Dressing-Based Traction Apparatus with Integrated Tourniquet for Improved Blood Draw
20230211128 · 2023-07-06
Inventors
- Jonathan Karl Burkholz (Salt Lake City, UT, US)
- Megan S. Scherich (Salt Lake City, UT, US)
- Yiping Ma (Layton, UT, US)
Cpc classification
International classification
Abstract
Provided herein is a catheter assembly, including a catheter adapter having a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween, a catheter extending from the distal end of the catheter adapter, a dressing comprising a proximal end, a distal end, and first and second sides extending therebetween, the dressing defining a second longitudinal axis and configured to cover at least a portion of the catheter adapter at a site of penetration into a patient's vasculature, the dressing further comprising an upper surface and a lower surface, the lower surface configured to contact skin of a patient, and a tourniquet configured to apply a radially-inward pressure to a limb of a patient near the site of penetration, the tourniquet configured to couple with the dressing.
Claims
1. A catheter assembly, comprising: a catheter adapter comprising a proximal end, a distal end, and a lumen extending along a first longitudinal axis therebetween; a catheter extending from the distal end of the catheter adapter; a dressing comprising a first end, a second end, and first and second sides extending therebetween, the dressing defining a second longitudinal axis and configured to cover at least a portion of the catheter adapter at a site of penetration into a patient's vasculature, the dressing further comprising an upper surface and a lower surface, the lower surface configured to contact skin of a patient; and a tourniquet configured to apply a radially-inward pressure to a limb of a patient near the site of penetration, the tourniquet configured to couple with the dressing.
2. The catheter assembly of claim 1, wherein the tourniquet comprises one or more arms configured to couple with the dressing.
3. The catheter assembly of claim 2, wherein the one or more arms are configured to be coupled with the dressing at one or more locations along the arms.
4. The catheter assembly of claim 1, wherein the dressing further comprises one or more pegs arranged on the upper surface.
5. The catheter assembly of claim 4, wherein the one or more pegs are arranged along the second longitudinal axis of the dressing, the second longitudinal axis being parallel to the first longitudinal axis.
6. The catheter assembly of claim 4, wherein the one or more pegs comprise at least one peg arranged along the first side and at least one peg arranged along the second side.
7. The catheter assembly of claim 4, wherein the one or more arms are configured to releasably couple to the one or more pegs.
8. The catheter assembly of claim 4, wherein the one or more arms comprise a plurality of openings, the openings configured to releasably couple to the one or more pegs.
9. The catheter assembly of claim 2, wherein the one or more arms are connected to the tourniquet at a plurality of locations.
10. The catheter assembly of claim 2, wherein the one or more arms are coupled with the dressing at a single location.
11. The catheter assembly of claim 2, wherein the one or more arms comprise a tensioning assembly.
12. The catheter assembly of claim 2, wherein the one or more arms couple to the dressing adjacent the proximal end of the catheter adapter.
13. The catheter assembly of claim 2, wherein the one or more arms couple to the dressing adjacent the distal end of the catheter adapter.
14. The catheter assembly of claim 2, wherein the one or more arms are formed of a flexible material.
15. The catheter assembly of claim 2, wherein the one or more arms are formed of an elastomeric material.
16. The catheter assembly of claim 2, wherein the one or more arms are formed of a rigid material.
17. The catheter assembly of claim 1, wherein the dressing comprises an adhesive arranged on the lower surface.
18. The catheter assembly of claim 1, further comprising an enclosure configured to cover at least a portion of the catheter adapter.
19. The catheter assembly of claim 1, wherein the tourniquet comprises a fastener configured to allow the tourniquet to be shortened and lengthened, thereby allowing differing amounts of radially-inward pressure to be applied to the patient's limb.
20. The catheter assembly of claim 1, further comprising a second tourniquet configured to apply a radially-inward pressure to a limb of a patient near the site of penetration, the second tourniquet configured to couple with the dressing.
21. The catheter assembly of claim 20, wherein the second tourniquet comprises one or more second arms configured to couple with the dressing.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0049]
[0050]
[0051]
[0052]
[0053]
[0054]
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
[0061]
[0062]
[0063]
[0064]
DESCRIPTION OF THE INVENTION
[0065] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
[0066] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
[0067] It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
[0068] Provided herein is a catheter assembly that allows a user to apply traction to an indwelling IV catheter to free the tip thereof from occlusions that could prevent withdrawing blood from, or injecting a composition through, the catheter. The traction may be applied in a temporally commensurate manner with application of a tourniquet, which can also improve withdrawal of blood through the catheter.
[0069] Referring to
[0070] With continuing reference to
[0071] Catheter assembly 110 may further include a tourniquet 130, which may be configured as a removably attachable component of the catheter assembly 110, configured to surround a limb of a patient and substantially or completely occlude flow of blood through one or more vessels thereof. Tourniquet 130 may be formed of any suitable material, such as an elastomeric material, a fabric material, a woven or non-woven material, and/or a film-like material. In non-limiting embodiments, tourniquet 130 is an inflatable device, optionally a reversibly inflatable device, that, when inflated compresses one or more blood vessels below the skin at the site of application, thereby substantially or completely occluding flow of blood therethrough. Tourniquet 130 may include a fastener 138, for example a hook and loop fastener, a pin and hole fastener, a releasable adhesive layer, a wrap and tie, or other like fastener to allow a user to adjust the length of the tourniquet, provide a radially compressive force to the patient, and occlude one or more blood vessels. Without wishing to be bound by the theory, it is believed that applying a tourniquet downstream of catheter 118, occlusion of the vessels causes distension of the vessels as blood collects, making blood withdrawal from the vessel in which catheter 118 is located far easier. Tourniquet 130 may be releasably, or permanently, coupled with dressing 120 and/or catheter adapter 110, as shown in the accompanying figures. In non-limiting embodiments, for example as shown in
[0072] With further reference to
[0073] With reference to
[0074] In non-limiting embodiments, one or more connection points 140 are releasable connection points for tourniquet 130 and/or arms 132, such as hook and loop connections, adhesive connections, and the like. In non-limiting embodiments, one or more connection points 140 are pegs, extending radially (relative to the longitudinal axis of catheter adapter 110) outward, away from the patient's skin. Connection points 140, such as pegs, maybe integral to dressing 130 and/or catheter adapter 110. In non-limiting embodiments, connection points 140 may be provided as a separate element, releasably or permanently attached to dressing 130, secured thereto by an adhesive, weld, loop and hook fastener, stitch, or other suitable attachment. Connection points 140 can include any features suitable to prevent tourniquet 130 and/or arms 132 from inadvertently decoupling from connection points 140 during application of tension or compression to dressing 120 and/or catheter adapter 110.
[0075] In non-limiting embodiments, for example as shown in
[0076] Turning to
[0077] Turning to
[0078] Turning to
[0079] Turning to
[0080] Turning to
[0081] Turning to
[0082] In non-limiting embodiments, tether 358 is coupled with extension tube 324. In non-limiting embodiments, tether 358 is coupled at one end thereof with extension tube 324, and is coupled at another end thereof with catheter adapter 310. Tether 358 may be coupled with catheter adapter 310 at a location opposite that of extension tube 324, such that the combination of tether 358 and extension tube 324 provides substantially equal tension and/or compression to catheter adapter 310 when extension tube 324 is coupled with tourniquet, thereby providing traction to catheter 318 without any significant rotational force, for example about the longitudinal axis of catheter adapter 310, being applied to catheter 318. In non-limiting embodiments, tether 358 is at least partially embedded in dressing 350.
[0083] Turning to
[0084] Turning to
[0085] With regard to
[0086] The catheter 518 may extend from the distal end 514 of the catheter adapter 510. In some embodiments, the catheter 518 may be used for blood collection, fluid delivery, patient or device monitoring, or other clinical needs. In some embodiments, the catheter 518 may include, for example, a peripheral IV catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, the catheter 518 may have been previously inserted into the vasculature of the patient and may be dwelling within the vasculature.
[0087] In some embodiments, a dressing 550 may securely apply traction to the catheter 112 while the catheter 112 is disposed within the vasculature of the patient. In some embodiments, the dressing 550 may include an adhesive 126 to secure the dressing 550 to the patient. In some embodiments, the dressing 550 may include a two-piece or two-section dressing 550 connected by an adjustment element 560. In some embodiments, the dressing 550 may include more than two sections, and may be connected by one or more adjustment elements 560, such as an adjustable tether or other suitable fastener or strap.
[0088] In some embodiments, each or some of the sections of the dressing 550 may be spaced apart from each other by a distance. The distance between the sections of the dressing 550 may be selected to optimize application of traction to the catheter 518. For example, in operation, some embodiments may apply traction to the catheter 518 by adjusting the distance between two or more of the dressing 550 pieces or sections. In some embodiments, the distance between the dressing 550 sections may be manually or automatically adjusted by the adjustment element 560. In some embodiments, adjusting the distance between the dressing 550 sections in this manner may exert tension between the dressing 550 sections to apply traction to the catheter 518.
[0089] In some embodiments, the dressing 550 may include a first section 552 adjustably coupled with a second section 554. In some embodiments, an adjustment element 560 may adjustably couple the first section 552 to the second section 554. The adjustment element 560 may include, for example, a tether, a winch, a ratchet, a pulley, a dial, a screw, a cable tie, or other suitable tensioning device or mechanism. Some embodiments of the adjustment element 560 may be releasable and/or removable to decouple the first and second sections 116, 118.
[0090] In some embodiments, the first section 552 may be independent of the second section 554. Some embodiments of the first section 552 may be configured to secure and/or maintain a position of the catheter adapter 102 and/or the catheter 518 to the patient via an adhesive 126, for example. In some embodiments, the first section 552 may include an aperture 124 or other suitable feature or mechanism to maintain the catheter adapter 102 and/or the catheter 518 in a substantially fixed position relative to the patient.
[0091] In some embodiments, the second section 554 may be adjustably positioned and/or secured relative to the first section 552 to apply traction to the catheter 518 within the vasculature. In some embodiments, the second section 554 may include an adhesive or other suitable device or mechanism to secure and/or maintain the position of the second section 554 relative to the patient. Some embodiments of the second section 554 may include a securing device or mechanism to secure and/or maintain the position of the second section 554 relative to the first section 552.
[0092] In some embodiments, the position of the second section 554 relative to the first section 552 may be adjusted by the adjustment element 560. In some embodiments, as shown in
[0093] In some embodiments, the tethers 562 may be configured to be adjusted individually such that each tether 562 individually pulls traction on the catheter 518. In some embodiments, the tethers 562 may be configured to be adjusted collectively as a single unit to pull traction on the catheter 518. In some embodiments, each tether 562 may pull traction on the catheter 518 in either a proximal or distal direction.
[0094] In some embodiments, tightening the tethers 562 may pull the skin of the patient such that the tip of the catheter 518 may be re-oriented within the vasculature. In some embodiments, repositioning the tip of the catheter 518 within the vasculature in this manner may clear a fluid path for infusion of fluid or medications or blood withdrawal. In some embodiments, the adjustment element 560 may be automatically or manually adjusted or loosened to return the dressing 550 to its initial position, thereby releasing traction on the catheter 518.
[0095] As shown in
[0096] In some embodiments, the adjustment element 560 may include one or more finger grips 564 to facilitate manual adjustment of the second section 554 of the dressing 550 relative to the first section 552 of the dressing 550. In some embodiments, a first finger grip 564 may be coupled with the first section 552 and a second finger grip 564 may be coupled with the second section 554. In some embodiments, the first section 552 and the second section 554 of the dressing 550 may be monolithically formed as a single unit. Some embodiments of finger grips 564 may be coupled with the catheter adapter 510.
[0097] In operation, a user, such as a medical professional, may utilize the finger grips 564 to adjust or maintain the position of the first section 552 relative to the patient while utilizing another finger grip 564 to adjust or maintain the position of the second section 554 relative to the first section 552. In some embodiments, the finger grips 564 may be utilized to maintain the position of the first section 552 while the position of the second section 554 may be adjusted relative to the first section 552 via another finger grip 564.
[0098] In some embodiments, a finger grip 564 may be utilized to adjust the position of the first section 552 in a proximal or distal direction while the position of the second section 554 may be simultaneously adjusted in an opposite direction via another finger grip 564. In some embodiments, the finger grips 564 may be utilized to adjust a tilt, incline, or other position or orientation of the first section 552 relative to the second section 554. In some embodiments, utilizing one or more finger grips 564 to manually adjust the position of the first section 552 relative to the second section 554 in this manner may apply traction to the catheter 518 to reposition the tip of the catheter 518 within the vasculature and thereby open a fluid path.
[0099] Referring now to
[0100] In some embodiments, the second section 554 may include an isolated section of the dressing 550, such as a tab 606 coupled with a distal end of the pad 600. In some embodiments, the pad 600 and the tab 606 may be monolithically formed as a single unit. In operation, the tab 606 may be pulled in a distal direction relative to the distal end 514 of the catheter adapter 510 to apply traction to the catheter 518. In some embodiments, the tab 606 may include an adhesive or other suitable mechanism to enable the tab 606 to be selectively moved in the distal direction and secured in place to apply continuous traction to the catheter 518. In some embodiments, the markings and/or the tab 606 may facilitate blood withdrawal by indicating a desired or optimal location for a clinician to apply pressure for blood withdrawal.
[0101] As shown in
[0102] Referring now to
[0103] Some embodiments of the traction mechanism 560 may be coupled with the stabilization pad 700 at a location substantially corresponding to a position of the catheter 518. In some embodiments, the traction mechanism 560 may include anchor points located on either side of the catheter 518 at or near its proximal end. In some embodiments, traction arms 566 may extend distally from the anchor points parallel to the catheter 518. In some embodiments, a traction plate 568 extending in a substantially transverse direction relative to the traction arms 566 may be coupled with or integrated with the distal ends of the traction arms 566. In some embodiments, the traction plate 568 may provide a distal anchor point for the traction mechanism 560.
[0104] In operation, in some embodiments, the traction arms 566 may be squeezed inwardly to straighten or to deform a contour of each of the traction arms 566 in an inward direction relative to the catheter 518. In some embodiments, this application of force may apply controlled traction to the catheter 518 to open a fluid path within the vasculature.
[0105] As shown in
[0106] Referring now to
[0107] In some embodiments, the traction mechanism 560 may be coupled with the first section 552 of the dressing 550 and may be configured to attach to the second section 554 of the dressing 114 to adjust the distance between the same. In some embodiments, the traction mechanism 560 may include an adjustable snap feature 570 to adjust the distance between the first section 552 and the second section 554. In this manner, some embodiments of the snap feature 570 may apply consistent traction to the catheter 518.
[0108] As shown in
[0109] In any case, some embodiments of the tension strap 572 may include the snap feature 570 coupled with or integrated with its distal end. In some embodiments, the snap feature 570 may include an extension or tab having one or more snap caps 1206 disposed along a length thereof. In some embodiments, each snap cap 574 may be configured to couple to a socket 576 coupled with or integrated with the second section 554 of the dressing 550. In some embodiments, the second section 554 may include multiple sockets 576 such that one or more of the snap caps 574 may be adjustably coupled with one or more of the sockets 576. In this manner, in some embodiments, the tension strap 572 may be tightened and/or loosened relative to the second section 554 of the dressing 550 to adjust traction applied to the catheter 518 in a controlled manner.
[0110] As shown in
[0111] Referring now to
[0112] As shown in
[0113] Also provided herein are methods of withdrawing blood from a vascular access device, or remediating a failed, or mitigating a potentially failed, vascular access device. As noted above, providing traction to a vascular access device, such as an indwelling catheter can improve blood withdrawal and/or delivery of medicaments through the catheter. Accordingly, in non-limiting embodiments, a method of withdrawing blood includes providing a catheter assembly as described herein. A user, such as a medical professional, may tighten the tourniquet, thereby occluding one or more of the underlying vessels and causing blood to pool near a tip of the indwelling catheter. At this point, blood withdrawal can be attempted. If blood withdrawal is unsuccessful, traction may be applied to the catheter, for example manually by the user by applying force with a finger. Following the application of traction, a second attempt to withdraw blood can be made. If the second attempt is unsuccessful, further traction may be applied to the catheter, for example by attaching a tourniquet arm, catheter arms, and/or increasing/decreasing tension or compression applied to a tourniquet arm or catheter arm, or between tourniquet and dressing, catheter adapter, connection feature, and/or traction mechanism, as described herein. This step may be repeated, as necessary, until blood can be withdrawn. Following successful withdrawal, the tourniquet may then be loosened or removed.
[0114] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.