Patent Grant
11541206
The present invention, in some embodiments thereof, relates to devices and methods for delivering a medical tube in a bodily passage, and more particularly, but not exclusively, to a removable catheter cap for covering the distal tip of a flexible medical tube, such as a catheter (e.g., a single or multiple lumen or tip catheter or a blunt-tip catheter), during delivery of the medical tube in a body lumen. Exemplary applications of the invention are: provision of a catheter assembly including a catheter and the removable catheter cap connected thereto; a medical kit including one or more catheters and one or more correspondingly configured removable catheter caps; and a method for delivering a catheter in a blood vessel of a subject.
In common practice, various medical tubes, such as catheters, are introduced into body lumens for performing a treatment, which can be local (e.g., dilatation of a narrowed portion of a vessel wall) or systemic (e.g., drug delivery via the vascular system), temporary or acute (e.g., deployment of a stent), or chronic (e.g., using a chronic hemodialysis catheter).
Catheters are commonly delivered to a target location in a blood vessel using the ‘Seldinger technique’, which most basically includes placing a guidewire from an entry point to the blood vessel and across the target location, passing an introducer sheath over the guidewire, optionally withdrawing the guidewire, and then delivering the catheter, via the introducer sheath, until reaching the target location. The introducer sheath serves as a closed track or channel in which the catheter and other instrumentation can be delivered.
When performing temporary or short term catheterization procedures, it is customary that the introducer sheath is removed from the body only after removing the catheter and any other relevant instrumentation. However, when the catheter is intended for long-term placement or implantation, the catheter can be introduced via a ‘peelable’ vascular sheath. This type of introducer sheath can be removed from the blood vessel while the implanted catheter remains in-place, by first splitting, tearing, or/and peeling portions of the sheath around the catheter, for example, along perforated tear lines or other weakened spots. Such technique is known practice for placing different types of catheters and other medical tubes, for example: tunneled dialysis catheters, peripherally inserted central catheter (PICC), port for central venous catheter, or delivery or extraction of pacemaker leads.
Use of a peelable sheath may be accompanied by potential failures, mostly due to anatomy or conditions of the host blood vessel. Vein laceration is an injury to vein walls that may occur during delivery of a peelable sheath, for example, due to buckling of the guidewire and inadvertent advancement of the dilator portion of the sheath through the vein (e.g., the superior vena cava), possibly, when the sheath is advanced through the vein over a relatively lax guidewire.
Structural characteristics of some catheters may also be found disadvantageous in current uses thereof. For example, catheters having a distal tip being fully blunt, substantially soft, or having an inadequate guidewire opening, cannot be used effectively, or at all, in deliveries over a guidewire or/and without a sheath. Blunt and soft catheter distal tips may also increase likelihood of delivery failures associated with peelable sheath applications. Other catheters, such as ones used for transcatheter aortic valve replacement (TAVR) surgeries, have relatively sharp or pointed tips, or/and optionally relatively rigid, which may cause injury to surrounding tissue (e.g., puncturing of heart tissue). Catheters may have only side holes, for example the Foley catheter for draining the urine bladder, and it may be advantageous to have their distal tip be blunt shaped, with a forward opening instead or in addition to the side holes. Some other medical tubes designs may limit intubation techniques, for example drainage or chest tubes which are currently inserted while grasping their distal tip with a ‘Kelly’ clamp, thereby causing discomfort to the patient.
In view of such shortcomings, as well as other limitations, in the field and art of the invention, there is need for developing and practicing new or/and improved devices, and applications thereof, for delivering medical tubes (such as catheters) in bodily passages.
The present invention, in some embodiments thereof, relates to devices and methods for delivering a medical tube in a bodily passage, and more particularly, but not exclusively, to a removable catheter cap for covering the distal tip of a flexible medical tube, such as a catheter (e.g., a single or multiple lumen or tip catheter or a blunt-tip catheter), during delivery of the medical tube in a body lumen, for example, via an over-the-wire insertion technique. Exemplary applications of the invention are: provision of a catheter assembly including a catheter and the removable catheter cap connected thereto; a medical kit including one or more catheters and one or more correspondingly configured removable catheter caps; and a method for delivering a catheter in a blood vessel of a subject.
According to an aspect of some embodiments of the present invention, there is provided a removable catheter cap, comprising: a cap body configured for being removably connectable to distal tip of a catheter, so as to facilitate capping of the catheter distal tip, and is sized and shaped for blocking passage of the cap body through a lumen of the catheter extending from the catheter distal tip to proximal end of the catheter, the cap body is transformable into at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen; and a cap releasing member configured to extend through the catheter proximal end when the removable catheter cap is connected to the catheter, and is selectively manipulatable for facilitating transformation of the cap body into the at least one constituent part or/and for facilitating withdrawal of the at least one constituent part from the catheter distal tip through the catheter lumen.
According to some embodiments of the invention, the cap body is configured to provide space between the catheter distal tip and surrounding tissue during delivery of the catheter within a blood vessel. According to some embodiments of the invention, the cap body has a shape or form that is tapered, ogival, or/and streamlined for facilitating traversability of the catheter in a blood vessel. According to some embodiments of the invention, the cap body is configured to reinforce a distal portion of the catheter when the removable catheter cap is connected to the catheter.
According to some embodiments of the invention, the removable catheter cap is configured as an atraumatic cap, wherein the cap body is more flexible, smoother, or/and softer than the catheter distal tip.
According to some embodiments of the invention, the cap releasing member is, or is operatively connected to, an end portion of the predefined constituent part that emerges from the cap body, and is extendable across the catheter lumen when the removable catheter cap is connected to the catheter. According to some embodiments of the invention, the cap releasing member is selectively manipulatable for facilitating disconnection and release of the cap body from connection to the catheter distal tip.
According to some embodiments of the invention, the cap body includes a guidewire opening sized for passing a guidewire therethrough, so as to facilitate passage of the catheter, when connected to the removable catheter cap, over the guidewire in a blood vessel. According to some embodiments of the invention, the cap body comprises a cap vertex and a cap base, wherein the cap body is configured with a cap cavity that spans between the cap vertex and the cap base, and the cap body is configured for housing the catheter distal tip. According to some embodiments of the invention, the cap body includes splittable or/and peelable lines or portions that are configured to facilitate the transformation of the cap body into the at least one predefined constituent part by separating the cap body along the splittable or/and peelable lines or portions. According to some embodiments of the invention, the cap body includes separable windings of the at least one predefined constituent part. According to some embodiments of the invention, the separable windings are interbonded, intertwined, or/and woven. According to some embodiments of the invention, the separable windings are configured to separate into the at least one predefined constituent part when the cap body is pulled against the catheter distal tip. According to some embodiments of the invention, the separable windings are configured to separate when the cap body is pulled against the catheter distal tip only above a predetermined pulling force.
According to some embodiments of the invention, the at least one predefined constituent part has an unwound free end configured as, or operatively connected to, an elongated pulling member, the pulling member is configured for transferring a pulling force to the cap body. According to some embodiments of the invention, the cap releasing member includes, extends from, or is connected to, the elongated pulling member.
According to some embodiments of the invention, the cap body includes, or is releasably connected to, a first extension sized and configured for insertion into the catheter lumen. According to some embodiments of the invention, the first extension, when extending into the catheter lumen, is configured to reinforce a distal portion of the catheter.
According to some embodiments of the invention, the catheter is a split-tip catheter comprising at least a first tip and a second tip, wherein the cap body is configured for releasably adjoining distal end-portions of the at least first and second tips.
According to an aspect of some embodiments of the present invention, there is provided a removable catheter cap, comprising: a cap body configured for being removably connectable to distal tip of a catheter, so as to facilitate capping of the catheter distal tip, and is sized and shaped for blocking passage of the cap body through a lumen of the catheter extending from the catheter distal tip to proximal end of the catheter, and the cap body includes interbonded, intertwined, or/and woven separable windings of at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen; wherein the separable windings are configured to separate into the at least one predefined constituent part when the cap body is pulled against the catheter distal tip.
According to some embodiments of the invention, the at least one predefined constituent part has an unwound free end portion configured as, or operatively connected to, an elongated pulling member, the pulling member is configured for transferring a pulling force to the cap body.
According to some embodiments of the invention, the removable catheter cap further comprises a cap releasing member that is configured to extend through the catheter proximal end, when the removable catheter cap is connected to the catheter, and is selectively manipulatable for facilitating transformation of the cap body into the at least one constituent part or/and for facilitating withdrawal of the at least one constituent part from the catheter distal tip through the catheter lumen. According to some embodiments of the invention, the cap releasing member is, or is operatively connected to, an end portion of the predefined constituent part that emerges from the cap body, and is extendable across the catheter lumen when the removable catheter cap is connected to the catheter.
According to an aspect of some embodiments of the present invention, there is provided a catheter assembly, comprising: a catheter having a catheter lumen extending from a distal tip to a proximal end of the catheter; and a removable catheter cap releasably connected to the catheter and comprising: a cap body configured for being removably connectable to the catheter distal tip, so as to facilitate capping of the catheter distal tip, and sized and shaped for blocking passage of the cap body through the catheter lumen, the cap body is transformable into at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen; and a cap releasing member configured to extend through the catheter proximal end when the removable catheter cap is connected to the catheter, and is selectively manipulatable for facilitating transformation of the cap body into the at least one constituent part or/and for facilitating withdrawal of the at least one constituent part from the catheter distal tip through the catheter lumen.
According to an aspect of some embodiments of the present invention, there is provided a catheter assembly, comprising: a catheter having a catheter lumen extending from a distal tip to a proximal end of the catheter; and a removable catheter cap releasably connected to the catheter and comprising a cap body configured for being removably connectable to the catheter distal tip, so as to facilitate capping of the catheter distal tip, and sized and shaped for blocking passage of the cap body through the catheter lumen, the cap body includes interbonded, intertwined, or/and woven separable windings of at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen; wherein the separable windings are configured to separate into the at least one predefined constituent part when the cap body is pulled against the catheter distal tip.
According to an aspect of some embodiments of the present invention, there is provided a medical kit, comprising: at least one catheter; and at least one removable catheter cap, each one of the at least one removable catheter cap is comprised of a cap body configured for being removably connectable to distal tip of a corresponding one of the at least one catheter, so as to facilitate capping of the catheter distal tip, and is sized and shaped for blocking passage of the cap body through a lumen of the corresponding catheter extending from the catheter distal tip to proximal end of the corresponding catheter, and the cap body includes interbonded, intertwined, or/and woven separable windings of at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen; wherein the separable windings are configured to separate into the at least one predefined constituent part when the cap body is pulled against the catheter distal tip.
According to some embodiments of the invention, the at least one predefined constituent part has an unwound free end portion configured as, or operatively connected to, an elongated pulling member, the pulling member is configured for transferring a pulling force to the cap body.
According to some embodiments of the invention, the removable catheter cap further comprises a cap releasing member that is configured to extend through the catheter proximal end, when the removable catheter cap is connected to the corresponding catheter, and is selectively manipulatable for facilitating transformation of the cap body into the at least one constituent part or/and for facilitating withdrawal of the at least one constituent part from the catheter distal tip through the catheter lumen. According to some embodiments of the invention, the cap releasing member is, or is operatively connected to, an end portion of the predefined constituent part that emerges from the cap body, and is extendable across the catheter lumen when the removable catheter cap is connected to the corresponding catheter.
According to an aspect of some embodiments of the present invention, there is provided a method for delivering a catheter in a blood vessel, the method comprising: inserting a guidewire in the blood vessel and across a target location; capping distal tip of the catheter with a removable catheter cap comprising a cap body having a guidewire opening sized for passing the guidewire therethrough; passing the guidewire through the guidewire opening, into and across a lumen of the catheter, to a proximal end of the catheter; pushing the catheter with the removable catheter cap thereon in the blood vessel and over the guidewire until reaching the target location; and transforming the cap body into at least one predefined constituent part that is sized and shaped to pass freely through the catheter lumen.
According to some embodiments of the invention, the removable catheter cap includes a cap releasing member, and wherein the transforming includes manipulating the cap releasing member from the catheter proximal end. According to some embodiments of the invention, the cap releasing member includes, or is operatively connected to, an elongated pulling member extendable from the removable catheter cap through the catheter distal tip and to the catheter proximal end, wherein the transforming includes pulling the elongated pulling member.
According to some embodiments of the invention, the method further comprises removing the at least one constituent part from the blood vessel via the catheter lumen.
According to some embodiments of the invention, the cap body is sized and shaped for blocking passage of the cap body through the catheter lumen, and includes separable windings of the at least one predefined constituent, the method further comprising: separating the separable windings by pulling the cap body against the catheter distal tip via an unwound free end portion of the at least one predefined constituent part.
According to some embodiments of the invention, the catheter is a split-tip catheter comprising at least a first tip and a second tip, wherein the capping includes holding the first and second tips adjoined to each other with the cap body, and wherein the transforming facilitates releasing the adjoined first and second tips.
All technical or/and scientific words, terms, or/and phrases, used herein have the same or similar meaning as commonly understood by one of ordinary skill in the art to which the invention pertains, unless otherwise specifically defined or stated herein. Exemplary embodiments of methods (steps, procedures), apparatuses (devices, systems, components thereof), equipment, and materials, illustratively described herein are exemplary and illustrative only and are not intended to be necessarily limiting. Although methods, apparatuses, equipment, and materials, equivalent or similar to those described herein can be used in practicing or/and testing embodiments of the invention, exemplary methods, apparatuses, equipment, and materials, are illustratively described below. In case of conflict, the patent specification, including definitions, will control.
Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative description of some embodiments of the present invention. In this regard, the description taken together with the accompanying drawings make apparent to those skilled in the art how some embodiments of the present invention may be practiced.
In the drawings:
The present invention, in some embodiments thereof, relates to devices and methods for delivering a medical tube in a bodily passage, and more particularly, but not exclusively, to a removable catheter cap for covering the distal tip of a flexible medical tube, such as a catheter (e.g., a single or multiple lumen or tip catheter or a blunt-tip catheter), during delivery of the medical tube in a body lumen, for example, via an over-the-wire insertion technique. Exemplary applications of the invention are: provision of a catheter assembly including a catheter and the removable catheter cap connected thereto; a medical kit including one or more catheters and one or more correspondingly configured removable catheter caps; and a method for delivering a catheter in a blood vessel of a subject.
An aspect of some embodiments of the present invention is provision of a removable catheter cap, including a cap body configured for being removably connectable to distal tip of a catheter, so as to facilitate capping of the catheter distal tip. In exemplary embodiments, the cap body is sized and shaped for blocking passage of the cap body through a lumen of the catheter extending from the catheter distal tip to proximal end of the catheter. In exemplary embodiments, the cap body is transformable into at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen. In exemplary embodiments, the removable catheter cap further includes a cap releasing member configured to extend through the catheter proximal end when the removable catheter cap is connected to the catheter, and is selectively manipulatable for facilitating transformation of the cap body into the at least one constituent part or/and for facilitating withdrawal of the at least one constituent part from the catheter distal tip through the catheter lumen.
An aspect of some embodiments of the present invention is provision of a removable catheter cap, including a cap body having interbonded, intertwined, or/and woven separable windings of at least one predefined constituent part that is sized and shaped to freely pass through the lumen of a catheter, wherein the separable windings are configured to separate into the at least one predefined constituent part when the cap body is pulled against the catheter distal tip.
An aspect of some embodiments of the present invention is provision of a catheter assembly, including a catheter, and a removable catheter cap releasably connected to the catheter. In exemplary embodiments, the catheter has a lumen extending from the catheter distal tip to the catheter proximal end. In exemplary embodiments, the removable catheter cap includes a cap body and a cap releasing member. In exemplary embodiments, the cap body is configured for being removably connectable to the catheter distal tip, so as to facilitate capping of the catheter distal tip, and sized and shaped for blocking passage of the cap body through the catheter lumen. In exemplary embodiments, the cap body is transformable into at least one predefined constituent part that is sized and shaped to freely pass through the catheter lumen. In exemplary embodiments, the cap releasing member is configured to extend through the catheter proximal end when the removable catheter cap is connected to the catheter, and is selectively manipulatable for facilitating transformation of the cap body into the at least one constituent part or/and for facilitating withdrawal of the at least one constituent part from the catheter distal tip through the catheter lumen.
An aspect of some embodiments of the present invention is provision of a medical kit, including at least one catheter, and at least one removable catheter cap. In exemplary embodiments, each one of the at least one removable catheter cap includes a cap body configured for being removably connectable to the distal tip of a corresponding one of the at least one catheter. In exemplary embodiments, the cap body facilitates capping of the catheter distal tip, and is sized and shaped for blocking passage of the cap body through a lumen of the corresponding catheter extending from the catheter distal tip to proximal end of the corresponding catheter.
An aspect of some embodiments of the present invention is provision of a method for delivering a catheter in a blood vessel, the method including: inserting a guidewire in the blood vessel and across a target location; capping the distal tip of the catheter with a removable catheter cap that includes a cap body having a guidewire opening sized for passing the guidewire therethrough; passing the guidewire through the guidewire opening, into and across a lumen of the catheter, to a proximal end of the catheter; pushing the catheter with the removable catheter cap thereon in the blood vessel and over the guidewire until reaching the target location; and transforming the cap body into at least one predefined constituent part that is sized and shaped to pass freely through the catheter lumen. In exemplary embodiments, the removable catheter cap includes a cap releasing member, and the transforming includes manipulating the cap releasing member from the catheter proximal end.
In exemplary embodiments, the cap releasing member includes, or is operatively connected to, an elongated pulling member extendable from the removable catheter cap through the catheter distal tip and to the catheter proximal end, the transforming includes pulling the elongated pulling member. The pulling member is optionally configured for transferring a pulling force to the cap body. For example, the cap releasing member may be in a form of a handheld element that is connected or joined to the elongated pulling member being in a form of a pull-wire. Alternatively, the cap releasing member may be a first portion (e.g., more proximal portion) and the elongated pulling member may be a second portion (e.g., a more distal portion) of a same element (e.g., a pull-wire). Optionally, additionally or alternatively, the cap releasing member is, or is operatively connected to, an end portion of the predefined constituent part that emerges from the cap body. Optionally, additionally or alternatively, the at least one predefined constituent part has an unwound (or non-wound) free end configured as, or operatively connected to, the elongated pulling member. In some embodiments, the cap releasing member or/and the elongated pulling member is a portion of the predefined constituent part, or, more particularly, of the unwound (or non-wound) free end thereof.
In exemplary embodiments, the method further includes removing the at least one constituent part from the blood vessel via the catheter lumen. In exemplary embodiments, the cap body is sized and shaped for blocking passage of the cap body through the catheter lumen, and includes separable windings of the at least one predefined constituent, and the method further includes separating the separable windings by pulling the cap body against the catheter distal tip via an unwound free end portion of the at least one predefined constituent part. In exemplary embodiments, the catheter is a split-tip catheter including at least a first tip and a second tip, and the capping includes holding the first and second tips adjoined to each other with the cap body, and the transforming facilitates releasing the adjoined first and second tips.
For purposes of better understanding exemplary embodiments of the present invention, in the following illustrative description thereof, reference is made to the figures (
Catheter 11 has a catheter lumen 12 extending from a distal tip 13 thereof to a proximal end 14 thereof. In some embodiments, catheter distal tip 13 is blunt so that capping it with the catheter cap 10 provides a front geometry being advantageous for improving traversability in a blood vessel. The removable catheter cap 10 may also serve and be configured as an atraumatic cap, by which it improves protection of surrounding tissue (e.g., blood vessel wall) during delivery.
Removable catheter cap 10 includes a cap body 15 and a cap releasing member 16. Cap body 15 is configured to cap catheter distal tip 13 when the removable catheter cap 10 is connected to catheter 11. As such, cap body 15 provides space between catheter distal tip 13 and surrounding tissue (blood vessel wall) during delivery of catheter 11 within a blood vessel.
Upon delivery to a chosen position, cap 10 (e.g., cap body 15) is disconnected from catheter 11 and removed from the blood vessel, in order to allow use of catheter 11 at the target location. For having it removed, cap body 15 is first reshaped or/and sized to allow its (or parts thereof) passing through the catheter (e.g., through a lumen in the catheter). Such reshaping and resizing may involve changing its structure, for example, by transforming of one or more components or portions thereof. The term ‘transforming’, as used herein, refers to any of the following possibilities or any combination thereof: separating, breaking, cracking, cutting, splitting, disjoining, detaching, dividing, unraveling, unwrapping, dismantling, disconnecting, tearing and disassembling, either into a single element or to a number of pieces, fragments or parts. Optionally, cap body 15 includes separable windings, which may be interbonded, intertwined or/and woven, and the transforming may include separation by force of this windings, into forming an at least one constituent part.
Cap body 15 is sized, shaped or/and configured to block passing thereof through catheter lumen 12. Cap body 15 has a shape or form that is tapered (e.g., ogival), at least in front (distal) portion thereof, and streamlined, for facilitating traversability of catheter 11 in the blood vessel. Cap body 15 includes a guidewire opening 19 sized for passing a guidewire 20 therethrough, so as to facilitate passage of catheter 11, when connected to the removable catheter cap 10, over guidewire 20 in a blood vessel.
Cap body 15 is transformable into at least one predefined constituent part 17 that is sized, shaped or/and configured to freely pass through catheter lumen 12. Cap body 15 may include splittable or/and peelable lines or portions 21, configured to facilitate cap body separability into the at least one predefined constituent part 17 along the splittable or/and peelable lines or portions 21. Optionally, additionally or alternatively, cap body 15 is fabricated from at least one bonded, intertwined or/and woven elongated pulling member 22, that forms the at least one predefined constituent part 17 when separated from the bonded or/and woven fabrication of cap body 15.
Cap releasing member 16 is configured to extend through catheter proximal end 14 when the removable catheter cap 10 is connected to catheter 11. Cap releasing member 16 emerges from cap body 15 and is extendable across catheter lumen 12, when the removable catheter cap 10 is connected to catheter 11. Cap releasing member 16 is selectively manipulatable to separate cap body 15 into at least one constituent part 17 and to withdraw (e.g., by pulling) the constituent part 17 from catheter distal tip 13 through catheter lumen 12. As such, cap releasing member 16 is selectively manipulatable for releasing cap body 15 from connection to catheter distal tip 13.
In some embodiments, cap body 15 is configured to separate into at least one predefined constituent part 17 when pulled against catheter distal tip 13, optionally only above a predetermined pulling force, using elongated pulling member 22. Accordingly, cap releasing member 16 extends from elongated pulling member 22 (but may include it or be connected thereto).
In some embodiments, cap body 15 reinforces a distal portion 18 of catheter 11 when the removable catheter cap 10 is connected thereto. Cap body 15 is releasably connected to an at least one extension 23 that is sized and configured for insertion into catheter lumen 12, optionally snugly fits thereinside. Extension 23 may be one of the predefined constituent parts 17. When extending into catheter lumen 12, extension 23 is configured to reinforce catheter distal portion 18.
Reference is made to
Atraumatic removable catheter cap 102 includes a cap body 104 which encloses a cap cavity 105 between a cap vertex 106 and a cap base 107. Cap body 104 is sized and configured for housing distal end portion 101 of catheter 100 with the blunt tip 103, in cap cavity 105. Cap vertex 106 includes a guidewire opening 109 sized for passing a guidewire GW therethrough into a first lumen 110 opened at blunt tip 103, via cap cavity 105, for allowing progress of the catheter with the atraumatic removable catheter cap thereon into the body and into a blood vessel BV over guidewire GW (e.g. by using an “over-the-wire” technique).
Catheter 100 is shown in
After deploying catheter 100 in blood vessel BV, the guidewire GW may be removed (as shown in
Atraumatic removable catheter cap 102 further includes a cap releasing member 113 which is sized and configured for passing along or/and through the catheter 100 and for operating release of cap body 104 from blunt tip 103 via proximal end 112 of the catheter 100. In some embodiments, cap body 104 is transformable (e.g., dismantlable into one or more pieces) and configured for selective separation into at least one predefined constituent part that is sized, shaped or/and configured to freely pass through catheter lumen 110, by activation of cap release member 113. Optionally, cap body 104 includes splittable or/and peelable lines or portions, or/and it may be fabricated from at least one bonded or/and woven elongated member. A maximal sized piece of these one or more pieces may be sized or/and compressible to a compressed size for allowing passage via a lumen of the catheter, such as first lumen 110. In some embodiments, the cap releasing member 113 includes an elongated pulling member that is optionally in a form of a pull-wire 114.
In some embodiments, exemplary steps for implementing deployment of catheter 100 in blood vessel BV may further include dismantling cap body 104. Dismantling may include activating cap releasing member 113 via proximal end 112 of the catheter, optionally by pulling pull-wire 114 (in a proximal direction).
Atraumatic removable catheter cap 202 includes a thin-walled cap body 204 which encloses a cap cavity 205 between a cap vertex 206 and a cap base 207. Cap body 204 is sized and configured for housing distal end portion 201 of catheter 200 with the blunt tip 203, in cap cavity 205. Cap vertex 206 includes a guidewire opening 209 sized for passing a guidewire GW therethrough into a first lumen 210 opened at blunt tip 203, via cap cavity 205, for allowing progress of the catheter with the atraumatic removable catheter cap thereon in blood vessel BV over guidewire GW (e.g. by using an “over-the-wire” technique).
Catheter 200, shown uncapped in
After deploying catheter 200 in blood vessel BV, the guidewire GW may be removed (as shown in
Atraumatic removable catheter cap 202 further includes a cap releasing member 213 which is sized and configured for passing along or/and through the catheter 200 and for operating release of cap body 204 from blunt tip 203 via proximal end 212 of the catheter 200. In some embodiments, cap body 204 is transformable (e.g., dismantlable into one or more pieces) and configured for selective separation into at least one predefined constituent part that is sized, shaped or/and configured to freely pass through a lumen of the catheter, such as first lumen 210, by activation of cap release member 213. Optionally, cap body 204 includes splittable or/and peelable lines or portions, or/and it may be fabricated from at least one bonded or/and woven elongated member. A maximal sized piece of these one or more pieces may be sized or/and compressible to a compressed size for allowing passage via a lumen of the catheter, such as first lumen 210. In some embodiments, the cap releasing member 213 includes an elongated pulling member that is optionally in a form of a pull-wire 214.
In some embodiments, exemplary steps for implementing deployment of catheter 200 in blood vessel BV may further include dismantling cap body 204. Dismantling may include activating cap releasing member 213 via proximal end 212 of the catheter, optionally by pulling pull-wire 214 (in a proximal direction).
Catheter 400 is shown at a fully deployed form in which the tips openings 410 and 412 are oriented to opposite directions one with each other. As such, first distal end region 403 and second distal end region 405 are optionally rotationally symmetric one with the other relative to a longitudinal axis of the catheter. According to some embodiments of the invention, elongated body 401 is elastically shapeable from a confined form, whereby the first 403 and second 405 end regions are forced to approximate each other within restricting boundaries, to the fully deployed form, whereby the first 403 and 405 second end regions are unconfined, such as with an atraumatic removable catheter cap, as will be further described below. Upon removal of any aligning or/and covering means, first distal end region 403 and second distal end region 405 may voluntarily slide against each other, such as in a scissor-like movement, up to the fully deployed form.
Atraumatic removable catheter cap 450 further includes a cap releasing member 456 which is sized and configured for passing along or/and through the catheter 400 and for operating release of cap body 451 from catheter 400 via proximal end of the catheter. In some embodiments, cap body 451 is transformable (e.g., dismantlable into one or more pieces) and configured for selective separation into at least one predefined constituent part that is sized, shaped or/and configured to freely pass through first lumen 409 or second lumen 411, by activation of cap release member 456. Optionally, cap body 451 includes splittable or/and peelable lines or portions, or/and it may be fabricated from at least one bonded or/and woven elongated member 457, optionally a single thread or a few threads, optionally made from soft wires but which are highly resistant to tears. A maximal sized piece of these one or more pieces may be sized or/and compressible to a compressed size for allowing passage via a lumen of the catheter, such as second lumen 411. In some embodiments, the cap releasing member 456 includes an elongated pulling member that is optionally in a form of a pull-wire 458. Dismantling of the atraumatic removable catheter cap 450 may include activating cap releasing member 456 via proximal end of the catheter, optionally by pulling pull-wire 458 (in a proximal direction).
The structure of atraumatic removable catheter cap 450 is optionally tapered relative to the guidewire GW, in order to allow smooth transition between the wire and cap. The atraumatic removable catheter cap 450 is optionally structurally robust for not collapsing upon insertion against resistance, especially at the skin. Optionally and additionally, atraumatic removable catheter cap 450 is impermeable to fluids such as blood, air or gas, for example if it is configured for insertion, while covering a catheter, into the abdominal cavity during laparoscopic procedures in which the cavity is inflated with gas, specifically CO2. The peeling atraumatic removable catheter cap 450 over the catheter should be done by the operator, optionally after catheter 400 is in place. In some embodiments, means are provided to prevent early or premature peeling of the cap. The operator should be able to peel the cap with a single hand motion. The can should not damage the catheter tip when peeled.
Reference is made to
Reinforcing member 502 is sized and configured to resist shapeability of medical tube 500 or/and to fortify the medical tube from damage during dismantling atraumatic removable catheter cap 501 or/and pulling pull-wire 508. Such resisting is applicable to external forces including at least one of shearing forces, bending forces, twisting forces, axially compressing forces, flattening forces and kinking forces.
Each of the following terms written in singular grammatical form: ‘a’, ‘an’, and ‘the’, as used herein, means ‘at least one’, or ‘one or more’. Use of the phrase ‘one or more’ herein does not alter this intended meaning of ‘a’, ‘an’, or ‘the’. Accordingly, the terms ‘a’, ‘an’, and ‘the’, as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases: ‘a unit’, ‘a device’, ‘an assembly’, ‘a mechanism’, ‘a component’, ‘an element’, and ‘a step or procedure’, as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.
Each of the following terms: ‘includes’, ‘including’, ‘has’, ‘having’, ‘comprises’, and ‘comprising’, and, their linguistic/grammatical variants, derivatives, or/and conjugates, as used herein, means ‘including, but not limited to’, and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase ‘consisting essentially of’.
The term ‘method’, as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.
Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range ‘from 1 to 6’ also refers to, and encompasses, all possible sub-ranges, such as ‘from 1 to 3’, ‘from 1 to 4’, ‘from 1 to 5’, ‘from 2 to 4’, ‘from 2 to 6’, ‘from 3 to 6’, etc., and individual numerical values, such as ‘1’, ‘1.3’, ‘2’, ‘2.8’, ‘3’, ‘3.5’, ‘4’, ‘4.6’, ‘5’, ‘5.2’, and ‘6’, within the stated or described numerical range of ‘from 1 to 6’. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.
Moreover, for stating or describing a numerical range, the phrase ‘in a range of between about a first numerical value and about a second numerical value’, is considered equivalent to, and meaning the same as, the phrase ‘in a range of from about a first numerical value to about a second numerical value’, and, thus, the two equivalently meaning phrases may be used interchangeably. For example, for stating or describing the numerical range of room temperature, the phrase ‘room temperature refers to a temperature in a range of between about 20° C. and about 25° C.’, and is considered equivalent to, and meaning the same as, the phrase ‘room temperature refers to a temperature in a range of from about 20° C. to about 25° C.’.
The term ‘about’, as used herein, refers to ±10% of the stated numerical value.
It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub-combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.
All publications, patents, and or/and patent applications, cited or referred to in this disclosure are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent, or/and patent application, was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this specification shall not be construed or understood as an admission that such reference represents or corresponds to prior art of the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
This application claims the benefit of priority under 35 USC 119(e) of U.S. Provisional Patent Application No. 62/301,013, filed 29 Feb. 2016, entitled “Atraumatic Cap for Medical Tubes and Catheters”, the contents of which are incorporated herein by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2017/051183 | 2/28/2017 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2017/149465 | 9/8/2017 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 5156592 | Martin et al. | Oct 1992 | A |
| 5647857 | Anderson | Jul 1997 | A |
| 5752937 | Otten | May 1998 | A |
| 5800414 | Cazal | Sep 1998 | A |
| 5947953 | Ash et al. | Sep 1999 | A |
| 6001079 | Pourchez | Dec 1999 | A |
| 6110146 | Berthiaume | Aug 2000 | A |
| 6482169 | Kuhle | Nov 2002 | B1 |
| 6513527 | Abdel-Aziz | Feb 2003 | B1 |
| 7108674 | Quinn | Sep 2006 | B2 |
| 7182746 | Haarala et al. | Feb 2007 | B2 |
| 7776005 | Haggstrom et al. | Aug 2010 | B2 |
| 8066660 | Gregersen et al. | Nov 2011 | B2 |
| 8092415 | Moehle et al. | Jan 2012 | B2 |
| 9539411 | Cully | Jan 2017 | B2 |
| 10213578 | Fukuoka | Feb 2019 | B2 |
| 11026669 | Castelli | Jun 2021 | B2 |
| 20020052641 | Monroe et al. | May 2002 | A1 |
| 20020062129 | Mikus et al. | May 2002 | A1 |
| 20030153898 | Schon et al. | Aug 2003 | A1 |
| 20040092863 | Raulerson et al. | May 2004 | A1 |
| 20040167463 | Zawacki et al. | Aug 2004 | A1 |
| 20050054989 | McGuckin et al. | Mar 2005 | A1 |
| 20050277862 | Anand | Dec 2005 | A1 |
| 20060025781 | Young et al. | Feb 2006 | A1 |
| 20060149350 | Patel et al. | Jul 2006 | A1 |
| 20070208276 | Volk et al. | Sep 2007 | A1 |
| 20070225661 | Ash et al. | Sep 2007 | A1 |
| 20080142005 | Schnell | Jun 2008 | A1 |
| 20090137944 | Haarala et al. | May 2009 | A1 |
| 20090204052 | Nimkar et al. | Aug 2009 | A1 |
| 20090204079 | Nimkar et al. | Aug 2009 | A1 |
| 20090209940 | Nimkar et al. | Aug 2009 | A1 |
| 20110011525 | Sanscoucy | Jan 2011 | A1 |
| 20120130392 | Levy et al. | May 2012 | A1 |
| 20120143123 | Agnew | Jun 2012 | A1 |
| 20120179102 | Blanchard | Jul 2012 | A1 |
| 20120209201 | Bellisario | Aug 2012 | A1 |
| 20130324964 | Florescu | Dec 2013 | A1 |
| 20140261407 | Roberts et al. | Sep 2014 | A1 |
| Number | Date | Country |
|---|---|---|
| 101918066 | Jul 2013 | CN |
| 1610853 | Jan 2006 | EP |
| 1792637 | Jun 2007 | EP |
| 2277579 | Jan 2011 | EP |
| 2446915 | Jan 2018 | EP |
| 91015255 | Oct 1991 | WO |
| 97009086 | Mar 1997 | WO |
| 03045464 | Jun 2003 | WO |
| Entry |
|---|
| International Search Report and Written Opinion dated Jun. 5, 2016 in International Patent Application No. PCT/IB2017/051183. |
| Number | Date | Country | |
|---|---|---|---|
| 20190054272 A1 | Feb 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62301013 | Feb 2016 | US |
