CA2187082A1 - Medical balloon folding into predetermined shapes - Google Patents
Medical balloon folding into predetermined shapesInfo
- Publication number
- CA2187082A1 CA2187082A1 CA002187082A CA2187082A CA2187082A1 CA 2187082 A1 CA2187082 A1 CA 2187082A1 CA 002187082 A CA002187082 A CA 002187082A CA 2187082 A CA2187082 A CA 2187082A CA 2187082 A1 CA2187082 A1 CA 2187082A1
- Authority
- CA
- Canada
- Prior art keywords
- balloon
- ribs
- webs
- mold
- corners
- 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
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1038—Wrapping or folding devices for use with balloon 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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
- A61M2025/1004—Balloons with folds, e.g. folded or multifolded
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
Abstract
An inflatable medical balloon (40) at its distal end for introduction into a body part especially through an endoscope (46) and method of making the balloon. When fully inflated, the balloon (40) is a continuous body of balloon material with a generally cylindrical shape and four ribs (44) formed in the body. The ribs (44) are longitudinally and equidistantly arranged around an axis (A) which extends from the proximal end to the distal end of the balloon (40). The ribs (44) are formed of stressed balloon material. Webs (45) of less stressed balloon material are disposed between the ribs (44), the ribs and the webs forming the balloon (40) and being expandable from a folded condition for insertion into the body part to an expanded condition with a generally cylindrical shape and a diameter substantially greater than the folded condition whereby to provide medical treatment and, after treatment being revertible into a folded condition of predetermined configuration with the webs (45) between the ribs (44) collapsing inwardly towards the axis (A).
Description
~ W095/2R9R5 21 ~ 7~ 2 MEDICAL BALLOON FOLDING
INTO IJk~ k~ ~: h-- IN~ SHAPES
The present invention relates to hAllonnR for catheters for insertion into parts of the body and particularly to a catheter with a balloon that after oYrAn~ion, use and evacu-ation of inflation fluids will fold itself into a predeter-mined shape o~ limited ~ r so that it can be easily withdrawn from t~i~ body. The balloon of the present inven-tion has special use with an endotracheal tube in which a folded balloon catheter is forced into the endotracheal tube before insertion into the trachea and before inflation.
After performing a medical ~Loc~du~ e, the balloon is deflat-ed and must be withdrawn back through the tube. Inflation of the balloon, we have found, ca~ss the ~ or of the balloon to increase from its origl~al folded and wrapped size to one which is large and bulky after def lation . The bulky deflated balloon is the quite difficult to withdraw throuqh the tube.
Description of the Prior Art In the prior art, catheters with single-walled balloons which collapse onto themselves are known. Exemplary of such a balloon is the device disclosed in the U. S. Patent to Hillstead, 5,037,392, in which a dilation balloon assembly is ~1iCCln~pd with three axially-extending longitudinal creases. Hillstead found when hAllonn~ were deflated after use, the lateral cross-section of the balloon could be greater than the flii ~r or lateral extent of a fully inflated or partially inflated balloon due to flattening.
Hillstead's balloon uses three side walls to eliminate flattening upon deflation into a wing-like configuration.
The balloon was particularly designed to insert a stent within an artery and to enable the balloon to expand the stent to a full size to engage the walls of the artery. The three-sided balloon can have relatively sharp sides due to _ WO 95l2 8 985 r~ 7 ~--~ 2 P ~ ~
the an angle of about 120. Triangular cross-sections are blade-like and can traumatically engage the walls of the vessel in which it is inserted.
The U. S. Patent to Schultze, 4,141,364, ~licclos~c an endotracheal tube which is col l Ars~ LL c.. ~ cL .,ely to the longitudinal ~ inn of the tube for insertion into the trachea of the patient. After the tube is in place it i5 ~Yr~nl~cl to open an uloL LLU~ Led pas__, _y th~L~:LhL~)uy~l by means of an ~Yp~n~ bl ~ cuff provided on the exterior of the tube to afford a seal between the trachea and the tube.
The U.S. Patent to Vigil, 3,209,799, ~l;c~-los~c a angio-plasty device in which four atherotomes are attached to the exterior of a balloon and the balloon is treated so that the atherotomes will be ~ uded in the balloon when it is deflated to provide covers which protect the patient from contact with the athc:r~t --' blade6.
The U. S. Patent to Smith, number 5,087,246, .l;cl05.,c a medical balloon that forms into flutes upon deflation to enable the balloon to be easily withdrawn through the endo-6cope. The flutes are formed by t~nC;nninq (stretching) then heating the tc-ncinn~r:l balloon. We have found that t~ncinn; nq weakens the catheter assembly at the balloon walls and can cause ~L~ LUL~ product failure.
The U. S. Patent to Farr et al., number 5,226,887, dis-closes a medical balloon that, when the balloon is neither inflated nor collapsed, has folding regions that are flat and reinf orcing regions that are curved . The f olding re-gions are less stiff than the reinforcing regions. The reinforcing regions, however, do not extend the full length of the balloon but rather are radially off-set at the distal ends which places ~LL~:sses on the balloon and makes it tl;l~fic--lt to pre~l;c~ ~hly fold the balloon after use and easily withdraw it through an ~n-ln6cope.
~Woss/28s8s ~7ia~8~ p~"~
Summary of the Invention According to the present invention we have developed a balloon catheter for insertion into a body part, for example the trachea, by means of an endotracheal tube. The inner .1~ i ~ Pr Of the tube is only slightly greater than the outer rl1 ' Pr of the folded and wrapped balloon. The balloon i8 made of balloon material which can be PYr~nrlPrl to a general-ly cylindrical shape. Ribs are formed in the balloon mate-rial and the6e ribs are longitll~lin~lly arranged and e~uidis-tantly separated from each other about the axis of the balloon. They extend from the proximal to the distal end of the balloon. Stiff ribs are formed of ~Le~ad balloon material and less stiff webs between the ribs are formed of less ~Lassed material. The balloon is PYp~nA Ihle from a folded and wrnpped configuration before use to an PYp~nr~Pd condition with a generally cylindrical shape to provide the medical LLèai '. After the medical ~.oceduLa, the balloon is deflated (by evacuation of the inflation fluid) to a diameter which allows it to be narrow enough to reenter the tube through which it was originally inserted.
One aspect of the invention involves a balloon for a catheter for i..LL~,du-,Lion into a body part through an endo-scope. The catheter ; nr~ rlPc a hollow shaft with a proximal and a distal end. The balloon is formed of a ~rlntinll~-lC
body of untensioned balloon material and has a generally cylindrical shape. Four ribs are ~; ~pocPd in the balloon and are formed of LLe~ed balloon material. The ribs are longitll~linS~lly and e~uidistantly dLLrlllyed around an axis and extend as straight lines over the distance between the proximal and distal end of the balloon. Webs of less stressed balloon material ~ posPd between the ribs. The ribs and the webs form the balloon and are expa~able from the folded condition of pre~lPtPrminPd shape to the P~nrlPcl condition with a generally cylindrical shape and a diameter Dub~Ldl~ially greatêr than the folded condition. Thê intro-duction of inflation fluid through the proximal end of the W095128985 ;~ 7~ P~ s shaft inflates the balloon 50 the medical LL~ai L can be provided. After L~ ~=ai ', the balloon is revertible to the folded condition of pr~PtPrminPd shape with the webs be-tween the ribs coll~r~in~J inwardly from the proximal to the distal end of the balloon towards the axis by withdrawal of the inf lation f luid (without the use of tension) so the bal-loon can be withdrawn through the Pn~ cope. A closure tip iB ~ po8Pd at the distal end of the balloon and a loosely floating guide wire is ~i ~posed within the balloon and in the tip. The guide wire extends from the shaft to the clo-sure and engages both the shaft and the closure.
Another aspect of the invention involves a medical balloon formed for attachment to a hollow catheter shaft and for s~hseq~l~nt illLLv~ on into a body part. The balloon is deflatable into a pr~t~ninPd shape of minimal dimen-sions to be withdrawn through a tube of a ~ Pr substan-tially the same as the minimum ~ n of the balloon. We place into a mold a preformed medical balloon formed of a C~nt-in~ body of balloon material that has a generally cylindrical shape when inflated. The mold has a length ~U~ L ~ l i ng to the desired length of the balloon and a generally polygonal cross section with side walls of sub-stantially the same width connected by corners, the spacing between opposed corners approximating the desired diameter of the balloon when inflated. The mold further has end members at each end and each of the end members has a pyram-idal shape terminating in an apex. The corners of the mold cuLLcD~al.d with the corners of the end members and opPnin~c are formed at the apexes for clamps that hold the balloon in place within the mold and allow for the il-LLv~ l ion of inflation fluid. The mold is heated to the softening point of the balloon and a ~L ~ uL iz ing f luid is f orced into the balloon to urge the balloon material against the sidewalls, into the corners and the end members whereby to establish DLL_ssed areas where the balloon engages the corners and form four radially t" Lt~ ed ribs with webs therebetween.
-WO95/28985 i? 1 87~2 P 9 .
T~ aLuLas used are between about 160 and 195C and pres-sures are between about 140 and 200 psi. The ribs extend cnntiml~u~ly from the distal to the proximal ends of the balloon. The webs are less DLL~ ed than the ribs due to ' 5 greater ~Yr~n~inn distances of the balloon material into the corners than to the sidewalls of the mold. The ribs and the webs form the balloon and are ~YrAn~Ahle from a folded condition f or insertion into the body part to an ~ d condition with a tli~ t~r D..L,,Lal,Lially greater than its folded condition whereby to provide medical treatment tc ;~he p2rt and thence, after LLc:ai L, into a folded condition with the webs cnl l Ar5; n~ inwardly towards the axis, the ribs extending parallel to the axis, each of the ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a ba~loon with ribs and webs as the body of the balloon. The ~dlloon is ~YrAn~l~bl e to a generally cylindrical shape by ~e i--LLo-lu- Lion of an expan-sion fluid and then collArsihle upon the withdrawal of the fluid into a DLLU~:LUL~ wherein the webs ~ollArSe between the ribs towards the axis to enable easy withdrawal from the body part.
In the preferred --'; L we use conv~ntinnAl bal-loon-forming stock of polyethylene terPrhthAl~te (PET).
Usually the PET is rli~pos~d between co-extruded layers of Selar such as ~ sed in the Wang et al no . 5 ,195, 969 and incvLuuLated herein by reference. Selar is a barrier resin made by the DuPont de ne Mours Company of Wilmington, Dela-ware. The balloon of our invention can be made by placing a pre-blown partially inflated balloon having a conV~nti wall ~hi~ n~c in a mold having a length CULL~ U~ ~1in~ to the desired length of the balloon and a generally sguare ~:LU~ s~_Lion with four side walls of substAntiAl ly the same width cnnn~cted by four corners. The ~id~ of the mold have widths between about 0 . 002 and 0 . 6 in. and each are of DubDLalltially the same, thereby providing a mold with a generally square cross section and corners of 90 degrees.
wo 9s/28985 ~ 7 r~ 6 Each of the end members of the mold have a pyramidal shape with the base CVL~ ;nq to the end of the polygonal seation of the mold. The mold is heated to the softening point of the plastic balloon material placed therein, gener-ally between about 160 and 195C, and a ~,~s.iuLlzing fluid, eg. nitrogen, is forced into the balloon 80 that the balloon expands to urge against the side walls, into the corners and against the end members. When the balloon expands into the corners, the ~YrAnci~n of the balloon is greater for the ribs than for the webs th~ }_ _cn since the distance between the axis and the corners is greater than the dis-tance between the axis - and the side walls. This additional stretching puts greater stress on the balloon where it meets the corners then where it meets the side walls of the mold.
The additional stress ma3ces the ribs more rigid than the webs which are ther~ . The balloon is then removed from the mold. It is ~YrAn~9Ahl~ to the generally cylin-drical shape by the i-lLL.~ n of ~YrAnai~n fluid and thence collArc~hl~ upon withdrawal of the fluid into a ~LLu~;Lu~e: where the webs between the rips collapse towards the axis to enable the balloon to be easily drawn through the tube of substantially the same inner tli as the outer diameter of the original wrapped and folded balloon.
Brief Description of the Drawings Figure 1 is a plan view of one half of a mold 6howing the open cavity which receives the balloon.
Figure 2 is a ~ .vD~-aecti-~nAl view of the top and bottom of the mold shown in Figure 1.
Figures 3, 4 and 5 are :LVSS se~Li~nAl views of the balloon of the present invention in three stages of inf la-tion: partial, full and evacuated.
Figure 6 is a side elevational view of the balloon according to our invention.
Figure 7 is a side view of a deflated balloon extending from an endotracheal tube.
WOgs/2898s ~ ¦ ~ 7~ r~
Description of the Pref erred F~h-yl; - ' _ Referring now to Figure 1 one half of a mold for form-ing the balloon of the present invention is shown and in Figure 2 both halves are shown. The mold body 10 ~ nrl l-~PS a cavity 11 with side walls 12 and 13. A corner 14 is dis-posed between the side walls. Each of the side walls 12 and 13 have substantially the same ~ i onC . The cor-ner 14 is a 90 angle. At each end of the ~ w~ 12 and 13 are pyramidal-shaped end members 2 and 3. The side walls of the body of the mold and the base of each of the end members 2 and 3 have the same dimensions 80 as to pro-vide continuous corners that terminate in an apex. A hole i5 formed at the apeYes at each end of the end members 2 and 3 to receive the ends of the balloon.
Figure 1 shows the lower half 15 of the mold as seen in Fiy~re 2. An upper half 16 covy~:Lates with the lower half 15 to form a cavity with four corners and four side walls. The upper half 16 and the lower half 15 are bolted t~ye:Ll.aI by bolts 17 and 18 that fit in holes 19 and 20.
An axis A passes from a left holder slot 22 through a right holder slot 23. These holder slots are of a diameter to hold a balloon 24 (shown in dotted lines). A gas is blown into the balloon 24, one end of which is blocked off, to expand it. The mold 10 is heated in conv~n~ nA l ways to soften the plastic of the balloon 24 and form the ribs and the webs thelL~L_ as will be described hereinafter. The balloon is not t~n~ n~l prior to disposition in the mold, thereby not stressing the balloon prior to its ~YrAn~; nn .
A view of a fully QYr~n~ balloon 40 is shown in Figure 6. When fully ~ 1 it has a generally cylindri-cal shape in its body section 41. End walls 42 and 43, in inflated condition, have generally rLa2~LLocullical shapes although, they too, have the ribs mentioned above. The balloon 40 is formed of conv~nti~nAl medical balloon forming materials such as polyethylene ter~rhth~lAte (PET). In the pref erred ' ' i - ~ of the present invention we use a coaxial extrusion of PET with Selar on each side thereof and th;. 1. "~c~Pc of Selar between about 0.0001 and 0. 00005 in. in each layer.
Webs 45, as better shown in Figures 3, 4 and 5, are ~ posed between ribs 44. The balloon has three config-urations. In the PYr~n~ state, as shown in Figures 4 and 6, it has a generally cylindrical shape. Prior to the expansion it is folded and wrapped, generally upon itself so that it can be readily inflated. Folding and wrapping is conventional in the medical balloon art to reduce the size of the balloon as much as pocc;hlP. As the balloon is inflated by blowing inflation fluid into tube 25 that is conventionally attached to the proximal end of the balloon 24 . It reaches an int~ ; Ate stage, as shown in Figure 3, in which it has a generally square ,vss-3ection.
This ; ntl '; Ate stage is passed during the inf lation until the balloon reaches the cylindrical shape shown in Figure 4.
The medical ~LoC~ L- is peLr~ -' while it is in the cylin-drical shape and while it is at its maximum diameter.
Following inflation and use, the inflating media is withdrawn through tube 25 and the four ribs 44 and the four webs 45 collapse inwardly towards the axis of the balloon.
As shown in Figure 5 the ribs 44 are relatively stiff and support the webs 45 ~; cp~cPd th~L~b~ . Thus the webs 45 col lArFe more readily. A smaller profile is ~Le:s~ ed which enables the balloon to be easily drawn into the endotracheal tube that was used for insertion of the balloon into the body. Comparing a balloon made in an octagonally cross ~c~; ~nP~l mold with one made according to the present inven-tion, that is a mold with a square cross section, we found that it took 6 . 65 lbs. to withdraw an octagonally shaped 18 mm. balloon from an ~ sc-~"e whereas it only took a mean force of 5. 0 lbs. to withdraw the square shaped balloon from an Pn~lo~rope of the same size. Thus the impact of the use of a square mold was to de-;L,~se the force required to withdraw the balloon from the Pn~srope . With h~ 11 o~nC
-wo 95l28985 21 8 7 0 8 2 r~
without ribs the balloon collapsed into a pancake-like ~LLU-iLULe which was e~LLL~ -ly difficult to withdraw through the ~los ~ ,e .
Referring to Figure 7 the balloon 40 is shown with the inflation media withdrawn through tube 25. A conventional stiffening wire 47 is tli~posP~ within the balloon 40 and extends from a closed distal end 48 through the balloon and into the tube 25 and out its end. Because of the relative stiffness between the webs and the ribs as described above withdrawal of the inflation media will cause the webs to collapse inwardly between the ribs. Pulling the end 25A of the tube will cause the balloon 40 to be easily drawn into an endotracheal tube 4 6 with a minimum of dif f iculty so the balloon 40 can be easily removed from the body.
With the four sided balloon of the present invention we found that it was pn~;hlP to inflate and deflate the bal-loon many times (e.g. 40 cycles at operating ~L~S~ LaS) and obtain the same folding action repeatably with the webs coll~rcing toward the axis and being supported by the ribs.
When withdrawn through the tube, the ribs are squeezed towards the axis of the balloon and the webs fold generally in the middle of the spaces between them thereby prPI:Pn~;
a profile that approximates the originally folded and wrapped balloon to enable it to be easily withdrawn through the tube. ~IJL~ VO:I the 90 angles provided by the use of four sides is DllLDL~ 1 ly "L~,u-~ed" and there are no "sharp" edges which might serve to impede catheter withdraw-al or in the worst case abrade tissue. In addition the continuous ribs, extending from the distal to the proximal end of the balloon as a straight line enable the entire balloon to be uniformly collapsed around its axis thereby Pnh~nnin~ the DLL-~ L~l of the balloon.
The balloon preform is loaded into a balloon machine and then blown with nitrogen in a heated oil bath using cones on either side of the unit to control the size, as is conventional. The outside diameter of the balloon is 80 to W09~2898~ ,708~ P~ 9!.
90% of its net shape. The balloon is then removed from the machine and cleaned of any residual oil . The f inal dimen-sions of the balloon are then es~hl ~ ~h~fl in a heat set process. In thi6 process the cylindrical balloon is placed S into a mold with a square 1~ uss s~_-ion. The area of the cavity perimeter is 4.27596 greater than the final balloon target circumference. The balloon is lowered into the lower half of an ~ m--n mold and inf lated to 10 psi . ~he top half of the mold is then clamped onto the lower half to cover the balloon . The balloon is then inf lated in two or more stages to a ~L~c:juLe between about 140 to 200 psi while the mold is heated to 160 to 195C. During this process the balloon is stretched in an axial direction the combination axial and radial stretching e~ uuL c.~s additional biaxial orientation.
It is a~a~ L that modif ications and changes can be made within the spirit and scope of the present invention.
It is our intention, however, only to be limited by the ~cope of the ~rrPn~lPfl claims.
INTO IJk~ k~ ~: h-- IN~ SHAPES
The present invention relates to hAllonnR for catheters for insertion into parts of the body and particularly to a catheter with a balloon that after oYrAn~ion, use and evacu-ation of inflation fluids will fold itself into a predeter-mined shape o~ limited ~ r so that it can be easily withdrawn from t~i~ body. The balloon of the present inven-tion has special use with an endotracheal tube in which a folded balloon catheter is forced into the endotracheal tube before insertion into the trachea and before inflation.
After performing a medical ~Loc~du~ e, the balloon is deflat-ed and must be withdrawn back through the tube. Inflation of the balloon, we have found, ca~ss the ~ or of the balloon to increase from its origl~al folded and wrapped size to one which is large and bulky after def lation . The bulky deflated balloon is the quite difficult to withdraw throuqh the tube.
Description of the Prior Art In the prior art, catheters with single-walled balloons which collapse onto themselves are known. Exemplary of such a balloon is the device disclosed in the U. S. Patent to Hillstead, 5,037,392, in which a dilation balloon assembly is ~1iCCln~pd with three axially-extending longitudinal creases. Hillstead found when hAllonn~ were deflated after use, the lateral cross-section of the balloon could be greater than the flii ~r or lateral extent of a fully inflated or partially inflated balloon due to flattening.
Hillstead's balloon uses three side walls to eliminate flattening upon deflation into a wing-like configuration.
The balloon was particularly designed to insert a stent within an artery and to enable the balloon to expand the stent to a full size to engage the walls of the artery. The three-sided balloon can have relatively sharp sides due to _ WO 95l2 8 985 r~ 7 ~--~ 2 P ~ ~
the an angle of about 120. Triangular cross-sections are blade-like and can traumatically engage the walls of the vessel in which it is inserted.
The U. S. Patent to Schultze, 4,141,364, ~licclos~c an endotracheal tube which is col l Ars~ LL c.. ~ cL .,ely to the longitudinal ~ inn of the tube for insertion into the trachea of the patient. After the tube is in place it i5 ~Yr~nl~cl to open an uloL LLU~ Led pas__, _y th~L~:LhL~)uy~l by means of an ~Yp~n~ bl ~ cuff provided on the exterior of the tube to afford a seal between the trachea and the tube.
The U.S. Patent to Vigil, 3,209,799, ~l;c~-los~c a angio-plasty device in which four atherotomes are attached to the exterior of a balloon and the balloon is treated so that the atherotomes will be ~ uded in the balloon when it is deflated to provide covers which protect the patient from contact with the athc:r~t --' blade6.
The U. S. Patent to Smith, number 5,087,246, .l;cl05.,c a medical balloon that forms into flutes upon deflation to enable the balloon to be easily withdrawn through the endo-6cope. The flutes are formed by t~nC;nninq (stretching) then heating the tc-ncinn~r:l balloon. We have found that t~ncinn; nq weakens the catheter assembly at the balloon walls and can cause ~L~ LUL~ product failure.
The U. S. Patent to Farr et al., number 5,226,887, dis-closes a medical balloon that, when the balloon is neither inflated nor collapsed, has folding regions that are flat and reinf orcing regions that are curved . The f olding re-gions are less stiff than the reinforcing regions. The reinforcing regions, however, do not extend the full length of the balloon but rather are radially off-set at the distal ends which places ~LL~:sses on the balloon and makes it tl;l~fic--lt to pre~l;c~ ~hly fold the balloon after use and easily withdraw it through an ~n-ln6cope.
~Woss/28s8s ~7ia~8~ p~"~
Summary of the Invention According to the present invention we have developed a balloon catheter for insertion into a body part, for example the trachea, by means of an endotracheal tube. The inner .1~ i ~ Pr Of the tube is only slightly greater than the outer rl1 ' Pr of the folded and wrapped balloon. The balloon i8 made of balloon material which can be PYr~nrlPrl to a general-ly cylindrical shape. Ribs are formed in the balloon mate-rial and the6e ribs are longitll~lin~lly arranged and e~uidis-tantly separated from each other about the axis of the balloon. They extend from the proximal to the distal end of the balloon. Stiff ribs are formed of ~Le~ad balloon material and less stiff webs between the ribs are formed of less ~Lassed material. The balloon is PYp~nA Ihle from a folded and wrnpped configuration before use to an PYp~nr~Pd condition with a generally cylindrical shape to provide the medical LLèai '. After the medical ~.oceduLa, the balloon is deflated (by evacuation of the inflation fluid) to a diameter which allows it to be narrow enough to reenter the tube through which it was originally inserted.
One aspect of the invention involves a balloon for a catheter for i..LL~,du-,Lion into a body part through an endo-scope. The catheter ; nr~ rlPc a hollow shaft with a proximal and a distal end. The balloon is formed of a ~rlntinll~-lC
body of untensioned balloon material and has a generally cylindrical shape. Four ribs are ~; ~pocPd in the balloon and are formed of LLe~ed balloon material. The ribs are longitll~linS~lly and e~uidistantly dLLrlllyed around an axis and extend as straight lines over the distance between the proximal and distal end of the balloon. Webs of less stressed balloon material ~ posPd between the ribs. The ribs and the webs form the balloon and are expa~able from the folded condition of pre~lPtPrminPd shape to the P~nrlPcl condition with a generally cylindrical shape and a diameter Dub~Ldl~ially greatêr than the folded condition. Thê intro-duction of inflation fluid through the proximal end of the W095128985 ;~ 7~ P~ s shaft inflates the balloon 50 the medical LL~ai L can be provided. After L~ ~=ai ', the balloon is revertible to the folded condition of pr~PtPrminPd shape with the webs be-tween the ribs coll~r~in~J inwardly from the proximal to the distal end of the balloon towards the axis by withdrawal of the inf lation f luid (without the use of tension) so the bal-loon can be withdrawn through the Pn~ cope. A closure tip iB ~ po8Pd at the distal end of the balloon and a loosely floating guide wire is ~i ~posed within the balloon and in the tip. The guide wire extends from the shaft to the clo-sure and engages both the shaft and the closure.
Another aspect of the invention involves a medical balloon formed for attachment to a hollow catheter shaft and for s~hseq~l~nt illLLv~ on into a body part. The balloon is deflatable into a pr~t~ninPd shape of minimal dimen-sions to be withdrawn through a tube of a ~ Pr substan-tially the same as the minimum ~ n of the balloon. We place into a mold a preformed medical balloon formed of a C~nt-in~ body of balloon material that has a generally cylindrical shape when inflated. The mold has a length ~U~ L ~ l i ng to the desired length of the balloon and a generally polygonal cross section with side walls of sub-stantially the same width connected by corners, the spacing between opposed corners approximating the desired diameter of the balloon when inflated. The mold further has end members at each end and each of the end members has a pyram-idal shape terminating in an apex. The corners of the mold cuLLcD~al.d with the corners of the end members and opPnin~c are formed at the apexes for clamps that hold the balloon in place within the mold and allow for the il-LLv~ l ion of inflation fluid. The mold is heated to the softening point of the balloon and a ~L ~ uL iz ing f luid is f orced into the balloon to urge the balloon material against the sidewalls, into the corners and the end members whereby to establish DLL_ssed areas where the balloon engages the corners and form four radially t" Lt~ ed ribs with webs therebetween.
-WO95/28985 i? 1 87~2 P 9 .
T~ aLuLas used are between about 160 and 195C and pres-sures are between about 140 and 200 psi. The ribs extend cnntiml~u~ly from the distal to the proximal ends of the balloon. The webs are less DLL~ ed than the ribs due to ' 5 greater ~Yr~n~inn distances of the balloon material into the corners than to the sidewalls of the mold. The ribs and the webs form the balloon and are ~YrAn~Ahle from a folded condition f or insertion into the body part to an ~ d condition with a tli~ t~r D..L,,Lal,Lially greater than its folded condition whereby to provide medical treatment tc ;~he p2rt and thence, after LLc:ai L, into a folded condition with the webs cnl l Ar5; n~ inwardly towards the axis, the ribs extending parallel to the axis, each of the ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a ba~loon with ribs and webs as the body of the balloon. The ~dlloon is ~YrAn~l~bl e to a generally cylindrical shape by ~e i--LLo-lu- Lion of an expan-sion fluid and then collArsihle upon the withdrawal of the fluid into a DLLU~:LUL~ wherein the webs ~ollArSe between the ribs towards the axis to enable easy withdrawal from the body part.
In the preferred --'; L we use conv~ntinnAl bal-loon-forming stock of polyethylene terPrhthAl~te (PET).
Usually the PET is rli~pos~d between co-extruded layers of Selar such as ~ sed in the Wang et al no . 5 ,195, 969 and incvLuuLated herein by reference. Selar is a barrier resin made by the DuPont de ne Mours Company of Wilmington, Dela-ware. The balloon of our invention can be made by placing a pre-blown partially inflated balloon having a conV~nti wall ~hi~ n~c in a mold having a length CULL~ U~ ~1in~ to the desired length of the balloon and a generally sguare ~:LU~ s~_Lion with four side walls of substAntiAl ly the same width cnnn~cted by four corners. The ~id~ of the mold have widths between about 0 . 002 and 0 . 6 in. and each are of DubDLalltially the same, thereby providing a mold with a generally square cross section and corners of 90 degrees.
wo 9s/28985 ~ 7 r~ 6 Each of the end members of the mold have a pyramidal shape with the base CVL~ ;nq to the end of the polygonal seation of the mold. The mold is heated to the softening point of the plastic balloon material placed therein, gener-ally between about 160 and 195C, and a ~,~s.iuLlzing fluid, eg. nitrogen, is forced into the balloon 80 that the balloon expands to urge against the side walls, into the corners and against the end members. When the balloon expands into the corners, the ~YrAnci~n of the balloon is greater for the ribs than for the webs th~ }_ _cn since the distance between the axis and the corners is greater than the dis-tance between the axis - and the side walls. This additional stretching puts greater stress on the balloon where it meets the corners then where it meets the side walls of the mold.
The additional stress ma3ces the ribs more rigid than the webs which are ther~ . The balloon is then removed from the mold. It is ~YrAn~9Ahl~ to the generally cylin-drical shape by the i-lLL.~ n of ~YrAnai~n fluid and thence collArc~hl~ upon withdrawal of the fluid into a ~LLu~;Lu~e: where the webs between the rips collapse towards the axis to enable the balloon to be easily drawn through the tube of substantially the same inner tli as the outer diameter of the original wrapped and folded balloon.
Brief Description of the Drawings Figure 1 is a plan view of one half of a mold 6howing the open cavity which receives the balloon.
Figure 2 is a ~ .vD~-aecti-~nAl view of the top and bottom of the mold shown in Figure 1.
Figures 3, 4 and 5 are :LVSS se~Li~nAl views of the balloon of the present invention in three stages of inf la-tion: partial, full and evacuated.
Figure 6 is a side elevational view of the balloon according to our invention.
Figure 7 is a side view of a deflated balloon extending from an endotracheal tube.
WOgs/2898s ~ ¦ ~ 7~ r~
Description of the Pref erred F~h-yl; - ' _ Referring now to Figure 1 one half of a mold for form-ing the balloon of the present invention is shown and in Figure 2 both halves are shown. The mold body 10 ~ nrl l-~PS a cavity 11 with side walls 12 and 13. A corner 14 is dis-posed between the side walls. Each of the side walls 12 and 13 have substantially the same ~ i onC . The cor-ner 14 is a 90 angle. At each end of the ~ w~ 12 and 13 are pyramidal-shaped end members 2 and 3. The side walls of the body of the mold and the base of each of the end members 2 and 3 have the same dimensions 80 as to pro-vide continuous corners that terminate in an apex. A hole i5 formed at the apeYes at each end of the end members 2 and 3 to receive the ends of the balloon.
Figure 1 shows the lower half 15 of the mold as seen in Fiy~re 2. An upper half 16 covy~:Lates with the lower half 15 to form a cavity with four corners and four side walls. The upper half 16 and the lower half 15 are bolted t~ye:Ll.aI by bolts 17 and 18 that fit in holes 19 and 20.
An axis A passes from a left holder slot 22 through a right holder slot 23. These holder slots are of a diameter to hold a balloon 24 (shown in dotted lines). A gas is blown into the balloon 24, one end of which is blocked off, to expand it. The mold 10 is heated in conv~n~ nA l ways to soften the plastic of the balloon 24 and form the ribs and the webs thelL~L_ as will be described hereinafter. The balloon is not t~n~ n~l prior to disposition in the mold, thereby not stressing the balloon prior to its ~YrAn~; nn .
A view of a fully QYr~n~ balloon 40 is shown in Figure 6. When fully ~ 1 it has a generally cylindri-cal shape in its body section 41. End walls 42 and 43, in inflated condition, have generally rLa2~LLocullical shapes although, they too, have the ribs mentioned above. The balloon 40 is formed of conv~nti~nAl medical balloon forming materials such as polyethylene ter~rhth~lAte (PET). In the pref erred ' ' i - ~ of the present invention we use a coaxial extrusion of PET with Selar on each side thereof and th;. 1. "~c~Pc of Selar between about 0.0001 and 0. 00005 in. in each layer.
Webs 45, as better shown in Figures 3, 4 and 5, are ~ posed between ribs 44. The balloon has three config-urations. In the PYr~n~ state, as shown in Figures 4 and 6, it has a generally cylindrical shape. Prior to the expansion it is folded and wrapped, generally upon itself so that it can be readily inflated. Folding and wrapping is conventional in the medical balloon art to reduce the size of the balloon as much as pocc;hlP. As the balloon is inflated by blowing inflation fluid into tube 25 that is conventionally attached to the proximal end of the balloon 24 . It reaches an int~ ; Ate stage, as shown in Figure 3, in which it has a generally square ,vss-3ection.
This ; ntl '; Ate stage is passed during the inf lation until the balloon reaches the cylindrical shape shown in Figure 4.
The medical ~LoC~ L- is peLr~ -' while it is in the cylin-drical shape and while it is at its maximum diameter.
Following inflation and use, the inflating media is withdrawn through tube 25 and the four ribs 44 and the four webs 45 collapse inwardly towards the axis of the balloon.
As shown in Figure 5 the ribs 44 are relatively stiff and support the webs 45 ~; cp~cPd th~L~b~ . Thus the webs 45 col lArFe more readily. A smaller profile is ~Le:s~ ed which enables the balloon to be easily drawn into the endotracheal tube that was used for insertion of the balloon into the body. Comparing a balloon made in an octagonally cross ~c~; ~nP~l mold with one made according to the present inven-tion, that is a mold with a square cross section, we found that it took 6 . 65 lbs. to withdraw an octagonally shaped 18 mm. balloon from an ~ sc-~"e whereas it only took a mean force of 5. 0 lbs. to withdraw the square shaped balloon from an Pn~lo~rope of the same size. Thus the impact of the use of a square mold was to de-;L,~se the force required to withdraw the balloon from the Pn~srope . With h~ 11 o~nC
-wo 95l28985 21 8 7 0 8 2 r~
without ribs the balloon collapsed into a pancake-like ~LLU-iLULe which was e~LLL~ -ly difficult to withdraw through the ~los ~ ,e .
Referring to Figure 7 the balloon 40 is shown with the inflation media withdrawn through tube 25. A conventional stiffening wire 47 is tli~posP~ within the balloon 40 and extends from a closed distal end 48 through the balloon and into the tube 25 and out its end. Because of the relative stiffness between the webs and the ribs as described above withdrawal of the inflation media will cause the webs to collapse inwardly between the ribs. Pulling the end 25A of the tube will cause the balloon 40 to be easily drawn into an endotracheal tube 4 6 with a minimum of dif f iculty so the balloon 40 can be easily removed from the body.
With the four sided balloon of the present invention we found that it was pn~;hlP to inflate and deflate the bal-loon many times (e.g. 40 cycles at operating ~L~S~ LaS) and obtain the same folding action repeatably with the webs coll~rcing toward the axis and being supported by the ribs.
When withdrawn through the tube, the ribs are squeezed towards the axis of the balloon and the webs fold generally in the middle of the spaces between them thereby prPI:Pn~;
a profile that approximates the originally folded and wrapped balloon to enable it to be easily withdrawn through the tube. ~IJL~ VO:I the 90 angles provided by the use of four sides is DllLDL~ 1 ly "L~,u-~ed" and there are no "sharp" edges which might serve to impede catheter withdraw-al or in the worst case abrade tissue. In addition the continuous ribs, extending from the distal to the proximal end of the balloon as a straight line enable the entire balloon to be uniformly collapsed around its axis thereby Pnh~nnin~ the DLL-~ L~l of the balloon.
The balloon preform is loaded into a balloon machine and then blown with nitrogen in a heated oil bath using cones on either side of the unit to control the size, as is conventional. The outside diameter of the balloon is 80 to W09~2898~ ,708~ P~ 9!.
90% of its net shape. The balloon is then removed from the machine and cleaned of any residual oil . The f inal dimen-sions of the balloon are then es~hl ~ ~h~fl in a heat set process. In thi6 process the cylindrical balloon is placed S into a mold with a square 1~ uss s~_-ion. The area of the cavity perimeter is 4.27596 greater than the final balloon target circumference. The balloon is lowered into the lower half of an ~ m--n mold and inf lated to 10 psi . ~he top half of the mold is then clamped onto the lower half to cover the balloon . The balloon is then inf lated in two or more stages to a ~L~c:juLe between about 140 to 200 psi while the mold is heated to 160 to 195C. During this process the balloon is stretched in an axial direction the combination axial and radial stretching e~ uuL c.~s additional biaxial orientation.
It is a~a~ L that modif ications and changes can be made within the spirit and scope of the present invention.
It is our intention, however, only to be limited by the ~cope of the ~rrPn~lPfl claims.
Claims (17)
1. A balloon catheter for introduction into a body part through an endoscope, said catheter having a shaft with a proximal and a distal end, said shaft further having at least one lumen and a balloon attached to the distal end of said shaft, said balloon having a proximal and a distal end, said catheter comprising:
a balloon formed of a continuous body of untensioned balloon material and having a generally cylindrical shape;
four ribs disposed in said balloon and being formed of stressed balloon material, said ribs being longitudinally and equidistantly arranged around an axis, said ribs extend-ing as straight lines over the distance between said proxi-mal and distal end of said balloon;
webs of less stressed balloon material disposed between said ribs, said ribs and said webs forming said balloon and being expandable from a folded condition of a predetermined shape for insertion into said body part through said endo-scope to an expanded condition with a generally cylindrical shape and a diameter substantially greater than said folded condition by the introduction of inflation fluid through the proximal end of said shaft whereby to provide medical treat-ment to said part and, after treatment, being revertible into a folded condition with the webs between said ribs collapsing inwardly from the proximal to the distal end of said balloon towards said axis by withdrawal of the infla-tion fluid without the use of tension to enable said balloon to be withdrawn through said endoscope;
means forming a closure disposed at the distal end of said balloon;
a stiffening wire to stiffen said balloon, said wire extending from said shaft to said closure means and engaging both said shaft and said closure means.
a balloon formed of a continuous body of untensioned balloon material and having a generally cylindrical shape;
four ribs disposed in said balloon and being formed of stressed balloon material, said ribs being longitudinally and equidistantly arranged around an axis, said ribs extend-ing as straight lines over the distance between said proxi-mal and distal end of said balloon;
webs of less stressed balloon material disposed between said ribs, said ribs and said webs forming said balloon and being expandable from a folded condition of a predetermined shape for insertion into said body part through said endo-scope to an expanded condition with a generally cylindrical shape and a diameter substantially greater than said folded condition by the introduction of inflation fluid through the proximal end of said shaft whereby to provide medical treat-ment to said part and, after treatment, being revertible into a folded condition with the webs between said ribs collapsing inwardly from the proximal to the distal end of said balloon towards said axis by withdrawal of the infla-tion fluid without the use of tension to enable said balloon to be withdrawn through said endoscope;
means forming a closure disposed at the distal end of said balloon;
a stiffening wire to stiffen said balloon, said wire extending from said shaft to said closure means and engaging both said shaft and said closure means.
2. The catheter according to claim 1 wherein the stiffening wire is attached to the proximal end of said shaft and the distal end of said balloon.
3. The catheter according to claim 1 wherein the bal-loon is formed of polyethylene terephthalate.
4. The catheter according to claim 1 wherein the bal-loon is formed of a base layer of polyethylene terephthalate with a layer of Selar disposed on either side of said base layer.
5. A balloon catheter for introduction into a tubular body conduit, said catheter having a shaft with a proximal and a distal end, said shaft further having at least one lumen and a balloon attached to the distal end of said shaft, said balloon having a proximal and a distal end, said catheter comprising:
a balloon formed of a continuous body of untensioned balloon material and having a generally cylindrical shape;
four ribs disposed in said balloon and being formed of stressed balloon material, said ribs being longitudinally and equidistantly arranged around an axis, said ribs extend-ing as straight lines over the distance between said proxi-mal and distal end of said balloon;
webs of less stressed balloon material disposed between said ribs, said ribs and said webs forming said balloon and being expanded from a folded condition of a predetermined shape for insertion into said body conduit to an expanded condition with a generally cylindrical shape and a diameter substantially greater than said folded condition by the introduction of inflation fluid through the proximal end of said shaft whereby to provide medical treatment within said conduit and, after treatment, being revertible into a folded condition with the webs between said ribs collapsing inward-ly from the proximal to the distal end of said balloon towards said axis by withdrawal of the inflation fluid without the use of tension to enable said balloon to be withdrawn from said conduit;
means forming a closure disposed at the distal end of said balloon;
a stiffening wire to stiffen said balloon, said wire extending from said shaft to said closure means and engaging both said shaft and said closure means.
a balloon formed of a continuous body of untensioned balloon material and having a generally cylindrical shape;
four ribs disposed in said balloon and being formed of stressed balloon material, said ribs being longitudinally and equidistantly arranged around an axis, said ribs extend-ing as straight lines over the distance between said proxi-mal and distal end of said balloon;
webs of less stressed balloon material disposed between said ribs, said ribs and said webs forming said balloon and being expanded from a folded condition of a predetermined shape for insertion into said body conduit to an expanded condition with a generally cylindrical shape and a diameter substantially greater than said folded condition by the introduction of inflation fluid through the proximal end of said shaft whereby to provide medical treatment within said conduit and, after treatment, being revertible into a folded condition with the webs between said ribs collapsing inward-ly from the proximal to the distal end of said balloon towards said axis by withdrawal of the inflation fluid without the use of tension to enable said balloon to be withdrawn from said conduit;
means forming a closure disposed at the distal end of said balloon;
a stiffening wire to stiffen said balloon, said wire extending from said shaft to said closure means and engaging both said shaft and said closure means.
6. The catheter according to claim 5 wherein the stiffening wire is attached to the proximal end of said shaft and the distal end of said balloon.
7. The catheter according to claim 5 wherein the bal-loon is formed of polyethylene terephthalate.
8. The catheter according to claim 5 wherein the bal-loon is formed of a base layer of polyethylene terephthalate with a layer of Selar disposed on either side of said base layer.
9. A medical balloon for subsequent attachment to a catheter shaft having a lumen for the introduction of an inflation fluid and subsequent introduction into a body conduit, said balloon being deflatable into a predetermined shape of minimal dimensions, said balloon being formed by the steps comprising:
placing into an elongated mold an untensioned, pre-formed medical balloon, said balloon having continuous body of balloon material terminating in a tip and having a gener-ally cylindrical shape when inflated, said mold having a length corresponding to the desired length of said balloon and a generally polygonal cross section with side walls of substantially the same width, said side walls being con-nected by corners, the spacing between opposed corners approximating the desired diameter of the balloon when inflated, said mold further having end members at each end, each of said end members having a pyramidal shape terminat-ing in an apex, said corners of said mold corresponding with the corners of the end members and openings at the apexes to receive the catheter shaft and the tip of the balloon;
heating said mold to the softening point of the balloon and forcing a pressurizing fluid into said balloon to urge said balloon material against the sidewalls and into said corners and into said end members whereby to establish stressed areas where said balloon engages said corners to form four radially arranged ribs with webs disposed there-between, said ribs extending continuously from the distal to the proximal ends of said balloon, said webs being less stressed than said ribs due to greater expansion distances of said balloon material into said corners than to said sidewalls of said mold, said ribs and said webs forming said balloon and being expandable from a folded condition for insertion into said body conduit to an expanded condition with a diameter substantially greater than its folded condi-tion whereby to provide medical treatment to said conduit and thence, after treatment, into a folded condition with the webs collapsing inwardly towards said axis, said ribs extending parallel to said axis, each of said ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a balloon with ribs and webs as the body of the balloon, said balloon being expandable to a generally cylindrical shape by the introduction of an expan-sion fluid and then collapsible upon the withdrawal of said fluid into a structure wherein said webs collapse between said ribs towards said axis to enable easy withdrawal from said body conduit;
opening said mold and removing said balloon from said mold.
placing into an elongated mold an untensioned, pre-formed medical balloon, said balloon having continuous body of balloon material terminating in a tip and having a gener-ally cylindrical shape when inflated, said mold having a length corresponding to the desired length of said balloon and a generally polygonal cross section with side walls of substantially the same width, said side walls being con-nected by corners, the spacing between opposed corners approximating the desired diameter of the balloon when inflated, said mold further having end members at each end, each of said end members having a pyramidal shape terminat-ing in an apex, said corners of said mold corresponding with the corners of the end members and openings at the apexes to receive the catheter shaft and the tip of the balloon;
heating said mold to the softening point of the balloon and forcing a pressurizing fluid into said balloon to urge said balloon material against the sidewalls and into said corners and into said end members whereby to establish stressed areas where said balloon engages said corners to form four radially arranged ribs with webs disposed there-between, said ribs extending continuously from the distal to the proximal ends of said balloon, said webs being less stressed than said ribs due to greater expansion distances of said balloon material into said corners than to said sidewalls of said mold, said ribs and said webs forming said balloon and being expandable from a folded condition for insertion into said body conduit to an expanded condition with a diameter substantially greater than its folded condi-tion whereby to provide medical treatment to said conduit and thence, after treatment, into a folded condition with the webs collapsing inwardly towards said axis, said ribs extending parallel to said axis, each of said ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a balloon with ribs and webs as the body of the balloon, said balloon being expandable to a generally cylindrical shape by the introduction of an expan-sion fluid and then collapsible upon the withdrawal of said fluid into a structure wherein said webs collapse between said ribs towards said axis to enable easy withdrawal from said body conduit;
opening said mold and removing said balloon from said mold.
10. the balloon according to claim 9 wherein the bal-loon is heated in the mold to a temperature between about 160 and 195°C and inflated at pressures between about 140 and 200 psi.
11. The balloon according to claim 9 wherein the bal-loon is formed of polyethylene terephthalate.
12. The balloon according to claim 9 wherein the bal-loon is formed of a base layer of polyethylene terephthalate with a layer of Selar polymer disposed on at least one side of said base layer.
13. An inflatable medical balloon for introduction into a body conduit, said balloon being deflatable into a predetermined shape of minimal dimensions, said balloon being formed by the steps comprising:
placing an untensioned, preformed medical balloon having continuous body of balloon material with a generally cylindrical shape when inflated in an elongated mold having a length corresponding to the desired length of said balloon and a generally square cross section with four side walls of substantially the same width connected by four corners, said elongated mold further having end members at each end, each of said end members having a pyramidal shape terminating in an apex with the corners of said mold corresponding with the corners of the end members;
heating said mold to the softening point of the balloon and forcing a pressurizing fluid into said balloon to urge said balloon material against the sidewalls and into said corners and into said end members whereby to establish stressed areas where said balloon engages said corners thereby forming four radially arranged ribs with webs there-between, said ribs extending continuously from the distal to the proximal ends of said balloon, said webs being less stressed than said ribs due to greater expansion distances of said balloon material into said corners then to said sidewalls of said mold, said ribs and said webs constituting said balloon and being expandable from a folded condition for insertion into said body conduit to an expanded condi-tion with a diameter substantially greater than its folded condition whereby to provide medical treatment to said conduit and thence, after treatment, into a folded condition with the webs collapsing inwardly towards said axis, said ribs extending parallel to said axis, each of said ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a balloon with ribs and webs as the body of the balloon, said balloon being expand-able to a generally cylindrical shape by the introduction of an expansion fluid and thence collapsible upon the withdraw-al of said fluid into a structure wherein said webs collapse towards said axis to enable easy withdrawal from said body conduit;
removing said balloon from said mold.
placing an untensioned, preformed medical balloon having continuous body of balloon material with a generally cylindrical shape when inflated in an elongated mold having a length corresponding to the desired length of said balloon and a generally square cross section with four side walls of substantially the same width connected by four corners, said elongated mold further having end members at each end, each of said end members having a pyramidal shape terminating in an apex with the corners of said mold corresponding with the corners of the end members;
heating said mold to the softening point of the balloon and forcing a pressurizing fluid into said balloon to urge said balloon material against the sidewalls and into said corners and into said end members whereby to establish stressed areas where said balloon engages said corners thereby forming four radially arranged ribs with webs there-between, said ribs extending continuously from the distal to the proximal ends of said balloon, said webs being less stressed than said ribs due to greater expansion distances of said balloon material into said corners then to said sidewalls of said mold, said ribs and said webs constituting said balloon and being expandable from a folded condition for insertion into said body conduit to an expanded condi-tion with a diameter substantially greater than its folded condition whereby to provide medical treatment to said conduit and thence, after treatment, into a folded condition with the webs collapsing inwardly towards said axis, said ribs extending parallel to said axis, each of said ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a balloon with ribs and webs as the body of the balloon, said balloon being expand-able to a generally cylindrical shape by the introduction of an expansion fluid and thence collapsible upon the withdraw-al of said fluid into a structure wherein said webs collapse towards said axis to enable easy withdrawal from said body conduit;
removing said balloon from said mold.
14. The balloon according to claim 13 wherein the bal-loon is heated in the mold to a temperature between about 160 and 195°C and inflated at pressures between about 140 and 200 psi.
15. The catheter according to claim 13 wherein the balloon is formed of polyethylene terephthalate.
16. The catheter according to claim 13 wherein the balloon is formed of a base layer of polyethylene tere-phthalate with a layer of Selar disposed on either side of said base layer.
17. An inflatable medical balloon for subsequent attachment to a catheter shaft having a lumen for the intro-duction of an inflation fluid and subsequent introduction into a body conduit, said balloon being deflatable into a predetermined shape of minimal dimensions to be withdrawn from said body conduit, said balloon being formed by the steps comprising:
placing into an elongated mold an untensioned, pre-formed medical balloon, said balloon having continuous body of balloon material terminating in a tip and having a gener-ally cylindrical shape when inflated, said mold having a length corresponding to the desired length of said balloon and a generally polygonal cross section with side walls of substantially the same width connected by corners, the spacing between opposed corners approximating the desired diameter of the balloon when inflated, said mold further having end members at each end, each of said end members having a pyramidal shape terminating in an apex, said cor-ners of said mold corresponding with the corners of the end members and openings at the apexes to receive the catheter shaft and the tip of the balloon;
heating said mold to the softening point of the balloon and forcing a pressurizing fluid into said balloon to urge said balloon material against the sidewalls, into said corners and said into end members whereby to establish stressed areas where said balloon engages said corners thereby forming four radially arranged ribs with webs there-between, said ribs extending continuously from the distal to the proximal ends of said balloon, said webs being less stressed than said ribs due to greater expansion distances of said balloon material into said corners than to said sidewalls of said mold, said ribs and said webs forming said balloon and being expandable from a folded condition for insertion into said body conduit to an expanded condition with a diameter substantially greater than its folded condi-tion whereby to provide medical treatment to said conduit and thence, after treatment, into a folded condition with the webs collapsing inwardly towards said axis, said ribs extending parallel to said axis, each of said ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a balloon with ribs and webs as the body of the balloon, said balloon being expandable to a generally cylindrical shape by the introduction of an expan-sion fluid and then collapsible upon the withdrawal of said fluid into a structure wherein said webs collapse between said ribs towards said axis to enable easy withdrawal from said body conduit;
opening the mold and removing the balloon from said mold.
placing into an elongated mold an untensioned, pre-formed medical balloon, said balloon having continuous body of balloon material terminating in a tip and having a gener-ally cylindrical shape when inflated, said mold having a length corresponding to the desired length of said balloon and a generally polygonal cross section with side walls of substantially the same width connected by corners, the spacing between opposed corners approximating the desired diameter of the balloon when inflated, said mold further having end members at each end, each of said end members having a pyramidal shape terminating in an apex, said cor-ners of said mold corresponding with the corners of the end members and openings at the apexes to receive the catheter shaft and the tip of the balloon;
heating said mold to the softening point of the balloon and forcing a pressurizing fluid into said balloon to urge said balloon material against the sidewalls, into said corners and said into end members whereby to establish stressed areas where said balloon engages said corners thereby forming four radially arranged ribs with webs there-between, said ribs extending continuously from the distal to the proximal ends of said balloon, said webs being less stressed than said ribs due to greater expansion distances of said balloon material into said corners than to said sidewalls of said mold, said ribs and said webs forming said balloon and being expandable from a folded condition for insertion into said body conduit to an expanded condition with a diameter substantially greater than its folded condi-tion whereby to provide medical treatment to said conduit and thence, after treatment, into a folded condition with the webs collapsing inwardly towards said axis, said ribs extending parallel to said axis, each of said ribs being radially offset from adjacent ribs by substantially the same distance, whereby to form a balloon with ribs and webs as the body of the balloon, said balloon being expandable to a generally cylindrical shape by the introduction of an expan-sion fluid and then collapsible upon the withdrawal of said fluid into a structure wherein said webs collapse between said ribs towards said axis to enable easy withdrawal from said body conduit;
opening the mold and removing the balloon from said mold.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/233,391 US5456666A (en) | 1994-04-26 | 1994-04-26 | Medical balloon folding into predetermined shapes and method |
| US08/233,391 | 1994-04-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2187082A1 true CA2187082A1 (en) | 1995-11-02 |
Family
ID=22877052
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002187082A Abandoned CA2187082A1 (en) | 1994-04-26 | 1995-03-28 | Medical balloon folding into predetermined shapes |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US5456666A (en) |
| EP (1) | EP0758914B1 (en) |
| JP (1) | JP3701312B2 (en) |
| CA (1) | CA2187082A1 (en) |
| DE (1) | DE69528167T2 (en) |
| WO (1) | WO1995028985A1 (en) |
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- 1995-03-28 DE DE69528167T patent/DE69528167T2/en not_active Expired - Lifetime
- 1995-03-28 CA CA002187082A patent/CA2187082A1/en not_active Abandoned
- 1995-03-28 JP JP52764395A patent/JP3701312B2/en not_active Expired - Fee Related
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- 1995-03-28 EP EP95916127A patent/EP0758914B1/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| DE69528167T2 (en) | 2003-01-09 |
| JP3701312B2 (en) | 2005-09-28 |
| EP0758914A1 (en) | 1997-02-26 |
| DE69528167D1 (en) | 2002-10-17 |
| EP0758914B1 (en) | 2002-09-11 |
| WO1995028985A1 (en) | 1995-11-02 |
| JPH09512190A (en) | 1997-12-09 |
| EP0758914A4 (en) | 1998-10-14 |
| US5478319A (en) | 1995-12-26 |
| US5456666A (en) | 1995-10-10 |
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Legal Events
| Date | Code | Title | Description |
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| FZDE | Discontinued |