08-12
WO2004066810A3 (en) 2005-04-14
US20040143293A1 (en) 2004-07-22
US20050277982A1 (en) 2005-12-15

Similar Documents

Publication Publication Date Title
US20060116717A1 (en) Articulated center post
US6913614B2 (en) Delivery system with safety tether
US20210378646A1 (en) Multi-layer braided structures for occluding vascular defects
US7582104B2 (en) Daisy design for occlusion device
US5451235A (en) Occluder and method for repair of cardiac and vascular defects
US7749238B2 (en) Occlusion device with flexible polymeric connector
US7625364B2 (en) Flexible center connection for occlusion device
US7413563B2 (en) Flexible medical device
US6960220B2 (en) Hoop design for occlusion device
US8366741B2 (en) Occlusion device with centering arm
US7905901B2 (en) Self-centering occlusion device
EP1013227B1 (en) Closure device for transcatheter operation and catheter assembly therefor
US7927351B2 (en) Occlusion device with flexible wire connector
US7972361B2 (en) Occlusion device with flexible spring connector
US7144410B2 (en) ASD closure device with self centering arm network
JP4989807B2 (en) System and method for treating septal defects
US7691115B2 (en) Occlusion device with flexible fabric connector
JPH11276490A (en) Closing plug for operation by catheter and catheter assembly
Garay et al. The Amplatzer* septal occluder

Legal Events

Date Code Title Description
AS Assignment

Owner name: CARDIA, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MARINO, JOSEPH A.;CORCORAN, MICHAEL P.;REEL/FRAME:017442/0828

Effective date: 20060105

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION