Patent Application
20100082000
The present disclosure relates generally to medical devices and, more specifically, to a peelable catheter with a reinforced tubular member used to position an elongate medical instrument within a body.
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Various devices have been proposed for introducing and/or positioning elongate medical instruments in the human body. For instance, various catheter systems, introducer sheaths, and other elongate tubular members have been proposed for these purposes. More specifically, these devices include a proximal portion that remains outside the body and a tubular member that extends into the body. A lumen extends through the proximal portion and the tubular member. A medical instrument, such as a cardiac pacemaker lead or other vascular instrument, passes through the lumen into the body, and then the medical professional positions the medical instrument into a desired position. For instance, in some embodiments, the medical instrument is positioned within the patient's heart, blood vessel, or other portion of the body. Then, the medical professional removes the tubular member of the catheter system, leaving the medical instrument in its intended position within the body.
Many catheter systems have been proposed that are designed to be removed without disturbing (i.e., inadvertently moving) the medical instrument from its desired position. For instance, in some catheter systems, the elongate tubular member can be torn and peeled apart longitudinally while being pulled out of the body, leaving the medical instrument in its intended position.
Although these conventional catheter systems have functioned for their intended purposes, problems remain. For instance, the tubular member is typically made out of a relatively flexible material so that it can be more easily peeled apart. However, when inserting and positioning the tubular member in the body, the tubular member often inadvertently flexes, bends, and twists when pushing longitudinally and/or subjecting the tubular member to torque forces. Accordingly, it can be difficult to properly position the catheter system within the body.
This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
A catheter system is disclosed for positioning of a medical instrument within a body. The catheter system includes a hub defining a main lumen therethrough for passage of the medical instrument. The catheter system also includes an elongate tubular member defining a lumen therethrough. The lumen of the elongate tubular member is in communication with the main lumen of the hub for further passage of the medical instrument. The elongate tubular member defines a first portion and a second portion. The catheter system also includes a reinforcement member that is fixedly coupled to and reinforces the elongate tubular member, the reinforcement member includes a first part, a second part, and a partition defined between the first and second parts. The first and second parts are adapted to selectively move away from each other along the partition to thereby move the first and second portions away from each other and to uncover the medical instrument.
In another aspect, a method of positioning a medical instrument relative to a body is disclosed. The method includes positioning a portion of a catheter system relative to the body. The catheter system includes a hub with a main lumen, an elongate tubular member defining a lumen that is in communication with the main lumen, and a reinforcement member that is fixedly coupled to and reinforces the elongate tubular member. The method also includes extending the medical instrument through the main lumen and the lumen of the elongate tubular member. Furthermore, the method includes moving portions of the elongate tubular member and parts of the reinforcement member away from each other along a predetermined partition of the reinforcement member to uncover the medical instrument.
In still another aspect, a catheter system is disclosed for positioning of a medical instrument within a body. The catheter system includes a hub defining a main lumen therethrough for passage of the medical instrument. The hub includes a first piece and a second piece that is removably coupled to the first piece. The catheter system also includes an elongate tubular member defining a longitudinal axis and defining a lumen therethrough. The lumen of the elongate tubular member is in communication with the main lumen of the hub for further passage of the medical instrument. The elongate tubular member defines a first portion and a second portion. Furthermore, the catheter system includes a reinforcement member that is fixedly coupled to and reinforces the elongate tubular member. The reinforcement member includes a first part, a second part, and a partition defined between the first and second parts. The first piece is coupled to the first portion of the elongate tubular member and the first part of the reinforcement member, and the second piece is coupled to the second portion of the elongate tubular member and the second part of the reinforcement member. Movement of the first piece away from the second piece causes a slit to propagate in the elongate tubular member generally parallel to the longitudinal axis and causes the first portion to move away from the second portion and the first part to move away from the second part.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features.
Referring initially to
As shown in
Furthermore, the catheter system 10 includes an elongate tubular member 22 defining a lumen 24 therethrough. The elongate tubular member 22 shares the axis X with the hub 14. The elongate tubular member 22 includes a proximal end 27 and a distal end 29. The proximal end 27 is coupled to the hub 14 in a manner to be discussed in greater detail below. The lumen 24 is in communication with the main lumen 20 of the hub 14. As will be discussed, the medical instrument 12 passes through the main lumen 20 and further passes through the lumen 24 and into the body.
Furthermore, the tubular member 22 defines a first portion 26 and a second portion 28. The first and second portions 26, 28 are each elongate, and each has an arcuate cross section. The first and second portions 26, 28 are disposed substantially symmetrically about the axis X such that the tubular member 22 is hollow and tubular. The first and second portions 26, 28 are operably secured so as to cooperatively define the lumen 24. In some embodiments, the first and second portions 26, 28 are integrally coupled such that the tubular member 22 is monolithic. As will be discussed in greater detail, the first and second portions 26, 28 are operable to move away from each after the medical instrument 12 has been positioned in the body in order to uncover the medical instrument 12 and to remove the catheter system 10.
Moreover, the catheter system 10 includes a reinforcement member 30, which is shown in phantom in
Accordingly, as will be discussed, the reinforcement member 30 reinforces the tubular member 22 such that the tubular member 22 resists kinking and such that torque forces transfer effectively through to the tubular member 22 while positioning the catheter system 10 relative to the body. In some embodiments, the reinforcement member 30 allows approximately 1:1 torque transfer from the proximal end 27 to the distal end 29. Accordingly, the catheter system 10 can be more quickly and easily positioned relative to the body.
In addition, the reinforcement member 30 includes a first part 36 and a second part 38 (
The first part 36 of the reinforcement member 30 is fixed to the first portion 26 of the tubular member 22, and the second part 38 is fixed to the second portion 28 of the tubular member 22. As will be described, the first and second parts 36, 38 are adapted to selectively move away from each other and part along the partitions 40 to thereby move the first and second portions 26, 28 away from each other once the medical instrument 12 has been positioned in the body. Thus, the reinforcement member 30 and tubular member 22 can peel apart, separate, break, sever, or split generally along the longitudinal axis X to uncover the medical instrument 12. More specifically, as will be described, the reinforcement member 30 and tubular member 22 can peel apart or separate due to slits that propagate generally parallel to the longitudinal axis X.
Various embodiments of the hub 14 will now be discussed in greater detail. The hub 14 includes a first piece 42 and a second piece 44 that are removably coupled to each other. The first piece 42 and second piece 44 are substantially symmetric with respect to the axis X. In some embodiments, the first and second pieces 42, 44 are made out of a polymeric, molded material, such as PEBAX. Also, the first and second pieces 42, 44 each have a generally arcuate cross section and include a handle 46a, 46b extending transverse and symmetrically away from the axis. Furthermore, the first and second pieces 42, 44 include a plurality of apertures 41 at the distal end 18 thereof, which provide added flexibility to the distal end 18 and which provide a relatively smooth transition from the hub 14 to the tubular member 22 so as to reduce the possibility of kinking of the tubular member 22 due to pushing the hub 14 along the axis X. Also, the first and second pieces 42, 44 include a respective abutment surface 45a, 45b, which are substantially flat so as to abut and mate with each other.
In some embodiments, the first and second pieces 42, 44 include a hydrophobic material (not specifically shown) for reducing leakage from the hub 14. For instance, the pieces 42, 44 can be constructed at least partially from hydrophobic material, such as PE or PTFE. The pieces 42, 44 can also be coated on the abutment surfaces 45a, 45b with a hydrophobic coating, such as silicone. Also, the entire hub 14 can be coated with a thin, continuous, low-tear strength material such that leaking is reduced and yet the pieces 42, 44 can be easily removed from each other.
Also, the first and second pieces 42, 44 each include a recess 48a, 48b that cooperate to define the main lumen 20 of the hub 14. In some embodiments, the recesses 48a, 48b are shaped such that the main lumen 20 is tapered. More specifically, in some embodiments, the main lumen 20 tapers such that the main lumen 20 is wider adjacent the proximal end 16 as compared to the distal end 18.
As shown in
In some embodiments illustrated in
In addition, in some embodiments illustrated in
Furthermore, in some embodiments, the first and second pieces 42, 44 each define a rounded slot 50a, 50b that extend generally along the axis X. The slots 50a, 50b cooperate to define an opening 52 that extends partially along the length of the hub 14 from the proximal end 16. The opening 52 substantially encompasses the main lumen 20. The opening 52 removably receives a retainer member 54, which removably couples the first and second piece 42, 44.
As best shown in
The retainer member 54 is moveable longitudinally along the X axis into and out of the opening 52. More specifically, the tubular portion 55 is moveably received in the opening 52. When the tubular portion 55 is disposed in the opening 52, the tubular portion 55 removably couples the first and second pieces 42, 44. Also, the tubular portion 55 can be selectively removed from the opening 52 generally along the X axis in order to decouple the first and second pieces 42, 44.
The notches 58a, 58b in the tubular portion 55 are included in order to avoid interference with the handles 46a, 46b. Also, in some embodiments, the first and second pieces 42, 44 cooperate to define a slot 53 at the proximal end 16 of the hub 14. The slot 53 receives the handle 56 of the retainer member 54 when the retainer member 54 is disposed in the opening 52.
Accordingly, the retainer member 54 securely couples the first and second pieces 42, 44. Also, the retainer member 54 can be easily removed from the opening 52 for facilitating decoupling of the first and second pieces 42, 44. It will be appreciated, however, that the first and second pieces 42, 44 could be secured in any suitable fashion, with or without the retainer member 54. For instance, the first and second pieces 42, 44 can be operably secured with an adhesive, in addition to or instead of the retainer member 54. Also, in some embodiments, the first and second pieces 42, 44 could be retained with clips, pins, and otherwise without departing from the scope of the present disclosure.
Now, various embodiments of the tubular member 22 will be discussed in greater detail. In some embodiments, the tubular member 22 has a longitudinal length that is greater than the longitudinal length of the reinforcement member 30. For instance, in some embodiments, the distal end 29 of the tubular member 22 extends longitudinally away from a corresponding end of the reinforcement member 30. In some embodiments, the distal end 29 is made longer than that of the reinforcement member 30 by dipping the tubular member 22 and reinforcement member 30 into a bath of polymeric material that adheres to the distal end 29. Accordingly, the distal end 29 is relatively soft, and the distal end 29 can be more easily moved through the body. Also, in some embodiments, the distal end 29 can include a material that highly visible in X-ray or other imaging methods. Furthermore, in some embodiments, the proximal end 27 of the tubular member 22 extends away from a corresponding end of the reinforcement member 30. As such, the proximal end 27 of the tubular member 22 can be more easily coupled to the hub 14 as will be described.
Specifically, as shown in the embodiment of
Accordingly, the proximal end 27 defines a plurality of tabs 60a, 60b. Each tab 60a, 60b extends into a corresponding one of the secondary lumens 51a, 51b as shown in
In some embodiments, other portions of the tubular member 22 are also coupled to the hub 14. For instance, in some embodiments, a portion of the tubular member 22 forward of the slit 59 is coupled to the hub 14 inside the main lumen 20 to further secure the hub 14 and tubular member 22. Also, in some embodiments, the hub 14 can be overmolded onto the tubular member 22 for operably securing the hub 14 and tubular member 22.
Also, as the first and second pieces 42, 44 of the hub 14 move away from each other, the predefined slit 59 propagates longitudinally along the tubular member 22 in a direction generally parallel to the axis X in order to reveal the medical instrument 12. It will be appreciated that the slits 59 facilitate peeling or separating of the tubular member 22 along the axis X. As such, the tubular member 22 can be easier to peel apart, and the tubular member 22 is more likely to peel relatively straight in a direction substantially parallel to the axis. Accordingly, the medical instrument 12 is less likely to be disturbed during peeling of the tubular member 22. It will be appreciated that the tubular member 22 could also be scored between the first and second portions 26, 28 with scoring (not shown) that meets the slits 59 to further facilitate peeling and to further define a predetermined failure mode.
Thus, referring initially to
Next, the medical instrument 12 is inserted by passing between the valve portions 43a, 43b and through the main lumen 20. The medical instrument 12 then further passes through the lumen 24 of the tubular member 22 into the body.
Then, the user grasps the handle 56 of the retainer member 54 with one hand and the hub 14 with the other and pulls the retainer member longitudinally away from the proximal end 16 of the hub 14. The retainer member 54 can then be discarded.
Next, the user grasps the handles 46a, 46b and pulls the first and second pieces 42, 44 away from each other away from the axis X as shown in
Accordingly, the catheter system 10 allows for easy positioning of the medical instrument 12. Also, the catheter system 10 can be easily positioned and removed from the body and is unlikely to disturb the medical instrument 12 from its intended position. Also, the system 10 can be positioned and removed by one person because of the various features described above. In addition, manufacture of the catheter system 10 can be completed relatively quickly and less expensively than systems of the prior art.
Moreover, as stated above, the reinforcement member 30 reinforces the tubular member 22 such that the tubular member 22 is sufficiently flexible, but yet is sufficiently stiff to allow pushing and/or torque forces to be transferred effectively through the tubular member 22. Thus, the tubular member 22 can be pushed into, twisted, and generally positioned within the body quickly and easily.
Various embodiments of the reinforcement member 30 will now be discussed with reference to
In the embodiments represented in
In some embodiments represented in
Furthermore, in some embodiments represented in
Alternatively, in some embodiments represented in
Also, in some embodiments represented in
In addition, in some embodiments represented in
Still further, in some embodiments represented in
In addition,
Furthermore, in some embodiments represented in
Accordingly, each of the reinforcement members 30, 130, 230, 330, 430, 530, 630, 730, 830 reinforces the tubular member 22 with sufficient resiliency and flexibility, and allows pushing, torque and other forces to effectively transfer through the tubular member 22. Thus, the tubular member 22 can be positioned within the body more easily. Also, the reinforcement members 30, 130, 230, 330, 430, 530, 630, 730, 830 can be easily parted in order to peel the tubular member 22 for removal of the catheter system 10.
Certain terminology is used herein for purposes of reference only, and thus is not intended to be limiting. For example, terms such as “upper,” “lower,” “above,” “below,” “top,” “upward,” and “downward” refer to directions in the drawings to which reference is made. Terms such as “front,” “back,” “rear,” and “side,” describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first,” “second,” and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.
When introducing elements or features and the exemplary embodiments, the articles “a,” “an,” “the” and “said” are intended to mean that there are one or more of such elements or features. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements or features other than those specifically noted. It is further to be understood that the method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.
The description of the disclosure is merely exemplary in nature and, thus, variations that do not depart from the gist of the disclosure are intended to be within the scope of the disclosure. Such variations are not to be regarded as a departure from the spirit and scope of the disclosure.
