Source: http://www.google.com/patents/US6428549?dq=5,960,411
Timestamp: 2016-05-31 05:57:36
Document Index: 42104898

Matched Legal Cases: ['art 18', 'art 24', 'art 18', 'art 506', 'art 506', 'art. 506', 'art 508', 'art 508', 'art 506', 'art 506', 'art 508', 'art 506', 'art 508', 'art 508', 'art 506', 'art 508', 'art 506', 'art 506', 'art 508', 'art 508']

Patent US6428549 - Device and method for suturing blood vessels and the like - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA method for sealing a tissue puncture that includes inserting into the puncture a device with needle exit and entry openings separated by a tissue receiving gap, positioning the device so that the tissue is located in the tissue receiving gap distally from the needle exit opening and proximally from...http://www.google.com/patents/US6428549?utm_source=gb-gplus-sharePatent US6428549 - Device and method for suturing blood vessels and the likeAdvanced Patent SearchPublication numberUS6428549 B1Publication typeGrantApplication numberUS 09/650,322Publication dateAug 6, 2002Filing dateAug 29, 2000Priority dateJun 11, 1996Fee statusPaidAlso published asEP1121055A1, EP1121055A4, EP1980211A2, EP1980211A3, US6436109, WO2001026561A1Publication number09650322, 650322, US 6428549 B1, US 6428549B1, US-B1-6428549, US6428549 B1, US6428549B1InventorsStavros KontosOriginal AssigneeX-Site, L.L.C.Export CitationBiBTeX, EndNote, RefManPatent Citations (12), Referenced by (73), Classifications (30), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetDevice and method for suturing blood vessels and the like
US 6428549 B1Abstract
A method for sealing a tissue puncture that includes inserting into the puncture a device with needle exit and entry openings separated by a tissue receiving gap, positioning the device so that the tissue is located in the tissue receiving gap distally from the needle exit opening and proximally from the needle entry opening and inserting a first needle coupled to a first portion of suture distally through the device through the tissue and into the needle entry lumen. The device is then rotated to a second portion of tissue and a second needle is inserted distally through the device through the second portion of tissue and into the needle entry lumen. The device is withdrawn from the patient and the suture is tightened to seal the puncture.
What is claimed is: 1. A method for sealing a puncture in an anatomical structure comprising the steps of:
inserting into the puncture a device including a needle exit opening and a needle entry opening separated by a tissue receiving gap; positioning the device so that the needle exit opening is located on a proximal side of the anatomical structure and the needle entry opening is located on a distal side of the anatomical structure with a first portion of the anatomical structure received within the tissue receiving gap; inserting a first needle coupled to a first portion of suture distally through the device to exit the device via the needle exit opening, penetrate the first portion of the anatomical structure and re-enter the device via the needle entry lumen; rotating the device so that a second portion of the anatomical structure is located within the tissue receiving gap between the needle exit and needle entry lumens; inserting a second needle coupled to a second portion of suture distally through the device to exit the device via the needle exit opening, penetrate the second portion of the anatomical structure and re-enter the device via the needle entry lumen; withdrawing the device from the anatomical structure; and tightening the first and second portions of suture to draw the sides of the puncture together. 2. The method according to claim 1, wherein the first and second portions of suture form a single continuous length of suture.
3. The method according to claim 1, wherein the puncture is formed in a blood vessel.
4. The method according to claim 3, wherein the step of positioning the device is performed by observing the flow of blood through a flashback lumen extending through the device.
5. The method according to claim 1, wherein the steps of inserting the first and second needles into the needle entry lumen are performed so that, when the first and second needles are inserted into the needle entry lumen, proximal ends of the each of the first and second needles are completely received within the needle entry lumen.
6. The method according to claim 5, wherein the first and second needles are inserted using a needle pushing member.
7. The method according to claim 1, wherein a minimum cross-sectional area of a connecting portion of the device extending from a proximal to a distal side of the tissue receiving gap is at least as great as a maximum cross-sectional area of a distal portion of the device extending distally from the tissue receiving gap.
This application is a division of U.S. Ser. No. 09/340,422 filed Jun. 28, 1999 which is a continuation-in-part of U.S. Ser. No. 09/126,316 filed Jul. 30, 1998 now U.S Pat. No. 6,024,747 which is a continuation-in-part of U.S. Ser. No. 08/661,844 filed Jun. 11, 1996 which is now U.S. Pat. No. 5,855,585 granted Jan. 5, 1999 and priority is claimed under 35 U.S.C. �120 based on this prior application.
Many surgical procedures require the insertion of catheters and/or surgical devices into blood vessels and other internal structures. For example, in the treatment of vascular disease, it is often necessary to insert an instrument such as a catheter into the blood vessel to perform the treatment procedure. Such treatment procedures often involve piercing a wall of the blood vessel, inserting an introducer sheath into the blood vessel via the opening, and maneuvering the procedural catheter through the introducer sheath to a target location within the blood vessel. Of course in order to complete such a procedure, the opening in the wall of the blood vessel must be sealed to .prevent bleeding while facilitating healing of the wound. This sealing has commonly been accomplished by the application of direct pressure over the puncture site by a physician or other trained medical professional. However, this technique is time consuming and may lead to complications such as thrombosis, which may be dangerous to the patient.
In addition, the present invention is directed to a method for sealing an opening in an anatomical structure comprising the steps of inserting into the opening a device including a needle exit opening and a needle entry opening separated by a tissue receiving gap and positioning the device so that the needle exit opening is located on a proximal side of the anatomical structure and the needle entry opening is located on a distal side of the anatomical structure with a first portion of the anatomical structure received within the tissue receiving gap. A first needle coupled to a first portion of suture is inserted distally through the device to exit the device via the needle exit opening, penetrate the first portion of the anatomical structure and re-enter the device via the needle entry lumen and the device is rotated so that a second portion of the anatomical structure is located within the tissue receiving gap between the needle exit and needle entry lumens. Then a second needle coupled to a second portion of suture is inserted distally through the device to exit the device via the needle exit opening, penetrate the second portion of the anatomical structure and re-enter the device via the needle entry lumen. the device is withdrawn from the anatomical structure and the first and second portions of suture are tightened to draw the sides of the opening together.
FIG. 70A shows a cross-sectional side view of an alternate needle pushing member for use in conjunction. with the device of FIG. 64;
In addition, a flash back lumen 30 extends from an opening 31 formed in the proximal part 18 through the central arcuate portion 22 to open into two needle retention bores 32 and 32′ formed side-by-side in the distal part 24. As seen in FIG. 3A, the flash back lumen 30 may be circular in cross-section and is sized to simultaneously accommodate two strands of the suture 41 and the two pull cords 43 and 43′. However, as shown in FIG. 3B, the cross-section of the flash back lumen 30 may preferably include side-by-side hemispherical channels 45 and 45′ for receiving the loop 41′ of the suture 41 and the two pull cords 43 and 43′. This helps to ensure that the second needle 37 is not accidentally drawn out of the needle retention bore 32′ when the first 37 is being pulled out. The needle retention bores 32 and 32′ extend from distal ends to openings 33 and 33′, respectively, formed at a position in the distal end of the central arcuate portion 22 opposite the opening 10. In addition, a substantially straight stiffening member may be inserted into the flash back lumen 30 in order to straighten the central arcuate portion 22 during. insertion of the device 1 into the body. Alternatively, the device 1 may be made straight and, after insertion into the body, a curved stiffening member may be inserted to bend the device 1 thereby creating the central arcuate portion 22.
Thereafter, the doctor rotates the device 1, as shown in FIG. 7, until the central arcuate portion 22 straddles the blood vessel wall in a desired position relative to the point at which the first end of the suture 41 penetrated the blood vessel wall. Those skilled in the art will understand that this “desired position” will usually be on the opposite side of the puncture, so that the device 1 will be rotated approximately 180� after the first needle 37 is withdrawn. When the device 1 is in the second desired orientation, the doctor draws the pull cord 13′ out of the opening 31 thereby urging the second needle 37 forward through the needle retention bore 32′ so that the pointed, proximal end of the second needle 37 is drawn through the wall of the blood vessel, enters the opening 10 and extends into the needle withdrawal lumen 26. The second needle 37 is withdrawn through the needle withdrawal lumen 26, drawing the second end of the suture 41 through the wall of the blood vessel and into the needle withdrawal lumen 26 as described above.
In addition, instead of the needle withdrawal lumen 26 of the first embodiment, the proximal part 18 of the device 1′ includes a substantially circular puncture needle channel SO extending from the first end 20 of the device 1′ to an opening 52 at a proximal end of the central arcuate portion 22. This puncture needle channel 50 is also shown including an optional slot 54 extending through the surface of the flexible tube 16 along the length of the puncture needle channel 50.
As described above, in order to close punctures larger than size 9.0 French, a single suture 41 may not be sufficient. Thus, as shown in FIG. 21, a device 1′″ according to a fourth embodiment of the invention may receive four needles 37 arranged side-by-side in four needle retention bores 32 formed in a flexible tube 16 of substantially oval cross-section. Other than the oval cross-section and the provision of four needles, the construction and operation of the device 1′″ is similar to that of the device 1 according to the first embodiment.
The oval cross section increases the stiffness of the device 1′″ in the plane in which the four needles lie side-by-side, while retaining flexibility to bend perpendicularly to that plane. The four needles 37 of the device 1′″ are coupled together in pairs and each pair of needles will be positioned so that the needles 37 of each pair penetrate the wall of the blood vessel on opposite sides of the puncture (approximately 180� apart). When the device 1′″ has been removed from the body, each pair is then knotted together and the two knots are tightened to seal the puncture.
Of course, those skilled in the art will understand that each of the variations of the device 1 according to the first embodiment may also be applied to the device 1′″. Similarly, those skilled in the art will recognize that four needles 37 may be received in a device 1′″ having two needle retention bores 32, each being of a length sufficient to hold two needles 37 arranged in series end-to-end.
Further details of the elongated member 116 are shown in FIG. 25. The distal portion 124 includes, for example, a single, axially-running needle chamber 132 holding, for example, a pair of needles 137. The needles 137 are not fully contained in the needle chamber 132. Instead, part of each needle 137 extends through a needle. channel 123.
In addition to being radially opposite from each other, the needle channel openings 133 are each, for example, radially offset 90� from the central position opening 202 and the central suture opening 203. The needle channel openings 133 are, for example, radially aligned with the minor axis of the oval central portion 122, while the central position opening 202 and the central suture opening 203 are located, for example, on the major axis of the central portion 122.
As can also be seen from FIG. 25, the device 101 according to this embodiment. may be manufactured in three sections: a first section including the proximal portion 118, the central portion 122, and the proximal end of the distal portion 124 containing the needle channels 123; a second section including only that part of the distal portion 124 containing the needle chamber 132; and a third section including only a soft tip 140 at the distal end of the distal portion 124. These various sections may preferably be formed separately, for example by extrusion or molding, and then fixed together.
FIGS. 26, 27 and 28 show cross-sectional views of the device 101 taken along lines 26—26, 27—27, and 28—28 of FIG. 25, respectively. FIG. 26 shows the distal portion 124 with the needle chamber 132 therein. The needle chamber 132 contains, for example, two needles 137, each needle 137 connected to an end of a length of suture 141. FIG. 27 shows the central portion 122 and the proximal face 233 of the distal portion 124. The suture 141 passes from the suture lumen 130 and central suture opening 202 into the needle channel openings 133. FIG. 28 shows the proximal portion 118 with the position indication lumen 201 and the suture lumen 130 therein. The suture lumen 130 contains two segments of a length .of suture 141.
A needle receiving body 220 of the device 101 is shown, for example, in FIGS. 29 and 30. The needle receiving body 220 as shown is an elongated member having a generally annular cross section for most of its length. Two protrusions 222 extend, for example, radially outward from a proximal end 221 of the. needle receiving body 220. The protrusions 222 assist in handling the needle receiving body 220.
The needle receiving body 220 has a device lumen 225 extending axially therethrough. The device lumen 225 shares, for. example, the same axis as the needle receiving body 220 as a whole (i.e. the device lumen 225 is radially centered within the needle receiving body 220). The device lumen 225 has a first inner diameter substantially the same diameter as, or slightly larger than, the outer diameter of the proximal portion 118 and a second inner diameter slightly larger than the first inner diameter so that an abutment 227 is formed at the intersection of the portion having the first inner diameter and the portion having the second inner diameter.
In an exemplary embodiment, anchor 160 is a flexible member. In an unbiased configuration, the end of the anchor 160 may form a curved anchor hook 164.
This unbiased configuration may be obtained, for example, when the anchor hook 164 is outside the position indication lumen control arm lumen 163 as shown in FIG. 44A. When the anchor hook 164 is within the control arm lumen 163, the interior wall of the position indication lumen biases the anchor hook 164 to a substantially straight configuration.
It will be understood by one of skill in the art that the control arm 162, and the anchor 160 are capable of movement between retraced and extended positions. In the retracted position, the control arm 162, projects distally into the control arm lumen 163 so that anchor 160, including anchor hook 164, are retracted into the control arm lumen 163. Several features may be employed to limit the distal movement of the control arm 162, if desired. For example, a control arm stop 166 may be attached to the portion of control arm outside the suture device 101. The control arm stop 166 will contact the distal end of the suture device 101 when the control arm 160 reaches a distal-most position. Similarly, the distal end of control arm 162 may contact a distal end face of the control arm lumen 163, preventing further distal movement of the control arm 162. Alternatively, the diameter of the control arm 162 may increase moving away from the distal end, so that the wider-diameter section of the control arm 162 is prevented from entering a distal portion of the control arm lumen 163 having a smaller diameter. Other configurations are possible, and any suitable arrangement may be employed if desired.
The operation of the device 101 according to this embodiment is shown in FIGS. 45-52. When an invasive procedure is performed on a patient which requires the insertion of a catheter into a blood vessel (or other structure within the body), an introducer sheath is inserted through the skin (S) into the patient's body through a puncture (P) in a wall of the blood vessel (BV). A guide wire 144 is inserted through the puncture to a target area within the blood vessel and a catheter is inserted through the introducer sheath, along the guide wire 144, to a target area within the blood vessel.
Platform 150 of device 400 is preferably cylindrical in shape, meaning only that platform 150 preferably includes a bore therethrough. It should be understood that the term cylindrical therefore includes any configuration having a bore therethrough. Platform 150 may then be located so that the bore is aligned with guide lumen 410. In this manner, guide wire 44 may extend through platform 150.
In practice, guide wire 44 may be inserted into a blood vessel as illustrated in FIG. 60. Device 400 may then be inserted over guide wire 44. Once device 400 has been positioned according to any method, including those described above, guide wire 44 may be withdrawn until fitting 420 and platform 150 are in contact. Guide wire 44.or device 400 (or both) may then be manipulated, e.g. rotated, to engage fitting 420 and platform 150. Guide wire 44 then may be further withdrawn to deploy needles 137, as illustrated in FIGS. 61 to 63. Because this deployment does not require pulling on suture 141, the chance of severing suture 141 is minimized. It should be understood that while the illustrated embodiment includes a suture lumen 130, suture may be completely housed in device 400 if desired.
FIGS. 64-70 show a device 500 according to a further embodiment of the invention including a tube 502 having a substantially circular cross-section extending between a handle 504 and a central part 506 which is coupled to a distal end of the tube 502. The central part 506 curves away from an axis of the tube 502 along an arc by which the central part. 506 returns toward the axis of the tube 502 to connect with a distal part 508. Thus, a distal end of the tube 502 faces a proximal end of the distal part 508 across a gap formed by the central part 506. A cross-sectional area of the central part 506 is substantially equal to that of the distal part 508 and the cross-sectional areas of both the central part 506 and the distal part 508 remain substantially constant along their entire lengths while a cross-sectional area of the tube 502 may preferably be equal or slightly greater than that of the distal part 508 and the central part 506. A guide wire lumen 507 extends through a distal portion of the distal part 508.
A needle insertion lumen 510 extends through the tube 502 and the handle 504 from an opening 512 formed in a proximal end of the handle 504 to an opening 514 formed at a distal end of the tube 502. A suture removal slot 513 extends through the surface of the handle 504 and the tube 502 to open an interior of the needle insertion lumen 510 to the outside of the device 500 along an entire length of the needle insertion lumen 510. A position indication lumen 516 extends from an opening 518 formed in the handle 504 through a portion of the central part 506 to openings 520 formed in the central part 506. A needle entry opening 522 formed in the proximal end of the distal part 508 extends into a needle receiving channel 524 which extends axially through the distal part 508. The needle receiving channel 524 extends for a length more than twice the length of needles 526 which are used with the. device. In an initial configuration, no needles are received within the device 500. Alternatively, all or a portion of a first needle 526 may be received within the needle insertion lumen 510 so long as the pointed distal end of the first needle 526 remains within the needle insertion lumen 510. As will be described below, in use, the device is first inserted into a patient and then, when in a desired suturing position, the first needle 526 is inserted into the needle insertion lumen 510 via opening 512 as shown in FIG. 65 after which a needle pusher 530 is slid through the needle insertion lumen 510 behind the first needle 526. A loop of suture 528 is coupled between the proximal ends of a pair of needles 526 and the suture removal slot 513 is sized so that the first needle 526 is retained within the needle insertion lumen 510 while the suture 528 may be drawn out of the needle insertion lumen 510 through suture removal slot 513.
In operation, when the device 700 is inserted into a blood vessel of a patient, the expandable member 742 is initially in a deflated state, extending along a surface of the device 700 adjacent to the flashback lumen 730 (see FIG. 73). When the device 700 is positioned so that the opening 733 is on a distal side of the puncture, and the opening 710 is positioned on the proximal side of the puncture, the physician provides a gas or a liquid through the inflation tube 740 to expand the expandable member 742. The expandable member 742 contacts a first portion of the blood vessel wall to aid in positioning the openings 733 and 710 of the device 700 at a first desired penetration location on the blood vessel wall. The expandable member 742 thus is used to prevent blood leakage during the sealing procedure by occluding the opening in the blood vessel wall. Thereafter, the user inserts a first needle 737 distally through the needle insertion lumen 726 as described above, to pierce the wall of the blood vessel at the first desired location, and enter the needle receiving channel 732 drawing a first end of a loop of suture 741 therethrough. The first needle 737 is pushed distally until the entire first needle 737 is completely received within the needle receiving channel 732.
There are many other variations of the above described embodiments which will be apparent to those skilled in the art. It is understood that these modifications are within the teaching of the present invention which is to be limited only by the claims appended hereto. In addition, although the operation of the various embodiments has been described in regard to the sealing of an opening in the. wall of a blood vessel, those skilled in the art will understand that this invention may also be used to seal openings in various internal organs and structures.
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Agency For Medical Innovations GmbhSurgical apparatusUS20110196387 *Aug 11, 2011Abbott LaboratoriesVascular suturing device* Cited by examinerClassifications U.S. Classification606/144, 606/139, 606/148International ClassificationA61B17/12, B41J2/165, B41J2/175, A61B17/04, A61B17/00, A61B17/06Cooperative ClassificationB41J2/1652, A61B2017/06057, A61B17/0057, A61B2017/0472, A61B17/0482, A61B2017/00663, A61B2017/047, A61B2017/0496, B41J2/17563, A61B17/0469, B41J2/175, A61B2017/0417, A61B2017/00637, A61B2017/00672, A61B17/0487European ClassificationB41J2/175F, B41J2/165C1, B41J2/175, A61B17/04E, A61B17/04G, A61B17/00PLegal EventsDateCodeEventDescriptionFeb 17, 2006SULPSurcharge for late paymentFeb 17, 2006FPAYFee paymentYear of fee payment: 4Feb 22, 2006REMIMaintenance fee reminder mailedJul 18, 2008ASAssignmentOwner name: DATASCOPE CORP., NEW JERSEYFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:X-SITE MEDICAL, LLC;REEL/FRAME:021253/0254Effective date: 20040521Jan 6, 2010FPAYFee paymentYear of fee payment: 8Feb 24, 2011ASAssignmentFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:DATASCOPE INVESTMENT CORP.;REEL/FRAME:025847/0978Owner name: ST. 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