Systems and methods for coverings

Abstract

The present invention relates to a hydrocephalus shunt system, comprising: an inlet portion (20) having a length between a first end and a second end, wherein the inlet portion includes an outer wall (12) defining a cannula and an outer wall surface, a first through-channel (30) extending from the outer wall surface to the cannula, wherein the first through-channel defines a first interior dimension; an outlet portion extending away from the second end; and a filter member (50) configured to extend over the inlet portion and cover at least one through hole, wherein the filter member includes a second through-channel (54), wherein the second through-channel defines a second interior dimension that is smaller than the first interior dimension; wherein fluid is operable to flow into the inlet portion through the first hole and reach the outlet portion.

Description

Technical Field

[0001] The present disclosure relates to a covering, and in particular to a covering material for at least a portion of a catheter. Background Art

[0002] This section provides background information related to the present disclosure which is not necessarily prior art.

[0003] A subject, such as a human patient, may suffer from a condition or disease for which treatment may be described. The disease may include hydrocephalus, which generally includes an overproduction of cerebral fluid in the ventricles and / or an abnormal absorption or outflow of cerebral fluid from the brain. Thus, the condition may result in an inappropriate or undesirable increase in the volume of cerebrospinal fluid (CSF) within the ventricles and increased brain pressure within the skull.

[0004] In various cases, a shunt can be implanted in a subject. The shunt can include an inflow conduit located within the ventricle and an outflow conduit located at a location remote from the brain. Thus, excess cerebrospinal fluid can flow from the ventricle to a selected location in the subject. The flow of CSF from the ventricle through the inflow conduit and the outflow conduit can allow for an appropriate or selected volume of CSF to be present in the brain to achieve a selected brain pressure within the skull. However, over a period of time, the inflow conduit or the outflow conduit may become clogged with material, requiring renovation to ensure proper or selected operation of the shunt system. Summary of the invention

[0005] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0006] The catheter can be positioned in a selected part of a subject, such as a cerebral ventricle of a human subject. The catheter can include a passage, such as a hole, through a selected portion of the catheter. In various embodiments, a through hole can be formed through the outer wall of the catheter. Thus, the catheter can include an elongated wall structure having one or more through holes formed therethrough.

[0007] The catheter may also include an internal cannula or channel to allow selected materials, such as liquids, to flow therethrough. In various embodiments, the catheter may allow the flow of cerebrospinal fluid (CSF). The catheter may be implanted as part of a shunt system to shunt or drain CSF from a first location to a second location.

[0008] The selected material may be positioned on at least a portion of the conduit, such as a portion including at least a plurality of through holes of the conduit. The selected material may be positioned on the conduit as a sleeve, membrane, or other suitable configuration. The covering material may be used as a filter or hole protection portion to assist or maintain a selected throughput of a flow through a hole formed in the conduit. Additionally, or alternatively, the covering may also be used as an ingrowth and / or encapsulation inhibitor. Thus, the covering may inhibit ingrowth and / or encapsulation in the hole and / or on the conduit.

[0009] Further areas of applicability will become apparent from the description provided herein.The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0011] Figure 1A and Figure 1B is a conduit having a filter material positioned above an inlet region according to various embodiments;

[0012] Figure 2 is a detailed view of the inlet area of ​​the duct and the filter material located thereon;

[0013] Figure 3 is an environmental schematic diagram of a shunt and system positioned within a subject according to various embodiments;

[0014] Figure 4A is a schematic diagram of an assembly of a conduit and a filter portion according to various embodiments; and

[0015] Figure 4B An assembly of a catheter and a filter portion according to various embodiments.

[0016] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0017] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0018] First reference Figure 1A and Figure 1B as well as Figure 2, a catheter 10 is shown. The catheter 10 includes a member or wall structure 12 that includes or defines an outer surface 14. The catheter 10 may include a selected length or be formed along a major or longitudinal axis 16. In various embodiments, the catheter 10 may be configured as an inlet or inlet catheter or portion for a hydrocephalus shunt. The hydrocephalus shunt may be constructed, such as formed, assembled and / or implanted to divert cerebrospinal fluid (CSF) from a location proximal to a first or inlet portion 20 to a second or distal end 24 (ie, distal end 24) at a location distal to the inlet end or portion 20. Figure 3 ).

[0019] The inlet portion 20 can be substantially located at or near the distal end or tip 22 of the catheter 10. Formed near the inlet end or through the inlet portion 20 can be a plurality of through holes 30. The plurality of through holes 30 can be formed through the outer surface 14 of the wall 12 and to the inner surface 34 through the wall 12. The inner surface 34 can define or form a passage 38. The passage 38 can be formed through the catheter 10 from the tip 22, or through the catheter 10 near the tip 22. The passage 38 can be formed as a cannula within the catheter 10. In various embodiments, as further discussed herein, the catheter 10 can be an inlet catheter and can be connected to a selected portion, as further discussed herein.

[0020] One or more of the inlet passages 30 of the inlet portion 20 may allow material to pass through the wall 12. Material may move from the external environment 40 through the passages 30 of the outer conduit wall 12 to the internal environment in the passages 38. Thus, material may move from the outside of the conduit 10 into the conduit 10.

[0021] The inlet portion 20 of the catheter may be formed from one or more layers, and the hole 30 may be formed completely therethrough. Thus, the passage 30 may be covered or protected by a covering or covering member 50. After the hole 30 is formed through the wall 12, the covering member 50 may be applied or assembled to the catheter 10.

[0022] Thus, the catheter 10 can be at least partially covered or encapsulated with a covering member 50. The covering member 50 can also be referred to as a filter 50. The filter 50 can include a material of a selected thickness (the distance between the outer surface in contact with the environment 40 and the inner surface closer to (e.g., in contact with) the catheter), such as about 0.001 millimeters (mm) to about 0.1 mm, and also includes about 0.004 mm to about 0.8 mm, and also includes about 0.004 mm to about 0.009 mm. The filter 50 can be formed in any suitable manner, such as formed as a tube, as described herein, to move and / or position on the catheter 10, such as on the outer surface 14 of the wall 12. However, as described herein, the filter 50 can also be formed as an elongated portion, which can be wrapped around the catheter 10, such as in a spiral manner, to extend along the length of the catheter 10. In various embodiments, the filter 50 is configured to cover at least a portion of the inlet region 20, including all. Therefore, the filter can be constructed and assembled to cover all holes 30 of the catheter 10.

[0023] The filter 50 may be formed of a suitable material, such as those comprising polytetrafluoroethylene (PTFE). In various embodiments, the material may be expanded polytetrafluoroethylene. The filter material may be selected or formed to allow a first selected material to pass through and enter the aperture 30 and inhibit or prevent a second selected material from entering the aperture 30. Exemplary materials include PTFE, PTFE, and PTFE, both sold by Zeus, Inc. and / or BioWeb TM Material.

[0024] The filter 50 includes one or more through holes or passages 54 formed through a wall or surface 56 of the filter 50. The through holes 54 may allow a selected material, such as a fluid including CSF, to pass through the through holes 54. However, the through holes 54 inhibit or prevent a second material, such as tissue, from passing through the filter 50.

[0025] Specific reference Figure 2 , which schematically illustrates a fluid 60 that may move in or around a filter 50 in an external environment 40. At a selected rate, the fluid 60 may move through the holes 54 generally in the direction of arrow 64. The fluid 60 may then be encapsulated between the filter 50 and the outer surface 14 of the conduit 10 and / or flow therebetween. As described above, the conduit 10, such as in the inlet region 20, includes one or more through-holes 30. Thus, the fluid 60 may flow generally in the direction of arrow 64 toward and through one or more of the through-holes 54. The liquid may flow generally in the direction of arrow 68 to pass through the through-holes 30 and enter the internal channel 38 of the conduit 10. Then, within the channel 38, the fluid may generally flow and may travel in a selected direction, such as generally in the direction of arrow 72.

[0026] Continue to refer to Figure 1A , Figure 1B and Figure 2 , and refer to Figure 3 , fluid 60 may flow along catheter 10, which may be an inlet catheter 10 from a ventricle 80 of a subject 84. As is generally understood by those skilled in the art, inlet catheter 10 may be positioned (i.e., implanted) in a ventricle to allow drainage of fluid 60 away from ventricle 80. Inlet catheter 10 may be part of a shunt system that includes a selected flow control system, such as valve 88.

[0027] The valve 88 may be implanted at an appropriate location within the subject 84. In various embodiments, the valve 88 may be implanted generally near the skull 92 of the subject 84, the torso of the subject 84, or any other appropriate location. It should be understood that the inlet conduit 10 may be connected to the valve 88, or any other appropriate flow control mechanism or system, such as a pump, an adjustable valve, a fixed valve, etc. Both the inlet conduit 10 and the valve 88 may be implanted within the subject 84.

[0028] The valve 88 may also be connected to an outlet catheter 96. The outlet catheter 96 may extend from the valve 88 to a selected location, such as a peritoneal cavity 98 of the subject 84. The inlet catheter 10, valve 88, and outlet catheter 96 may generally be understood as a shunt system, such as a hydrocephalus shunt system. The shunt system may be implanted entirely within the subject 84.

[0029] The fluid may flow through inlet catheter 10 in the direction of arrow 72, through valve 88, and through outlet catheter 96 generally in the direction of arrow 102. The fluid may then drain or pass through outlet catheter 96 into peritoneal cavity 98 or any other suitable location of subject 84. It should be appreciated that outlet catheter 96 may be positioned at a suitable location within subject 84 to allow CSF to be drained from ventricle 80 to a suitable location, such as a location with high blood flow. Thus, as shown in FIG. Figure 3 As shown, inlet catheter 10, valve 88 and outlet catheter 96 may be implanted or positioned within subject 84 as a CSF diversion system.

[0030] When positioned in the subject 84, the filter 50 can completely and / or substantially restrict the material that enters or moves into contact with the inlet area 20 including the through hole 30 in the fluid 60. In other words, the filter 50 can inhibit the passage or movement of non-fluid into the channel 30 of the catheter 10. Therefore, the filter 50 provides a physical barrier between the through hole 30 and the external environment 40. The inlet catheter 10 that can be positioned and fixed in the subject 84 can be positioned at an anatomical position. Therefore, the filter 50 can limit or eliminate the inward growth of solid or soft tissue through the filter 50 toward the catheter 10. Therefore, even for a period of time, such as including 5 years, more than 10 years, more than 20 years or an appropriate time, the through hole 30 will remain substantially open. Therefore, the filter 50 can extend the service life of at least the inlet catheter 10 and / or the entire shunt system.

[0031] Thus, the filter 50 allows the fluid 60 to pass through the filter 50 and through the through-holes 30 into the catheter 10. However, soft tissue or other tissue or particles having a diameter greater than the size of the through-holes 54 in the filter 50 do not enter the area or volume between the filter 50 and the catheter 10. Thus, the soft tissue or other tissue or particles do not grow into or enter the through-holes 30. Thus, the through-holes 30 can remain substantially open and unobstructed for draining CSF or fluid 60 for an extended period of time.

[0032] Continuing to refer to Figures 1 and Figure 2 , and refer to Figure 4A , the filter 50 may be formed as a tube having an outer wall 56 and a first end 120 and a second end 124. Figure 2 As shown, the filter 50 shaped as a tube may then be moved in the direction of arrow 128 to be positioned (ie, assembled) on the catheter 10 .

[0033] The filter 50 can be secured to the catheter 10 in a suitable manner, such as by a suitable securing member, adhesive, melting, welding, etc. For example, an adhesive material can be positioned near the second end 124 and near the first end 120 as a first respective adhesive strip or portion 130 and a second respective adhesive strip or portion 134. It should be understood that the adhesive strips or portions 130, 134 can be applied as a liquid, solid, etc., and can be disposed to substantially surround the catheter 10. Thus, the adhesive portions 130, 134 can seal the respective ends of the filter 50 relative to the inlet region 20, such as near the ends 120, 124. In various embodiments, the inlet region 20 is substantially and / or completely sealed relative to the external environment 40, except for the through-hole 30 of the filter 50.

[0034] In various embodiments, refer back to Figure 1B, a selected number of holes 30 may remain uncovered by the filter 50. For example, the holes 30 may be formed into a plurality of rows 30a, 30b, etc. spaced axially along the catheter 10. A selected number of holes 30, such as a selected number of rows (e.g., one or two rows) 30a, may remain open and / or uncovered by the filter 50. In other words, the filter may terminate at the end 50a shown in dashed lines. Therefore, those skilled in the art will appreciate that the filter will not need to cover all of the holes 30.

[0035] In various embodiments, the filter may be provided as a filter strip or portion 50' that may be wrapped around the catheter 10 to form a filtering structure on the catheter 10. Figure 4B As shown, filter material 50' can be wrapped around conduit 10. In order to wrap, filter material 50' can be formed or provided as an elongated member. Then, filter material 50' can be wound around the major axis 16 of conduit 10 roughly. In various embodiments, filter material 50' can be wrapped around conduit 10 in a circular or circular motion such as roughly along the direction of arrow 140. Filter material 50' can be wound to ensure the overlap and / or contact of the edge so that the filter material forms a complete coverage on channel 30. In various embodiments, the edge of the wrapper can also include adhesive to ensure sealing. Therefore, filter material 50' can be formed on or positioned on conduit 10 to form filter 50 on conduit 10. Similarly, filter 50 can be fixed to conduit 10, such as above inlet area 20, with suitable adhesive, physical connection, etc.

[0036] In summary, the inlet catheter 10 is provided with a filter 50 to minimize or eliminate the passage of materials other than the fluid 60 through or in contact with the catheter. As described above, the fluid 60 may include CSF surrounding the catheter 10 or in the external environment 40 relative to the catheter. Thus, the CSF may flow through the filter 50 into the internal passage 38 of the catheter 10 and be diverted to an appropriate location, such as the peritoneal cavity of the subject 84. Thus, the filter 50 may protect and eliminate non-liquid materials from growing inwardly or coming into contact with the catheter 10, particularly in the inlet region 20, and / or only in the inlet region 20, to extend the useful life of the catheter 10. In various embodiments, the filter material may be used as a protector to inhibit, including eliminating, material inward growth and / or encapsulation of the catheter by materials, such as tissue inward growth.

[0037] Exemplary embodiments are provided to make the present disclosure comprehensive and to fully convey its scope to those skilled in the art. Many specific details, such as examples of specific components, devices, and methods, are set forth to provide a thorough understanding of the embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that the exemplary embodiments may be embodied in many different forms, and should not be construed as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0038] For the purpose of illustration and description, the foregoing description of the embodiments has been provided. The foregoing description is not intended to be exhaustive or to limit the present disclosure. The individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in selected embodiments, where applicable, even if not specifically shown or described. The same element or feature may be varied in a variety of ways. Such variations should not be considered as departing from the present disclosure, and all such modifications are intended to be included within the scope of the present disclosure.

Claims

1. A hydrocephalus shunt system, comprising: an inlet portion having a length between a first end and a second end, wherein the inlet portion includes a wall defining a cannula and a plurality of first through-holes, the wall having an inner wall surface and an outer wall surface, the first through-holes extending from the outer wall surface to the inner wall surface and into the cannula, wherein each of the first through-holes defines a first interior dimension; an outlet portion extending away from the second end; as well as a filter member separate from the inlet portion and configured to extend over at least a portion of the inlet portion and cover at least one and less than all of the first through-holes, wherein the separate filter member includes a plurality of second through-holes formed through the separate filter member, wherein each of the second through-holes defines a second interior dimension that is less than the first interior dimension; The sizes and structures of the plurality of first through holes and the plurality of second through holes are set to: allow fluid to pass through the plurality of second through holes of the separated filter member and flow into the inlet portion axially along the outer wall surface of the inlet portion, and flow into the cannula through the plurality of first through holes of the inlet portion and flow to the outlet portion, and prevent solids from passing through the plurality of second through holes of the separated filter member.

2. The system according to claim 1, further comprising: A flow regulating portion is interposed between the inlet portion and the outlet portion.

3. The system of claim 1 , wherein the separated filter element comprises an outer wall having an outer surface and an inner surface, wherein each of the plurality of second through holes extends from the outer surface through the filter element to the inner surface, and the separated filter element is configured to allow fluid to flow into the outer surface of the separated filter element and flow to the inner surface. 4 . The system of claim 3 , wherein the plurality of second through-holes comprises a plurality of second through-holes formed along a length of the separate filter members. 5 . The system of claim 4 , wherein each of the second plurality of through-holes is configured to prevent tissue ingrowth.

6. The system of claim 4, wherein the second plurality of through holes are formed independently of the formation of the filter member.

7. The system according to any one of claims 1 to 6, further comprising: A fixing portion is configured to fix the filter member relative to the inlet portion.

8. The system of claim 7, wherein the securing portion is an adhesive applied to the first and second ends of the filter member and at the inlet portion, wherein the adhesive is applied in the form of a band around the inlet portion at the first and second ends.

9. The system of claim 7, wherein the fixed portion is a weld formed between the filter member and the inlet portion.

10. The system of claim 8, wherein the filter member is an elongated tube and is configured to slide over the inlet portion, wherein the adhesive is applied only to the first and second ends of the elongated tube to substantially cover the inlet portion at the first and second ends.

11. The system of any one of claims 1 to 6, wherein the filter member comprises an elongate member wrapped around the inlet portion.

12. The system of any one of claims 1 to 6, wherein the filter member is formed from a material comprising polytetrafluoroethylene.

13. A method of limiting ingrowth of material into a hydrocephalus shunt system according to claim 1, comprising: assembling the filter element onto the inlet portion; as well as The assembly of the filter member and the access portion is prepared for at least partial implantation within a subject.

14. A hydrocephalus shunt system, comprising: A catheter having: an inlet portion having a length between a first end and a second end, wherein the inlet portion of the catheter includes a wall defining a cannula and a plurality of first through-holes, the wall having an inner wall surface and an outer wall surface, the first through-holes extending from the outer wall surface to the inner wall surface and into the cannula, wherein each of the plurality of first through-holes defines a first interior dimension; and Export part, wherein the conduit is configured for fluid to flow into the conduit through at least one of the plurality of first through holes of the inlet portion and to the outlet; a filter member assembled over the inlet portion to cover at least one and less than all of the first through-holes, wherein the filter member includes a plurality of second through-holes, wherein each of the second through-holes defines a second interior dimension that is smaller than the first interior dimension; The sizes and configurations of the plurality of first through holes and the plurality of second through holes are configured to allow fluid to pass through at least one of the plurality of second through holes of the filter member, axially along the outer wall surface of the inlet portion, through the plurality of first through holes of the inlet portion, into the cannula and into the outlet portion, and prevent solids from passing through the hydrocephalus shunt system.

15. The system of claim 14, wherein the filter member is formed from polytetrafluoroethylene.

16. The system of claim 14, wherein the second interior dimension inhibits tissue ingrowth.

17. The system of claim 16, wherein the second interior dimension is selected to extend the useful life of the inlet portion.

18. The system of any one of claims 14 to 17, wherein the assembly of the filter member and the inlet portion is configured for implantation in a subject.

19. The system of claim 18, wherein the conduit is configured to be connected to a flow control system.

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