US20160213359A1 - Front-end loader for prosthetic occluders and methods thereof - Google Patents
Front-end loader for prosthetic occluders and methods thereof Download PDFInfo
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- US20160213359A1 US20160213359A1 US15/087,815 US201615087815A US2016213359A1 US 20160213359 A1 US20160213359 A1 US 20160213359A1 US 201615087815 A US201615087815 A US 201615087815A US 2016213359 A1 US2016213359 A1 US 2016213359A1
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- occluder
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/076—Surgical instruments, devices or methods, e.g. tourniquets for removing surgical staples or wound clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
- A61B2017/00575—Implements 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
- A61B2017/00575—Implements 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
- A61B2017/00592—Elastic or resilient implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
- A61B2017/00575—Implements 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
- A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
Definitions
- the invention generally relates to a system, and related methods, for the percutaneous transluminal front-end loading delivery and retrieval of devices used to repair cardiac defects. More particularly, the invention relates to an improved front-end loader device.
- Prosthetic occluders for repairing intracardiac defects such as interatrial and interventricular septal shunts, patent ductus arteriosus, patent foramen ovale, and occlusion of the left atrial appendage, are well known in the art.
- systems for percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder have been described. Representative is “System for the Percutaneous Transluminal Front-End Loading Delivery of a Prosthetic Occluder”, U.S. Pat. No. 5,486,193 (Bourne et al.), the entirety of which is expressly incorporated by reference herein, which discloses a complete system including a front-end loading portion, a control assembly, and an introducer.
- a first problem that may arise with current front-end loaders is the introduction of air into the indwelling introducer sheath when the front-end loader is introduced into the hub of the introducer sheath to deliver or retrieve a prosthetic occluder.
- Air that is introduced into a closed system, such as the introducer sheaths known in the art may find its way into the patient's cardiovascular system, risking acute pulmonary embolism, myocardial infarction, stroke, and possibly death.
- a second problem with current front-end loaders is that they are not well suited, should the need arise, for the retrieval of a prosthetic occluder from the heart or a vessel. Occasionally during a procedure to implant a prosthetic occluder in a patient, the occluder is an improper fit, deploys improperly, or is in some way damaged and must be retrieved from the patient. With current front-end loaders, significant problems often arise in attempting to collapse and withdraw the prosthetic occluder from the lumen of the introducer sheath into the lumen of the front-end loader.
- the proximal portion of the prosthetic occluder may catch on the distal end of the front-end loader, potentially preventing removal of the occluder.
- the prosthetic occluder may become snagged on the distal end of the front-end loader, necessitating the removal of the introducer sheath and the front-end loader from the patient in order to remove the occluder.
- the prior art lacks a reliable and efficient system for ensuring that the occluder can be withdrawn into the front-end loader so that the introducer sheath will not have to be removed from the patient.
- an object of the present invention to provide a front-end loader that minimizes or eliminates the introduction of air into an indwelling introducer sheath and that facilitates the retrieval of a prosthetic occluder without removal of the indwelling introducer sheath, should the need to do so arise.
- the invention provides a system, and related methods, for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder to and from, respectively, a patient's heart.
- a percutaneous transluminal system for a prosthetic occluder uses a front-end loader device comprising a tube to deliver or retrieve prosthetic occluders.
- the tube of the front-end loader is beveled at its distal end.
- the beveled end serves to minimize or eliminate the introduction of air into the introducer sheath.
- the beveled distal end of the tube of the front-end loader is chamfered, either partly or entirely, around its rim. The chamfered rim facilitates the removal of a prosthetic occluder from the patient's body, should the need to do so arise.
- the invention includes a percutaneous transluminal system for a prosthetic occluder, including a front-end loader.
- the front-end loader has a proximal portion that includes an expanded lumen, and a distal portion that includes a tube.
- the tube has a proximal end, a distal end, and a lumen that extends from the proximal end to the distal end.
- the distal end of the tube is beveled to font' a beveled end. The beveled end receives the prosthetic occluder.
- the beveled end may be chamfered. The chamfering may occur partially or, alternatively, entirely around the perimeter of the distal end of the tube.
- the expanded lumen of the proximal portion of the front-end loader may be tapered.
- the expanded tapered lumen may be conically shaped.
- the beveled end receives the prosthetic occluder to withdraw it from a patient's body or the beveled end receives the prosthetic occluder to deliver it into the patient's body.
- the beveled end receives the prosthetic occluder through the distal end of the tube.
- the prosthetic occluder may be an intracardiac occluder used to treat, for example, an atrial septal defect, a ventricular septal defect, patent ductus arteriosus, patent foramen ovale, or occlusion of the left atrial appendage.
- the invention in another aspect, includes a percutaneous transluminal system for a prosthetic occluder, including a front-end loader.
- the front-end loader has a proximal portion that includes an expanded lumen, and a distal portion that includes a tube.
- the tube has a proximal end, a distal end, a lumen that extends from the proximal end to the distal end, and a chamfered rim.
- the chamfered rim is positioned at the distal end of the tube, which receives the prosthetic occluder.
- the distal end of the tube is beveled.
- the chamfered rim may be chamfered partially or, alternatively, entirely around the perimeter of the distal end of the tube.
- the expanded lumen of the proximal portion of the front-end loader may be tapered.
- the expanded tapered lumen may be conically shaped.
- the distal end of the tube receives the prosthetic occluder to withdraw it from a patient's body or the distal end receives the prosthetic occluder to deliver it into the patient's body.
- the distal end of the tube receives the prosthetic occluder through the distal end.
- the prosthetic occluder may be an intracardiac occluder used to treat, for example, an atrial septal defect, a ventricular septal defect, patent ductus arteriosus, patent foramen ovale, or occlusion of the left atrial appendage.
- the invention provides a method for delivering a collapsible prosthetic occluder to a patient.
- the method includes the step of providing a front-end loader according to the invention described above.
- the method further includes the steps of receiving the prosthetic occluder in the lumen of the tube and delivering the prosthetic occluder to the patient.
- the method may further include the step of introducing the beveled end of the front-end loader into the lumen of a portion of an introducer sheath for the prosthetic occluder and crossing a gland.
- the invention provides a method for retrieving a collapsible prosthetic occluder from a patient.
- the method includes the step of providing a front-end loader according to the invention described above.
- the method further includes the steps of receiving the prosthetic occluder in the lumen of the tube and retrieving the prosthetic occluder from the patient.
- FIG. 1A is a fragmented plan view of one embodiment of the percutaneous transluminal front-end loading delivery and retrieval system according to the invention.
- FIG. 1B is an assembled plan view of the percutaneous transluminal front-end loading delivery and retrieval system illustrated in FIG. 1A .
- FIG. 2 is a cross-sectional view of one embodiment of the front-end loader illustrated in FIG. 1A .
- FIG. 3 is a cross-sectional view of another embodiment of the front-end loader illustrated in FIG. 1A .
- FIG. 4 is a perspective end view of one embodiment of the distal end of the front-end loader illustrated in FIG. 3 .
- FIG. 5 is a plan view of one embodiment of the distal end of the front-end loader according to the invention positioned near one embodiment of the proximal end of the introducer sheath according to the invention.
- FIG. 6 is a plan view of the distal end of the front-end loader illustrated in FIG. 5 positioned within the lumen of the proximal end of the introducer sheath illustrated in FIG. 5 .
- FIG. 7 is a plan view of the distal end of the front-end loader illustrated in FIG. 6 further positioned within the lumen of the proximal end of the introducer sheath illustrated in FIG. 6 .
- FIGS. 8A-8C illustrate the stages, during one embodiment of a retrieval of a prosthetic occluder from a patient, for collapsing the prosthetic occluder in the front-end loader according to the invention.
- the invention pertains to a system, and related methods, for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder.
- Prosthetic occluders may be used to repair congenital or acquired defects (shunts) in the heart or the major blood vessels thereof, including interatrial and interventricular septal shunts, such as a patent foramen ovale, patent ductus arteriosus, and occlusion of the left atrial appendage.
- the percutaneous transluminal front-end loading delivery and retrieval system 10 includes a control assembly 14 , a front-end loader 12 , and an introducer sheath 150 .
- the control assembly 14 , the front-end loader 12 , and the introducer sheath 150 are, as shown, separate components.
- the control assembly 14 when joined together in an assembled state, the control assembly 14 is located at the proximal end 50 of the percutaneous transluminal front-end loading delivery and retrieval system 10 , i.e., at the end of the delivery and retrieval system 10 that is closest to an operator (e.g., a physician).
- the introducer sheath 150 is located at the distal end 52 of the delivery and retrieval system 10 and the front-end loader 12 is positioned between the control assembly 14 and the introducer sheath 150 .
- the front-end loader 12 has a proximal end 20 , a distal end 17 , and a first lumen 26 proximal to and joined to a second lumen 18 . Together, the first lumen 26 and the second lumen 18 extend from the proximal end 20 of the front-end loader 12 to the distal end 17 of the front-end loader 12 .
- the first lumen 26 is conically shaped and wider than the second lumen 18 .
- the front-end loader 12 includes one lumen.
- the front-end loader 12 includes but one lumen that narrows from the proximal end 20 of the front-end loader 12 to the distal end 17 of the front-end loader 12 .
- the introducer sheath 150 has a proximal end 54 , a distal end 56 , and a lumen 152 extending from the proximal end 54 to the distal end 56 .
- the introducer sheath 150 may include, at its proximal end 54 , a hub 158 .
- the introducer sheath 150 is inserted, at its distal end 56 , into a patient's body and advanced until the distal end 56 reaches a defect site in the patient's body, such as the heart.
- an occluder 200 for example, a septal occluder as described in U.S. Pat. Nos. 5,709,707; 5,425,744; and 5,451,235, is loaded into the first lumen 26 of the front-end loader 12 at its proximal end 20 .
- the operator collapses the occluder 200 , or a portion thereof.
- the operator collapses the occluder 200 , or a portion thereof, by drawing on, for example, sutures attached to the occluder 200 .
- the operator then advances the occluder 200 from the conically shaped first lumen 26 to the narrower second lumen 18 , thereby further collapsing the occluder 200 into a narrow configuration within the second lumen 18 of the front-end loader 12 at its distal end 17 .
- the occluder 200 may be loaded directly into the second lumen 18 of the front-end loader 12 at its distal end 17 .
- the occluder 200 may be flushed by infusing an appropriate solution, such as, for example, sterile saline and/or heparin, through the first lumen 26 and the second lumen 28 . Such flushing of the occluder 200 eliminates any air that is trapped within the occluder 200 itself.
- the occluder 200 is then in a suitable configuration and state for loading into the lumen 152 of the indwelling introducer sheath 150 at its proximal end 54 .
- the distal end 17 of the front-end loader 12 enclosing the occluder 200 , is inserted into the lumen 152 of the hub 158 at the proximal end 54 of the previously placed indwelling introducer sheath 150 .
- the control assembly 14 is used to advance the occluder 200 from the second lumen 18 of the front-end loader 12 into and throughout the lumen 152 of the indwelling introducer sheath 150 .
- the occluder 200 At the distal end 56 of the indwelling introducer sheath 150 , which has already been positioned near the defect site in the patient's body, such as the heart, the occluder 200 , through actuation of the control assembly 14 , is released and deployed from the lumen 152 of the indwelling introducer sheath 150 in a fully expanded open configuration.
- the front-end loader 12 includes an expanded proximal portion 21 and an elongated distal portion 27 .
- the expanded proximal portion 21 has a proximal end 20 , a distal end 19 , and a first lumen 26 extending from the proximal end 20 to the distal end 19 .
- the expanded proximal portion 21 includes a first outer surface 57 , a second outer surface 58 , a third outer surface 60 , and a fourth outer surface 62 .
- the first outer surface 57 and the fourth outer surface 62 are each substantially similar to the outer surface of a short cylinder.
- the second outer surface 58 is substantially similar to the outer surface of a lower portion of a cone and the third outer surface 60 is substantially similar to the outer surface of a longer cylinder.
- the first outer surface 57 and the fourth outer surface 62 can include any number of threadable engagements 63 extending therefrom.
- the threadable engagements 63 may be used to engage corresponding receivable threads on the hub 158 .
- the expanded proximal portion 21 can include any number of outer surfaces that are substantially similar to any geometrical shape, each with or without any number of threadable engagements 63 extending therefrom.
- the expanded proximal portion 21 includes a first inner surface 64 and a second inner surface 66 .
- the first inner surface 64 extends from the proximal end 20 of the expanded proximal portion 21 to an end point 68 , which is located proximal to the distal end 19 of the expanded proximal portion 21 .
- the second inner surface 66 extends from the end point 68 to the distal end 19 of the expanded proximal portion 21 .
- the first lumen 26 narrows from the proximal end 20 of the expanded proximal portion 21 to the end point 68 by tapering.
- the first inner surface 64 may be shaped substantially similar to the inner surface of a hollow cone.
- the first inner surface 64 may be shaped substantially similar to the inner surface of a hollow triangular prism.
- the end point 68 may be positioned at any point along the long axis of the expanded proximal portion 21 . In another embodiment of the expanded proximal portion 21 , the end point 68 is positioned substantially equal with the distal end 19 of the expanded proximal portion 21 .
- the expanded proximal portion 21 includes only the first inner surface 64 , and not also the second inner surface 66 , and the first lumen 26 narrows from the proximal end 20 of the expanded proximal portion 21 all the way to the distal end 19 of the expanded proximal portion 21 by tapering.
- the first inner surface 64 may be shaped substantially similar to the inner surface of a hollow cone.
- the first inner surface 64 may be shaped substantially similar to the inner surface of a hollow triangular prism.
- the expanded proximal portion 21 may include multiple inner surfaces and the first lumen 26 may narrow from the proximal end 20 to the end point 68 , or, alternatively, the distal end 19 , in a stepwise fashion.
- the degree by which the first lumen 26 narrows may be, but need not be, equal on each step.
- the elongated distal portion 27 includes a tube 15 with a proximal end 24 , a distal end 17 , and a second lumen 18 extending from the proximal end 24 to the distal end 17 .
- the proximal end 24 of the tube 15 is positioned substantially equal with the distal end 19 of the expanded proximal portion 21 .
- the tube 15 and the expanded proximal portion 21 form one integral component.
- the proximal end 24 of the tube 15 is positioned proximal to the distal end 19 of the expanded proximal portion 21 , but distal to the end point 68 .
- the tube 15 is a separate component from the expanded proximal portion 21 .
- the proximal end 24 of the tube 15 is fitted within the lumen 26 of the expanded proximal portion 21 at its distal end 19 and is fixed to the second inner surface 66 of the expanded proximal portion 21 by, for example, an adhesive or molten plastic.
- a cross-section of the outer surface 78 of the tube 15 is circular.
- a cross-section of the outer surface 78 of the tube 15 taken at a point in the appropriate aforementioned range, may be shaped like any other geometrical shape, including, but not limited to, a triangle, a square, a rectangle, a parallelogram, a semi-circle, an ellipse, a wedge, or a diamond.
- the second lumen 18 of the tube 15 is narrower than the broadest portion 80 of the first lumen 26 of the expanded proximal portion 21 .
- the second lumen 18 of the tube 15 is sized to compress the occluder 200 (see FIG. 1A ) to a predetermined cross-sectional area, such that the occluder 200 is compatible for insertion into the lumen 152 of the introducer sheath 150 at its proximal end 54 (see FIG. 1A ).
- a cross-section of the second lumen 18 of the tube 15 taken at a point between the proximal end 24 and the base 29 of the tube 15 , and/or of the first lumen 26 of the expanded proximal portion 21 , taken at a point between the end point 68 and the distal end 19 of the expanded proximal portion 21 , is circular.
- a cross-section of the second lumen 18 of the tube 15 and/or of the first lumen 26 of the expanded proximal portion 21 may be shaped like any other geometrical shape, including, but not limited to, a triangle, a square, a rectangle, a parallelogram, a semi-circle, an ellipse, a wedge, or a diamond.
- the distal end 17 of the tube 15 of the elongated distal portion 27 of the front-end loader 12 is trimmed transversely at an angle in the range greater than 0 degrees to about 75 degrees, preferably 45 degrees, from a line 40 drawn perpendicular to the long axis of the tube 15 of the elongated distal portion 27 to form a beveled end 22 .
- the beveled end 22 of the tube 15 of the elongated distal portion 27 has a tip 23 and the base 29 , which is proximal to the tip 23 .
- the distance 82 between the distal end 19 of the expanded proximal portion 21 and the tip 23 of the beveled end 22 of the tube 15 is in the range of 1 to 4 inches, preferably about 21 ⁇ 2 inches.
- the distance 84 between the distal end 19 of the expanded proximal portion 21 and the base 29 of the beveled end 22 of the tube 15 is in the range of 9/10 to 3 63/64 inches, preferably about 2 9/20 inches.
- the distance 86 between the base 29 and the tip 23 of the beveled end 22 of the tube 15 is in the range of 1/64 to 1/10 of an inch, preferably about 1/20 of an inch.
- the distal end 17 of the tube 15 of the elongated distal portion 27 is trimmed transversely to form the beveled end 22 and its rim 25 is also chamfered to form a chamfered rim 25 .
- the rim 25 of the distal end 17 of the tube 15 is chamfered, but the distal end 17 of the tube 15 is not also trimmed transversely at an angle from the line 40 (see FIG. 2 ).
- the distal end 17 of the tube 15 is a straight edge cut perpendicular to the long axis of the front-end loader 12 (i.e., the distal end 17 of the tube 15 is trimmed transversely so that the distal end 17 is flush with the line 40 ).
- the front-end loader 12 includes the chamfered rim 25 , but it does not also include the beveled end 22 .
- the chamfered rim 25 is chamfered around the entire perimeter of the distal end 17 of the tube 15 .
- the chamfered rim 25 includes an outer rim 70 and an inner rim 72 .
- the width 79 of the chamfered rim 25 measured from the inner rim 72 to the outer rim 70 , is in the range of 5/1000 to 30/1000 of an inch, preferably about 15/1000 of an inch.
- the size of the tube 15 of the elongated distal portion 27 is in the range of 4 French to 15 French.
- the width 79 of the chamfered rim 25 is substantially uniform around the entire perimeter of the distal end 17 of the tube 15 .
- the width 79 of the chamfered rim 25 is not uniform, but varies, around the perimeter of the distal end 17 of the tube 15 .
- the distal end 17 of the tube 15 is chamfered only partly around its perimeter, either in one continuous section or intermittently.
- the tube 15 of the elongated distal portion 27 may be made from suitable plastic materials (e.g., polytetrafluoroethylene (PTFE), other polymers and copolymers, polyurethane, polycarbonate, polyethylene, nylon, and polyether block amides, such as the Pebax® brand sold by Elf Atochem) and/or from suitable metals (e.g., stainless steel).
- suitable plastic materials e.g., polytetrafluoroethylene (PTFE), other polymers and copolymers, polyurethane, polycarbonate, polyethylene, nylon, and polyether block amides, such as the Pebax® brand sold by Elf Atochem
- suitable metals e.g., stainless steel
- the invention provides a method for introducing and retrieving an implant to and from, respectively, an anatomical site in a patient.
- the implant in one embodiment, is the intracardiac occluder 200 .
- the invention for example, is a method for implanting and retrieving the intracardiac occluder 200 destined to occlude a septal defect, such as, for example, a patent foramen ovale. Briefly, the procedure involves cannulating the right femoral vein with an 8 French introducer sheath and then manipulating a 7 French end hole angiocatheter to the right heart. An angiocardiogram may be performed to determine the anatomy of the septal defect (e.g. the patent foramen ovale).
- An exchange guidewire is then passed through the angiocatheter and the septum is crossed with the guidewire and, optionally, the angiocatheter.
- the angiocatheter With the guidewire placed across the septal defect (e.g., the patent foramen ovale), the angiocatheter is replaced with the introducer sheath 150 .
- the introducer sheath 150 is advanced over the guidewire through the right heart so that the distal end 56 of the introducer sheath 150 lies in the left atrium.
- the flexible distal end 56 of the introducer sheath 150 may be pre-bent to conform to the anatomy within the heart.
- the exchange guidewire, and a dilator if used to predilate the vascular route, are removed and the introducer sheath 150 is flushed to eliminate air and any clots.
- the hub 158 of the indwelling introducer sheath 150 includes a proximal end 54 , a distal end 88 , and a gland 90 .
- the gland 90 is a resilient elastomer and includes distal portions 91 , 93 and proximal portions 95 , 97 .
- the distal portions 91 , 93 of the gland 90 are pressure sealed together by blood 94 , which is located distal to the distal portions 91 , 93 of the gland 90 .
- Air 92 is located proximal to the distal portions 91 , 93 of the gland 90 .
- the initially sealed distal portions 91 , 93 of the gland 90 prevent the air 92 from penetrating distally beyond the distal portions 91 , 93 of the gland 90 and further into the indwelling introducer sheath 150 .
- the distal end 17 of the tube 15 of the front-end loader 12 is inserted into the hub 158 .
- the beveled end 22 of the tube 15 first crosses through the proximal portions 95 , 97 of the gland 90 .
- the tip 23 of the beveled end 22 of the tube 15 then separates the distal portion 91 of the gland 90 from the distal portion 93 of the gland 90 and the beveled end 22 of the tube 15 crosses through the distal portions 91 , 93 of the gland 90 .
- the beveled end 22 of the tube 15 crosses through the distal portions 91 , 93 of the gland 90 , the beveled end 22 permits the blood 94 to flow proximally through the gland 90 and, eventually, out of the proximal end 54 of the introducer sheath 150 , as indicated by arrow 96 .
- the proximal flow of the blood 94 displaces the air 92 proximally and, eventually, displaces, the air 92 from the proximal end 54 of the introducer sheath 150 , as indicated by arrow 96 .
- the air 92 is prevented from advancing distally beyond the distal portions 91 , 93 of the gland 90 and further into the introducer sheath 150 .
- the introduction of the air 92 into the vasculature through the introducer sheath 150 can be reduced or eliminated.
- air 92 might otherwise percolate into the artery into which the introducer sheath 150 has been placed and thereby create a risk of air embolism.
- the distal portions 91 , 93 and proximal portions 95 , 97 of the gland 90 seal around the outer surface 78 of the tube 15 of the front-end loader 12 , thereby preventing any further introduction of air 92 into the vasculature via the indwelling introducer sheath 150 and any further proximal flow of blood 94 out of the proximal end 54 of the indwelling introducer sheath 150 .
- the occluder 200 is ready to be introduced, through actuation of the control assembly 14 (see FIG. 1A ), from the second lumen 18 of the tube 15 into the lumen 152 of the introducer sheath 150 .
- the control assembly 14 located proximal to the front-end loader 12 and outside of the patient, is advanced by the operator distally into and through the first lumen 26 and second lumen 18 of the front-end loader 12 to extend the narrowly collapsed occluder 200 from the second lumen 18 of the tube 15 into the lumen 152 of the introducer sheath 150 .
- the introducer sheath 150 may, at this point, be flushed by infusing an appropriate solution through a side leg 162 of the introducer sheath 150 .
- the occluder 200 may then be advanced, by the control assembly 14 , throughout the lumen 152 of the indwelling introducer sheath 150 .
- the occluder 200 In certain circumstances, such as when fluoroscopy or other imaging methods reveal that the occluder 200 is damaged or too small to seal the defect under repair, retrieval of the occluder 200 is required. In order to remove the occluder 200 from the patient with minimal blood loss, the occluder 200 must be withdrawn from the lumen 152 of the introducer sheath 150 into the front-end loader 12 . Referring now to FIG. 8A , in one embodiment according to the method of the invention, the occluder 200 may be withdrawn from the lumen 152 of the introducer sheath 150 into the second lumen 18 of the tube 15 of the front-end loader 12 .
- the occluder 200 is withdrawn proximally into the second lumen 18 of the tube 15 at the distal end 17 of the front-end loader 12 .
- the occluder 200 enters the second lumen 18 of the tube 15 by sliding through the opening defined by the chamfered rim 25 at the distal end 17 of the tube 15 . Because the occluder 200 slides over the smooth slope of the chamfered rim 25 as it enters the second lumen 18 of the tube 15 , the chamfered rim 25 eases retrieval of the occluder 200 .
- the occluder 200 is much less likely to catch or snag on the distal end 17 of the tube 15 during retrieval than it is in the absence of the chamfered rim 25 .
- the inability to withdraw the occluder 200 into the second lumen 18 of the tube 15 during an attempted retrieval is, therefore, less likely to result.
- the front-end loader 12 may be completely withdrawn, through the gland 90 of the hub 158 , from the introducer sheath 150 .
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Abstract
The invention pertains to a system, and related methods, for the percutaneous transluminal delivery and retrieval of a prosthetic occluder through a front-end loader. The prosthetic occluder may be, for example, an intracardiac occluder for a patent foramen ovale. The system includes, in one embodiment, a front-end loader having a beveled distal end. In another embodiment, the system includes a front-end loader having a chamfered rim at the beveled distal end.
Description
- This application is a divisional of U.S. application Ser. No. 10/667,747, filed Sep. 22, 2003, currently pending, which claims the benefit under 35 USC §119(e) to U.S. Application Ser. No. 60/412,953, which was filed on Sep. 23, 2002.
- The invention generally relates to a system, and related methods, for the percutaneous transluminal front-end loading delivery and retrieval of devices used to repair cardiac defects. More particularly, the invention relates to an improved front-end loader device.
- Prosthetic occluders for repairing intracardiac defects, such as interatrial and interventricular septal shunts, patent ductus arteriosus, patent foramen ovale, and occlusion of the left atrial appendage, are well known in the art. Moreover, systems for percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder have been described. Representative is “System for the Percutaneous Transluminal Front-End Loading Delivery of a Prosthetic Occluder”, U.S. Pat. No. 5,486,193 (Bourne et al.), the entirety of which is expressly incorporated by reference herein, which discloses a complete system including a front-end loading portion, a control assembly, and an introducer.
- Significant problems exist, however, with the front-end loaders currently known in the art. A first problem that may arise with current front-end loaders is the introduction of air into the indwelling introducer sheath when the front-end loader is introduced into the hub of the introducer sheath to deliver or retrieve a prosthetic occluder. Air that is introduced into a closed system, such as the introducer sheaths known in the art, may find its way into the patient's cardiovascular system, risking acute pulmonary embolism, myocardial infarction, stroke, and possibly death.
- A second problem with current front-end loaders is that they are not well suited, should the need arise, for the retrieval of a prosthetic occluder from the heart or a vessel. Occasionally during a procedure to implant a prosthetic occluder in a patient, the occluder is an improper fit, deploys improperly, or is in some way damaged and must be retrieved from the patient. With current front-end loaders, significant problems often arise in attempting to collapse and withdraw the prosthetic occluder from the lumen of the introducer sheath into the lumen of the front-end loader. For instance, in withdrawing the prosthetic occluder from the lumen of the introducer sheath into the lumen of the front-end loader, the proximal portion of the prosthetic occluder may catch on the distal end of the front-end loader, potentially preventing removal of the occluder. For example, the prosthetic occluder may become snagged on the distal end of the front-end loader, necessitating the removal of the introducer sheath and the front-end loader from the patient in order to remove the occluder. In essence, the prior art lacks a reliable and efficient system for ensuring that the occluder can be withdrawn into the front-end loader so that the introducer sheath will not have to be removed from the patient.
- It is, therefore, an object of the present invention to provide a front-end loader that minimizes or eliminates the introduction of air into an indwelling introducer sheath and that facilitates the retrieval of a prosthetic occluder without removal of the indwelling introducer sheath, should the need to do so arise.
- The invention provides a system, and related methods, for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder to and from, respectively, a patient's heart.
- In accordance with the invention, a percutaneous transluminal system for a prosthetic occluder, and related methods, use a front-end loader device comprising a tube to deliver or retrieve prosthetic occluders. The tube of the front-end loader is beveled at its distal end. When the front-end loader is introduced into the hub of an indwelling introducer sheath, the beveled end serves to minimize or eliminate the introduction of air into the introducer sheath. Additionally, the beveled distal end of the tube of the front-end loader is chamfered, either partly or entirely, around its rim. The chamfered rim facilitates the removal of a prosthetic occluder from the patient's body, should the need to do so arise.
- In one aspect, the invention includes a percutaneous transluminal system for a prosthetic occluder, including a front-end loader. The front-end loader has a proximal portion that includes an expanded lumen, and a distal portion that includes a tube. The tube has a proximal end, a distal end, and a lumen that extends from the proximal end to the distal end. The distal end of the tube is beveled to font' a beveled end. The beveled end receives the prosthetic occluder.
- In various embodiments of this aspect of the invention, the beveled end may be chamfered. The chamfering may occur partially or, alternatively, entirely around the perimeter of the distal end of the tube. In another embodiment, the expanded lumen of the proximal portion of the front-end loader may be tapered. Moreover, the expanded tapered lumen may be conically shaped. In an additional embodiment, the beveled end receives the prosthetic occluder to withdraw it from a patient's body or the beveled end receives the prosthetic occluder to deliver it into the patient's body. For example, the beveled end receives the prosthetic occluder through the distal end of the tube. The prosthetic occluder may be an intracardiac occluder used to treat, for example, an atrial septal defect, a ventricular septal defect, patent ductus arteriosus, patent foramen ovale, or occlusion of the left atrial appendage.
- In another aspect, the invention includes a percutaneous transluminal system for a prosthetic occluder, including a front-end loader. The front-end loader has a proximal portion that includes an expanded lumen, and a distal portion that includes a tube. The tube has a proximal end, a distal end, a lumen that extends from the proximal end to the distal end, and a chamfered rim. The chamfered rim is positioned at the distal end of the tube, which receives the prosthetic occluder.
- In various embodiments of this aspect of the invention, the distal end of the tube is beveled. The chamfered rim may be chamfered partially or, alternatively, entirely around the perimeter of the distal end of the tube. In another embodiment, the expanded lumen of the proximal portion of the front-end loader may be tapered. Moreover, the expanded tapered lumen may be conically shaped. In an additional embodiment, the distal end of the tube receives the prosthetic occluder to withdraw it from a patient's body or the distal end receives the prosthetic occluder to deliver it into the patient's body. For example, the distal end of the tube receives the prosthetic occluder through the distal end. The prosthetic occluder may be an intracardiac occluder used to treat, for example, an atrial septal defect, a ventricular septal defect, patent ductus arteriosus, patent foramen ovale, or occlusion of the left atrial appendage.
- In another aspect, the invention provides a method for delivering a collapsible prosthetic occluder to a patient. The method includes the step of providing a front-end loader according to the invention described above. The method further includes the steps of receiving the prosthetic occluder in the lumen of the tube and delivering the prosthetic occluder to the patient. In an embodiment of this aspect of the invention, the method may further include the step of introducing the beveled end of the front-end loader into the lumen of a portion of an introducer sheath for the prosthetic occluder and crossing a gland.
- In yet another aspect, the invention provides a method for retrieving a collapsible prosthetic occluder from a patient. The method includes the step of providing a front-end loader according to the invention described above. The method further includes the steps of receiving the prosthetic occluder in the lumen of the tube and retrieving the prosthetic occluder from the patient.
- The foregoing and other objects, aspects, features, and advantages of the invention will become more apparent from the following description and from the claims.
- In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.
-
FIG. 1A is a fragmented plan view of one embodiment of the percutaneous transluminal front-end loading delivery and retrieval system according to the invention. -
FIG. 1B is an assembled plan view of the percutaneous transluminal front-end loading delivery and retrieval system illustrated inFIG. 1A . -
FIG. 2 is a cross-sectional view of one embodiment of the front-end loader illustrated inFIG. 1A . -
FIG. 3 is a cross-sectional view of another embodiment of the front-end loader illustrated inFIG. 1A . -
FIG. 4 is a perspective end view of one embodiment of the distal end of the front-end loader illustrated inFIG. 3 . -
FIG. 5 is a plan view of one embodiment of the distal end of the front-end loader according to the invention positioned near one embodiment of the proximal end of the introducer sheath according to the invention. -
FIG. 6 is a plan view of the distal end of the front-end loader illustrated inFIG. 5 positioned within the lumen of the proximal end of the introducer sheath illustrated inFIG. 5 . -
FIG. 7 is a plan view of the distal end of the front-end loader illustrated inFIG. 6 further positioned within the lumen of the proximal end of the introducer sheath illustrated inFIG. 6 . -
FIGS. 8A-8C illustrate the stages, during one embodiment of a retrieval of a prosthetic occluder from a patient, for collapsing the prosthetic occluder in the front-end loader according to the invention. - The invention pertains to a system, and related methods, for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder. Prosthetic occluders may be used to repair congenital or acquired defects (shunts) in the heart or the major blood vessels thereof, including interatrial and interventricular septal shunts, such as a patent foramen ovale, patent ductus arteriosus, and occlusion of the left atrial appendage.
- Referring to
FIG. 1A , the percutaneous transluminal front-end loading delivery andretrieval system 10, according to the invention described herein, includes acontrol assembly 14, a front-end loader 12, and anintroducer sheath 150. Thecontrol assembly 14, the front-end loader 12, and theintroducer sheath 150 are, as shown, separate components. - Referring now to
FIG. 1B , when joined together in an assembled state, thecontrol assembly 14 is located at theproximal end 50 of the percutaneous transluminal front-end loading delivery andretrieval system 10, i.e., at the end of the delivery andretrieval system 10 that is closest to an operator (e.g., a physician). Theintroducer sheath 150 is located at thedistal end 52 of the delivery andretrieval system 10 and the front-end loader 12 is positioned between thecontrol assembly 14 and theintroducer sheath 150. - Referring again to
FIG. 1A , in one embodiment according to the invention, the front-end loader 12 has aproximal end 20, adistal end 17, and afirst lumen 26 proximal to and joined to asecond lumen 18. Together, thefirst lumen 26 and thesecond lumen 18 extend from theproximal end 20 of the front-end loader 12 to thedistal end 17 of the front-end loader 12. Thefirst lumen 26 is conically shaped and wider than thesecond lumen 18. Alternatively, in another embodiment, the front-end loader 12 includes one lumen. For example, the front-end loader 12 includes but one lumen that narrows from theproximal end 20 of the front-end loader 12 to thedistal end 17 of the front-end loader 12. For its part, theintroducer sheath 150 has aproximal end 54, a distal end 56, and alumen 152 extending from theproximal end 54 to the distal end 56. Theintroducer sheath 150 may include, at itsproximal end 54, ahub 158. - In general, the
introducer sheath 150 is inserted, at its distal end 56, into a patient's body and advanced until the distal end 56 reaches a defect site in the patient's body, such as the heart. In one embodiment, anoccluder 200, for example, a septal occluder as described in U.S. Pat. Nos. 5,709,707; 5,425,744; and 5,451,235, is loaded into thefirst lumen 26 of the front-end loader 12 at itsproximal end 20. Optionally, prior to loading theoccluder 200 into thefirst lumen 26, the operator collapses theoccluder 200, or a portion thereof. In one embodiment, the operator collapses theoccluder 200, or a portion thereof, by drawing on, for example, sutures attached to theoccluder 200. Once placed in thefirst lumen 26 of the front-end loader 12, the operator then advances theoccluder 200 from the conically shapedfirst lumen 26 to the narrowersecond lumen 18, thereby further collapsing theoccluder 200 into a narrow configuration within thesecond lumen 18 of the front-end loader 12 at itsdistal end 17. Alternatively, in another embodiment, theoccluder 200 may be loaded directly into thesecond lumen 18 of the front-end loader 12 at itsdistal end 17. Once in the narrow collapsed configuration, theoccluder 200 may be flushed by infusing an appropriate solution, such as, for example, sterile saline and/or heparin, through thefirst lumen 26 and the second lumen 28. Such flushing of theoccluder 200 eliminates any air that is trapped within theoccluder 200 itself. Theoccluder 200 is then in a suitable configuration and state for loading into thelumen 152 of theindwelling introducer sheath 150 at itsproximal end 54. Thedistal end 17 of the front-end loader 12, enclosing theoccluder 200, is inserted into thelumen 152 of thehub 158 at theproximal end 54 of the previously placedindwelling introducer sheath 150. Thecontrol assembly 14 is used to advance theoccluder 200 from thesecond lumen 18 of the front-end loader 12 into and throughout thelumen 152 of theindwelling introducer sheath 150. At the distal end 56 of theindwelling introducer sheath 150, which has already been positioned near the defect site in the patient's body, such as the heart, theoccluder 200, through actuation of thecontrol assembly 14, is released and deployed from thelumen 152 of theindwelling introducer sheath 150 in a fully expanded open configuration. - Referring now to
FIG. 2 , the front-end loader 12 includes an expandedproximal portion 21 and an elongateddistal portion 27. The expandedproximal portion 21 has aproximal end 20, a distal end 19, and afirst lumen 26 extending from theproximal end 20 to the distal end 19. In one embodiment according to the invention, the expandedproximal portion 21 includes a firstouter surface 57, a secondouter surface 58, a thirdouter surface 60, and a fourthouter surface 62. The firstouter surface 57 and the fourthouter surface 62 are each substantially similar to the outer surface of a short cylinder. The secondouter surface 58 is substantially similar to the outer surface of a lower portion of a cone and the thirdouter surface 60 is substantially similar to the outer surface of a longer cylinder. The firstouter surface 57 and the fourthouter surface 62 can include any number ofthreadable engagements 63 extending therefrom. Thethreadable engagements 63 may be used to engage corresponding receivable threads on thehub 158. In alternative embodiments, the expandedproximal portion 21 can include any number of outer surfaces that are substantially similar to any geometrical shape, each with or without any number ofthreadable engagements 63 extending therefrom. - As illustrated in
FIG. 2 , in one embodiment of the expandedproximal portion 21, the expandedproximal portion 21 includes a firstinner surface 64 and a secondinner surface 66. The firstinner surface 64 extends from theproximal end 20 of the expandedproximal portion 21 to anend point 68, which is located proximal to the distal end 19 of the expandedproximal portion 21. The secondinner surface 66 extends from theend point 68 to the distal end 19 of the expandedproximal portion 21. In the embodiment shown, thefirst lumen 26 narrows from theproximal end 20 of the expandedproximal portion 21 to theend point 68 by tapering. In one embodiment, the firstinner surface 64 may be shaped substantially similar to the inner surface of a hollow cone. Alternatively, the firstinner surface 64 may be shaped substantially similar to the inner surface of a hollow triangular prism. - The
end point 68 may be positioned at any point along the long axis of the expandedproximal portion 21. In another embodiment of the expandedproximal portion 21, theend point 68 is positioned substantially equal with the distal end 19 of the expandedproximal portion 21. The expandedproximal portion 21 includes only the firstinner surface 64, and not also the secondinner surface 66, and thefirst lumen 26 narrows from theproximal end 20 of the expandedproximal portion 21 all the way to the distal end 19 of the expandedproximal portion 21 by tapering. Again, the firstinner surface 64 may be shaped substantially similar to the inner surface of a hollow cone. Alternatively, the firstinner surface 64 may be shaped substantially similar to the inner surface of a hollow triangular prism. - In yet another embodiment, the expanded
proximal portion 21 may include multiple inner surfaces and thefirst lumen 26 may narrow from theproximal end 20 to theend point 68, or, alternatively, the distal end 19, in a stepwise fashion. The degree by which thefirst lumen 26 narrows may be, but need not be, equal on each step. - Referring still to
FIG. 2 , in one embodiment of the elongateddistal portion 27, the elongateddistal portion 27 includes atube 15 with a proximal end 24, adistal end 17, and asecond lumen 18 extending from the proximal end 24 to thedistal end 17. In the embodiment shown, the proximal end 24 of thetube 15 is positioned substantially equal with the distal end 19 of the expandedproximal portion 21. In such an embodiment, thetube 15 and the expandedproximal portion 21 form one integral component. In another embodiment, the proximal end 24 of thetube 15 is positioned proximal to the distal end 19 of the expandedproximal portion 21, but distal to theend point 68. In such an embodiment, thetube 15 is a separate component from the expandedproximal portion 21. The proximal end 24 of thetube 15 is fitted within thelumen 26 of the expandedproximal portion 21 at its distal end 19 and is fixed to the secondinner surface 66 of the expandedproximal portion 21 by, for example, an adhesive or molten plastic. - hi one embodiment according to the invention, a cross-section of the
outer surface 78 of thetube 15, taken at a point between the proximal end 24 and abase 29 of thetube 15, is circular. Alternatively, a cross-section of theouter surface 78 of thetube 15, taken at a point in the appropriate aforementioned range, may be shaped like any other geometrical shape, including, but not limited to, a triangle, a square, a rectangle, a parallelogram, a semi-circle, an ellipse, a wedge, or a diamond. - The
second lumen 18 of thetube 15 is narrower than thebroadest portion 80 of thefirst lumen 26 of the expandedproximal portion 21. Thesecond lumen 18 of thetube 15 is sized to compress the occluder 200 (seeFIG. 1A ) to a predetermined cross-sectional area, such that theoccluder 200 is compatible for insertion into thelumen 152 of theintroducer sheath 150 at its proximal end 54 (seeFIG. 1A ). - In one embodiment, a cross-section of the
second lumen 18 of thetube 15, taken at a point between the proximal end 24 and thebase 29 of thetube 15, and/or of thefirst lumen 26 of the expandedproximal portion 21, taken at a point between theend point 68 and the distal end 19 of the expandedproximal portion 21, is circular. In alternative embodiments, a cross-section of thesecond lumen 18 of thetube 15 and/or of thefirst lumen 26 of the expandedproximal portion 21, each respectively taken at a point in the appropriate aforementioned range, may be shaped like any other geometrical shape, including, but not limited to, a triangle, a square, a rectangle, a parallelogram, a semi-circle, an ellipse, a wedge, or a diamond. - With continued reference to
FIG. 2 , thedistal end 17 of thetube 15 of the elongateddistal portion 27 of the front-end loader 12 is trimmed transversely at an angle in the range greater than 0 degrees to about 75 degrees, preferably 45 degrees, from aline 40 drawn perpendicular to the long axis of thetube 15 of the elongateddistal portion 27 to form abeveled end 22. Thebeveled end 22 of thetube 15 of the elongateddistal portion 27 has atip 23 and thebase 29, which is proximal to thetip 23. Thedistance 82 between the distal end 19 of the expandedproximal portion 21 and thetip 23 of thebeveled end 22 of thetube 15 is in the range of 1 to 4 inches, preferably about 2½ inches. Thedistance 84 between the distal end 19 of the expandedproximal portion 21 and thebase 29 of thebeveled end 22 of thetube 15 is in the range of 9/10 to 3 63/64 inches, preferably about 2 9/20 inches. Thedistance 86 between the base 29 and thetip 23 of thebeveled end 22 of thetube 15 is in the range of 1/64 to 1/10 of an inch, preferably about 1/20 of an inch. - Referring now to
FIG. 3 , in one embodiment according to the invention, thedistal end 17 of thetube 15 of the elongateddistal portion 27 is trimmed transversely to form thebeveled end 22 and itsrim 25 is also chamfered to form a chamferedrim 25. In an alternative embodiment (not shown), therim 25 of thedistal end 17 of thetube 15 is chamfered, but thedistal end 17 of thetube 15 is not also trimmed transversely at an angle from the line 40 (seeFIG. 2 ). Rather, thedistal end 17 of thetube 15 is a straight edge cut perpendicular to the long axis of the front-end loader 12 (i.e., thedistal end 17 of thetube 15 is trimmed transversely so that thedistal end 17 is flush with the line 40). Accordingly, in this latter alternative embodiment, the front-end loader 12 includes the chamferedrim 25, but it does not also include thebeveled end 22. - Referring now to
FIG. 4 , in one embodiment, the chamferedrim 25 is chamfered around the entire perimeter of thedistal end 17 of thetube 15. The chamferedrim 25 includes anouter rim 70 and aninner rim 72. Thewidth 79 of the chamferedrim 25, measured from theinner rim 72 to theouter rim 70, is in the range of 5/1000 to 30/1000 of an inch, preferably about 15/1000 of an inch. The size of thetube 15 of the elongateddistal portion 27 is in the range of 4 French to 15 French. - In one embodiment according to the invention, the
width 79 of the chamferedrim 25 is substantially uniform around the entire perimeter of thedistal end 17 of thetube 15. In another embodiment, thewidth 79 of the chamferedrim 25 is not uniform, but varies, around the perimeter of thedistal end 17 of thetube 15. In yet another embodiment, thedistal end 17 of thetube 15 is chamfered only partly around its perimeter, either in one continuous section or intermittently. - Referring again to
FIG. 2 , thetube 15 of the elongateddistal portion 27 may be made from suitable plastic materials (e.g., polytetrafluoroethylene (PTFE), other polymers and copolymers, polyurethane, polycarbonate, polyethylene, nylon, and polyether block amides, such as the Pebax® brand sold by Elf Atochem) and/or from suitable metals (e.g., stainless steel). In one embodiment, thetube 15 of the elongateddistal portion 27 may primarily be made from suitable plastic materials, with thedistal end 17 of thetube 15 of the elongateddistal portion 27 reinforced by metal. - In another aspect, the invention provides a method for introducing and retrieving an implant to and from, respectively, an anatomical site in a patient. The implant, in one embodiment, is the
intracardiac occluder 200. The invention, for example, is a method for implanting and retrieving theintracardiac occluder 200 destined to occlude a septal defect, such as, for example, a patent foramen ovale. Briefly, the procedure involves cannulating the right femoral vein with an 8 French introducer sheath and then manipulating a 7 French end hole angiocatheter to the right heart. An angiocardiogram may be performed to determine the anatomy of the septal defect (e.g. the patent foramen ovale). An exchange guidewire is then passed through the angiocatheter and the septum is crossed with the guidewire and, optionally, the angiocatheter. With the guidewire placed across the septal defect (e.g., the patent foramen ovale), the angiocatheter is replaced with theintroducer sheath 150. Theintroducer sheath 150 is advanced over the guidewire through the right heart so that the distal end 56 of theintroducer sheath 150 lies in the left atrium. To facilitate steering and manipulation of the assembly, the flexible distal end 56 of theintroducer sheath 150 may be pre-bent to conform to the anatomy within the heart. The exchange guidewire, and a dilator if used to predilate the vascular route, are removed and theintroducer sheath 150 is flushed to eliminate air and any clots. - Referring now to
FIG. 5 , in one embodiment according to the method of the invention, thehub 158 of theindwelling introducer sheath 150 includes aproximal end 54, adistal end 88, and agland 90. In the exemplary embodiment shown, thegland 90 is a resilient elastomer and includesdistal portions proximal portions end loader 12, thedistal portions gland 90 are pressure sealed together byblood 94, which is located distal to thedistal portions gland 90.Air 92 is located proximal to thedistal portions gland 90. The initially sealeddistal portions gland 90 prevent theair 92 from penetrating distally beyond thedistal portions gland 90 and further into theindwelling introducer sheath 150. - Referring now to
FIG. 6 , in one embodiment according to the method of the invention, thedistal end 17 of thetube 15 of the front-end loader 12 is inserted into thehub 158. As thedistal end 17 of thetube 15 is inserted into thehub 158, thebeveled end 22 of thetube 15 first crosses through theproximal portions gland 90. Thetip 23 of thebeveled end 22 of thetube 15 then separates thedistal portion 91 of thegland 90 from thedistal portion 93 of thegland 90 and thebeveled end 22 of thetube 15 crosses through thedistal portions gland 90. As thebeveled end 22 of thetube 15 crosses through thedistal portions gland 90, thebeveled end 22 permits theblood 94 to flow proximally through thegland 90 and, eventually, out of theproximal end 54 of theintroducer sheath 150, as indicated byarrow 96. The proximal flow of theblood 94 displaces theair 92 proximally and, eventually, displaces, theair 92 from theproximal end 54 of theintroducer sheath 150, as indicated byarrow 96. As such, theair 92 is prevented from advancing distally beyond thedistal portions gland 90 and further into theintroducer sheath 150. Thus, the introduction of theair 92 into the vasculature through theintroducer sheath 150 can be reduced or eliminated. In the absence of thebeveled end 22 of thetube 15 of the front-end loader 12 (i.e., where thedistal end 17 of thetube 15 is a straight edge cut perpendicular to the long axis of the front-end loader 12, as in the prior art),air 92 might otherwise percolate into the artery into which theintroducer sheath 150 has been placed and thereby create a risk of air embolism. - Referring now to
FIG. 7 , as the front-end loader 12 is advanced further into theintroducer sheath 150, thedistal portions proximal portions gland 90 seal around theouter surface 78 of thetube 15 of the front-end loader 12, thereby preventing any further introduction ofair 92 into the vasculature via theindwelling introducer sheath 150 and any further proximal flow ofblood 94 out of theproximal end 54 of theindwelling introducer sheath 150. Once thedistal end 17 of thetube 15 of the front-end loader 12 is positioned beyond thedistal end 88 of thehub 158, theoccluder 200, previously collapsed, as described above, into a narrow configuration within thesecond lumen 18 of thetube 15, is ready to be introduced, through actuation of the control assembly 14 (seeFIG. 1A ), from thesecond lumen 18 of thetube 15 into thelumen 152 of theintroducer sheath 150. Thecontrol assembly 14, located proximal to the front-end loader 12 and outside of the patient, is advanced by the operator distally into and through thefirst lumen 26 andsecond lumen 18 of the front-end loader 12 to extend the narrowly collapsedoccluder 200 from thesecond lumen 18 of thetube 15 into thelumen 152 of theintroducer sheath 150. Optionally, theintroducer sheath 150 may, at this point, be flushed by infusing an appropriate solution through aside leg 162 of theintroducer sheath 150. Theoccluder 200 may then be advanced, by thecontrol assembly 14, throughout thelumen 152 of theindwelling introducer sheath 150. - In certain circumstances, such as when fluoroscopy or other imaging methods reveal that the
occluder 200 is damaged or too small to seal the defect under repair, retrieval of theoccluder 200 is required. In order to remove theoccluder 200 from the patient with minimal blood loss, theoccluder 200 must be withdrawn from thelumen 152 of theintroducer sheath 150 into the front-end loader 12. Referring now toFIG. 8A , in one embodiment according to the method of the invention, theoccluder 200 may be withdrawn from thelumen 152 of theintroducer sheath 150 into thesecond lumen 18 of thetube 15 of the front-end loader 12. - Referring to
FIG. 8B , by proximally withdrawing thecontrol assembly 14, theoccluder 200 is withdrawn proximally into thesecond lumen 18 of thetube 15 at thedistal end 17 of the front-end loader 12. Theoccluder 200 enters thesecond lumen 18 of thetube 15 by sliding through the opening defined by the chamferedrim 25 at thedistal end 17 of thetube 15. Because theoccluder 200 slides over the smooth slope of the chamferedrim 25 as it enters thesecond lumen 18 of thetube 15, the chamferedrim 25 eases retrieval of theoccluder 200. With the chamferedrim 25 at thedistal end 17 of thetube 15, theoccluder 200 is much less likely to catch or snag on thedistal end 17 of thetube 15 during retrieval than it is in the absence of the chamferedrim 25. The inability to withdraw theoccluder 200 into thesecond lumen 18 of thetube 15 during an attempted retrieval is, therefore, less likely to result. - Referring now to
FIG. 8C , once theoccluder 200 is proximally withdrawn past thebase 29 of thebeveled end 22 of thetube 15, the front-end loader 12 may be completely withdrawn, through thegland 90 of thehub 158, from theintroducer sheath 150. - Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description but instead by the spirit and scope of the following claims.
Claims (4)
1. A front-end loader for a percutaneous transluminal system for an intracardiac device, said front-end loader comprising:
a proximal portion comprising a proximal end, a distal end, and an expanded lumen positioned therebetween, said expanded lumen having a conical shape and a constantly tapering diameter from said proximal end of said proximal portion to said distal end of said proximal portion; and
a distal portion comprising a tube comprising a proximal end, a distal end, a lumen extending therethrough, said lumen of said distal portion being co-extensive with said expanded lumen of said proximal portion;
wherein said tube comprises a beveled edge at said distal end; and
further wherein said tube comprises a chamfered rim around the entire inner perimeter of said beveled edge, said chamfered rim comprising an outer rim and an inner rim and having a width therebetween, said inner rim positioned proximal to said outer rim, and wherein said width between said outer rim and said inner rim varies about the entire perimeter.
2. The front-end loader of claim 1 , wherein said intracardiac device comprises an intracardiac occluder.
3. The front-end loader of claim 2 , wherein said intracardiac occluder comprises an occluder for treating an atrial septal defect.
4. The front-end loader of claim 2 , wherein said intracardiac occluder comprises an intracardiac occluder for treating a ventricular septal defect
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/087,815 US20160213359A1 (en) | 2002-09-23 | 2016-03-31 | Front-end loader for prosthetic occluders and methods thereof |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US41295302P | 2002-09-23 | 2002-09-23 | |
US10/667,747 US9326758B2 (en) | 2002-09-23 | 2003-09-22 | Front-end loader for prosthetic occluders and methods thereof |
US15/087,815 US20160213359A1 (en) | 2002-09-23 | 2016-03-31 | Front-end loader for prosthetic occluders and methods thereof |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/667,747 Division US9326758B2 (en) | 2002-09-23 | 2003-09-22 | Front-end loader for prosthetic occluders and methods thereof |
Publications (1)
Publication Number | Publication Date |
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US20160213359A1 true US20160213359A1 (en) | 2016-07-28 |
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US10/667,747 Active 2029-08-27 US9326758B2 (en) | 2002-09-23 | 2003-09-22 | Front-end loader for prosthetic occluders and methods thereof |
US15/087,815 Abandoned US20160213359A1 (en) | 2002-09-23 | 2016-03-31 | Front-end loader for prosthetic occluders and methods thereof |
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US10/667,747 Active 2029-08-27 US9326758B2 (en) | 2002-09-23 | 2003-09-22 | Front-end loader for prosthetic occluders and methods thereof |
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US (2) | US9326758B2 (en) |
EP (1) | EP1545319A1 (en) |
JP (1) | JP4532275B2 (en) |
AU (1) | AU2003270777A1 (en) |
CA (1) | CA2498880A1 (en) |
WO (1) | WO2004026146A1 (en) |
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-
2003
- 2003-09-22 WO PCT/US2003/029472 patent/WO2004026146A1/en active Application Filing
- 2003-09-22 JP JP2004538221A patent/JP4532275B2/en not_active Expired - Fee Related
- 2003-09-22 AU AU2003270777A patent/AU2003270777A1/en not_active Abandoned
- 2003-09-22 CA CA002498880A patent/CA2498880A1/en not_active Abandoned
- 2003-09-22 US US10/667,747 patent/US9326758B2/en active Active
- 2003-09-22 EP EP03752489A patent/EP1545319A1/en not_active Withdrawn
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EP1545319A1 (en) | 2005-06-29 |
AU2003270777A1 (en) | 2004-04-08 |
US20040133230A1 (en) | 2004-07-08 |
WO2004026146A1 (en) | 2004-04-01 |
JP4532275B2 (en) | 2010-08-25 |
WO2004026146B1 (en) | 2004-05-06 |
US9326758B2 (en) | 2016-05-03 |
CA2498880A1 (en) | 2004-04-01 |
JP2006500110A (en) | 2006-01-05 |
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