US20120193391A1 - Endovascular flexible stapling device - Google Patents
Endovascular flexible stapling device Download PDFInfo
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- US20120193391A1 US20120193391A1 US13/435,582 US201213435582A US2012193391A1 US 20120193391 A1 US20120193391 A1 US 20120193391A1 US 201213435582 A US201213435582 A US 201213435582A US 2012193391 A1 US2012193391 A1 US 2012193391A1
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- defect
- guide wire
- flexible
- patient
- introducer
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- 230000007547 defect Effects 0.000 claims abstract description 36
- 238000000034 method Methods 0.000 claims abstract description 27
- 210000003462 vein Anatomy 0.000 claims description 14
- 208000008883 Patent Foramen Ovale Diseases 0.000 claims description 12
- 208000013914 atrial heart septal defect Diseases 0.000 claims description 7
- 230000007246 mechanism Effects 0.000 claims description 7
- 208000035478 Interatrial communication Diseases 0.000 claims description 6
- 206010003664 atrial septal defect Diseases 0.000 claims description 6
- 210000003191 femoral vein Anatomy 0.000 claims description 6
- 208000001910 Ventricular Heart Septal Defects Diseases 0.000 claims description 4
- 201000003130 ventricular septal defect Diseases 0.000 claims description 4
- 230000000694 effects Effects 0.000 claims description 3
- 210000005245 right atrium Anatomy 0.000 claims description 3
- 230000003213 activating effect Effects 0.000 claims 4
- 230000000747 cardiac effect Effects 0.000 claims 4
- 238000002592 echocardiography Methods 0.000 claims 2
- 210000003361 heart septum Anatomy 0.000 claims 2
- 210000001105 femoral artery Anatomy 0.000 claims 1
- 210000005166 vasculature Anatomy 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 abstract description 9
- 230000008439 repair process Effects 0.000 abstract description 8
- 230000007027 foramen ovale closure Effects 0.000 abstract description 6
- 230000001746 atrial effect Effects 0.000 description 4
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 208000025339 heart septal defect Diseases 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 238000013175 transesophageal echocardiography Methods 0.000 description 3
- 208000032382 Ischaemic stroke Diseases 0.000 description 2
- 230000003872 anastomosis Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 208000032750 Device leakage Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 150000001242 acetic acid derivatives Chemical class 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 229940127218 antiplatelet drug Drugs 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 238000011221 initial treatment Methods 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 238000013160 medical therapy Methods 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000000106 platelet aggregation inhibitor Substances 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
-
- 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
- A61B2017/00646—Type of implements
- A61B2017/00668—Type of implements the implement being a tack or a staple
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
-
- 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
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
- A61B2017/3425—Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports
Definitions
- the present invention relates to a flexible stapling device. More particularly, this invention relates to a flexible endovascular stapling device useful for intravascular procedures such as patent foramen ovale closure, atrial septal defect closure, valve repair, or valve replacement, which is designed to avoid open heart surgery by permitting the closure of the defect and/or valve repair or replacement utilizing a stapling means which is positioned by using a flexible shaft/guide wire system or by direct vision.
- Cryptogenic strokes potentially account for 40% of the 500,000 strokes which occur in the United States each year. Many of these events may be associated with a patent foramen ovale (small atrial septal defect) which permits debris in the venous circulation to cross over into the arterial circulation where it may travel to the brain. Treatment for these patients often includes open heart surgery to close the defect.
- small atrial septal defect small atrial septal defect
- the present invention provides for a endovascular flexible stapling device. More particularly, this invention provides for a flexible endovascular stapling device for a procedure such as patent foramen ovale closure, which is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means which is positioned by using a flexible shaft/guide wire system introduced via the femoral vein or the jugular vein.
- a stapling means which is positioned by using a flexible shaft/guide wire system introduced via the femoral vein or the jugular vein.
- One application for the flexible stapling device of the present invention is to pass the device via a femoral vein into the right atrium of the heart and, with the guidance of trans-esophageal echocardiography, position the device, and then fire one or more staples to obtain closure of the defect.
- FIG. 1 is a longitudinal, partly cross-sectional view of the flexible stapling device of the present invention
- FIG. 1( a ) is an end view of the flexible stapling device of FIG. 1 showing in cross-section the position of the staples prior to use for effecting closure of a defect;
- FIG. 1( b ) is a lateral view of a typical staple which is incorporated into the distal end of the device of FIG. 1 ;
- FIG. 1( c ) is a cross-sectional view of the distal end of the device of FIG. 1( a ), showing a staple in a closed position;
- FIG. 2 is a longitudinal view of the introducer element used for insertion of the flexible stapling device
- FIG. 3 is a longitudinal view of the guidewire upon which the flexible stapling device of the present invention glides to position the device in proximity to the defect to be closed;
- FIG. 4 is a longitudinal view of a typical dilator which is used for gradually increasing the size of a vein to permit the easy introduction of the flexible stapling device of the present invention.
- FIG. 5 is a perspective view of a staple useful according to the invention.
- the present invention is directed to an endovascular flexible stapling device. More particularly, this invention relates to a transfemoral flexible stapling device useful for a number of intravascular procedures.
- the flexible stapling device can be used for patent foramen ovale closure which is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means which is positioned by using a flexible shaft/guide wire system.
- the device can also be used for atrial or ventricular septal defect closure or valve repair or replacement by an endovascular route or by direct vision.
- the device of the present invention is designed to avoid open heart surgery by allowing for the closure of the septal defect utilizing a flexible shaft device which incorporates a stapling means.
- This device may be introduced by a femoral vein into the right atrium of the patient's heart where, with the guidance of transesophageal echocardiography, the device may be positioned and staples may be fired.
- FIG. 1 a longitudinal, partly cross-sectional view of the flexible stapling device 1 of the present invention is shown, wherein the essential components are depicted.
- a flexible catheter shaft 10 is shown which incorporates at the proximal end 11 multiple hand grips 12 for maneuvering the device 1 into a patient's vein and properly locating the distal end 14 in proximity to the defect to be closed.
- Distal to the hand grips 12 is a guidewire port 16 , through which passes the proximal end of a guidewire 18 over which the flexible stapling device 1 slides and is guided into position.
- Guidewire port 16 could optionally be located elsewhere, for example, at the proximal portion 17 of hand grips 12 .
- a slide mechanism 20 for retracting a retractable external housing 22 , located at the distal end 14 of flexible shaft 10 .
- Slide mechanism 20 is operatively connected by suitable actuation means 24 to retractable external housing 22 to facilitate retraction of the housing 22 once the distal end 14 of the device 1 has been properly positioned in proximity to the defect to be closed.
- Retractable housing 22 could comprise a cylindrical member having an inner diameter slightly greater than the outer diameter of shaft 10 .
- retractable housing 22 Located within retractable housing 22 are one or more, preferably 2 or 4, barbed staples 26 which have been properly positioned to present intimate contact between the barbed tips 28 of the staples 26 and the portion of the patient's septum to be closed once external housing 22 has been retracted.
- FIG. 1 ( a ) is a cross-sectional view of the distal end of the flexible device 1 of FIG. 1 showing four separate barbed staples 26 releasably positioned on a staple holding member 27 within external housing 22 .
- Each of the staples 26 has been preformed and has barbed ends 28 for insertion into the septum wall presenting the defect.
- Holding member 27 for the staples 26 has a guidewire exit port 30 through which the guidewire 18 extends distally from the flexible shaft 10 of the device.
- An actuator such as handgrips 12 or, optionally, an actuator 15 , is operatively connected to holding member 27 and/or staple closer 25 , so that staples 26 are simultaneously closed and released when the handgrips 12 are squeezed together or actuator 15 is activated.
- the operative connection can be mechanical, electrical, or other.
- holding member 27 could be either re-fitted with new staples 26 or replaced with a replacement holding member 27 with staples already in place, e.g., a “clip”.
- FIG. 1( b ) a typical barbed staple 26 is depicted showing the angular preformed configuration of the staple 26 .
- the barbed tips 28 allow for the insertion of the staples to effect closure of the defect without allowing them to spontaneously release from the wall in which they have been inserted.
- FIG. 1( c ) represents the distal end of flexible device 1 where external housing 22 has been retracted and staple 26 has been closed. Barbed ends 28 of staple 26 are in a closed, almost touching position.
- staple closer 25 moves distally relative to holding member 27 to cause barbed ends 28 to close on the intended target tissue or organ, such as the septum.
- other mechanisms that can be activated proximally are operatively connected to a distal staple holding member, and cause the staples to close on an intended target could be used in place of the system described here.
- device 1 could optionally comprise fiber optics and/or light or imaging transmitting means, as well as one or more working channels or lumens.
- FIG. 2 a longitudinal view of an introducer element 40 of the system of the present invention is depicted.
- a one way-valve 42 is located at the proximal end 41 of the introducer element 40 , and a generally circular opening 44 is located at the distal end thereof.
- FIG. 3 depicts a perspective view of the guidewire 50 showing a curved tip 52 at the distal end thereof.
- FIG. 4 depicts a perspective view of a typical dilator 60 , which can be a set of two or more progressively larger dilators for gradual dilation of a vein or artery.
- the last dilator passes first through introducer 40 and then into, for example, a vein.
- the lengths could be 20 cm, 20 cm, and 55 cm.
- An orifice 62 is located at the proximal end of dilator 60 for passage of the guidewire.
- a tapered tip 64 is located near the distal end thereof, and a generally circular opening 66 is located at the distal end.
- the flexible shaft of the stapling device of the present invention may be effectively constructed of a suitable wire-reinforced polymeric material.
- the material chosen should allow for the easy curvature of the shaft of the device without the need for excessive forces being applied, while at the same time providing for the necessary overall rigidity to the shaft to allow for the insertion of the device in the patient's vein.
- the flexible stapling device depicted in FIG. 1 will be approximately 110 cm. Shorter or longer overall lengths are also contemplated as may be required to effect a particular procedure.
- the overall diameter of the cross-section of the flexible shaft 10 of the device 1 depicted in FIG. 1 is approximately 5 mm. It is contemplated that similar devices may be constructed having overall diameters of the flexible shaft which vary somewhat to accommodate the different size veins into which the device must be inserted. Therefore, shaft diameters could range from about 5 to about 15 mm.
- the retractable external housing 22 at the distal end of the device 1 will have an overall diameter of approximately 5.5 mm to 16 mm. Again, variations in this diameter are contemplated depending upon the needs of a particular procedure and to accommodate patients having unduly small veins.
- the barbed staples which are located at the distal end of the stapler device will have an overall length of approximately 4 mm to 14 mm. Again, the precise configuration of the staple, the actual dimensions of the barbs as well as the overall size of the staple itself, are variables which will be determined by the conditions which prevail in carrying out any particular procedure and the physiological requirements of the patient involved.
- the number and actual location of staples within the retractable external housing 22 may also vary depending upon the needs of a particular procedure.
- each staple 70 may have a filament 72 extending from staple 70 a sufficient length that the proximal end of each filament would extend outside the patient's body. Then, if staple 70 were not positioned properly, the surgeon could retrieve staple 70 by pulling firmly on filament 72 . If staple 70 is properly positioned, filament 72 would merely be cut. It is contemplated that a length of from about 20 to 100 cm of filament 72 would be fixedly attached to each staple 70 .
- the filaments 72 could be comprised of any flexible, physiologically acceptable natural or manufactured material, such as acetates or polyacetates, etc., used in sutures. The distal end of each filament 72 would be glued or physically affixed to each staple 70 .
- the overall length of this element taken from the base of the one-way valve located at the proximal end thereof to the distal tip of the element, will be from about 30 to 60 cm, preferably approximately 50 cm.
- the overall diameter of the introducer element at the distal end will be from about 6 mm to 20 mm, or as initially depicted approximately 6.7 mm, to accommodate the passage of the flexible shaft stapling device through the opening provided.
- the guidewire which is depicted in FIG. 3 will have an overall length of at least from about 90 to 130 cm, preferably 110 cm, to properly function with the flexible shaft stapling device depicted in FIG. 1 .
- the overall diameter of the guidewire will generally be from about 0.30 to 0.50 mm, preferably about 0.38 mm, although variations in the actual diameter of the guidewire are contemplated.
- the dilator depicted in FIG. 4 is typical of a series of three or more dilators which vary in length from about 20 to 55 cm.
- the overall diameter of the largest cross-section of each dilator will be no more than the opening provided at the distal end of the introducer element. It is, therefore, contemplated that the overall diameter of the dilators will be from about 5 to 15 mm.
- one or more of the smaller diameter dilators is inserted into a femoral vein to permit gradual enlargement of the patient's vein using successively larger diameter dilators and ultimately to allow entry of the introducer element.
- the largest in the series of dilators used will be inserted first through the introducer element and then into the vein which had been previously enlarged using smaller diameter dilators.
- a flexible stapling device according to the invention is then inserted through the introducer over the guidewire and with the aid of trans-esophageal echocardiography or other similar procedure, the distal end of the flexible stapler device is positioned adjacent or near to the patent foramen ovale requiring closure.
- the staples are then propelled or fired by retracting the external housing utilizing the slide mechanism provided in the proximal end of the flexible stapler shaft.
- the flexible stapling device of the invention is useful for patent foramen ovale closure, there are other intravascular procedures for which the flexible stapling device can be used. Such procedures include, for example, the correction of atrial septal or ventricle septal defect, closure of paravalvular leaks, or annuloplasty repair of valvular insufficiency or valve replacement.
- the flexible stapling device need not be inserted percutaneously. In certain applications a cut down procedure at the leg can be employed with direct vision of the procedure or with the heart open during minimally invasive surgery. In addition, multiple sizes of the flexible stapling device should be available.
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Abstract
A flexible endovascular stapling device is used for an intravascular procedure to repair a defect, such as a foramen ovale closure. The procedure is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means which is positioned by using a flexible/shaft/guidewire system. Also, in a staple useful for surgical application in a body, there is an improvement wherein the distal portion of a filament having proximal and distal portions is fixedly attached to the staple.
Description
- This application is a divisional of co-pending, commonly assigned U.S. patent Application Ser. No. 12/140,605, filed Jun. 17, 2008, which in turn is a divisional of commonly assigned U.S. patent application Ser. No. 10/104,876, filed Mar. 21, 2002, now U.S. Pat. No. 7,794,474, which in turn is a continuation of commonly assigned U.S. patent application Ser. No. 09/242,969, filed Jun. 7, 1999, now U.S. Pat. No. 6,482,224, which in turn is a National Phase application of PCT Patent Application No. PCT/US97/14772, filed Aug. 22, 1997, which in turn is based upon and claims the benefit of the priority of commonly assigned U.S. Provisional Patent Application Ser. No. 60/024,640, filed Aug. 22, 1996, each of which is incorporated herein in its entirety.
- The present invention relates to a flexible stapling device. More particularly, this invention relates to a flexible endovascular stapling device useful for intravascular procedures such as patent foramen ovale closure, atrial septal defect closure, valve repair, or valve replacement, which is designed to avoid open heart surgery by permitting the closure of the defect and/or valve repair or replacement utilizing a stapling means which is positioned by using a flexible shaft/guide wire system or by direct vision.
- Cryptogenic strokes potentially account for 40% of the 500,000 strokes which occur in the United States each year. Many of these events may be associated with a patent foramen ovale (small atrial septal defect) which permits debris in the venous circulation to cross over into the arterial circulation where it may travel to the brain. Treatment for these patients often includes open heart surgery to close the defect.
- A number of prior art references are known:
- U.S. Pat. No. 4,473,077, which issued to Noiles et al. on Sep. 25, 1984, discloses a flexible shafted surgical stapler generally useful for anastomosis procedures;
- U.S. Pat. No. 4,485,817, which issued to Swiggett on Dec. 4, 1984, teaches a stapler with flexible shaft construction having hydraulic transmission/drive means. This stapler is used primarily for anastomosis of hollow body vessels; and
- U.S. Pat. No. 5,042,707, which issued to Taheri on Aug. 27, 1991, relates to an articulated stapler for use in the vascular system.
- However, none of the above references teaches the use of a flexible stapler for intravascular procedures such as patent foramen ovale closure or a flexible stapler suitable for these procedures.
- It is an object of the invention to provide an endovascular flexible stapling device.
- It is also an object of the invention to provide an endovascular flexible stapling device useful for closure of a patent foramen ovale defect, atrial or ventricular septal defect closure, valve repair, or valve replacement, without the need for open heart surgery.
- It is a further object of the invention to provide a method of performing intravascular procedures whereby a endovascular flexible stapling device is inserted into a body.
- It is a yet further object of the invention to provide for a method of closing a patent foramen ovale defect, atrial or ventricular septal defect closure, valve repair, or valve replacement, without the need for open heart surgery.
- These and other objects of the invention will become apparent from the following discussion of the invention.
- The present invention provides for a endovascular flexible stapling device. More particularly, this invention provides for a flexible endovascular stapling device for a procedure such as patent foramen ovale closure, which is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means which is positioned by using a flexible shaft/guide wire system introduced via the femoral vein or the jugular vein. One application for the flexible stapling device of the present invention is to pass the device via a femoral vein into the right atrium of the heart and, with the guidance of trans-esophageal echocardiography, position the device, and then fire one or more staples to obtain closure of the defect.
- The construction and obvious advantages of the system provided for by the present invention will be more clearly understood from the following description of the various specific embodiments when read in conjunction with the accompanying drawings.
-
FIG. 1 is a longitudinal, partly cross-sectional view of the flexible stapling device of the present invention; -
FIG. 1( a) is an end view of the flexible stapling device ofFIG. 1 showing in cross-section the position of the staples prior to use for effecting closure of a defect; -
FIG. 1( b) is a lateral view of a typical staple which is incorporated into the distal end of the device ofFIG. 1 ; -
FIG. 1( c) is a cross-sectional view of the distal end of the device ofFIG. 1( a), showing a staple in a closed position; -
FIG. 2 is a longitudinal view of the introducer element used for insertion of the flexible stapling device; -
FIG. 3 is a longitudinal view of the guidewire upon which the flexible stapling device of the present invention glides to position the device in proximity to the defect to be closed; -
FIG. 4 is a longitudinal view of a typical dilator which is used for gradually increasing the size of a vein to permit the easy introduction of the flexible stapling device of the present invention; and -
FIG. 5 is a perspective view of a staple useful according to the invention. - The present invention is directed to an endovascular flexible stapling device. More particularly, this invention relates to a transfemoral flexible stapling device useful for a number of intravascular procedures. For example, the flexible stapling device can be used for patent foramen ovale closure which is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means which is positioned by using a flexible shaft/guide wire system. However, the device can also be used for atrial or ventricular septal defect closure or valve repair or replacement by an endovascular route or by direct vision.
- As noted above, many of the cryptogenic strokes which occur in the United States each year can be associated with the existence of the small atrial septal defects known as patent foramen ovale defects. Historically the primary treatment used for patients who may have been diagnosed with such defects has been medical therapy with anticoagulants or anti-platelet agents, or open heart surgery to repair the septal defect.
- The device of the present invention is designed to avoid open heart surgery by allowing for the closure of the septal defect utilizing a flexible shaft device which incorporates a stapling means. This device may be introduced by a femoral vein into the right atrium of the patient's heart where, with the guidance of transesophageal echocardiography, the device may be positioned and staples may be fired.
- The invention can perhaps be better appreciated by making reference to the drawings. With reference to
FIG. 1 , a longitudinal, partly cross-sectional view of the flexible stapling device 1 of the present invention is shown, wherein the essential components are depicted. Aflexible catheter shaft 10 is shown which incorporates at the proximal end 11 multiple hand grips 12 for maneuvering the device 1 into a patient's vein and properly locating the distal end 14 in proximity to the defect to be closed. Distal to the hand grips 12 is aguidewire port 16, through which passes the proximal end of aguidewire 18 over which the flexible stapling device 1 slides and is guided into position.Guidewire port 16 could optionally be located elsewhere, for example, at theproximal portion 17 of hand grips 12. - Distal to guidewire
port 16 is aslide mechanism 20 for retracting a retractableexternal housing 22, located at the distal end 14 offlexible shaft 10.Slide mechanism 20 is operatively connected by suitable actuation means 24 to retractableexternal housing 22 to facilitate retraction of thehousing 22 once the distal end 14 of the device 1 has been properly positioned in proximity to the defect to be closed.Retractable housing 22 could comprise a cylindrical member having an inner diameter slightly greater than the outer diameter ofshaft 10. - Located within
retractable housing 22 are one or more, preferably 2 or 4,barbed staples 26 which have been properly positioned to present intimate contact between thebarbed tips 28 of thestaples 26 and the portion of the patient's septum to be closed onceexternal housing 22 has been retracted. -
FIG. 1 (a) is a cross-sectional view of the distal end of the flexible device 1 ofFIG. 1 showing four separatebarbed staples 26 releasably positioned on astaple holding member 27 withinexternal housing 22. Each of thestaples 26 has been preformed and hasbarbed ends 28 for insertion into the septum wall presenting the defect. Holdingmember 27 for thestaples 26 has aguidewire exit port 30 through which theguidewire 18 extends distally from theflexible shaft 10 of the device. - An actuator such as
handgrips 12 or, optionally, anactuator 15, is operatively connected to holdingmember 27 and/or staple closer 25, so thatstaples 26 are simultaneously closed and released when thehandgrips 12 are squeezed together oractuator 15 is activated. The operative connection can be mechanical, electrical, or other. After discharge ofstaples 26, holdingmember 27 could be either re-fitted withnew staples 26 or replaced with areplacement holding member 27 with staples already in place, e.g., a “clip”. - In
FIG. 1( b) a typicalbarbed staple 26 is depicted showing the angular preformed configuration of thestaple 26. Thebarbed tips 28 allow for the insertion of the staples to effect closure of the defect without allowing them to spontaneously release from the wall in which they have been inserted. -
FIG. 1( c) represents the distal end of flexible device 1 whereexternal housing 22 has been retracted andstaple 26 has been closed. Barbed ends 28 ofstaple 26 are in a closed, almost touching position. In one embodiment of the invention, staple closer 25 moves distally relative to holdingmember 27 to cause barbed ends 28 to close on the intended target tissue or organ, such as the septum. Optionally, other mechanisms that can be activated proximally, are operatively connected to a distal staple holding member, and cause the staples to close on an intended target could be used in place of the system described here. Also, it is contemplated that device 1 could optionally comprise fiber optics and/or light or imaging transmitting means, as well as one or more working channels or lumens. - With reference to
FIG. 2 , a longitudinal view of anintroducer element 40 of the system of the present invention is depicted. A one way-valve 42 is located at the proximal end 41 of theintroducer element 40, and a generally circular opening 44 is located at the distal end thereof. -
FIG. 3 depicts a perspective view of theguidewire 50 showing acurved tip 52 at the distal end thereof. -
FIG. 4 depicts a perspective view of atypical dilator 60, which can be a set of two or more progressively larger dilators for gradual dilation of a vein or artery. The last dilator passes first throughintroducer 40 and then into, for example, a vein. In a set of three dilators, the lengths could be 20 cm, 20 cm, and 55 cm. Anorifice 62 is located at the proximal end ofdilator 60 for passage of the guidewire. A taperedtip 64 is located near the distal end thereof, and a generallycircular opening 66 is located at the distal end. - It is contemplated that the flexible shaft of the stapling device of the present invention may be effectively constructed of a suitable wire-reinforced polymeric material. Preferably the material chosen should allow for the easy curvature of the shaft of the device without the need for excessive forces being applied, while at the same time providing for the necessary overall rigidity to the shaft to allow for the insertion of the device in the patient's vein.
- In overall length the flexible stapling device depicted in
FIG. 1 will be approximately 110 cm. Shorter or longer overall lengths are also contemplated as may be required to effect a particular procedure. - The overall diameter of the cross-section of the
flexible shaft 10 of the device 1 depicted inFIG. 1 is approximately 5 mm. It is contemplated that similar devices may be constructed having overall diameters of the flexible shaft which vary somewhat to accommodate the different size veins into which the device must be inserted. Therefore, shaft diameters could range from about 5 to about 15 mm. - The retractable
external housing 22 at the distal end of the device 1 will have an overall diameter of approximately 5.5 mm to 16 mm. Again, variations in this diameter are contemplated depending upon the needs of a particular procedure and to accommodate patients having unduly small veins. - The barbed staples which are located at the distal end of the stapler device will have an overall length of approximately 4 mm to 14 mm. Again, the precise configuration of the staple, the actual dimensions of the barbs as well as the overall size of the staple itself, are variables which will be determined by the conditions which prevail in carrying out any particular procedure and the physiological requirements of the patient involved.
- The number and actual location of staples within the retractable
external housing 22 may also vary depending upon the needs of a particular procedure. - In an optional embodiment of the invention shown in
FIG. 5 , each staple 70 may have afilament 72 extending from staple 70 a sufficient length that the proximal end of each filament would extend outside the patient's body. Then, ifstaple 70 were not positioned properly, the surgeon could retrievestaple 70 by pulling firmly onfilament 72. Ifstaple 70 is properly positioned,filament 72 would merely be cut. It is contemplated that a length of from about 20 to 100 cm offilament 72 would be fixedly attached to each staple 70. Thefilaments 72 could be comprised of any flexible, physiologically acceptable natural or manufactured material, such as acetates or polyacetates, etc., used in sutures. The distal end of eachfilament 72 would be glued or physically affixed to each staple 70. - With regard to the introducer element depicted in
FIG. 2 , it is generally contemplated that the overall length of this element, taken from the base of the one-way valve located at the proximal end thereof to the distal tip of the element, will be from about 30 to 60 cm, preferably approximately 50 cm. The overall diameter of the introducer element at the distal end will be from about 6 mm to 20 mm, or as initially depicted approximately 6.7 mm, to accommodate the passage of the flexible shaft stapling device through the opening provided. - The guidewire which is depicted in
FIG. 3 will have an overall length of at least from about 90 to 130 cm, preferably 110 cm, to properly function with the flexible shaft stapling device depicted inFIG. 1 . The overall diameter of the guidewire will generally be from about 0.30 to 0.50 mm, preferably about 0.38 mm, although variations in the actual diameter of the guidewire are contemplated. - The dilator depicted in
FIG. 4 is typical of a series of three or more dilators which vary in length from about 20 to 55 cm. - The overall diameter of the largest cross-section of each dilator will be no more than the opening provided at the distal end of the introducer element. It is, therefore, contemplated that the overall diameter of the dilators will be from about 5 to 15 mm.
- In the method of the invention one or more of the smaller diameter dilators is inserted into a femoral vein to permit gradual enlargement of the patient's vein using successively larger diameter dilators and ultimately to allow entry of the introducer element. The largest in the series of dilators used will be inserted first through the introducer element and then into the vein which had been previously enlarged using smaller diameter dilators.
- After the introducer element has been properly positioned within the patient's vein, and the guidewire positioned through the defect, a flexible stapling device according to the invention is then inserted through the introducer over the guidewire and with the aid of trans-esophageal echocardiography or other similar procedure, the distal end of the flexible stapler device is positioned adjacent or near to the patent foramen ovale requiring closure. The staples are then propelled or fired by retracting the external housing utilizing the slide mechanism provided in the proximal end of the flexible stapler shaft.
- While, as described above, the flexible stapling device of the invention is useful for patent foramen ovale closure, there are other intravascular procedures for which the flexible stapling device can be used. Such procedures include, for example, the correction of atrial septal or ventricle septal defect, closure of paravalvular leaks, or annuloplasty repair of valvular insufficiency or valve replacement.
- Also, the flexible stapling device need not be inserted percutaneously. In certain applications a cut down procedure at the leg can be employed with direct vision of the procedure or with the heart open during minimally invasive surgery. In addition, multiple sizes of the flexible stapling device should be available.
- It will be further apparent to one skilled in this art that the improvements provided for in the present invention, while described with relation to certain specific physical embodiments also lend themselves to being applied in other physical arrangements not specifically provided for herein, which are nonetheless within the spirit and scope of the invention taught here.
Claims (7)
1. In a staple useful for surgical application in a body, the improvement wherein the distal portion of a filament having proximal and distal portions is fixedly attached to the staple.
2. A method of effecting intravascular closure comprising;
advancing a guide wire percutaneously or by incision into a patient's vein;
advancing an introducer over the guide wire where the introducer has distal and proximal ends and the proximal end of the introducer remains outside the patient's body;
advancing a guide wire through the introducer and distally to a position through a defect in the patient's heart septum or other appropriate location;
advancing a flexible stapling device having distal and proximal ends, where said distal end comprises staples and the proximal end comprises actuating means to cause the staples to be fired;
positioning the distal end of the flexible shaft stapling device in proximity to the defect;
activating the actuating means to fire the staples to close at least a portion of the defect; and
withdrawing the flexible stapling device and then the introducer from the patient's vein.
3. A method of effecting intravascular closure comprising;
advancing a guide wire percutaneously or by incision into a patient's vein;
advancing an introducer over the guide wire where the introducer has distal and proximal ends and the proximal end of the introducer remains outside the patient's body;
advancing a guide wire through the introducer and distally to a position through a defect in the patient's heart septum or other appropriate location;
advancing a flexible stapling device having distal and proximal, ends, where said distal end comprises staples and a retractable external housing and the proximal end comprises a slide mechanism operably connected to the external housing, said slide mechanism causing the external housing to move from an extended position to a retracted position and causing the staples to he fired in the retracted position;
positioning the distal end of the flexible shaft stapling device in proximity to the defect;
activating the slide mechanism to effect the positioning of the staples located at the distal end of the flexible shaft; and
withdrawing the flexible stapling device and then the introducer from the patient's vein.
4. A method for closing a patent foramen ovale defect in the heart comprising the steps of:
introducing a guide wire into a femoral vein to a location in the right atrium of the heart, and through defect to be repaired;
placing a flexible shaft device over the guide wire;
moving the device along the guide wire into a position proximate the detect to he repaired under the guidance of echocardiography; and
activating the flexible shaft device to close at least a portion of the defect,
5. A method for correcting a defect in the heart by closing said defect, comprising the steps of:
introducing a guide wire into a femoral vein to a location in the heart and to the defect to be repaired;
placing a flexible shaft device over the guide wire;
moving the device along the guide wire into a position proximate the defect to be repaired under the guidance of echocardiography; and
activating the flexible shaft device to close at least a portion of the defect.
6. A method of claim 36 wherein the defect to be corrected is chosen from a list comprising: a valvular leak, a patent foramen ovale, an atrial septal defect, a ventricular septal defect, or an annulus of the heart.
7. A method for closing a cardiac defect, comprising the steps of:
introducing a guide wire into a patient's femoral artery;
advancing the guide wire through the patient's vasculature to the situs of a cardiac defect to be closed;
mounting a flexible stapling device onto the guide wire and moving the device along the guide wire into a position proximate the cardiac defect to be closed; and
actuating the device such that a staple closes at least a portion of the cardiac defect.
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US15/447,051 Abandoned US20170172569A1 (en) | 1996-08-22 | 2017-03-01 | Endovascular flexible stapling device |
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Also Published As
Publication number | Publication date |
---|---|
US9610078B2 (en) | 2017-04-04 |
AU4082497A (en) | 1998-03-06 |
US20080249565A1 (en) | 2008-10-09 |
WO1998007375A1 (en) | 1998-02-26 |
US8048110B2 (en) | 2011-11-01 |
US8167905B2 (en) | 2012-05-01 |
US20020099389A1 (en) | 2002-07-25 |
US20120095490A1 (en) | 2012-04-19 |
US20150265274A1 (en) | 2015-09-24 |
US20170172569A1 (en) | 2017-06-22 |
US6482224B1 (en) | 2002-11-19 |
US9468437B2 (en) | 2016-10-18 |
US7794474B2 (en) | 2010-09-14 |
US20150265273A1 (en) | 2015-09-24 |
US20080272174A1 (en) | 2008-11-06 |
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