Artifical valve
Claim Score by NHIP
Abstract
Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertably deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Term
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Projected expiry passed 28 April 2022, 4.4 years ago.
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39 claims: 4 independent, 35 dependent
- 1A medical device, comprising:a membrane implantable in a body lumen and invertably deformable between a first position and a second position, wherein the membrane is invertible in response to the direction of fluid flow through the lumen.
- 13A medical system, comprising:a plurality of membranes, each membrane implantable in a body lumen and invertably deformable between a first position and a second position, wherein the membrane is invertible in response to the direction of fluid flow through the lumen.
- 29A method, comprising:positioning at least one membrane in a body lumen, each membrane invertably deformable between a first position and a second position, wherein the at least one membrane is invertible in response to the direction of fluid flow through the lumen relative to the membrane in the first position.
- 34Broadest claimClaim Score 90, very broad(NHIP)A method of controlling flow in a body lumen, the method comprising:invertably deforming a membrane between a first position and a second position, wherein the membrane is invertible in response to the direction of fluid flow through the lumen.
Independent claims4
41 paragraphs in 5 sections, as filed
FIELD OF THE INVENTION
[0001] This invention relates to medical devices for use in a body lumen.
BACKGROUND
[0002] A venous valve functions to prevent retrograde flow of blood and allow only antegrade flow of blood to the heart. Referring to FIG. 1A, a healthy venous valve <b>12</b> is illustrated in a vessel <b>10</b>. The valve is bicuspid, with opposed cusps <b>14</b>. In the closed condition, the cusps <b>14</b> are drawn together to prevent retrograde flow (arrow <b>16</b>) of blood. Referring to FIG. 1B, if the valve is incompetent, the cusps <b>14</b> do not seal properly and retrograde flow of blood occurs. Incompetence of a venous valve is thought to arise from at least the following two medical conditions: varicose veins and chronic venous insufficiency.
SUMMARY
[0003] This invention relates to medical devices for use with a body lumen. In one aspect, the invention features a medical device including a membrane implantable in a body lumen and invertably deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen. The membrane can be invertable relative to a radial direction of the body lumen. The membrane can be reversibly deformable between the first position and the second position.
[0004] Implementations can include one or more of the following. The membrane can define a portion of a cone, and can include an anchoring element adjacent a vertex of the cone. The membrane can include an anchoring element configured to embed within the body lumen, or alternatively configured to penetrate through the body lumen. The anchoring element may be, for example, a loop or a barb. The membrane can be formed of a polymer, for example, a polyurethane, polyethylene or fluoroplastic.
[0005] In another aspect, the invention features a medical system. The system includes multiple membranes, each membrane implantable in a body lumen and invertably deformable between a first position and a second position. Each membrane is invertible in response to the direction of fluid flow through the lumen.
[0006] Implementations of the system can include one or more of the following. The membranes can be symmetrically implantable in the body lumen. Each membrane can be invertable relative to a radial direction of the body lumen and can be deformable by fluid flow in the body lumen. At least one membrane can be reversibly deformable between the first position and the second position. At least one membrane can define a portion of a cone and can include an anchoring element adjacent a vertex of the cone. At least one membrane can include an anchoring element configured to embed within the body lumen or alternatively configured to penetrate through the body lumen. The anchoring element can be, for example, a loop or a barb. At least one membrane can be formed of a polymer, for example, a polyurethane, polyethylene or fluoroplastic.
[0007] In another aspect, the invention features a method. The method includes positioning at least one membrane in a body lumen, each membrane invertably deformable between a first position and a second position. Each membrane is invertible in response to the direction of fluid flow through the lumen.
[0008] Implementations of the method can include one or more of the following. The method can include positioning multiple membranes in the body lumen. The multiple membranes can be positioned symmetrically in the body lumen. The method can include penetrating an anchoring element of the at least one membrane through the body lumen or, alternatively, embedding an anchoring element of the at least one membrane into the body lumen.
[0009] In another aspect, the invention features a method of controlling flow in a body lumen. The method includes invertably deforming a membrane between a first position and a second position, the membrane being invertible in response to the direction of fluid flow through the lumen. Implementations can include one or more of the following. The membrane in the second position and a portion of the body lumen can define a cavity. Deformation of the membrane can be relative to a radial axis of the body lumen. The membrane can be deformable by fluid flow in the body lumen. The membrane in the first position and the membrane in the second position can be approximately mirror images of each other. The method can further include invertably deforming a plurality of membranes.
[0010] Embodiments may have one or more of the following advantages. One or more invertible membranes, which can function as artificial valve cusps, can be implanted at a treatment site using a catheter. As such, implantation is minimally invasive and avoids surgery and the possibility of the inherent complications. The membrane is fabricated from a polymer such as a polyurethane, polyethylene or fluoroplastic, which materials are more easily accessible than a natural tissue excised from an animal, and can be manufactured with consistency and efficiency that could be more difficult or more expensive using a natural tissue.
[0011] Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
[0012]FIGS. 1A and 1B are illustrations of a venous valve and an incompetent venous valve, respectively.
[0013]FIGS. 2A, 2B, and <b>2</b>C are partial perspective views of an embodiment of a valve cusp.
[0014]FIG. 3 is a cross-sectional view of the valve cusp of FIG. 2A, taken along line <b>3</b>-<b>3</b>.
[0015]FIG. 4 is a cross-sectional view of the valve cusp of FIG. 2C, taken along line <b>4</b>-<b>4</b>.
[0016]FIGS. 5A, 5B, <b>5</b>C, <b>5</b>D and <b>5</b>E are schematic views of an embodiment of a method for implanting a valve cusp.
[0017]FIGS. 6A and 6B are partial perspective views of an embodiment of a valve cusp.
[0018]FIGS. 7A and 7B are partial perspective views of an embodiment of a valve cusp.
[0019]FIG. 8 is a cross-sectional view of the valve cusp of FIG. 7A, taken along line <b>8</b>-<b>8</b>.
[0020]FIG. 9 is a cross-sectional view of the valve cusp of FIG. 7A, taken along line <b>9</b>-<b>9</b>.
[0021]FIG. 10 is a partial perspective view of an embodiment of an anchoring element.
[0022]FIG. 11 is a partial perspective view of an embodiment of an anchoring element.
DETAILED DESCRIPTION
[0023] Referring to FIGS. <b>2</b>A-<b>2</b>C through FIG. 4, a pair of artificial valve cusps <b>30</b> are illustrated positioned within a vessel <b>46</b>, e.g., a vein. Cusps <b>30</b> can be positioned upstream or downstream relative to an incompetent venous valve, such as the valve shown in FIG. 1B. Each artificial valve cusp <b>30</b> includes at least one anchoring element <b>38</b> attached to an invertable portion <b>42</b>, here, an approximately triangular, flexible membrane. Anchoring element <b>38</b> is generally configured to hold invertable portion <b>39</b> at a desired location in vessel <b>46</b>. For example, anchoring element <b>38</b> can embed itself within a wall <b>44</b> of vessel <b>46</b>, or penetrate through the wall to secure cusp <b>30</b> to the vessel. Invertable portion <b>42</b> is capable of deforming between a first position and a second position, e.g., between an opened condition and a closed position, in response to flow of body fluid in vessel <b>46</b> to allow or to reduce the flow in the vessel.
[0024] Referring particularly to FIG. 2A and FIG. 3, the cusps <b>30</b> are shown in a first position in which each cusp <b>30</b> forms an approximate semi-cone, such that an opening <b>50</b> is formed by the curved surfaces of the cusps <b>30</b>. The opening <b>50</b> allows antegrade flow of a fluid through the vessel in the direction indicated by arrow <b>48</b>. The membranes of invertable portions <b>42</b> are relatively thin and can conform closely to the vessel wall <b>44</b> to maximize the size of opening <b>50</b>. However, each cusp <b>30</b> is also held slightly away from the wall <b>44</b> of the vessel <b>46</b> by the anchoring element <b>38</b>, such that a gap <b>52</b> is formed between the invertable portion <b>42</b> and the wall <b>44</b>.
[0025] Referring particularly to FIG. 2B, retrograde flow of fluid (arrows <b>51</b>) in the vessel can accumulate in the gap <b>52</b> and exert pressure on the invertable portion <b>42</b> of the cusp <b>30</b>. Since invertable portion <b>42</b> is flexible, it can deform under the exerted pressure and invert to form another approximate semi-cone, as shown in FIG. 2C. That is, each cusp <b>30</b> forming a first semi-cone in the first position can invert or flip relative to a radial axis of vessel <b>46</b> to form a second semi-cone that is approximately the mirror image of the first semi-cone. As the interior <b>32</b> of the second semi-cone accumulates retrograde flowing fluid, pressure is exerted on the interior of cusp <b>30</b>, causing the cusp to move away from the wall <b>44</b> of the vessel. As a result, the space <b>53</b> between the two cusps <b>30</b> narrows, the size of opening <b>50</b> decreases, and fluid flow through the vessel and past the cusps is reduced (FIG. 4).
[0026] The cusps <b>30</b> can remain in the second position until antegrade fluid flow exerts sufficient pressure on the surface of cusps <b>30</b> opposite interior <b>32</b> and inverts the cusps to the first position. Thus, cusps <b>30</b> provide an artificial valve that automatically responds to the flow of fluid or pressure changes in vessel <b>46</b>.
[0027]FIGS. 5A to <b>5</b>E show one method of positioning cusps <b>30</b> at a treatment site in vessel <b>46</b> using a catheter <b>18</b> that may be delivered into the vessel <b>46</b> percutaneously. The catheter <b>18</b> is generally adapted for delivery through the vessel <b>46</b>, e.g., using a guidewire. Catheter <b>18</b> includes a long, flexible body having a central portion <b>21</b>, and a retractable sheath <b>22</b> over the central portion. Referring particularly to FIG. 5B, a cross-sectional view of FIG. 5A taken along line <b>5</b>-<b>5</b>, two grooves <b>25</b> are formed on either side of the central portion <b>21</b>, and a push rod <b>28</b> is positioned inside each of the grooves <b>25</b>. Each cusp <b>30</b> is positioned in a groove <b>25</b> in a compacted state and held in place by the retractable sheath <b>22</b> until delivery at the treatment site.
[0028] Catheter <b>18</b> can be delivered to the treatment site using endoprosthesis delivery techniques, e.g., by tracking an emplaced guidewire with central lumen <b>101</b>. At the treatment site, the retractable sheath <b>22</b> is retracted proximally to form an opening <b>26</b> at the end of each groove <b>25</b>. Referring particularly to FIG. 5C, push rods <b>28</b> are used to push each cusp <b>30</b> distally toward the opening <b>26</b> to push the anchoring element <b>38</b> out of the opening <b>26</b>. The cusps <b>30</b> are pushed out of the openings <b>26</b> until the anchoring elements <b>38</b> secure the cusps <b>30</b> to the wall <b>44</b> of the vessel <b>46</b>. For example, the anchoring elements <b>38</b> can embed within the wall <b>44</b> or penetrate the wall <b>44</b> and secure to the exterior of the vessel <b>46</b>.
[0029] After each cusp <b>30</b> is secured to the vessel <b>46</b>, the retractable sheath <b>22</b> is retracted to fully expose the cusps <b>30</b> (FIG. 5D). The central portion <b>21</b> is then pulled proximally past the flexible (and deflectable) cusps <b>30</b> and retracted from the vessel <b>46</b> (FIG. 5E). The cusps <b>30</b>, now secured to the wall <b>44</b>, can deform between the first and second positions, as described above.
[0030] Cusps <b>30</b> are preferably made of a biocompatible material capable of reversible deformation as described above. Each cusp <b>30</b> can be formed from a thin, flexible material, such as a polyurethane, polyethylene or fluoroplastic, for example, polytetrafluoroethylene (PTFE). Invertable portion <b>42</b> can be formed of one or more materials. For example, invertable portion <b>42</b> may include an edge portion that is relatively more flexible or more compliant than another portion of the invertable portion to help the edges meet and seal when the cusps <b>30</b> are in the second position. Cusps <b>30</b> can include a radiopaque material, such as a polymer including a radiopacifier, e.g., tantalum metal or bismuth oxychloride, for positioning and monitoring the cusps.
[0031] Similarly, anchoring element <b>38</b> is preferably biocompatible. The anchoring element <b>38</b> can be formed of a relatively rigid material, such as a polymer having suitable hardness, for example, acrylonitrile-butadiene-styrene (ABS). Other materials can be used, such as metals (e.g., tantalum, tungsten or gold), alloys (e.g., stainless steel or Nitinol), and ceramics. Anchoring elements <b>38</b> can include a radiopaque material for positioning and monitoring cusps <b>30</b>. The anchoring element can be embedded in the invertible portion or fixed to a surface of the invertible portion with, for example, adhesive.
[0032] Other Embodiments
[0033] In other embodiments, any number of cusps can be anchored to the wall <b>44</b> of the vessel <b>46</b> to function as a valve for preventing retrograde flow of blood through the blood vessel <b>46</b>.
[0034] Referring to FIGS. 6A and 6B, a single cusp <b>60</b> can be used. The cusp <b>60</b> can be transported to the treatment site and anchored to the wall <b>44</b> of a vessel <b>46</b> in the same manner as described above using a catheter. In a first position, the cusp <b>60</b> forms an approximate semi-cone, with the edges <b>63</b> of the semi-cone facing the wall <b>44</b> opposite from where the cusp <b>60</b> is anchored to the wall <b>44</b>. The interior of the cone forms a channel <b>64</b> allowing fluid flow past the cusp <b>60</b>. The anchoring element <b>65</b> holds the cusp <b>30</b> slightly away from the wall <b>44</b> such that a gap <b>66</b> is formed between the cusp <b>60</b> and the wall <b>44</b>. Retrograde flowing fluid can accumulate in the gap <b>66</b> and exert pressure on the cusp <b>60</b>, deforming the cusp <b>60</b> and widening the gap <b>66</b> until the pressure on the cusp <b>60</b> inverts the cusp. Referring particularly to FIG. 6B, in an inverted position the cusp <b>60</b> forms an approximate cone with the wall <b>44</b> and accumulates retrograde flowing fluid in a sack <b>68</b> formed by the interior of the cone. Accumulated fluid can exert pressure on the cusp <b>60</b>, causing the cusp <b>60</b> to move away from the wall <b>44</b>. As a result, the space <b>66</b> between the cusp <b>60</b> and the wall <b>44</b> opposite the anchoring element narrows, until the cusp <b>60</b> touches the wall <b>44</b>, in a second position as shown. In the second position, flow is reduced past the cusp <b>60</b> relative to the flow when the cusp <b>60</b> was in the first position. The cusp <b>60</b> remains in the second position until pressure exerted on the cusp <b>60</b> by the antegrade flow of fluid is sufficient to invert the cusp <b>60</b> to the first position.
[0035] Referring to FIGS. <b>7</b>A-<b>7</b>B, three cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>can be symmetrically secured to the wall <b>44</b> of a vessel <b>46</b> in a similar manner as described above. Referring particularly to FIG. 7A, the cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>are shown in first position that does not substantially impede flow of a fluid through the vessel <b>46</b>. As shown in FIG. 8, the surfaces of the cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>conform to the wall <b>44</b> of the vessel <b>46</b>, allowing a substantial opening <b>72</b> for flow past the cusps <b>70</b><i>a</i>-<b>70</b><i>c. </i>
[0036] Each cusp <b>70</b><i>a</i>-<b>70</b><i>c </i>is held away from the wall <b>44</b> by anchoring elements <b>71</b><i>a</i>-<b>71</b><i>c</i>, such that a gap <b>76</b> is formed between each cusp and the wall <b>44</b>. As described above, retrograde flowing fluid accumulates in the gap <b>76</b> and exerts pressure on the cusp <b>70</b>, causing the cusp to deform away from the wall <b>44</b>, until the cusps invert.
[0037] Referring particularly to FIG. 7B, in an inverted position the interior of each cusp <b>70</b><i>a</i>-<b>70</b><i>c </i>accumulates retrograde flowing fluid. Exerting pressure on the cusps causes them to move toward one another, until the cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>meet in a second position and reduce flow past the cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>relative to the when the cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>are in the first position. Referring to FIG. 9, the opening <b>72</b> is significantly reduced, thus restricting the fluid flow. The cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>remain in the second position until pressure exerted on the cusps <b>70</b><i>a</i>-<b>70</b><i>c </i>by antegrade flow of fluid inverts the cusps to the first position.
[0038] Although the embodiments above describe a device having one to three cusps, any number of cusps can be used to prevent retrograde flow through a vessel. The cusps can be arranged symmetrically as shown, or can be arranged in any other configuration. Although the embodiments described above included cusps of similar size and configuration, cusps of differing sizes and configurations can be used in conjunction with each other.
[0039] The anchoring element can take a number of different forms that permit the end of the cusp to penetrate the wall of a blood vessel and restrain the end of the cusp from re-entering the vessel. For example, the anchoring element can be a barb element, as shown in the embodiments described above. Alternatively, the anchoring element can be a T-hook device <b>80</b> as shown in FIG. 10, wherein T-hook <b>80</b> penetrates the wall of a vessel and hooks <b>82</b> prevent the anchor from re-entering the vessel. In another embodiment, the anchoring element can define a loop <b>84</b>, as shown in FIG. 11, wherein the looped end <b>86</b> prevents the anchor from re-entering the vessel.
[0040] In other embodiments, a cusp can include more than one anchoring element. A cusp can have other polygonal configurations. For example, a generally rectangular cusp can be secured to a vessel using two anchoring elements adjacent to two corners of the cusp. The cusp can form a semi-cylinder.
[0041] Other embodiments are within the scope of the following claims.
Contents5
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14 members in 7 offices
Priority claims2
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| ES2297147T3 | Spain | T3 | |
| DE60317886T2 | Germany | T2 | |
| US7682385B2 | United States of America | B2 |
46 transactions on the USPTO file
Allowed after 1 non-final rejection and 1 final rejection.
- Non-final rejections
- 1
- Final rejections
- 1
- RCEs
- 0
- Appeals
- 0
Over time
Point at a mark for the transactionTransactions
| Event | |
|---|---|
| Expire Patent | |
| Post Issue Communication - Certificate of Correction | |
| Recordation of Patent Grant Mailed | |
| Patent Issue Date Used in PTA CalculationAllowed | |
| Issue Notification MailedAllowed | |
| Receipt into Pubs | |
| Application Is Considered Ready for Issue | |
| Issue Fee Payment Verified | |
| Issue Fee Payment Received | |
| Receipt into Pubs | |
| Receipt into Pubs | |
| Workflow - File Sent to Contractor | |
| Receipt into Pubs | |
| Dispatch to Publications | |
| Mail Notice of AllowanceAllowed | |
| Notice of Allowance Data Verification CompletedAllowed | |
| Date Forwarded to Examiner | |
| Response after Final Action | |
| Correspondence Address Change | |
| Change in Power of Attorney (May Include Associate POA) | |
| Mail Final Rejection (PTOL - 326)Final rejection | |
| Final RejectionFinal rejection | |
| Date Forwarded to Examiner | |
| Workflow - Drawings Finished | |
| Workflow - Drawings Matched with File at Contractor | |
| Information Disclosure Statement (IDS) Filed | |
| Information Disclosure Statement (IDS) Filed | |
| Response after Non-Final Action | |
| Change in Power of Attorney (May Include Associate POA) | |
| Mail-Record Petition Decision of Granted Related to Attorney | |
| Correspondence Address Change | |
| Petition Entered | |
| Mail Non-Final RejectionNon-final rejection | |
| Non-Final RejectionNon-final rejection | |
| Case Docketed to Examiner in GAU | |
| Incoming Letter Pertaining to the Drawings | |
| Information Disclosure Statement (IDS) Filed | |
| Information Disclosure Statement (IDS) Filed | |
| Case Docketed to Examiner in GAU | |
| Transfer Inquiry to GAU | |
| Application Dispatched from OIPE | |
| Application Is Now Complete | |
| Additional Application Filing Fees | |
| Applicant has submitted new drawings to correct Corrected Papers problems | |
| IFW Scan & PACR Auto Security Review | |
| Initial Exam Team nn |
8 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Lapsed due to failure to pay maintenance feeLapsedFP | FP | |
| Information on status: patent discontinuationPATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362STCH | STCH | |
| Lapse for failure to pay maintenance feesLapsedLAPS | LAPS | |
| Maintenance fee reminder mailedREMI | REMI | |
| Fee paymentFPAY | FPAY | |
| Fee payment procedurePAYOR NUMBER ASSIGNED (ORIGINAL EVENT CODE: ASPN); ENTITY STATUS OF PATENT OWNER: LARGE ENTITYFEPP | FEPP | |
| Certificate of correctionCC | CC | |
| AssignmentAS | AS |
Numbers
- Publication, DOCDB
- 2003191525
- Publication, EPODOC
- US2003191525
- Application
- 10115557
- Application, DOCDB
- 11555702
- Application, EPODOC
- US20020115557
Titles
- English
- Artifical valve
Patent term adjustment
- A delay
- +29 daysthe office missed an examination deadline
- Applicant delay
- −4 days
- Net adjustment
- 25 days
Classification
- CPC, 2
- A61F2/2475
- A61F2/2412
- IPC, 2
- A61F2 06
- A61F2 24
- USPC, 3
- 623001240
- 623002170
- 623023680