WO2017042693A1 - Dispositif prothétique pour accès pour hémodialyse - Google Patents

Dispositif prothétique pour accès pour hémodialyse Download PDF

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Publication number
WO2017042693A1
WO2017042693A1 PCT/IB2016/055326 IB2016055326W WO2017042693A1 WO 2017042693 A1 WO2017042693 A1 WO 2017042693A1 IB 2016055326 W IB2016055326 W IB 2016055326W WO 2017042693 A1 WO2017042693 A1 WO 2017042693A1
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WO
WIPO (PCT)
Prior art keywords
fistula
tubular
secondary channels
side wall
tubular fistula
Prior art date
Application number
PCT/IB2016/055326
Other languages
English (en)
Inventor
Andrea CUMINO
Original Assignee
Cumino Andrea
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cumino Andrea filed Critical Cumino Andrea
Publication of WO2017042693A1 publication Critical patent/WO2017042693A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655—Arterio-venous shunts or fistulae

Definitions

  • the present invention pertains, in general, in the medical-surgical field; in particular, the invention relates to a prosthetic device for access for hemodialysis.
  • Hemodialysis which is necessary in patients in end-stage renal failure, is an extrarenal blood purification process.
  • a connection with the patient's bloodstream is provided through an external circuit, so that the blood is conveyed to the apparatus for hemodialysis.
  • This unit using a combination of semi-permeable filters, removes toxic substances, restores alkaline radicals and acts on the acid-base balance. Finally, it adjusts the volume of liquid to be deleted.
  • the patient on average three times a week, must normally and mandatorily perform such treatment.
  • one of the main problems of the method is how to ensure a hemodialysis access allowing an external circuit to be connected to the circulatory flow of the patient, in such a way that access is usable in a simple, repetitive, easier and safe way.
  • the contemplated solutions are represented by arteriovenous fistulas (hereinafter, denoted by the acronym FAV) and tunneled or no-tunneled catheters.
  • FAV arteriovenous fistulas
  • the FAV is a connection, surgically created, between an artery and a contiguous vein in a determined anatomical site, so as to create a cannulation point at high flow, constant flow rate and low peripheral resistance.
  • FAVs may be native and prosthetic.
  • the present prosthetic FAV (hereinafter, FAV-p) is generally manufactured with a biological material (bovine ureter, bovine mesenteric artery, etc.), but more frequently in e-PTFE (expanded polytetrafluoroethylene) which can be thin-walled , concrete, conical, hepa- rinized, preformed.
  • the connection can be of the "loop" or "straight" type (depending on the orientation of the fistula compared to the implant blood vessels, as well as the position and orientation of the anastomosis).
  • a connection is made between the brachial artery and the brachial, cephalic, basilica or axillary vein. Potentially, such a connection can be made between all arterial and venous districts, which are surgically treatable.
  • FAV-p are subjected to a plurality of even very serious complications, which can be divided into local and general complications.
  • the local complications include infection and fracture.
  • the infection is caused by repeated punctures for hemodialysis and contaminations by bacteria, especially localized in the skin (Staphylococcus aureus). It is the second-leading cause of death in uremic patients, and is a major cause of loss of the access for the hemodialysis (with an incidence ranging between 1 1% and 20%). It can degenerate in sepsis.
  • the FAV-p is subject to infection up to 5 times more than native FAV (FAV-n). It can cause chronic anemia resistant to EPO administration (which is a subclinical infection indicator).
  • the fracture may instead be caused by repeated puncture of the prosthesis with dialysis needles of large dimensions, which determines the breakage of the prosthetic structure, "repaired" by the organic tissue that covers the implant after its placement.
  • hyperplasia may be observed in cannulation points with intraluminal protrusion of cicatricial fibrous material. In such cases, it is said that there is “mid graft” stenosis.
  • the general complications include the "steal syndrome”, the “large arm syndrome”, heart failure and venous neo-intimal hyperplasia (NIH).
  • venous hyperflow caused by the high flow rate coming from the contiguous artery determines a stagnation of the upstream venous segment, with edema of the arm (forearm and hand) up to severe trophic consequences on the tissue.
  • Heart failure can occur in cases where there is a high flow rate within the fistula (high flow fistula > 1 ,000-1 ,500 ml/min), and the latter is quite proximal to the central venous vessels. In this way, there is an overload of the right chambers of the heart, which can lead to a clinically evident decompensation of heart-lung circle.
  • N1H venous neo-intimal hyperplasia
  • this situation determines the increase of the resistance downstream of the FAV-p, the reduction of the flow rate and ultimately the loss of the access due to the occlusion of the FAV-p itself.
  • the main hypotheses identify two types of mechanisms, according to whether such mechanisms are related or notto the blood stream-induced stress.
  • prior art has been focused on systems for minimizing the mismatch between the thickness and the diameter of the synthetic graft wall and the venous wall (by providing thinner wall prostheses and more compliant anastomosis profiles).
  • prosthetic terminals have been created for providing fluid dynamics models able to stress the receiving vessel in a less invasive way and in less sensitive areas.
  • cytostatic or cytotoxic drugs applied on DEB drug eluting balloon, or balloons which eluent a medication
  • DCS drug coated stents, or stents coated with drugs
  • This condition requires a continuous maintenance for maintaining the patency of the access for dialysis, with 2-4 procedures (endovascular or surgical) a year on average to prevent clogging of the FAV (which is the first cause of hospitalization for patients treated with dialysis).
  • the social costs for maintaining the patency of the access are extremely high as a whole. Indeed, the increasing worsening of the health conditions of patients to be treated (the elderly and multi-pathological), and an increase in the number of patients directly proportional to the increasing average age of the population, have to be considered.
  • One object of the present invention is to overcome the above-mentioned problems, providing a solution that significantly reduces the occurrence of complications with respect to the prosthetic fistula.
  • a FAV works, since its creation, 24 hours a day, 365 days a year, for a total of about 8760 hours/year.
  • the dialysis requires, as actual hours of accessibility to the arteriovenous system, about 4 hours per session for three sessions/week, approximately 624 hours.
  • the ratio between the actual dialysis needs in terms of time and the overall operation of a standard FAV is thus 624/8760, or about 7%.
  • a prosthetic device is a tri-modular system, which comprises a tubular prosthesis, three catheters and an occlusion balloon.
  • the tubular prosthesis will be normally anastomosed between an artery and a vein, ensuring a high volume and low resistance flow.
  • the prosthesis may be arranged with a "loop” or a “straight” configuration, depending on the anatomical implantation site.
  • Three catheters will derive from the prosthetic body (preferably by casting), two of which for drawing and re-entering the blood that will go to dialysis filters and return purified.
  • the third catheter will be for controlling the occlusion balloon.
  • the occlusion balloon is an inflatable body, integral with a side of the lumen of the prosthesic body, which in the retracted position will ensure the flow passage within the fistula, and that once stretched by insufflating liquid or air will occupy partially or totally the lumen of the fistula, causing respectively the controlled reduction of the flow in the fistula or its complete occlusion at the end of the dialysis procedure.
  • a prosthetic device according to the invention, there would be a drastic reduction in the onset occurrence and development of the NIH (neo-intimal hyperplasia), as there would be neither the time nor the operation continuity necessary to determine the irritant stimulus on the vein wall which induces the development of proliferative inflammatory mechanisms underlying the hyperplasia.
  • NIH neuro-intimal hyperplasia
  • a prosthetic device for hemodialysis access having the features defined in in claim 1.
  • Preferred embodiments of the invention are defined in the dependent Claims.
  • FIG. 1 is a schematic front view in partial cross section of a prosthetic device for access for hemodialysis, according to an embodiment of the present invention
  • FIGS. 2 and 3 are schematic views of the prosthetic device of Figure 1, represented in two operating conditions;
  • FIGS. 4, 5 and 6 are schematic front views in partial transparency of a prosthetic device for access for hemodialysis, according to three distinct alternative embodiments of the present invention
  • FIGS. 7A to 7C are schematic front views in partial cross section of a prosthetic device according to an alternative embodiment of the present invenstion, illustrated in three distinct operating stages;
  • FIG. 8 schematically show some fittings applicable to a prosthetic device according to the present invention.
  • a prosthetic device 9 for hemodialysis access comprises a tubular fistula 10.
  • the tubular fistula 10 comprises a side wall 10a, having an elongated and preferably cylindrical shape, and two end sections 10b, being in general vaguely lanceolate in order to facilitate the connection of the fistula 10 to the blood vessels (more precisely, it is possible for the ends of the prosthesis to be worked with a spatula in a convenient size and shape so as to facilitate the suture and anastomosis to the vessels).
  • the end sections 10b are connected to the blood vessels in such a way that a conveniently radiused internal profile is provided, so as to reduce or prevent the generation of harmful shear stresses in the anastomotic site (that is, in the connecting portion between the fistula 10 and the above mentioned blood vessels).
  • the inflatable body 16 Inside the tubular fistula 10 there is at least one occlusion balloon or inflatable body 16, adapted to expand within the fistula 10 so as to reduce or cling to the passage section.
  • the inflatable body 16 can be placed in fluid communication with a catheter or primary channel 18, outgoing from the tubular fistula 10.
  • the inflatable body 16 is a single body which extends longitudinally along the entire or almost the entire side wall 10a, but more inflatable bodies 16 may also be present, as shown for example in Figures 7A to 7C.
  • the primary channel 18 is adapted to inlet and withdraw a fluid (air, water or other means) from the inflatable body 16, so that said inflatable body 16 can move from a retracted rest condition, in which a maximum degree of fluid communication is allowed between the op- posite ends of the tubular fistula 10, to an active inflated condition, in which the cross- section of the tubular fistula 10 is partially occluded (intermediate degree of fluid communication) or substantially entirely (zero degree of fluid communication).
  • the inflatable body 16 At the maximum degree of fluid communication, the inflatable body 16 is deflated, and occupies a minimum volume in the passing port in the side wall 10a.
  • the occlusion balloon can be mono or multi-lobed.
  • the ends of the inflatable body 16 when fully inflated, do not protrude beyond the end sections 10b (i.e., do not penetrate the vessel lumen), remaining flush with the anastomosis so as to restore the continuity of the vessel wall, and therefore minimizing the alterations of the internal profile of the vessel so as to reduce or avoid tangential vortices and actions in the resting phase of the fistula 10.
  • the inflatable body 16 may elongate so as to achieve also a dilatation of the anastomotic site, according to an embodiment not shown.
  • the inflatable body 16 adheres to the side wall 10a of said tubular fistula 10 along substantially the entire length in the axial direction of said side wall 10a. In this way, the opposite ends of the inflatable body 16 will conveniently be flush with respect to the anastomosis (as shown in Figure 3).
  • the inflatable body 16 lies on a diametral plane of the tubular fistula 10 (dividing the fistula 10 substantially in two semi-tubular portions which extend in the axial direction), and can expand radially until the cross-section of the flow passage through the fistula is occluded.
  • the inflatable body 16 substantially extends along the whole length of the fistula 16 and is secured along the side edges thereof to the inner face of the side wall 10a.
  • in the side wall 10a of the tubular fistula 10 are present permanent radial holes 10c, placed in contact with respective catheters or secondary channels 12, 14 which protrude from said tubular fistula 10.
  • the contact between the permanent radial holes 10c and the secondary channels 12, 14 is sealed, so that the secondary channels can pass through said permanent radial holes 10c or be connected to, and in fluid communication with, them (as it will better appreciated later on).
  • the radial holes 10c may conveniently be circular (if the secondary channels 12, 14 penetrate the side wall 10a with a purely radial direction), or may have for example an oblong or elliptical shape (in the case in which the secondary channels 12, 14 enter along a more or less inclined direction, so as to orient parallel to the axis of the fistula 10 once inside of the side wall 10a).
  • the secondary channels 12, 14 are occludable when the inflatable body 16 is in the active inflation condition (partial or total, depending on the position of the radial holes with respect to the inflatable body).
  • the presence of the secondary channels 12, 14, the purpose of which is respectively to withdraw the blood flow coming from a vessel, to convey it towards the machine for dialysis treatment and re-enter it in the patient's circulation, allows to avoid the perforation of the tubular fistula 10 with dialysis needles (preventing the above problems related to infection, fracture, etc.). Furthermore, besides the aforesaid complications with respect to the side wall 10a of the fistula 10, the possible perforation by means of dialysis needles may puncture or damage the inflatable body 16.
  • the permanent radial holes 10c may be connected to, and in fluid communication with, the secondary channels 12, 14, by means of respective withdrawal and inlet openings 12a and 14a, oriented in a substantially radial direction with respect to the tubular fistula 10 (as in the example in Figure 1).
  • withdrawal and inlet openings 12a, 14a Through such withdrawal and inlet openings 12a, 14a, the blood flow can be conveyed to and from the apparatus for the dialysis treatment.
  • the secondary channels 12, 14 can pass through the permanent radial holes 10c.
  • the respective withdrawal and inlet openings 12a and 14a of the secondary channels 12, 14 are located inside the tubular fistula 10, and may be oriented substantially in the axial direction relative to the tubular fistula 10 (which is the case shown in Figures 4, 5 and 6).
  • the withdrawal and inlet openings 12a and 14a have edges that fit the internal profile of the cross section of the tubular fistula 10. In this way, the expansion of the inflatable body 16 occludes the passage section of such withdrawal and inlet openings and 12a, 14a.
  • At least one of the secondary channels 12, 14 has a curved portion in a direction substantially circumferential with respect to the tubular fistula 10, preferably following the inner surface of the side wall 10a (as shown in Figures 4 to 6). In this way, it will be possible to orient the withdrawal and inlet openings 12a and 14a along the axial direction.
  • said curved portion can be extended so that the respective secondary channel 12, 14 may follow a spiral curve.
  • FIGs 7A to 7C illustrate a further embodiment of the tubular fistula 10 according to the invention.
  • a fluid communication is allowed between the end sections 10b.
  • the balloons 16 are inflated ( Figure 7B)
  • the passage of fluid through the fistula 10 is inhibited; this phase can be conveniently exploited to perform a washing of the fistula 10, i.e. to evacuate the waste fluid inside the side wall 10a and, conveniently, to circulate a washing drug (per se known) inside the same.
  • a washing drug per se known
  • the side wall 10a of the fistula can be collapsible, and may for example be deflated by drawing the contents through one or both secondary channels 12, 14.
  • the time during which the fistula 10 is in a tubular configuration furtherly reduces, preventing the stagnation at the inside of coagulated blood or harmful substances, which may potentially be colonized by bacteria that can cause infections.
  • the primary 18 and secondary 12, 14 channels have free ends on which are applicable alternatively a sharp terminal 20 or a valve assembly 24, respectively, to facilitate the tunneling of the catheters 12, 14, 18 (up to make them leak out in a convenient cutaneous site), and to allow an easy and immediate connection to the machine for dialysis treatment (not shown).
  • the apparent advantages achieved thanks to the present invention are the remarkable improvement of the accessibility to the dialysis treatment site (with beneficial effects on patient comfort), as well as the less freqient onset of complications that imply risks for the patient's health and frequent maintenance.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un dispositif prothétique (9) pour accès pour hémodialyse comprenant une fistule tubulaire (10) à l'intérieur de laquelle au moins un corps gonflable (16) est présent, corps qui peut changer depuis un état rétracté, dans lequel il y a une communication fluidique entre les extrémités opposées de la fistule tubulaire (10), vers un état gonflé, dans lequel la fistule tubulaire est partiellement ou totalement obstruée.
PCT/IB2016/055326 2015-09-07 2016-09-07 Dispositif prothétique pour accès pour hémodialyse WO2017042693A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITUB2015A003456A ITUB20153456A1 (it) 2015-09-07 2015-09-07 Dispositivo protesico per accesso da emodialisi
IT102015000049020 2015-09-07

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WO2017042693A1 true WO2017042693A1 (fr) 2017-03-16

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070249987A1 (en) * 2001-06-20 2007-10-25 The Regents Of The University Of California Hemodialysis access with on-off functionality
TWM391395U (en) * 2010-05-28 2010-11-01 Qing-Yang Wu Apparatus capable of adjusting flux of dialysis fistula
US20110009947A1 (en) * 2009-03-13 2011-01-13 Stanley Batiste Endothelial scaffold graft and method therefor

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070249987A1 (en) * 2001-06-20 2007-10-25 The Regents Of The University Of California Hemodialysis access with on-off functionality
US20110009947A1 (en) * 2009-03-13 2011-01-13 Stanley Batiste Endothelial scaffold graft and method therefor
TWM391395U (en) * 2010-05-28 2010-11-01 Qing-Yang Wu Apparatus capable of adjusting flux of dialysis fistula

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Publication number Publication date
ITUB20153456A1 (it) 2017-03-07

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