Vacuum pump and shock absorber for artificial limb

[0001] This is a continuation-in-part for previously filed and co-pending application Ser. No. 09/534,274 filed Mar. 23, 2000, which is a continuation of application Ser. No. 09/325,297, filed Jun. 3, 1999 and titled “Hypobarically-Controlled Socket for Artificial Limb.”

BACKGROUND OF THE INVENTION

[0002] The present invention relates to prosthetic devices and more particularly to various embodiments of a vacuum pump and shock absorber for an artificial limb.

[0003] An amputee is a person who has lost part of an extremity or limb such as a leg or arm which commonly may be termed as a residual limb. Residual limbs come in various sizes and shapes with respect to the stump. That is, most new amputations are either slightly bulbous or cylindrical in shape while older amputations that may have had a lot of atrophy are generally more conical in shape. Residual limbs may further be characterized by their various individual problems or configurations including the volume and shape of a stump and possible scar, skin graft, bony prominence, uneven limb volume, neuroma, pain, edema or soft tissue configurations.

[0004] Referring to FIGS. 1 and 2, a below the knee residual limb <b>10</b> is shown and described as a leg <b>12</b> having been severed below the knee terminating in a stump <b>14</b>. In this case, the residual limb <b>10</b> includes soft tissue as well as the femur <b>16</b>, knee joint <b>18</b>, and severed tibia <b>20</b> and fibula <b>22</b>. Along these bone structures surrounded by soft tissue are nerve bundles and vascular routes which must be protected against external pressure to avoid neuromas, numbness and discomfort as well as other kinds of problems. A below the knee residual limb <b>10</b> has its stump <b>14</b> generally characterized as being a more bony structure while an above the knee residual limb may be characterized as including more soft tissue as well as the vascular routes and nerve bundles.

[0005] Referring to FIG. 2, amputees who have lost a part of their arm <b>26</b>, which terminates in a stump <b>28</b> also may be characterized as having vascular routes, nerve bundles as well as soft and bony tissues. The residual limb <b>10</b> includes the humerus bone <b>30</b> which extends from below the shoulder to the elbow from which the radius <b>34</b> and ulna <b>36</b> bones may pivotally extend to the point of severance. Along the humerus bone <b>30</b> are the biceps muscle <b>38</b> and the triceps muscle <b>40</b> which still yet may be connected to the radius <b>34</b> and the ulna, <b>36</b>, respectively.

[0006] In some respects, the residual limb amputee that has a severed arm <b>26</b> does not have the pressure bearing considerations for an artificial limb but rather is concerned with having an artificial limb that is articulable to offer functions typical of a full arm, such as bending at the elbow and grasping capabilities. An individual who has a paralyzed limb would also have similar considerations wherein he or she would desire the paralyzed limb to having some degree of mobility and thus functionality.

[0007] Historically, artificial limbs typically used by a leg amputee were for the most part all made out of wood such as an Upland Willow. The limbs were hand carved with sockets for receiving the stump <b>14</b> of the residual limb <b>10</b>. Below the socket would be the shin portion with the foot below the shin. These wooden artificial limbs were covered with rawhide which often were painted. The sockets of most wood limbs were hollow as the limbs were typically supported in the artificial limb by the circumferential tissue adjacent the stump <b>14</b> rather than at the distal end of the stump <b>14</b>.

[0008] Some artificial limbs in Europe were also made from forged pieces of metal that were hollow. Fiber artificial limbs were also used which were stretched around a mold after which they were permitted to dry and cure. Again, these artificial limbs were hollow and pretty much supported the residual limb about the circumferential tissue adjacent the stump <b>14</b>.

[0009] All of these various artificial limbs have sockets to put the amputee's stump <b>14</b> thereinto. There are generally two categories of sockets. There are hard sockets wherein the stump goes right into the socket actually touching the socket wall without any type of liner or stump sock. Another category of sockets is a socket that utilizes a liner or insert. Both categories of sockets typically were opened ended sockets where they had a hollow chamber in the bottom and no portion of the socket touched the distal end of the stump <b>14</b>. So, the stump was supported about its circumferential sides as it fits against the inside wall of the sockets.

[0010] These types of sockets caused a lot of shear force on the stump <b>14</b> as well as had pressure or restriction problems on the nerve bundles and vascular flow of fluid by way of the circumferential pressure effect of the socket on the limb. This pressure effect could cause a swelling into the ends of the socket where an amputee may develop severe edema and draining nodules at the end of their stump <b>14</b>.

[0011] With time, prosthetists learned that by filling in the socket's hollow chamber and encouraging a more total contact with the stump and the socket, the swelling and edema problems could be eliminated. However, the problematic tissue configurations, such as bony prominences, required special consideration such as the addition of soft or pliable materials to be put into the socket.

[0012] Today, most artificial limbs are constructed from thermoset plastics such as polyester resins, acrylic resins, polypropylenes and polyethylenes, which are perhaps laminated over a nylon stockinette which also may be impregnated by the various resins.

[0013] In the past, most artificial limbs were suspended from the amputee's body by some form of pulley, belt or strap suspension often used with various harnesses and perhaps leather lacers or lacings. Another method of suspending artificial limbs is known as the wedge suspension wherein an actual wedge is built into the socket which is more closed at its top opening. The wedge in the socket cups the medial femoral condyle or knuckle at the abductor tubical. Yet another form of suspension is referred to as the shuttle system or a mechanical hookup or linkup wherein a thin suction liner is donned over the stump that has a docking device on the distal end which mechanically links up with its cooperative part in the bottom of the socket chamber. Sleeve suspensions were also used wherein the amputee may use a latex rubber tube which forms into a rubber-like sleeve which would be rolled on over both the top of the artificial limb and onto the amputee's thigh. The sleeve suspensions have been used in combination with other forms of suspensions techniques.

[0014] Both the use of a positive pressure system and the use of a negative pressure system (or hypobaric closed chamber) have been utilized in the field of prosthetics. At one time, for pressure systems “inflatable inner tubes” were used to fit into sockets. Presently, there are pneumatic “bags” which are strategically placed over what people consider to be good weight-bearing areas to increase pressure to help accommodate for volume changes within the socket.

[0015] The problem with this is that it is a very specific pressure and creates atrophy and loss of tissue dramatically over these high pressure areas. None of these systems employs positive pressure distributed over the total contact area between the residual limb and the artificial limb socket to accommodate volume changes within the socket.

[0016] The negative pressure aspects have been utilized for a closed chamber in that a socket is donned by pulling in with a sock, pulling the sock out of the socket and then closing the opening with a valve. This creates a seal at the bottom and the stump is held into the socket by the hypobaric seal. However, there are no systems that employ a negative pressure produced by a vacuum pump to lock the residual limb to the artificial limb.

[0017] The older systems were initially started in Germany. They were an open-ended socket, meaning there was an air chamber in the bottom of the socket. This did not work particularly well because it would cause swelling of the residual limb into the chamber created by the negative draw of suspending the weight of the leg and being under a confined area. This would lead to significance edema which would be severe enough to cause stump breakdown and drainage.

[0018] It was later discovered in America that total contact was essential between the residual limb and the socket and once you had total contact the weight was distributed evenly or the suspension was distributed over the whole surface of the limb rather than just over the open chamber portion of the socket.

[0019] The human body as a whole is under approximately one atmosphere of pressure at sea level. It keeps and maintains a normal fluid system throughout the body. When an amputee dons a prosthesis and begins taking the pressures of transmitting the weight of the body through the surface area of the residual limb to the bone, there is increased pressure on the residual limb equal to one atmosphere plus whatever additional pressures are created by weight bearing. This increased pressure causes the eventual loss of fluids within the residual limb to the larger portion of the body which is under less pressure. This loss of fluids causes the volume of the residual limb to decrease during the day. It varies from amputee to amputee, but it is a constant among all amputees and the more “fleshy” and the softer the residual limb, the more volume fluctuation there will be. The greater the weight and the smaller the surface area, the greater the pressures will be and the more “swings” there will be in fluids. In the past, the amputee had to compensate for this volume decrease by removing the artificial limb and donning additional stump socks to make up for the decreased residual limb volume.

[0020] Japanese patent JP 7-155343 A discloses a pump to apply pressure or suction to an artificial limb socket, in order to attach the artificial limb to the limb stump. However, this patent does not disclose the use of vacuum to draw the residual limb into firm and total contact with the socket, nor does it disclose the use of vacuum to prevent loss of residual limb fluids due to weight-bearing pressures.

[0021] U.S. Pat. No. 5,888,230 discloses the use of a vacuum pump connected between the limb and a liner. However, this invention is essentially inoperable because the liner will conform to the stump at all times, by an interference fit, so that there is no space between the residual limb and the liner against which to draw a vacuum. In any case, the patent does not disclose application of vacuum to the socket cavity in such a manner as to draw the residual limb firmly and totally against the interior of the socket. Instead, the patent discloses the use of shims between the liner and the socket. Without total contact between the residual limb and the socket, the limb may swell into the space between the limb and the socket. Also, the patent does not disclose the use of vacuum to prevent reduction in volume of the artificial limb due to weight-bearing pressures.

[0022] U.S. Pat. No. 5,549,709 discloses several embodiments of a hypobarically-controlled artificial limb. However, all of these embodiments required two sockets: an outer socket and an inner socket. Applicant has found that the present invention offers improved performance without the requirement for two sockets. A single socket works equally well or better than two sockets.

[0023] Also, it has been found that it is essentially impossible to maintain a perfect, airtight seal between the residual limb and the sockets disclosed in U.S. Pat. No. 5,549,709, with the result that slow air leakage into the sockets diminishes the vacuum in the sockets. With the reduction in vacuum, the beneficial effects of the vacuum also slowly diminish. Consequently, there is a need for a means for maintaining the vacuum in the socket cavity in the presence of some air leakage past the seal.

[0024] While some of these devices addressed some of the problems associated with prosthetics, none of the artificial limbs, liners and socket, individually or in combination, offered a prosthesis that presented a total contact relationship with the residual limb; absorbed and dissipated shear, shock and mechanical forces transmitted to the limb tissues by the artificial limb; controlled residual limb volume; and used negative pressure as a locking device to hold the residual limb into the socket.

[0025] There is a need for a vacuum pump and shock absorber for an artificial limb to maintain the vacuum in the cavity in the presence of some air leakage past the seal.

SUMMARY OF THE INVENTION

[0026] A principal object and advantage of the present invention is that it includes a weight-activated vacuum pump that automatically maintains vacuum in the cavity of the artificial limb socket as the wearer walks on the artificial limb.

[0027] Another principle object and advantage of the present invention is that it provides a shock absorbing function.

[0028] Another principle object and advantage of the present invention is that the amount of shock absorption is adjustable by the wearer.

[0029] Another principle object and advantage of the present invention is that it provides an anti-rotation function.

[0030] Another principle object and advantage of the present invention is that the degree of anti-rotation is adjustable by the wearer.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031]FIG. 1 is a side elevational view of the tissue and skeletal structure of an amputee's residual limb;

[0032]FIG. 2 is a side elevational view of a residual limb in the form of an amputated arm showing the skeletal and muscular structure of the residual limb;

[0033]FIG. 3 is an exploded elevational view of the residual limb donning the polyurethane sleeve, stretchable nylon sleeve, liner, nylon sheath and socket of an artificial limb;

[0034]FIG. 4 is a cross-section of the artificial limb in FIG. 3, which is a first embodiment of the artificial limb;

[0035]FIG. 5 is a cross-section of the artificial limb similar to FIG. 4, showing a second embodiment of the artificial limb;

[0036]FIG. 6 is the same as FIG. 5, but showing compression of the inner socket under the influence of positive air pressure;

[0037]FIG. 7 is a cross-section of the artificial limb showing a third embodiment of the artificial limb;

[0038]FIG. 8 is a cross-section of the artificial limb showing a fourth embodiment of the artificial limb;

[0039]FIG. 9 is an elevational view of the polyurethane sleeve and second stretchable nylon sleeve rolled over the socket and residual limb with clothing shown in broken outline;

[0040]FIG. 10 is a cross-section of the artificial limb showing a fifth embodiment of the artificial limb;

[0041]FIG. 11 is a cross-section of the artificial limb showing a sixth embodiment of the artificial limb;

[0042]FIG. 12 is a detailed view of the vacuum mechanism in FIG. 1 <b>1</b>;

[0043]FIG. 13 is a cross-section of the artificial limb showing a seventh embodiment of the artificial limb;

[0044]FIG. 14 is a detailed view of the vacuum mechanism and suspension sleeve of FIG. 13;

[0045]FIG. 15 is a cross-section of the artificial limb showing an eighth embodiment of the artificial limb;

[0046]FIG. 16 is a cross-section of the artificial limb showing a ninth embodiment of the artificial limb;

[0047]FIG. 17 is an exploded perspective view of a first embodiment of a weight-activated vacuum pump and shock absorber;

[0048]FIG. 18 is a diagrammatic exploded view of a first embodiment of a weight-activated vacuum pump and shock absorber;

[0049]FIG. 19A is a side elevational view of a first embodiment of a weight-activated vacuum pump and shock absorber;

[0050]FIG. 19B is a cross-section along the lines <b>19</b>B of FIG. 19A;

[0051]FIG. 20 is a cross-section along the lines <b>20</b> of FIG. 19B;

[0052]FIG. 21 is a cross-section along the lines <b>21</b> of FIG. 19B;

[0053]FIG. 22 is a detailed cross-section of a first embodiment of a weight-activated vacuum pump and shock absorber in the unweighted state;

[0054]FIG. 23 is the same as FIG. 22, except that the wearer's weight is being applied to the pylon of the artificial limb;

[0055]FIG. 24 is the same as FIG. 23, with the wearer's weight fully applied to the pylon of the artificial limb;

[0056]FIG. 25 is the same as FIG. 23, with the wearer's weight being removed from the pylon of the artificial limb;

[0057]FIG. 26 is a top perspective view of a second embodiment of a weight-actuated vacuum pump and shock absorber, with some structure removed;

[0058]FIG. 27A is a side perspective view of a second embodiment of a weight-actuated vacuum pump and shock absorber. FIG. 27B is a schematic of the intake/exhaust port and one-way valves of this embodiment;

[0059]FIG. 28 is a perspective view of some internal structure of a second embodiment of a weight-actuated vacuum pump and shock absorber; and

[0060]FIG. 29A is a top plan view of a second embodiment of a weight-actuated vacuum pump and shock absorber. FIG. 29B is a cross-section along the lines <b>29</b>B of FIG. 29A.

[0061]FIG. 30 is a perspective view of a third embodiment of a weight-actuated vacuum pump and shock absorber.

[0062]FIG. 31 is a cross-section showing the internal structure of the third embodiment of FIG. 30, showing the pump without any of the wearer's weight applied to it.

[0063]FIG. 32 is the same as FIG. 31, but with the wearer's weight applied.

[0064]FIG. 33 is the same as FIG. 32, but with the wearer's weight being removed.

[0065]FIG. 34 is a side elevational view of the pump of the third embodiment in place on an artificial limb.

[0066]FIG. 35 is a cross-section showing the internal structure of a fourth embodiment of a weight-actuated vacuum pump and shock absorber without any of the wearer's weight applied to it.

[0067]FIG. 36 is the same as FIG. 35, but with the wearer's weight beginning to be applied.

[0068]FIG. 37 is the same as FIG. 36, but with all of the wearer's weight applied.

[0069]FIG. 38 is the same as FIG. 37, but with the wearer's weight being removed.

[0070]FIG. 39A is a side elevational view of an artificial foot, employing the fourth embodiment of a weight-actuated vacuum pump and shock absorber

[0071]FIG. 39B is the same as FIG. 39A, rotated 90 degrees.

[0072]FIG. 40 is a side elevational view of an artificial limb for an above-the-knee amputee, with the fourth embodiment of the weight-actuated vacuum pump and shock absorber.

[0073]FIG. 41 is a front elevational view, similar to FIG. 40.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0074]FIG. 3 shows a hypobarically-controlled artificial limb <b>50</b>. The hypobarically-controlled artificial limb <b>50</b> includes an outer socket <b>52</b>, shin <b>54</b>, and foot <b>56</b>. The outer socket <b>52</b> has a volume and shape to receive a substantial portion of the residual limb <b>14</b> with a space <b>58</b> therebetween.

[0075] A first embodiment of the hypobarically-controlled artificial limb <b>50</b> is shown in FIG. 4. The hypobarically-controlled artificial limb <b>50</b> further includes a flexible inner socket <b>60</b> with a cavity <b>62</b> with a volume and shape for receiving a substantial portion of the residual limb <b>14</b> and fitting in the space <b>58</b> between the outer socket <b>52</b> and the residual limb <b>14</b>. The inner socket <b>60</b> has an inner surface <b>64</b> opposing the residual limb <b>14</b> and an outer surface <b>66</b> opposing the outer socket <b>52</b>.

[0076] A vacuum source <b>70</b> may conveniently be attached to the shin or pylon <b>54</b>. The vacuum source <b>70</b> may preferably be a mechanical or motor-driven pump <b>72</b>. The vacuum source <b>70</b> is connected to a power source <b>83</b>, which may be a battery.

[0077] A vacuum valve <b>74</b> is suitably connected to the vacuum source <b>70</b>. The vacuum valve <b>74</b> may preferably be disposed on the outer socket <b>52</b>. A vacuum tube <b>76</b> connects the vacuum valve <b>74</b> to the cavity <b>62</b>. It will be seen that the vacuum source will cause the residual limb <b>14</b> to be drawn into firm contact with the inner surface <b>64</b> of the inner socket <b>60</b>.

[0078] The hypobarically-controlled artificial limb <b>50</b> also includes a regulator means <b>80</b> for controlling the vacuum source <b>70</b>. Preferably, the regulator means <b>80</b> may be a digital computer <b>82</b>. Alternately, the regulator means may be a vacuum regulator. The regulator means <b>80</b> is connected to a power source <b>83</b>, which may be a battery.

[0079] A seal means <b>84</b> makes an airtight seal between the residual limb <b>14</b> and the outer socket <b>52</b>. Preferably, the seal means <b>84</b> is a nonfoamed, nonporous polyurethane suspension sleeve <b>86</b> which rolls over and covers the outer socket <b>52</b> and a portion of the residual limb <b>14</b>. Alternatively, the seal means <b>84</b> may be any type of seal which is airtight.

[0080] The hypobarically-controlled artificial limb <b>50</b> may also include a thin sheath <b>90</b> between the residual limb <b>14</b> and the inner surface <b>64</b> of the inner socket <b>60</b>. As vacuum is applied to the cavity <b>62</b>, the sheath <b>90</b> will allow the vacuum to be evenly applied throughout the cavity <b>62</b>. Without the sheath <b>90</b>, the residual limb <b>14</b> might “tack up” against the inner surface <b>64</b> and form a seal which might prevent even application of the vacuum to the cavity <b>62</b>. The sheath <b>90</b> may also be used to assist the amputee into a smooth and easy fitting into the inner socket <b>60</b>. The sheath <b>90</b> is preferably made of thin knitted nylon.

[0081] The hypobarically-controlled artificial limb <b>50</b> may also include a nonfoamed, nonporous polyurethane liner <b>92</b> receiving the residual limb <b>14</b> and disposed between the sheath <b>90</b> and the residual limb <b>14</b>. The liner <b>92</b> provides a total-contact hypobaric suction, equal weight distribution socket liner. The liner <b>92</b> readily tacks up to the skin of the residual limb <b>14</b> and provides total contact with the limb <b>14</b>. The liner <b>92</b> absorbs and dissipates shock, mechanical and shear forces typically associated with ambulation.

[0082] The hypobarically-controlled artificial limb <b>50</b> may also include a stretchable nylon second sleeve <b>94</b> for rolling over and covering the suspension sleeve <b>86</b> to prevent clothing from sticking to and catching the suspension sleeve <b>86</b>.

[0083] Referring to FIG. 3, the polyurethane tubular sleeve <b>86</b> may be appreciated alone and in combination with the urethane liner <b>92</b> together with the optional nylon sheath <b>90</b> and second stretchable nylon sleeve <b>94</b>.

[0084] More specifically, the amputee takes the stretchable nylon second sleeve <b>94</b>, suitably made of a spandex-like material and rolls it up over the stump <b>14</b> to the upper portions of the residual limb suitably as the thigh of a leg <b>12</b>. Next, the polyurethane sleeve <b>86</b> is also rolled upwardly over the residual limb <b>10</b>. Thereafter, the liner <b>92</b> is optionally donned.

[0085] Next, the amputee may optionally utilize the nylon sheath <b>90</b> which is suitably of a non-stretching, thin, friction reducing nylon. As stated, this sheath <b>90</b> optionally may be used to assist the amputee into a smooth and easy fitting into the inner socket <b>60</b>. Alternatively, the sheath <b>90</b> may be avoided and the liner <b>92</b> simply inserted into the inner socket <b>60</b> of the artificial limb <b>50</b>.

[0086] Next, the amputee simply grasps the rolled over portion of the polyurethane sleeve <b>86</b> and rolls it over a substantial portion of the outer socket <b>52</b>. The sleeve <b>86</b> makes an airtight seal between the residual limb <b>14</b> and the outer socket <b>52</b>.

[0087] As can be appreciated, the polyurethane sleeve <b>86</b> is tacky. Consequently, the stretchable nylon second sleeve <b>94</b> may be utilized and rolled over the polyurethane sleeve <b>86</b>.

[0088] The amputee then sets the regulator means <b>80</b> to cause the vacuum source <b>70</b> to apply vacuum through the vacuum valve <b>74</b> and vacuum tube <b>76</b> to the cavity <b>62</b>. Enough vacuum is applied to cause the residual limb (with optional coverings) to be drawn firmly against the inner surface <b>64</b> of the inner socket <b>60</b>, which is flexible. The vacuum source <b>70</b> may preferably maintain a vacuum in the range of 0 to 25 inches of mercury (ideally fifteen to twenty inches).

[0089] It will be seen that the vacuum within the inner socket <b>60</b> will cause the hypobarically-controlled artificial limb <b>50</b> to be suspended from the residual limb <b>14</b>. The vacuum will lock the residual limb <b>14</b> into the inner socket <b>60</b> without causing swelling of the residual limb into the socket, because of the total contact of the residual limb <b>14</b> with the inner socket <b>60</b>. That is, there is no open chamber between the residual limb <b>14</b> and the inner socket <b>60</b> which would draw on the residual limb.

[0090] As the volume of the residual limb <b>14</b> decreases during the day due to weight-bearing pressures, the regulator means <b>70</b> may appropriately adjust the vacuum source <b>70</b> to draw the residual limb <b>14</b> more firmly against the inner socket <b>60</b> and thus compensate for the loss of residual limb volume. The vacuum may also partially oppose the loss of fluids from the residual limb caused by weight-bearing pressures.

[0091] A second embodiment of the hypobarically-controlled artificial limb <b>50</b> is shown in FIGS. 5 and 6. The second embodiment of the hypobarically-controlled artificial limb <b>50</b> is as described above, with the exception that the inner socket <b>60</b>A is compressible as well as being flexible. Instead of a vacuum source, the second embodiment has a positive air pressure source <b>100</b>, which may preferably be a motor-driven pump <b>102</b>. The regulator means <b>80</b>, which may be a digital computer <b>82</b>, controls the positive air pressure source <b>100</b>. The regulator means and positive air pressure source <b>100</b> are connected to a power source <b>83</b>, which may be a battery. A positive pressure valve <b>104</b> connects the space <b>58</b> to the positive air pressure source <b>100</b>, for compressing the inner socket <b>60</b>A as the volume of the residual limb decreases.

[0092] It will be seen that as the volume of the residual limb <b>14</b> decreases during the day due to weight-bearing pressures, the regulator means <b>80</b> may control the positive air pressure source <b>100</b> to cause air pressure to compress the inner socket <b>60</b>A to compensate for the decreased volume of the residual limb, as shown in FIG. 6.

[0093] A third embodiment of the hypobarically-controlled artificial limb <b>50</b> is shown in FIG. 7. The third embodiment is a combination of the first and second embodiments described above.

[0094] The mechanical motor-driven pump <b>72</b> may act as both the vacuum source <b>70</b> and the positive air pressure source <b>100</b>. The regulator means <b>80</b>, vacuum source <b>70</b> and positive air pressure source <b>100</b> are connected to a power source <b>83</b>, which may be a battery.

[0095] The vacuum source <b>70</b>, under control of the regulator means <b>80</b>, will compensate for reduced residual limb volume up to a certain point. From that point on, the regulator means <b>80</b> will cause the positive air pressure source <b>100</b> to further compensate for reduced residual limb volume as described above. The third embodiment thus uses both vacuum and positive air pressure working together to lock the residual limb <b>14</b> into the inner socket <b>60</b> and reduce socket volume to compensate for fluid loss in the residual limb <b>14</b>. The exact point at which the changeover is made between vacuum compensation and positive air pressure compensation is controlled by the regulator means <b>80</b>, which as described may be a digital computer appropriately programmed for the socket environment.

[0096] A fourth embodiment of the hypobarically-controlled artificial limb <b>50</b> is shown in FIG. 8. The fourth embodiment is like the first embodiment, but includes two vacuum valves: a first vacuum valve <b>106</b> and a second vacuum valve <b>110</b>, both connected to the vacuum source <b>70</b>. The first vacuum valve <b>106</b> connects the vacuum source <b>70</b> to the space <b>58</b>. The space <b>58</b> contains a semi-compressible material <b>108</b>, such as polystyrene beads, as disclosed in U.S. Pat. No. 4,828,325, herein incorporated by reference.

[0097] To don the artificial limb <b>50</b>, the amputee proceeds as described above. After inserting the residual limb <b>14</b> (with optional coverings) into the inner socket <b>60</b>B, which is both compressible and expandable, and rolling the suspension sleeve <b>86</b> over the outer socket <b>52</b>, the amputee activates the regulator means <b>80</b>, causing the vacuum source <b>70</b> to apply a vacuum to the space <b>58</b>. This causes the material <b>108</b> to lock mechanically together into a rigid mass, conforming to the shape of the residual limb <b>14</b>. The inner socket <b>60</b>B may expand slightly under the weight of the residual limb <b>14</b> and under the influence of vacuum.

[0098] It will be seen that the semi-compressible molding material <b>108</b> can be molded to the contours of the residual limb <b>14</b> without using a custom-building process to produce a custom socket. The outer socket <b>52</b> may appropriately occur in standard sizes, such as small, medium, and large. The inner socket <b>60</b>B may also occur in standard sizes such as small, medium, and large. Adaptation of the inner socket <b>60</b>B to the contours of the residual limb <b>14</b> occurs through solidifying the material <b>108</b> under the influence of vacuum.

[0099] The second vacuum valve <b>110</b> connects the vacuum source <b>70</b> to the cavity <b>62</b> as previously described, for locking the residual limb <b>14</b> into the inner socket <b>60</b>B.

[0100] The fourth embodiment may also include a positive air pressure source <b>100</b> as previously described, to adjust the size of the inner socket <b>60</b>B to compensate for decreased residual limb volume.

[0101] The fourth embodiment may also include a thin sheath <b>90</b>, liner <b>92</b>, and second sleeve <b>94</b>, as previously described.

[0102] The positive air pressure source <b>100</b> may also be used for shock absorption and a dynamic response in the ankle and foot sections of the artificial limb <b>50</b>, by means of a connection <b>120</b>.

[0103] A fifth embodiment of the hypobarically-controlled artificial limb <b>50</b> is shown in FIG. 10. This embodiment is the same as the first embodiment shown in FIG. 4, with some changes. First, vacuum source <b>71</b> may be a hand-operated vacuum pump <b>71</b> which may remove air from the cavity <b>62</b> down to approximately 15-25 inches of mercury. A suitable hand-operated vacuum pump is marketed under the trademark MITY VAC II® by Neward Enterprises, Inc. of Cucamonga, Calif.

[0104] The fifth embodiment also includes the seal means <b>84</b> which preferably consists of a non-foamed, nonporous polyurethane suspension sleeve <b>86</b> for rolling over and covering a portion of the residual limb <b>14</b>. A portion of the seal means <b>86</b> is adapted to be disposed between the outer socket <b>52</b> and the inner socket <b>60</b>. The sleeve may be made of any of a variety of air-impervious elastomers.

[0105] The fifth embodiment, shown in FIG. 10 also includes a mechanical interlock <b>67</b>, <b>59</b> for interlocking the inner socket <b>62</b> with the outer socket <b>52</b>. Preferably, the mechanical interlock consists of a first detent <b>67</b> in the inner socket <b>62</b> and a second detent <b>59</b> in the outer socket <b>52</b>. The first detent <b>67</b> engages the second detent <b>59</b> to lock the inner socket <b>60</b> into the outer socket <b>52</b>.

[0106] A sixth embodiment of the hypobarically-controlled artificial limb of the present invention is shown in FIGS. 11 and 12. The sixth embodiment is like the first embodiment shown in FIG. 4, with some changes.

[0107] First, the inner socket is specifically intended to be removably from the outer socket. To provide a positive mechanical connection between the inner socket and outer socket and yet allow the inner socket to be easily removed, the sixth embodiment includes a mechanical interlock <b>103</b> engaging the inner socket <b>60</b> and the outer socket <b>52</b>. Preferably, the mechanical interlock may be an extension <b>104</b> which is attached to the inner socket <b>60</b> and a docking device <b>106</b> attached to the outer socket <b>52</b> and receiving the extension <b>104</b>, and a locking mechanism <b>105</b> engaging the extension <b>104</b> and the docking device <b>106</b>.

[0108] The extension may be any sort of protrusion from the inner socket, such as a bulge or tab. Preferably, the extension <b>104</b> comprises a shuttle pin <b>108</b>.

[0109] The locking mechanism may be any sort of member which engages both the extension <b>104</b> and the docking device <b>106</b>, such as a screw, wire, or pin. Preferably, the locking mechanism <b>105</b> comprises a second pin <b>110</b> which extends outside the outer socket <b>52</b> as to be accessible.

[0110] Second, the sixth embodiment includes two thin sheaths, rather than one. A first inner sheath <b>90</b> may preferably be disposed between the residual limb <b>14</b> and the inner surface <b>64</b> of the inner socket <b>60</b>. As vacuum is applied to the cavity <b>62</b>, the inner sheath <b>90</b> will allow the vacuum to be evenly applied throughout the cavity <b>62</b>. Without the inner sheath <b>90</b>, the residual limb <b>14</b> might “tack up” against the inner surface <b>64</b> and form a seal which might prevent even application of the vacuum to the cavity <b>62</b>. The inner sheath <b>90</b> may also be used to assist the amputee into a smooth and easy fitting into the inner socket <b>60</b>.

[0111] An outer sheath <b>93</b> is preferably disposed between the suspension sleeve <b>86</b> and the inner socket <b>60</b>, thereby preventing the suspension sleeve from tacking to the inner socket <b>60</b>. Such tacking would cause friction between the inner socket <b>60</b> and the sleeve <b>86</b> which would cause the sleeve to wear out. Such tacking might also cause restrictions in the movement of the residual limb. The outer sheath <b>93</b> also protects the suspension sleeve <b>86</b> from being damaged by friction with the inner socket <b>60</b>.

[0112] The sixth embodiment also preferably includes an adhesive pressure tape <b>95</b> adapted to cover the outer sheath <b>93</b>, suspension sleeve <b>86</b>, and the second sleeve <b>94</b> and sealing the outer sheath <b>93</b>, suspension sleeve <b>86</b>, and the second sleeve <b>94</b> to the inner socket <b>60</b>. The tape <b>95</b> locks all of these layers to the inner socket so that they do not come loose during movement.

[0113] In the sixth embodiment, the suspension sleeve <b>86</b> goes between the inner socket <b>60</b> and the outer socket <b>52</b>, so that the sleeve <b>86</b> is protected from damage.

[0114] In the sixth embodiment, the inner socket <b>60</b> has a rigid lower portion <b>98</b> and a substantially flexible upper portion <b>96</b>. The rigid lower portion assists in weight-bearing while the substantially flexible upper portion allows for movement of the residual limb <b>14</b>. As the knee is bent from fully straight to fully flexed, the width of the knee changes rather significantly and in a hard, non-flexible socket brim, there can be excessive pressure on the residual limb <b>14</b>. The substantially flexible upper portion <b>96</b> makes the artificial limb <b>50</b> more comfortable and more adaptive to these changes. For the same reason, the outer socket <b>52</b> has a rigid lower portion <b>102</b> and a substantially flexible upper portion <b>100</b>.

[0115] Preferably, the top edge of the inner socket <b>60</b> is below the top edge of the outer socket <b>52</b> so that the sleeve <b>86</b> is protected from impact. Preferably, the top edge of the inner socket <b>60</b> may be {fraction (3/16)} inch below the top edge of the outer socket <b>52</b>.

[0116] The sixth embodiment includes extensive modifications to the vacuum system.

[0117] First, a vacuum fitting <b>78</b> has been added to the inner socket <b>60</b> to attach the vacuum tube <b>76</b>. The vacuum fitting <b>78</b> allows the attachment of a vacuum sensor <b>79</b> adapted to sense the amount of vacuum in the cavity <b>62</b> and a sensor lead <b>81</b> is attached to the sensor <b>79</b> connecting the sensor <b>79</b> to the regulator means <b>80</b>, thus conveying the sensed vacuum to the regulator means <b>80</b>.

[0118] A vacuum valve <b>74</b> is placed between the cavity <b>62</b> and the vacuum source <b>70</b> to maintain vacuum in the cavity <b>62</b>. Typically, the vacuum valve <b>74</b> is a one-way valve or non-return valve.

[0119] In the sixth embodiment, the vacuum source <b>70</b>, vacuum tube <b>76</b>, vacuum valve <b>74</b>, regulator means <b>80</b>, and power source <b>83</b> are all attached to the outer socket <b>52</b> in the space <b>58</b> between the outer socket <b>52</b> and inner socket <b>60</b>. In this way, these delicate components are protected against being damaged by impact. Because of the placement of the regulator means <b>80</b> within the outer socket <b>52</b>, a vacuum control <b>77</b> is provided extending outside the outer socket <b>52</b> to allow manual control of the regulator means <b>80</b>.

[0120] The amputee dons the sixth embodiment in a manner similar to that earlier described, with some modifications. First, the outer sheath <b>93</b> is put on the residual limb <b>14</b> after rolling the suspension sleeve <b>86</b> upward over the residual limb and before donning the liner <b>92</b>. After donning the inner sheath <b>90</b> over the liner <b>92</b>, the amputee inserts the residual limb <b>14</b> into the inner socket <b>60</b>. Next, the outer sheath <b>93</b>, suspension sleeve <b>86</b>, and second sleeve <b>94</b> are rolled down over the inner socket <b>60</b>, and the adhesive pressure tape <b>95</b> is applied. Next, the wearer sets the regulator means <b>80</b> to an appropriate vacuum level by means of the vacuum control <b>77</b>, and connects the vacuum tube <b>76</b> to the vacuum fitting <b>78</b>. The inner socket <b>60</b> is then placed within the outer socket <b>52</b> so that the shuttle pin <b>108</b> engages the docking device <b>106</b> and the locking pin <b>110</b> is set to engage the shuttle pin <b>108</b> and the docking device <b>106</b>, providing a positive mechanical interlock.

[0121] A seventh embodiment of the hypobarically-controlled artificial limb of the present invention is shown in FIG. 13. The seventh embodiment is similar to the sixth embodiment, with some changes.

[0122] First, the mechanical interlock <b>103</b> does not engage the inner socket <b>60</b>. Instead, the mechanical interlock engages the outer socket <b>52</b> and the suspension sleeve <b>86</b>. To accomplish this, the suspension sleeve <b>86</b> covers the entire inner socket <b>60</b>, and the suspension sleeve <b>86</b> has the extension <b>104</b> or shuttle pin <b>108</b> embedded in the suspension sleeve at the distal end of the suspension sleeve, as shown in FIG. 14. Preferably, the extension <b>104</b> has a portion <b>104</b>A embedded in the suspension sleeve. This portion <b>104</b>A may be a disk or umbrella <b>104</b>A. The extension <b>104</b> then engages the docking device <b>106</b> as previously described.

[0123] Second, the suspension sleeve <b>86</b> is modified to support the additional weight imposed on the suspension sleeve <b>86</b> due to the outer socket <b>52</b> and artificial limb. In particular, the suspension sleeve <b>86</b> is fabricated from a material which allows circumferential expansion but resists longitudinal stretching under the weight of the artificial limb. Such a material is described in U.S. Pat. No. 5,571,208, herein incorporated by reference.

[0124] The sleeve <b>86</b> preferably contains fabric threads which may be oriented circumferentially around the sleeve. The threads preferably are comprised of double-knit polyurethane. The threads may also include nylon. The threads permit the sleeve <b>86</b> to expand circumferentially so that the sleeve may be slipped onto the residual limb <b>14</b> and so that the lower portion may be slipped over the inner socket <b>52</b>. The threads are preferably connected together with cross-links, which also may be preferably comprised of polyurethane. The cross-links and threads form a matrix which allows circumferential expansion but resists longitudinal stretching under the weight of the artificial limb. By example, the sleeve <b>86</b> may have a 4-to-1 ratio of circumferential stretch relative to longitudinal stretch.

[0125] The sleeve <b>86</b> may have a portion above the inner socket <b>52</b> which is manufactured of material which allows both vertical and horizontal stretching, to increase flexibility.

[0126] An eighth embodiment of the hypobarically-controlled artificial limb of the present invention is shown in FIG. 15.

[0127] Unlike earlier embodiments, the artificial limb <b>50</b> of the eighth embodiment has only a single socket <b>60</b> rather than inner and outer sockets and is thus considerably simpler.

[0128] The socket <b>60</b> has a volume and shape to receive a substantial portion of the residual limb <b>14</b> with a cavity <b>62</b> therebetween.

[0129] A nonfoamed, nonporous polyurethane liner <b>92</b> is preferably adapted to receive the residual limb <b>14</b> and to be disposed between the residual limb <b>14</b> and the socket <b>60</b>.

[0130] A vacuum source <b>70</b> is connected to the cavity <b>62</b> by a vacuum valve <b>78</b>, thereby drawing the residual limb <b>14</b> into firm contact with the socket <b>60</b>.

[0131] A seal means <b>84</b> makes a seal between the residual limb <b>14</b> and the socket <b>60</b> to minimize air leakage into the cavity <b>62</b>. It has been found that it is impossible to make a perfect seal, with the result that air leakage can occur at rates up to 30 cc per minute. As air leaks into the cavity <b>62</b>, it is necessary to activate the vacuum source <b>70</b> to restore vacuum in the cavity. Furthermore, it has been found that when the vacuum in the cavity is about 5 inches of mercury, the residual limb may lose up to 6 to 15% of its volume during the day, whereas if the vacuum in the cavity is 15-25 inches of mercury, the residual limb loses only about 1% of its volume during the day.

[0132] To minimize the time that the vacuum source, such as a vacuum pump <b>72</b>, needs to run to maintain vacuum in the cavity, a ninth embodiment of the artificial limb <b>50</b> is shown in FIG. 16. The ninth embodiment is the same as the eighth embodiment, but a vacuum reservoir <b>110</b> is added between the vacuum source <b>70</b> and the vacuum valve <b>78</b>. The vacuum reservoir <b>110</b> has a volume substantially larger than the cavity <b>62</b>. Suitably, the vacuum reservoir may have a volume of 2 gallons or 9000 cc while the volume of the cavity <b>62</b> may be only about 100 cc or even less.

[0133] It will be seen that as air leaks into the cavity <b>62</b>, the air will be pulled into the vacuum reservoir <b>110</b>, thereby maintaining the vacuum in the cavity <b>62</b>.

[0134] When the vacuum in the reservoir <b>110</b> reaches a certain minimum threshold, the vacuum source <b>70</b> may be activated to restore vacuum to the vacuum reservoir <b>110</b>. The vacuum source <b>70</b> may be activated either manually or by a regulator means (not shown).

[0135] The artificial limb <b>50</b> typically includes a shin or pylon <b>54</b> and a foot <b>56</b>, as shown in FIG. 3. Preferably, the vacuum reservoir <b>110</b> is attached to the shin <b>54</b> between the socket <b>60</b> and the foot <b>56</b>. However, the vacuum reservoir may also be carried separately, as for example in a backpack. Depending on the placement of the vacuum reservoir <b>110</b>, a vacuum tube <b>76</b> may be necessary to connect the vacuum reservoir <b>110</b> to the vacuum valve <b>78</b>.

[0136] If the volume of the vacuum reservoir <b>110</b> is about 9000 cc and air leaks into the cavity <b>62</b> at about 75 cc per minute, it will be seen that the intervals between activation of the vacuum source <b>70</b> can be up to about 120 minutes.

[0137] The artificial limb <b>50</b> of the eighth and ninth embodiments may preferably further comprise the following.

[0138] An inner sheath <b>90</b> may be adapted to be disposed between the liner <b>92</b> and the socket, to ensure even distribution of vacuum in the cavity <b>62</b>, as earlier described. Preferably, the inner sheath <b>90</b> may be thin knitted nylon. The sheath <b>90</b> may also be affixed to the outside of the liner <b>92</b>.

[0139] The seal means <b>84</b> is preferably a nonfoamed, nonporous polyurethane suspension sleeve <b>86</b> for rolling over and covering the socket <b>60</b> and a portion of the artificial limb <b>14</b>, as earlier described.

[0140] A stretchable nylon second sleeve <b>94</b> for rolling over and covering the suspension sleeve <b>86</b> may be added to prevent clothing from sticking to and catching on the suspension sleeve <b>86</b>, as earlier described.

[0141] The vacuum source <b>70</b> is preferably a motor or mechanical driven vacuum pump <b>72</b>, as earlier described. A vacuum tube <b>76</b> may be necessary to connect the vacuum pump <b>72</b> to the vacuum valve <b>78</b>, depending on the placement of the vacuum pump <b>72</b>. istead of using a vacuum reservoir to maintain the vacuum in the cavity, a weight-actuated vacuum pump may be employed.

[0142] A first embodiment of a vacuum pump and shock absorber for an artificial limb is shown in FIGS. <b>17</b>-<b>25</b>.

[0143] The vacuum pump and shock absorber <b>200</b> in one aspect comprises a housing <b>210</b> fixedly attached to the socket <b>60</b> and having a housing top wall <b>212</b> and housing side walls <b>214</b>.

[0144] A cylinder <b>220</b> reciprocates within the housing <b>210</b> and sealingly engages the housing side walls <b>214</b>. The cylinder <b>220</b> has a cylinder top wall <b>222</b> and cylinder side walls <b>224</b>.

[0145] The cylinder <b>220</b> is fixedly attached to a cap <b>230</b> and the cap <b>230</b> is fixedly attached to the pylon <b>54</b>.

[0146] A piston <b>260</b> is fixedly attached to the housing <b>210</b> and reciprocates within the cylinder <b>220</b>. Preferably, the piston <b>260</b> screws to the housing <b>210</b>.

[0147] The cylinder top wall <b>222</b>, cylinder side walls <b>224</b>, and piston <b>260</b> cooperate to form a first chamber <b>240</b>.

[0148] The cylinder top wall <b>222</b>, the housing top wall <b>212</b>, and the housing side walls <b>214</b> cooperate to form a second chamber <b>250</b>.

[0149] The piston <b>260</b>, cylinder side walls <b>224</b> and cap <b>230</b> cooperate to form a third chamber <b>241</b>.

[0150] A first valve means <b>270</b> connects the first chamber <b>240</b> and the second chamber <b>250</b> to the cavity <b>62</b> and to the atmosphere. A second valve means <b>280</b> connects the second chamber <b>250</b> and the first chamber <b>240</b> to the cavity <b>62</b> and to the atmosphere. An intake/exhaust port <b>272</b> is placed between the first valve means <b>270</b> and the first chamber <b>240</b>. An intake port <b>274</b> connects the second chamber <b>250</b> to the first valve means <b>270</b>. An exhaust port <b>28</b><b>4</b> connects the second chamber <b>250</b> to the second valve means <b>280</b>.

[0151] Preferably, the first valve means <b>270</b> may be a three-way valve <b>272</b> and the second valve means <b>280</b> is a second three-way valve <b>282</b>.

[0152] The weight-activated vacuum pump <b>200</b> also preferably comprises an anti-rotation collar <b>290</b> between the cylinder <b>220</b> and the housing <b>210</b>.

[0153] A first seal <b>300</b> is placed between the piston <b>260</b> and the cylinder side walls <b>224</b> and a second seal <b>310</b> is placed between the cylinder side walls <b>224</b> and the housing side walls <b>214</b>. Preferably a first bushing <b>320</b> is placed between the cap <b>230</b> and the housing side walls <b>214</b> and a second bushing <b>330</b> is placed between the cylinder side walls <b>224</b> and the housing side walls <b>214</b>.

[0154] Preferably, the housing top wall <b>210</b> has a hollow core <b>216</b> and the piston <b>260</b> has a stem <b>262</b> slidingly engaging the hollow core <b>216</b>. Most preferably, the intake/exhaust port <b>272</b> traverses the stem <b>262</b>.

[0155] The weight-actuated vacuum pump and shock absorber <b>200</b> also preferably comprises a spring <b>340</b> biasing the cylinder <b>220</b> toward the housing top wall <b>212</b>. Alternatively, compressed air in the third chamber <b>241</b> biases the cylinder <b>220</b> toward the housing top wall <b>212</b>. An adjustment valve <b>350</b> may be provided to vary the pressure of compressed air between the piston <b>260</b> and the cap <b>230</b>.

[0156] Operation of the first embodiment of the weight-actuated vacuum pump and shock absorber <b>200</b> may now be described.

[0157]FIG. 22 shows the pump <b>200</b> in a state where the wearer is not applying any body weight to the pylon <b>54</b>, as when sitting down or at the completion of the swing phase of walking. As can be seen, the piston <b>260</b> abuts the cylinder top wall <b>220</b>, forced there either by compressed air in the third chamber <b>241</b> or by the spring <b>340</b>. The housing <b>210</b>, which is attached to the piston <b>260</b> is at the top of its travel, with the second chamber <b>250</b> expanded to its maximum volume. The first valve means <b>270</b> is closed, sealing off the cavity <b>62</b> from the pump <b>200</b>. The second valve means <b>280</b> is open to atmosphere.

[0158]FIG. 23 shows what happens as the wearer begins to apply body weight to the pylon <b>54</b>. The housing <b>210</b>, attached to the socket <b>60</b> by connector <b>218</b>, is forced downward, carrying the piston <b>260</b> with it. The housing side walls <b>214</b> slide along the cylinder side walls <b>224</b>. Because the cylinder <b>220</b> is fixed to the pylon <b>54</b> and does not move, this motion of the housing <b>210</b> decreases the volume of the second chamber <b>250</b>, causing air to be forced out of the second chamber <b>250</b> through the second valve means <b>280</b>, as shown by the dark arrow. Simultaneously, the piston <b>260</b> moving downwardly within the first chamber <b>240</b> draws air from the cavity <b>62</b> through the first valve means <b>270</b>, which has connected the intake/exhaust port <b>272</b> to the cavity <b>62</b>, producing a vacuum in the cavity <b>62</b>, as shown by the light arrows. The motion of the piston <b>260</b> will also compress air in the third chamber <b>241</b> between the piston <b>260</b> and the cap <b>230</b>, providing a shock absorbing function.

[0159]FIG. 24 shows the state where the wearer has placed all of his body weight on the pylon <b>54</b>, and the housing <b>210</b> and piston <b>260</b> are at their maximum travel relative to the cylinder <b>220</b>. The first chamber <b>240</b> is at its maximum volume and the second chamber <b>250</b> is at its minimum volume. The first valve means <b>270</b> has been switched to connect the second chamber <b>250</b> to the cavity <b>62</b>.

[0160]FIG. 25 shows what happens when the wearer removes his body weight from the pylon <b>54</b>, as in the beginning of the swing phase of ambulation. Under the influence of compressed air in the third chamber <b>241</b> or of the spring <b>340</b>, the housing <b>210</b> and piston <b>260</b> are forced upwardly, causing air in the first chamber <b>240</b> to be forced out of the first chamber <b>240</b> through the intake/exhaust port <b>272</b> and second valve means <b>280</b> to atmosphere, as shown by the dark arrows. Simultaneously, the motion of the housing <b>210</b> increases the volume of the second chamber <b>250</b>, causing air to be drawn into the second chamber <b>250</b> from the cavity <b>62</b> through the first valve means <b>270</b>, again increasing the amount of vacuum in the cavity <b>62</b>, as shown by the light arrows.

[0161] Throughout operation of the pump <b>200</b>, the anti-rotation collar <b>290</b> prevents the cylinder <b>220</b> from rotating within the housing <b>210</b>.

[0162] A second embodiment of a weight-actuated vacuum pump and shock absorber is shown in FIGS. <b>26</b>-<b>29</b>. Unlike the first embodiment, which is a double-action pump, the second embodiment is a single-action pump.

[0163] The weight-actuated vacuum pump <b>400</b> comprises a cylinder <b>410</b> attached to the pylon <b>54</b> and having a first chamber <b>420</b> therein. A piston <b>430</b> reciprocates within the first chamber <b>420</b>. The piston <b>430</b> extends outside the cylinder <b>410</b> and is fixedly attached to the socket <b>62</b> as by connector <b>218</b>. Preferably, the cylinder <b>410</b> has a top wall <b>412</b> with an aperture <b>414</b> therethrough, and the piston <b>430</b> has a stem <b>432</b> slidingly engaging the aperture <b>414</b>.

[0164] The piston has a seal <b>436</b> along its periphery separating the first chamber <b>420</b> from a second chamber <b>422</b> between the piston <b>430</b> and the cylinder top wall <b>412</b>.

[0165] The cylinder top wall <b>412</b> may preferably further comprise a plurality of tubes <b>416</b> with a closed end <b>416</b>A and open end <b>416</b>B, the open end <b>416</b>B facing the socket <b>60</b>. The stem <b>432</b> may have a plurality of projections <b>434</b> slidingly engaging said tubes <b>416</b>. The projections <b>434</b> sliding within the tubes <b>416</b> prevent the stem <b>432</b> from rotating within the aperture <b>414</b>.

[0166] An intake/exhaust port <b>440</b> is connected to the first chamber <b>420</b>. A first one-way valve <b>450</b> connects the intake/exhaust port <b>440</b> to the cavity <b>62</b>. A second one-way valve <b>460</b> connects the intake/exhaust port to atmosphere.

[0167] Optionally, a spring <b>470</b> biases the piston <b>430</b> toward the socket <b>60</b>. Alternatively, compressed air in the first chamber <b>420</b> biases the piston <b>430</b> toward the socket <b>60</b>. An adjustment valve <b>480</b> may be used to vary the pressure of compressed air in the first chamber <b>420</b>.

[0168] Applicant has found that the pump may generate up to 22 inches mercury of vacuum in the cavity as the wearer takes seven steps.

[0169] Operation of the second embodiment may now be described.

[0170] As the wearer brings his body weight to bear on the pylon <b>54</b>, the piston <b>430</b> is forced downwardly within the cylinder <b>418</b> against compressed air or the spring <b>470</b>, providing a shock-absorbing effect. At the same time, air is drawn into the second chamber <b>422</b> from the cavity <b>62</b> through the first one-way valve <b>450</b> and the intake/exhaust port <b>440</b>, producing a vacuum within the cavity <b>62</b>.

[0171] As the wearer removes his body weight from the pylon <b>54</b>, the piston <b>430</b> is forced upwardly within the first cylinder <b>410</b> either by the spring <b>470</b> or compressed air, forcing air out of the second chamber <b>422</b> through the intake/exhaust port <b>440</b> and the second one-way valve <b>460</b> to atmosphere.

[0172] A third embodiment of a weight-actuated vacuum pump is shown in FIGS. <b>30</b>-<b>34</b>.

[0173] The third embodiment of the pump <b>510</b> comprises a cylinder <b>512</b> having a first wall <b>514</b>, a second wall <b>516</b> and side walls <b>518</b>. The first wall <b>514</b>, second wall <b>516</b>, and side walls <b>518</b> enclose a chamber <b>520</b> therein, all as best seen in FIG. 31.

[0174] A piston <b>530</b> reciprocates within the cylinder <b>512</b>, in chamber <b>520</b>. A seal <b>532</b> is placed between the piston <b>530</b> and the cylinder side walls <b>518</b>.

[0175] As the piston reciprocates within the cylinder <b>512</b>, a vacuum chamber <b>540</b> is formed by the piston <b>530</b>, seal <b>532</b>, side walls <b>518</b> and first wall <b>514</b>, as best seen in FIG. 32.

[0176] An intake port <b>550</b> connects the vacuum chamber <b>540</b> to the socket cavity <b>62</b>, as best seen in FIG. 34. This connection can be made in any suitable way, but preferably is made by vacuum tube <b>76</b>.

[0177] An exhaust port <b>552</b> connects the vacuum chamber <b>540</b> to atmosphere.

[0178] The third embodiment may also include a shock absorber <b>560</b> to absorb shock to the wearer of the residual limb caused by ambulation.

[0179] In one embodiment, the shock absorber <b>560</b> further comprises a spring <b>562</b> adapted to be compressed under the weight of the wearer of the artificial limb. The spring may be adjustable by adjustment screw <b>563</b> to set the amount of shock absorption.

[0180] The shock absorber <b>560</b> may also comprise a compression chamber <b>564</b> filled with a fluid, the fluid in the compression chamber <b>564</b> being adapted to be compressed by the piston <b>530</b> under the weight of the wearer of the artificial limb. In one embodiment, the compression chamber <b>564</b> is formed by the piston <b>530</b>, the seal <b>532</b>, the side walls <b>518</b> and the second wall <b>516</b>, and the fluid that is being compressed is air. The maximum compression of the fluid in the compression chamber may be adjustable by the user to set the amount of shock absorption. For example, compressed air may be introduced into the compression chamber <b>564</b> at a particular pressure by the use of tank valve <b>566</b>.

[0181] As the wearer brings his body weight to bear on the cylinder head <b>513</b> (which is connected to the socket <b>60</b>), the piston <b>530</b> travels upwardly as shown by the arrows, compressing both the air in the compression chamber <b>564</b> and the spring <b>562</b>, as best seen in FIG. 32. At the same time, the volume of the vacuum chamber <b>540</b> is increasing, pulling air from the socket cavity <b>62</b> through the vacuum hose <b>76</b> and through a one-way check valve <b>551</b> into the vacuum chamber <b>540</b> through the intake port <b>550</b>.

[0182] As the wearer removes his body weight from the cylinder head <b>513</b>, the now compressed air in the compression chamber <b>564</b> and/or the compressed spring <b>562</b> forces the cylinder head <b>513</b> and cylinder upwards toward the socket <b>60</b>, so that the piston <b>530</b> travels downwardly as shown by the arrows in FIG. 33. This action decreases the volume of the vacuum chamber <b>540</b>, expelling the air in the vacuum chamber <b>540</b> to atmosphere through a one-way valve <b>553</b> and exhaust port <b>552</b>.

[0183] A fourth embodiment of a weight-actuated vacuum pump is shown in FIGS. <b>35</b>-<b>38</b>.

[0184] The fourth embodiment of the pump <b>610</b> comprises a cylinder <b>612</b> having a first wall <b>614</b>, a second wall <b>616</b> and side walls <b>618</b>. The first wall <b>614</b>, second wall <b>616</b>, and side walls <b>618</b> enclose a chamber <b>620</b> therein. The chamber <b>620</b> may be filled with air.

[0185] A piston <b>630</b> reciprocates within the cylinder <b>612</b>, in chamber <b>620</b>. A seal <b>632</b> is placed between the piston <b>630</b> and the cylinder side walls <b>618</b>.

[0186] As the piston reciprocates within the cylinder <b>612</b>, a vacuum chamber <b>640</b> is formed by the piston <b>630</b>, seal <b>632</b>, side walls <b>618</b> and first wall <b>614</b>, as best seen in FIG. 36.

[0187] An intake port <b>650</b> connects the vacuum chamber <b>640</b> to the socket cavity <b>62</b>, as best seen in FIG. 39<i>a</i>. This connection can be made in any suitable way, but preferably is made by vacuum tube <b>76</b>.

[0188] An exhaust port <b>652</b> connects the vacuum chamber <b>640</b> to atmosphere. The intake port <b>650</b> and <b>652</b> may be the same, with external one-way valves (not shown) to prevent unwanted airflow.

[0189] The fourth embodiment may also include a shock absorber <b>660</b> to absorb shock to the wearer of the residual limb caused by ambulation.

[0190] The shock absorber <b>660</b> may comprise a compression chamber <b>664</b> with wall <b>666</b>, filled with a fluid. The fluid may be air or hydraulic fluid. A second piston <b>634</b> reciprocates within the chamber <b>664</b>. The second piston <b>634</b> has a seal <b>636</b>. The second piston <b>634</b>, seal <b>636</b>, and wall <b>666</b> form an overflow chamber <b>668</b>. The maximum compression of the fluid in the chamber <b>664</b> may be adjustable by the user to set the amount of shock absorption. For example, needle valve <b>670</b> may adjustable by valve adjustment <b>680</b> to limit the flow of fluid from chamber <b>664</b> to chamber <b>668</b>.

[0191] As the wearer brings his body weight to bear on the piston <b>630</b> (which is connected to the socket <b>60</b>), the piston <b>630</b> travels downwardly as shown by the arrows, as best seen in FIGS. 36 and 37. This causes the volume of the vacuum chamber <b>640</b> to increase, pulling air from the socket cavity <b>62</b> through the vacuum hose <b>76</b> and through an external one-way check valve (not shown) into the vacuum chamber <b>640</b> through the intake port <b>650</b>. Simultaneously, air in chamber <b>620</b> is compressed by the downward motion of the piston <b>630</b>.

[0192] At the same time, the second piston <b>634</b> moves against the fluid in chamber <b>664</b>. Under the force of the second piston <b>634</b>, fluid is forced out of chamber <b>664</b> through needle valve <b>670</b> into overflow chamber <b>668</b>, providing a shock absorbing effect, the extent of which is regulated by the needle valve <b>670</b>.

[0193] As the wearer removes his body weight from the piston <b>630</b>, the now compressed air in chamber <b>620</b> forces the piston <b>630</b> upwards toward the socket <b>60</b> as shown by the arrows in FIG. 38. This action decreases the volume of the vacuum chamber <b>640</b>, expelling the air in the vacuum chamber <b>640</b> to atmosphere through a one-way check valve (not shown) and exhaust port <b>652</b>.

[0194] At the same time, fluid is forced out of overflow chamber <b>668</b> through the needle valve <b>670</b> into chamber <b>664</b>, providing a dampening effect against abrupt motion of the piston <b>630</b>.

[0195]FIGS. 39<i>a </i>and <b>39</b><i>b </i>show that the fourth embodiment <b>610</b> may be used with an artificial foot F attached to the socket <b>60</b>, to provide a mechanical vacuum pump and shock absorber.

[0196]FIGS. 40 and 41 show that the fourth embodiment <b>610</b> may be used with an above-the-knee artificial limb <b>10</b> to provide a mechanical vacuum pump and shock absorber. In the above-the-knee artificial limb <b>10</b>, the socket <b>60</b> is connected to a joint J that pivots, simulating the motion of a knee joint. When weight is applied to the joint as shown in FIG. 40, weight is transferred to the pump <b>610</b>, which draws air from the socket cavity <b>62</b> into the vacuum cavity <b>640</b> as described above. Then, as the wearer moves his other leg forward, the joint J pivots, allowing the knee to bend and allowing the pump <b>610</b> to exhaust air from the vacuum chamber <b>640</b> as previously described.

[0197] The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof, and it is therefore desired that the present embodiment be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.