US20080097146A1 - Cardiac support device with low friction delivery structures - Google Patents
Cardiac support device with low friction delivery structures Download PDFInfo
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- US20080097146A1 US20080097146A1 US11/478,350 US47835006A US2008097146A1 US 20080097146 A1 US20080097146 A1 US 20080097146A1 US 47835006 A US47835006 A US 47835006A US 2008097146 A1 US2008097146 A1 US 2008097146A1
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- Prior art keywords
- lubricious
- jacket
- support device
- cardiac support
- portions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
- A61F2002/2484—Delivery devices therefor
Definitions
- the invention is a cardiac support device having low friction delivery-enhancing structures.
- Cardiac support devices are structures, sometimes referred to as jackets, that surround all or portions of a diseased heart. These devices are intended to treat chronic heart failure or other cardiac disease, which may be associated valvular dysfunction, by constraining expansion of the heart. They can be delivered and implanted using conventional cardiothoracic surgical techniques or minimally invasive surgical procedures. Devices of these types and associated delivery tools and methods are shown, for example, in the following U.S. patents, all of which are incorporated herein by reference in their entirety.
- the present invention is an improved cardiac support device that can be efficiently implanted within a patient.
- One embodiment of the invention includes a jacket for constraining cardiac expansion and one or more lubricious elements releasably secured with respect to an inside surface of the jacket.
- the lubricious elements include a plurality of strips of lubricious material releasably secured to a base portion of the jacket.
- FIG. 1 is an isometric side view of a cardiac support device in accordance with one embodiment of the present invention, with portions thereof broken away to illustrate the lubricious element assemblies.
- FIG. 2 is an isometric side view of the cardiac support device shown in FIG. 1 , illustrating the side of the device opposite that shown in FIG. 1 .
- FIGS. 3A and 3B are detailed illustrations of the opposite sides of the lubricious element assemblies shown in FIGS. 1 and 2 , in an unreleased state.
- FIGS. 4A and 4B are illustrations of the opposite sides of the lubricious element assemblies shown in FIGS. 3A and 3B , in a partially released state.
- FIGS. 5A and 5B are illustrations of the opposite sides of the lubricious element assemblies shown in FIGS. 3A and 3B , in a fully released state.
- FIG. 6 is an isometric view of a delivery device in accordance with one embodiment of the invention, shown in a retracted state, that can be used to position the cardiac support device shown in FIG. 1 on a patient's heart.
- FIG. 7 is an isometric view of the delivery device shown in FIG. 6 , shown in an extended state.
- FIG. 8 is an isometric view of the delivery device shown in FIGS. 6 and 7 , shown in the retracted state with the cardiac support device shown in FIGS. 1 and 2 loaded thereon.
- FIG. 9 is an isometric view of the delivery device and loaded cardiac support device shown in FIG. 8 , shown in the extended state.
- FIGS. 10A and 10B are detailed illustrations of the opposite sides of a portion of the delivery device and loaded cardiac support device shown in FIGS. 8 and 9 , showing the distal end of the delivery device support member extending into a pocket in an upper section of a lubricious member.
- FIG. 11 is a detailed illustration of a portion of the delivery device and loaded cardiac support device shown in FIGS. 8 and 9 , showing the handle of the delivery device and the lubricious members of the lubricious element assemblies releasably attached thereto.
- FIG. 12 is an isometric side view of a cardiac support device in accordance with a second embodiment of the invention.
- FIG. 13 is an isometric side view, with portions thereof broken away, of a cardiac support device in accordance with a third embodiment of the invention.
- FIG. 14 is an isometric view of a delivery device in accordance with another embodiment of the invention, shown in an extended state.
- FIGS. 1 and 2 are illustrations of the opposite sides of a cardiac support device (CSD) 10 in accordance with one embodiment of the invention.
- CSD 10 includes a jacket 12 , a self-adjusting securing structure in the form of an elastic band 14 in a hem 16 on the base end 18 of the jacket, and a plurality of lubricious element assemblies 20 .
- the illustrated embodiment of jacket 12 is generally conical and has an apex end 22 opposite the base end 18 . Both the base end 18 and apex end 22 are open to permit access to the internal volume of the jacket 12 .
- Lubricious element assemblies 20 are attached to the jacket 12 near the base end 18 , extend along the inside surface of the jacket, and extend through and beyond the open apex end 22 .
- CSD 10 includes six lubricious element assemblies 20 in the illustrated embodiment, other embodiments (not shown) include more or fewer such assemblies.
- the lubricious element assemblies 20 facilitate the deployment or positioning of CSD 10 on a patient's heart by providing a lubricious (i.e., relatively low friction) interface between at least portions of the inside surface of the jacket 12 and the epicardial (or other) surface of the heart while the CSD is being slid onto the heart. After deployment of the CSD 10 , all or portions of the lubricious element assemblies are removed from the CSD and patient.
- Jacket 12 and/or the securing structure can be similar or identical to those described in any of the following U.S. patents and applications assigned to Acorn Cardiovascular, Inc., all of which are incorporated herein by reference: U.S. Pat. No. 5,702,343; U.S. Pat. No. 6,155,972; U.S. Pat. No. 6,193,648; U.S. Pat. No. 6,482,146; U.S. Pat. No. 6,682,476; U.S. Pat. No. 6,902,524; U.S. Pat. No. 6,425,856; U.S. Pat. No. 6,908,426; U.S. Pat. No. 6,572,533; U.S. Pat. No.
- the jacket 12 can be similar or identical to those described in U.S. Pat. No. 6,702,732 and U.S. Pat. No. 6,723,041, both of which are assigned to Paracor and are incorporated herein by reference.
- the material of jacket 12 can be an open-cell construction of a polyester knit material as more fully described in U.S. Pat. No. 6,482,146.
- the material of jacket 12 can be an open-cell construction of a polyester knit material as more fully described in U.S. Pat. No. 6,951,534.
- These examples of jacket 12 and the securing structure are not limiting. Other jackets 12 and securing structures and methods can also be used.
- the apex end 22 can be an open or closed apex.
- FIGS. 3A and 3B are illustrations of the removal member side 30 and opposite lubricious member side 32 of one of the lubricious element assemblies 20 .
- the lubricious element assemblies 20 include a lubricious member 34 and a removal member 36 .
- Lubricious member 34 has a relatively low friction surface on at least the lubricious member side 32 of the assembly 20 (i.e., on the side of the member that will engage the heart when the CSD 10 is placed on the heart).
- the lubricious member 34 is a flexible strip of PTFE (i.e., fluorinated polymer) sheet material. Both of the entire surfaces of this PTFE lubricious member 34 therefore have a low friction surface.
- the lubricious member 34 can take other forms.
- Lubricious member 34 can, for example, be high density polyethylene, low density polyethylene, ultra high molecular weight polyethylene, RulonTM co-polymer, graphite doped polymer and polymer impregnated with lubricious materials.
- lubricious members can have a substrate of any of the materials described above, or other materials including non-lubricious materials, with all or portions of their opposite surfaces coated with relatively low friction material.
- Non-limiting examples of lubricious coatings that can be used with the invention include hydrophilic and hydrophobic coatings such as hyaluronic acid, polyethylene glycol, PTFE and silicone.
- the lubricious surface portions are provided by materials or coatings that may not themselves be relatively low friction, but have relatively low friction characteristics when wet by liquids. Hydrogels are one example of materials of these types.
- the member 34 can be a sheet of polymer or other material having low-friction coatings on all or portions of its opposite surfaces.
- the size (e.g., the length and width) of the lubricious members 34 can also be different that those shown and described herein.
- the lubricious members 34 can be sized to line all or substantially all of the inside surface of the jacket 12 .
- An upper portion 38 of the lubricious member 34 is attached to the jacket 12 .
- the upper portion 38 of lubricious member 34 includes a folded section that extends over the base end 18 of the jacket 12 .
- Stitches 40 can be used to attach the upper portion 38 of lubricious member 34 to the jacket 12 .
- the lubricious element assemblies 20 can be attached to other portions of jacket 12 , and other structures or methods (e.g., adhesives) can be used to secure the assemblies or lubricious members such as 34 to the jacket.
- a pocket 42 is also formed in the upper portion 38 of lubricious member 34 . Pocket 42 opens toward a lower portion 44 of the lubricious member 34 on the lubricious member side 32 of the assembly 20 . As described below, pocket 42 is used to mount the CSD 10 to a delivery tool for deployment of the CSD.
- Removal member 36 is operated to remove the lubricious member 34 from the jacket 12 following the positioning of the CSD 10 on the heart.
- the removal member 36 includes an actuating member 50 connected to the lubricious member 34 .
- the removal member 36 cooperates with a hole 48 through the lubricious member 34 that functions as a weakening structure.
- the actuating member 50 includes a pull member 52 and a tear member 54 in the embodiment shown.
- Pull member 52 is an elongated member having a proximal end 56 that can be accessed by a surgeon.
- the pull member 52 is an elongated strip of PTFE material.
- Tear member 54 connects a distal end 58 of the pull member 52 to the lubricious member 34 near the weakening structure.
- the tear member 54 is a thin metal member having an attachment portion 60 and tear strip 62 joined by a connecting portion 64 .
- the attachment portion 60 is attached (e.g., by adhesive) to the distal end 66 of pull member 52 .
- Connecting portion 64 extends through the hole 48 .
- Tear strip 62 is attached to the lubricious member 34 (e.g., by adhesive) and includes edges 68 that extend at an angle to the sides of the lubricious member.
- removal member 36 to release and remove the lubricious member 34 (and the removal member) from the CSD 10 can be described with reference to FIGS. 4A , 4 B, 5 A and 5 B.
- the base end 18 of the jacket 12 and the upper portion 38 of the lubricious member 34 will be engaged during the removal process by a member extending into the pocket 42 .
- a surgeon or other clinician will engage the pull member 52 (e.g., near its proximal end 56 ) by hand or using an instrument, and pull the pull member in a direction 70 generally away from the upper portion 38 of the lubricious member 34 .
- FIGS. 4A and 4B show the portion of the lubricious member 34 below the hole 48 partially severed from the portion of the member above the hole. With continued actuation of the pull member 52 this action will cause the portion of the lubricious member 34 below the hole 48 to be completely severed from the portion of the member above the hole as shown in FIGS. 5A and 5B .
- FIGS. 6 and 7 illustrate a delivery device 100 in accordance with one embodiment of the invention that can be used to deliver and deploy or position the CSD 10 on the heart of a patient.
- the delivery device 100 includes a body 104 having a distal end 105 , a deployment mechanism 106 and an actuating mechanism 112 .
- the body 104 is a generally tubular member, and includes a plurality of elongated slots 113 (six are shown in the illustrated embodiment) extending through the body at a location adjacent to the actuating mechanism 112 .
- Actuating mechanism 112 includes a handle 120 that is slidably mounted to the body 104 . Structures such as pins 122 on the handle 120 extend into the slots 113 .
- Deployment mechanism 106 includes a plurality (six are shown) of support members 1 18 within the body 104 . Proximal ends (not visible) of each of the support members 118 are connected to the pins 122 within the body 104 . The distal portions 119 of the support members 118 are located near the distal end 105 of the body 104 .
- Other embodiments of delivery device 100 include a suction cup connected to a vacuum source or other structure for releasably engaging the distal end 105 of the body 104 to the heart during delivery procedures.
- Handle 120 is actuated to drive the deployment mechanism 106 between a first retracted or closed state shown in FIG. 6 and a second extended or open state shown in FIG. 7 .
- the support members 118 are in a reduced-diameter configuration. In the illustrated embodiment this configuration is achieved by the handle withdrawing at least portions of the support members 118 into the distal end 105 of the body 104 . Distal end portions 119 of the support members 118 extend from the body 104 in the illustrated embodiment when the deployment mechanism 106 is in the retracted state.
- the handle 120 is slid toward the distal end 105 of the body 104 , the support members 118 are driven to the extended state shown in FIG. 7 at which the distal ends form an open array or enlarged-diameter configuration.
- Support members 118 can be resilient structures formed from polymer, metal or other materials.
- the members 118 (or portions thereof) can be formed of PTFE or other materials having low friction characteristics or coatings.
- the members 118 can also be preshaped so that they assume the open array configuration shown in FIG. 7 when the deployment mechanism 106 is in the extended state. These resilient support members 118 will be urged into the reduced diameter configuration by the body 104 when the deployment mechanism 106 is moved to the retracted state.
- other structures are used to cause the deployment mechanism to move between the retracted and extended states.
- FIG. 8 is an illustration of the CSD 10 mounted or loaded on the delivery device 100 , with the deployment mechanism 106 in the retracted state.
- FIG. 9 is an illustration of the delivery device 100 with the CSD 10 loaded thereon, with the deployment mechanism 106 in the extended state.
- the base end 18 of CSD 10 is releasably mounted to the delivery device 100 by inserting the distal end portions 119 of the support members 118 into the pockets 42 of the lubricious element assemblies 20 .
- Other structures or methods can also be used to releasably secure the CSD 10 and/or the upper or distal portions of the lubricious element assemblies 20 to the support members 118 of the deployment mechanism 106 .
- the illustrated embodiment of delivery device 100 is configured to receive the CSD 10 on the outside of the body 104 when in the retracted state, the CSD can be partially or fully enclosed within the body or other structures of the delivery device in other embodiments (not shown).
- the lower portions 44 of the lubricious members 34 are releasably secured to the handle 120 .
- the illustrated embodiment of the invention includes a plurality of pins 140 (one for each lubricious member 34 ) extending from the handle 120 at circumferentially-spaced locations.
- the lower portions 44 of the lubricious members 34 include structures such as holes 142 that can engage the pins 140 .
- Other structures or methods can be used to releasably secure the lubricious members 34 to the delivery device 100 .
- the proximal ends of the lubricious members 34 are not releasably secured to the delivery device 100 .
- handle 120 When the CSD 10 is positioned at a desired location adjacent to the apex of the patient's heart, handle 120 is actuated to drive the deployment mechanism 106 to its extended state shown in FIG. 9 . When in the extended state, the deployment mechanism 106 will open the base end 18 of the jacket 12 .
- the delivery device 100 can then be further manipulated to slide the CSD 10 over the heart of the patient, and to position the CSD at the desired location on the heart. During this portion of the delivery procedure the opposite ends of the CSD 10 remain constrained on delivery device 100 .
- the delivery device 100 can therefore be manipulated as needed to locate the CSD at the desired position (e.g. the delivery device can be moved forwardly, rearwardly and rotated, and corresponding motions transferred to the CSD).
- the presence of the lubricious members 34 between the epicardial surface of the patient's heart and the jacket 12 during this portion of the procedure reduces the friction between the heart surface and jacket, enabling the jacket to be more efficiently implanted.
- the lubricious members 34 can be removed after the CSD 10 is positioned on the heart.
- the lubricious members 34 are removed through the apex end 22 of the jacket 12 through the use of pull members 52 .
- This action can be accomplished by the surgeon grasping the proximal end 56 of the pull members 52 and removing the pull members from the handle 120 (e.g., by disengaging the holes 142 from the pins 122 ).
- the lubricious members 34 can be separated from the jacket 12 and both the lubricious members and the pull members withdrawn from the pericardial space and patient's body through the surgical access site.
- the relatively low friction surfaces of the lubricious members 34 and pull members 52 facilitate the removal of these structures from the implanted CSD 10 while minimizing disruptions of the CSD position on the patent's heart.
- the handle 120 of the delivery device 100 is actuated to return the deployment mechanism 106 to the retracted state so it can be withdrawn through the surgical access site.
- the securing structure e.g., elastic band 14
- the delivery device 100 can be withdrawn before the removal of the lubricious members 34 .
- FIG. 12 is an illustration of a cardiac support device (CSD) 210 in accordance with a second embodiment of the invention.
- CSD 210 includes a jacket 212 , a self-adjusting securing structure in the form of an elastic band 214 in a hem 216 on a base end 218 of the jacket, and a plurality of lubricious element structures 220 .
- Jacket 212 has a closed apex end 222 in this embodiment of the invention, and lubricious element structures 220 are configured to be removed from the open base end 218 of the jacket.
- CSD 210 can be substantially the same as or similar to CSD 10 described above.
- Lubricious element structures 220 include a lubricious member portion 234 and pull member portion 252 .
- the lubricious member portions 234 are located on the inside surface of the jacket 212 . In the illustrated embodiment the lubricious member portions 234 extend from the base end 218 of jacket 212 toward the apex end 222 .
- the pull member portions 252 are connected to the lubricious member portions 234 over the base end 218 of jacket 212 , and extend from the base end of the jacket 212 on the outside of the jacket.
- the lubricious member portions 234 are effectively releasably secured with respect to the jacket 212 by the interconnection with the pull member portions 252 .
- lubricious member portions 234 and pull member portions 252 are portions of a unitary strip of PTFE, with the strip folded over the base end 218 of the jacket 212 .
- the lubricious member portions 234 and pull member portions 252 can be different elements that are joined together.
- the lubricious member portions 234 and pull member portions 252 can be formed from different materials. In general, the lubricious member portions 234 and pull member portions 252 can be formed from the same materials as those of the lubricious members 34 and pull members 52 of CSD 10 described above.
- CSD 210 can be implanted onto the heart of a patient using a delivery device 100 of the type described above in connection with FIGS. 6 and 7 .
- pockets 242 near the base end 218 of the CSD 210 can be used to engage the support members 118 of the deployment mechanism 106 .
- the pockets 242 can, for example, be formed on the outside of the jacket 212 (e.g., on the hem 216 ) or on the pull members portions 252 .
- Holes 241 on the proximal portions 244 of the pull member portions 252 can be used to releasably engage the pull member portions to the handle 120 of the delivery device 100 .
- the CSD 210 can be loaded onto the delivery device 100 with the support members 118 on the outside of the jacket 212 (e.g., between the jacket and the pull member portions 252 ).
- the CSD can be completely or partially withdrawn into the distal end 105 of the body 104 , with the pull member portions 252 extending along the outside of the body 104 .
- Other structures and approaches can also be used to releasably secure the proximal portions 244 of the pull members portions 252 to the delivery device 100 .
- the delivery device 100 loaded with the CSD 210 as described above can be inserted into the patient's pericardial space, deployed to the extended state and the CSD positioned on the patient's heart in a manner similar to that described above in connection with CSD 10 .
- the pull member portions 252 can be grasped by the surgeon, released from the handle 120 , and pulled in a direction generally away from the CSD to remove the lubricious member portions 234 from between the jacket 212 and the heart. Specifically, by pulling the pull member portions 252 , the lubricious member portions 234 are pulled over the base end 218 of the jacket 212 .
- the support members 118 of the delivery device 106 can provide support to enable the lubricious member portions 234 to be removed in the matter described above.
- friction reducing members or structures such as rollers or rounded surfaces on the distal portions 119 of the support members 118 can be configured to be located adjacent to the lubricious member portions 234 to enhance the ability of the lubricious member portions to be removed by the action of the pull member portions 252 .
- the delivery device can include additional stages or structures (e.g., another set of members such as the support members 118 ) that provide support enabling the lubricious member portions 234 to be removed.
- Lubricious member portions 234 provide friction-reducing advantages similar to those described above in connection with CSD 10 during the implantation of the CSD 210 on a patient's heart.
- FIG. 13 is an illustration of a cardiac support device (CSD) 310 in accordance with a third embodiment of the invention.
- CSD 310 includes a jacket 312 , a hem 316 on a base end 318 of the jacket, a hem 321 extending between the base end and the apex end 322 , and a lubricious member 320 .
- Jacket 312 has a closed apex end 322 , and does not include a self-adjusting securing structure in this embodiment of the invention.
- CSD 310 is configured to be implanted on a patient's heart through conventional open-chest procedures (e.g., through a sternotomy). Other than the differences described herein, including those of the lubricious member 320 , CSD 310 can be substantially the same as or similar to CSD 10 described above.
- Lubricious member 320 is a cup-shaped member having a shape corresponding to the interior surface of the jacket 312 .
- the lubricious member 320 is formed from a plurality of sections 323 attached to one another by structures such as stitches 325 .
- the lubricious member 320 can be formed from the same materials as those of lubricious members 34 of CSD 10 described above. Stitches such as those shown at 327 can be used to releasably secure the lubricious member 320 to the jacket 312 .
- lubricious member 320 is a unitary member that lines substantially the entire inside surface of jacket 312
- other embodiments cover lesser portions of the jacket, or include a plurality or individual and separate sections that together line substantially all or lesser portions of the inside surface of the jacket.
- Other structures such as adhesives can be used to releasably secure the lubricious member 320 or its sections to the jacket 312 .
- the lubricious member 320 is not releasably attached to the jacket 312 .
- a surgeon can by hand slide the CSD 310 over the patient's heart. After the CSD 310 is located, the surgeon can open the jacket 312 and manually (e.g., by hand or through the use of an instrument) remove the lubricious member 320 .
- the hem 321 can be opened between the base end 318 and apex end 322 of the jacket 312 , and the lubricious member 320 withdrawn through that opening.
- any structures releasably securing the lubricious member 320 to the jacket 312 can be removed (e.g., stitches 327 can be cut).
- the opening in the jacket 312 is closed (e.g., by restitching the hem 321 ).
- the jacket 312 can be properly sized and fit onto the heart.
- Other structures or methods can also be used to open and close the jacket 312 after it has been initially placed on the patent's heart.
- Use of the lubricious member 320 enhances the efficiency by which the jacket 312 can be implanted during the surgical procedure.
- FIG. 14 is an illustration of a delivery device 400 in accordance with another embodiment of the invention.
- Delivery device 400 can be used to deliver and deploy a conventional or otherwise known CSD including, but not limited to, those described in this document and the patents and patent applications identified above and incorporated herein.
- delivery device 400 can be used to deliver a CSD that is free from lubricious structures such as 20 , 220 and 320 , while still providing the efficient, low-friction delivery advantages of the other embodiments of the invention described herein.
- delivery device 400 includes a body 404 having a distal end 405 , a deployment mechanism 406 having lubricious support members 418 , and an actuating mechanism 412 .
- the body 404 is a generally tubular member, and includes a plurality of elongated slots 413 extending through the body at a location adjacent to the actuating mechanism 412 .
- Actuating mechanism 412 includes a handle 420 that is slidably mounted to the body 404 . Structures such as pins 422 on the handle 420 extend into the slots 413 .
- Deployment mechanism 406 includes a plurality (six are shown) of lubricious support members 418 within the body 404 .
- Proximal ends of the support members 418 are connected to the pins 422 within the body 404 .
- the distal portions 419 of the lubricious support members 418 are located near the distal end 405 of the body 404 .
- Other embodiments of delivery device 400 can include different or additional structures including, for example, a suction cup or other structures on the distal end 405 of body 404 for engaging the heart during the use of the device.
- Handle 420 is actuated to drive the deployment mechanism 406 between a first retracted or closed state (not shown) and a second extended or open state shown in FIG. 14 .
- the lubricious support members 418 are in a reduced-diameter configuration (similar to that of the embodiment shown in FIG. 6 ). In the illustrated embodiment this configuration is achieved by the handle 420 withdrawing at least portions of the lubricious support members 418 into the distal end 405 of the body 404 .
- Distal end portions 419 of the lubricious support members 418 extend from the body 404 in some embodiments of the invention when the deployment mechanism 406 is in the retracted state in other embodiments (not shown), the support members 418 are not enclosed within the body 404 when in the retracted state.
- the handle 420 is slid toward the distal end 405 of the body 404 , the lubricious support members 418 are driven to the extended state shown in FIG. 14 at which the distal ends 419 form an open array or enlarged-diameter configuration.
- Lubricious support members 418 can be resilient structures formed from materials such as metals and polymers. The resilient nature of the support members 418 enables the members to move radially with respect to the body 404 during movement between the retracted and extended states. In some embodiments of the invention the support members 418 can also curve in a circumferential direction from a flat configuration to an arced configuration generally conforming to the shape of adjacent portions of the heart. At least portions of the interior surfaces 421 of the support members 418 (i.e., the surfaces that will be adjacent or in contact with the heart during CSD delivery) are lubricious.
- the lubricious support members 418 can, for example, be formed from the materials of lubricious elements 34 described above, or from the materials of the support members 118 of delivery device 100 described above. In embodiments having lubricious support members 418 including materials that are not lubricious, coatings of lubricious materials such as those described above in connection with lubricious elements 34 can be applied to all or portions of the non-lubricious portions of the support members 418 .
- the lubricious support members 418 have greater surface area than the support members 118 of delivery device 100 described above, thereby enhancing the friction-reducing characteristics of the support members.
- the lubricious support members 418 are generally paddle-shaped in that they have a relatively large surface area, with substantial surface portions of the members having a width that is substantially greater than the thickness of the members.
- the amount of lubricious surface on the support members 418 is sufficient or effective to enable the delivery device 400 to substantially reduce the amount of friction that would otherwise be present between a CSD and heart during delivery, and thereby enable the efficient positioning of the CSD.
- the lubricious support members 418 have other shapes and sizes in other embodiments of the invention (not shown). In general, the greater the amounts of lubricious surface area on the support members 418 , the greater the efficiency of the delivery device 400 .
- Delivery device 400 can be used and operated in a manner similar to that of delivery device 100 described above to deliver and deploy a CSD on a patient's heart.
- the CSD used in connection with delivery device 400 need not, however, include lubricious element structures such as 20 , 220 and 320 described above in connection with other embodiments of the invention, since the lubricious support members 418 can provide sufficient friction reduction.
- the CSD (not shown) can be releasably attached at its base end to the distal ends 419 of lubricious support members 418 , with the support members 418 on the inside surface of the CSD jacket extending through an open apex.
- the delivery device 400 and attached CSD can, in the retracted state, have a configuration similar to that of delivery device 100 and CSD 10 shown and described in connection with FIG. 8 .
- the delivery device 400 and CSD are inserted into the patient's pericardial space and manipulated into position adjacent to the heart in a manner similar to that of delivery device 100 described above.
- handle 420 is actuated to drive the deployment mechanism 406 to its extended state shown in FIG. 14 .
- the deployment mechanism 406 When in the extended state, the deployment mechanism 406 will open the base end of the jacket and have a configuration similar to that of delivery device 100 and CSD 10 shown and described in connection with FIG. 9 .
- the delivery device 400 and CSD can then be further manipulated to slide the CSD over the patient's heart and to position the CSD at the desired location on the heart.
- the CSD can then be detached from the deployment mechanism 406 , and the delivery device 400 withdrawn from the surgical access site.
- the presence of the lubricious support members 418 between the epicardial surface of the patient's heart and the CSD jacket reduces the friction between the heart surface and jacket, enabling the CSD to be more efficiently implanted.
- lubricious material is positioned on the surface of the heart before the CSD is positioned on the heart.
- the lubricious material is then removed (e.g., through the base or an open apex of the CSD) after the device is positioned.
Abstract
A cardiac support device that can be efficiently implanted on a patient's heart. The cardiac support device includes a jacket for constraining cardiac expansion and one or more lubricious elements releasably secured with respect to an inside surface of the jacket.
Description
- The invention is a cardiac support device having low friction delivery-enhancing structures.
- Cardiac support devices are structures, sometimes referred to as jackets, that surround all or portions of a diseased heart. These devices are intended to treat chronic heart failure or other cardiac disease, which may be associated valvular dysfunction, by constraining expansion of the heart. They can be delivered and implanted using conventional cardiothoracic surgical techniques or minimally invasive surgical procedures. Devices of these types and associated delivery tools and methods are shown, for example, in the following U.S. patents, all of which are incorporated herein by reference in their entirety.
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Inventor Name Patent/Publication No. Alferness 5,702,343 Alferness et al. 6,123,662 Vanden Hoek et al. 6,293,906 Alferness et al. 6,482,146 Lau et al. 6,702,732 Cox et al. 6,730,016 Walsh et al. 6,902,522 Girard et al. 6,951,534 - During the delivery procedures portions of the cardiac support devices sometimes encounter frictional resistance on the heart surface during placement. There is, therefore, a continuing need for improved methods and associated devices for use during the delivery of cardiac support devices. An invention of this type that can enhance the efficiency of the delivery procedure would be especially desirable.
- The present invention is an improved cardiac support device that can be efficiently implanted within a patient. One embodiment of the invention includes a jacket for constraining cardiac expansion and one or more lubricious elements releasably secured with respect to an inside surface of the jacket. In another embodiment of the invention the lubricious elements include a plurality of strips of lubricious material releasably secured to a base portion of the jacket.
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FIG. 1 is an isometric side view of a cardiac support device in accordance with one embodiment of the present invention, with portions thereof broken away to illustrate the lubricious element assemblies. -
FIG. 2 is an isometric side view of the cardiac support device shown inFIG. 1 , illustrating the side of the device opposite that shown inFIG. 1 . -
FIGS. 3A and 3B are detailed illustrations of the opposite sides of the lubricious element assemblies shown inFIGS. 1 and 2 , in an unreleased state. -
FIGS. 4A and 4B are illustrations of the opposite sides of the lubricious element assemblies shown inFIGS. 3A and 3B , in a partially released state. -
FIGS. 5A and 5B are illustrations of the opposite sides of the lubricious element assemblies shown inFIGS. 3A and 3B , in a fully released state. -
FIG. 6 is an isometric view of a delivery device in accordance with one embodiment of the invention, shown in a retracted state, that can be used to position the cardiac support device shown inFIG. 1 on a patient's heart. -
FIG. 7 is an isometric view of the delivery device shown inFIG. 6 , shown in an extended state. -
FIG. 8 is an isometric view of the delivery device shown inFIGS. 6 and 7 , shown in the retracted state with the cardiac support device shown inFIGS. 1 and 2 loaded thereon. -
FIG. 9 is an isometric view of the delivery device and loaded cardiac support device shown inFIG. 8 , shown in the extended state. -
FIGS. 10A and 10B are detailed illustrations of the opposite sides of a portion of the delivery device and loaded cardiac support device shown inFIGS. 8 and 9 , showing the distal end of the delivery device support member extending into a pocket in an upper section of a lubricious member. -
FIG. 11 is a detailed illustration of a portion of the delivery device and loaded cardiac support device shown inFIGS. 8 and 9 , showing the handle of the delivery device and the lubricious members of the lubricious element assemblies releasably attached thereto. -
FIG. 12 is an isometric side view of a cardiac support device in accordance with a second embodiment of the invention. -
FIG. 13 is an isometric side view, with portions thereof broken away, of a cardiac support device in accordance with a third embodiment of the invention. -
FIG. 14 is an isometric view of a delivery device in accordance with another embodiment of the invention, shown in an extended state. -
FIGS. 1 and 2 are illustrations of the opposite sides of a cardiac support device (CSD) 10 in accordance with one embodiment of the invention. As shown, CSD 10 includes ajacket 12, a self-adjusting securing structure in the form of anelastic band 14 in ahem 16 on thebase end 18 of the jacket, and a plurality of lubricious element assemblies 20. The illustrated embodiment ofjacket 12 is generally conical and has anapex end 22 opposite thebase end 18. Both thebase end 18 andapex end 22 are open to permit access to the internal volume of thejacket 12. - Lubricious element assemblies 20 are attached to the
jacket 12 near thebase end 18, extend along the inside surface of the jacket, and extend through and beyond theopen apex end 22. Although CSD 10 includes six lubricious element assemblies 20 in the illustrated embodiment, other embodiments (not shown) include more or fewer such assemblies. As described in greater detail below, the lubricious element assemblies 20 facilitate the deployment or positioning ofCSD 10 on a patient's heart by providing a lubricious (i.e., relatively low friction) interface between at least portions of the inside surface of thejacket 12 and the epicardial (or other) surface of the heart while the CSD is being slid onto the heart. After deployment of theCSD 10, all or portions of the lubricious element assemblies are removed from the CSD and patient. -
Jacket 12 and/or the securing structure can be similar or identical to those described in any of the following U.S. patents and applications assigned to Acorn Cardiovascular, Inc., all of which are incorporated herein by reference: U.S. Pat. No. 5,702,343; U.S. Pat. No. 6,155,972; U.S. Pat. No. 6,193,648; U.S. Pat. No. 6,482,146; U.S. Pat. No. 6,682,476; U.S. Pat. No. 6,902,524; U.S. Pat. No. 6,425,856; U.S. Pat. No. 6,908,426; U.S. Pat. No. 6,572,533; U.S. Pat. No. 6,673,009; U.S. Pat. No. 6,951,534; and application Ser. No. 11/367,759, filed Mar. 3, 2006, and entitled Self-Adjusting Securing Structure For A Cardiac Support Device. In still other embodiments thejacket 12 can be similar or identical to those described in U.S. Pat. No. 6,702,732 and U.S. Pat. No. 6,723,041, both of which are assigned to Paracor and are incorporated herein by reference. In one embodiment, the material ofjacket 12 can be an open-cell construction of a polyester knit material as more fully described in U.S. Pat. No. 6,482,146. In yet another embodiment, the material ofjacket 12 can be an open-cell construction of a polyester knit material as more fully described in U.S. Pat. No. 6,951,534. These examples ofjacket 12 and the securing structure are not limiting.Other jackets 12 and securing structures and methods can also be used. Furthermore, theapex end 22 can be an open or closed apex. -
FIGS. 3A and 3B are illustrations of the removal member side 30 and oppositelubricious member side 32 of one of thelubricious element assemblies 20. As shown, thelubricious element assemblies 20 include alubricious member 34 and aremoval member 36.Lubricious member 34 has a relatively low friction surface on at least thelubricious member side 32 of the assembly 20 (i.e., on the side of the member that will engage the heart when theCSD 10 is placed on the heart). In the illustrated embodiment, thelubricious member 34 is a flexible strip of PTFE (i.e., fluorinated polymer) sheet material. Both of the entire surfaces of this PTFElubricious member 34 therefore have a low friction surface. In other embodiments (not shown) thelubricious member 34 can take other forms.Lubricious member 34 can, for example, be high density polyethylene, low density polyethylene, ultra high molecular weight polyethylene, Rulon™ co-polymer, graphite doped polymer and polymer impregnated with lubricious materials. Alternatively or in addition, lubricious members can have a substrate of any of the materials described above, or other materials including non-lubricious materials, with all or portions of their opposite surfaces coated with relatively low friction material. Non-limiting examples of lubricious coatings that can be used with the invention include hydrophilic and hydrophobic coatings such as hyaluronic acid, polyethylene glycol, PTFE and silicone. In yet other embodiments of the invention, the lubricious surface portions are provided by materials or coatings that may not themselves be relatively low friction, but have relatively low friction characteristics when wet by liquids. Hydrogels are one example of materials of these types. By way of example only, themember 34 can be a sheet of polymer or other material having low-friction coatings on all or portions of its opposite surfaces. The size (e.g., the length and width) of thelubricious members 34 can also be different that those shown and described herein. For example, thelubricious members 34 can be sized to line all or substantially all of the inside surface of thejacket 12. - An
upper portion 38 of thelubricious member 34 is attached to thejacket 12. In the embodiment shown, theupper portion 38 oflubricious member 34 includes a folded section that extends over thebase end 18 of thejacket 12.Stitches 40 can be used to attach theupper portion 38 oflubricious member 34 to thejacket 12. In other embodiments (not shown) thelubricious element assemblies 20 can be attached to other portions ofjacket 12, and other structures or methods (e.g., adhesives) can be used to secure the assemblies or lubricious members such as 34 to the jacket. Apocket 42 is also formed in theupper portion 38 oflubricious member 34.Pocket 42 opens toward alower portion 44 of thelubricious member 34 on thelubricious member side 32 of theassembly 20. As described below,pocket 42 is used to mount theCSD 10 to a delivery tool for deployment of the CSD. -
Removal member 36 is operated to remove thelubricious member 34 from thejacket 12 following the positioning of theCSD 10 on the heart. In the embodiment shown, theremoval member 36 includes an actuatingmember 50 connected to thelubricious member 34. Theremoval member 36 cooperates with ahole 48 through thelubricious member 34 that functions as a weakening structure. The actuatingmember 50 includes apull member 52 and a tear member 54 in the embodiment shown. Pullmember 52 is an elongated member having aproximal end 56 that can be accessed by a surgeon. In one embodiment thepull member 52 is an elongated strip of PTFE material. Although the use of this low friction material in this application provides advantages such as enhanced friction reduction, other structures (e.g., other materials, strings or wires; not shown) can also be used. Tear member 54 connects a distal end 58 of thepull member 52 to thelubricious member 34 near the weakening structure. In the embodiment shown, the tear member 54 is a thin metal member having anattachment portion 60 andtear strip 62 joined by a connectingportion 64. Theattachment portion 60 is attached (e.g., by adhesive) to thedistal end 66 ofpull member 52. Connectingportion 64 extends through thehole 48. Tearstrip 62 is attached to the lubricious member 34 (e.g., by adhesive) and includesedges 68 that extend at an angle to the sides of the lubricious member. - The operation of
removal member 36 to release and remove the lubricious member 34 (and the removal member) from theCSD 10 can be described with reference toFIGS. 4A , 4B, 5A and 5B. As will be described below, thebase end 18 of thejacket 12 and theupper portion 38 of thelubricious member 34 will be engaged during the removal process by a member extending into thepocket 42. With thebase end 18 of thejacket 12 supported in this manner, a surgeon or other clinician will engage the pull member 52 (e.g., near its proximal end 56) by hand or using an instrument, and pull the pull member in adirection 70 generally away from theupper portion 38 of thelubricious member 34. This action will cause theedges 68 of thetear strip 62 to sever thelubricious member 34, starting at thehole 48.FIGS. 4A and 4B show the portion of thelubricious member 34 below thehole 48 partially severed from the portion of the member above the hole. With continued actuation of thepull member 52 this action will cause the portion of thelubricious member 34 below thehole 48 to be completely severed from the portion of the member above the hole as shown inFIGS. 5A and 5B . -
FIGS. 6 and 7 illustrate adelivery device 100 in accordance with one embodiment of the invention that can be used to deliver and deploy or position theCSD 10 on the heart of a patient. Thedelivery device 100 includes abody 104 having adistal end 105, adeployment mechanism 106 and anactuating mechanism 112. Thebody 104 is a generally tubular member, and includes a plurality of elongated slots 113 (six are shown in the illustrated embodiment) extending through the body at a location adjacent to theactuating mechanism 112.Actuating mechanism 112 includes ahandle 120 that is slidably mounted to thebody 104. Structures such aspins 122 on thehandle 120 extend into theslots 113.Deployment mechanism 106 includes a plurality (six are shown) of support members 1 18 within thebody 104. Proximal ends (not visible) of each of thesupport members 118 are connected to thepins 122 within thebody 104. Thedistal portions 119 of thesupport members 118 are located near thedistal end 105 of thebody 104. Other embodiments of delivery device 100 (not shown) include a suction cup connected to a vacuum source or other structure for releasably engaging thedistal end 105 of thebody 104 to the heart during delivery procedures. - Handle 120 is actuated to drive the
deployment mechanism 106 between a first retracted or closed state shown inFIG. 6 and a second extended or open state shown inFIG. 7 . In the retracted state shown inFIG. 6 , thesupport members 118 are in a reduced-diameter configuration. In the illustrated embodiment this configuration is achieved by the handle withdrawing at least portions of thesupport members 118 into thedistal end 105 of thebody 104.Distal end portions 119 of thesupport members 118 extend from thebody 104 in the illustrated embodiment when thedeployment mechanism 106 is in the retracted state. When the handle120 is slid toward thedistal end 105 of thebody 104, thesupport members 118 are driven to the extended state shown inFIG. 7 at which the distal ends form an open array or enlarged-diameter configuration. -
Support members 118 can be resilient structures formed from polymer, metal or other materials. For example, the members 118 (or portions thereof) can be formed of PTFE or other materials having low friction characteristics or coatings. Themembers 118 can also be preshaped so that they assume the open array configuration shown inFIG. 7 when thedeployment mechanism 106 is in the extended state. Theseresilient support members 118 will be urged into the reduced diameter configuration by thebody 104 when thedeployment mechanism 106 is moved to the retracted state. In other embodiments, other structures (not shown) are used to cause the deployment mechanism to move between the retracted and extended states. -
FIG. 8 is an illustration of theCSD 10 mounted or loaded on thedelivery device 100, with thedeployment mechanism 106 in the retracted state.FIG. 9 is an illustration of thedelivery device 100 with theCSD 10 loaded thereon, with thedeployment mechanism 106 in the extended state. As perhaps best shown inFIGS. 10A and 10B , in the illustrated embodiment thebase end 18 ofCSD 10 is releasably mounted to thedelivery device 100 by inserting thedistal end portions 119 of thesupport members 118 into thepockets 42 of thelubricious element assemblies 20. Other structures or methods (not shown) can also be used to releasably secure theCSD 10 and/or the upper or distal portions of thelubricious element assemblies 20 to thesupport members 118 of thedeployment mechanism 106. Although the illustrated embodiment ofdelivery device 100 is configured to receive theCSD 10 on the outside of thebody 104 when in the retracted state, the CSD can be partially or fully enclosed within the body or other structures of the delivery device in other embodiments (not shown). - As perhaps best shown in
FIG. 11 , thelower portions 44 of thelubricious members 34 are releasably secured to thehandle 120. The illustrated embodiment of the invention includes a plurality of pins 140 (one for each lubricious member 34) extending from thehandle 120 at circumferentially-spaced locations. Thelower portions 44 of thelubricious members 34 include structures such asholes 142 that can engage thepins 140. Other structures or methods (not shown) can be used to releasably secure thelubricious members 34 to thedelivery device 100. In still other embodiments of the invention (not shown) the proximal ends of thelubricious members 34 are not releasably secured to thedelivery device 100. - In the retracted state shown in
FIG. 8 , thedeployment mechanism 106 causes theCSD 10 to be in a collapsed state adjacent to the exterior surface of thebody 104. Thebase end 18 of thejacket 12 is engaged with thedistal end portions 119 of thesupport members 118, and thelower portions 44 of thelubricious members 34 are engaged with thehandle 120. The opposite ends of theCSD 10 are therefore effectively constrained, preventing substantial movement of the CSD with respect to thedelivery device 100 along the longitudinal axis of the delivery device. Thedelivery device 100 can then be manipulated to insert the distal end of the delivery device and theCSD 10 mounted thereon into the pericardial space of a patient (not shown) through a relatively small incision using minimally invasive surgical procedures. Thedelivery device 100 can be moved forwardly and rearwardly during this procedure without disengaging theCSD 10 from the delivery device. Sub-xyphoid or other desired access approaches can be used for these minimally invasive delivery procedures. - When the
CSD 10 is positioned at a desired location adjacent to the apex of the patient's heart, handle 120 is actuated to drive thedeployment mechanism 106 to its extended state shown inFIG. 9 . When in the extended state, thedeployment mechanism 106 will open thebase end 18 of thejacket 12. Thedelivery device 100 can then be further manipulated to slide theCSD 10 over the heart of the patient, and to position the CSD at the desired location on the heart. During this portion of the delivery procedure the opposite ends of theCSD 10 remain constrained ondelivery device 100. Thedelivery device 100 can therefore be manipulated as needed to locate the CSD at the desired position (e.g. the delivery device can be moved forwardly, rearwardly and rotated, and corresponding motions transferred to the CSD). The presence of thelubricious members 34 between the epicardial surface of the patient's heart and thejacket 12 during this portion of the procedure reduces the friction between the heart surface and jacket, enabling the jacket to be more efficiently implanted. - The
lubricious members 34 can be removed after theCSD 10 is positioned on the heart. In the embodiment of the invention described above, thelubricious members 34 are removed through theapex end 22 of thejacket 12 through the use ofpull members 52. This action can be accomplished by the surgeon grasping theproximal end 56 of thepull members 52 and removing the pull members from the handle 120 (e.g., by disengaging theholes 142 from the pins 122). With continued motion of thepull members 52 in a direction generally away from thejacket 12 against the stabilizing force provided by thesupport members 118 of thedeployment device 106 as described above in connection with FIGS. 3A and 3B-5A and 5B, thelubricious members 34 can be separated from thejacket 12 and both the lubricious members and the pull members withdrawn from the pericardial space and patient's body through the surgical access site. The relatively low friction surfaces of thelubricious members 34 and pullmembers 52 facilitate the removal of these structures from the implantedCSD 10 while minimizing disruptions of the CSD position on the patent's heart. Following the removal of thelubricious members 34, thehandle 120 of thedelivery device 100 is actuated to return thedeployment mechanism 106 to the retracted state so it can be withdrawn through the surgical access site. The securing structure (e.g., elastic band 14) then functions to hold theCSD 10 on the heart. In other embodiments (not shown) thedelivery device 100 can be withdrawn before the removal of thelubricious members 34. -
FIG. 12 is an illustration of a cardiac support device (CSD) 210 in accordance with a second embodiment of the invention.CSD 210 includes a jacket 212, a self-adjusting securing structure in the form of anelastic band 214 in ahem 216 on abase end 218 of the jacket, and a plurality oflubricious element structures 220. Jacket 212 has a closedapex end 222 in this embodiment of the invention, andlubricious element structures 220 are configured to be removed from theopen base end 218 of the jacket. Other than the closedapex end 222 and the features oflubricious element structures 220 described below,CSD 210 can be substantially the same as or similar toCSD 10 described above. -
Lubricious element structures 220 include alubricious member portion 234 and pullmember portion 252. Thelubricious member portions 234 are located on the inside surface of the jacket 212. In the illustrated embodiment thelubricious member portions 234 extend from thebase end 218 of jacket 212 toward theapex end 222. Thepull member portions 252 are connected to thelubricious member portions 234 over thebase end 218 of jacket 212, and extend from the base end of the jacket 212 on the outside of the jacket. Thelubricious member portions 234 are effectively releasably secured with respect to the jacket 212 by the interconnection with thepull member portions 252. Other embodiments of the invention (not shown) include other structures for releasably securing thelubricious member portions 234 to the jacket 212. In the illustrated embodiment thelubricious member portions 234 and pullmember portions 252 are portions of a unitary strip of PTFE, with the strip folded over thebase end 218 of the jacket 212. In other embodiments (not shown) thelubricious member portions 234 and pullmember portions 252 can be different elements that are joined together. In still other embodiments (not shown), thelubricious member portions 234 and pullmember portions 252 can be formed from different materials. In general, thelubricious member portions 234 and pullmember portions 252 can be formed from the same materials as those of thelubricious members 34 and pullmembers 52 ofCSD 10 described above. -
CSD 210 can be implanted onto the heart of a patient using adelivery device 100 of the type described above in connection withFIGS. 6 and 7 . For example, pockets 242 near thebase end 218 of theCSD 210 can be used to engage thesupport members 118 of thedeployment mechanism 106. Thepockets 242 can, for example, be formed on the outside of the jacket 212 (e.g., on the hem 216) or on thepull members portions 252.Holes 241 on theproximal portions 244 of thepull member portions 252 can be used to releasably engage the pull member portions to thehandle 120 of thedelivery device 100. TheCSD 210 can be loaded onto thedelivery device 100 with thesupport members 118 on the outside of the jacket 212 (e.g., between the jacket and the pull member portions 252). When thedelivery device 100 loaded with the CSD 210 (not shown) is in the retracted state, the CSD can be completely or partially withdrawn into thedistal end 105 of thebody 104, with thepull member portions 252 extending along the outside of thebody 104. Other structures and approaches (not shown) can also be used to releasably secure theproximal portions 244 of thepull members portions 252 to thedelivery device 100. - The
delivery device 100 loaded with theCSD 210 as described above can be inserted into the patient's pericardial space, deployed to the extended state and the CSD positioned on the patient's heart in a manner similar to that described above in connection withCSD 10. After theCSD 210 is properly located on the patient's heart, thepull member portions 252 can be grasped by the surgeon, released from thehandle 120, and pulled in a direction generally away from the CSD to remove thelubricious member portions 234 from between the jacket 212 and the heart. Specifically, by pulling thepull member portions 252, thelubricious member portions 234 are pulled over thebase end 218 of the jacket 212. Thesupport members 118 of thedelivery device 106 can provide support to enable thelubricious member portions 234 to be removed in the matter described above. In other embodiments (not shown), friction reducing members or structures such as rollers or rounded surfaces on thedistal portions 119 of thesupport members 118 can be configured to be located adjacent to thelubricious member portions 234 to enhance the ability of the lubricious member portions to be removed by the action of thepull member portions 252. In still other embodiments (also not shown), the delivery device can include additional stages or structures (e.g., another set of members such as the support members 118) that provide support enabling thelubricious member portions 234 to be removed. After the lubricious member portions 234 (and the pull member portions 252) are removed from the patient, thedelivery device 100 can be removed in the manner described above in connection withCSD 10.Lubricious member portions 234 provide friction-reducing advantages similar to those described above in connection withCSD 10 during the implantation of theCSD 210 on a patient's heart. -
FIG. 13 is an illustration of a cardiac support device (CSD) 310 in accordance with a third embodiment of the invention.CSD 310 includes ajacket 312, ahem 316 on abase end 318 of the jacket, ahem 321 extending between the base end and theapex end 322, and alubricious member 320.Jacket 312 has a closedapex end 322, and does not include a self-adjusting securing structure in this embodiment of the invention.CSD 310 is configured to be implanted on a patient's heart through conventional open-chest procedures (e.g., through a sternotomy). Other than the differences described herein, including those of thelubricious member 320,CSD 310 can be substantially the same as or similar toCSD 10 described above. -
Lubricious member 320 is a cup-shaped member having a shape corresponding to the interior surface of thejacket 312. In the embodiment shown, thelubricious member 320 is formed from a plurality ofsections 323 attached to one another by structures such as stitches 325. Thelubricious member 320 can be formed from the same materials as those oflubricious members 34 ofCSD 10 described above. Stitches such as those shown at 327 can be used to releasably secure thelubricious member 320 to thejacket 312. Although the illustrated embodiment oflubricious member 320 is a unitary member that lines substantially the entire inside surface ofjacket 312, other embodiments (not shown) cover lesser portions of the jacket, or include a plurality or individual and separate sections that together line substantially all or lesser portions of the inside surface of the jacket. Other structures (not shown) such as adhesives can be used to releasably secure thelubricious member 320 or its sections to thejacket 312. In still other embodiments (not shown) thelubricious member 320 is not releasably attached to thejacket 312. - During implantation, a surgeon can by hand slide the
CSD 310 over the patient's heart. After theCSD 310 is located, the surgeon can open thejacket 312 and manually (e.g., by hand or through the use of an instrument) remove thelubricious member 320. For example, thehem 321 can be opened between thebase end 318 andapex end 322 of thejacket 312, and thelubricious member 320 withdrawn through that opening. If necessary, any structures releasably securing thelubricious member 320 to thejacket 312 can be removed (e.g., stitches 327 can be cut). Following the removal of thelubricious member 310, the opening in thejacket 312 is closed (e.g., by restitching the hem 321). By this closure procedure thejacket 312 can be properly sized and fit onto the heart. Other structures or methods can also be used to open and close thejacket 312 after it has been initially placed on the patent's heart. Use of thelubricious member 320 enhances the efficiency by which thejacket 312 can be implanted during the surgical procedure. -
FIG. 14 is an illustration of adelivery device 400 in accordance with another embodiment of the invention.Delivery device 400 can be used to deliver and deploy a conventional or otherwise known CSD including, but not limited to, those described in this document and the patents and patent applications identified above and incorporated herein. In one embodiment,delivery device 400 can be used to deliver a CSD that is free from lubricious structures such as 20, 220 and 320, while still providing the efficient, low-friction delivery advantages of the other embodiments of the invention described herein. - As shown,
delivery device 400 includes abody 404 having adistal end 405, adeployment mechanism 406 havinglubricious support members 418, and anactuating mechanism 412. Thebody 404 is a generally tubular member, and includes a plurality ofelongated slots 413 extending through the body at a location adjacent to theactuating mechanism 412.Actuating mechanism 412 includes ahandle 420 that is slidably mounted to thebody 404. Structures such aspins 422 on thehandle 420 extend into theslots 413.Deployment mechanism 406 includes a plurality (six are shown) oflubricious support members 418 within thebody 404. Proximal ends of thesupport members 418 are connected to thepins 422 within thebody 404. Thedistal portions 419 of thelubricious support members 418 are located near thedistal end 405 of thebody 404. Other embodiments of delivery device 400 (not shown) can include different or additional structures including, for example, a suction cup or other structures on thedistal end 405 ofbody 404 for engaging the heart during the use of the device. - Handle 420 is actuated to drive the
deployment mechanism 406 between a first retracted or closed state (not shown) and a second extended or open state shown inFIG. 14 . In the retracted state, thelubricious support members 418 are in a reduced-diameter configuration (similar to that of the embodiment shown inFIG. 6 ). In the illustrated embodiment this configuration is achieved by thehandle 420 withdrawing at least portions of thelubricious support members 418 into thedistal end 405 of thebody 404.Distal end portions 419 of thelubricious support members 418 extend from thebody 404 in some embodiments of the invention when thedeployment mechanism 406 is in the retracted state in other embodiments (not shown), thesupport members 418 are not enclosed within thebody 404 when in the retracted state. When thehandle 420 is slid toward thedistal end 405 of thebody 404, thelubricious support members 418 are driven to the extended state shown inFIG. 14 at which the distal ends 419 form an open array or enlarged-diameter configuration. -
Lubricious support members 418 can be resilient structures formed from materials such as metals and polymers. The resilient nature of thesupport members 418 enables the members to move radially with respect to thebody 404 during movement between the retracted and extended states. In some embodiments of the invention thesupport members 418 can also curve in a circumferential direction from a flat configuration to an arced configuration generally conforming to the shape of adjacent portions of the heart. At least portions of theinterior surfaces 421 of the support members 418 (i.e., the surfaces that will be adjacent or in contact with the heart during CSD delivery) are lubricious. Thelubricious support members 418 can, for example, be formed from the materials oflubricious elements 34 described above, or from the materials of thesupport members 118 ofdelivery device 100 described above. In embodiments havinglubricious support members 418 including materials that are not lubricious, coatings of lubricious materials such as those described above in connection withlubricious elements 34 can be applied to all or portions of the non-lubricious portions of thesupport members 418. - In the embodiment shown in
FIG. 14 thelubricious support members 418 have greater surface area than thesupport members 118 ofdelivery device 100 described above, thereby enhancing the friction-reducing characteristics of the support members. Thelubricious support members 418 are generally paddle-shaped in that they have a relatively large surface area, with substantial surface portions of the members having a width that is substantially greater than the thickness of the members. The amount of lubricious surface on thesupport members 418 is sufficient or effective to enable thedelivery device 400 to substantially reduce the amount of friction that would otherwise be present between a CSD and heart during delivery, and thereby enable the efficient positioning of the CSD. Thelubricious support members 418 have other shapes and sizes in other embodiments of the invention (not shown). In general, the greater the amounts of lubricious surface area on thesupport members 418, the greater the efficiency of thedelivery device 400. -
Delivery device 400 can be used and operated in a manner similar to that ofdelivery device 100 described above to deliver and deploy a CSD on a patient's heart. As noted above, the CSD used in connection withdelivery device 400 need not, however, include lubricious element structures such as 20, 220 and 320 described above in connection with other embodiments of the invention, since thelubricious support members 418 can provide sufficient friction reduction. Briefly, the CSD (not shown) can be releasably attached at its base end to the distal ends 419 oflubricious support members 418, with thesupport members 418 on the inside surface of the CSD jacket extending through an open apex. Any conventional or otherwise known releasable attachment structure, including but not limited to those described in the patents and applications incorporated herein, can be used for this purpose. Thedelivery device 400 and attached CSD can, in the retracted state, have a configuration similar to that ofdelivery device 100 andCSD 10 shown and described in connection withFIG. 8 . Thedelivery device 400 and CSD are inserted into the patient's pericardial space and manipulated into position adjacent to the heart in a manner similar to that ofdelivery device 100 described above. After thedelivery device 400 is positioned at a desired location adjacent to the apex of the patient's heart, handle 420 is actuated to drive thedeployment mechanism 406 to its extended state shown inFIG. 14 . When in the extended state, thedeployment mechanism 406 will open the base end of the jacket and have a configuration similar to that ofdelivery device 100 andCSD 10 shown and described in connection withFIG. 9 . Thedelivery device 400 and CSD can then be further manipulated to slide the CSD over the patient's heart and to position the CSD at the desired location on the heart. The CSD can then be detached from thedeployment mechanism 406, and thedelivery device 400 withdrawn from the surgical access site. The presence of thelubricious support members 418 between the epicardial surface of the patient's heart and the CSD jacket reduces the friction between the heart surface and jacket, enabling the CSD to be more efficiently implanted. - Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention. For example, in yet another embodiment of the invention, lubricious material is positioned on the surface of the heart before the CSD is positioned on the heart. The lubricious material is then removed (e.g., through the base or an open apex of the CSD) after the device is positioned.
Claims (25)
1. A cardiac support device, including:
a jacket for constraining cardiac expansion; and
one or more lubricious elements releasably secured with respect to an inside surface of the jacket.
2. The cardiac support device of claim 1 wherein the one or more lubricious elements includes a plurality of lubricious elements at spaced locations around the inside of the jacket.
3. The cardiac support device of claim 2 wherein:
the jacket has an open base portion; and
the lubricious elements are releasably secured to the jacket at the base portion.
4. The cardiac support device of claim 3 wherein the lubricious elements further include delivery tool-engaging structures.
5. The cardiac support device of claim 4 wherein the delivery tool-engaging structures are located at the base portion.
6. The cardiac support device of claim 5 wherein the delivery tool-engaging structures include pockets.
7. The cardiac support device of claim 1 wherein the one or more lubricious elements include first portions secured to the jacket.
8. The cardiac support device of claim 1 and further including a removal structure for removing at least portions of the one or more lubricious elements from the jacket.
9. The cardiac support device of claim 8 wherein the removal structure includes a weakened structure on the one or more lubricious elements for enabling second portions of the one or more elements to be separated from first portions secured to the jacket.
10. The cardiac support device of claim 9 wherein the removal structure further includes an actuating structure connected to the one or more lubricious elements, for causing the second portions of the lubricious elements to be separated from the first portions when actuated.
11. The cardiac support device of claim 10 wherein the actuating structure is connected to the one or more lubricious elements at the weakened structure.
12. The cardiac support device of claim 11 wherein the actuating structure further includes a tear strip on the one or more lubricious elements at the weakened structure and connected to the actuating structure, for causing the second portions of the lubricious elements to be separated from the first portions at the weakened structure upon actuation of the actuating structure.
13. The cardiac support device of claim 12 wherein the actuating structure further includes a pull member connected to the tear strip.
14. The cardiac support device of claim 13 wherein the pull member is formed from lubricious material.
15. The cardiac support device of claim 13 wherein the pull member is located between the jacket and the lubricious elements
16. The cardiac support device of claim 13 wherein the pull member includes a delivery device-engaging structure.
17. The cardiac support device of claim 10 wherein the actuating structure is on an inside of the jacket.
18. The cardiac support device of claim 8 wherein the removal structure includes:
weakened structures on the one or more lubricious elements; and
actuating structure coupled to the one or more lubricious elements, for causing the lubricious elements to be released from the jacket when actuated.
19. The cardiac support device of claim 8 wherein the removal structure is connected to the lubricious elements at a base end of the jacket, for removal of the lubricious elements through the base end of the jacket.
20. The cardiac support device of claim 19 wherein the removal structure includes a pull member connected to the lubricious elements.
21. The cardiac support device of claim 19 wherein the jacket has a closed apex.
22. The cardiac support device of claim 1 wherein the one or more lubricious elements includes a single unitary lubricious element inside the jacket.
23. The cardiac support device of claim 8 wherein the removal structure includes one or more pull members connected to the one or more lubricious elements.
24. The cardiac support device of claim 23 wherein:
the jacket has an open apex; and
the one or more pull members are connected to the one or more lubricious elements through the open apex, enabling removal of the lubricious elements through the open apex.
25. The cardiac support device of claim 23 wherein the one or more pull members are connected to the one or more lubricious elements at a base end portion of the jacket, enabling removal of the lubricious elements through the base end portion.
Priority Applications (6)
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US11/478,350 US20080097146A1 (en) | 2006-06-29 | 2006-06-29 | Cardiac support device with low friction delivery structures |
US11/478,309 US20080004488A1 (en) | 2006-06-29 | 2006-06-29 | Low friction delivery tool for a cardiac support device |
EP07799122A EP2032072A4 (en) | 2006-06-29 | 2007-06-28 | Low friction delivery tool for a cardiac jacket |
PCT/US2007/072345 WO2008003034A2 (en) | 2006-06-29 | 2007-06-28 | Low friction delivery tool for a cardiac jacket |
CA2656495A CA2656495C (en) | 2006-06-29 | 2007-06-28 | Low friction delivery tool and method for a cardiac support device |
US12/333,045 US8100821B2 (en) | 2006-06-29 | 2008-12-11 | Low friction delivery tool for a cardiac support device |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US11/478,311 US20080004489A1 (en) | 2006-06-29 | 2006-06-29 | Low friction delivery method for a cardiac support device |
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US11/478,309 US20080004488A1 (en) | 2006-06-29 | 2006-06-29 | Low friction delivery tool for a cardiac support device |
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US12/333,045 Expired - Fee Related US8100821B2 (en) | 2006-06-29 | 2008-12-11 | Low friction delivery tool for a cardiac support device |
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EP (1) | EP2032072A4 (en) |
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Also Published As
Publication number | Publication date |
---|---|
US8100821B2 (en) | 2012-01-24 |
CA2656495A1 (en) | 2008-01-03 |
EP2032072A2 (en) | 2009-03-11 |
EP2032072A4 (en) | 2009-12-30 |
CA2656495C (en) | 2013-09-17 |
WO2008003034A3 (en) | 2008-10-02 |
WO2008003034A2 (en) | 2008-01-03 |
US20090131743A1 (en) | 2009-05-21 |
US20080004488A1 (en) | 2008-01-03 |
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