METHOD FOR PERITONEAL REMOVAL OF ELECTROLYTES AND INFLAMMATORY MEDIATORS
A method of peritoneal removal of electrolytes and inflammatory mediators. The method begins with infusing a treatment solution into the peritoneal cavity of a patient by way of a catheter. The treatment solution is drained from the peritoneal cavity by way of the catheter. During the draining, the treatment solution is filtered for removing electrolytes and inflammatory mediators.
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Pursuant to 37 C.F.R. § 1.78(a)(4), this application claims the benefit of and priority to prior filed co-pending Provisional Application Ser. No. 62/410,135, filed Oct. 19, 2016, which is expressly incorporated herein by reference.
RIGHTS OF THE GOVERNMENTThe invention described herein may be manufactured and used by or for the Government of the United States for all governmental purposes without the payment of any royalty.
FIELD OF THE INVENTIONThe present invention relates generally to peritoneal dialysis and, more particularly, to methods of binding electrolytes or inflammatory mediators.
BACKGROUND OF THE INVENTIONWhile severe illness or injury is, in itself, difficult for the patient and physician treatment, these conditions are often further complicated by increased levels of electrolytes and inflammatory mediators. Conventionally, electrolyte removal involves renal replacement therapy, which requires significant supplies and personnel. Such demands on resources makes in-field treatment at least difficult if not impossible. Likewise, inflammatory mediators are conventionally removed via continuous venovenous hemodialysis, plasma exchange, or hemoperfusion. Again, there is a significant requirement of resources, thus limiting it use during deployment.
In either instance, treatment requires large bore catheterization to a major vein. For example,
While the exemplary system of
Given such difficulties in treating complications associated illness and injury, there remains a need for methods of peritoneal removing of electrolytes and inflammatory mediators that minimizes the need of resources and thus accessible for deployment and in-the-filed use.
SUMMARY OF THE INVENTIONThe present invention overcomes the foregoing problems and other shortcomings, drawbacks, and challenges of conventional methods of removing peritoneal electrolytes and inflammatory mediators. While the invention will be described in connection with certain embodiments, it will be understood that the invention is not limited to these embodiments. To the contrary, this invention includes all alternatives, modifications, and equivalents as may be included within the spirit and scope of the present invention.
According to an embodiment of the present invention, a method of peritoneal removal of electrolytes and inflammatory mediators begins with infusing a treatment solution into the peritoneal cavity of a patient by way of a catheter. The treatment solution is drained from the peritoneal cavity by way of the catheter. During the draining, the treatment solution is filtered for removing electrolytes and inflammatory mediators.
In accordance with other embodiments of the present invention, the method includes elevating a treatment solution container above an infusion site of a patient such that the treatment solution infuses into the peritoneal cavity of the patient by way of a catheter. The treatment solution container may be lowered to below the infusion site so as to drain the treatment solution from the peritoneal cavity. Electrolytes and inflammatory mediators may be filtered from the treatment solution during infusion, during draining, or both.
Yet other embodiments of the present invention are directed to a method of peritoneal removal of electrolytes and inflammatory mediators and includes implanting a filter cartridge into the peritoneal cavity of a patient. The filter cartridge includes a binding agent enclosed within a porous surgical packing material. A treatment solution is infused into the peritoneal cavity of the patient and drawn from the peritoneal cavity by way of the filter cartridge.
Additional objects, advantages, and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
It should be understood that the appended drawings are not necessarily to scale, presenting a somewhat simplified representation of various features illustrative of the basic principles of the invention. The specific design features of the sequence of operations as disclosed herein, including, for example, specific dimensions, orientations, locations, and shapes of various illustrated components, will be determined in part by the particular intended application and use environment. Certain features of the illustrated embodiments have been enlarged or distorted relative to others to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustration.
DETAILED DESCRIPTION OF THE INVENTIONReferring now to the figures, and in particular to
Referring now to
As illustrated in
The combination dilator 84 and delivery sheath 82 are directed, in unison, over the guidewire 76 toward the incision 70. As the dilator 84 and delivery sheath 82 move across the incision 70 and into the peritoneal cavity 54 (
As shown in
Looking now to
Referring again to
Turning now to
Optionally, if necessary, the incision 70 may be closed to further secure placement of the catheter 52 within the peritoneal cavity 54 (
Referring again to
Fluid flow through the three-way valve 102 may be configured such that treatment solution flows into and through the peritoneal catheter 52 and into the peritoneal cavity 54, permitting the treatment solution to be instilled into the cavity 54 (Block 114). The treatment solution comprises saline with optional binding agents. According to some embodiments of the present invention, the binding agents may be chelators configured to absorb inflammatory mediators, metals, or other solutes from the peritoneal cavity 54.
After a period of time, sufficient for achieving equilibration, the treatment solution may be drained from the peritoneal cavity 52, via the peritoneal catheter 52 and three-way valve 106 to the fluid storage tank 112 (Block 116). The treatment solution is filtered (Block 118), which may accomplished after being drained into the fluid storage tank 112 or, as specifically illustrated, as the treatment solution flows through the catheter 110 extending between the three-way valve 106 and the fluid storage tank 112. As such, the fluid path along the catheter 110 includes a filter 120 configured to remove inflammatory mediators.
According to some embodiments of the present invention, the filter 120 may incorporate a polymer, such as those described in U.S. Application Publication No. 2013/0195792, entitled METHOD OF TREATING INFLAMMATION, and filed on Apr. 1, 2011; U.S. Application Publication No. 2014/0294751, entitled HEMOCOMPATIBILITY MODIFIERS FOR CROSS-LINKED POLYMERIC MATERIAL, and filed Mar. 31, 2014; or U.S. Application Publication no. 2015/0118673, entitled POLYMERIC SORBENT FOR REMOVAL OF IMPURITIES FROM WHOLE BLOOD AND BLOOD PRODUCTS, and filed Aug. 10, 2012. Such polymer is configured to remove inflammatory mediators via the principle of size exclusion (molecules of the intended size are trapped within the polymer structure). According to other embodiments of the present invention, binding agents may comprise resins, diffusion tubes, or other novel binding agents, including, for example, those that are described in U.S. Pat. No. 8,216,560, issued on Jul. 10, 2012, and entitled ION BINDING POLYMERS AND USES THEREOF.
Once the treatment solution has drained into the fluid storage tank 112, and filtered, a determination as to whether further dialysis is made (Decision Block 122). Such determination may include, for example, laboratory analysis of the blood, analysis of electrocardiogram, or clinical evaluation by a physician. If further dialysis is required (“YES” branch of decision block 122), then a further determination as to whether the treatment solution is spent is made (Decision Block 124). Said another way, if the drained and filtered treatment solution within the fluid storage tank 112 has inflammatory mediators above a threshold concentration (“YES” branch of decision block 124), then the process may return to instilling clean treatment solution into the peritoneal cavity (Block 114). However, if the concentration of inflammatory mediators within the drained and filtered treatment solution in the fluid storage tank 112 is below such threshold concentration (“NO” branch of decision block 124), then treatment solution within the fluid storage tank 112 may be instilled into the peritoneal cavity 52 (Block 126) and the process continues.
If further dialysis is neither required nor desired (“NO” branch of decision block 122), then the process ends.
An alternative embodiment of the present invention is illustrated in
While not specifically illustrated, yet another embodiment is envisioned in which the filter may be incorporated into the treatment solution container 130 as opposed to being an inline filter.
With reference now to
In
While the implantable cartridge 158 is within the peritoneal cavity 148, electrolytes and inflammatory mediators, for example, potassium, may flow down a concentration gradient into that fluid. In the setting of hyperkalemia, the concentration of potassium can be 6 meq/L. With standard peritoneal dialysis, if 2 L of fluid (with a concentration of 0 meq/L of potassium) are infused into the peritoneum, potassium will flow down a concentration gradient until the concentrations equalize and a total of 12 meq (6 meq/L×2 L) will be removed. However once the concentrations equilibrate, no further substances transmit from the blood. The same process occurs for other electrolytes and inflammatory mediators. However, with the implantable cartridge 158 in the peritoneal cavity 148, the potassium would be bound, keeping the potassium concentration in the fluid at close to 0 meq/L, which would enable continued removal without exchange of fluid.
The position of the cartridge 158 may be largely dependent on surgeon preference, but should generally be in a location have sufficient surface area. To increase surface area available for binding, fluid may be instilled into the peritoneal cavity 148.
Turning now to
If desired, the surgical opening may then be closed (Block 176). With the pump activated, a wound vacuum is applied (Block 178). In such arrangement, fluid extracted from the peritoneal cavity 148 by way of the wound drain 166 and pump 158 may be filtered and re-instilled to into the peritoneal cavity 158.
The patient 144 may be monitored (Block 180) until such a time that the cartridge 158, drain 166, pump 168, and filter 174 are no longer required and, thus, removed (Block 182).
While the present invention has been illustrated by a description of one or more embodiments thereof and while these embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope of the general inventive concept.
Claims
1. A method of peritoneal removal of electrolytes and inflammatory mediators, the method comprising:
- infusing a treatment solution into the peritoneal cavity of a patient by way of a catheter;
- draining, by way of the catheter, the treatment solution from the peritoneal cavity; and
- filtering electrolytes and inflammatory mediators from the treatment solution while the treatment solution is draining.
2. The method of claim 1, wherein filtering electrolytes and inflammatory mediators further comprises:
- positioning a filter in fluid communication with the catheter, the filter comprising: a proximal end; a distal end; a lumen extending between the proximal and distal ends; and a filler within the lumen of the filter, the filler configured to remove electrolytes, inflammatory mediators, or both by size exclusion.
3. The method of claim 2, wherein the filler is selected from the group consisting of:
- a polymer, a resin, or diffusion tubes configured to remove inflammatory mediators.
4. The method of claim 2, the filler comprising a binding agent configured to selectively bind electrolytes, inflammatory mediators, or both.
5. The method of claim 4, wherein the binding agent is selected from the group consisting of:
- a polymer, a resin, or diffusion tubes configured to remove inflammatory mediators.
6. The method of claim 1, wherein infusing the treatment solution further comprises:
- a treatment solution container fluidically coupled to a distal end of the catheter, the treatment solution container configured to support the treatment solution.
7. The method of claim 6, wherein infusing the treatment solution further comprises:
- elevating the treatment solution container above an infusion site of the patient.
8. The method of claim 6, wherein draining the treatment solution further comprises:
- lowering the treatment solution container below an infusion site of the patient.
9. The method of claim 6, further comprising:
- elevating the treatment solution container above an infusion site of the patient for infusing the treatment solution; and
- lowering the treatment solution container below the infusion site for draining the treatment solution.
10. The method of claim 1, wherein the treatment solution comprises:
- saline; and
- a binding agent configured to selectively bind electrolytes, inflammatory mediators, or both.
11. A method of peritoneal removal of electrolytes and inflammatory mediators, the method comprising:
- elevating a treatment solution container above an infusion site of the patient;
- while elevating, infusing a treatment solution from the treatment solution into the peritoneal cavity of the patient by way of a catheter;
- lowering the treatment solution container below the infusion site for draining the treatment solution;
- while lowering, draining, by way of the catheter, the treatment solution from the peritoneal cavity; and
- filtering electrolytes and inflammatory mediators from the treatment solution during the infusing, during the draining, or both.
12. The method of claim 11, wherein filtering electrolytes and inflammatory mediators further comprises:
- positioning a filter in fluid communication with the catheter, the filter comprising: a proximal end; a distal end; a lumen extending between the proximal and distal ends; and a filler within the lumen of the filter, the filler configured to remove electrolytes, inflammatory mediators, or both.
13. The method of claim 12, wherein the filler is selected from the group consisting of:
- a polymer, a resin, or diffusion tubes configured to remove inflammatory mediators.
14. The method of claim 11, wherein filtering electrolytes and inflammatory mediators further comprises:
- positioning a filter in fluid communication with the catheter, the filter comprising: a proximal end; a distal end; a lumen extending between the proximal and distal ends; and a filler within the lumen of the filter, the filler comprising a binding agent configured to selectively bind electrolytes, inflammatory mediators, or both.
15. The method of claim 14, wherein the binding agent is selected from the group consisting of:
- a polymer, a resin, or diffusion tubes configured to remove inflammatory mediators.
16. The method of claim 11, wherein the treatment solution comprises:
- saline; and
- a binding agent configured to selectively bind electrolytes, inflammatory mediators, or both.
17. The method of claim 11, further comprising:
- re-instilling the treatment solution by, again, elevating the treatment solution container above the infusion site.
18. The method of claim 17, further comprising:
- again draining the treatment solution by again lowering the treatment solution container to below the infusion site.
19. A method of peritoneal removal of electrolytes and inflammatory mediators, the method comprising:
- implanting a filter cartridge in the peritoneal cavity of a patient;
- infusing a treatment solution into the peritoneal cavity of a patient; and
- drawing the treatment solution from the peritoneal cavity through the filter cartridge;
- wherein the filter cartridge comprises a binding agent enclosed within a porous surgical packing material.
20. The method of claim 19, wherein drawing the treatment solution further comprises:
- pulling the treatment solution from the peritoneal cavity by way of a would drain.
21. The method of claim 20, wherein the wound drain is fluidically coupled to a pump.
22. The method of claim 19, further comprising:
- re-instilling the treatment solution into the peritoneal cavity.
23. The method of claim 19, wherein the binding agent is configured to selectively bind electrolytes, inflammatory mediators, or both.
24. The method of claim 23, wherein the binding agent is selected from the group consisting of:
- a polymer, a resin, or diffusion tubes configured to remove inflammatory mediators.
Type: Application
Filed: Oct 13, 2017
Publication Date: Apr 19, 2018
Applicant: Government of the United States as Represented by the Secretary of the Air Force (Wright-Patterson AFB, OH)
Inventors: Ian Stewart (Lodi, CA), Jonathan Sosnov (San Antonio, CA), James Ross (Portland, OR)
Application Number: 15/783,094