WO2022215001A1 - Catheter assembly including extruded polymer material for stiffness - Google Patents
Catheter assembly including extruded polymer material for stiffness Download PDFInfo
- Publication number
- WO2022215001A1 WO2022215001A1 PCT/IB2022/053226 IB2022053226W WO2022215001A1 WO 2022215001 A1 WO2022215001 A1 WO 2022215001A1 IB 2022053226 W IB2022053226 W IB 2022053226W WO 2022215001 A1 WO2022215001 A1 WO 2022215001A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- polymer material
- catheter
- tube
- ribbon
- balloon
- Prior art date
Links
- 239000002861 polymer material Substances 0.000 title claims abstract description 66
- 230000006835 compression Effects 0.000 claims abstract description 7
- 238000007906 compression Methods 0.000 claims abstract description 7
- 238000005728 strengthening Methods 0.000 claims abstract description 4
- 238000000034 method Methods 0.000 claims description 15
- 238000010276 construction Methods 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 238000007789 sealing Methods 0.000 claims 1
- 239000010410 layer Substances 0.000 description 38
- 239000003351 stiffener Substances 0.000 description 30
- 239000000463 material Substances 0.000 description 19
- 229920002614 Polyether block amide Polymers 0.000 description 6
- 239000012530 fluid Substances 0.000 description 6
- 229920001903 high density polyethylene Polymers 0.000 description 5
- 239000004700 high-density polyethylene Substances 0.000 description 5
- 210000003739 neck Anatomy 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 3
- 239000000654 additive Substances 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 238000005096 rolling process Methods 0.000 description 2
- JHWNWJKBPDFINM-UHFFFAOYSA-N Laurolactam Chemical compound O=C1CCCCCCCCCCCN1 JHWNWJKBPDFINM-UHFFFAOYSA-N 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229920000299 Nylon 12 Polymers 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- VPRUMANMDWQMNF-UHFFFAOYSA-N phenylethane boronic acid Chemical compound OB(O)CCC1=CC=CC=C1 VPRUMANMDWQMNF-UHFFFAOYSA-N 0.000 description 1
- -1 portions (e.g. Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
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
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- 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
- A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C55/00—Shaping by stretching, e.g. drawing through a die; Apparatus therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C63/00—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor
- B29C63/02—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor using sheet or web-like material
- B29C63/04—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor using sheet or web-like material by folding, winding, bending or the like
- B29C63/12—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor using sheet or web-like material by folding, winding, bending or the like by winding spirally
- B29C63/14—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor using sheet or web-like material by folding, winding, bending or the like by winding spirally around tubular articles
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
- A61M2025/0047—Coatings for improving slidability the inner layer having a higher lubricity
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C67/00—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
- B29C67/0014—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00 for shaping tubes or blown tubular films
- B29C67/0022—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00 for shaping tubes or blown tubular films using an internal mandrel
Definitions
- This disclosure is related generally to a catheter assembly, and more particularly to a balloon catheter assembly having a reinforced inflation lumen to resist pressure exerted on the inflation lumen when the balloon is inflated.
- Balloons mounted on the distal ends of catheters or other medical devices are widely used in medical treatment.
- a medical balloon may be used to widen a vessel into which the catheter is inserted, open a blocked vessel and/or deliver a medical device (e.g., a stent) to a treatment location inside a body, among other uses.
- the balloon is delivered to a treatment location by inserting the balloon in an uninflated configuration through a body lumen (e.g., a blood vessel).
- Balloons can be inserted through a body lumen by tracking the uninflated balloon through an introducer sheath and/or along a guidewire.
- the balloon is inflated.
- the balloon is deflated and withdrawn from the patient's body. In some cases, the balloon may later be re-introduced into the same or another body lumen of the patient.
- the present disclosure provides a catheter that includes a catheter tube defining the guidewire lumen with the catheter tube including an extruded polymer material. Molecules of the extruded polymer material extend circumferentially around the catheter tube to stiffen the catheter tube for strengthening the catheter tube against radial compression forces.
- the present disclosure provides a method of making a catheter.
- the method includes the steps of extruding a polymer material such that molecules of the extruded polymer material extend axially along the polymer material and wrapping the extruded polymer material around a mandrel to form a catheter tube whereby the molecules of the polymer material extend circumferentially around the catheter tube.
- FIG. 1 is a fragmentary perspective of a balloon catheter
- FIG. 2A is cross-section of the balloon catheter through line 2A-2A in FIG. 1 ;
- FIG. 2B is cross-section of the balloon catheter through line 2B-2B in FIG. 1;
- FIG. 3A is a side elevation of an inner inflation tube of the balloon catheter
- FIG. 3B is a cross-section of the inner inflation tube through line 3B-3B in
- FIG. 3A
- FIG. 3C is cross-section of the inner inflation tube through line 3C-3C in FIG.
- FIG. 4 is a fragmentary perspective of a balloon catheter of another embodiment
- FIG. 5 is a fragmentary perspective of an inner inflation tube of the balloon catheter in FIG. 4;
- FIG. 6 is a cross-section of the inner inflation tube in FIG. 5;
- FIG. 7A is an illustration of a sheet rolling process for making a guidewire lumen
- FIG. 7B is an illustration of a guidewire lumen made by the process in FIG.
- FIG. 7C is another illustration of a guidewire lumen made by the process in FIG. 7A;
- FIG. 8 is an illustration of a ribbon wrapping process for making a guidewire lumen of another embodiment
- FIG. 9 is an illustration of a process of making a guidewire lumen of another embodiment
- FIGS. 10 and 11 are illustrations of ribbons for forming a guidewire lumen
- FIG. 12 is an illustration of a tube formed by ribbon wrapping.
- a balloon catheter is generally indicated at reference number 10.
- the balloon catheter 10 comprises a medical balloon assembly, generally indicated at 12, and an inflation conduit assembly, generally indicated at 14.
- the inflation conduit assembly 14 defines an inflation lumen 15 and is fluidly coupled to the balloon assembly 12 to deliver inflation fluid through the inflation lumen to the interior of the balloon assembly.
- the balloon assembly 12 comprises at least one balloon 16.
- the balloon assembly 12 may include an additional number of balloons without departing from the scope of the disclosure.
- Each balloon may comprise one or more layers each having the same or different properties and constructions.
- the balloons 16 may be formed by any suitable manner such as from parisons or extrusion. As will be explained in greater detail below, inflation of the balloon 16 exerts pressure on the inside of the balloon, creating stress on the portion of the inflation conduit 14 extending through the balloon. In particular, the inflation conduit 14 experiences radial compression as a result of the pressure exerted by the inflated balloon. In conventional balloon catheters, the stresses on the inflation conduit can cause the inflation lumen to collapse preventing a guide wire from moving freely within the lumen.
- the balloon catheter 10 comprises a fully assembled balloon catheter that includes the medical balloon assembly 12, among other components.
- the balloon catheter 10 may also comprise a stent (not shown) received around the deflated balloon assembly 12.
- a medical balloon assembly can comprise a subassembly of the balloon catheter.
- a balloon catheter 10 comprises the medical balloon assembly 12 in a subassembly separate from the inflation conduit 14.
- the balloon 16 comprises a single piece of monolithic material.
- the balloon 16 is formed from a bondable material, such as one of a PEBA and a nylon (e.g., one of PEBAX® elastomer and nylon 12).
- the balloon 16 can also have other configurations.
- one or more of the balloons of the balloon assembly can comprise a multi-layer balloon (e.g., co-extruded, multilayer balloon) or have other arrangements of sections of discrete materials.
- portions (e.g., layers) of the balloon that contact the inflation conduit are formed from bondable materials such that the components of the medical balloon assembly can be secured by direct bonds.
- the balloon 16 comprises a proximal neck defining the proximal end of the balloon and a distal neck defining the distal end of the balloon.
- a length of the balloon 16 extends along an axis of the balloon from the proximal end to the distal end thereof, and an inflatable portion 17 extends along the length of the balloon assembly between the proximal and distal necks.
- the inflatable portion 17 of the balloon 16 comprises a body, a proximal cone extending between the proximal neck and the body, and a distal cone extending between the distal neck and the body.
- the inflatable portion 17 When inflation fluid is delivered to the interior of the balloon 16 through the inflation conduit 14, the inflatable portion 17 is configured to radially expand from an uninflated configuration (not shown) to an inflated configuration (FIG. 1). Thus, the inflatable portion 17 defines an interior space of the balloon 16 when the balloon is inflated.
- the inflatable portion 17 in the uninflated configuration of the balloon 16, the inflatable portion 17 comprises folds (e.g., wings) that are configured to wrap circumferentially around the balloon.
- the balloon can also have other arrangements in the uninflated configuration in certain embodiments.
- the balloon 16 can be one of non-compliant, semi-compliant, and compliant in the inflated configuration.
- the inflatable portion 17 of the balloon 16 has a generally cylindrical shape having conically tapered end segments in the inflated configuration. In one or more embodiments, the balloon 16 has other shapes in the inflated configuration.
- the illustrated inflation conduit 14 is part of an elongate catheter body of the illustrated balloon catheter 10.
- the inflation conduit 14 has a proximal end portion configured for connection to an inflation fitting, a distal end portion secured to the balloon assembly 12, and a length extending along an axis of the inflation conduit from the proximal end portion to the distal end portion.
- the inflation conduit is connectable to a source of inflation fluid (not shown) for inflating the balloon 16.
- the inflation lumen 15 extends from the proximal end portion to the distal end portion to provide fluid communication between the source of inflation fluid and the interior of the balloon assembly 12.
- the illustrated inflation conduit 14 comprises an inner inflation tube, generally indicated at reference numeral 20, and an outer inflation tube 22.
- the inflation lumen 15 is located radially between the inner inflation tube 20 and the outer inflation tube 22.
- the inflation conduit 14 can have other configurations (e.g., the inflation conduit can comprise a single tube).
- the inner inflation tube 20 functions as a guidewire tube defining a guidewire lumen 24.
- the guidewire lumen 24 is configured to slidably receive a guidewire GW therein such that the balloon catheter 10 can be advanced along a body lumen by sliding along a preplaced guidewire.
- the illustrated inner inflation tube 20 comprises a proximal portion 26, an intermediate portion 28 extending distally from the proximal portion, and a distal portion 30, extending distally from the intermediate portion.
- the inner inflation tube 20 of the inflation conduit 14 comprises a three-layer construction including an inner layer 32, a tie layer 34 disposed around the inner layer, and an outer layer 36 disposed around the tie layer.
- the tie layer 34 is configured to bond the inner layer 32 to the outer layer 36.
- the inner layer 32 comprises HDPE and the outer layer 36 comprises Pebax. The lubricious qualities of HDPE facilitate movement of the guidewire GW in the inner inflation tube 20.
- the inner inflation tube 20 can have other configurations.
- the inner inflation tube 20 can comprise a single layer tube.
- a lubricious layer or coating may be disposed on an inner surface of the inner inflation tube 20 to facilitate guidewire delivery.
- At least one stiffener 38 is provided on or as part of the inner inflation tube 20 to reinforce the tube against compression forces exerted on the inflation conduit 14 when the balloon 16 is inflated.
- the stiffener 38 prevents the inner inflation tube 20 from being collapsed, or at least partially collapsed, under the pressure of the inflated balloon 16. Therefore, a condition of guidewire lock where the inner inflation tube 20 compresses around the guidewire GW preventing the guidewire from freely moving within the inner inflation tube is prevented.
- the stiffener 38 is coextruded with outer layer 36 of the inflation tube 20. Coextruding the stiffener 38 allows the inner inflation tube 20 to maintain its outer diameter keeping the low profile configuration of the inner inflation tube.
- the stiffener 38 may comprise a stiffer polymer material than the outer layer 36 to reinforce the strength of the outer layer while still maintaining the flexibility of the inner inflation layer 20.
- the stiffener 38 may comprise a stiffer Pebax material than the Pebax material of the outer layer 36.
- the stiffener 38 comprises Pebax 72D. Still other polymer materials are envisioned.
- the stiffener 38 comprises a polymer material extruded in a spiral configuration around the outer layer 36.
- a single continuous stiffener element 38 extends along the inner inflation tube 20. The spiral configuration allows the inner inflation tube 20 to maintain its flexibility while avoiding preferential bending in one direction/area.
- the spiral configuration of the stiffener 38 may have a constant pitch as illustrated, or the pitch may vary along an extension of the stiffener. It will be understood that reducing the pitch of the stiffener 38 will increase the relative stiffness of the inner inflation tube 20 at that particular location, and increasing the pitch of the stiffener will reduce the relative stiffness of the inner inflation tube at that particular location.
- the stiffener 38 may also have a constant width and/or thickness, or the width/thickness of the stiffener may vary along the length of the extrusion. In the illustrated embodiment, the stiffener 38 is located only in the distal portion 30 of the inner inflation tube 20. In particular, the stiffener 38 is located primarily within the inflation portion 17 of the balloon 16.
- the stiffener 38 could be located at other portions (i.e., intermediate portion 28 and proximal portion 26) without departing from the scope of the disclosure. Additionally, the stiffener 38 may be located in two or more sections of the inner inflation tube 20. Thus, the stiffener 38 may be located in all or at least two of the proximal portion 26, intermediate portion 28, and distal portion 30. Further, the stiffener 38 may be implemented in any application where it is desired to increase the strength of the guidewire lumen. This includes locations remote from the balloon, and in catheters that do not have balloons.
- an outer diameter of the inner inflation tube 20 may also vary along a length L of the inner inflation tube which may alter the stiffness of the tube along its length.
- the outer diameter of the inner inflation tube 20 tapers along at least a part of the intermediate portion 28 such that the proximal portion 26 has a larger outer diameter than the distal portion 30.
- An inner diameter of the inner inflation tube 20 may remain substantially constant along the length L of the inner inflation tube to facilitate receipt of the guidewire GW. Therefore, a thickness of the inner inflation tube 20 is greater along the proximal portion 26 than the distal portion 30.
- locating the stiffener 38 in the reduced thickness section of the distal portion 30 reinforces the distal portion equipping the distal portion to withstand the pressures exerted on the distal portion from the inflated balloon 16.
- the balloon catheter 110 may comprise an inflation conduit 114 including an inner inflation tube 120 having stiffeners 138 that extend axially along a length of the inner inflation tube such that the stiffeners extend generally parallel to a longitudinal axis of the inner inflation tube.
- the stiffeners 138 are circumferentially spaced around the inner inflation tube 120. In the illustrated embodiment, there are five stiffeners 138 equally spaced around the circumference of the inner inflation tube 120. However, more or less stiffeners 138 having different spacing is envisioned without departing from the scope of the disclosure.
- the balloon catheter 110 is otherwise constructed and functions substantially the same as balloon catheter 10 of the previous embodiment.
- a sheet of polymer 240 may be extruded such that molecules 242 (broadly, stiffeners) of the polymer generally extend in a common direction.
- the molecules extend transverse to a longitudinal axis of the sheet 240.
- the molecules 242 may extend generally orthogonal to the longitudinal axis of the sheet 240.
- a guidewire lumen 244 is created by rolling the sheet 240 around a mandrel 246 to form a tube 248 made from the sheet. The molecules 242 will then extend circumferentially around the guidewire lumen 244.
- This orientation of the molecules 242 increases the strength of the tube 248 against radial compression. Strengthening the tube 248 radially may also allow the device (e.g., catheter), apart which the tube is included, to maintain a low profile and/or increase the size of the guidewire lumen 244 without sacrificing the strength of the tube. Additionally, this configuration of the tube 248 creates a reinforced guidewire lumen 244 using only polymer materials.
- edges of the sheet 240 are heat or laser bonded to seal the edges of the sheet forming the tube 248 (FIG. 7B). Applying heat to the tube 248 may also smooth out an inner surface of the tube to facilitate delivering a guidewire through the tube.
- the tube 248 could be formed by other means without departing from the scope of the disclosure. For instance, the edges of the sheet 240 could be laminated to form the tube 248 (FIG. 7C).
- the construction of the tube 248 could be formed as part of a multilayer tube including the tube 248 as one of the layers.
- the tube 248 could be formed as a top/outer layer of a three-layer tube including a middle tie layer and an inner layer (e.g., HDPE layer).
- an inner layer e.g., HDPE layer.
- a ribbon of polymer material 340 could be extruded and wrapped around a mandrel 346 to form a tube 348 (e.g., catheter tube) defining a guidewire lumen.
- the ribbon 340 is extruded such that molecules 342 (broadly, stiffeners) of the material extend longitudinally along the extruded ribbon.
- the ribbon 340 is then stretched longitudinally and wrapped in a spiral configuration around the mandrel 346 such that the molecules 342 of the material extend circumferentially around the tube 348.
- the heat from extruding the ribbon of material 340 bonds the spiraled ribbon sections together forming the resulting tube 348.
- a heat shrink can be placed over the spiraled ribbon 340 and heated to bond the spiraled segments together to form the tube 348.
- the tube 348 alone can define the guidewire lumen or the ribbon or polymer material 340 could be wrapped around another tube to define the guidewire lumen.
- a single or multi-layer tube may be used as a mandrel for the ribbon 340 to be wrapped around the tube to form a tube including both the single/multi-layer tube and the wrapped ribbon.
- a ribbon of material 340’ is wrapped around an inner liner 345’ which is disposed around a mandrel 346’ .
- the inner liner 345 ’ comprises a multi-layer tube.
- the inner liner 345’ may include an inner layer of HDPE and a tie layer disposed around the inner layer.
- the ribbon 340’ is wrapped in a spiral configuration around the inner liner 345’ and mandrel 346’ such that molecules 342’ (broadly, stiffeners) of the material extend circumferentially around the resulting tube 348’ comprising the inner liner 345’ and the wrapped ribbon 340’.
- the resulting tube is a tri layer tube including the inner layer of HDPE, the middle tie layer, and the outer ribbon layer.
- Other tube configurations including the wrapped ribbon layer are envisioned without departing from the scope of the disclosure.
- the ribbon of polymer material 340, 340’ comprises a single polymer material.
- the ribbon of material could be formed from a plurality of different polymer materials.
- polymer materials having different hardness levels could be extruded together to form a ribbon of polymer material comprising multiple polymers.
- a ribbon of material 340A may include an inner longitudinally extending strip of harder polymer material and outer longitudinally extending strips of softer polymer material (FIGS. 10A and 11A).
- a ribbon of material 340B may include an inner longitudinally extending strip of softer polymer material and outer longitudinally extending strips of harder polymer material (FIGS. 10B and 1 IB).
- a ribbon of material 340C may include a first longitudinally extending strip of harder polymer material and a second, adjacent longitudinally extending strip of softer polymer material (FIGS. IOC and 11C).
- a ribbon of material 340D may include a longitudinally extending strip of harder polymer material embedded within a longitudinally extending strip of softer polymer material (FIGS. 10D and 1 ID). The ribbons 340A-D when stretched and wrapped around a mandrel in a spiral configuration will produce a tube having alternating soft and hard sections spaced longitudinally along a length of the tube to provide strength to the tubing to resist radial compression while maintaining flexibility of the tube for traversing through the body.
- the ribbon 12 illustrates a tube 448 having a relatively soft longitudinal section 450 formed from a softer polymer material, and a relatively hard longitudinal section 452 form from a harder polymer material. Still other configurations of polymer materials are envisioned.
- the ribbon may also include a polymer material and an additive included in the polymer material. For example, an additive improving the lubricity of the ribbon material could be added to the polymer material.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Manufacturing & Machinery (AREA)
- Mechanical Engineering (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202280035265.8A CN117320776A (en) | 2021-04-07 | 2022-04-06 | Catheter assembly comprising extruded polymeric material for rigidity |
EP22716507.3A EP4319851A1 (en) | 2021-04-07 | 2022-04-06 | Catheter assembly including extruded polymer material for stiffness |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202163171793P | 2021-04-07 | 2021-04-07 | |
US63/171,793 | 2021-04-07 | ||
US17/653,786 US20220323729A1 (en) | 2021-04-07 | 2022-03-07 | Catheter assembly including extruded polymer material for stiffness |
US17/653,786 | 2022-03-07 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2022215001A1 true WO2022215001A1 (en) | 2022-10-13 |
Family
ID=81308502
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2022/053226 WO2022215001A1 (en) | 2021-04-07 | 2022-04-06 | Catheter assembly including extruded polymer material for stiffness |
Country Status (2)
Country | Link |
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EP (1) | EP4319851A1 (en) |
WO (1) | WO2022215001A1 (en) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995005555A1 (en) * | 1993-08-18 | 1995-02-23 | W. L. Gore & Associates, Inc. | A thin-wall polytetrafluoroethylene tube |
US20070088296A1 (en) * | 2005-10-04 | 2007-04-19 | Leeflang Stephen A | Catheters with lubricious linings and methods for making and using them |
US20100087789A1 (en) * | 2008-08-29 | 2010-04-08 | AUST Development, LLC | Apparatus and methods for making coated liners and tubular devices including such liners |
US20100121312A1 (en) * | 2008-11-07 | 2010-05-13 | Biotronik Vi Patent Ag | Catheter Shaft |
-
2022
- 2022-04-06 EP EP22716507.3A patent/EP4319851A1/en active Pending
- 2022-04-06 WO PCT/IB2022/053226 patent/WO2022215001A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995005555A1 (en) * | 1993-08-18 | 1995-02-23 | W. L. Gore & Associates, Inc. | A thin-wall polytetrafluoroethylene tube |
US20070088296A1 (en) * | 2005-10-04 | 2007-04-19 | Leeflang Stephen A | Catheters with lubricious linings and methods for making and using them |
US20100087789A1 (en) * | 2008-08-29 | 2010-04-08 | AUST Development, LLC | Apparatus and methods for making coated liners and tubular devices including such liners |
US20100121312A1 (en) * | 2008-11-07 | 2010-05-13 | Biotronik Vi Patent Ag | Catheter Shaft |
Also Published As
Publication number | Publication date |
---|---|
EP4319851A1 (en) | 2024-02-14 |
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