`USOO7736355B2
`
`(12) United States Patent
`(10) Patent N0.:
`US 7,736,355 B2
`
`Itou et al.
`(45) Date of Patent:
`Jun. 15, 2010
`
`(54)
`
`INTRAVASCULAR FOREIGN MATTER
`SUCTION ASSEMBLY
`
`(75)
`
`Inventors: Takenari Itou, Shizuoka (JP); Tetsuya
`Fukuoka Shizuoka (JP)
`
`.
`(73) Assrgnee: Terumo Kabushiki Kaisha,
`Shibuya—Kua Tokyo (JP)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1300 days.
`
`5,569,204 A
`10/1996 Cramer
`5,938,645 A
`8/1999 Gordon
`6,849,068 B1 *
`2/2005 Bagaoisan el al.
`2002/0177800 A1
`11/2002 Bagamsan 6t 31'
`2003/0050600 A1
`3/2003 Ressemann et al.
`
`FOREIGN PATENT DOCUMENTS
`
`.......... 604/523
`
`W0
`
`WO 00/69498
`
`11/2000
`
`
`
`OTHJR PUBLICATIONS
`Official Action (Communication Pursuant to Article 96(2) EPC)
`issued by the European Patent Office in corresponding European
`Patent Application No. 05 020 435.3, Jul. 25, 2007.
`
`(21) Appl. N0.: 11/232,876
`
`* cited by examiner
`
`(22)
`
`(65)
`
`Filed:
`
`5013- 231 2005
`_
`_
`_
`PM“ Publlcatlon Data
`US 2006/0069381 A1
`Mar. 30, 2006
`
`Foreign Application Priority Data
`(30)
`............................. 2004-276291
`Sep. 24, 2004
`(JP)
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Int. Cl.
`
`(2006.01)
`A61M 25/00
`U.S. Cl.
`....................................... 604/523; 604/264
`Field of Classification Search ................... 604/19,
`604/192, 264, 523, 507, 526, 164.01, 101.03,
`604/101.04, 173, 508
`Sec application file for complete search history.
`References Cited
`
`
`
`U.S. PATENT DOCUMENTS
`
`5,011,488 A
`5,226,888 A *
`5,385,562 A *
`5,527,292 A
`
`4/1991 Ginsburg
`7/1993 Arney ................... 604/10307
`1/1995 Adams et al.
`............... 604/528
`6/1996 Adams el al.
`
`Primary ExamineriNicholas D Lucchesi
`Assistant Examiner4hristopher D Koharski
`(74) Attorney, Agent, or FirmiBuchanan Ingersoll &
`Rooney PC
`
`(57)
`
`ABSTRACT
`
`An intravascular foreign matter suction assembly is insertable
`into a blood vessel having a relatively small diameter and
`exhibits a high suction force. The intravascular foreign matter
`suction assembly includes a combination of a guiding cath-
`eter for being inserted to an ostium of a coronary artery of the
`aorta and a suction catheter inserted in the lumen of the
`guiding catheter and extending farther than the distal end of
`the guiding catheter for removing foreign matter in a blood
`vessel which exists at a target location in the coronary artery
`The suction catheter includes a tubular portion provided on
`the distal end side and a wire portion provided on the proxi-
`mal end side of the tubular portion and wherein the wire
`portion has a distal end errrbedded in a wall which forms the
`tubular portion.
`
`11 Claims, 10 Drawing Sheets
`
`
`
`5
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`l
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`2
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`Page 1
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`Medtronic Exhibit 1007
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`Page 1
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`Medtronic Exhibit 1007
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`

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`U.S. Patent
`
`Jun. 15, 2010
`
`Sheet 1 0f 10
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`US 7,736,355 B2
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`FIGJA
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`12
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` \
`
`FIG.1D
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`Page 2
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`Medtronic Exhibit 1007
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`Page 2
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`Medtronic Exhibit 1007
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`

`

`U.S. Patent
`
`Jun. 15, 2010
`
`Sheet 2 0f 10
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`US 7,736,355 B2
`
`FIG.2
`
`
`
`MW%3&E
`HI}
`
`
`imun-m
`
`
`m
`Wm‘fimm‘mm
`
`
`
`II
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`Page 3
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`Medtronic Exhibit 1007
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`Page 3
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`Medtronic Exhibit 1007
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`

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`U.S. Patent
`
`Jun. 15, 2010
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`Sheet 3 0f 10
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`US 7,736,355 B2
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`FIG.3
`
`
`AWL—~3-fl --rmm_.—:—-:,w=—=u—:.—=..—=. -aE
`
`
`‘u‘““r;?_f_dPM_--=;¢—!_-:=.—_-=Hafiz—in:—
`
`
`
`
`212
`
`211
`
`24
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`Page 4
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`Medtronic Exhibit 1007
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`Page 4
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`Medtronic Exhibit 1007
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`U.S. Patent
`
`Jun. 15, 2010
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`Sheet 4 0f 10
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`US 7,736,355 B2
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`FIGA
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`
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`Page 5
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`Medtronic Exhibit 1007
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`Page 5
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`Medtronic Exhibit 1007
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`

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`U.S. Patent
`
`Jun. 15, 2010
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`Sheet 5 0f 10
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`US 7,736,355 B2
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`FIG.5
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`Page 6
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`Medtronic Exhibit 1007
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`Page 6
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`Medtronic Exhibit 1007
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`

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`U.S. Patent
`
`Jun.15
`
`9
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`2010
`
`Sheet60f10
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`US 7,736,355 132
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`
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`Page 7
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`Medtronic Exhibit 1007
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`Page 7
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`Medtronic Exhibit 1007
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`

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`U.S. Patent
`
`Jun. 15, 2010
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`Sheet 7 0f 10
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`US 7,736,355 B2
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`
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`Page 8
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`Medtronic Exhibit 1007
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`Page 8
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`Medtronic Exhibit 1007
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`U.S. Patent
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`Jun. 15, 2010
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`Sheet 8 0f 10
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`US 7,736,355 B2
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`FIG.8
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`82
`
`8D
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`9
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`Page 9
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`Medtronic Exhibit 1007
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`Page 9
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`Medtronic Exhibit 1007
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`U.S. Patent
`
`Jun. 15, 2010
`
`Sheet 9 0f 10
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`US 7,736,355 132
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`FIG.9A
`
`Tube length
`0
`
`Pressure
`
`
`gauge
`
`
`section
`
`Roller numo
`
`
`Tube length
`200mm
`
` Tube length
`700mm
`
`
`
`
`leieht
`measured
`
`
`Glycerin solution
`
`
`
`FIG.9'.B
`
`
`
`Comparative example
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`Page 10
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`Medtronic Exhibit 1007
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`Page 10
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`Medtronic Exhibit 1007
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`

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`///////////////
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`Page 11
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`US 7,736,355 B2
`
`1
`INTRAVASCULAR FOREIGN MATTER
`SUCTION ASSEMBLY
`
`
`
`FIELD OF THE INVENTION
`
`This invention relates to an intrava scular foreign manner
`suction assembly, and method, for sucking, sampling and
`removing a foreign matter such as a thrombus or an embolus
`which makes a cause of constriction in a blood vessel.
`
`IO
`
`BACKGROUND OF THE INVENTION
`
`It is known that, if foreign matter such as thrombi or emboli
`choke a blood vessel such as a coronary artery of the heart,
`then it obstructs the flow of the blood and causes a serious
`disorder. One known catheter assembly for sucking such a
`thrombus as described above is disclosed in US. Pat. No.
`5,569,204.
`The catheter assembly disclosed in US. Pat. No. 5,569,204
`includes three catheters combined, namely a central catheter,
`a dilator provided on the inner side ofthe central catheter, and
`an outside catheter provided on the outside of the central
`catheter. After the catheter assembly reaches a target location,
`the dilator is pulled out, and a thrombus and so forth are
`sucked and removed through the lumen of the central catheter
`by a suction device connected to the proximal end of the
`central catheter. Further, with the catheter assembly disclosed
`in US. Pat. No. 5,569,204, ifa thrombus or the like chokes the
`central catheter, then the central catheter is pulled out, and the
`pulled out central catheter is washed or a new central catheter
`is prepared and inserted into the outside catheter, or after the
`choked central catheter is pulled out, suction is performed
`using the outside catheter.
`The catheter assembly of US. Pat. No. 5,569,204 having
`such a configuration as described above makes use of the
`lumen of the central catheter or the outside catheter as a
`suction path for the suction. The inner diameter of the lumen
`of each of the catheters has a constant dimension from the
`distal end to the proximal end, and the inner diameter cannot
`avoid being restricted by the finest portion of the blood vessel
`into which the catheter assembly is inserted. The finest por-
`tion of the blood vessel is usually an extremity position into
`which the catheter assembly is inserted.
`
`
`
`SUMIVIARY OF THE INVENTION
`
`According to the present invention, an intravascular for-
`eign matter suction assembly for sucking a foreign matter
`existing in a blood vessel comprises a guiding catheter includ-
`ing a distal end and a proximal end and forming a lumen
`extending from the distal end to the proximal end configured
`to be inserted into a blood vessel until a position on proximal
`side of a target location in the blood vessel is reached. The
`intravascular foreign matter suction assembly further coni-
`prises a suction catheter comprising a tubular portion pro-
`vided on a distal side of the suction catheter, the tubular
`portion including a distal tube end and a proximal tube end
`and a solid wire-like portion provided at the proximal tube
`end of said tubular portion and having a distal end embedded
`in a wall which forms said tubular portion. Said suction cath-
`eter configured to be inserted in said lumen of said guiding
`catheter and said tubular portion is configured to project
`outwardly beyond the distal end of said guiding catheter for
`removing foreign matter existing at the target location in the
`blood vessel.
`According to a preferred embodiment, the intravascular
`foreign matter suction assembly is an apparatus for sucking
`
`45
`
`50
`
`55
`
`2
`and removing a foreign matter positioned at a deep location in
`a coronary artery ofthe heart or the like and includes a guiding
`catheter for being inserted to a location on proximal side ofa
`target location such as an ostium portion of a coronary artery
`of the heart in the aorta. The intravascular foreign matter
`suction assembly further includes a suction catheter extend-
`ing through the lumen of the guiding catheter into the coro-
`nary artery further than the distal end for sucking thrombi or
`ernboli, and a distal end protective catheter for protecting the
`wall of the blood vessel from the distal end of the suction
`catheter.
`
`More preferably, the suction catheter includes a tubular
`portion provided on the distal side and a solid wire-like por-
`tion provided on the proximal side and having a distal end
`embedded in a wall which fomis the tubular portion. Further,
`the tubular portion ofthe suction catheter has a soft tip whose
`distal end is flexible in order to reduce the damage to the blood
`vessel, and includes a reinforcing member so that, even where
`it has a small material thickness, it is not kinked and, if the
`wire—like portion is rotated by a hand, then also the distal end
`of the suction catheter is rotated. Furthermore, the suction
`catheter has a hydrophilic lubricative coating layer provided
`on the surface of an outer side resin layer. Further. the tubular
`portion of the suction catheter is shorter than the guiding
`catheter, and the total length of the tubular portion and the
`wire—like portion is greater than that of the guiding catheter.
`The invention also relates to a method of sucking foreign
`matter from a blood vessel which comprises the steps of:
`A) inserting into a blood vessel a guiding catheter until a
`distal side of the guiding catheter reaches a proximal side of
`a target location;
`B) inserting into a lumen of the guiding catheter a suction
`catheter comprising a tubular portion and a solid wire portion
`extending from a proximal side of the tubular portion,
`wherein a distal side ofthe tubular portion projects forwardly
`beyond the distal side of the guiding catheter, and a proximal
`side of the tubular portion is disposed inside of the guiding
`catheter; and
`C) applying suction to the guiding catheter which is trans-
`mitted to the tubular portion for sucking the foreign matter
`into the distal side of the tubular portion.
`
`
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The objects and advantages of the invention will become
`apparent from the following detailed description of a pre—
`ferred embodiment thereof in connection with the accompa—
`nying drawing in which like numerals designate like ele—
`ments, and in which:
`FIGS. 1A-1F are views showing several devices which
`comprise an intravascular foreign matter suction assembly of
`the present invention is used; wherein FIG. 1A is a side view
`of a guiding catheter, FIG. IR is a side View of a suction
`catheter; FIG. 1C is a side View ofaY—shaped connector; FIG.
`
`1D is a side view of a suction syringe; FIG. IE is a side view
`ofa protective catheter; and FIG. 1F is a side View ofa guide
`wire;
`FIG. 2 is a View showing a cross section of a distal end
`portion of a guiding catheter 1;
`FIG. 3 is a View showing a cross section of a distal end
`portion of a suction catheter 2;
`FIG. 4 is a view illustrating a joining method between a
`tubular portion and a wire-like portion of the suction catheter
`2.:
`
`FIG. 5 is a View showing the devices shown in FIG. 1 which
`are in an assembled state;
`
`Page 12
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`

`

`US 7,736,355 B2
`
`3
`
`IO
`
`2O
`
`25
`
`3O
`
`35
`
`40
`
`45
`
`50
`
`55
`
`3
`FIG. 6 illustrates a manner wherein the apparatus of the
`embodiment is disposed at a target location which is in a
`coronary artery of the heart;
`FIG. 7A is a side view showing a modification to a suction
`catheter;
`FIG. 7B is a front end view of FIG. 7A;
`FIG. 8 is a view illustrating a manner of removal of a
`thrombus by the modification;
`FIGS. 9A, 9B are views illustrating a manner of a com-
`parative experiment, wherein FIG. 9A is a schematic view of
`an example according to the present invention, and FIG. 9B is
`a schematic view of a comparative example; and
`FIG. 10 is a View illustrating a result of the comparative
`experiment.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`FIG. 1 is a view showing several devices used when an
`intravascular foreign matter suction assembly according to an
`embodiment of the present invention is used.
`Referring to FIGS. 1A-1F, reference numeral 1 denotes a
`guiding catheter (see FIG. 1A); 2 denotes a suction catheter
`(see FIG. 1B); 3 denotes a Y—shaped cormector serving as a
`branching connector (see FIG. 1C); 4 denotes a syringe serv-
`ing as a negative pressure generating device (see FIG. 1D); 5
`denotes a distal end protective catheter (see FIG. 1E); and 6
`denotes a guide wire (see FIG. 1F).
`FIG. 2 shows a sectional view of a distal end portion ofthe
`guiding catheter 1 of FIG. 1A. The guiding catheter 1 includes
`a body portion 11 which in turn includes an inner layer 110
`made of a resin material having a sliding property such as a
`fluorocarbon resin represented by PTFE, a reinforcing layer
`111 made of a metal wire made of stainless steel or the like,
`and an outer layer 112 for covering the reinforcing layer 111,
`a flexible distal tip 12, and a connector 13 provided at the
`proximal end of the body portion 11. The body portion 11
`forms a tubular wall which defines a lumen. In the flexible
`distal tip 12, filler such as tttngsten, bismuth oxide or barium
`sulfate which are X—ray contrast agents is mixed by 50 to 70
`wt %, and therefore, the flexible distal tip 12 ftmctions as an
`X—ray contrast marker (radiopaque marker). Therefore. the
`operator can confirm the position of the distal end portion of
`the guiding catheter 1 in the body of the patient on an X—ray
`image.
`FIG. 3 shows a sectional View of a distal end portion ofthe
`suction catheter 2 of FIG. 1B. Referring to FIG. 3, the suction
`catheter 2 includes a distal side tubular portion 24, and a
`proximal side wire-like portion 25 formed from a solid metal
`wire and an outer layer such as a polymer coating. The tubular
`portion 24 includes a tubular body portion 21 which in turn
`includes an inner layer 210 made of a resin material having a
`sliding property such as a fluorocarbon resin represented by
`PTFE, a reinforcing layer 211 made of a metal wire made of
`stainless steel or the like, and an outer layer 212 for covering
`the reinforcing layer 211, a distal tip 22 provided at the distal
`end of the tubular body portion 21, and a proximal tip 23
`provided at the proximal end of the tubular body portion 21.
`The tubular portion 24 has an outer diameter with which the
`tubular portion 24 can be inserted into the lumen of the
`guiding catheter 1, and the wire-like portion25 has a sectional
`area smaller than the sectional area of the tube wall of the
`tubular portion 24.
`Further, a lubricative coating layer is formed on the surface
`of the tubular portion 24 by performing hydrophilic lubrica—
`tive coating which exhibits a high lubricating property when
`it is wet so that sliding friction of the tubular portion 24 with
`
`4
`the imier face of a blood vessel or with the inner surface ofthe
`lumen ofthe guiding catheter 1 is reduced thereby to enhance
`the insertion feasibility.
`The front free end of the distal tip 22 has a shape inclined
`obliquely with respect to the longitudinal direction of the
`distal tip 22 to increase the area of the inlet opening thereof
`thereby to facilitate suction of a foreign matter and further
`achieve an effect that the distal end of the suction catheter 2
`can advance easily between the foreign matter and the inner
`wall of the blood vessel. Although also the rear end of the
`proximal tip 23 is similarly inclined obliquely, this is effective
`to assure the length of the wall for embedding the distal end of
`the wire-like portion 25 firmly in the proximal tip 23 and
`assure a large opening area on the proximal end side to
`enhance the suction force. Since each of the distal tip 22 and
`the proximal tip 23 is formed such that a filler such as tung-
`sten, bismuth oxide or baritnn sulfate, which are X-ray con-
`trast agents, is mixed by 50 to 70 wt % in a matrix made of a
`resin or a matrix made of a metal is plated with gold, it
`functions as an X-ray contrast marker (radiopaque marker).
`Consequently, the operator can confirm the positions of the
`distal end portion of the suction catheter 2 and the proximal
`end portion ofthe tubular portion 24 in the body ofthe patient
`on an X—ray image.
`FIG. 4 is a View illustrating an example of a method of
`joining the wire—like portion 25 and the tubular portion 24
`together. Referring to FIG. 4, the proximal tip 23 includes a
`body which in turn includes a proximal end portion 231
`formed by obliquely cutting one end of a metal pipe such as a
`pipe of stainless steel and a distal end portion 232 formed by
`working the other end portion of the metal pipe into a spiral
`shape. The imier and outer faces of the body are coated with
`a resin. The proximal end portion 231 is secured firmly by
`being welded to the distal end of the wire-like portion 25
`crushed into a form ofa flat plate so that it may not be broken
`during use. The resin layers which cover the inner and outer
`faces of the proximal tip 23 are secured to the tubular body
`portion 21 by fusion. Where the proximal tip 23 is formed
`from such a metal material as described above, the surface of
`the proximal tip 23 is plated with gold. The portion plated
`with gold functions as an X-ray contrast marker (radiopaque
`marker).
`The distal end protective catheter 5 of FIG. 1E includes a
`distal end tubular portion 54 which in turn includes a tubular
`body portion 51, a distal tip 52 provided at the distal endoft 1e
`tubular body portion 51, a proximal tip 53 provided at tie
`proximal end of the tubular body portion 51, and a proximal
`end side wire-like portion 55 formed from a metal wire, T 1e
`distal end protective catheter 5 is inserted in the lumen of t 1e
`suction catheter 2 and projects from the distal end of t 1e
`suction catheter 2 such that it acts as a protective safety tip
`upon insertion into a blood vessel. The distal tip 52 is made of
`a flexible material and has a thickness greater than that of tie
`distal tip 22 of the suction catheter 2 and has a rotmded
`extremity. The tubular portion 54 and the wire-like portion 55
`can be joined together by a method similar to that used for t 1e
`suction catheter 2 shown in FIG. 4. Also the distal tip 52 and
`the proximal tip 53 ofthe distal end protective catheter 5 have
`a function as a radiopaque marker similarly to those of tie
`suction catheter 2.
`The lumen of the tubular body portion 51 of the distal end
`protective catheter 5 has a size sufficient to receive the guide
`wire 6 of FIG. 1F therein.
`FIG. 5 shows the devices and so forth shown in FIG. 1 in a
`state wherein they are assembled for use. In the present
`embodiment, the intravascular foreign matter suction assem-
`bly is inserted into a blood vessel in a state illustrated in FIG.
`
`
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`

`US 7,736,355 B2
`
`5
`5. Referring to FIG. 5, reference numeral 7 denotes an intro-
`ducer sheath. The introducer sheath 7 is usually used upon
`ordinary catheter operation, and the introducer sheath 7 is
`disposed in such a form that it extends from the skin to the
`inside of a blood vessel thereby to form a path which inter-
`connects the outside of the body and the inside of the blood
`vessel. Then, catheters are inserted into and used while in the
`introducer sheath 7. Consequently, the burden on the patient
`such as pain which is caused by a device slidably moving on
`a damaged portion of the living organism can be reduced.
`Referring to FIG. 5, theY-shaped connector 3 of FIG. 1C is
`connected to the connector 13 of the guiding catheter 1; the
`suction catheter 2 is disposed in the lumen of the guiding
`catheter 1; the distal end of the distal end protective catheter
`5 is inserted in the lumen of the suction catheter 2; and the
`guide wire 6 is inserted in the lumen of the distal end protec-
`tive catheter 5. The respective proximal ends of the suction
`catheter 2, the distal end protective catheter 5, and the guide
`wire 6 are introduced to the outside through a main connector
`portion 31 of the Y—shaped connector 3. A valve (packing)
`which can close up a bore is built in the main connector
`portion 31 and can selectively clamp and fix the guide wire 6,
`the wire-like portion 25 or 55 to prevent leakage of the blood.
`The syringe 4 is connected to a sub connector portion 32 of
`the Y—shaped connector 3 through a tube 41.
`FIG. 6 illustrates a manner of locating the assembly of the
`present embodiment is at a target location 80 in a coronary
`artery of the heart.
`Referring to FIG. 6, since the guiding catheter 1 is disposed
`in the aorta 81 of a comparatively great diameter, it can be
`formed such that each of the inner and outer diameters of the
`guiding catheter 1 has a comparatively great dimension. The
`distal end of the guiding catheter 1 is secured in such a form
`that it is hooked at an ostium 821 of a coronary artery 82.
`The tubular portion24 ofthe suctioncatheter 2 has an outer
`diameter with which it can be inserted into the coronary artery
`82 and is introduced along the guide wire 6 to the target
`location 80 positioned at a deep location. The tubular portion
`24 is designed so as to have a sufiicient axial length so that the
`proximal end of the tubular portion 24 in an open state may
`not leap out from the distal end ofthe guiding catheter 1 upon
`such introduction of the tubular portion 24.
`The introduction ofthe suction catheter 2 and the distal end
`protective catheter 5 to the deep location is performed by
`pushing in the wire-like portions 25 and 55 on the proximal
`end side. Accordingly, the sum total ofthe lengths in the axial
`direction ofthe wire-l ike portion 25 and the tubularportion 24
`and the sum total of the length in the axial direction of the
`wire-like portion 55 and the tubular portion 54 are designed
`longer by 50 mm or more than the length of the guiding
`catheter 1 in the axial direction, If the tubular portion 24 is
`excessively long, then the suction force decreases, and if the
`wire-like portion 25 is excessively long, then there is the
`possibility that the proximal end opening of the tubular por-
`tion 24 may project from the distal end ofthe guiding catheter
`1. Therefore, it is not preferable that the sum total of the
`lengths in the axial direction of the wire-like portion 25 and
`the tubular portion 24 exceeds the length of the guiding cath-
`eter 1 in the axial direction by more than 400 mm. Accord-
`ingly, it is preferable for the total length ofthe tubular portion
`24 and the wire-like portion 25 of the suction catheter 2 to be
`greater than the length of the guiding catheter 1 by at least 50
`mm but no more than 400 mm.
`The devices mentioned have the following dimensions.
`The guiding catheter 1 preferably has dimensions equal to
`those of a guiding catheter used in ordinary catheter opera-
`tion. As a standard length of a guiding catheterused normally,
`
`10
`
`45
`
`50
`
`55
`
`6O
`
`6
`the total length is approximately 1,000 mm. In the following,
`dimensions of the devices where the length of the guiding
`catheter 1 is 1,000 mm are given. If the length of the guiding
`category changes, then also the lengthwise dimensions of the
`wire—like portions ofthe devices are preferably changed simi—
`larly.
`Preferably, the length of the tubular portion 24 of the suc—
`tion catheter 2 is a little greater than a length with which the
`tubular portion 24 can reach a coronary artery ofthe heart and
`particularly is 100 mm to 200 mm Where the length of the
`tubular portion 24 is smaller than 100 mm, depending upon
`the target location, the distal end of the tubular portion 24
`cannot sometimes reach the target location, but where the
`length ofthe tubular portion 24 is greater than 200 mm, there
`is the possibility that a preferable suction force may not be
`obtained. Preferably, the length of the wire-like portion 25 of
`the suction catheter 2 ranges from 950 mm to 1,200 mm. Ifthe
`length of the wire—like portion 25 is smaller than 950 m,
`then the tubular portion 24 at the distal end of the wire-like
`portion 25 cannot be extended sufficiently. On the other hand,
`ifthe length of the wire-like portion 25 is greater than 1,200
`m, then there is the possibility that the proximal end open-
`ing of the tubular portion 24 may project from the distal end
`of the guiding catheter 1. If the proximal end opening of the
`tubular portion 24 were to project from the distal end of the
`guiding catheter 1, then upon suction, the blood would be
`sucked not at the distal end ofthe suction catheter 2 but at the
`
`distal end of the guiding catheter 1. It is to be noted that the
`proximal tip 23 provided at the proximal end of the tubular
`portion 24 has a function of a radiopaque marker, the operator
`can observe an X—ray image to confirm so that the proximal
`tip 23 of the suction catheter 2 may not advance further than
`the distal end of the guiding catheter 1.
`The length of the tubular portion 54 of the distal end pro-
`tective catheter 5 preferably ranges from 20 mm to 50 m. If
`the length of the tubular portion 54 were smaller than 20 m,
`then the effect of protecting the distal end of the suction
`catheter 2 when the suction catheter 2 is advanced would not
`be achieved sufiiciently. However, if the length of the tubular
`portion 54 were longer than 50 mm, then the flexibility of the
`distal end portion thereof would be insufficient when the
`tubular portion 54 is combined with the suction catheter 2 to
`such a degree that it could not be introduced well into a
`winding blood vessel.
`The preferred devices have the following diameters. In
`particular, the guiding catheter 1 is formed from a guiding
`catheter of 6 Fr (2.06 mm) which is used popularly and has an
`inner diameter of 1,8 mm, The outer diameter of the suction
`catheter 2 preferably is within a range from 1.65 mm to 1.75
`mm. In particular, the difference between the inner diameter
`of the guiding catheter 1 and the outer diameter of the suction
`catheter 2 preferably is within a range from 0.05 mm to 0.15
`m. If the difference is smaller than 0.05 m, then the
`passing performance (sliding performance) of the guiding
`catheter 1 in the suction catheter 2 is low and the convenience
`in use is poor. On the other hand, if the difference is greater
`than 0. 1 5 m, then when a sucking operation is performed by
`the syringe 4, the blood is sucked in through the gap (clear-
`ance) between the distal end of the guiding catheter 1 and the
`suction catheter 2, which causes the suction performance
`from the distal end of the suction catheter 2 to deteriorate. It
`is to be notedthat, since a lubricative coating layer is provided
`on the surface of the tubular body portion 21 of the suction
`catheter 2, even when the clearance is small, the suction
`catheter 2 can move smoothly in the guiding catheter 1.
`
`Page 14
`
`Medtronic Exhibit 1007
`
`Page 14
`
`Medtronic Exhibit 1007
`
`

`

`US 7,736,355 B2
`
`7
`An example of a method ofuse of the intravascular foreign
`matter suction assembly of the present embodiment
`is
`described below.
`
`(1 The introducer sheath 7 is inserted into and disposed in
`the aorta of a femoral region by an ordinary method (e.g., the
`Seldinger method).
`(2 The guiding catheter 1 to which theY-shaped connector
`3 to which the syringe 4 is attached is connected and which
`has the guide wire 6 fitted therein is inserted into the intro-
`ducer sheath 7 and secured to the ostium of a coronary artery.
`(3‘ The guide wire 6 is inserted to a target location while an
`X—ray image is observed.
`(4 A combination of the suction catheter 2 and the distal
`end protective catheter 5 is inserted into the guiding catheter
`1 along the guide wire 6.
`(5 The distal end ofthe combination ofthe suction catheter
`2 and the distal end protective catheter 5 is inserted to the
`targe location 80.
`(6 The distal end protective catheter 5 is pulled out.
`(7 The suction catheter 2 is operated so as to be rotated,
`pushed or pulled until the distal end opening thereof is intro—
`duced to a location in front of a thrombus 80 as seen in FIG.
`6
`
`(8 The syringe 4 is operated for suction to recover foreign
`matters in the blood vessel such as the thrombus through the
`distal end of the suction catheter 2.
`
`
`
`Modification:
`FIGS. 7A—7B are Views showing a modification of the
`suction catheter of the embodiment described above. In the
`suction catheter 9 shown in those figures, a guide wire lumen
`tube 92 having a small diameter is secured to the distal end of
`a tubular portion 91. It is to be noted that a proximal end side
`wire—like portion not shown of the suction catheter 9 has the
`same structure as that of the embodiment described herein-
`above. According to the present modification, since the fol-
`low-up performance of the suction catheter 9 along the guide
`wire 6 is enhanced, where the diseased part is positioned in a
`blood vessel having a severe winding or at a portion near to
`the periphery, the opening can be directed to a thrombus 80 as
`seen in FIG. 8 and can suck and remove the thrombus 80
`efficiently. Further, the neces sity for the distal end protective
`catheter 5 is eliminated.
`The outer diameter of the guide Wire lumen tube 92 is
`smaller than one halfthe inner diameter ofthe tubular portion
`91 so that the guide wire lumen tube 92 may not make an
`obstacle to the suction.
`
`EXAMPLE
`
`An intravascular foreign matter suction assembly of the
`embodiment described above having dimensions specified in
`Table 1 below was fabricated.
`
`TABLE 1
`
`Overall
`length Outer diameter
`(mm)
`(mm)
`
`Inner
`diameter
`(mm)
`
`1000
`150
`
`1100
`
`20
`
`1300
`
`2.06
`1.72
`
`0.45
`
`1.35
`
`0.45
`
`1.8
`1.5
`
`7
`
`0.5
`
`i
`
`Name of device
`
`Guiding catheter 1
`Suction catheter 2 (tubular
`portion)
`Suction catheter 2 (Wire-like
`portion)
`Distal end protective catheter 5
`(tubular portion)
`Distal end protective catheter 5
`(wire-like portion)
`
`8
`
`(Comparative Experiment)
`A comparative experiment of the suction force was con-
`ducted in a configuration shown in FIGS. 9A-9B using the
`intravascular foreign matter suction assembly ofthe example
`and a straight catheter (total length of 1,100 mm) having a
`tubular form along the overall length thereofand having inner
`and outer diameters equal to those ofthe tubular portion ofthe
`suction catheter used in the apparatus of the example.
`For the experiment, a method was used wherein the distal
`end of the catheter was received in a water tank in which
`glycerin solution of a concentration of 47 wt % was filled, and
`in a state wherein the guide wire was threaded, the glycerin
`solution was sucked at a rate of 100 ml/min by means of a
`roller pump which was on the market. The weight ofthe liquid
`obtained by the suction for 2 minutes and the maximum
`negative pressure recorded within the period were measured.
`The projecting length of the distal end of the suction cath-
`eter of the example from the guiding catheter was 100 mm.
`Accordingly, the effective sectional area used for the suction
`was 1.6 mm2 at the distance of 150 mm on the distal end side
`and 2.1 mm2 at the distance of 950 mm on the proximal end
`side (the effective sectional area is given as a value except for
`the sectional area (0.2 mm2x2) of the guide Wire 6 and the
`catheter Wire—like portion 25 of the suction catheter 2).
`As a comparative example, a straight catheter having an
`outer diameter of 1.72 m, an inner diameter of 1.5 mm and
`an overall length of 1,100 mm which are equal to the dimen—
`sions of the tubular portion of the suction catheter of the
`example was used. Accordingly. the effective sectional area is
`1.6 mm2 over the overall length (the effective sectional area is
`given as a value except for the sectional area (0.2 mmz) of the
`guide wire 6.)
`The roller pump serving as a suction apparatus, a pressure
`gauge and so forth other than the catheters were used com-
`monly to the example and the comparative example.
`While an embodiment of the present invention is described
`above, the present invention is not limited to the embodiment
`described above. For example, a syringe presented as the
`negative pressure generation means can be replaced by a
`pump.
`What is claimed is:
`1. An intravascular foreign matter suction assembly for
`sucking foreign matter existing in a blood vessel, comprising:
`a guiding catheter including a distal end and a proximal end
`and forming a lumen extending from the distal endto the
`proximal end, the guiding catheter configured to be
`inserted into a blood vessel until a position on proximal
`side ofa target location in the blood vessel is reached;
`a suction catheter comprising a tubular portion provided on
`a distal side of the suction catheter, the tubular portion
`including a distal tube end and a proximal tube end, and
`a solid wire portion provided at the proximal tube end of
`said tubu