Patent Application
20230381456
The present disclosure relates generally to exchanging a catheter in a patient, and more particularly to performing portions of a catheter exchange procedure without the assistance of radiography or other imaging.
Catheters are used for a multiplicity of different medical treatments and interventional procedures in modern medicine. A typical catheter includes an elongate flexible body having one or more passages or lumens extending from a proximal end of the catheter outside of the patient to one or more treatment locations within the patient's body. The lumens can be used to pass a variety of liquid agents for imaging, nutrition, hydration, or medicinal treatment of a patient at targeted locations, as well as various interventional tools for establishing or reestablishing access within a patient's vasculature or other structures within a patient's body.
Typical catheter placement includes advancing a wire guide into the patient's body and tracking a catheter over the wire guide to a desired location. Some techniques involve placement of the catheter only briefly until a specific procedure can be completed, followed by withdrawal. Other interventions require the catheter to remain within the patient for a more extended period of time. In one example, a catheter known generally in the art as a gastro jejunal or “GJ” feeding tube is advanced into a patient's gastro-intestinal or “GI” tract with a first feeding port in the catheter placed in a patient's stomach and a second feeding port placed more distally, below the pylorus and in the patient's small intestine. Different nutrition and hydration substances can be delivered into the stomach versus the small intestine, at different times, or in different ways. Over the course of time it is common for so-called GJ tubes to become clogged, with material at least partially obstructing the feeding port(s). While efforts can be made to clear the obstruction, it is commonly desirable to simply swap out the GJ tube for a replacement. Proper placement of a GJ tube can be challenging, however, and in some instances the GJ tube, whether clogged or not, can become displaced from a desired treatment location.
Catheter exchange techniques are known where one catheter is swapped out for another catheter using a common wire guide advanced through the first catheter and then maintained in place while the first catheter is removed and a replacement catheter advanced over the wire guide. While such techniques can be successful, it is conventional to perform such procedures with the assistance of live radiography. Suites for live radiography in a hospital setting often need to be reserved in advance, and thus scheduling a catheter exchange or other procedures can be administratively burdensome. One known GJ tube apparatus is set forth in co-pending and commonly owned U.S. patent application Ser. No. 17/767,747, filed Apr. 8, 2022, and a National Stage Application of PCT/US22/13325.
In one aspect, a method of exchanging a catheter includes producing a first image on an electronic display establishing positioning of a first catheter at a treatment location within a patient, and advancing an exchange wire through the first catheter to a predefined target insertion depth. The method further includes removing the first catheter from the patient, and advancing a replacement catheter over the exchange wire. The method still further includes producing a second image on an electronic display confirming placement of the second catheter at the treatment location within the patient.
In another aspect, a method of swapping out a gastro-jejunal (GJ) feeding tube includes confirming, via fixed radiography, a jejunal feeding tip of a first GJ tube within a patient remains below the pylorus in a patient's gastro-intestinal (GI) tract. The method further includes swapping the first GJ tube for a replacement GJ tube over a common exchange wire without radiography. The method still further includes confirming, via fixed radiography, a jejunal feeding tip of the replacement GJ tube within the patient is below the pylorus in the patient's GI tract.
In still another aspect, a catheter includes an elongate tubular body defining a longitudinal axis and including a proximal end, a distal tip having a distal feed opening formed therein, and a medial feed opening formed axially between the proximal end and the distal tip. The elongate tubular body further includes a first feed lumen extending to the distal feed opening, a second feed lumen extending to the medial feed opening, and a normally closed retrieval lumen originating at an origination location axially between the medial feed opening and the distal tip and terminating at a termination location distal to the origination location. The catheter further includes a transducer within the distal tip.
Referring to
Catheter 22 includes an elongate tubular body 24 defining a longitudinal axis 26 and including a proximal end 28, a distal tip 30 having a distal feed opening 32 formed therein, and a medial feed opening 34 formed axially between proximal end 28 and distal tip 30. Referring also now to
Retrieval lumen 52 originates at an origination location 54 axially between medial feed opening 34 and distal tip 30 and terminates at a termination location distal to origination location 54. Termination location 56 may be in distal tip 30 in some embodiments, although the present disclosure is not thereby limited. Elongate tubular body 24 also includes therein a plug 57 separating second feed lumen 50 from normally closed retrieval lumen 52 in the illustrated embodiments. This configuration allows plug 57 to be installed in a single lumen thereby dividing the lumen into two parts. In other embodiments, separate, parallel lumens might be used. Elongate tubular body 24 may also include therein an anti-cut structure 59. Anti-cut structure 59 can include an embedded metallic piece or sleeve or wire that limits a cut depth of a cutting tool such as a surgical scalpel through elongate tubular body 24 in a radial direction. Rather than a metallic material, anti-cut structure 59 could be formed of a relatively harder or tougher polymeric material such as a polyimide material. Elongate tubular body 24 may otherwise be formed predominantly of nylon in some embodiments. Catheter 24 may also include a disk 44 or other attached structure along elongate tubular body 24 that is to be positioned outside a patient and resists insertion of catheter 22 further into the patient's body than is desired. In addition, an anti-slip sleeve 46 is attached to elongate tubular body 24 and can, typically in cooperation with a securing clamp, disk, or other attached device, resist catheter 22 slipping into the patient's body when elongate tubular body 24 is cut for purposes further discussed herein. “Sleeve” 46 may or may not have a conventional sleeve-like structure and could be formed of a variety of materials or have a variety of shapes, including having a multiple parts. In some instances, a clamp releasably connectable to catheter 22 could perform the function of a sleeve. In an implementation, catheter 22 may have a structure substantially identical but for some differences disclosed herein to the catheter/GJ tube structure disclosed in commonly owned co-pending U.S. application Ser. No. 17/767,747, a National Stage application of PCT/US22/13325, filed Apr. 8, 2022, and hereby incorporated by reference.
Referring also now to
It should be appreciated the present disclosure is applicable without regard to the particular manner, frequency, or mechanism used to produce a signal from transducer(s) 58 that can be used to generate upon a display 70 a visual indication of a location or approximate location of distal tip 30 within a patient's anatomy. An image on an electronic display as contemplated herein includes a true image of a catheter or parts thereof within a patient's anatomy as well as various constructed images that are representative of catheter positioning. For instance, a constructed image of this nature could display a graph, a chart, an X-Y coordinate system, or an X-Y-Z coordinate system, and indicia or data reflecting relative catheter placement, to name a few examples. It is also contemplated that production of an image enabling visual monitoring of catheter location can occur via radiography. In a further implementation fixed radiography can be used for certain steps in a catheter exchange procedure and not used in other steps in a catheter exchange procedure.
Referring also now to
As explained above, it can be desirable to exchange or swap out one catheter for another, including the exchange of GJ tubes. Referring to
From the state depicted in
As noted above, a variety of technologies are contemplated for producing images on electronic display 70, or any suitable electronic display, including radiography. In the clinical environment it can be inconvenient and time consuming to obtain scheduling and access to a live radiography suite. Access to a fixed X-ray machine can be, however, more readily and rapidly obtainable. The present disclosure contemplates exchanging catheters without the need for live radiography, and including producing the first image via fixed radiography that establishes the first catheter is at a treatment location within the patient, and then producing the second image confirming placement of the second catheter at the treatment location with fixed radiography. Intervening aspects of the disclosed methodology, including swapping a first catheter such as a GJ feed tube for a replacement GJ feed tube, can occur without radiography altogether. Accordingly, swapping out a catheter according to the present disclosure can be achieved by way of equipment and procedures available in a traditional emergency room environment. By providing an indelible indicator on exchange wire 14 a clinician can perform the entire procedure by first obtaining a fixed radiograph via a conventional X-ray machine, swapping the catheters without any imaging whatsoever, and then confirming correct placement again utilizing the traditional X-ray equipment. This strategy is contemplated to provide significant advantages respecting availability or lack of availability, and/or cost, of live radiography equipment as well as related administratively burdensome healthcare procedures.
The present description is for illustrative purposes only, and should not be construed to narrow the breadth of the present disclosure in any way. Thus, those skilled in the art will appreciate that various modifications might be made to the presently disclosed embodiments without departing from the full and fair scope and spirit of the present disclosure. Other aspects, features and advantages will be apparent upon an examination of the attached drawings and appended claims. As used herein, the articles “a” and “an” are intended to include one or more items, and may be used interchangeably with “one or more.” Where only one item is intended, the term “one” or similar language is used. Also, as used herein, the terms “has,” “have,” “having,” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based, at least in part, on” unless explicitly stated otherwise.
| Number | Date | Country | |
|---|---|---|---|
| 63346563 | May 2022 | US |
