Source: http://www.docstoc.com/docs/50078394/Device-And-Method-For-Suturing-Blood-Vessels-And-The-Like---Patent-5810849
Timestamp: 2014-09-19 11:15:30
Document Index: 302616986

Matched Legal Cases: ['art 18', 'art 24', 'art 18', 'art 24', 'art 18', 'art 18', 'art 24', 'art 18', 'art 18', 'art 18', 'art 24', 'art 24', 'art 18', 'art 24', 'art 24', 'art 24', 'art 18', 'art 24', 'art 24', 'art 18', 'art 18', 'art 18', 'art 24', 'art 18', 'art 18', 'art 24', 'art 18', 'art 24', 'art 18', 'art 24', 'arts 18', 'art 18']

Device And Method For Suturing Blood Vessels And The Like - Patent 5810849
United States Patent: 5810849
A61B 17/00&amp;nbsp(20060101); A61B 17/12&amp;nbsp(20060101); A61B 17/04&amp;nbsp(20060101); A61B 017/04&amp;nbsp()
606/1,138,139,144,145,148,149,222,224,228,213,205
1.  A device for sealing a hole in an anatomical structure within a living body comprising:
opening across a gap formed by the central part between the proximal and distal parts;  and
2.  The device according to claim 1, wherein the movable surface is rotatably coupled to the proximal and distal parts so that, upon rotation of the movable surface relative to the proximal and distal parts, the movable surface is moved away from
3.  The device according to claim 2, wherein the movable surface rotates about the flash-back lumen.
4.  The device according to claim 3, further comprising a rotating element rotatably coupled to the end portion of the proximal part and non-rotatably coupled to the movable surface so that, upon rotation of the rotating element relative to the
5.  The device according to claim 3, wherein the rotating element is coupled to the proximal part via a tube rotatably received within a proximal portion of the flash-back lumen and wherein the rotating element is coupled to the movable surface
6.  The device according to claim 1, wherein the movable surface includes an expandable member which, when inflated moves the movable surface away from the outer surfaces of the proximal and distal parts.
7.  The device according to claim 6, further comprising an inflation lumen extending from the proximal end of the proximal part to the expandable member.
8.  The device according to claim 7, wherein when one of a gas and a fluid is supplied to the inflation lumen, the expandable member is inflated so that the central part projects away from the central axis.
9.  The device according to claim 6, wherein the expandable member includes a balloon.
10.  A method for sealing holes in anatomical structures within a living body, comprising the steps of:
is coupled between distal ends of the first and second needles;  and
fastening the first and second parts of the length of suture together to form a first suture loop;  and
11.  The method according to claim 10, wherein the device is inserted into the hole along a previously inserted guide wire.
12.  The method according to claim 10, wherein the step of projecting the movable surface away from the outer surfaces of the proximal and distal parts includes rotating the movable surface relative to the proximal and distal parts.
13.  The method according to claim 12, wherein a flashback lumen extends to one of an opening formed in the central part and the at least one needle retention channel, and wherein the movable surface rotates about the axis.
14.  The method according to claim 13, wherein a rotating element is rotatably coupled to the proximal part and wherein the rotating element is non-rotatably coupled to the movable part so that, when the rotating element is rotated relative to
15.  The method according to claim 10, wherein the movable surface includes an expandable member and wherein the step of projecting the movable surface away from the outer surfaces of the proximal and distal parts includes inflating the
16.  The method according to claim 15, wherein an inflation lumen extends from the proximal end of the proximal part to the expandable member.
17.  The method according to claim 16, wherein the expandable member is inflated by supplying one of gas and liquid to the expandable member via the inflation lumen.
18.  The method according to claim 15, wherein the expandable member includes a balloon.  Description
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, i.e., 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 sides of the opening in the wall of the blood vessel must be sealed to prevent bleeding while facilitating healing
of the wound.  At present, this sealing is commonly accomplished by application of direct pressure over the puncture site by a physician or other trained medical professional.  Due to the dangers of thrombosis, the substantial reduction of blood flow
through the blood vessel due to the application of pressure is undesirable and potentially dangerous to the patient.  In addition, the procedure is extremely time consuming; often requiring that pressure be applied for forty-five minutes or more to
Other sealing techniques include the application of a biogenic sealing material over the opening to seal the wound.  However, proper placement of the sealing material is difficult to achieve and, the plug of sealing material left inside the blood
As a result, devices have been developed which are inserted through the puncture in order to suture openings created in blood vessels.  However, these devices suffer from various drawbacks.
For example, U.S.  Pat.  No. 5,417,699 to Klein et al. describes a device wherein two needles coupled to a distal end of an insertion shaft are surrounded by an outer sheath during insertion into an internal structure.  Once inside the internal
structure, the outer sheath is withdrawn and bowed sections of the needles, which had been constrained within the outer sheath against an outward spring bias, deploy away from the insertion shaft.  The insertion shaft is then withdrawn drawing the
needles through the walls of the internal structure.  The arcuate shape of the needles is intended to bring the needles back along a curved path toward the insertion shaft so that the free ends of the needles may be captured on the shaft and the device
withdrawn from the body.  Thereafter, the distal ends of the needles must be detached from the insertion shaft so that a length of suture extending between distal ends of the two needles may be drawn through the walls of the internal structure to seal
However, the curved shape of the proximal ends of the needles of this device requires an insertion sheath of increased diameter.  Thus, after withdrawal of a treatment catheter from an opening formed in an internal structure, insertion of the
increased diameter outer sheath of the device of Klein et al. actually expands the opening in the wall of the internal structure.  In addition, the device of Klein et al. employs several slidably mounted concentric shafts and mechanisms for the
The present invention is directed to a device for sealing an opening in an anatomical structure within a living body.  The device includes a flexible tube including a proximal part extending substantially along an axis and a distal part coupled
to the proximal part by a central part.  The proximal part includes an end portion which, when the device is in an operative position, is located outside the body.  The device also includes at least one needle retention channel formed within the distal
part for holding a plurality of needles therein.  The needle retention channel extends to an opening formed in the proximal end of the distal part.  The device further includes a needle receiving channel formed within the proximal part and extending from
an opening formed in the distal end of the proximal part to a proximal opening.  A lumen extending through the central part is fluidly coupled to the opening formed in the proximal end of the distal part and is fluidly coupled to an opening formed in the
end portion of the proximal part.  A movable surface is coupled to the central part and adapted to project away from the axis to position the opening in the distal end of the proximal part and the opening in the proximal end of the distal part on
substantially along a central axis.  After the device has been inserted into the blood vessel, the central part is moved to contact the blood vessel wall at a first location to position a portion of the blood vessel wall within a gap formed between the
proximal and distal parts so that an opening formed in the distal part is on a distal side of a first portion of the blood vessel wall, and an opening formed in the proximal part is on a proximal side of the first portion of the blood vessel wall.  The
channel to bring a first end of the suture through the blood vessel wall.  Thereafter, the device is rotated to a second desired position so that a second portion of the blood vessel wall adjacent to the opening is located within the gap and one of a
the needle receiving channel so that the second end of the suture is drawn through the second portion of the blood vessel wall.  The first and second ends of the suture are then secured together to seal the opening.
like.  The device 1 includes flexible tube 16 of substantially circular cross-section, which has a proximal part 18 and a distal part 24.  The proximal part 18 extends from a first end 20 through a central arcuate portion 22 to a second end 21 which
mates with a proximal end 23 of the distal part 24.  The central arcuate portion may preferably be substantially circular or angular and forming a gap of 0.100&quot; to 0.600&quot;.  The flexible tube 16 is preferably constructed of a thermoplastic such as
polyurethane, polyethylene, or the like, in two or three parts bonded together.  The various parts of the flexible tube 16 may preferably be either extruded or molded.  Those skilled in the art will recognize that it will be more economical to extrude
the parts including one or two lumens, while the more complex, and curved sections of the flexible tube 16 may be molded.  The length of the flexible tube may be selected to fit the requirements of a particular situation and is preferably between 1&quot; and
16&quot; in length.
The flexible tube 16 includes a large interior needle withdrawal lumen 26 which extends through the proximal part 18 from the first end 20 to an opening 10 at a proximal end of the central arcuate portion 22.  As seen in FIGS. 3A and 3B, the
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&#39; 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&#39;.  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&#39; for receiving the loop 41&#39; of the suture 41 and the two pull cords 43 and 43&#39;.  This helps to ensure that the second needle 37 is not accidentally drawn out of the needle retention bore 32&#39; when the
first 37 is being pulled out.  The needle retention bores 32 and 32&#39; extend from distal ends to openings 33 and 33&#39;, 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
As seen in FIGS. 4A and 4B, the retention bores 32 and 32&#39; have cross-sectional shapes including first portions 35, each shaped to receive a needle 37 and second portions 39, each shaped to receive a suture 41 and pull cord 43 or 43&#39;.  The first
portions 35 are shaped to correspond to the cross-section of the needles 37 which in the preferred embodiment is substantially circular.  The second portions 39, which are of reduced size so that the needles 37 are unable to enter, may be either
rectangular or triangular projections extending from the first portions 35 and are sufficiently large to simultaneously accommodate the suture 41 and one of the pull cords 43 and 43&#39;.  The suture 41, which will preferably be in the range of 0.004&quot; to
0.010&quot; in diameter and from 15&quot; to 35&quot; in length, may be formed of either &quot;reabsorbable&quot; or &quot;non-reabsorbable&quot; material, as is well known in the art.  The pull cords 43 and 43&#39; will preferably be formed of non-reabsorbable material and will be of similar
diameter to the suture 41.  Those skilled in the art will recognize that the function of the pull cords 43 and 43&#39; may be filled by a loop 41&#39; of the suture 41 coupled between the distal ends of the needles 37 extended through the flash back lumen 30 so
that, when the loop 41&#39; of the suture 41 is extended proximally, the needles 37 are urged proximally through the needle retention bores 32 and 32&#39;.
As the device 1 according to the first embodiment includes a single pair of needles, this device should preferably be used to close punctures of 9.0 French size and smaller (each French size representing 0.013&quot; in diameter).  The flexible tube 16
will, therefore, preferably be 6.0 or 8.0 French size.  As described below in reference to further embodiments of the invention, devices employing two or more pairs of needles 37 may be employed to close punctures larger than 9.0 French size.  Each of
the needles 37 may preferably be constructed of stainless steel, be between 2&quot; and 8&quot;, in length and have a diameter between 0.010&quot; and 0.030&quot;.
When the device 1 is in an operative configuration, the suture 41 extends between the distal ends of two needles 37 received in the needle retention bores 32 and 32&#39;.  In the first embodiment of the invention, optional pull cords 43, 43&#39; extend
from the distal end of each of the needles 37 through the second portions 39 of the needle retention bores 32 and 32&#39;, via the flash back lumen 30, to the opening 31.  However, the suture 41 may, alternatively, extend from the distal ends of the needles
37 through the second portions 39 of the needle retention bores 32 and 32&#39;, via the flash back lumen 30, to the opening 31 so that a portion of the suture loop 41&#39; which extends out from the opening 31 may provide the function of the pull cords 43 and
43&#39;, as described below.
into the patient&#39;s body through a puncture (P) in a wall of the blood vessel (BV).  A guide wire 44 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
44, to a target area within the blood vessel.  After the procedure is complete, the catheter and the introducer sheath are withdrawn and the guide wire 44 is left in place.  A proximal end of the guide wire 44 is then inserted through the guide wire
By observing the flash back lumen 30 and the needle withdrawal lumen 26, the doctor may determine when the device 1 is in the desired position.  Specifically, when the device 1 is inserted far enough into the blood vessel, blood will be observed
in the flash back lumen 30.  However, if blood is observed in the needle withdrawal lumen 26, the doctor knows that the device 1 has been inserted too far into the blood vessel.
As the device 1 is inserted into the blood vessel, the flexible tube 16 bends so that the device 1 is received within, and extends in the direction of the blood vessel without straining the vessel.  In this position, the openings 33 and 33&#39; are
of the needle 37 is drawn through the wall of the blood vessel, enters the opening 10 and extends into the needle withdrawal lumen 26.  The needle 37 is then withdrawn through the needle withdrawal lumen 26, drawing a first end of the suture 41 through
the wall of the blood vessel and into the needle withdrawal lumen 26.  The needle 37 is drawn forward by means of the pull cord 43 until a proximal end of the needle 37 protrudes from the proximal end of the needle withdrawal lumen 26.  The proximal end
of the needle 37 is then grasped by the doctor and withdrawn from the needle withdrawal lumen 26.  In order to ensure that the needles 37 will extend through the needle withdrawal lumen 26, the needles 37 will preferably be at least 4&quot; in length.
wall.  Those skilled in the art will understand that this &quot;desired position&quot; will usually be on the opposite side of the puncture, so that the device 1 will be rotated approximately 180.degree.  after the first needle 37 is withdrawn.  When the device 1
is in the second desired orientation, the doctor draws the pull cord 43&#39; out of the opening 31 thereby urging the second needle 37 forward through the needle retention bore 32&#39; 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
order to seal the puncture.  of course, those skilled in the art will appreciate that, once the two ends of the suture 41 have been drawn through the blood vessel wall, various other methods of fastening the two ends together may be employed.
FIGS. 11-19 show a suturing device according to a second embodiment of the present invention.  The flexible tube 16 of the device 1&#39; according to the second embodiment is preferably similar in size and flexibility to the device 1 of the first
embodiment and differs only as described below.  In addition, those skilled in the art will recognize that, except where specifically stated, each of the variations described above in reference to the first embodiment may also be applied to all other
As seen in FIG. 12, the cross-section of the proximal part 18 of the device 1&#39; shows a flash back lumen 30 of circular cross-section.  The flash back lumen 30 of this embodiment extends from the first end 20, through the proximal part 18 to an
In addition, instead of the needle withdrawal lumen 26 of the first embodiment, the proximal part 18 of the device 1&#39; includes a substantially circular puncture needle channel 50 extending from the first end 20 of the device 1&#39; 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.
A puncture needle 56, having an increased diameter gripping surface 58 at a proximal end, is slidably received in the puncture needle channel 50.  The puncture needle 56 includes a central channel 59 extending from an opening 60 formed in the
gripping surface 58 to an opening 61 formed in a distal end 62 of the puncture needle 50.  One suture 41, integrally formed with or coupled to a respective anchor member 64, is received within the central channel 59.  The anchor member 64 may be
Those skilled in the art will recognize that, if the puncture needle 56 is provided with a slot extending from a proximal end to a distal end thereof, a suture loop 41&#39; may be formed with a single suture 41 having anchor members 64 at both ends.
That is, after a first end of the suture has been inserted into the suture retention chamber 72, a first length of this suture 41 may be drawn out through the slot and a second anchor member 64 attached to a second end of the suture 41 may be inserted
into the suture retention chamber 72 through a second portion of the blood vessel wall as described above.  Thereafter, the device 1&#39; is withdrawn from the body and the two ends of the suture loop 41&#39; are tied together and, using known techniques, the
An opening 68 opposite the opening 52 at a distal end of the central arcuate portion 22, extends through a needle reception slot 70 to a suture retention chamber 72 which has an increased diameter relative to the needle reception slot 70.  Those
suture retention chamber 72 during withdrawal of the device 1&#39; from the body.
In operation as shown in FIGS. 15-19, the device 1&#39; is positioned with the central arcuate portion 22 straddling the blood vessel wall with the openings 52 and 68 on opposite sides of the wall (proximal and distal, respectively) and rotated to a
As described above in regard to the device 1, the flash back lumen 30 may be used to determine whether or not the device 1&#39; is in the desired position.  Specifically, when the device 1&#39; is in the desired position, blood should be observed only in
the flash back lumen 30, not in the needle channel 50.  Blood in the needle channel 50 indicates that the device 1&#39; has been advanced too far into the blood vessel.  That is, blood in the needle channel 50 indicates that the opening 52 is improperly
positioned within the blood vessel.  When the device 1&#39; is properly positioned, the doctor presses upon the gripping surface 58 to urge the a sharp, distal end of the puncture needle 56 distally out of the opening 52, through the wall of the blood vessel
When the puncture needle 56 has been inserted into the suture retention chamber 72, the doctor pushes the plunger 66 distally within the central channel 59 to release the anchor member 64 into the suture retention chamber 72.  The puncture needle
Where the device 1&#39; includes the optional slot 54, the suture 41 may then be withdrawn from the puncture needle channel 50 through the slot 54.  This allows the diameter of the puncture needle channel 50 to be minimized while providing sufficient
room for the puncture needle 56 to pass therethrough.  Then a second anchor member 64 and a second suture 41 are inserted into the central channel 59.
As shown in FIG. 17, the doctor then reorients the device 1&#39; into the second desired position, as described above in regard to the first embodiment, the doctor presses upon gripping the surface 58 to urge the sharp, distal end of the puncture
needle 56 distally out of the opening 52, through the wall of the blood vessel and into the opening 56 so that the opening 61 is within the suture retention chamber 72.  Thereafter, the doctor inserts the plunger 66 into the central channel 59 and pushes
it forward to release the anchor member 64 and the second suture 41 into the suture retention chamber 72.  Those skilled in the art will understand that, instead of inserting a second suture 41 at this point, a gripping device may be introduced through
the central channel 59 into the suture retention chamber 72 to grab and retrieve the anchor member 64 and draw it out through the central channel 59.  This allows for the formation of a suture loop 41&#39; without the need to knot two separate strands of
The doctor then withdraws the device 1&#39; from the body, as shown in FIG. 22, so that the ends of the sutures 41 extending from the opening 68 may be cut to release the sutures from the anchor members 64.  Then, as shown in FIGS. 23 and 24, these
Those skilled in the art will understand that, for larger punctures, the device 1&quot; may be used to insert as many sutures 41 as are required to seal the puncture.  Specifically, in order to close punctures larger than size 9.0 French, a single
suture 41 may not be sufficient.  Therefore, instead of using the device 1&quot; as described above to insert two sutures 41 approximately 180.degree.  apart, a doctor may, for example, insert four sutures 41 at 90.degree.  intervals using the technique
described above.  Then, when the device 1&quot; has been withdrawn from the body, the doctor must knot together a first pair of sutures 41 which are separated by approximately 180.degree.  and then knot the second pair.  The two pairs of sutures 41 may be
A device 1&quot; according to a third embodiment of the present invention is shown in FIG. 20.  Aside from a modified distal part 24 as described below, the construction and operation of the device 1&quot; may be identical to either of the first and second
Specifically, the distal part 24 of the device 1&quot; is constructed so that it has enhanced flexibility relative to the proximal part 18.  In addition, the distal part 24 is biased so that, when in an unstressed state, it is &quot;J&quot; shaped--that is, the
distal part 24 is curved so that the distal opening 38 formed in the second end 40 faces proximally.  This facilitates insertion of the device 1&quot; so that it contacts an inner wall of the blood vessel without damaging it.  Specifically, the flexibility
and &quot;J&quot; shape of the second end 40 allows the second end 40 to deflect away from the blood vessel&#39;s lining without penetrating or damaging the lining thereof.  Of course, when received on the guide wire 44, the &quot;J&quot; shape of the distal part 24 will be
less pronounced.  However, the bias will maintain a slight curvature of the second end 40 deflecting the impact of the device 1&quot; from the inside lining of the blood vessel.
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&#39;&quot; 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 is cross-section and the provision of four needles, the construction and operation of the device 1&#39;&quot; is similar to that
The oval cross section increases the stiffness of the device 1&#39;&quot; 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&#39;&quot; 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.degree.  apart).  When the device 1&#39;&quot; has been removed from the
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&#39;&quot;.  Similarly, those skilled in the art will recognize that four needles 37 may
be received in a device 1&#39;&quot; having two needle retention bores 32, each being of a length sufficient to hold two needles 37 arranged in series end-to-end.
A device 1a according to a fifth embodiment of the present invention is shown in FIG. 22.  Aside from the construction of the central portion 22, a new rotating element 100 and a flashback lumen 30 as described below, the construction and
The central portion 22 includes a rotatable member 101 rotatably coupled between the proximal part 18 and the distal part 24.  Specifically, the rotatable member 101 may rotate around the flashback lumen 30 by e.g., 180.degree..  This creates a
gap 105 between the proximal end of the distal part 24 and the distal end of the proximal part 18.  The device 1a includes a rotating element 100 which is coupled to the rotatable member 101 so that, upon rotation by the user of the rotating element 100,
the rotatable member 101 rotates by a corresponding angle.  The rotating element 100 is connected to the proximal part 18 at the first end 20.  The flashback lumen 30 of this embodiment extends from a proximal end 102 of the rotating element 100, through
the rotating element 100 and the proximal part 18, through the rotatable member 101 and into the distal part 24.  The rotating element 100 may be coupled to the rotatable member 101 via a tube 103 slidably received in the proximal part 18 so that an
inner diameter of the tube 103 forms a proximal part of the flashback lumen 30.  A distal end of this tube 103 is fixably and/or non-rotatably coupled to the rotatable member 101.  Of course, those skilled in the art will understand that the flashback
lumen 30 may extend to any opening which, when the device is in an operative position within a blood vessel, is located within the blood vessel.  That is, the flashback lumen 30 may extend to a hole formed in the outer surface of the rotatable member 101
continuous surface with outer surfaces of the proximal part 18 and the distal part 24 (see FIG. 23).  In this position, the device 1a preferably forms a substantially continuous cylinder.  As with the prior embodiments, the device 1a is positioned so
that the opening 33 is within the blood vessel while the opening 10 is outside the puncture on the proximal side of the blood vessel.  The physician then rotates the rotating element 100 by, e.g., 180.degree., to rotate an upper surface 107 of the
rotatable member 101 away from the corresponding portions of the proximal part 18 and the distal part 24, to create a gap 105 between the proximal part 18 and the distal part 24.  The user then notes the flow of blood through the flashback lumen 30 to
ensure that the blood vessel wall is positioned between the openings 33 and 10.  Thus, as described in regard to the previous embodiments, a needle 37 can be drawn from one of the needle retention bores 32 via the suture 41 to pierce the wall of the
blood vessel.  The device is then rotated to a second position within the opening in the blood vessel wall and a second one of the needles 37 is drawn through a second portion of the blood vessel wall.  The ends of the suture are then coupled together to
seal the opening.  One of ordinary skill in the art will understand that the rotatable member 101 can be rotated to other positions beside the 180.degree.  rotation shown, so long as the gap 105 is sufficient to allow the needles 37 to pass between the
FIG. 24 illustrates a device 1b according to a sixth embodiment of the present invention.  The construction and operation of the device 1b is substantially similar to that of the fifth embodiment of the present invention, except for the
Specifically, the central portion 22 is located within a gap 214 situated between the proximal and distal parts 18 and 24.  The central portion includes an expandable member 212, preferably a balloon, which is adapted to be inflated via the
inflation tube 210, which extends from the proximal end of the proximal part 18 to an inflation opening 220 formed at the distal end of the proximal portion 18.  When air or other fluid is supplied to the expandable member 212 via inflation tube 210, the
expandable member 212 expands away from a surface of the central portion 22 opposite the gap 214 to press against the wall of the blood vessel.  This pushes the device 1b toward a portion of the blood vessel wall opposite the expandable member 212 so
In operation, when the device 1b is inserted into a blood vessel of a patient, the expandable member 212 is initially in a deflated state, extending along a surface of the device 1b adjacent to the flashback lumen 30 (see FIG. 25).  When the
member 212.  The expandable member 212 contacts a first portion of the blood vessel wall to aid in positioning the openings 33 and 10 of the device 1a at a first desired penetration location on the blood vessel wall.  The expandable member 212 may thus
be used to prevent blood leakage by sealing the puncture.  Thereafter, the user draws a needle 37 from the needle retention bore 32, as described above, to pierce the wall of the blood vessel at the first desired location, drawing a first end of a loop
The user then deflates the expandable member 212 and rotates the device 1b to a second position within the puncture.  Thereafter, the user reinflates the expandable member 212 and draws a second needle 37, and a second end of a length of suture
There are many 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
Device and method for suturing blood vessels and the like, Kontos, Stavros Kontos, Application number 08 871-789, Surgery, blood vessel, suture needle, surgical instrument, needle insertion, distal portion, proximal portion, blood vessels, Surgical suture, the like, needle retention
The present invention relates generally to surgical instruments, and more specifically to devices for the suturing of punctures in blood vessels, internal organs and internal tissues accessed via a tissue tract.BACKGROUND OF THE INVENTIONMany 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, i.e., acatheter, 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 proceduralcatheter through the introducer sheath to a target location within the blood vessel. Of course in order to complete such a procedure, the sides of the opening in the wall of the blood vessel must be sealed to prevent bleeding while facilitating healingof the wound. At present, this sealing is commonly accomplished by application of direct pressure over the puncture site by a physician or other trained medical professional. Due to the dangers of thrombosis, the substantial reduction of blood flowthrough the blood vessel due to the application of pressure is undesirable and potentially dangerous to the patient. In addition, the procedure is extremely time consuming; often requiring that pressure be applied for forty-five minutes or more toachieve acceptable sealing.Other sealing techniques include the application of a biogenic sealing material over the opening to seal the wound. However, proper placement of the sealing material is difficult to achieve and, the plug of sealing material left inside the bloodvessel may result in serious health risks to the patient.As a result, devices have been developed which are inserted through the puncture in order to suture openings created in blood vessels. However, these devices suffer from various drawbacks.For ex
SUTURING STITCH IN TIME