Indwelling medical device having an infusion cuff

Abstract

An indwelling medical device with an infusion cuff and methods for using the device to deliver a medicament to a patient are described. The indwelling medical device provides improved securement techniques and removal techniques and further provides the ability to deliver medications to multiple loci within the body of a patient.

Description

INDWELLING MEDICAL DEVICE HAVING AN INFUSION CUFFRELATED APPLICATION

[0001] This Application claims the benefit of U.S. Provisional Patent Application No. 63 / 670,290, filed July 12, 2024, which is incorporated by reference herein in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] Certain embodiments of the present invention are directed to an indwelling medical device having an infusion cuff and methods for using the same. Such embodiments contemplate administration of a medicament via the infusion cuff to a tissue of a patient to aid in the securement and subsequent release of the indwelling medical device, as well to treat infections.Description of the Prior Art

[0003] Indwelling medical devices are routinely used in the field of medicine to introduce a liquid material, such as a medicament, nutrition, or other active agents to a particular locus in a patient. These devices can involve long-term administration of the desired liquid material, which requires surgical or intravenous implantation and securement through stitching and in connection with, for example, treatment of short bowel syndrome, terminal kidney failure, and other chronic medical conditions. In the administration of such treatments, avoiding infection and dislodgment of the indwelling medical device is of critical importance.

[0004] Intravascular catheters are one of the most common indwelling medical devices. These devices are placed into a patient’s vascular system for extended periods of time and present a substantial and continuous potential of infection. Current techniques for securement and removal are insufficient for mitigating the risks intravascular catheters pose to a patient, which are associated with insertion, care, occlusion, infection, removal, and the like. Accordingly, there is a need in the art for an indwelling medical device with improved securement to minimize infection and dislodgement, as well as improved removal.SUMMARY OF THE INVENTION

[0005] According to one aspect of the present invention there is provided an indwelling medical device comprising an elongate tubular body, an infusion cuff, and a cuff lumen. The elongatetubular body comprises a proximal end, a distal end, an outer wall extending between the proximal and distal ends, and one or more primary lumens extending between the proximal and distal ends. The infusion cuff encircles the outer wall of the elongate tubular body at a portion located between the tubular body proximal and distal ends and positioned within a body of a patient during use of the device. The infusion cuff comprises a liquid-permeable material permitting communication between the cuff lumen and the exterior of the infusion cuff. The cuff lumen extends from the proximal end of the elongate tubular body and terminates at the infusion cuff.

[0006] According to another aspect of the present invention there is provided an indwelling medical device comprising an elongate tubular body, an infusion cuff, and a cuff lumen. The elongate tubular body comprises a proximal end, a distal end, an outer wall extending between the proximal and distal ends, and at least one primary lumen extending between the proximal and distal ends. The proximal end of the elongate tubular body is adapted for introducing a first liquid into the at least one primary lumen, and the distal end of the elongate tubular body is adapted for placement within a body of a patient and for delivering the first liquid from the at least one primary lumen into the body of the patient. The infusion cuff encircles the outer wall of the elongate tubular body at a portion located between the tubular body proximal and distal ends, is adapted for subcutaneous placement within the body of the patient, and comprises a liquid permeable material adapted to deliver a second liquid from the cuff lumen into the body of the patient. The cuff lumen extends from the tubular body proximal end and terminates at the infusion cuff.

[0007] According to still a further aspect of the present invention there is provided a method for delivering a medicament to a tissue surrounding an infusion cuff of an indwelling medical device inserted into a patient. The method comprises steps of subcutaneously inserting an elongate tubular body of the indwelling medical device into a body of the patient, positioning the infusion cuff within the body of the patient, and providing a medicament into a cuff lumen. The method also provides that the elongate tubular body comprises a proximal end, a distal end, an outer wall extending between the proximal and distal ends, and one or more primary lumens extending between the proximal and distal ends and that the infusion cuff encircles the outer wall of the elongate tubular body at a portion located between the proximal and distal ends of the elongate tubular body. The method further provides that the cuff lumen extends from the proximal end of the elongate tubular body and terminates at the infusion cuff and thatthe infusion cuff comprises a liquid-permeable material permitting communication between the cuff lumen and an exterior of the infusion cuff. Lastly, the method provides that the medicament travels from the cuff lumen through the infusion cuff to the exterior of the infusion cuff.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a perspective view of an example indwelling medical device, in accordance with aspects herein.

[0009] FIG. 2 is a perspective view of an alternative embodiment of the indwelling medical device including an additional primary lumen and an additional primary access hub, in accordance with aspects herein.

[0010] FIG. 3 is an enlarged view of an infusion cuff of the indwelling medical device of FIG. 1, in accordance with aspects herein.

[0011] FIG. 4 is a cross-sectional view taken at line 4-4 of FIG. 3, in accordance with aspects herein.

[0012] FIG. 5 is a cross-sectional view taken at line 5-5 of FIG. 3, in accordance with aspects herein.

[0013] FIG. 6 is a cross-sectional view similar' to FIG. 4 but showing an alternative embodiment of the indwelling medical device in which the elongate tubular body is at least partially excluded therefrom, in accordance with aspects herein.

[0014] FIG. 7 is a cross-sectional view, similar- to FIG. 4, of an alternative example indwelling medical device, in accordance with aspects herein.

[0015] FIG. 8 is a cross-sectional view, similar to FIG. 4, of an alternative example indwelling medical device, in accordance with aspects herein.

[0016] FIG. 9 is a perspective view of the indwelling medical device of FIG. 1 in use, in accordance with aspects herein.

[0017] FIG. 10 is a cross-sectional view taken at line 10-10 of FIG. 9, in accordance with aspects herein.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0018] In example aspects, an indwelling medical device having an infusion cuff and method for delivering a medicament to a tissue of a patient surrounding the infusion cuff are provided.The device and method operate to improve securement and removal of the indwelling medical device. As such, aspects herein contemplate that the indwelling medical device is configured such that one or more medicaments (e.g., a liquid medicament) introduced into a cuff lumen are infused to a tissue surrounding the infusion cuff. The one or more medicaments can be configured to improve securement of the indwelling medical device by encouraging fibrin growth, such as growth hormone, thrombin, Vitamin K, fibrinogen, clotting factor, and the like. Additionally, the one or more medicaments can be configured to improve removal of the indwelling medical device by fragmenting or loosening a fibrin clot formed around the infusion cuff, such as fibrinolytic or thrombolytic agents including, but not limited to, collagenase, streptokinase, tissue-plasminogen activator (t-PA) in a native form, recombinant t-PA (e.g., alteplase, reteplase and / or tenecteplase), and the like. Further, the one or more medicaments can be configured to treat infection and / or other medical ailments, such as antibiotics, nutrients, and the like. In some aspects, the one or more medicaments may include one or more subcutaneous medications, which may be any medication for subcutaneous administration including, but not limited to, insulin, GLP-1 receptor agonists, Lovenox, and the like.

[0019] In addition, other example aspects herein contemplate that the indwelling medical device is configured to also deliver a medicament intravenously to a patient. These aspects further contemplate that the indwelling medical device is configured such that one or more medicaments (e.g., a liquid medicament) introduced into one or more primary lumens are intravenously infused into a patient at a distal end of the indwelling medical device, which is inserted into a body of the patient.

[0020] FIG. 1 shows a perspective view of an example indwelling medical device 10. Generally, the indwelling medical device 10 includes a proximal-end portion 12 and a distal-end portion 14. As will be discussed with more detail in connection with FIGs. 9 and 10, the proximal- end portion 12 can include a portion of the indwelling medical device 10 near a clinician and / or external to a body of a patient when the indwelling medical device 10 is in use. Similarly, the distal-end portion 14 can include a portion of the indwelling medical device 10 near and / or within the body of the patient when the indwelling medical device 10 is in use. Continuing, the indwelling medical device 10 includes one or more access hubs 20 at the proximal-end portion 12 and an insertable end 30 at the distal-end portion 14. Each of the one or more access hubs 20 is configured to hold and / or supply a medicament, and the inscrtablc end 30 is configured to be, at least partially, inserted, indwelled, and / or implanted into a patient (e.g.,intravenously) and to then deliver the medicament. Moreover, the insertable end 30 is also configured to cooperate with one or more placement components (not shown) that aid in insertion, indwelling, and / or implantation of the indwelling medical device 10 into a patient. For instance, the insertable end 30 may be releasably coupled with and / or in cooperation with a needle, a guidewire, and / or other placement components (not shown) to facilitate placement of the indwelling medical device 10 at a suitable location within a body of a patient. Continuing, once placement is complete, the needle, the guidewire, and / or the other placement components may be removed from the patient’ s body while the insertable end 30 remains in place to subsequently deliver a medicament to the patient.

[0021] In the examples shown in the FIGs, the indwelling medical device 10 is depicted as a tunneled cuffed catheter, but aspects herein contemplate that the indwelling medical device 10 may be a different type of indwelling medical device and / or may include any combination of aspects related thereto. Examples of such indwelling medical devices include, but are not limited to, intravascular catheters, pleural drainage catheters, peritoneal drainage catheters, percutaneous drainage catheters, peripherally inserted central catheters, central venous catheters, endoluminal access tubes, gastric access tubes, dialysis catheters, and the like.

[0022] Continuing with to FIG. 1, at a high level, the indwelling medical device 10 comprises an elongate tubular body 100, an infusion cuff 200, a cuff lumen 300, and one or more primary lumens 400, which includes a first primary lumen 402. The elongate tubular body 100 extends in the indwelling medical device 10 from the proximal-end portion 12 to the distal-end portion 14 and has a proximal end 102, a distal end 104, and an outer wall 110, which forms a tubular shape extending between the proximal and distal ends 102, 104. The infusion cuff 200 encircles the outer wall 110 of the elongate tubular body 100 at a cuff portion 106, which is between the proximal and distal ends 102, 104 and at a location of the elongate tubular body 100 that is positioned within a body of a patient during use of the indwelling medical device 10.

[0023] The cuff lumen 300 extends from the proximal-end portion 12 and terminates in the indwelling medical device 10 at or near the infusion cuff 200, while the first primary lumen 402 extends in the indwelling medical device 10 from the proximal-end portion 12, through the infusion cuff 200, and to the distal-end portion 14, terminating at the insertable end 30. In this example, the outer wall 110 of the elongate tubular body 100 forms an exterior encasing (c.g., a sheath, sleeve, and the like) through which the cuff lumen 300 and the first primary lumen 402 at least partially extend in the indwelling medical device 10. As such, the elongatetubular body 100, the cuff lumen 300, and the first primary lumen 402 are discrete components in the medical indwelling device 10. Notwithstanding, aspects herein contemplate that the elongate tubular body 100, the cuff lumen 300, the one or more primary lumens 400, and / or any portion thereof may be included, arranged, and / or configured in the indwelling medical device 10 in manners that differ from the example shown in FIG. 1 (as well as FIGs. 2-5, 9, and 10). Such aspects contemplate that the elongate tubular body 100, the cuff lumen 300, the first primary lumen 402, and / or one or more portions may have a different arrangement and / or configuration in alternative embodiments of the indwelling medical device 10 and / or may be integral components in alternative example indwelling medical devices. These aspects will be further discussed below in connection with FIGs. 6-8.

[0024] The indwelling medical device 10 further comprises a proximal cuff transition 112 and a distal cuff transition 114, each of which is generally located at an opposing end of the cuff portion 106. That is, the proximal cuff transition 112 is positioned at, near, and / or adjacent to a proximal end (not identified) of the cuff portion 106, and similarly, the distal cuff transition 114 is positioned at, near, and / or adjacent to a distal end (not identified) of the cuff portion 106. Additionally, the proximal and distal cuff transitions 112, 114 may each be formed by a portion of the elongate tubular body 100, a portion of the infusion cuff 200, and / or portions of both the elongate tubular body 100 and / or the infusion cuff 200. In example aspects, the proximal and distal cuff transitions 112, 114 may each be configured to facilitate insertion and / or removal of the indwelling medical device 10 during use, which may be achieved by altering a shape, size, and / or structure (e.g., gradually increasing or decreasing thickness, outer diameter, and / or outer circumference) of the elongate tubular body 100 and / or the infusion cuff 200 at portions thereof that form the proximal and distal cuff transitions 112, 114. These examples aspects further contemplate that a shape, size, and / or structure the elongate tubular body 100 and / or the infusion cuff 200 are altered in a manner that forms a minimally sloped and / or smoothed portion of an exterior surface of the indwelling medical device 10 at each of the proximal and distal cuff transitions 112, 114.

[0025] Referring again to FIG. 1, the proximal and distal cuff transitions 112, 114 are each formed by the elongate tubular body 100, and at each of the proximal and distal cuff transitions 112, 114, the elongate tubular body 100 has a conical shape. More specifically, as the elongate tubular body 100 extends in a direction toward the infusion cuff 200 in each of the proximal and distal cuff transitions 112, 114, an outer diameter and / or an outer circumference (notidentified) of the elongate tubular body 100 gradually increases. Further, at end portions of the proximal and distal cuff transitions 112, 114 adjoining the infusion cuff 200, the outer diameter and / or the outer circumference (not identified) of the elongate tubular body 100 is similar to that of the infusion cuff 200. As such, at each of the proximal and distal cuff transitions 112, 114, the elongate tubular body 100 has a truncated cone shape and / or conical taper in a direction away from the infusion cuff 200. In related aspects contemplated herein, a thickness (not identified) of the outer wall 110 of the elongate tubular body 100 may also be gradually changed at each of the proximal and distal cuff transitions 112, 114. In such aspects, the thickness of the outer wall 110 may be changed in a manner that corresponds to the changes of the outer diameter and / or an outer circumference of the elongate tubular body 100 in the example of FIG. 1. For instance, the thickness of the outer wall 110 may gradually increase as the elongate tubular body 100 extends at direction toward the infusion cuff 200 in each of the proximal and distal cuff transitions 112, 114. Additional aspects related to the proximal and distal cuff transitions 112, 114 will be further discussed below.

[0026] Additional aspects herein contemplate that the one or more access hubs 20 is configured to be in communication with the cuff lumen 300 and the one or more primary lumens 400 and in turn, is further configured to introduce a medicament into each of the cuff lumen 300 and the one or more primary lumens 400. In the example of FIG. 1, the one or more access hubs 20 comprises a first primary access hub 21 in communication with the first primary lumen 402 and a cuff access hub 23 in communication with the cuff lumen 300. Further, the first primary access hub 21, the first primary lumen 402, and the insertable end 30 are configured such that the first primary access hub 21 receives and delivers a medicament to a patient via the first primary lumen 402 and then through the insertable end 30. In this same vein, the cuff access hub 23, the cuff lumen 300, and the infusion cuff 200 are configured such that the cuff access hub 23 receives and delivers a medicament to a patient via the cuff lumen 300 and the infusion cuff 200. In one aspect, the cuff access hub 23 may include a cuff reservoir (not shown) configured to hold, store, and / or retain one or more medicaments, to be in communication with the cuff lumen 300, and to introduce one or more medicaments into the cuff lumen 300 that are then delivered to the infusion cuff 200. Such aspects contemplate that the cuff reservoir may be integrally formed as a part of the cuff access hub 23 and also contemplate that the cuff reservoir may be a discrete component (c.g., a bag, a syringe, a container, and the like) that communicates with the cuff access hub 23 via one or more tubes and / or ports.

[0027] In yet another aspect, the indwelling medical device 10 may include an outflow channel (not shown) that is configured to regulate pressure in the indwelling medical device 10 and / or various components thereof. These aspects contemplate that an outflow channel may be integrally formed with one or more of the infusion cuff 200, the cuff lumen 300, the one or more primary lumens 400, and / or the one or more access hubs 20. In one example, an outflow channel may be a cuff outflow channel that is in communication with the infusion cuff 200 and is configured to release and / or dissipate excess pressure on the infusion cuff 200 by redirecting pressure to flow through the cuff lumen 300 and the cuff access hub 23. These and related aspects are presented with more detail below, but first, an alternative example of an indwelling medical device will be discussed.

[0028] Turning now to FIG. 2, an alternative embodiment of an indwelling medical device 11 is depicted. As can be seen, the indwelling medical device 11 includes many of the same components and aspects as the indwelling medical device 10, such as the proximal-end portion 12, the distal-end portion 14, the one or more access hubs 20, the insertable end 30. Moreover, the indwelling medical device 10 also comprises the elongate tubular body 100, the infusion cuff 200, the cuff lumen 300, and the one or more primary lumens 400, and the elongate tubular body 100 and the infusion cuff 200 have a same and / or similar configuration at the proximal and distal cuff transitions! 12, 114. The indwelling medical device 11 differs from the indwelling medical device 10 in that the one or more primary lumens 400 includes the first primary lumen 402 and a second primary lumen 404, which, like the first primary lumen 402, extends in the indwelling medical device 11 from the proximal-end portion 12, through the infusion cuff 200, and to the distal-end portion 14, terminating at the insertable end 30. In turn, the one or more access hubs 20 also includes a second primary access hub 22, as well the first primary access hub 21 and the cuff access hub 23. As such, the second primary access hub 22, the second primary lumen 404, and the insertable end 30 are configured such that the second primary access hub 22 receives and delivers a medicament to a patient via the primary lumen 404 and then the insertable end 30.

[0029] FIG. 3 depicts an enlarged view of a portion of the indwelling medical device 10 that includes the infusion cuff 200. As shown, the infusion cuff 200 has a proximal cuff end 202, a distal cuff end 204, and a cuff body 210 extending between the proximal and distal cuff ends 202, 204 and around the elongate tubular body 100. Moreover, the infusion cuff 200 has a cylindrical shape with an internal passage through which the elongate tubular body 100extends. As previously mentioned, the infusion cuff 200 is mounted to the elongate tubular body 100 and is positioned thereon at the cuff portion 106, which is a region on the elongate tubular body 100 that corresponds to a location of the infusion cuff 200. In some aspects, a position of the infusion cuff 200 along the elongate tubular body 100 may differ from that which is depicted in the FIGs. and is contemplated to be adjustable to alter a location of the infusion cuff 200 within a patient’s body during use of the indwelling medical device 10. These aspects further contemplate that a region of the elongate tubular body 100 including the cuff portion 106, the proximal cuff transition 112, and / or the distal cuff transition 114 is also adjustable to maintain correspondence with a position of the infusion cuff 200.

[0030] As further shown in FIG. 3, the infusion cuff 200 encircles the outer wall 110 of the elongate tubular body 100, and in turn, also encircles the first primary lumen 402 and the cuff lumen 300. Moreover, the infusion cuff 200 has an outer surface 212, which forms an exterior- most portion that is surrounded by a tissue of a patient when the indwelling medical device 10 is in use. In example aspects, the infusion cuff 200 is configured to be in communication with the cuff lumen 300 and an external environment adjacent to the outer surface 212. Stated another way, the infusion cuff 200 is configured receive a medicament from the cuff lumen 300 and to then infuse the medicament to a tissue of patient’s body surrounding the infusion cuff 200. Such aspects contemplate the infusion cuff 200 a liquid-permeable material, which may be attributable to a material construction and / or a type of material included in the infusions cuff 200. For instance, the infusion cuff 200 may be a nonwoven formed of natural fibers, synthetic fibers, or a combination thereof (e.g., a fibrous nonwoven material). In aspects, the infusion cuff 200 may comprise any nonwoven, woven, and / or knit construction that allows for a passage of liquid therethrough. Such aspects contemplate that the infusion cuff 200 may be constructed from types of materials including, but not limited to, natural materials (e.g., cotton, flax, silk, cellulose-based compositions, naturally occurring fibrous compositions, and the like), synthetic materials (e.g., polyester, polyurethane, polypropylene, polyethylene, rayon, and the like), and combinations thereof. In one aspect, the infusion cuff 200 is a nonwoven formed of synthetic polyester (e.g., Dacron). In another aspect, the infusion cuff 200 may include a type of material that is configured to encourage fibrin growth and / or engraftment with a tissue of a patient surrounding the infusions cuff 200 during use of the indwelling medical device 10. To better explain these and other aspects related to the infusioncuff 200, additional reference is now made to FIGs. 4 and 5, each of which depict a crosssection view of the indwelling medical device 10 at the corresponding line of FIG. 3.

[0031] Initially, the arrows of FIGs. 3-5 (and FIGs. 6-8) that extend through the elongate tubular body 100, the infusion cuff 200, the cuff lumen 300, and / or portions thereof are intended to illustrate a manner in which fluid flows though the indwelling medical device 10. As best shown in FIGs. 4 and 5, the infusion cuff 200 includes an inner surface 214, which forms an interior-most portion that is adjacent to the elongate tubular body 100 and / or the cuff lumen 300. Between the outer and inner surfaces 212, 214, the infusion cuff 200 comprises a cuff body 210 that predominately forms its overall, interior structure. As mentioned, the infusion cuff 200 is configured such that a fluid may pass through therethrough, and in the example shown, the infusion cuff 200 comprises one or more interior openings 224 positioned on and extending through the inner surface 214 and one or more exterior openings 222 positioned on an extending through the inner surface 212. Continuing, the one or more exterior and interior openings 222, 224 are configured to be in communication with one another, and thus, a medicament may enter the infusion cuff 200 through the one or more interior openings 224 on the inner surface 214, pass through the cuff body 210, and then exit the infusion cuff 200 through the one or more exterior openings 222 on the outer surface 212. Aspects herein contemplate that the one or more exterior and interior openings 222, 224 may be formed and / or defined by gaps and / or spaces among material fibers that form the infusion cuff 200.

[0032] As previously mentioned, aspects herein contemplate the indwelling medical device 10 may comprises a configuration and / or arrangement of the elongate tubular body 100 and / or the infusion cuff 200 at the proximal and distal cuff transitions 112, 114 that differs from the examples shown in the FIGs. In such aspects, the infusion cuff 200, rather than the elongate tubular body 100, may form the proximal and distal cuff transitions 112, 114. In an example of such aspects, the cuff 200 may have a conical shape at each of the proximal and distal cuff transitions 112, 114 in which an outer diameter and / or an outer circumference (not identified) of the infusion cuff 200 gradually decreases as the infusion cuff 200 extends in a direction toward the elongate tubular body 100. Continuing, at end portions of the proximal and distal cuff transitions 112, 114 adjoining with the elongate tubular body 100, the outer diameter and / or the outer circumference (not identified) of the infusion cuff 200 may be similar to that of the elongate tubular body 100, and thus, the infusion cuff 200 may have a truncated cone shape and / or conical taper at each of the proximal and distal cuff transitions 112, 114.

[0033] Further aspects contemplate that a thickness (not identified) of the cuff body 210 may also be gradually changed in a manner that corresponds to the changes of the outer diameter and / or the outer circumference (not identified) of the infusion cuff 200 in the aforementioned example. For instance, the thickness of the cuff body 210 may gradually decrease as the infusion cuff 200 extends in a direction toward the elongate tubular body 100 in each of the proximal and distal cuff transitions 112, 114. Stated differently, the proximal and distal cuff ends 202, 204 may taper as the infusion cuff 200 extends toward the elongate tubular body 100. Related aspects herein contemplate the proximal and distal cuff transitions 112, 114 may be formed by extended portions of the proximal and distal cuff ends 202, 204 of the infusion cuff 200. In one such aspect, each extended portion of the proximal and distal cuff ends 202, 204 may be tapered (e.g., have a truncated cone shape, conical taper, and the like) in the proximal and distal cuff transitions 112, 114.

[0034] Turning now to related aspects of the cuff lumen 300 and with continued reference to FIGs. 4 and 5, the cuff lumen 300 includes a cuff lumen wall 310 that is formed into a tubular shape and defines an interior channel extending from a cuff lumen proximal end (not identified) to a cuff lumen terminal end 304. The cuff lumen 300 further includes one or more cuff lumen outlet ports 322 that are configured to provide communication between the cuff lumen 300 and the infusion cuff 200. More specifically, the one or more cuff lumen outlet ports 322 extend through the cuff lumen wall 310 and are positioned around the cuff lumen 300 at or near or at the cuff lumen terminal end 304. In the example shown, the one or more cuff lumen outlet ports 322 are a plurality of slits formed through the cuff lumen wall 310. Aspects herein contemplate that the one or more cuff lumen outlet ports 322 may include apertures, orifices, slits, holes, and / or any combination thereof.

[0035] In related aspects of the elongate tubular body 100 and with reference still to FIGs. 4 and 5, the elongate tubular body 100 includes one or more outlet ports 122 that are configured to provide communication between the cuff lumen 300 and the infusion cuff 200. The one or more outlet ports 122 extend through the outer wall 110 of the elongate tubular body 100 and are positioned around the elongate tubular body 100 at the cuff portion 106. In the example of FIGs. 4 and 5, the one or more outlet ports 122 are a plurality of slits formed through the outer wall 110, but aspects herein contemplate that the one or more outlet ports 122 may include apertures, orifices, slits, holes, and / or any combination thereof.

[0036] In additional aspects, the indwelling medical device 10 may include additional features configured to further facilitate delivery of a medicament to the infusion cuff 200 from the cuff lumen 300. With reference to FIG. 5, the indwelling medical device 10 comprises a proximal cuff seal 252, a distal cuff seal 254, and a cuff chamber 250 formed between the proximal and distal cuff seals 252, 254 and within the elongate tubular body 100. The proximal cuff seal 252 is positioned adjacent the proximal cuff end 202 and is configured to prevent the flow of fluid therethrough but to provide a passageway for the cuff lumen 300 and the first primary lumen 402. Similarly, the distal cuff seal 254 is positioned adjacent the distal cuff end 204 and is configured to prevent the flow of fluid therethrough but to provide a passageway for the first primary lumen 402. Accordingly, the proximal and distal cuff seals 252, 254 and the cuff portion 106 of the elongate tubular body 100 cooperatively form the cuff chamber 250. Aspects herein contemplate that the proximal and distal cuff seals 252, 254 and features thereof may differ from what is depicted in FIG. 5. In such aspects, the proximal and distal seals 252, 254 may include any structural form and / or features that are suitable for forming a liquid impermeable chamber. One example aspect contemplates that the proximal and distal seals 252, 254 may be integrally formed as part of the structure of the elongate tubular body 100, the cuff 200, and / or the cuff lumen 300.

[0037] As previously mentioned, aspects herein contemplate that the elongate tubular body 100, the cuff lumen 300, the one or more primary lumens 400, and / or any portion thereof may be included, arranged, and / or configured in manners that differ from the example indwelling medical device 10 shown in FIG. 1 (as well as FIGs. 2-5, 9, and 10). Examples of such aspects are illustratively depicted in FIGs. 6-8, which are cross-sectional views similar to FIG. 4.

[0038] FIG. 6 depicts an alternative embodiment of the indwelling medical device 10 in which the elongate tubular body 100 is excluded from and / or includes interruption at a portion of the indwelling medical device 10 that includes the infusion cuff 200. As shown in FIG. 6, this embodiment permits direct communication between cuff lumen 300 and the infusion cuff 200. Accordingly, a medicament introduced into the cuff lumen 300 travels through the one or more cuff lumen outlet ports 322 and to the one or more interior openings 224. From there the medicament enters the infusion cuff 200, passes through the cuff body 210, and then exits the infusion cuff 200 through the one or more exterior openings 222. In accordance with aspects herein, the infusion cuff 200 may be constructed of a liquid-permeable material, and as such, the medicament may permeate through the infusion cuff 200 to enter the patient’s body throughthe permeable outer surface 212 of the infusion cuff 200. In other aspects, related to this embodiment, it is contemplated that the elongate tubular body 100 may be further excluded from additional portions and / or an entirety of the indwelling medical device 10. Such aspects contemplate that the elongate tubular body 100 may be included at the proximal-end portion 12 and excluded from the distal-end portion 14.

[0039] In further aspects, which are illustratively depicted in FIGs. 7 and 8, the elongate tubular body 100, the cuff lumen 300, the one or more primary lumens 400, and / or any portion thereof may be combined and / or integrated components in alternative example indwelling medical devices. FIG. 7 shows a cross-sectional view, similar to FIG. 4, of an alternative example indwelling medical device 30 in which an elongate tubular body 130 includes a cuff lumen 330 and a first primary lumen 432. As shown in FIG. 7, this example permits the cuff lumen 330 to directly communicate with the infusion cuff 200 in a manner that allows for a consistent and / or evenly distributed passage of fluid. The elongate tubular body 130 has an outer wall 140 that includes a primary lumen wall portion (not identified) and a cuff lumen wall portion 340, which collectively form an external boundary of the elongate tubular body 130. The first primary lumen 432 is included along an internal side of the elongate tubular body 130 and is enclosed within an interior channel of the primary lumen wall portion. In this example, the cuff lumen 330 is included in the elongate tubular body 130 at a remining interior portion and is within an interior channel defined by the cuff lumen wall portion 340 and the primary lumen wall portion. Accordingly, a medicament introduced into the cuff lumen 330 travels through the one or more cuff lumen outlet ports 352 and to the one or more interior openings 224. From there the medicament enters the infusion cuff 200, passes through the cuff body 210, and then exits the infusion cuff 200 through the one or more exterior openings 222. In accordance with aspects herein, the infusion cuff 200 may be constructed of a liquid-permeable material, and as such, the medicament may permeate through the infusion cuff 200 to enter the patient’s body through the permeable outer surface 212 of the infusion cuff 200. In other aspects related to this embodiment, it is contemplated that the first primary lumen 432 may be included in the elongate tubular body 130 along external side of the outer wall 140.

[0040] FIG. 8 also shows a cross-sectional view, similar to FIG. 4, of an alternative example indwelling medical device 60 in which an elongate tubular body 160 includes a cuff lumen 360 and the first primary lumen 402. As shown in FIG. 8, this example again permits the cuff lumen 360 to directly communicate with the infusion cuff 200 in a manner that allows for aconsistent and / or evenly distributed passage of fluid. In this example, the first primary lumen 402 is included in the elongate tubular body 160 at a central portion of an interior channel defined by an outer wall 170 the elongate tubular body 160. The cuff lumen 360 is included within the elongate tubular body 160 at an interior portion defined by the outer wall 170 and the first primary lumen 402. As such, a medicament introduced into the cuff lumen 360 travels through the one or more cuff lumen outlet ports 382 and to the one or more interior openings 224. From there the medicament enters the infusion cuff 200, passes through the cuff body 210, and then exits the infusion cuff 200 through the one or more exterior openings 222. In accordance with aspects herein, the infusion cuff 200 may be constructed of a liquid-permeable material, and as such, the medicament may permeate through the infusion cuff 200 to enter the patient’s body through the permeable outer surface 212. In other aspects related to this embodiment, it is contemplated that the outer wall 170 of the elongate tubular body 160 may be formed of and / or include a cuff lumen wall from the proximal end to the infusion cuff 200 and may be formed of and / or include a first primary lumen wall from the infusion cuff 200 to the distal end.

[0041] With reference now to FIGs. 9 and 10, the indwelling medical device 10 is depicted during use and is shown as subcutaneously inserted into an arm of a patient 500. Accordingly, the proximal-end portion 12 of the indwelling medical device 10 is located exterior to a body 502 of the patient 500, and thus, the primary access hub 21 and the cuff access hub 23 are also located exterior to the body of the patient. Continuing, the distal-end portion 14 is positioned within the body 502 of the patient 500, and thus, the infusion cuff 200, a distal portion of the elongate tubular body 100 from the cuff portion 106 is also positioned within the body 502 of the patient 500. In example aspects, the indwelling medical device 10 is configured to deliver a first medicament (e.g., a first liquid, first liquid medicament, and the like) to a first locus 504 of the patient 500, which may be a subcutaneous tissue surrounding the infusion cuff 200 and is further configured to deliver a second medicament (e.g., a second liquid, second liquid medicament, and the like) to a second locus 506 of the patient 500, which may be positioned distally to the infusion cuff 200 and proximate a distal-end portion of the indwelling medical device 10. Such aspects further contemplate that the first and second medicaments may be delivered to the patient simultaneously.Experiment

[0042] As has been discussed, example aspects herein contemplate that the indwelling medical device is configured to have improved securement and / or removal during use, which is at least partly attributable a medicament that is infused to a tissue surrounding the infusion cuff. In accordance with these aspects, the following studies and tests were conducted, which yielded results demonstrating that a collagenase medicament improves (e.g., eases) removal of the indwelling medical device described herein.

[0043] Materials and Methods

[0044] Materials used in the Experiment include catheters comprising the features and aspects described herein, injected substances, and mice. A Mark 10 ES-10 test platform with a Mark 10 series 5 M5-10 force gauge was used to remove the catheters and obtain data on the maximum and total force required for removal.

[0045] Methods related to catheter placement, catheter injection, catheter removal. In addition, multiple studies were conducted including a pilot study, dwell time study, alteplase study, and collagenase study.

[0046] Collagenase Study Methods

[0047] In an anticipation of greater localized tissue breakdown with collagenase, a lower injection volume was selected to decrease surrounding soft tissue infiltration.

[0048] 20 animals had bilateral catheters placed with a dwell time of 6-weeks (+ / - 2 days). At 6 weeks (+ / - 2 days), the animals were euthanized. Immediately after euthanasia, animals were injected with 0.05 mL of collagenase in PBNS, with the following doses:

[0049] 1. 3 males, 3 females - injection of 0.05 mL PBNS;

[0050] 2. 3 males, 3 females — injection of 0.05 ml PBNS with 2.5 units collagenase;

[0051] 3. 3 males, 3 females - injection of 0.05 mL PBNS with 5 units collagenase;

[0052] 4. 1 male - injection of 0.05 mL PBS with 15 units collagenase.

[0053] Pollowing injections, the mice were kept warm at approximately 37 degrees Celsius for 6 hours on a warming pad, to maintain the active temperature of collagenase. Catheters were then removed using the motorized tension force gauge. A representative catheter from each dosing group was placed in formalin for later microscopic evaluation. Additional tissue dissection around the flanks and abdomen was performed to evaluate localized tissue breakdown.

[0054] Collagenase Study Results

[0055] Because of a greater anticipated localized tissue breakdown with administration of collagenase, a lower carrier injection volume of 0.1 ml was initially selected to decrease infiltration into surrounding soft tissue. An initial collagenase dosing study in live mice was performed to establish a dosing range. Doses were based on previous studies on mouse tendon injury models, however subcutaneous administration of collagenase via implanted catheters demonstrated even greater than anticipated tissue breakdown in the surrounding tissues resulting in an inability to acquire relevant data. Therefore, since collagenase functions independent of circulating factors in the blood, all further collagenase injections in this study were performed post euthanasia. In addition, a lower carrier injection volume of 0.05 mL was chosen to further decrease infiltration into surrounding soft tissues. Finally, a purer form of collagenase (reference # C9891) was tested at much lower doses, 2.5 units, 5 units, and 15 units, and compared to carrier only injections of PBNS. The results of this study demonstrated a statistically significant decrease in tension force required for removal of the catheters in all collagenase treatment groups while PBNS only injections were statistically similar to all control groups in previous studies.

[0056] A catheter from each removal group was placed in formalin for histological evaluation. The animals were then necropsied to evaluate the localized effect of collagenase. The 2.5-unit dose group demonstrated a limited 1-1.5 cm area of localized hemorrhage in the subcutaneous space, while the 5-unit group demonstrated a 1.5-2 cm area of localized hemorrhage. The single animal receiving the 15-unit dose demonstrated a >3 cm area of hemorrhage extending along the flank.

[0057] Of note, one catheter (CF13R) in the 5-unit dosing cohort malfunctioned during injection. The internal tip of the catheter was incompletely occluded allowing collagenase to bypass the cuff and delivering the medication directly to the subcutaneous space distal to the tip of the catheter. This catheter required 4.06 N of force for removal, compared to the 0.37 N required for removal of the functioning catheter (CF13L) on the contralateral side. On necropsy, CF13R demonstrated hemorrhage along the flank and extending to the abdomen from the distal tip of the catheter with minimal hemorrhage around the cuff, as compared to the localized hemorrhage around the cuff observed in CF13L, which received the targeted medication directly into the cuff as intended.

[0058] Conclusions Demonstrated by Experiment Results

[0059] Catheters comprising the features and aspects described herein allow successful injection of medications directly into the infusion cuff.

[0060] When placed in the subcutaneous space of mice, there is expected tissue ingrowth into the infusion cuffs of these catheters with increased ingrowth over time resulting in a measurable increase in removal force for longer catheter dwell times.

[0061] Catheters comprising the features and aspects herein that have been implanted in the subcutaneous space of mice long enough for tissue ingrowth to occur demonstrate a significant decrease in removal force 6 hours after injection of collagenase, while there is no change in removal force after injections of normal saline, phosphate buffered normal saline, or alteplase.

[0062] Additional considerations

[0063] Notwithstanding the depictions of the FIGs., it is to be understood that other examples of the indwelling medical devices 10, 11, 30, 60 arc contemplated herein. Such examples may include any combination of components and aspects thereof contemplated herein. For instance, aspects herein contemplate that an indwelling medical device may be configured to include more than one cuff lumen and / or more than two primary lumens, which may be arranged in a differing manner than as depicted in the FIGs. In one such example, the one or more cuff lumens may be positioned exterior to the elongate tubular body. In another example, the indwelling medical device may exclude an elongate tubular' body, and in another example the cuff lumen and the one or more primary lumens may be configured such that the cuff lumen is a larger tubular structure through which the one or more primary lumens extend.

[0064] As used herein, the phrase "and / or," when used in a list of two or more items, means that any one of the listed items can be employed by itself or any combination of two or more of the listed items can be employed. For example, if a composition is described as containing or excluding components A, B, and / or C, the composition can contain or exclude A alone; B alone; C alone; A and B in combination; A and C in combination; B and C in combination; or A, B, and C in combination.

[0065] Although the disclosure has been described with reference to the examples illustrated in the attached figures, it is noted that equivalents may be employed, and substitutions made herein, without departing from the scope of the disclosure as recited in the claims.

Claims

We claim:

1. An indwelling medical device comprising: an elongate tubular body comprising a proximal end, a distal end, an outer wall extending between the proximal and distal ends, and one or more primary lumens extending between the proximal and distal ends; an infusion cuff encircling the outer wall of the elongate tubular body at a portion located between the tubular body proximal and distal ends and positioned within a body of a patient during use of the device, a cuff lumen extending from the proximal end of the elongate tubular body and terminating at the infusion cuff, the infusion cuff comprising a liquid-permeable material permitting communication between the cuff lumen and the exterior of the infusion cuff.

2. The indwelling medical device of claim 1, wherein the infusion cuff comprises one or more interior openings in communication with the cuff lumen and the liquid-permeable material of the infusion cuff.

3. The indwelling medical device of claim 2, wherein the cuff lumen comprises one or more cuff lumen outlet ports in communication with the one or more interior openings of the infusion cuff.

4. The indwelling medical device of claim 3, wherein the one or more cuff lumen outlet ports comprise a plurality of slits extending though a cuff wall of the cuff lumen.

5. The indwelling medical device of claim 1, wherein the liquid-permeable material of the infusion cuff comprises a fibrous nonwoven material.

6. The indwelling medical device of claim 1, wherein the indwelling medical device is an intravenous catheter.

7. The indwelling medical device of claim 1, wherein the indwelling medical device is a tunneled cuffed catheter.

8. The indwelling medical device of claim 1, wherein the one or more primary lumens comprises a first primary lumen and a second primary lumen.

9. The indwelling medical device of claim 1, further comprising a cuff transition from an end of the infusion cuff and in a direction toward the elongate tubular body, wherein the cuff transition tapers.

10. The indwelling medical device of claim 9, wherein the cuff transition is formed by the infusion cuff.

11. The indwelling medical device of claim 9, wherein the cuff transition is formed by the elongate tubular body.

12. An indwelling medical device comprising: an elongate tubular body comprising a proximal end, a distal end, an outer wall extending between the proximal and distal ends, and at least one primary lumen extending between the proximal and distal ends, the proximal end adapted for introducing a first liquid into the at least one primary lumen, the distal end adapted for placement within a body of a patient and for delivering the first liquid from the at least one primary lumen into the body of the patient; an infusion cuff encircling the outer wall of the elongate tubular body at a portion located between the tubular body proximal and distal ends and adapted for subcutaneous placement within the body of the patient; and a cuff lumen extending from the tubular body proximal end and terminating at the infusion cuff, the infusion cuff comprising a liquid-permeable material adapted to deliver a second liquid from the cuff lumen into the body of the patient.

13. The indwelling medical device of claim 12, wherein the infusion cuff comprises one or more interior openings in communication with the cuff lumen and the liquid- permeable material of the infusion cuff.

14. The indwelling medical device of claim 12, wherein the liquid-permeable material comprises a fibrous nonwoven material.

15. The indwelling medical device of claim 12, wherein the at least one primary lumen comprises a first primary lumen and a second primary lumen.

16. The indwelling medical device of claim 12, wherein the at least one primary lumen and the cuff lumen are configured to simultaneously deliver the first and second liquids into the body of the patient.

17. The indwelling medical device of claim 12, wherein the liquid comprises a growth hormone, thrombin, vitamin k, or fibrinogen.

18. The indwelling medical device of claim 12, wherein the liquid comprises a fibrinolytic agent, a lytic enzyme, or a combination thereof.

19. The indwelling medical device of claim 12, wherein the liquid comprises an antibiotic, one or more subcutaneous medications, or a combination thereof.

20. A method for delivering a medicament to a tissue surrounding an infusion cuff of an indwelling medical device inserted into a patient, the method comprising; inserting an elongate tubular body of the indwelling medical device into a body of the patient, the elongate tubular body comprising a proximal end, a distal end, an outer wall extending between the proximal and distal ends, and one or more primary lumens extending between the proximal and distal ends; positioning the infusion cuff within a body of the patient, the infusion cuff encircling the outer wall of the elongate tubular body at a portion located between the proximal and distal ends of the elongate tubular body; and providing a medicament into a cuff lumen, the cuff lumen extending from the proximal end of the elongate tubular body and terminating at the infusion cuff, wherein the infusion cuff comprises a liquid-permeable material permitting communication between the cuff lumen and an exterior of the infusion cuff, wherein the medicament travels from the cuff lumen through the infusion cuff to the exterior of the infusion cuff.

21. The method according to claim 20, wherein the medicament is selected from one of a growth hormone, thrombin, vitamin k, or fibrinogen.

22. The method according to claim 20, wherein the medicament is a fibrinolytic agent, a lytic enzyme, or a combination thereof.

23. The method according to claim 20, wherein the medicament is a first medicament and further comprising: providing a second medicament into the cuff lumen, wherein the second medicament travels from the cuff lumen through the infusion cuff to the exterior of the infusion cuff.

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