CA2186878A1 - Coronary sinus catheter introducer system - Google Patents
Coronary sinus catheter introducer systemInfo
- Publication number
- CA2186878A1 CA2186878A1 CA002186878A CA2186878A CA2186878A1 CA 2186878 A1 CA2186878 A1 CA 2186878A1 CA 002186878 A CA002186878 A CA 002186878A CA 2186878 A CA2186878 A CA 2186878A CA 2186878 A1 CA2186878 A1 CA 2186878A1
- Authority
- CA
- Canada
- Prior art keywords
- introducer
- coronary sinus
- dilator
- distal end
- guide wire
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Abstract
A coronary sinus catheter introducer system in which an introducer is installed in the right atrium of the cardiovascular system of a patient for delivery of a coronary sinus catheter into the coronary sinus. A bend near the distal end of the introducer enables placement of the end of the introducer into the coronary sinus opening and within the coronary sinus. A soft pliable tip end provided on the introducer minimizes abrasion of the coronary sinus and its opening by the introducer.
Description
CORON~RY 8IN~J8 ~ ,O~u~ 8~-.~t5 Rr~ GUND OF T~S INVIÇ~TION
The ~er^~t invention relates to medical devices for i.,LLod~cing catheters or the like into the cardioVA~cl~l Ar ~y~tem of the body.
Catheter in-~Gducers provide a conduit for passage of catheters and other medical devices, for example, guide wires, through the body flesh into a blood vessel or other body pa~^ge way. In a typical situation, when a catheter il.L~Gl~cer is used, a guide wire is placed in the body to align the i..-~Gd~cer within the main vein in which it is being placed. A dilator/i~.L~Gducer combination is then r~ over the guide wire. Once the i.,L~oducer has been advanced to its end position, the dilator and guide wire are removed, and then the catheter is passed down the i--L~oducer to its desired end position within the body of the patient.
I..LLGd~cers are used in various organs of the body. For example, in the surgical removal of the gall bladder or cholecystectomy; i.e., a cholangiography catheter is placed into the cystic duct by means of the cholangiography catheter inserter described in U.S. Patent No. 5,167,645. U.S. Patent No. 5,093,393 describes a medical device for i..L~oducing catheters or the like into blood vessels of the body.
The ~er^~t invention relates to medical devices for i.,LLod~cing catheters or the like into the cardioVA~cl~l Ar ~y~tem of the body.
Catheter in-~Gducers provide a conduit for passage of catheters and other medical devices, for example, guide wires, through the body flesh into a blood vessel or other body pa~^ge way. In a typical situation, when a catheter il.L~Gl~cer is used, a guide wire is placed in the body to align the i..-~Gd~cer within the main vein in which it is being placed. A dilator/i~.L~Gducer combination is then r~ over the guide wire. Once the i.,L~oducer has been advanced to its end position, the dilator and guide wire are removed, and then the catheter is passed down the i--L~oducer to its desired end position within the body of the patient.
I..LLGd~cers are used in various organs of the body. For example, in the surgical removal of the gall bladder or cholecystectomy; i.e., a cholangiography catheter is placed into the cystic duct by means of the cholangiography catheter inserter described in U.S. Patent No. 5,167,645. U.S. Patent No. 5,093,393 describes a medical device for i..L~oducing catheters or the like into blood vessels of the body.
2 1 ~6878 Flexible catheters used in the cardiovascular system, for ex~mple a guiding catheter of variable, operator-controlled flexibility to be used in the performance of a percutaneQ~
translumenal coronary angioplast procedure is described in U.S. Patent Nos. 4,822,325 and 4,909,787, a guiding catheter of ~ome complexity is also shown in U.S. Patent No. 4,759,748, and a guide which can be i,.~L~d~ced into a narrow passage in a human or other animal body is described in U.S. patent No.
5,131,406.
However, none of the above noted catheters include a catheter guide system nor do any of the particular guides described in~G~ ~G~ ate features which place the catheter i..L.~l~cer within the coronary sinus of the cardiovA~c~lAr 6ystem prior to the cardiac pro~edu~e to be performed within the body.
8~NARY OF 5~ INVENTION
By ~G~ ast the coronary sinus catheter i,-L,~l~cer 6ystem of the ~L~ -ent invention operates within the cardioVA~c~l Ar ~y~tem to pecifically guide the il-~4l~cer into the coronary ~inus of the cardiovA~c~lAr system, enables the i~ Gduction of a coronary ~inus catheter through the i.,L~ er and into the coronary sinus, with the il,LLGd~cer rem~Aining in place during the coronary ~Gcedure to be monitored by the coronary sinus catheter.
21 ~6~
woss/27s26 3 PCT~S95/03714 To be operative with the coronary sinus catheter, the coronary sinus illL~o~ cPr includes a bend at its lower end that better enables the il.LIo~ cer to be placed within the coronary ~inus. The coronary sinus catheter introducer 6ystem al~o includes a dilator which enables placement of the catheter i-,L~ cer into the cardiovarc~ r ~ystem, and also includes a means for enabling the i.,~ cer to eng~ge a guide wire placed in the cardiovArcl~l ar ~ystem.
These and other features of the invention will be seen from the following description of the preferred embodiment and from the claims, and should be considered with the drawings provided with such description for a better understAn~ing of the invention.
D~8CRIPTION OF T~ DRA~ING~
Figure l is a schematic re~ ?ntation of the placement of a guide wire into the cardiovA~cl~lAr system of a patient;
Figure 2 is a detail of Figure l in which the heart of Figure l i~ enlarged;
Figure 3 is a detail of Figure 2 in which the coronary ~inus catheter i,.L~o~ cer system of the ~ ^nt invention places the coronary sinus i,l~o~cer within the patient in the vicinity of the coronary sinus;
2 1 ~6~3/8 w095/27526 4 PcT~sss/o37l4 Figure 4 i~ a figure similar to Figure 3 in which the guide wire has been removed from the coronary sinus catheter i..L.~l~aer system;
Figure S is a figure similar to Figure 4 in which the dilator of the coronary sinus catheter i~lL~Gd~cer system of the ~ t invention has been removed;
Figure 6 is a figure similar to Figure 5 in which the coronary sinus catheter i..L.~ c~r now resides within the coronary sinus of the patient;
Figure 7 is a figure similar to Figure 6 in which the coronary sinus catheter is now diD~ -e~ within the coronary sinus of the patient;
Figure 8 is an elevational view of the separate elements of the coronary sinus catheter i,L-G~cer system of the nt invention;
Figure 9 is a 6ectional view of the assembled coronary ~inus catheter i.,L~o~ er ~ystem taken along lines 8-8 of Figure 7;
Figure 10 is a detail of the coronary sinus catheter i.,L.~lt~cer system showing the bend in the coronary sinus i.,L,Gd~cer prior to the placement of the dilator therein;
2 1 ~
Figure 11 i~ a detail similar of Figure 9 with the dilator of the coronary sinus catheter i~.LLvducer ~ystem of the present invention fully placed within the coronary 6inus i..L~ducer.
D~TAIL~D D~sCRTPTToN o~ ~R ~ P~ ~R~DIM$~
The ~r~-ent invention i~ best ~.deL~ood by first ~tarting with a description of the environment in which the in~ention operates. A~ shown in Figures 1 and 2, to place the coronary ~inu~ in~LGducer 20 of the ~r-!~ent invention in the body, it i~ firet required that a guide wire 12 be in6erted into the jugular vein 14 to travel along the jugular vein to the superior vena cava 15 of the heart and into the right atrium 16 and into the vicinity of the coronary sinus 17 at the coronary sinus ore~ing 17a within the right atrium.
The guide wire 12 is placed in the jugular vein 14 t~ h the use of the Seldinger technique. This tech~jque ~ay be u~ed for g~ining arterial or venous access. It involves locating the ves~el by palpation and entering it with a locator needle through the ~kin tpercutaneou~ insertion).
once the vessel i~ entered, the guide wire 12 i~ inserted through the needle ,not shown) and the needle i~ removed.
Thi~ re can be done quickly, does not require ~urgical inci~ion and ~ ~-erves the site of insertion for r~ule es.
21 86~7B
WO 95/27~26 6 PCTIUS95/03714 m e superior vena cava returns blood from the upper half of the body, and opens into the upper and posterior part of the atrium. It6 orifice i6 directed downward and forward and has no valve. The coronary sinus 17 ~eLUL~ the greater part of the blood from the sub6tance of the heart. Its op~ning 17a is placed LC~J3e-- the orifice of the inferior vena cava and the atri~e.---icular ~p~ning~ and i6 protected by a thin, se~i-circular valve, termed the valve of the coronary sinu6, which ~G~ the lower part of the orifice. It ~ e..~8 the r~gurgitation of blood into the ~inus during the contraction of the atrium. Thi~ valve may be double or it may be cribriform.
Placement of the coronary sinus i..L-~ c~r 20 of the present invention i6 be6t seen tlLou~l. the eeries of Figure6 3 L~v~ 7. A6 shown in Figure 3, the guide wire 12 i6 fir~t ~ ce~ into the cardiovA~c~lAr 6y6tem through the ~ugular vein 14 and then through the 6uperior vena cava 15 to place its di6tal end in the vicinity of the coronary sinu~ opening 17a.
$hen the dilator 18 receive6 the coronary i.-L~ -r 20 in a ~anner to be de6cribed in ~ore detail below, then the dilator and il.~Lf~ er co~aination ~?FC~ along the guide wire 12 through the ~ugular vein 14, through the ~uperior vena cava 15 and into the right atrium 16 to the position shown in Figure 3 in which the guide wire 12 with its di6tal end 12a, the dilator 18 with its tip or distal end 18a and the 2 1 8b878 WO 95/27~26 7 PCT/US9~/03714 i..L~ r 20 with it~ tip or distal end 20a are all in the right atrium in the vicinity of the coronary sinus opening 17a.
- In Figure 4 guidewire 12 has been removed from the combination of dilator 18 and i--L~cer 20 to leave dilator tip nd 18a and i..L.v~ucer end 20a in the vicinity of the coronary sinus opening 17a within the right atrium 16.
In Figure 5 coronary sinu~ i..L.~l~ce~ 20 with its tip end 20a iB shown in the right atrium. I..LL~ducer 20 i8 bent at bend or bent section 22 to place tip end 20a of the i--L-~ll~er in the vicinity of the coronary ~inus or~ni ng 17a. In Figure 5 the dilator 18, which i~ a relatively stiff straight memb~er, has been removed from the coronary sinuC i~.L~ol~cer 20 and the bent section 22 ha~ been restored to the coronary ~inus i..Ll~ucer to tilt it toward the oreni~ 17a of the coronary ~inus 17 and to enable the i..L.~i~cer tip end 20a to be placed within the coronary ~inu~ 17 a~ ~hown in Figure 6. In Figure 7 a coronary ~inu~ catheter 40 has b~een delivered into the coronary sinus of the patient.
The structure of the coronary sinuc catheter i~ o~ucer ~ystem of the ~L~tnt invention i~ best under~tood by ref~ 6 to Figure~ 8 - 11. At the top of Figure 8 i~ shown the guide wire 12 which i~ e~centially a long metallic coiled wire preferably made of a metal which will not interact with body fluid~, 6uch a~ stainlec~ ~teel. A_ ~hown in Figure~ 8 - 21 ~8~8 WO 95/27526 8 PCT/US95tO3714 and 9, dilator 18 is a relatively stiff member having a luer fitting 23 at one end with a longitudinal rod 24 exten~ing from the luer fitting 22. The longit~l~inAl rod 24 is a~,oximately 30 - 40 centimeters inches in length and is preferably made of a material which will not interact with body fluidfi ~uch as a relatively ~tiff polyurethane material.
The rod 24 includes a ~e..~Lal longit~AinAl bore 24a. The rod 24 receive~ a coating 24b, also preferably made of a material non-reactive with body fluids, ~uch as polyurethane. The dilator 18 is relatively inflexible, and is ex~e~ed to follow a path from the jugular vein 14, into the superior vena cava 15 and thereafter into the right atrium 16 of the heart. The luer fitting 23 receives an end cap (not shown) during installation of the dilator-i,lL~ol~er combination in the right atrium to minimize blood loss therethrough.
The i~ o-l~cer 20 comprises a longit~Ai~l t~h~lar main body portion 26 having a luer fitting 28 at a proximal end thereof. Similarly, the luer fitting 28 receives an end cap (not shown) which may be received following removal of the guide wire and dilator and prior to catheter installation to minimize blood loss through the tube 26. Luer fitting 28 a1BO
includes an eyelet 28a for a ~r-~~ to be described later.
The main body portion 26 i6 a relatively inflexible longit~A i n- 1 plastic tube having a pleated section 26a at its proximal end to give some flexibility to the il.LLo~ r 20 at the ~unction at the tube 26 and the luer fitting 28. Al~o a ~oft plastic bumper 26b is provided at the distal end of the W095/27526 2 1 8 6 8 7 8 PCT~S95/03714 plastic tube 26 to prevent abrasive contact between the coronary sinus 17 and the coronary sinus opening 17a and the i,-L~ cer 20 when the distal end 20a of the introducer 20 i~
placed within the coronary sinus 17.
The bend 22 at the distal end 20a of the coronary sinu~
i..-Lc~ Ger 20 is shown in more detail in Figure 10. The distal end 20a of the i..LrGd~cer 20 includes the bumper 26b and extend~ about 2 - 4 centimeters beyond the bent section 22 at an angle between 30 - 45O from the longit~ n~l axis of the tube 26.
It is the purpose of the dilator 18 to take the bend 22 out of the il.LrG~ cer 20 during the placement of the coronary sinus i--L-Gd~cer within the body of the patient as shown in Figures 3 - 7. Therefore, as shown in Figure 11, when the dilator 18 is fully exten~e~ to place its tip end 18a L~yG-,d the bumper 26b at the distal end of the tube 26, the tube 26 is fully aligned along its longit~A~ axis to remove the bend 22 from the i.-L~Gducer 20. MG~ eo~er there is a tight tolerance between the pliable bumper 26b of the i.,L~o~ c~r 20 and the dilator 18 to minimize blood loss to the patient through the interface between the dilator outer face and the inner lace of the i..L.Gd~cer body.
w095/27s26 ~ 2 1 ~ ~ 8 ~ 8 PCT~S95/03714 -' When the dilator 18 is removed from the coronary sinus i..L,~l~rer 20, the bend 22 returns to the coronary sinus er to enable placement of its end 20a in the coronary ~inus openin~ 17a.
Altho~h the invention has been described with reference to the preferred embodiment, other emhoAiments can achieve the same results. Variations and modifications of the ~ ent invention will be obvious to those skilled in the art and it is intenA^~ to cover in the apended claims all such modifications and eguivalents. The entire disclosures of all applications, patents, and publications cited above, and of the co~e~o-~lin~ application are hereby inco~ ~G~ ated by reference.
translumenal coronary angioplast procedure is described in U.S. Patent Nos. 4,822,325 and 4,909,787, a guiding catheter of ~ome complexity is also shown in U.S. Patent No. 4,759,748, and a guide which can be i,.~L~d~ced into a narrow passage in a human or other animal body is described in U.S. patent No.
5,131,406.
However, none of the above noted catheters include a catheter guide system nor do any of the particular guides described in~G~ ~G~ ate features which place the catheter i..L.~l~cer within the coronary sinus of the cardiovA~c~lAr 6ystem prior to the cardiac pro~edu~e to be performed within the body.
8~NARY OF 5~ INVENTION
By ~G~ ast the coronary sinus catheter i,-L,~l~cer 6ystem of the ~L~ -ent invention operates within the cardioVA~c~l Ar ~y~tem to pecifically guide the il-~4l~cer into the coronary ~inus of the cardiovA~c~lAr system, enables the i~ Gduction of a coronary ~inus catheter through the i.,L~ er and into the coronary sinus, with the il,LLGd~cer rem~Aining in place during the coronary ~Gcedure to be monitored by the coronary sinus catheter.
21 ~6~
woss/27s26 3 PCT~S95/03714 To be operative with the coronary sinus catheter, the coronary sinus illL~o~ cPr includes a bend at its lower end that better enables the il.LIo~ cer to be placed within the coronary ~inus. The coronary sinus catheter introducer 6ystem al~o includes a dilator which enables placement of the catheter i-,L~ cer into the cardiovarc~ r ~ystem, and also includes a means for enabling the i.,~ cer to eng~ge a guide wire placed in the cardiovArcl~l ar ~ystem.
These and other features of the invention will be seen from the following description of the preferred embodiment and from the claims, and should be considered with the drawings provided with such description for a better understAn~ing of the invention.
D~8CRIPTION OF T~ DRA~ING~
Figure l is a schematic re~ ?ntation of the placement of a guide wire into the cardiovA~cl~lAr system of a patient;
Figure 2 is a detail of Figure l in which the heart of Figure l i~ enlarged;
Figure 3 is a detail of Figure 2 in which the coronary ~inus catheter i,.L~o~ cer system of the ~ ^nt invention places the coronary sinus i,l~o~cer within the patient in the vicinity of the coronary sinus;
2 1 ~6~3/8 w095/27526 4 PcT~sss/o37l4 Figure 4 i~ a figure similar to Figure 3 in which the guide wire has been removed from the coronary sinus catheter i..L.~l~aer system;
Figure S is a figure similar to Figure 4 in which the dilator of the coronary sinus catheter i~lL~Gd~cer system of the ~ t invention has been removed;
Figure 6 is a figure similar to Figure 5 in which the coronary sinus catheter i..L.~ c~r now resides within the coronary sinus of the patient;
Figure 7 is a figure similar to Figure 6 in which the coronary sinus catheter is now diD~ -e~ within the coronary sinus of the patient;
Figure 8 is an elevational view of the separate elements of the coronary sinus catheter i,L-G~cer system of the nt invention;
Figure 9 is a 6ectional view of the assembled coronary ~inus catheter i.,L~o~ er ~ystem taken along lines 8-8 of Figure 7;
Figure 10 is a detail of the coronary sinus catheter i.,L.~lt~cer system showing the bend in the coronary sinus i.,L,Gd~cer prior to the placement of the dilator therein;
2 1 ~
Figure 11 i~ a detail similar of Figure 9 with the dilator of the coronary sinus catheter i~.LLvducer ~ystem of the present invention fully placed within the coronary 6inus i..L~ducer.
D~TAIL~D D~sCRTPTToN o~ ~R ~ P~ ~R~DIM$~
The ~r~-ent invention i~ best ~.deL~ood by first ~tarting with a description of the environment in which the in~ention operates. A~ shown in Figures 1 and 2, to place the coronary ~inu~ in~LGducer 20 of the ~r-!~ent invention in the body, it i~ firet required that a guide wire 12 be in6erted into the jugular vein 14 to travel along the jugular vein to the superior vena cava 15 of the heart and into the right atrium 16 and into the vicinity of the coronary sinus 17 at the coronary sinus ore~ing 17a within the right atrium.
The guide wire 12 is placed in the jugular vein 14 t~ h the use of the Seldinger technique. This tech~jque ~ay be u~ed for g~ining arterial or venous access. It involves locating the ves~el by palpation and entering it with a locator needle through the ~kin tpercutaneou~ insertion).
once the vessel i~ entered, the guide wire 12 i~ inserted through the needle ,not shown) and the needle i~ removed.
Thi~ re can be done quickly, does not require ~urgical inci~ion and ~ ~-erves the site of insertion for r~ule es.
21 86~7B
WO 95/27~26 6 PCTIUS95/03714 m e superior vena cava returns blood from the upper half of the body, and opens into the upper and posterior part of the atrium. It6 orifice i6 directed downward and forward and has no valve. The coronary sinus 17 ~eLUL~ the greater part of the blood from the sub6tance of the heart. Its op~ning 17a is placed LC~J3e-- the orifice of the inferior vena cava and the atri~e.---icular ~p~ning~ and i6 protected by a thin, se~i-circular valve, termed the valve of the coronary sinu6, which ~G~ the lower part of the orifice. It ~ e..~8 the r~gurgitation of blood into the ~inus during the contraction of the atrium. Thi~ valve may be double or it may be cribriform.
Placement of the coronary sinus i..L-~ c~r 20 of the present invention i6 be6t seen tlLou~l. the eeries of Figure6 3 L~v~ 7. A6 shown in Figure 3, the guide wire 12 i6 fir~t ~ ce~ into the cardiovA~c~lAr 6y6tem through the ~ugular vein 14 and then through the 6uperior vena cava 15 to place its di6tal end in the vicinity of the coronary sinu~ opening 17a.
$hen the dilator 18 receive6 the coronary i.-L~ -r 20 in a ~anner to be de6cribed in ~ore detail below, then the dilator and il.~Lf~ er co~aination ~?FC~ along the guide wire 12 through the ~ugular vein 14, through the ~uperior vena cava 15 and into the right atrium 16 to the position shown in Figure 3 in which the guide wire 12 with its di6tal end 12a, the dilator 18 with its tip or distal end 18a and the 2 1 8b878 WO 95/27~26 7 PCT/US9~/03714 i..L~ r 20 with it~ tip or distal end 20a are all in the right atrium in the vicinity of the coronary sinus opening 17a.
- In Figure 4 guidewire 12 has been removed from the combination of dilator 18 and i--L~cer 20 to leave dilator tip nd 18a and i..L.v~ucer end 20a in the vicinity of the coronary sinus opening 17a within the right atrium 16.
In Figure 5 coronary sinu~ i..L.~l~ce~ 20 with its tip end 20a iB shown in the right atrium. I..LL~ducer 20 i8 bent at bend or bent section 22 to place tip end 20a of the i--L-~ll~er in the vicinity of the coronary ~inus or~ni ng 17a. In Figure 5 the dilator 18, which i~ a relatively stiff straight memb~er, has been removed from the coronary sinuC i~.L~ol~cer 20 and the bent section 22 ha~ been restored to the coronary ~inus i..Ll~ucer to tilt it toward the oreni~ 17a of the coronary ~inus 17 and to enable the i..L.~i~cer tip end 20a to be placed within the coronary ~inu~ 17 a~ ~hown in Figure 6. In Figure 7 a coronary ~inu~ catheter 40 has b~een delivered into the coronary sinus of the patient.
The structure of the coronary sinuc catheter i~ o~ucer ~ystem of the ~L~tnt invention i~ best under~tood by ref~ 6 to Figure~ 8 - 11. At the top of Figure 8 i~ shown the guide wire 12 which i~ e~centially a long metallic coiled wire preferably made of a metal which will not interact with body fluid~, 6uch a~ stainlec~ ~teel. A_ ~hown in Figure~ 8 - 21 ~8~8 WO 95/27526 8 PCT/US95tO3714 and 9, dilator 18 is a relatively stiff member having a luer fitting 23 at one end with a longitudinal rod 24 exten~ing from the luer fitting 22. The longit~l~inAl rod 24 is a~,oximately 30 - 40 centimeters inches in length and is preferably made of a material which will not interact with body fluidfi ~uch as a relatively ~tiff polyurethane material.
The rod 24 includes a ~e..~Lal longit~AinAl bore 24a. The rod 24 receive~ a coating 24b, also preferably made of a material non-reactive with body fluids, ~uch as polyurethane. The dilator 18 is relatively inflexible, and is ex~e~ed to follow a path from the jugular vein 14, into the superior vena cava 15 and thereafter into the right atrium 16 of the heart. The luer fitting 23 receives an end cap (not shown) during installation of the dilator-i,lL~ol~er combination in the right atrium to minimize blood loss therethrough.
The i~ o-l~cer 20 comprises a longit~Ai~l t~h~lar main body portion 26 having a luer fitting 28 at a proximal end thereof. Similarly, the luer fitting 28 receives an end cap (not shown) which may be received following removal of the guide wire and dilator and prior to catheter installation to minimize blood loss through the tube 26. Luer fitting 28 a1BO
includes an eyelet 28a for a ~r-~~ to be described later.
The main body portion 26 i6 a relatively inflexible longit~A i n- 1 plastic tube having a pleated section 26a at its proximal end to give some flexibility to the il.LLo~ r 20 at the ~unction at the tube 26 and the luer fitting 28. Al~o a ~oft plastic bumper 26b is provided at the distal end of the W095/27526 2 1 8 6 8 7 8 PCT~S95/03714 plastic tube 26 to prevent abrasive contact between the coronary sinus 17 and the coronary sinus opening 17a and the i,-L~ cer 20 when the distal end 20a of the introducer 20 i~
placed within the coronary sinus 17.
The bend 22 at the distal end 20a of the coronary sinu~
i..-Lc~ Ger 20 is shown in more detail in Figure 10. The distal end 20a of the i..LrGd~cer 20 includes the bumper 26b and extend~ about 2 - 4 centimeters beyond the bent section 22 at an angle between 30 - 45O from the longit~ n~l axis of the tube 26.
It is the purpose of the dilator 18 to take the bend 22 out of the il.LrG~ cer 20 during the placement of the coronary sinus i--L-Gd~cer within the body of the patient as shown in Figures 3 - 7. Therefore, as shown in Figure 11, when the dilator 18 is fully exten~e~ to place its tip end 18a L~yG-,d the bumper 26b at the distal end of the tube 26, the tube 26 is fully aligned along its longit~A~ axis to remove the bend 22 from the i.-L~Gducer 20. MG~ eo~er there is a tight tolerance between the pliable bumper 26b of the i.,L~o~ c~r 20 and the dilator 18 to minimize blood loss to the patient through the interface between the dilator outer face and the inner lace of the i..L.Gd~cer body.
w095/27s26 ~ 2 1 ~ ~ 8 ~ 8 PCT~S95/03714 -' When the dilator 18 is removed from the coronary sinus i..L,~l~rer 20, the bend 22 returns to the coronary sinus er to enable placement of its end 20a in the coronary ~inus openin~ 17a.
Altho~h the invention has been described with reference to the preferred embodiment, other emhoAiments can achieve the same results. Variations and modifications of the ~ ent invention will be obvious to those skilled in the art and it is intenA^~ to cover in the apended claims all such modifications and eguivalents. The entire disclosures of all applications, patents, and publications cited above, and of the co~e~o-~lin~ application are hereby inco~ ~G~ ated by reference.
Claims (26)
1. An introducer system for delivery of a coronary sinus catheter, said system comprising:
a guide wire having a proximal and a distal end;
an introducer comprising a tube having a longitudinal main body portion and opposite ends, an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite open end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent a distal end section thereof to better position said open distal introducer end in the vicinity of the coronary sinus opening; and a longitudinal dilator having a bore to receive the guide wire wherein, the dilator is placed in the introducer to remove said pre-determined bend and align said distal end section with the main body portion during installation, the guide wire is delivered into the cardiovascular system to dispose its distal end in the right atrium, the introducer is installed on the dilator to provide a dilator-introducer combination, said combination then descends along the guide wire and into the right atrium, then the guide wire and the dilator member are removed following introducer installation to restore said pre-determined bend in the distal end section of the introducer to position the open distal end of the introducer in the vicinity of the coronary sinus opening, and a coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
a guide wire having a proximal and a distal end;
an introducer comprising a tube having a longitudinal main body portion and opposite ends, an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite open end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent a distal end section thereof to better position said open distal introducer end in the vicinity of the coronary sinus opening; and a longitudinal dilator having a bore to receive the guide wire wherein, the dilator is placed in the introducer to remove said pre-determined bend and align said distal end section with the main body portion during installation, the guide wire is delivered into the cardiovascular system to dispose its distal end in the right atrium, the introducer is installed on the dilator to provide a dilator-introducer combination, said combination then descends along the guide wire and into the right atrium, then the guide wire and the dilator member are removed following introducer installation to restore said pre-determined bend in the distal end section of the introducer to position the open distal end of the introducer in the vicinity of the coronary sinus opening, and a coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
2. An introducer system for delivery of a coronary sinus catheter, said system comprising-a guide wire having opposite ends;
an introducer including a linear main body portion comprising a tube having opposite ends, an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite open end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent a distal end section: and a dilator installed in the introducer to remove said pre-determined bend and align said distal end section with the main body portion during installation, wherein the guide wire is delivered into the cardiovascular system to dispose a distal end thereof in the right acrium, the introducer and dilator descend along the guide wire and into the right atrium, the guide wire and dilator are removed to restore said pre-determined bend in the distal end section of the introducer to be restored to position the open distal introducer end in the vicinity of the coronary sinus opening following introducer installation and the coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
an introducer including a linear main body portion comprising a tube having opposite ends, an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite open end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent a distal end section: and a dilator installed in the introducer to remove said pre-determined bend and align said distal end section with the main body portion during installation, wherein the guide wire is delivered into the cardiovascular system to dispose a distal end thereof in the right acrium, the introducer and dilator descend along the guide wire and into the right atrium, the guide wire and dilator are removed to restore said pre-determined bend in the distal end section of the introducer to be restored to position the open distal introducer end in the vicinity of the coronary sinus opening following introducer installation and the coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
3. The system is claimed in claim 2 wherein the dilator includes a longitudinal core having a central bore therein.
4. The system is claimed in claim 3 wherein a sheath overlies the core of the dilator.
5. The system is claimed in claim 4 wherein the sheath of the dilator comprises a polyurethane material.
6. The system is claimed in claim 5 wherein the dilator includes a luer fitting in its proximal end.
7. The system is claimed in claim 1 wherein the introducer includes a flexible bumper at its distal end to minimize abrasion in the engagement of the end of the introducer with the coronary sinus and the coronary sinus opening.
8. The system is claimed in claim 7 wherein the introducer includes a luer fitting at its proximal end.
9. The system is claimed in claim 8 wherein an accordion pleat is disposed in the tube at the junction of the luer fitting and said proximal end to provide added fiexibility to the introducer.
10. The system is claimed in claim 9 wherein the luer fitting on the introducer includes an eyelet for suturing the luer fitting of the introducer to the patient.
11. An introducer system for delivery of a coronary sinus catheter, said system comprising:
an introducer comprising a tube having a longitudinal main body portion and opposite ends, one an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite open end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent said one a distal end section thereof in the installed position to better position said introducer in the vicinity of the coronary sinus opening; and a longitudinal dilator member placed in the introducer to remove said pre-determined bend and align said bend said distal end section with the main body portion during installation, wherein the introducer is installed on the dilator to provide a dilator-introducer combination, said combination then depends into the right atrium, then the dilator member is removed following introducer installation to restore the said pre-determined bend in the distal end section of the introducer to position the open distal end of the introducer in the vicinity of the coronary sinus opening, and a coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
an introducer comprising a tube having a longitudinal main body portion and opposite ends, one an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite open end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent said one a distal end section thereof in the installed position to better position said introducer in the vicinity of the coronary sinus opening; and a longitudinal dilator member placed in the introducer to remove said pre-determined bend and align said bend said distal end section with the main body portion during installation, wherein the introducer is installed on the dilator to provide a dilator-introducer combination, said combination then depends into the right atrium, then the dilator member is removed following introducer installation to restore the said pre-determined bend in the distal end section of the introducer to position the open distal end of the introducer in the vicinity of the coronary sinus opening, and a coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
12. The system is claimed in claim 11 wherein the core of the dilator includes a longitudinal core having a central bore therein.
13. The system is claimed in claim 12 wherein a sheath overlies the core of the dilator.
14. The system is claimed in claim 13 wherein the sheath of the dilator comprises a polyurethane material.
15. The system is claimed in claim 14 wherein the dilator includes a luer fitting in its proximal end.
16. The system is claimed in claim 11 wherein the introducer includes a flexible bumper at its distal end to minimize abrasion in the engagement of the end of the introducer with the coronary sinus and the coronary sinus opening.
17. The system is claimed in claim 11 when the introducer includes a luer fitting at its proximal end.
18. The system is claimed in claim 17 wherein an accordion pleat is disposed in the tube at the junction of the luer fitting and said proximal end to provide added flexibility to the introducer.
19. The system as claimed in claim 1? wherein the luer fitting on the introducer includes an eyelet for suturing the luer fitting of the introducer to the patient.
20. An introducer system for delivery of a coronary sinus catheter, said system comprising:
an introducer including a tube having a longitudinal main body portion and opposite ends, an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent a distal end section to better position said open distal end of the introducer in the vicinity of the coronary sinus opening; and a longitudinal straightening member placed in the introducer for removing pre-determined bend and aligning said distal end section with the main body portion during installation, wherein the introducer and said member descend into the cardiovascular system and into the right atrium, and following introducer installation, said straightening member is removed to restore said pre-determined bend in the distal end section of the introducer and position the introducer open distal end in the vicinity of the coronary sinus opening, and a coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
an introducer including a tube having a longitudinal main body portion and opposite ends, an open distal end of the introducer to be installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite end to be disposed at a surface jugular entry point, said introducer of resilient material and having a pre-determined bend adjacent a distal end section to better position said open distal end of the introducer in the vicinity of the coronary sinus opening; and a longitudinal straightening member placed in the introducer for removing pre-determined bend and aligning said distal end section with the main body portion during installation, wherein the introducer and said member descend into the cardiovascular system and into the right atrium, and following introducer installation, said straightening member is removed to restore said pre-determined bend in the distal end section of the introducer and position the introducer open distal end in the vicinity of the coronary sinus opening, and a coronary sinus catheter is delivered through the introducer and into the coronary sinus of the patient.
21. The system is claimed in claim 20 wherein the introducer includes a flexible bumper at its distal end to minimize abrasion in the engagement of the introducer with the coronary sinus and the coronary sinus opening.
22. The system is claimed in claim 21 when the introducer includes a luer fitting at its proximal end.
23. The system is claimed in claim 22 wherein an accordion pleat is disposed in the tube at the junction of the luer fitting and said proximal end to provide added flexibility to the introducer.
24. The system is claimed in claim 23 wherein the luer fitting on the introducer includes an eyelet for suturing the luer fitting of the introducer to the patient.
25. A method for delivery of a coronary sinus catheter, said method comprising:
providing a guide wire having a proximal and a distal end;
providing an introducer, said introducer comprising a tube having a longitudinal main body portion and opposite ends;
providing a bend near the distal end of the introducer to better position said introducer end in the vicinity of the coronary sinus opening providing a longitudinal dilator member having an internal bore to receive the guide wire;
placing the dilator in the introducer to align the bend with the main body portion during installation of the introducer in the cardiovascular system of a patient;
delivering the guide wire into the cardiovascular system to dispose its distal end in the right atrium;
lowering the dilator-introducer combination along the guide wire and into the right atrium to install one end of the introducer adjacent the coronary sinus opening and dispose an opposite end at a surface jugular entry point;
removing the guide wire and the dilator member following introducer installation to restore the bend and position the introducer end in the vicinity of the coronary sinus opening;
and delivering a coronary sinus catheter through the introducer and into the coronary sinus of the patient.
providing a guide wire having a proximal and a distal end;
providing an introducer, said introducer comprising a tube having a longitudinal main body portion and opposite ends;
providing a bend near the distal end of the introducer to better position said introducer end in the vicinity of the coronary sinus opening providing a longitudinal dilator member having an internal bore to receive the guide wire;
placing the dilator in the introducer to align the bend with the main body portion during installation of the introducer in the cardiovascular system of a patient;
delivering the guide wire into the cardiovascular system to dispose its distal end in the right atrium;
lowering the dilator-introducer combination along the guide wire and into the right atrium to install one end of the introducer adjacent the coronary sinus opening and dispose an opposite end at a surface jugular entry point;
removing the guide wire and the dilator member following introducer installation to restore the bend and position the introducer end in the vicinity of the coronary sinus opening;
and delivering a coronary sinus catheter through the introducer and into the coronary sinus of the patient.
26. A method for delivery of a coronary sinus catheter, said method comprising:
providing a guide wire having opposite ends;
providing an introducer comprising a tube having a linear main body portion and opposite ends, and being of sufficient length to have one end of the introducer installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite end disposed at a surface jugular entry point;
providing said introducer with a bend adjacent said one end;
installing a dilator member in the introducer to provide a dilator- introducer combination and to align said bend with the main body portion during installation;
delivering the guide wire into the cardiovascular system to dispose one end thereof in the right atrium;
lowering the dilator-introducer combination along the guide wire to dispose the one end thereof in the right atrium;
removing the guide wire and the dilator from the introducer to restore the bend therein to position the end of the introducer in the vicinity of the coronary sinus opening; and delivering the coronary sinus catheter through the introducer and into the coronary sinus of the patient.
providing a guide wire having opposite ends;
providing an introducer comprising a tube having a linear main body portion and opposite ends, and being of sufficient length to have one end of the introducer installed adjacent the coronary sinus opening in the cardiovascular system of a patient and an opposite end disposed at a surface jugular entry point;
providing said introducer with a bend adjacent said one end;
installing a dilator member in the introducer to provide a dilator- introducer combination and to align said bend with the main body portion during installation;
delivering the guide wire into the cardiovascular system to dispose one end thereof in the right atrium;
lowering the dilator-introducer combination along the guide wire to dispose the one end thereof in the right atrium;
removing the guide wire and the dilator from the introducer to restore the bend therein to position the end of the introducer in the vicinity of the coronary sinus opening; and delivering the coronary sinus catheter through the introducer and into the coronary sinus of the patient.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/226,143 US5488960A (en) | 1994-04-11 | 1994-04-11 | Coronary sinus catheter introducer system |
| US08/226,143 | 1994-04-11 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2186878A1 true CA2186878A1 (en) | 1995-10-19 |
Family
ID=22847743
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002186878A Abandoned CA2186878A1 (en) | 1994-04-11 | 1995-03-22 | Coronary sinus catheter introducer system |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5488960A (en) |
| EP (1) | EP0755278B1 (en) |
| JP (1) | JPH09511663A (en) |
| AT (1) | ATE278432T1 (en) |
| CA (1) | CA2186878A1 (en) |
| DE (1) | DE69533617T2 (en) |
| ES (1) | ES2230547T3 (en) |
| WO (1) | WO1995027526A1 (en) |
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1994
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-
1995
- 1995-03-22 WO PCT/US1995/003714 patent/WO1995027526A1/en active IP Right Grant
- 1995-03-22 ES ES95914865T patent/ES2230547T3/en not_active Expired - Lifetime
- 1995-03-22 CA CA002186878A patent/CA2186878A1/en not_active Abandoned
- 1995-03-22 EP EP95914865A patent/EP0755278B1/en not_active Expired - Lifetime
- 1995-03-22 JP JP7526355A patent/JPH09511663A/en not_active Ceased
- 1995-03-22 AT AT95914865T patent/ATE278432T1/en not_active IP Right Cessation
- 1995-03-22 DE DE69533617T patent/DE69533617T2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| WO1995027526A1 (en) | 1995-10-19 |
| US5488960A (en) | 1996-02-06 |
| ATE278432T1 (en) | 2004-10-15 |
| ES2230547T3 (en) | 2005-05-01 |
| JPH09511663A (en) | 1997-11-25 |
| EP0755278B1 (en) | 2004-10-06 |
| EP0755278A1 (en) | 1997-01-29 |
| DE69533617T2 (en) | 2005-11-24 |
| DE69533617D1 (en) | 2004-11-11 |
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| Casal | A fascial dilator for percutaneous drainage procedures. |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |