The present invention relates to a tube for an intravascular medical device, and in particular to a sensor guide wire comprising such a tube.
Today, there is an increased need for invasive measurements of physiological variables. For example, when investigating cardiovascular diseases, it is strongly desired to obtain local measurements of blood pressure, flow and temperature in order to evaluate the condition of the subject under measurement. Therefore, methods and devices have been developed for disposing a miniature sensor inside the body of an individual at a location where the measurements should be performed, and for communicating with the miniature sensor in order to provide the physician or medical technician with critical information as to the status of a patient's condition. Typically, the miniature sensor is arranged at a distal end of a guide wire, which is generally known in the art, and used for example in connection with the treatment of coronary disease.
The distal end of the guide wire is inserted into the body of a patient, for example into an opening of the femoral artery, and placed at a desired location. Once the guide wire is placed by the physician into the appropriate location, the miniature sensor can measure the blood pressure and/or flow. The measurement of blood pressure is a way to diagnose e.g. the significance of a stenosis. For evident reasons, the dimensions of the sensor and the guide wire are fairly small; the guide wire typically has a diameter of 0.35 mm. The sensor element may, for example, be embodied by an elongated, essentially rectangular chip with a pressure sensitive member in the form of a membrane provided thereon.
In order to power the sensor and to communicate signals representing the measured physiological variable to a control unit acting as an interface device disposed outside the body, one or more microcables for transmitting the signals are connected to the sensor, and are routed along the guide wire to be passed out from the vessel to an external control unit via a connector assembly. Most commonly, extremely thin electrical cables are provided inside the guide wire, which itself is provided in the form of a tube (having an outer diameter of e.g. 0.35 min), oftentimes made of stainless steel. In order to increase the bending strength and maneuverability of the tubular guide wire, a core wire is positioned inside the tube. The mentioned electrical leads are positioned in the space between the inner lumen wall of the tube and the core wire. Furthermore, the sensor chip is often arranged in a short tube, also referred to as a jacket or a sleeve. The jacket is hollow and accommodates, besides the sensor chip, a portion of a core wire and often at least one microcable. A first coil may be attached to the distal end of the jacket, and optionally a second coil may be attached to the proximal end of the jacket. The first and second coils may be attached to the respective end of the jacket, e.g. by gluing, welding or alternatively soldering. One purpose of the first coil is to enable the steering of the sensor guide wire through winding blood vessels. To help the user easily guide the wire through such tortuous vessel systems, the distal coil is often radioopaque, such that it is visible on an angiogram.
A large flexibility of the sensor guide wire can be advantageous in that it allows the sensor guide wire to be introduced into small and tortuous vessels. It should, however, also be recognized that if the core wire is too flexible, it would be difficult to push the sensor guide forward into the vessels, i.e. the sensor guide wire must possess a certain “pushability” and a certain “torquability.” Additionally, the sensor guide must be able to withstand the mechanical stress exerted on the core wire especially in sharp vessel bends.
Besides being flexible enough, it can be also important that the sensor guide wire tip responds when steering the sensor guide wire through the tortuous vessels, i.e. the sensor guide wire tip should also have sufficient “steering response.” “Steering response” is a measure of the behavior of a sensor guide wire when the sensor guide wire tip is subjected to a non-linear pathway and rotated. The “steering response” of a sensor guide wire tip is a general property of the distal tip components.
Several different designs of sensor guide wires are known in the prior art, and examples of such sensor guide wires are disclosed in U.S. Pat. No. 6,167,763 B1, which describes the cantilevered mounting of the sensor element, U.S. RE39,863 E1, which discloses the sensor element and U.S. Pat. No. 6,248,083 B1, showing the complete sensor guide wire assembly, which all are assigned to the assignee of the present application, and which are hereby all incorporated by reference for the devices and methods described therein.
A presently used sensor wire (the PressureWire™) has proven to fulfill the high requirements regarding torque response. However, the inventors of the present invention have identified a need for a sensor guide wire with further improved torsional rigidity, which thus has a higher polar moment of inertia. There is further a need for a sensor guide wire for which torque response and bending stiffness are optimized to suit the specific needs of each portion of the sensor guide wire.
It is generally known to provide an intravascular medical device with a so-called hypotube to achieve specific properties of the medical device. For example in WO 2009/020961 A1, a medical device for intravascular use comprising a hypotube is disclosed. The object is to provide a medical device which is configured to have a preferential bending direction, which in particular is achieved by providing slots having different widths.
Furthermore, EP 1545680 B1 also discloses a medical device for navigating through the anatomy. The medical device comprises a hypotube provided with slots, wherein the slots may be of unequal size.
In US 2010/0145308 A1, a medical device including an elongated tubing provided with slots in the wall is disclosed. The slots in a group may be unequal in size.
However, these known hypotubes do not possess the required torque response. A further drawback with known hypotubes is that twisting of the hypotube might lead to permanent deformation.
An object of the present invention is to achieve a sensor guide wire with improved torque response.
A further object of the present invention is to provide a sensor guide wire with improved torque response, while keeping the low bending stiffness, such that the sensor guide wire allows for the same bending radius as the current sensor guide wire.
Still another object of the present invention is to provide a sensor guide wire for which torsion and bending stiffness may be tailored according to specific needs.
The above mentioned objects may be achieved by providing the sensor guide e with a tube making up essentially the entire length of the sensor guide wire, from the proximal end to a distal portion of the sensor guide wire.
According to one aspect of the present invention, the tube may be implemented in any intravascular medical device, such as a sensor guide wire, a guide wire, a catheter or similar device.
In accordance with one embodiment of the present invention, the tube may have a longitudinal extension along a longitudinal axis A, and the tube may comprise a tube wall having a specified thickness. The tube wall may be provided with a plurality of through-going slots, wherein each slot has an essentially elongated shape along a main extension B extending along the circumference of the tube. Each slot has a width W and a length L along the main extension B, and wherein at least two slots are provided in a plane perpendicular to the longitudinal axis A, and the main extension B of the at least two slots are in said plane. A predetermined number of planes with slots may be provided along the tube, and the lengths L of the slots in the same perpendicular plane are essentially the same. The lengths L of the slots in different planes vary along the longitudinal extension of the tube according to a predefined pattern.
The tube according to an embodiment of the present invention can be flexible enough when it comes to bending while keeping much of its torsional rigidity.
By implementing the suggested tube in a sensor guide wire, a higher torsional rigidity can be achieved. The tube can be provided for a sensor guide wire having a higher polar moment of inertia, while keeping the low bending stiffness, such that the sensor guide wire allows for the same bending radius as the presently used wires.
Thus, according to another aspect, the present invention may relate to a sensor guide wire for intravascular measurements of at least one physiological or other variable in a living body.
The sensor guide wire according to one embodiment of the present invention may comprise a tube, the sensor guide wire having a proximal region, a distal sensor region and a tip region. The sensor guide wire may comprise a sensor element arranged in the sensor region, the sensor element comprising a sensor portion, for measuring said variable and to generate a sensor signal in response to said variable. The tube may extend at least partly along said proximal region.
According to yet another aspect of the present invention, the tube may further extend at least partly along the distal sensor region of the sensor guide wire, wherein the tube is adapted to enclose at least a part of the sensor element, and being provided with at least a first sensor opening in the distal sensor region.
The predetermined pattern of the tube may allow an optimized ratio between torsional and bending rigidity.
According to a further aspect, the present invention may relate to a sensor guide wire comprising a tube, which sensor guide wire is “core-wire free,” i.e., no core wire is arranged inside and along the tube.
It is to be understood that both the foregoing general description and the following detailed descriptions are exemplary and explanatory only, and are not restrictive of the invention as claimed.
The features, aspects and advantages of the present invention will become apparent from the following description, appended claims, and the accompanying exemplary embodiments shown in the drawings, which are briefly described below.
With reference to
In
As further illustrated in
In the embodiment shown in
According to another embodiment, four slots 3 may be provided in each perpendicular plane P. In this case, preferably, the slots 3 in a perpendicular plane P are displaced approximately 45° with respect to each adjacent perpendicular plane P. In case of four slots 3 in each plane P, the degree of displacement may be any angle between 0° and 90°. As mentioned above, in case of 0° or 90°, there is no displacement between the slots 3 in the adjacent planes P. Preferably, the degree of displacement is the same between all perpendicular planes P. However, the degree of displacement with respect to an adjacent perpendicular plane P may vary along the tube 1. Preferably, the number of slots 3 provided in each plane P is between 3 and 10.
In the embodiment illustrated in
According to the predefined pattern shown in
In one embodiment, the length LA, along the longitudinal axis A, of the distal section 5 is approximately 150 mm. The length LA, along the longitudinal axis A, of the proximal section 6 may be approximately 200 mm. However, the length LA of the distal section 5 may be between 0-3000 mm, and the length of the proximal section 6 may be between 0-3000 mm.
According to one embodiment, the tube 1 is adapted to extend at least partly along the length of a guide wire, a sensor guide wire, or a catheter.
In one embodiment, the tube 1 is provided with a coating covering all, or parts of, the slots. The coating may be made from polyimide, polyurethane, polypropylene, or thermoplastic elastomers, such as a styrene-diene triblock copolymers, polyolefin blend, block copolyurethane, block copoly(ether-ester) and block copoly(ether-amide). In some embodiments, providing the tube 1 with a coating completely covering slots 3 is advantageous in that it prevents ambient fluid, e.g. blood, from entering into the interior of the tube 1. In other embodiments, the coating may provide either a hydrophilic or hydrophobic outer surface, to optimize the frictional forces between the outer surface of the tube 1 and e.g. the vessel wall or a catheter. This can be accomplished by choosing a material with proper hydrophilic/hydrophobic properties or by surface modification and/or treatment of abovementioned polymeric coating materials.
As illustrated in
According to one embodiment, as illustrated by the diagram shown in
In one embodiment, the tube 1 has an inner diameter of approximately 0.25 mm, and an outer diameter of approximately 0.35 mm.
In
As illustrated in
In the embodiment shown in
Thus, according to one embodiment, as illustrated in
In one embodiment, no core wire is arranged to extend along the proximal region 9. In another embodiment, no core wire is arranged to extend along the distal sensor region 10. In yet another embodiment, no core wire is arranged to extend along the proximal region 9 and the distal sensor region 10. Accordingly, the sensor guide wire 8 may be core wire free, wherein the tube 1 provides the same properties as a core wire. A security string (not shown) may extend from a proximal end (not shown) to a distal end 14, or at least to the tip region 11, of the sensor guide wire 8. The security string may be a flexible wire running inside the tube 1.
Preferably, the security string is embodied by a relatively thin flexible wire. The security string may be attached, at its distal end to e.g. a distal part of the sensor guide wire 8. Preferably, the security string is attached essentially at the distal end 14, or to a tip core wire (not shown) running along the tip region 11 of the sensor guide wire 8. The reason for arranging such a security string is to ensure all parts are held together by the string. However, in another embodiment, the sensor guide wire 8 may be provided with a core wire running inside and along the tube 1.
According to the embodiments shown in
The distal sensor region 110 is further provided with at least a first sensor opening 107. The distal sensor region 110 may be provided with additional openings 107 allowing access to the sensor element 12. As seen in
In one embodiment, no core wire is arranged to extend along the proximal region 109. In another embodiment, no core wire is arranged to extend along the distal sensor region 110. In yet another embodiment, no core wire is arranged to extend along the proximal region 109 and the distal sensor region 110. Accordingly, the sensor guide wire 108 may be core wire free, wherein the tube 101 provides the same properties as a core wire. A security string (not shown) may extend from a proximal end (not shown) to a distal end, or at least to the tip region 111, of the sensor guide wire 108. The security string may be a flexible wire running inside the tube 101.
Preferably, the security string is embodied by a relatively thin flexible wire. The security string may be attached, at its distal end to e.g. a distal part of the sensor guide wire 108. Preferably, the security string is attached essentially at the distal end of the senor guide wire 108. However, in another embodiment, the sensor guide wire 108 may be provided with a core wire running inside and along the tube 101.
With reference to
In
In
In the embodiment shown in
As illustrated in
The tube 101 may be provided with a plurality of slots.
In
As illustrated in
In the embodiment of
The distal sensor region 210 is further provided with at least a first sensor opening 207. The distal sensor region 210 may be provided with additional openings 207 allowing access to the sensor element. As seen in
In one embodiment, no core wire is arranged to extend along the proximal region 209. In another embodiment, no core wire is arranged to extend along the distal sensor region 210. In yet another embodiment, no core wire is arranged to extend along the proximal region 209 and the distal sensor region 210. Accordingly, the sensor guide wire 208 may be core wire free, wherein the tube 201 provides the same properties as a core wire. A security string (not shown) may extend from a proximal end (not shown) to a distal end, or at least to the tip region 211, of the sensor guide wire 208. The security string may be a flexible wire running inside the tube 201.
Preferably, the security string is embodied by a relatively thin flexible wire. The security string may be attached, at its distal end to e.g. a distal part of the sensor guide wire 208. Preferably, the security string is attached essentially at the distal end of the senor guide wire 208. However, in another embodiment, the sensor guide wire 208 may be provided with a core wire running inside and along the tube 201.
With reference to
In
The tube 201 may be provided with a plurality of slots.
In
In
As illustrated in
In
As illustrated in
In the embodiment of
According to other embodiments, the proximal regions 9, 109, and 209 may be exchanged for one another among the embodiments of
The tube 1, 101, 201 according to any of the above embodiments may be produced by providing an elongated sheet material, e.g. made from steel or nitinol, which is subsequently bent or shaped into an essentially cylindrical elongated tube 1, 101, 201. The slots may be provided in the sheet material prior to shaping the sheet material 1, 101, 201 into a tube 1, 101, 201 or after the sheet material has been shaped into a tube 1, 101, 201. The slots may be provided by laser cutting, etching, grinding or by using any other technique suitable to provide slots in the sheet material or the elongated tube 1, 101, 201. The predetermined pattern in the tube 1, 101, 201 may for example be provided by photoetching, which is a process wherein photographic pattern transfer and etch technique are combined.
According to another embodiment of the present invention, a guide wire and sensor assembly may have an overall distal section of around 320 mm having a slot design for enhanced functionality of the assembly. The overall distal section of this embodiment having the slot design would include a semi-flexible section of around 290 mm (as a distal portion of the proximal region having the slots), a 2.12 mm sensor jacket housing (as the distal sensor region) and a 30 mm tip section (as the tip region). The slot size (width and/or width), the number of slots in a cross section, the slot cut angle and the distance between slots will be changed to suit the required stiffness and flexibility of the distal section of the assembly. This embodiment would contain combination of either two and three slots or only two slots or only three slots along the overall distal section except in the sensor jacket housing. The sensor jacket housing section may include 1-6 slots in a cross section. The slot width would be anything between 0.01 mm and 0.1 mm and the slot cut angle would be between 70° and 160° along the overall distal section having the slot design except in the sensor jacket housing. The angle typically is more relevant to laser cutting process. However when another slot making process is used, the slot circumferential length should be equal to what is defined in the laser processing. The sensor jacket housing would include slots with a width between 0.005 mm and 2 mm and a cut angle between 5° and 180°. The slot position will be rotated along the tube to have predetermined minimum directional properties along the wire. This rotation angle may be in between 0°-180°. A suitable material for this embodiment would be linear or super elastic nitinol, all type of steel and any metal/alloy whose Young Modulus lies between 50 GPa and 250 GPa. A shape memory properties may be incorporated in the 30 mm tip section by a suitable heat treatment process. The creation of the cut/slots is not limited to a laser cutting process, but any other process creating cut such as etching, EDM and machining could be used. Flexibility, torqucability and tip floppiness are important properties of the guide wire assembly during PCI procedure while the conventional ways to design a guide wire assembly tip with solid metals or material such as stainless steel does not have much freedom to change stiffness along the wire. These conventional designs would also include several parts glued or mechanically joined together.
For this embodiment, as the flexibility is changed smoothly along the length of the guide wire, friction against the wall will be less, especially in a complex tortuous path, as the bending force against the wall is less. Since the friction is minimized, torque transfer will be improved. Since this embodiment may include a sensor jacket housing and a flexible tip as a single unitary one-piece component without any joint, it possibly eliminates potential torque absorbing points as well as weak mechanical joints. Since this embodiment can include a flexible slotted tip design, there is a possibility to use radioopaque polymer inside the tube.
In
In
The tube section 303 may be used as a section of a tube in any of the previously-mentioned embodiments. For example, the tube section 303 may be used in place of the section of tube in the proximal region 109 in
Besides those embodiments depicted in the figures and described in the above description, other embodiments of the present invention are also contemplated. For example, any single feature of one embodiment of the present invention may be used in any other embodiment of the present invention. For example, the following is a list of embodiments, but the invention should not be viewed as being limited to these embodiments.
(I) A tube (1) for an intravascular medical device, said tube (1) having a longitudinal extension along a longitudinal axis A, and that said tube (1) comprising a tube wall (2) having a specified thickness t, and being provided with a plurality of through-going slots (3),
wherein each slot (3) has an essentially elongated shape along a main extension B extending along the circumference of said tube (1), wherein each slot (3) has a width W and a length L along said main extension B, and
wherein at least two slots (3) are provided in a plane P perpendicular to said longitudinal axis A, said main extension B of said at least two slots (3) being in said plane P, and that a predetermined number of planes P with slots (3) are provided along said tube (1),
wherein the lengths L of said slots (3) in the same perpendicular plane P are essentially the same, and that said lengths L of said slots (3) in different planes vary along said longitudinal extension of said tube (1) according to a predefined pattern.
(II) The tube according to embodiment (I), wherein said slots (3) in said same perpendicular plane P are separated by a slot separation part (4).
(III) The tube according to any of embodiments (I)-(II), wherein said slots (3) in said same perpendicular plane P are equally distributed around said circumference of said tube (1).
(IV) The tube according to any of embodiments (I)-(III), wherein according to said predefined pattern said lengths L of said slots (3) decreases in a proximal direction of said tube (1).
(V) The tube according to embodiment (VI), wherein said lengths L of said slots (3) decreases continuously.
(VI) The tube according to any of the preceding embodiments, wherein according to said predefined pattern said lengths L of said slots (3) are equal in a distal section (5) of said tube (1).
(VII) The tube according to embodiment (VI), wherein the length LA, along said longitudinal axis A, of said distal section (5) is approximately 150 mm.
(VIII) The tube according to any of the preceding embodiments, wherein said length L of a slot (3) is defined by a slot angle α, being the center angle of said perpendicular plane P.
(IX) The tube according to embodiment (VIII), wherein said slot angle is 0°<α<160°.
(X) The tube according to embodiment (IX), wherein said slot angle α is approximately 40° in said distal section (5) of said tube (1).
(XI) The tube according to any of embodiments (VIII)-(X), wherein said slot angle α decreases from approximately 40° to approximately 0° in a proximal section (6) of said tube (1).
(XII) The tube according to embodiment (XI), wherein the length LA, along said longitudinal axis A, of said proximal section (6) is approximately 200 mm.
(XIII) The tube according to any of embodiments (VI)-(VII) or (IX)-(XII), wherein said distal section (5) and said proximal section (6) are arranged adjacent to each other.
(XIV) The tube according to any of the preceding embodiments, wherein the slots (3) in said perpendicular plane P are displaced in relation to the slots (3) in an adjacent perpendicular plane P.
(XV) The tube according to any of the preceding embodiments, wherein said tube (1) is adapted to extend at least partly along the length of a guide wire, a sensor guide wire, or a catheter.
(XVI) The tube according to any of the preceding embodiments, wherein said tube (1) is provided with a coating covering all, or parts of, said slots (3).
(XVII) The tube according to any of the preceding embodiments, wherein adjacent perpendicular planes P are separated by a predetermined separation distance d, being approximately 0.1 mm.
(XVIII) The tube according to any of the preceding embodiments, wherein said predetermined number of planes P is approximately in the interval 1000-5000.
(XIX) The tube according to any of the preceding embodiments, wherein said width W of a slot (3) being approximately 0.05 mm.
(XX) The tube according to any of the preceding embodiments, wherein said tube (3) having an inner diameter of approximately 0.25 mm, and an outer diameter of approximately 0.35 mm.
(XXI) A sensor guide wire for intravascular measurements of at least one physiological or other variable in a living body, the sensor guide wire (8) having a proximal region (9), a distal sensor region (10) and a tip region (11), the sensor guide wire (8) comprising:
a sensor element (12) arranged in said sensor region (10), and comprising a sensor portion (13), for measuring said variable and to generate a sensor signal in response to said variable,
wherein said sensor guide wire (8) comprises a tube (1) according to any of embodiments (I)-(XX), and in that said tube (1) extends at least partly along said proximal region (9) of said sensor guide wire (8).
(XXII) A sensor guide wire according to embodiment (XXI), wherein said tube (1) extends at least partly along said distal sensor region (10).
(XXIII) A sensor guide wire according to embodiment (XXII), wherein said tube (1) is adapted to enclose at least a part of said sensor element (12), and is provided with at least a first sensor opening (7) in said distal sensor region (10).
(XXIV) A sensor guide wire according to any of embodiments (XXII)-(XXIII), wherein said sensor region (10) is an integrated part of said tube (1).
(XXV) A sensor guide wire according to any of embodiments (XXI)-(XXII), wherein said sensor guide wire is provided with a jacket (15) adapted to enclose at least a part of said sensor element (12), and being provided with at least a first sensor opening (7) in said distal sensor region (10).
(XXVI) A sensor guide wire according to any of embodiments (XXI)-(XXV), wherein said jacket (15) is attached to said tube (1).
(XXVII) A sensor guide wire according to any of embodiments (XXI)-(XXVI), wherein no core wire is arranged to extend along said proximal region (9).
(XXVIII) A sensor guide wire according to any of embodiments (XXI)-(XXVII), wherein no core wire is arranged to extend along said distal sensor region (10).
(XXIX) A sensor guide wire according to any of embodiments (XXI)-(XXVIII), wherein said proximal section (6) of said tube (1) is arranged in said proximal region (9) of said sensor guide wire (8).
(XXX) A sensor guide wire according to any of embodiments (XXI)-(XXIX), wherein said distal section (5) of said tube (1) is arranged in said proximal region (9) of said sensor guide wire (8).
(XXXI) A sensor guide wire according to any of the preceding embodiments, wherein a security string extends from a proximal end to a distal end (14) of said sensor guide wire (8).
(XXXII) A sensor guide wire according to embodiment (XXXI), wherein said security string is a flexible wire running inside said tube (1).
The present invention is not limited to the above-described preferred embodiments. Various alternatives, modifications and equivalents may be used. Therefore, the above embodiments should not be taken as limiting the scope of the invention.
This application claims priority from U.S. Provisional Application 61/642,101, filed May 3, 2012, incorporated herein by reference in its entirety.
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Number | Date | Country | |
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20130296718 A1 | Nov 2013 | US |
Number | Date | Country | |
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61642101 | May 2012 | US |