巴西专利BR112015017424B1 LOW PROFILE ACCESS DOOR

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专利摘要:
low profile access door. a low profile access port for subcutaneous implantation within a patient's body is disclosed. the access port includes a receiving cavity that provides a relatively large subcutaneous target to allow a catheter support needle to access the port without difficulty. in addition, the access port includes a valve/seal assembly to allow injection of fluid under pressure through the port, preventing backflow. in one embodiment, therefore, a low-profile access port comprises a body that includes a conduit with an inlet port at a proximal end thereof, and a receiving cavity. the receiving cavity is concave formed to direct a support catheter needle into the conduit through the inlet port. the receiving cavity is oriented substantially to a skin surface when implanted subcutaneously into the patient to relieve needle impingement. a valve/seal assembly arranged in the conduit allows the catheter to pass through it, preventing backflow of fluid.
公开号:BR112015017424B1
申请号:R112015017424-8
申请日:2014-01-23
公开日:2022-01-18
发明作者:Jason R. Stats；Bret Hamatake；Dwight T. Hibdon；Kelly J. Christian；Amir Orome；Scott Walter Snyder
申请人:C.R. Bard, Inc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[0001] This application claims the benefit of US Provisional Patent Application No. US 61/755,913, filed January 23, 2013, and entitled "Low Profile Access Door", which is incorporated herein by reference in its totality. SUMMARY SUMMARY
[0002] Briefly, embodiments of the present invention are directed to a low profile access port for subcutaneous implantation within a patient's body. The access port includes a receiving cup that provides a relatively large subcutaneous target to allow a supporting catheter needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to allow injection of fluid under pressure through the port, preventing backflow.
[0003] In one embodiment, therefore, a low-profile access door comprises a body that includes a conduit with an inlet opening at a proximal end thereof, and a receiving cavity. The receiving cavity is concave in the form of directing a support catheter needle into the conduit through the inlet port. The receiving cavity is oriented substantially to a skin surface when implanted subcutaneously into the patient to alleviate needle impingement thereon. A valve/seal assembly arranged in the conduit allows the catheter to pass through it, preventing fluid backflow.
[0004] These and other features of embodiments of the present invention will become more apparent from the following description and the appended claims, or may be learned by practicing embodiments of the invention as set forth below. BRIEF DESCRIPTION OF THE DRAWINGS
[0005] A more particular description of the present invention will be rendered with reference to specific embodiments thereof which are illustrated in the accompanying drawings. It is to be understood that these drawings only describe typical embodiments of the invention and are therefore not to be regarded as limiting its scope. Example embodiments of the invention will be described and explained with additional specificity and detail using the accompanying drawings in which:
[0006] Figs. 1A-1E show various views of an access door according to one embodiment;
[0007] FIG. 2 is a cross-sectional view of the access door of FIGS. 1A-1E;
[0008] FIG. 3A-3C are various views of a low profile access door according to one embodiment;
[0009] FIG. 4 is a top view of a low profile access door, according to one embodiment;
[00010] FIG. 5 is a perspective view of a low profile access door, according to one embodiment;
[00011] FIG. 6 is a perspective view of a low profile access door, according to one embodiment;
[00012] FIGS. 7A and 7B are various views of an access door, according to one embodiment; and
[00013] FIGS. 8A and 8B are various views of an access door, according to one embodiment. DETAILED DESCRIPTION OF SELECTED ACHIEVEMENTS
[00014] Reference will now be made to the figures, where similar structures will be provided with designations as a reference. It is understood that the drawings are diagrams and schematic representations of exemplary embodiments of the present invention, and are not limiting or necessarily designed to scale.
[00015] For clarity, it is to be understood that the term "proximal" refers to a direction relatively closer to a clinician using the device being described herein, while the term "distal" refers to a direction relatively farther away. of the clinician. For example, the end of a catheter placed inside a patient's body is considered a distal end of the catheter, while the end of the catheter remaining outside the body is a proximal end of the catheter. Furthermore, the terms "including", "has", and "having", as used herein, including the claims, have the same meaning as the word "comprising".
[00016] Embodiments of the present invention are generally intended for an access port for subcutaneous implantation within a patient's body. The access port is implanted transcutaneously accessible by a supporting catheter needle, such as a peripheral catheter intravenous ("PIV"), so as to place the IVP catheter in fluid communication with the access port. A fluid outlet from the access port is operatively connected to a permanent non-catheter disposed within a patient's vasculature, in one embodiment, to allow infusion and/or removal of fluid from the patient's vasculature to take place. through the IVP catheter.
[00017] According to one embodiment, the access port defines a low profile so as to facilitate ease of placement within the patient's subcutaneous tissue. In addition, the access port is configured to provide a relatively large subcutaneous target to allow the catheter or other suitable catheter support needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to allow injection of fluids through the access port at a relatively high flow rate, such as about 5 ml per second at a pressure of about 300 psi (also referred to herein as "power injection"). Possible applications for the access port described herein include administering medication and other fluids to the patient, apheresis, aspiration of liquids, etc.
[00018] Reference is first made to Figs. 1A-1E , which show various details of an access port, generally designated 10, in accordance with one embodiment. As shown, the port 10 includes a body 12 which is defined in the present embodiment by a first part 12A and a second part 12b (Fig. IE). In the present embodiment the port body 12 includes a metal, such as titanium, and as such, the second portion 12B is snap-fitted into engagement with the first portion 12A to define the body, although it is appreciated that the port body may include a variety of other materials, including metals, thermoplastics, ceramics, etc.
[00019] Port body 12 in the present embodiment defines a substantially concave-shaped receiving cavity 14 for receiving and directing a support catheter needle (FIG. 2) to operatively connect with port 10, as described further below. In particular, the substantially concave shape of the receiving cavity 14 is configured to direct a bearing needle of the catheter (Fig. 2) which impinges thereon to an inlet opening 16 which serves as an opening for a conduit 18 defined by the port body. 12. The open and superficial nature of the receptor cavity 14 together with its orientation substantially upward (i.e., toward the patient's skin surface), so that it is substantially parallel to the skin surface when implanted subcutaneously under the patient's skin. patient (i.e., the receiving cavity is substantially parallel to the skin surface when the skin is at rest, or not deformed by digital pressure or manipulation), allows the receiving cavity to present a large, easily accessible target for the needle when introduced on the skin, as can be seen in FIG. 2. FIG. 2 further shows that port 10 defines a relatively low profile height, which allows relatively shorter needle lengths to be used to access the port after implantation.
[00020] Palpation features 26 are included with the port body 12 to help a clinician detect and/or identify port 10 via the palpating finger after implantation under the patient's skin. In detail, the palpation 26 features in the present embodiment include a protrusion 26A disposed near the proximal end of the receiving cavity 14 and a ridge 26B disposed above and curving around a distal portion of the receiving cavity. FIG. 1B shows that the palpation features extend above the general superior plane defined by port 10, so as to facilitate the palpation features by a clinician in order to locate the position and/or orientation of the receptor cavity 14. Note- If a variety of other sizes, configurations, numbers, etc., of palpation features can be included in the port in addition to what is shown and described here.
[00021] A guide groove 28 is defined in the receiving cup 14 and is aligned longitudinally with the inlet hole 16 of the conduit 18. The guide groove 28 is defined as a depression with respect to adjacent portions of the cavity surface 14 and extends distally along the surface of the receiving cavity a proximal portion of the receiving cavity so as to provide a guidance path for guiding the distal tip of the needle of the support catheter toward the inlet port 16 once that the impingement of the needle inside the guide groove is made. This, in turn, reduces the possibility of the needle slipping through and out of the receiving cavity 14 during insertion. Note that these and other similar features, while differing in shape and configuration, may also be included in the other ports disclosed herein.
[00022] As best seen in FIG. 1E, port body 12 further defines conduit 18 as a pathway through which a transcutaneously inserted catheter can pass so as to place the catheter in fluid communication with port 10. As shown, conduit 18 is in communication with the receiving cavity 14 through the inlet port 16. A first conduit portion 18A of the conduit 18 extends distally from the inlet port 16 in a downwardly angled direction from the perspective shown in FIG. 1E for a bend 30, wherein a second conduit portion 18B of the conduit angles upward slightly and changes direction at a predetermined angle Q. Note that angular orientation Qi in one embodiment is about 37 degrees, but may vary therefrom, in other embodiments, including angles less than 37 degrees in each embodiment. The magnitude of the Q angle depends, in one embodiment, on several factors, including the size of the catheter and/or needle to be inserted into the port conduit, the size of the conduit itself, etc.
[00023] Conduit 18 then extends into and through a cavity 20A defined by a valve housing 20 of the port body. Conduit 18 extends to an open distal end of stem 24 of port 10. Conduit 18 is sized to allow catheter 40 (Fig. 2) to pass therethrough, as will be seen.
[00024] As mentioned, the valve housing 20 defines a cavity 20A through which the conduit passes and which houses a valve/seal assembly 22. The valve/seal assembly 22 includes a sealing member, or seal 32, which defines a central hole through which the catheter 40 can pass, a first slit valve 34A and 34B a second slit valve. Seal 32 and valves 34A, 34B are pressed together in one embodiment and secured in place within cavity 20A, as shown in FIG. 1 AND. The slits of slit valves 34A, 34B are rotationally offset from each other by about 90 degrees in the present embodiment, although other relationships are possible.
[00025] The seal 32 and valves 34A, 34B of the valve/seal assembly 22 cooperate to allow fluid flow therethrough of the catheter 40 (Fig. 2) at the same time preventing the backflow of fluid through the catheter. valve/seal assembly. Indeed, in one embodiment the seals described herein prevent the flow of fluid around the outside of the catheter when the catheter is disposed through the seal, while the valves are suitable for preventing the flow of fluid when no catheter is passed therethrough. As such, when the catheter 40 is not inserted through the same valve/seal assembly 22 seals to prevent the passage of air or fluid. In the present embodiment, the seal 32 and valves 34A, 34B include silicone, although other suitably compatible materials may be employed.
[00026] The port 10 of the present embodiment includes an overmolded portion 36 that covers the port body 12. The portion 36 includes moldable silicone or other suitably compatible material and surrounds the body 12, as shown, so as to provide a relatively smooth surface. soft for port 10 and reduce patient discomfort after port implantation. The overmolded portion 36 includes two predetermined suture sites 38, best seen in FIG. 1C, to suture the port 10 with the patient's tissue, although the sutures may be passed through other portions of the moldable portion, if desired. The overmolded portion 36-36A further defines a relatively flat bottom surface so as to provide a stable surface for the port 10 in its position within the tissue pocket after implantation. In contrast, the port shown in FIG. 3C includes a bottom surface with a slightly rounded profile.
[00027] FIG. 2 shows details relating to the insertion of catheter 40 disposed over needle 42, in accordance with one embodiment. After locating the hole 10 by palpation along the entire skin by the palpation features 26, a clinician uses the needle from the support catheter 42 to pierce a surface of the skin 44 and insert the needle 42A until a distal tip impinges on the same, in a portion of the receiving cavity 14, as shown. Note that, due to the orientation of the receptor cavity 14 as substantially parallel to the surface of the skin, the needle 42 can impinge on the receptor cavity at an insertion angle 2 that is relatively steep, which facilitates the ease of insertion of the needle for inside the body. In fact, in one embodiment a needle inserted substantially orthogonally through the patient's skin may impinge on the receiving cavity of the access port.
[00028] Needle 42 is manipulated until distal tip 42A is received within guide groove 28, which will allow the distal end to be guided along groove into entry opening 16. Needle 42 is then inserted through the inlet opening 16 and into the first part 18A of the conduit 18 until it is interrupted by the bend 30. The needle 42 can then be supported proximally out a short distance, and the catheter 40 advances over the needle so that the catheter curves and the curve last advances 30 to second portion 18B of conduit 18. Catheter advancement continues such that a distal end 40a of catheter 40 advances into and beyond seal hole 32 and, through both valve slots the valve/seal slit 34A, 34B 40. Once the distal end assembly 40A of the catheter 40 has extended distally beyond the valve/seal assembly 22, further advancement may cease and fluid transfer through from door 4 0 and catheter 10 may commence, including infusion and/or aspiration through stem 24. Once fluid transfer is complete, catheter 40 may be withdrawn proximally through valve/seal assembly 22 and conduit, in it is then withdrawn through the skin surface 44 and out of the patient.
[00029] FIGS. 3A-3C illustrate details of an access door 110, in accordance with another embodiment. Note that there are several similarities between port 10 and the other ports shown and described here. As such, selected single port aspects are discussed below. As shown, port 110 includes a body 112 which in turn includes a first body portion 112A and a second body portion 112B, best seen in FIG. 3C. The body 112 of the present embodiment includes a thermoplastic, such as an acetyl resin in the present embodiment. As such, the first and second body portions 112A, 112B are ultrasonically welded together to define the body 12, in the present embodiment. As before, a receiving cavity 114 is included with the body 112 and is operatively connected to a conduit 118 through an inlet port 116. Also, note that a variety of materials can be used to define the port body, cavity reception, conduit, etc.
[00030] A valve/seal assembly 122 is disposed within a cavity 120A that is defined by a valve housing 120, which in the present embodiment, is defined by the first body portion 112A. The valve/seal assembly 122 includes a proximal end 132 sealing with a central hole for the passage of the catheter, two slit valves 134A, 134B each with a groove arranged at an offset of 90 degrees to the other, and a seal. 135 with a central hole, also referred to herein as a sphincter seal.
[00031] The distal seal 135 includes on its distal surface a frusto-conical portion 135 disposed around the central bore of the seal that is configured to provide a sphincter-like seal on the outer surface of a catheter as it extends through the catheter. valve/seal assembly. The frusto-cone portion 135A is arranged such that any fluid that re-impacts the frusto-conical portion will cause the seal to attach to the outer surface of the catheter in an even tighter coupling, preventing Thus, reflux past the outer surface of the catheter when high fluid pressures are present, such as in the case of energy injection. As mentioned, other valve/seal combinations can also be included in the valve/seal assembly.
[00032] In the present embodiment, the receiving cavity 114 and a portion of the conduit 118 proximal to the valve/seal assembly 122 both include a needle-impenetrable liner that prevents the distal end of a needle from the cutting surface when it impinges. the same. This, in turn, prevents the creation of unwanted stains from materials excavated by the needle. Various suitable materials can be employed for the impenetrable-needle material, including glass, ceramics, metals, etc. In one embodiment, the components of port 110 are all non-metallic, such that the port is considered MR-safe, wherein the port does not produce undesirable artifacts on MRI images taken of the patient when the port is therein. implanted.
[00033] FIG. 4 illustrates additional features of port 110, in accordance with another embodiment. As shown, in the present embodiment the receiving cavity 18 includes radiopaque indicia 128 to indicate a feature of the port 110. Here, the radiopaque markings 128 include a "C" and a "T" which are formed from a radiopaque material such as tungsten, bismuth trioxide, etc., so as to be visible after implantation of the port through x-ray imaging technology. For example, the radio-opaque material may be formed as an insert which is insert molded included in the port body, as a flowable material which is initially injected into a cavity in the port body prior to hardening, etc. In embodiments in that the body is metallic gate, the radiopaque indicia may be formed by etching, etching, or otherwise producing a relative thickness difference between the marks and the material surrounding the gate body, so as to produce a ray contrast -x-discernible that shows up in an x-ray image.
[00034] In the present embodiment, radiopaque indicia CT 128 indicates to an observer that the port is capable of injecting fluid feed therethrough. In addition to this feature, other features may be indicated by various other types of indications, as appreciated by one of skill in the art.
[00035] Furthermore, in the present embodiment the top view of port 110 of FIG. 4 indicates that the port body 112 in the region surrounding the recipient cavity 114 defines a generally triangular shape, which can be palpated by a clinician after implantation and can not only indicate the location of the recipient cavity, but also a special feature of the port. , such as its ability to be used for energy injection. Of course, the receiving cavity can define other shapes than being triangular, in other embodiments.
[00036] FIG. 4 further shows that distributed around the perimeter of the receiving cavity 114 are three palpation features 126, i.e., three suture plugs 126A disposed in corresponding holes defined in the port body 112. The suture plug 126A includes ascending silicone bumps at present. embodiment and can serve to locate the position of post-implant recipient cavity 114 when they are palpated by a physician prior to needle insertion into the patient. Various other palpation features may be included with the port in other embodiments.
[00037] FIG. 5 shows details of a low profile port 210 according to one embodiment, including a body 212 defining a concavely-molded receiving cavity 214 and an inlet port 216 positioned slightly off-center with respect to the receiving cavity. A rod 224 is included as a fluid outlet.
[00038] FIG. 6 depicts the low-profile port 210, in accordance with another embodiment, wherein the body 212 defining additional surface features, including a raised palpation feature 226 distal to the receiving cavity 214. In light of FIGS. 5 and 6, it is therefore appreciated that the port can be configured in a variety of shapes and configurations to provide a low profile solution for providing vascular access. Note also that the receiver cavity shape, design and configuration may vary from those explicitly shown and described herein.
[00039] FIGS. 7A and 7B show various details of a low-profile dual-body access door 310 in accordance with one embodiment, wherein each of the door bodies 312 defines a receiving cavity 314 that is laterally turned and includes an entrance door 316 which leads to a conduit 318. Conduit 318 extends distally to a valve/seal assembly 322 disposed in a valve housing 320, which in the present embodiment, is defined by a portion of the body 312. Conduit 318 extends through port 324. A conformable moldable portion 324 caps each body portions 312 of port 310 and operatively joins the bodies together. Bodies 312 can include any suitable material, including metals, thermoplastics, etc.
[00040] FIGS. 8A and 8B show various details of a low profile dual-body access port 410, in accordance with one embodiment, wherein a port body 412 defines dual fluid means. Each fluid means includes a receiving cavity 414 defined by body 412 and facing a substantially upward orientation from the perspective shown in FIGS. 8A and 8B. An inlet port 416 is included with each receiving cavity 414 and defines the opening for a conduit 418. Each conduit 418 extends distally to a valve/seal assembly 422 disposed in a valve housing 420, which in the present embodiment, is defined by a portion of body 412. Conduit 418 extends through hole 424. Body 412 may include any suitable material, including metals, thermoplastics, etc.
[00041] Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the embodiments is therefore indicated by the appended claims and not by the foregoing description. All changes that come within the meaning and scope of equivalence of the claims are to be embraced by their scope.

权利要求:
Claims (14)
[0001]
1. A low profile access port for subcutaneous placement of a patient comprising: a body (12) that includes: a conduit (18) that includes an inlet port (16) at a proximal end thereof; and a receiving cavity (14) in communication with the inlet port (16), the receptacle cavity (14) concavely formed to direct a support catheter needle into the conduit (18) through the inlet port (16). ), the receiving cavity (14) substantially oriented towards a skin surface, when implanted subcutaneously within the patient, a valve/seal assembly (22) disposed in the conduit (18) that allows the passage of the catheter therethrough, characterized in that wherein the receiving cavity (14) further includes a guide groove (28) for guiding a tip that distally impinges on the needle of the support catheter to the inlet port (16).
[0002]
2. Access door, according to claim 1, characterized in that the conduit (18) includes a first conduit part (18A) and a second conduit part (18B), the second conduit part (18B) is positioned distal to and in an angular orientation with respect to the first portion of the conduit so as to prevent passage of the needle from the support catheter, while allowing passage of the catheter.
[0003]
3. Access door, according to claim 2, characterized in that the second part of the conduit (18B) is arranged at an angle of less than about 37 degrees in relation to the first part of the conduit (18A).
[0004]
4. Access port, according to claim 1, characterized in that the receiving cavity (14) is positioned substantially parallel to the skin surface when the access port is implanted subcutaneously, wherein preferably, a needle inserted substantially orthogonally across the patient's skin may impinge on the receiving cavity (14) of the access port.
[0005]
5. Access door, according to claim 1, characterized in that the conduit (18) extends from the receiving cavity (14) to an exit of a rod (24) of the access door, and in that the port further comprises at least one palpation feature (26) to allow a clinician to palpate the location of the subcutaneously implanted port.
[0006]
6. Access door, according to claim 5, characterized in that the at least one palpation feature (26) includes a projection (26A) and a rib (26B) arranged in the proximity of the receiving cavity (14). ), the at least one palpation feature (26) includes at least one suture hole plug (126A) disposed proximate the receiving cavity (14).
[0007]
7. Access door, according to claim 1, characterized in that the body (12) of the access door substantially defines a triangular shape over the receiving cavity (14).
[0008]
8. Access port according to claim 1, characterized in that the valve/seal assembly (22) includes a first seal (32), a first slit valve (34A), and a second slit valve (34B) positioned in a sandwiched configuration with respect to each other.
[0009]
9. An access port according to claim 1, characterized in that at least a portion of the receiving cavity (14) includes a needle-impenetrable material, the needle-impenetrable material preferably including at least one of metal , glass and ceramics.
[0010]
10. Access door, according to claim 1, characterized in that the body (12) includes at least one of a metal and a thermoplastic material.
[0011]
11. Access port, according to claim 10, characterized in that at least a portion of the body (12) includes at least one of titanium and acetyl resin.
[0012]
12. Access door, according to any one of claims 1 to 11, characterized in that the entrance door (16) is substantially centered in the receiving cavity (14).
[0013]
13. Access door, according to claim 1, characterized in that the body (12) defines at least first and second receiving cavity (14), each receiving cavity (14) in communication with a conduit (18) through an inlet port (16), each conduit (18) having a valve/seal assembly (22) disposed therein.
[0014]
14. A method of making a low profile access port for subcutaneous placement of a patient, the method comprising: providing first (12A) and second (12B) body portions of the access port, the first body part (12A) defining a portion of a conduit (18), the conduit (18) including an inlet port (16) at a proximal end thereof, the first body portion (12A) further defining a receiving cavity (14) in communication with the inlet port (16), the receptacle cavity (14) concavely formed to direct a support catheter needle into the conduit (18), through the inlet port (16), the receptacle cavity (14) configured , so as to be oriented substantially toward a surface of the skin, when implanted subcutaneously within the patient, the first body portion (12A), further including at least one palpation feature (26) for indicating a feature of the access door; place a valve assembly / seal (22) in the conduit portion (18); joining the second body portion (12B) from the access port to the first body portion (12A), sandwiching the valve/seal assembly (22) therebetween, the second body portion (12B) including a stem (24) providing a fluid outlet for the conduit (18) characterized in that the receiving cavity (14) includes a guide groove (28) for directing a distal impact tip of the catheter needle towards the inlet port. (16).

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法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2020-01-14| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-07-27| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

2021-11-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2022-01-04| B09W| Correction of the decision to grant [chapter 9.1.4 patent gazette]|Free format text: REFERENTE A RPI 2654 DE 16/11/2021. |

2022-01-18| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/01/2014, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201361755913P| true| 2013-01-23|2013-01-23|

US61/755,913|2013-01-23|

PCT/US2014/012721|WO2014116810A1|2013-01-23|2014-01-23|Low-profile access port|

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