CA2185814A1 - Packaging sheaths for intra-aortic balloon catheters - Google Patents
Packaging sheaths for intra-aortic balloon cathetersInfo
- Publication number
- CA2185814A1 CA2185814A1 CA002185814A CA2185814A CA2185814A1 CA 2185814 A1 CA2185814 A1 CA 2185814A1 CA 002185814 A CA002185814 A CA 002185814A CA 2185814 A CA2185814 A CA 2185814A CA 2185814 A1 CA2185814 A1 CA 2185814A1
- Authority
- CA
- Canada
- Prior art keywords
- tube
- passageway
- plastic
- entry section
- internal
- 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
- A61M25/002—Packages specially adapted therefor ; catheter kit packages
Abstract
An intra-aortic balloon packaging sheath (10) is provided which includes a long slim extruded plastic tube (12) for storing a furled thin-walled intra-aortic balloon. An entry section (14) of the same plastic is injection molded onto one end (26) of the tube, with the entry section (14) including an outwardly flared entry port surface (22) which is spaced from one end (26) of the tube, and an internal passageway (38) which is co-linear and congruent with the end of the tube (26) through the intersection of the second internal passageway (32) with the outwardly flared passageway (22). Thereby a smooth internal surface (36) is provided through the flared passageway (22) into the internal passageway (38) and through the latter into the tube (12). The exit end (16) is reformed by being inverted outwardly and back.
Description
Wo 95l25466 ~ ,3' ~' ~ 1 218~8~4 r~^r~.~ BHEATH8 FOR INT.~-~ C BABLOoN C~ r~oR
FIr r n OF Tl~r TNVENTION
This invention relates to packaging sheaths for the balloon portion of intra-aortic balloon catheters. Such sheaths are used for the pa -l~Aqi n~ of the furled balloon 5 section of an intra-aortic balloon catheter (IABC) during the later stages of production and proces6ing of those devices~ and for subsequent shipping and h.qnAl in~ up to the point of the catheter being withdrawn from the sheath by a health care provider at the point and time of f inal 10 preparation for insertion into the vascular system of a patient .
BAvK~iKvuNL~ OF THE INVEN~ION
Intra-aortic balloon pumps tIABP) are used to 15 provide counter pulsation within the aorta of ailing hearts over substantial periods of time, e.g. to provide ventricular assistance during cardiogenic shock, low cardiac output in post operative care, weaning from cardiop~ ry bypass, treatment for refractory unstable 20 angina, and other circumstances of sllhnrrr-l cardiac function. Such pumps include a large flexible intra-aortic balloon (IAB) which is readily inflatable under low p~:sDuLe to substantial size and disp1a~ - . The balloon is mounted on a catheter device for insertion of 25 the balloon into a remote artery, typically a femoral artery, and through the intervening vascular system of the patient to the aortic pumping site while the balloon is deflated and furled.
An intra-aortic balloon typically is a flexible 30 balloon of substantial size, i.e. on the order of about 0 . 5" to about 1. 0" in diameter when in an inflated but unstretched condition, and about 8" to 12" in length.
Typical sizes are of 30cc, 40cc and 50cc displA ~nt.
The balloon IQay be formed of any suitable material, with _ _ _ _ _ _, ... .. . . ... . .. . . ..
Wo 95/25466 PCT/US95/03465 polyurethene presently being preferred. A hydrophilic coating preferably covers the balloon and forms a lubricous outer surface which is very 61ippery when wetted by an aqueous fluid, such as blood, while 5 permitting processing and furling of the balloon and hAn~lin~ of the balloon and related pump m~ AniFm in a normal manner when dry. Presently preferred coatings and appropriate modes of applying such coatings are disclosed in co-pending Application No. 08/170,513, filed DPcPmhPr 20, 1993, the disclosure of which is inco,yvLated herein by this reference.
The hAllnonc are formed of thin films, as by a dip-casting process. One example is a polyether based polyurethene balloon of about 0.003" - 0.005" wall 15 thickness formed by dip-molding on an ~Lv~riately shaped mandrel, with later addition of a hydrophilic coating as referred to above. One presently preferred ,~ '- 'ir L utilizes such balloons with wall thir~npc~-cpc in the lower end of this range, i.e. 0.003" - 0.004". It 20 will be appreciated that the balloons are rather frail from a ---hAnir~l standpoint, and can be scratched or torn if not handled carefully and with appropriate sa~eguards during packaging, shipping and subsequent hAnrll in~ by the health care providers in the course of 25 removâl from the pA~ A~in~ in prepaLation for use.
In the course of mânufacture, each balloon is ~r -1Pr1 into a catheter assembly, with opposite ends of the balloon being bonded to the distal ends of two coaxial lumens. The balloon also is tightly furled about 30 a distal portion of the inner lumen to facilitate subsequent insertion through a small opening into â
patient's vascular system. The sllhAcc~ ' ly of the lumens and furled balloon then is threaded through a small packaging sheath, with the furled balloon thereby being 35 drawn into the sheath which tightly 2,urL~,u.-ds the furled balloon section. The sheath remains on the balloon ând maintains the balloon in its furled compaction to a WO 95/25466 1 ~,111).,,~ '''
FIr r n OF Tl~r TNVENTION
This invention relates to packaging sheaths for the balloon portion of intra-aortic balloon catheters. Such sheaths are used for the pa -l~Aqi n~ of the furled balloon 5 section of an intra-aortic balloon catheter (IABC) during the later stages of production and proces6ing of those devices~ and for subsequent shipping and h.qnAl in~ up to the point of the catheter being withdrawn from the sheath by a health care provider at the point and time of f inal 10 preparation for insertion into the vascular system of a patient .
BAvK~iKvuNL~ OF THE INVEN~ION
Intra-aortic balloon pumps tIABP) are used to 15 provide counter pulsation within the aorta of ailing hearts over substantial periods of time, e.g. to provide ventricular assistance during cardiogenic shock, low cardiac output in post operative care, weaning from cardiop~ ry bypass, treatment for refractory unstable 20 angina, and other circumstances of sllhnrrr-l cardiac function. Such pumps include a large flexible intra-aortic balloon (IAB) which is readily inflatable under low p~:sDuLe to substantial size and disp1a~ - . The balloon is mounted on a catheter device for insertion of 25 the balloon into a remote artery, typically a femoral artery, and through the intervening vascular system of the patient to the aortic pumping site while the balloon is deflated and furled.
An intra-aortic balloon typically is a flexible 30 balloon of substantial size, i.e. on the order of about 0 . 5" to about 1. 0" in diameter when in an inflated but unstretched condition, and about 8" to 12" in length.
Typical sizes are of 30cc, 40cc and 50cc displA ~nt.
The balloon IQay be formed of any suitable material, with _ _ _ _ _ _, ... .. . . ... . .. . . ..
Wo 95/25466 PCT/US95/03465 polyurethene presently being preferred. A hydrophilic coating preferably covers the balloon and forms a lubricous outer surface which is very 61ippery when wetted by an aqueous fluid, such as blood, while 5 permitting processing and furling of the balloon and hAn~lin~ of the balloon and related pump m~ AniFm in a normal manner when dry. Presently preferred coatings and appropriate modes of applying such coatings are disclosed in co-pending Application No. 08/170,513, filed DPcPmhPr 20, 1993, the disclosure of which is inco,yvLated herein by this reference.
The hAllnonc are formed of thin films, as by a dip-casting process. One example is a polyether based polyurethene balloon of about 0.003" - 0.005" wall 15 thickness formed by dip-molding on an ~Lv~riately shaped mandrel, with later addition of a hydrophilic coating as referred to above. One presently preferred ,~ '- 'ir L utilizes such balloons with wall thir~npc~-cpc in the lower end of this range, i.e. 0.003" - 0.004". It 20 will be appreciated that the balloons are rather frail from a ---hAnir~l standpoint, and can be scratched or torn if not handled carefully and with appropriate sa~eguards during packaging, shipping and subsequent hAnrll in~ by the health care providers in the course of 25 removâl from the pA~ A~in~ in prepaLation for use.
In the course of mânufacture, each balloon is ~r -1Pr1 into a catheter assembly, with opposite ends of the balloon being bonded to the distal ends of two coaxial lumens. The balloon also is tightly furled about 30 a distal portion of the inner lumen to facilitate subsequent insertion through a small opening into â
patient's vascular system. The sllhAcc~ ' ly of the lumens and furled balloon then is threaded through a small packaging sheath, with the furled balloon thereby being 35 drawn into the sheath which tightly 2,urL~,u.-ds the furled balloon section. The sheath remains on the balloon ând maintains the balloon in its furled compaction to a WO 95/25466 1 ~,111).,,~ '''
2~85~4 minimum effective outside diameter during sterilization, packaging, shipping and h~nr~l ;n-J, up to the place and time of insertion into the patient. While in its sheath, the furled balloon also typically is heated, e. g . to a t~ a~UL~ on the order of about 135F for about 12-16 ,7 hours, to âSSiSt in setting and thereby sustaining the furling during insertion following removal from the packaging sheath by the user.
Each sheath unit typically has been an extruded plastic tube, often with a substantial end-section affixed to one end of the tube as by being bonded or molded thereonto. The end section is of substantial size and body to provide a convenient means for gripping, hAn-11 in~ and restraining the sheath unit against the forces of insertion and removal of the catheter balloon section. The end section also forms a graduated or flared inlet to assist in guiding the furled balloon section into the tube. The opposite or removal end of the tube often has been simply the square cut end ~ormed during guillotine severance of the respective sheath tube from ân indeterminate length of such tubing.
At the point of use, the balloon section is vithdrawn from its p~cl- Ir,~j ng sheath by the health care user. It will be appreciated that this withdrawal may occur under conditions of stress and time urgency, by a wide variety of personnel.
In all events, it is desirable to provide a high degree of protection and assurance against scratching, âbrasion or other damage to the balloon in the course of its insertion into and subsequent removal from the packaging sheath.
It is an object of this invention to provide vvæd packaging sheaths for intra-aortic balloon catheters .
It is a more specific object of this invention to provide such sheaths which reduce or avoid risks of .
Wo 95l25466 ~1 8581 4 4 O
scratching, abrasion or other damage to the balloon in the course of its insertion into the packaging sheath.
It is yet another object of this invention to provide such packaging sheaths of designs which reduce or 5 avoid the risk of scratching, abrasion or other damage to the balloon in the course of its removal from the packaging sheath.
STTMMARY OF TM~ lNV~ JN
An intra-aortic balloon packaging sheath is provided which; nrl~ oc a long slim tube for storing a furled thin-walled intra-aortic balloon. The tube has a bore of uniform ~:Lo~s-scction throughout its length. An entry section is molded onto one end of the tube, with the entry section including an outwardly f lared entry port surface which is spaced from one end of the tube, and an internal p~ rjeway which is co-linear and congruent with the internal cross-section of the tube from the respective end of the tube through the intersection of the second internal passageway with the outwardly flared passageway. Thereby a smooth internal surface is provided through the flared pa~s~eway into the internal passageway and through the later into the tube.
In a preferred omho~;- L the tube is an extruded plastic tube and the entry section is a plastic molding of the same plastic whereby the molding of the end section onto the tube results in fusion bonding of the molded end section with the respective end portion of the sheath tube.
The opposite end of the sheath tube, which normally constitutes the catheter removal end, is inverted such that a distal end portion is turned outwardly and back circumjacent another portion of the tube wall to form a smoothly rounded exit passageway of the tube at this end.
In the preferred embodiment, this end portion of the tubular passageway also is slightly f lared .
WO 95/25466 . ~,IIU.~
21858~4 5 These f eatures provide smooth entry and exit sections, respectively, to m;nimi7e or avoid any risk of scratching, abrasion or other damage to the balloon in the course of its insertion into and subsequent removal 5 from the packaging sheath.
Brief Descri~tion of the Drawinas Fig. 1 is an enlarged side view of a packaging sheath for an intra-aortic balloon catheter, employing 10 t~lrhin~C of this invention.
Fig. 2 is a right-end view of the device of Fig. 1, taken generally along line 2-2 and looking in the direction of the arrows.
Fig. 3 is a left-end view of the device of Fig. 1, 5 taken generally along line 3-3 of Fig. 1 and looking in the direction of the arrows.
Fig. 4 is a somewhat enlarged side view, partially in section, illustrating the construction at the junction of the sheath tube and the end portion of the device in 20 Fig. 1.
Fig. 4A is a further enlarged fragmentary sectional view COL L ~ n-l i n~ to Fig . 4 .
Fig. 5 is an enlarged side view of the catheter removal end of the device of Fig. 1, taken partially in 25 section along an axial dii LLal plane as indicated by line 5-5 of Fig. 3.
Fig. 6 is a sectional view taken generally along line 6-6 of Fig. 1.
Fig. 7 illustrates the positioning of a core pin and 30 injection mold relative to a sheath tube for forming ân end ell~L~ce and related entry p~ eway configuration of the device of Fig. 1.
Fig. 8 is a sectional view showing the distal end of the sheath tube mounted on a heated tipping die for 35 reforming this end of the sheath tu~e.
Fig. 9 is a view COLL~ din~ to Fig. 8, showing the distal end being ref ormed by inversion .
_ __ . . _ .. _. . . . ___ __ woss/2s466 r~ A7l~
While the invention will be further described in connection with certain pref erred : ': ; r ~ Ls ~ it is not intended to limit the invention to those Pmho~ -ts. On the ~ .LLC~Ly, it is intended to cover all alternatives, 5 modif ications and equivalents as may be ; nrl~ Pd within the spirit and scope of the invention.
n~TATTT~n DESCRIPTION OF ~ K~ EMBODIMENTS
A packaging sheath unit 10 is illustrated which 10 comprises an elongated sheath tube 12 with a T-shaped entrance end section 14 at one end. The opposite end portion of the tube, at its distal or exit end 16 is reformed by being inverted outwardly and back upon itself, as will be referred to further below.
The tube 12 is a small circular cylindrical tube, typically being cut from an indeterminate length of L uded plastic tubing . The entrance section 14 includes a center portion 22 which is in co-axial ~iuLL~,u-lding relationship to the respective end portion of the tube 12 and the axial extension of its inner cylindrical bore, and a pair of oppositely ~ posPd wing portions 23. The wing portions extend outward from the center portion 22, forming a T-shape therewith.
The section 22 includes a collar portion 24, a guide portion 28 and an intervening portion 34. The collar portion 24 ~ULL~UIIdS and is bonded to the adjacent end portion 26 of the tube. The guide portion 28 defines a truncated conical or funnel shaped smooth interior guide surface 30 which is spaced from and rOA~Ally aligned with the distal end 32 of the tube 12. The intervening portion 34 defines a circular cylindrical surface 36 which is co-axial and congruent with the inner bore surface 38 of the end portion 26 of the tube 12 and extends outward to an intersection with the surface 30.
The surfaces 30, 36, 38 form a smooth continuous series of surfaces comprising the funnel shaped entrance, the intervening portion and the inner bore of the tube, W0 9~5466 without any sharp edges, sho~ Prs, cut-edges, burrs or rouqhn~. This provides a smooth continuum of ~urfaces from the t:llLLCli~c~ end of the guide 30 into the tube 12 for insertion of the balloon section of the catheter into 5 the sheath unit 10 with little or no risk of abrasion, -j scratching or tearing of the material of the balloon, even where the furled balloon has a snug compacting fit in the bore 38.
The end section 14 also provides a convenient 10 gripping area or handle for ~nir~ ting and securing the sheath unit during insertion of the catheter assembly into the tube 12, and subsequently withdrawing the catheter unit therefrom. The end section 14 also is useful for securing and retaining the sheath unit in an 15 appropriate cavity of a shipping tray both during shipping and while the catheter assembly is withdrawn therefrom, in the r~ d mode of removal of the catheter units at the point of use. Thus, while the illustrated configuration of the external portions is a 20 T-shape c~LL-~-L,. ~linq generally to catheter sheaths used heretofore by the Cardiac Assist Division of St. Jude Medical , Inc ., it will be appreciated that any of a variety of conf igurations may be employed .
Referring particularly to Fig. 5, at the distal end 25 16 a short end portion 40 of the tube wall is inverted over the adjacent portion 42 to lie circumjacent thereto, forming an intervening annular fold or bight 44 and thereby readily forming a smoothly rounded annular exit surface 46 from the bore of the tube 12. The resulting 30 exit surface avoids exposure of the balloon to any cut edges, other sharp corners or rollqhn~c as a balloon catheter section is withdrawn through this end of the sheath, even if the withdrawal is not directly co-axial but is at some angle of def lection in any direction 35 relative to the extended axis of the tube 12.
A preferred manner of forming the entrance section 14 by injection molding is illustrated schematically in .. .. ... . _ _ _ Wo 95l25466 r~
21~5~14 a Fig. 7. The respective end portion 26 of the tube 12 extends into an a~L-~Liate cavity of an injection mold 50. A core pin 52 includes a cylindrical smooth surfaced extension 54 which preferably is slightly oversize 5 relative to bore 38 to provide a slight interference fit within the bore of the tube 12. The core pin 52 also includes a smooth-walled truncated conical section 56 for forming the entrance guide surface 30. It will be observed that the tube 12 is positioned such that its 10 proximal end 32 is spaced a significant distance from the conical surface 56, for the formation of the transition section 34 and related smooth inner surface 36 therebetween. An appropriate molding material is injected into the cavity in a known manner to form the 15 end section 14.
The material to be molded for forming the section 14 should be compatible with the material of the tube 12, such as to ef f ect a good bond therebetween . In the preferred ~mhorli-- L both the tube and the injection 20 molding material are high density polyethylene to insure compatibility and substantially the same melting t~ ClLUL~:S~ e.g. 380-450F range, or about 420F. It is believed that the use of c~ l; n~ materials results in partial melting of the mating annular and end 25 surfaces of the tube 12 in the course of the injection molding of the end section, thereby providing a melt/merge fusion bond at these interfaces and particularly at and along the interface of end 32, which further assures the formation of a unified continuum of
Each sheath unit typically has been an extruded plastic tube, often with a substantial end-section affixed to one end of the tube as by being bonded or molded thereonto. The end section is of substantial size and body to provide a convenient means for gripping, hAn-11 in~ and restraining the sheath unit against the forces of insertion and removal of the catheter balloon section. The end section also forms a graduated or flared inlet to assist in guiding the furled balloon section into the tube. The opposite or removal end of the tube often has been simply the square cut end ~ormed during guillotine severance of the respective sheath tube from ân indeterminate length of such tubing.
At the point of use, the balloon section is vithdrawn from its p~cl- Ir,~j ng sheath by the health care user. It will be appreciated that this withdrawal may occur under conditions of stress and time urgency, by a wide variety of personnel.
In all events, it is desirable to provide a high degree of protection and assurance against scratching, âbrasion or other damage to the balloon in the course of its insertion into and subsequent removal from the packaging sheath.
It is an object of this invention to provide vvæd packaging sheaths for intra-aortic balloon catheters .
It is a more specific object of this invention to provide such sheaths which reduce or avoid risks of .
Wo 95l25466 ~1 8581 4 4 O
scratching, abrasion or other damage to the balloon in the course of its insertion into the packaging sheath.
It is yet another object of this invention to provide such packaging sheaths of designs which reduce or 5 avoid the risk of scratching, abrasion or other damage to the balloon in the course of its removal from the packaging sheath.
STTMMARY OF TM~ lNV~ JN
An intra-aortic balloon packaging sheath is provided which; nrl~ oc a long slim tube for storing a furled thin-walled intra-aortic balloon. The tube has a bore of uniform ~:Lo~s-scction throughout its length. An entry section is molded onto one end of the tube, with the entry section including an outwardly f lared entry port surface which is spaced from one end of the tube, and an internal p~ rjeway which is co-linear and congruent with the internal cross-section of the tube from the respective end of the tube through the intersection of the second internal passageway with the outwardly flared passageway. Thereby a smooth internal surface is provided through the flared pa~s~eway into the internal passageway and through the later into the tube.
In a preferred omho~;- L the tube is an extruded plastic tube and the entry section is a plastic molding of the same plastic whereby the molding of the end section onto the tube results in fusion bonding of the molded end section with the respective end portion of the sheath tube.
The opposite end of the sheath tube, which normally constitutes the catheter removal end, is inverted such that a distal end portion is turned outwardly and back circumjacent another portion of the tube wall to form a smoothly rounded exit passageway of the tube at this end.
In the preferred embodiment, this end portion of the tubular passageway also is slightly f lared .
WO 95/25466 . ~,IIU.~
21858~4 5 These f eatures provide smooth entry and exit sections, respectively, to m;nimi7e or avoid any risk of scratching, abrasion or other damage to the balloon in the course of its insertion into and subsequent removal 5 from the packaging sheath.
Brief Descri~tion of the Drawinas Fig. 1 is an enlarged side view of a packaging sheath for an intra-aortic balloon catheter, employing 10 t~lrhin~C of this invention.
Fig. 2 is a right-end view of the device of Fig. 1, taken generally along line 2-2 and looking in the direction of the arrows.
Fig. 3 is a left-end view of the device of Fig. 1, 5 taken generally along line 3-3 of Fig. 1 and looking in the direction of the arrows.
Fig. 4 is a somewhat enlarged side view, partially in section, illustrating the construction at the junction of the sheath tube and the end portion of the device in 20 Fig. 1.
Fig. 4A is a further enlarged fragmentary sectional view COL L ~ n-l i n~ to Fig . 4 .
Fig. 5 is an enlarged side view of the catheter removal end of the device of Fig. 1, taken partially in 25 section along an axial dii LLal plane as indicated by line 5-5 of Fig. 3.
Fig. 6 is a sectional view taken generally along line 6-6 of Fig. 1.
Fig. 7 illustrates the positioning of a core pin and 30 injection mold relative to a sheath tube for forming ân end ell~L~ce and related entry p~ eway configuration of the device of Fig. 1.
Fig. 8 is a sectional view showing the distal end of the sheath tube mounted on a heated tipping die for 35 reforming this end of the sheath tu~e.
Fig. 9 is a view COLL~ din~ to Fig. 8, showing the distal end being ref ormed by inversion .
_ __ . . _ .. _. . . . ___ __ woss/2s466 r~ A7l~
While the invention will be further described in connection with certain pref erred : ': ; r ~ Ls ~ it is not intended to limit the invention to those Pmho~ -ts. On the ~ .LLC~Ly, it is intended to cover all alternatives, 5 modif ications and equivalents as may be ; nrl~ Pd within the spirit and scope of the invention.
n~TATTT~n DESCRIPTION OF ~ K~ EMBODIMENTS
A packaging sheath unit 10 is illustrated which 10 comprises an elongated sheath tube 12 with a T-shaped entrance end section 14 at one end. The opposite end portion of the tube, at its distal or exit end 16 is reformed by being inverted outwardly and back upon itself, as will be referred to further below.
The tube 12 is a small circular cylindrical tube, typically being cut from an indeterminate length of L uded plastic tubing . The entrance section 14 includes a center portion 22 which is in co-axial ~iuLL~,u-lding relationship to the respective end portion of the tube 12 and the axial extension of its inner cylindrical bore, and a pair of oppositely ~ posPd wing portions 23. The wing portions extend outward from the center portion 22, forming a T-shape therewith.
The section 22 includes a collar portion 24, a guide portion 28 and an intervening portion 34. The collar portion 24 ~ULL~UIIdS and is bonded to the adjacent end portion 26 of the tube. The guide portion 28 defines a truncated conical or funnel shaped smooth interior guide surface 30 which is spaced from and rOA~Ally aligned with the distal end 32 of the tube 12. The intervening portion 34 defines a circular cylindrical surface 36 which is co-axial and congruent with the inner bore surface 38 of the end portion 26 of the tube 12 and extends outward to an intersection with the surface 30.
The surfaces 30, 36, 38 form a smooth continuous series of surfaces comprising the funnel shaped entrance, the intervening portion and the inner bore of the tube, W0 9~5466 without any sharp edges, sho~ Prs, cut-edges, burrs or rouqhn~. This provides a smooth continuum of ~urfaces from the t:llLLCli~c~ end of the guide 30 into the tube 12 for insertion of the balloon section of the catheter into 5 the sheath unit 10 with little or no risk of abrasion, -j scratching or tearing of the material of the balloon, even where the furled balloon has a snug compacting fit in the bore 38.
The end section 14 also provides a convenient 10 gripping area or handle for ~nir~ ting and securing the sheath unit during insertion of the catheter assembly into the tube 12, and subsequently withdrawing the catheter unit therefrom. The end section 14 also is useful for securing and retaining the sheath unit in an 15 appropriate cavity of a shipping tray both during shipping and while the catheter assembly is withdrawn therefrom, in the r~ d mode of removal of the catheter units at the point of use. Thus, while the illustrated configuration of the external portions is a 20 T-shape c~LL-~-L,. ~linq generally to catheter sheaths used heretofore by the Cardiac Assist Division of St. Jude Medical , Inc ., it will be appreciated that any of a variety of conf igurations may be employed .
Referring particularly to Fig. 5, at the distal end 25 16 a short end portion 40 of the tube wall is inverted over the adjacent portion 42 to lie circumjacent thereto, forming an intervening annular fold or bight 44 and thereby readily forming a smoothly rounded annular exit surface 46 from the bore of the tube 12. The resulting 30 exit surface avoids exposure of the balloon to any cut edges, other sharp corners or rollqhn~c as a balloon catheter section is withdrawn through this end of the sheath, even if the withdrawal is not directly co-axial but is at some angle of def lection in any direction 35 relative to the extended axis of the tube 12.
A preferred manner of forming the entrance section 14 by injection molding is illustrated schematically in .. .. ... . _ _ _ Wo 95l25466 r~
21~5~14 a Fig. 7. The respective end portion 26 of the tube 12 extends into an a~L-~Liate cavity of an injection mold 50. A core pin 52 includes a cylindrical smooth surfaced extension 54 which preferably is slightly oversize 5 relative to bore 38 to provide a slight interference fit within the bore of the tube 12. The core pin 52 also includes a smooth-walled truncated conical section 56 for forming the entrance guide surface 30. It will be observed that the tube 12 is positioned such that its 10 proximal end 32 is spaced a significant distance from the conical surface 56, for the formation of the transition section 34 and related smooth inner surface 36 therebetween. An appropriate molding material is injected into the cavity in a known manner to form the 15 end section 14.
The material to be molded for forming the section 14 should be compatible with the material of the tube 12, such as to ef f ect a good bond therebetween . In the preferred ~mhorli-- L both the tube and the injection 20 molding material are high density polyethylene to insure compatibility and substantially the same melting t~ ClLUL~:S~ e.g. 380-450F range, or about 420F. It is believed that the use of c~ l; n~ materials results in partial melting of the mating annular and end 25 surfaces of the tube 12 in the course of the injection molding of the end section, thereby providing a melt/merge fusion bond at these interfaces and particularly at and along the interface of end 32, which further assures the formation of a unified continuum of
3 o surf aces from the tapered guide surf ace 3 0 into the bore of the tube 12. Accordingly, the drawings sometimes show the interfaces between the sheath tube and the molded-on end section in da~hed lines.
By way of further example, for packaging an 8 Fr 35 IABC the tubing 12 is an extruded high density polyethylene tube having an ID of about .120", an OD of about .133" and a wall thickness of about .065". The _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .. _ _ _ _ . _ _ _ .. ... _ W0 95/25466 1~
~85814 9 collar Eection is about .250" in length overall, which includes a transition surface section 36 about . 025"
long, and a conical entrance 30 with an inr ll7~r9 angle of about 60. The main body of each wing is about .310"
5 wide and .098" thick, and the two wings 23 have a total span of about 1.19".
The inverted configuration of tle distal end 16 may be provided by any suitable t~hn i ~1 ~ . A currently preferred method is a hot die forming process as 10 illustrated generally in Figs. 8 and 9. A die block 70 is f ormed with an appropriate generally u-shaped recess 72 to receive one end of the tube 12. A die pin 74 extends co-axially into the cavity 72 and is of a size to fit snugly within the bore of the tube 12. The pin 74, 15 and adjacent portions of the block 70 if and as nec~6F~ry, are heated by any d~Lo~Liate means to a LuL~ sufficient to soften the material of the inserted end portion of the tube 12 such that axial pL~ ULr~ cau&es the distal tube portion 40 to be 20 p~oy~,~ssively inverted over the next adjacent tube portion 42, as illustrated. That is, the end portion 40 is progressively enlarged in diameter and turned back in circ~mjacent relation to the next sll~ cee~7.;n~ portion 42 of the tube. The result is a rounded, smooth annular 25 exit surface 46 formed by reverse bending and rolling back the end portion 40 of the tube 12. Any sharp edges, burrs or roughness that may have been f orm7ed at the distal end of the tube 12 during its formation are removed from the area of contact with the balloon during 3 o withdrawal . The pin 74 and cavity 72 may be of a configuration to also provide a slight outward taper or - flare in the exit end of the sheath tube, as illustrated in Fig. 5.
It will be appreciated that improved packaging 35 sheaths for the balloon portion of intra-aortic balloon catheters have been provided which meet the objects of this invention.
.. . ... . ...
WO 95l25466 P~ .,,5lQ~ 1 '' 2l85814 LO O
The invention has been described in con61derable detail with reference to certain e~mho~; L6, and particularly with respect to the preferred ~mhor~ 5 thereof. However, it will be under6tood that variation6, 5 modifications and; ~ 6 may be made, particularly by tho6e 6killed in thi6 art and in light of the tea~h i n~6 ref erred to herein within the spirit and 6cope of the invention a6 claimed.
By way of further example, for packaging an 8 Fr 35 IABC the tubing 12 is an extruded high density polyethylene tube having an ID of about .120", an OD of about .133" and a wall thickness of about .065". The _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .. _ _ _ _ . _ _ _ .. ... _ W0 95/25466 1~
~85814 9 collar Eection is about .250" in length overall, which includes a transition surface section 36 about . 025"
long, and a conical entrance 30 with an inr ll7~r9 angle of about 60. The main body of each wing is about .310"
5 wide and .098" thick, and the two wings 23 have a total span of about 1.19".
The inverted configuration of tle distal end 16 may be provided by any suitable t~hn i ~1 ~ . A currently preferred method is a hot die forming process as 10 illustrated generally in Figs. 8 and 9. A die block 70 is f ormed with an appropriate generally u-shaped recess 72 to receive one end of the tube 12. A die pin 74 extends co-axially into the cavity 72 and is of a size to fit snugly within the bore of the tube 12. The pin 74, 15 and adjacent portions of the block 70 if and as nec~6F~ry, are heated by any d~Lo~Liate means to a LuL~ sufficient to soften the material of the inserted end portion of the tube 12 such that axial pL~ ULr~ cau&es the distal tube portion 40 to be 20 p~oy~,~ssively inverted over the next adjacent tube portion 42, as illustrated. That is, the end portion 40 is progressively enlarged in diameter and turned back in circ~mjacent relation to the next sll~ cee~7.;n~ portion 42 of the tube. The result is a rounded, smooth annular 25 exit surface 46 formed by reverse bending and rolling back the end portion 40 of the tube 12. Any sharp edges, burrs or roughness that may have been f orm7ed at the distal end of the tube 12 during its formation are removed from the area of contact with the balloon during 3 o withdrawal . The pin 74 and cavity 72 may be of a configuration to also provide a slight outward taper or - flare in the exit end of the sheath tube, as illustrated in Fig. 5.
It will be appreciated that improved packaging 35 sheaths for the balloon portion of intra-aortic balloon catheters have been provided which meet the objects of this invention.
.. . ... . ...
WO 95l25466 P~ .,,5lQ~ 1 '' 2l85814 LO O
The invention has been described in con61derable detail with reference to certain e~mho~; L6, and particularly with respect to the preferred ~mhor~ 5 thereof. However, it will be under6tood that variation6, 5 modifications and; ~ 6 may be made, particularly by tho6e 6killed in thi6 art and in light of the tea~h i n~6 ref erred to herein within the spirit and 6cope of the invention a6 claimed.
Claims (18)
1. An intra-aortic balloon packaging sheath comprising:
an elongated slim tube for storing a furled intra-aortic balloon, said tube having an internal bore extending along its length; and an entry section affixed on one end of said tube, said entry section including a first portion defining an outwardly flared passageway spaced from said one end of said tube and a second portion extending from said one end of said tube and intersecting said outwardly flared passageway, said second portion defining an internal passageway which is a co-linear and congruent extension of the internal bore of said tube from said one end of said tube to said outwardly flared passageway, whereby a smooth internal surface is provided from said flared passageway into said internal passageway and through the latter passageway into said bore of said tube.
an elongated slim tube for storing a furled intra-aortic balloon, said tube having an internal bore extending along its length; and an entry section affixed on one end of said tube, said entry section including a first portion defining an outwardly flared passageway spaced from said one end of said tube and a second portion extending from said one end of said tube and intersecting said outwardly flared passageway, said second portion defining an internal passageway which is a co-linear and congruent extension of the internal bore of said tube from said one end of said tube to said outwardly flared passageway, whereby a smooth internal surface is provided from said flared passageway into said internal passageway and through the latter passageway into said bore of said tube.
2. The invention as in claim 1 wherein said bore section of said tube is cylindrical.
3. The invention as in claim 2 wherein said tube is an extruded plastic tube and said entry section is a plastic molding molded onto said tube at said one end thereof.
4. The invention as in claim 1 wherein said entry section is a molding molded onto said tube at said one end thereof.
5. The invention as in claim 4 wherein said tube is formed of plastic and said entry section is formed of a plastic which is compatible with the plastic of said tube and has substantially the same melting temperature.
6. The invention as in claim 5 wherein said tube and said entry section are formed of similar plastic materials.
7. The invention as in claim 6 wherein said tube is an extruded plastic tube and said entry section is a plastic molding molded onto said tube at said one end thereof.
8. The invention as in claim 7 wherein a distal portion of the other end of said tube wall is flared radially to form a smooth internal exit surface.
9. The invention as in claim 8 wherein an end portion of said tube wall extends circumjacent another portion of said tube wall and an intervening portion therebetween forms a rounded annular bight portion at the distal end of said tube, whereby the exposed surface of said bight portion forms said exit surface.
10. The invention as in claim 8 wherein a distal portion of said tube wall is spread radially outward and inverted over an adjacent portion of said tube wall.
11. The invention as in claim 7 wherein each of said tube and said entry section is formed of high density polyethylene.
12. An intra-aortic balloon packaging sheath comprising an elongated extruded plastic thin-walled tube for storing a furled intra-aortic balloon, said tube having an internal bore extending along its length, and at least one end of said tube having a distal portion of said wall spread radially outward and inverted over an adjacent portion of said tube wall, whereby a smooth annular end configuration is provided for passage therethrough of an intra-aortic balloon to be stored in said sheath.
13. The invention as in claim 12 wherein said sheath includes an entry section on the other end of said tube, said entry section including a first portion defining an outwardly flared passageway.
14. The invention as in claim 13 wherein said flared passageway is spaced from said other end of said tube and said entry section includes a second portion extending from said other end of said tube and intersecting said outwardly flared passageway, said second portion defining an internal passageway which is a co-linear and congruent extension of the internal cross section of said tube from said other end of said tube to said outwardly flared passageway, whereby a smooth internal surface is provided from said flared passageway into said internal passageway and through the latter passageway into said tube.
15. A method of forming an intra-aortic balloon packaging sheath, comprising the steps of providing an extruded plastic sheath tube having an internal bore therethrough; and molding an entry section onto one end portion of said sheath tube by partially inserting into the bore of said end portion a core pin of a size corresponding to the bore of said tube and with a portion of said core pin of the same cross-section exposed externally of said end section, providing a male mold form of a configuration which flares outwardly from the end of said exposed portion of said core pin, and insert molding a plastic over said core pin and in contact with the external surface of said end portion of said tube, thereby forming a smooth-walled entrance passageway into said tube, which passageway includes a flared outer portion and a smooth walled transition into said tube bore.
16. The invention as in claim 15 wherein said plastic being injection molded and the plastic of which said tube is formed have substantially the same melting temperature.
17. The invention as in claim 16 wherein the plastic used for said injection molding is of essentially the same composition as the extruded plastic tube.
18. The invention as in claim 17 wherein both said injection molding and said tube are formed of high density polyethylene.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/210,551 US5524757A (en) | 1994-03-18 | 1994-03-18 | Packaging sheaths for intra-aortic balloon catheters |
| US08/210,551 | 1994-03-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2185814A1 true CA2185814A1 (en) | 1995-09-28 |
Family
ID=22783350
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002185814A Abandoned CA2185814A1 (en) | 1994-03-18 | 1995-03-20 | Packaging sheaths for intra-aortic balloon catheters |
Country Status (5)
| Country | Link |
|---|---|
| US (2) | US5524757A (en) |
| EP (1) | EP0750471A4 (en) |
| JP (1) | JPH10501994A (en) |
| CA (1) | CA2185814A1 (en) |
| WO (1) | WO1995025466A1 (en) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6592552B1 (en) * | 1997-09-19 | 2003-07-15 | Cecil C. Schmidt | Direct pericardial access device and method |
| WO2009117663A2 (en) | 2008-03-20 | 2009-09-24 | Medrad, Inc. | Direct stream hydrodynamic catheter system |
| US9586023B2 (en) | 1998-02-06 | 2017-03-07 | Boston Scientific Limited | Direct stream hydrodynamic catheter system |
| US6821295B1 (en) | 2000-06-26 | 2004-11-23 | Thoratec Corporation | Flared coronary artery bypass grafts |
| US6899727B2 (en) | 2001-01-22 | 2005-05-31 | Gore Enterprise Holdings, Inc. | Deployment system for intraluminal devices |
| US7214220B2 (en) * | 2001-09-21 | 2007-05-08 | Boston Scientific Scimed, Inc. | Intravascular device with carrier tube engagement member |
| US7625365B2 (en) * | 2001-09-21 | 2009-12-01 | Boston Scientific Scimed, Inc. | Intravascular device and carrier tube with interference fit member |
| US6669624B2 (en) | 2002-03-26 | 2003-12-30 | O. Howard Frazier | Temporary heart-assist system |
| US8308789B2 (en) * | 2004-07-16 | 2012-11-13 | W. L. Gore & Associates, Inc. | Deployment system for intraluminal devices |
| US20080275393A1 (en) * | 2004-08-24 | 2008-11-06 | Bonnette Michael J | Isolation thrombectomy catheter system |
| US8162878B2 (en) | 2005-12-05 | 2012-04-24 | Medrad, Inc. | Exhaust-pressure-operated balloon catheter system |
| WO2009079539A1 (en) | 2007-12-17 | 2009-06-25 | Medrad, Inc. | Rheolytic thrombectomy catheter with self-inflation distal balloon |
| US8439878B2 (en) * | 2007-12-26 | 2013-05-14 | Medrad, Inc. | Rheolytic thrombectomy catheter with self-inflating proximal balloon with drug infusion capabilities |
| ES2752298T3 (en) * | 2008-01-29 | 2020-04-06 | Medical Components Inc | Introducing hub assembly with hub and method for attaching the hub to a hub tube |
| US7694810B1 (en) | 2009-02-26 | 2010-04-13 | Boston Scientific Scimed, Inc. | Carrier tube assembly for packaging a medical device |
| JP5595686B2 (en) * | 2009-07-29 | 2014-09-24 | テルモ株式会社 | Catheter storage tube |
| US8235209B2 (en) | 2010-08-11 | 2012-08-07 | Boston Scientific Scimed, Inc. | Medical device packaging and methods for preparing and packaging medical devices |
| US8973748B2 (en) | 2011-01-19 | 2015-03-10 | Boston Scientific Scime, Inc. | Medical device packaging and methods for preparing and packaging medical devices |
| US9096368B2 (en) | 2011-01-19 | 2015-08-04 | Boston Scientific Scimed, Inc. | Medical device packaging and methods for preparing and packaging medical devices |
| CN103008380A (en) * | 2012-12-26 | 2013-04-03 | 西南铝业（集团）有限责任公司 | 12500T horizontal extruder guide path |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3865666A (en) * | 1973-05-08 | 1975-02-11 | Int Paper Co | Method of making a catheter |
| US3959429A (en) * | 1975-02-03 | 1976-05-25 | International Paper Company | Method of making a retention catheter and molding a tip thereon |
| DK146150C (en) * | 1981-06-15 | 1983-12-05 | Richard Bent Nissen | HOSE FOR INTRODUCTION IN A TUBE-SHAPED SPACE |
| EP0228787A1 (en) * | 1985-11-08 | 1987-07-15 | Datascope Corp. | Prefolded balloon catheter |
| US4801015A (en) * | 1986-04-16 | 1989-01-31 | Shiley Inc. | Releasable holder and package assembly for a prosthetic heart valve |
| US4997084A (en) * | 1988-05-13 | 1991-03-05 | Opielab, Inc. | Packaging system for disposable endoscope sheaths |
| US5343861A (en) * | 1989-04-10 | 1994-09-06 | Herman Wesley K | Disposable tonometer cover with fluorescein dye |
| WO1991014473A1 (en) * | 1990-03-19 | 1991-10-03 | Taut, Incorporated | Injection molding of a thin-walled elongated tubular product such as a catheter |
| US5125416A (en) * | 1990-12-11 | 1992-06-30 | University Of Massachusetts Medical Center | Guidewire holder |
| US5167634A (en) * | 1991-08-22 | 1992-12-01 | Datascope Investment Corp. | Peelable sheath with hub connector |
| GB9213379D0 (en) * | 1992-06-24 | 1992-08-05 | Smiths Industries Plc | Medico-surgical devices |
| US5262113A (en) * | 1992-08-06 | 1993-11-16 | Carmien Joseph A | Method of making a plastic encased tool component having a lightweight hollow core |
-
1994
- 1994-03-18 US US08/210,551 patent/US5524757A/en not_active Expired - Lifetime
-
1995
- 1995-03-20 CA CA002185814A patent/CA2185814A1/en not_active Abandoned
- 1995-03-20 EP EP95914124A patent/EP0750471A4/en not_active Withdrawn
- 1995-03-20 JP JP7524755A patent/JPH10501994A/en not_active Ceased
- 1995-03-20 WO PCT/US1995/003465 patent/WO1995025466A1/en not_active Application Discontinuation
- 1995-06-07 US US08/483,923 patent/US5935501A/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US5935501A (en) | 1999-08-10 |
| US5524757A (en) | 1996-06-11 |
| JPH10501994A (en) | 1998-02-24 |
| WO1995025466A1 (en) | 1995-09-28 |
| EP0750471A1 (en) | 1997-01-02 |
| EP0750471A4 (en) | 1999-03-24 |
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
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