WO2015169289A1

WO2015169289A1 - Sealing ring, and system composed of sealing ring and stump socket

Info

Publication number: WO2015169289A1
Application number: PCT/DE2015/100188
Authority: WO
Inventors: Harald Gottlieb; Jens Volkmar; Andreas Leiniger
Original assignee: Otto Bock Healthcare Gmbh
Priority date: 2014-05-09
Filing date: 2015-05-08
Publication date: 2015-11-12
Also published as: DE102014006689A1; DE102014006689B4

Abstract

The invention relates to a sealing ring for securing on a proximal end (21) of a stump socket (2) with a sleeve-shaped main body (10) which has securing means (15, 16) for fastening the main body (10) on the stump socket (2), wherein an inwardly protruding sealing lip (18) is arranged on the main body (10).

Description

Sealing ring and system of sealing ring and butt receiving

The invention relates to a sealing ring for attachment to a proximal end of a butt receiving with a sleeve-shaped body having fastening means for fixing the base body to the butt receiving and a system of such a sealing ring and a butt receiving. The stump can be designed as a prosthesis stem and the sealing ring as a so-called seat ring, the sealing ring increases both the comfort and security against unwanted detachment of the stump receiving from the stump.

People who need a Exoprothesenkniegelenk with a lower leg tube and a prosthetic foot, this usually stuck to a thigh stump on a buttock. The stump receiver is attached to a so-called upper part or upper connecting means of the prosthetic knee joint and ensures that the prosthetic knee joint is securely held in the correct orientation on the thigh stump. About the butt, it is possible to create the prosthetic device and store it again if necessary.

A common way of attaching the prosthesis provides that on the thigh stump a liner is drawn, which consists for example of silicone or polyurethane and in addition to the support of the soft tissue tissue provides a protective and cushioning function for the thigh stump. At the distal end of the liner, a mechanical locking element, the so-called pin, can be arranged, with which a mechanical attachment to the stump receptacle, for example on a thigh shaft made of wood or a fiber-reinforced plastic occurs. In addition to a mechanical definition, it is alternatively or additionally possible to effect an optionally additional securing of the butt receiving to the liner via an applied negative pressure. The DE 83 13 938 U1 relates to a leg prosthesis with a shaft portion having a slotted in the axial direction, open on both sides and circumferentially elastically expandable shaft sleeve which is connected via a bracket to the base. The shaft sleeve can be designed as a thigh shaft and attached to the leading, ie at the proximal end, have a padding.

EP 1 875 881 A1 relates to a prosthesis socket with an outlet valve arranged at the distal end, in order to be able to push out the enclosed air during the insertion of a prosthetic liner. In the shaft, a groove is incorporated, in which a seal is inserted.

US 8,097,043 B2 relates to a prosthesis stem having an outlet valve and a liner which is insertable into the prosthesis stem. At least one sealing element is arranged at the distal end of the liner and extends annularly around the main body of the liner.

US 8,372,159 B2 relates to a sealing sleeve for a prosthetic liner, in which a circumferential sealing ring is attached to the outside.

US 8,394,150 B2 relates to a prosthetic liner with a proximal seal, wherein the liner is held over a pin in the prosthesis socket. The seal extends from outside over the prosthesis stem and abuts the liner on the outside.

WO 03/024370 A1 relates to a prosthesis stem with an inwardly projecting seal, which is formed from a supple, air-impermeable material. Also described is a liner which can be received in the prosthesis socket. An outwardly facing and outwardly bulging wall of a conformable, air-impermeable material is provided on the liner which serves as a seal for sealing the liner against the wall of a prosthetic socket.

WO 2009/062489 A1 relates to a liner for accommodating amputation stumps for use in prosthetic stems, wherein the liner is double-walled from an inner liner and an outer liner. The liner allows for improved sealing by a vacuum between the liner and the prosthetic stem by providing the inner liner and the outer liner in the middle and / or distal ~ ~

len third are fixed together and the outer liner is designed to seal with the prosthetic shaft.

WO 2012/051385 A1 relates to a liner which is designed to form an interface between a thigh stump and a thigh shaft. A resilient sealing element is radially from the liner. A medium-fillable chamber is provided to allow adjustment of the liner volume to the conditions of use. WO 2013/028647 A1 relates to a liner with a sealing component in the distal section. On the outer surface, a sealing component is provided for engaging a prosthesis stem.

Prosthetic shafts or buttocks often have a bulging shape towards the proximal end, which can lead to comfort and sealing problems because the protruding rim can cause leaks and discomfort when sitting. For liners that are held at least partially under vacuum in the prosthesis stem, this can lead to a loss of safety and a loss of comfort.

Object of the present invention is therefore to provide a sealing ring and a system of a sealing ring and a buttock receiving, with which these problems can be avoided or at least reduced. This object is achieved by a sealing ring with the features of

Hauptanspruches and solved a system with the features of the independent claim. Advantageous embodiments and further developments of the invention are disclosed in the subclaims, the figures and the description. The sealing ring for attachment to a proximal end of a butt receiving with a sleeve-shaped base body having fastening means for fixing the base body to the butt receiving, provides that on the base body an inwardly projecting sealing lip is arranged. Due to the arrangement of the "

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Dichtnnges at the proximal end of the stump, for example, the thigh shaft, the lower leg shaft, or a shaft of an upper limb, it is possible to provide a fixedly connected to the stump receiving component that allows customization of prosthetic stems or buttocks to the respective user, so that It is possible either to adapt standard prefabricated prosthesis stems or stump shots to the respective user or to make a simple adjustment to fluctuations on the thigh or thigh stump or another limb without having to produce a completely new shaft or a completely new stump abutment. Both the liners to be applied to the stump and the stump receptacle do not have to be completely re-adjusted; replacement of the sealing ring is sufficient to increase the wearing comfort of a prosthesis at the shaft edge, for example when sitting, and at the same time a vacuum system with which the prosthesis shaft and so that the rest of the prosthesis is held on the user to use improved. This is due to the main body, the

Padding function and the fixing takes over, arranged a radially inwardly projecting sealing lip, which provides an improved sealing effect. The main body is for this airtight or sealing fixed to the stump receptacle, so that an improved proximal seal of the liner is made to the prosthesis stem. The sealing ring is particularly fixed when applied to a femoral stem at the upper stem edge and extends beyond it in the proximal direction to provide cushioning and a smooth transition from the generally rigid stem edge to the stump. The sealing ring is then a seat ring with an extended functionality, namely with the extension of an improved sealing function. For this purpose, the sealing lip is part of the sealing ring with a comfort-enhancing

Seat ring portion connected or formed thereon.

The sealing lip is advantageously formed on the base body in order to simplify the assembly of the sealing ring or the seat ring with sealing function and to perform any assembly steps to complete the sealing ring.

In principle, it is also possible for the sealing lip to protrude radially inward only partially around the circumference of the base body, provided that it is ensured that those portions of the base _

- 5 - body, which are not provided with a sealing lip, provide sufficient tightness between a liner and the body.

The sealing ring may be formed oriented at an angle between 80 ° and 100 °, preferably 90 ° to the stump longitudinal axis. The orientation of the sealing lip to the stump axis may vary in order to increase the space available for the vacuum effect and / or to align the sealing lip in an angle optimized for the sealing effect. The sealing ring is made of an elastomer, advantageously formed of silicone, which combines a simple production, high operability with high density and a pleasant load bearing behavior.

The wall thickness of the main body is preferably greater than the wall density of the sealing lip, in order to provide sufficient padding on the one hand in the shaft region and, on the other hand, to provide sufficient material to be able to fix fastening means for fixing the basic body to the butt receiving sufficiently stable. The wall thickness of the main body can be twice as thick or larger than the wall thickness of the sealing lip, the relatively thin sealing lip causing good deformability and conforming to the liner surface. The main body takes over the function of comfort increase by padding and supernatant on the proximal end or the shaft edge and is located on the inside of the shaft edge on the shaft or is attached thereto. On the outer circumference of the main body, a groove for receiving a sealing ring, an adhesive element and / or form-locking elements which are attached to the butt receiving, be formed. Through the groove, it is possible to provide an additional sealing possibility between the outer circumference of the sealing ring and the butt receiving. About an adhesive element, the determination of the sealing ring or the body in the proximal portion of the prosthesis stem done or additional security, for example, when using mechanical securing means, such as screws, rivets or clips, are provided. It is also possible that in the groove positive locking elements that on the "

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Are arranged inside of the butt receiving, for example, molded or attached thereto, are added, so that a positive locking of the sealing ring can be done on the buttock. The groove can be provided, for example, with an undercut, in which a circumferential projection of a web, which is formed or attached to the inner periphery of the butt receiving, engages.

On the outside of the base body, an adhesive zone may be formed, which causes a bonding of the base body to the inside of the butt.

At the distal end of the base body, a passage opening for a stump is formed, in order to be able to introduce the stump into the stump receptacle together with the prosthesis liner, which may have been applied thereto. The prosthetic liner can be held either exclusively via a vacuum system or via a mechanical locking system, for example a pin or a shuttle lock in conjunction with the vacuum system on the prosthesis receptacle.

Advantageously, the seal is arranged in the distal region of the main body, which allows a simplified production of the sealing ring.

The system of a sealing ring, as described above, and a

Butt insertion provides that the sealing ring protrudes proximally via the butt joint. This makes it possible to achieve effective cushioning by means of the soft sealing ring in the edge area of the butt receiving means and at the same time to bring about an improved sealing effect and an improved allocation of the butt receiving to the user through the inwardly projecting seal.

The sealing ring advantageously extends over only a portion of the

Buttock, especially only over the proximal region, only to provide where both a padding as well as a reinforcement of the sealing effect is desired. The stump receptacle, in particular in the embodiment as a thigh receptacle, is advantageously designed as a cup-shaped outer shaft, for example as a thigh outer shaft, which consists of an airtight or substantially airtight material and has a substantially closed cross-section, optionally with an outlet valve, at the entrance of the stump in the prosthesis exterior, squeeze out the air trapped therein and reversibly secure the outer shaft to the prosthesis user via negative pressure or with negative pressure support in conjunction with a mechanical fastener.

On the main body can be arranged a radially inwardly projecting sealing lip. The body provides the seat ring functionality to provide cushioning in the area of the prosthetic margin. The sealing ring is a combination of seat ring for padding of the shaft edge and a seal for improving the security against wear.

Hereinafter, an embodiment of the invention will be explained in more detail with reference to the accompanying figures. FIG. 1 shows a sealing ring in a posterior view;

Figure 2 - a sealing ring in a lateral view;

FIG. 3 shows a sealing ring in a plantar view,

Figure 4 - a sectional view of a sealing ring in a butt without stump;

FIG. 5 shows a detailed representation of FIG. 4;

FIG. 6 shows an arrangement according to FIG. 4 with an inserted thigh stump; - ο -

FIG. 7 shows a variant of FIG. 4 in the M-L section;

Figure 8 shows a variant with tilted arranged sealing ring;

Figures 9

and 10 variants of Figure 5 with different orientations of the sealing lip; such as

Figure 1 1 is a partial perspective view of a variant of the invention.

FIG. 1 shows a sealing ring 1 made of a silicone material in a posterior view. A lateral side portion 1 1 and a medial side portion 12 are formed opposite each other increased, wherein the lateral portion 1 1 protrudes in the proximal direction over the medial portion 12. Between the two sections 1 1, 12, the anterior and posterior edge regions of the sealing ring 1 are formed recessed. The sealing ring 1 has a main body 10, which is substantially sleeve-shaped and has a closed cross-section and is provided in the lateral region with fastening means 15 in the form of setting nuts, via which it is possible, the sealing ring 1 on a not shown truncated uptake , For example, a prosthesis stem, reversibly fastened by screws. In the distal end region 13 of the sealing ring 1, an adhesive region 16 is provided, which causes additional fastening by means of the adhesive layer 16 in addition to the mechanical, form-fitting fastening means 15 in the form of setting nuts. The adhesive layer 16 is arranged or formed circumferentially around the outer circumference of the main body 10.

FIG. 2 shows a lateral view of the sealing ring 1 with the base body, the four setting nuts 15 and the encircling adhesive area 16. The lateral area 11 is above the medial area 12 and the anterior and posterior areas in the proximal area.

FIG. 3 shows the sealing ring 1 in a plantar view, the base body 10 with a substantially constant wall thickness is in its sleeve shape and the closed NEN cross-section as well as a radially projecting from the main body 10 inwardly sealing lip 18, which is formed circumferentially in the illustrated embodiment and connects to the lower distal end of the body 10. Within the sealing lip 18, a passage opening 19 is formed, through which an unillustrated thigh stump can be passed with a prosthetic liner, when the sealing ring 1 is mounted on the stump receptacle. The integrally formed sealing lip 18 is substantially perpendicular to the inner wall of the butt receiving 2 radially inwardly. Figure 4 shows the sealing ring 1 and a butt receiving 2 in the assembled state in a schematic sectional view. In the figure 4, the silicone sealing ring 1 is shown in the mounted state within the stump receptacle 2. The stump receptacle 2 is designed as a cup-shaped, substantially closed thigh shaft with a proximal insertion opening. The sealing ring 1 is formed with its base body 10 substantially collinear with the side wall of the stump receptacle 2 and lies tightly in the proximal region 21 of the stump receptacle 2. By the adhesive zone 16, not shown, an additional, distal, tight connection between the base body 10 and the inner contour of the stump receptacle 2 is effected. The fastening means 15 in the form of setting nuts which are formed and arranged below the lateral elevation in the lateral region 11 are reversibly and positively fixed to the stump receptacle 2 by means of screws which are not shown in the side wall of the stump receptacle 2. The sealing ring 1 communicates with its proximal region 17 via the proximal edge of the stump receptacle 2, so as to effect a cushioning by the soft silicone material of the sealing ring 1 at the proximal edge of the stump receptacle 2.

The installation situation of the sealing ring 1 on the stump receptacle 2 is shown in FIG. 5, in which the proximal region 21, which relates approximately to 1/3 to 1/5 of the total length of the stump receptacle 2, can be recognized. In the proximal region 21, the base body 10 of the sealing ring 1 lies tightly against, the proximal region 17 of the sealing ring 1 projects beyond the proximal edge of the butt receiving means 2 and the sealing lip 18 extends substantially perpendicularly radially to the side wall of the butt joint. _{Λ n}

- 10 - decrease 2 inwards. In addition to the adhesive zone 16 and the form-locking fasteners 15 in conjunction with the screws, it is possible to provide further types of fixing the flexible and elastic sealing ring 1 to the stump receptacle 2, for example via inwardly projecting Formschlusselemen- te with undercuts in grooves within engage the base body 10 and prevent unwanted removal of the sealing ring 1 from the stump box 2.

FIG. 6 shows the detailed view according to FIG. 5 in the applied state, on a thigh stump 4 a prosthesis liner 3, for example of a silicone or another elastomer, is pulled up and inserted through the proximal opening of both the sealing ring and through the insertion opening in the proximal region 21. The integrally formed sealing lip 18 was pushed outward by the thigh stump 4 and the liner 3 and lies sealingly against the inner wall of the stump receptacle 2. The liner 3 was pushed through the passage opening 19, the sealing lip 18 was thereby displaced and expanded in the proximal direction, so that the sealing lip 18 fits tightly against the prosthetic liner 3. Together with the mechanical and adhesive attachment of the base body 10 to the proximal region 21 of the butt insertion, an improved seal is thus provided, in particular in the proximal region 21 of the butt insertion, otherwise due to the usually widening configuration of the butt insertion 2 a relative mobility or relative displacement between a prosthetic liner 3 and the stump 2 is. As a result, air could penetrate between the liner 3 and the prosthesis shaft 2, which would be unfavorable in the case of a negative pressure or negative pressure-supported attachment of the prosthetic device with prosthetic knee joint to the stump receptacle 2 and the components adjoining it at the thigh stump 4 distally. The supernatant of the proximal region 17 of the main body 10 via the proximal edge of the stump receptacle 2 provides a padding for the user.

FIG. 7 shows a variant of the invention in a medial-lateral section. As in FIG. 4, the sealing lip 18 is formed at an angle of approximately 90 ° to the longitudinal axis 25 of the butt receiving means 2. The Proximalbereiche 17 of _{Λ Λ}

- 1 1 -

Sealing ring 1 are in each case over the medial and lateral edge of the stump receptacle 2 over and allow Abpolstern and a dense system of system from butt receiving 2 and sealing ring 1 on the stump, not shown. It can be seen from FIG. 7 that the medial protrusion of the proximal region 17 is greater than the lateral protrusion.

A variant of the invention is shown in Figure 8, in which the plane in which the sealing lip 18 is tilted oriented to the longitudinal extension 25 of the stump receptacle 2, so that, unlike the embodiment of Figure 7, the longitudinal extent is not perpendicular to the level is within which the sealing lip 18 is located. By this arrangement, the lateral space is increased within the stump box 2. The obliquely oriented orientation of the sealing lip 18 to the longitudinal extent below the stump axis 25, it is possible to optimally orient the sealing lip 18 with respect to the sealing effect on the introduced stump and thus to optimize the sealing effect.

In the figures 9 and 10 variants of Figure 5 are shown, in the figure 9 it can be seen that the angle a, which is formed between the base body 10 of the sealing ring 1 and the sealing lip 18 is greater than 90 °, while in the Figure 10 of the base body 10 and the sealing lip 18 is a closed angle α is less than 90 °. The variant of FIG. 9 facilitates insertion of a stump, whereas in the variant according to FIG. 10 the sealing lip 18 only has to be radially compressed and expanded again after reaching a right angle. In the variant according to FIG. 9, the vacuum space is reduced in a direction distal to the sealing lip, in the variant according to FIG. 10 the vacuum space distal to the sealing lip 18 is increased in comparison to FIG.

1 shows in a perspective partial sectional view of a stump receptacle 2 in the form of a prosthesis outer shaft, which is made of a dimensionally stable material, in particular a fiber-reinforced plastic. In the closed distal end region of the stump receptacle 2, a vent valve 22 is arranged, which allows escape of air in the stump receptacle 2 when inserting a stump with a liner. About the valve 22 is also a _{Λ n}

- 12 -

Ventilation possible, so that the stump with the liner from the stump box 2 can be moved out again.

In the proximal region 21 of the stump receptacle 2, the sealing ring 1 is arranged on the inner side of the stump receptacle 2 and fixed in a form-fitting manner via fastening means 15 in the form of screws. The screws 15 penetrate the Stumpfaufnahme 2 and are screwed into the setting nuts, not shown within the sealing ring 1. Due to the screwing, a defined assignment of the sealing ring 1 to the stump receptacle 2 can take place both in the longitudinal extent and in the circumferential direction. In addition to the positive fastening means 15 in the form of screws and nuts, sealing and adhesive strips 16 are arranged at the distal end region of the sealing ring and extend in a circular fashion. The sealing and adhesive strips 16 are arranged in the illustrated embodiment completely circumferentially around the outside of the sealing ring 1 around. Intermediate see the two sealing and adhesive strips 16 are positively acting fastening means 15 are arranged.

The distal end of the sealing ring 1 forms the inwardly-standing sealing lip 18, which is integrally formed on the sealing ring 1. Centrally within the sealing lip 18, the passage opening 19 for the stump, or the prosthetic liner with

Formed blunt.

Both in the lateral portion 1 1 as well as in the medial portion 12 of the sealing ring 1 is about the edge of the stump receptacle 2 in the proximal region 21, in the illustrated embodiment, the supernatant of the sealing ring 1 is given over the entire circumference of the stump.

The adhesive strips 16 or the adhesive zones 16 in the form of the circumferential strips have a roughened structure in the illustrated embodiment. This roughened structure can be formed for example by a textile which is applied during the manufacture of the sealing ring 1 on the outside. The attachment or connection of the Texti Istreifen 16 'takes place in that the textile strips 16' during the manufacture of the sealing ring 1 against the _{Λ n}

- 13 -

Sealing ring base material, for example silicone, to be pressed in order to be inseparably connected to the sealing ring 1 after the vulcanization or crosslinking of the sealing ring material.

The fabric strips 16 'are between 8 mm and 15 mm wide and have a material thickness of about 1 mm. In order to secure the sealing ring 1 in the stump receptacle 2, a bonding agent or an adhesive is applied to the outside of the respective adhesive zone in order to effect a full surface and complete bonding and thus sealing of the sealing ring 1 on the inside of the stump receptacle 2. The applied adhesive is advantageously partially flexible in order to ensure a secure fixation of the sealing ring 1 during movements during the tightening and removal of the stump receptacle 2. About the form-fitting fastening means 15, the bonding in the region of the adhesive zones 16 and adhesive zone 16 is additionally supported. Likewise, the screwing and fastening means 15, which are arranged between the two textile strips 16 ', support the tightness between the outside of the sealing ring 1 and the inside of the butt end 2.

The gluing over the gluing zones 16 or gluing zone 16 with the textile strips 16 'described in connection with FIG. 11 can also be carried out in the embodiments according to the preceding figures. The adhesive or adhesion promoter can be applied as a separate component after the production of the sealing ring on the outside, the adhesive zone can also be formed as a permanent adhesive area.

The sealing ring 1 serves on the one hand for padding in the distal region 21 of the butt receiving by a circumferential, tubular or sleeve-shaped portion of the sealing ring 1 rests against the inside of the stump receptacle 2. In addition, the sealing of the stump receptacle 2 and thus the secure fit of an inserted stump or liner is improved by the radially inwardly projecting sealing lip 18. The sealing ring 1 can be placed on a smooth inner wall of the butt receiving 2 and fixed there without a complex form-fitting sealing ring receptacle, for example in the form of a groove, should be provided.

Claims

Sealing ring for attachment to a proximal end (21) of a stump receptacle (2) with a sleeve-shaped base body (10), which has fastening means (15, 16) for fixing the base body (10) to the stump receptacle (2), characterized in that An inwardly projecting sealing lip (18) is arranged on the base body (10).

Sealing ring according to claim 1, characterized in that the sealing lip (18) is formed on.

Sealing ring according to claim 1 or 2, characterized in that the sealing lip (18) is designed to be circumferential.

Sealing ring according to one of the preceding claims, characterized in that the sealing lip (18) is oriented at an angle between 80° and 100°, preferably at an angle of 90°, to a blunt axis.

Sealing ring according to one of the preceding claims, characterized in that the sealing ring (1) is made of an elastomer.

Sealing ring according to one of the preceding claims, characterized in that the wall thickness of the base body (10) is greater than that of the sealing lip (18).

Sealing ring according to one of the preceding claims, characterized in that a groove (14) is formed on the outer circumference of the base body (10) for receiving a sealing ring, an adhesive element and/or form-fitting elements which are attached to the stub receptacle (2).

Sealing ring according to one of the preceding claims, characterized in that an adhesive zone (16) is formed on the outside of the base body (10).

9. Sealing ring according to one of the preceding claims, characterized in that a passage opening (19) for a stump is formed on the distal region (13).

10. Sealing ring according to one of the preceding claims, characterized in that the seal (18) is arranged in the distal region (13) of the base body (10).

1 1 . Sealing ring according to one of the preceding claims, characterized in that it is designed as a seat ring for arrangement on a prosthetic socket.

12. System consisting of a sealing ring (1) according to one of the preceding claims and a stump receptacle (2), characterized in that the sealing ring (1) projects proximally beyond the stump receptacle (2).

13. System according to claim 12, characterized in that the sealing ring (1) does not extend over the entire longitudinal extent of the stump receptacle (2).

14. System according to claim 12 or 13, characterized in that the stump receptacle (2) is designed as a cup-shaped outer shaft.

15. System according to one of claims 12 to 14, characterized in that the stump receptacle (2) is designed as a thigh receptacle.

16. System according to one of claims 12 to 15, characterized in that an inwardly projecting sealing lip (18) is arranged on the base body (10).